Clinical trial NCT03536884
Conditions: Chronic Plaque Psoriasis Moderate to Severe Chronic Plaque Psoriasis
Keywords: Bimekizumab PSO Psoriasis
Sponsor: UCB Biopharma SRL
Start date: 2018-06-13; Completion date: 2023-08-09
Enrollment: 743 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).

Detailed description:
The study consists of a 48-week double-blind Treatment Period, an optional 96-week open-label extension (OLE) Period and an optional 48-week OLE2 Period for eligible subjects in the USA and Canada.

Arms: arm 1: Subjects randomized to this arm will receive bimekizumab dosage regimen 1 (BKZ 1).

At Week 16 subjects will be re-randomized and continue to receive BKZ 1 or to switch to bimekizumab regimen 2 (BKZ 2).

Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period.

Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit.

Eligible subjects who completed OLE, have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2. arm 2: Subjects randomized to this arm will receive bimekizumab dosage regimen 2 (BKZ 2) starting at Week 16 after initial treatment on bimekizumab regimen 1 (BKZ 1) for 16 weeks.

Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period.

Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit.

Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2. arm 3: Subjects will receive secukinumab. Subjects allowed to enroll in the open-label extension (OLE) Period will be re-randomized to receive bimekizumab dosage regimen 1 (BKZ 1) or bimekizumab dosage regimen 2 (BKZ 2).

Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Interventions: intervention 1: Bimekizumab intervention 2: Secukinumab intervention 3: Placebo
Intervention descriptions: intervention 1: Subjects will receive bimekizumab at pre-specified time-points. intervention 2: Subjects will receive secukinumab at pre-specified time-points. intervention 3: Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.

Protocol documents:
Prot_000.pdf: 
UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 1 of 263
PROTOCOL PS0015 AMENDMENT 5.4
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND,
SECUKINUMAB-CONTROLLED, PARALLEL-GROUP STUDY 
TO EVALUATE THE EFFICACY AND SAFETY OF 
BIMEKIZUMAB IN ADULT SUBJECTS WITH MODERATE TO 
SEVERE CHRONIC PLAQUE PSORIASIS
PHASE 3b
EudraCT Number: 2017-003784-35
IND Number: 128707
Sponsor:
UCB Biopharma SRL
Allée de la Recherche 60
1070 Brussels
BELGIUM
Protocol/Amendment number
Date
Type of amendment
Final Protocol
26 Mar 2018
Not applicable
Protocol Amendment 1
17 Oct 2018
Substantial
Protocol Amendment 1.1 (US, Australia, Belgium, Poland, and 
Germany)
11 Jan 2019
Non-substantial
Protocol Amendment 2
06 May 2019
Substantial
Protocol Amendment 3
23 May 2019
Substantial
Protocol Amendment 3.1 (US, Australia, Poland, and Germany)
23 May 2019
Non-substantial
Protocol Amendment 4
06 Feb 2020
Non-substantial
Protocol Amendment 4.1 (US, Poland, and Germany)
12 Feb 2020
Non-substantial
Protocol Amendment 5
09 Jun 2020
Substantial
Protocol Amendment 5.1 (US)
09 Jun 2020
Not applicable
Protocol Amendment 5.2 (Poland and Germany)
18 Jun 2020
Substantial
Protocol Amendment 5.3 (Canada)
01 Oct 2021
Not applicable
Protocol Amendment 5.4 (US)
01 Oct 2021
Not applicable
Confidential Material
Confidential
This document is the property of UCB and may not – in full or in part – be passed on, 
reproduced, published, or otherwise used without the express permission of UCB.
PUBLIC 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 2 of 263
STUDY CONTACT INFORMATION
Sponsor
UCB Biopharma SRL
Allée de la Recherche 60
1070 Brussels, BELGIUM
Sponsor Study Physician
Name:
Address:
UCB Biopharma SRL
Chemin du Foriest
B-1420 Braine-l’Alleud
Belgium
Phone:
Fax:
Clinical Project Manager
Name:
Address:
UCB BIOSCIENCES GmbH
Alfred-Nobel-Str. 10
40789 Monheim
GERMANY
Phone:
Fax:
Clinical Trial Biostatistician
Name:
Address:
UCB
208 Bath Road, Slough, SL1 3WE, UK
Phone:
Fax:
PUBLIC 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 3 of 263
Clinical Monitoring Contract Research Organization
Name:
PAREXEL International (IRL) Limited-Ireland
Address:
Ireland Limited
70 Sir John Rogerson’s Quay
Dublin 2, IRELAND
Phone:
+353 (1) 477 3171
Fax:
+353 (1) 477 3308
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
ati
za
or
uth
application and any extensions or variations thereof. 


UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 4 of 263
SERIOUS ADVERSE EVENT REPORTING
Serious adverse event reporting (24h)
Fax
Europe and Rest of the World: +32 2 386 24 21
USA and Canada: +1 800 880 6949
or +1 866 890 3175
Email
Global: DS_ICT@ucb.com 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
ati
riz
tho
application and any extensions or variations thereof. 


UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 5 of 263
TABLE OF CONTENTS
LIST OF ABBREVIATIONS..................................................................................................12
1
SUMMARY.....................................................................................................................16
2
INTRODUCTION ...........................................................................................................18
2.1
Psoriasis .......................................................................................................................18
2.1.1
Global epidemiology of psoriasis ........................................................................19
2.1.2
Current treatments for psoriasis...........................................................................19
2.2
Bimekizumab...............................................................................................................21
2.2.1
Clinical.................................................................................................................22
2.2.1.1
Completed studies .....................................................................................22
2.2.1.2
Ongoing studies.........................................................................................23
2.2.2
Nonclinical...........................................................................................................23
3
STUDY OBJECTIVES....................................................................................................24
3.1
Primary objective.........................................................................................................24
3.2
Secondary objectives ...................................................................................................24
3.3
Other objectives ...........................................................................................................24
4
STUDY VARIABLES.....................................................................................................25
4.1
Primary efficacy variable.............................................................................................25
4.2
Secondary variables .....................................................................................................25
4.2.1
Secondary efficacy variables ...............................................................................25
4.2.2
Secondary safety variables ..................................................................................25
4.3
Other variables.............................................................................................................25
4.3.1
Other efficacy variables.......................................................................................25
4.3.2
Other safety variables ..........................................................................................26
4.3.3
Pharmacokinetic variable.....................................................................................27
4.3.4
Immunological variable.......................................................................................27
5
STUDY DESIGN.............................................................................................................27
5.1
Study description .........................................................................................................27
5.2
Study periods ...............................................................................................................27
5.2.1
Screening Period..................................................................................................28
5.2.2
Treatment Period .................................................................................................28
5.2.3
OLE Period ..........................................................................................................29
5.2.4
OLE2 Period ........................................................................................................30
5.2.5
Safety Follow-Up Periods....................................................................................30
5.2.6
Premature End of Treatment................................................................................31
5.3
Study duration per subject ...........................................................................................31
5.4
Planned number of subjects and sites ..........................................................................31
5.5
Anticipated regions and countries................................................................................32
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01 Oct 2021
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Bimekizumab
PS0015
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5.6
Schedule of study assessments.....................................................................................32
5.7
Schematic diagram.......................................................................................................44
5.8
Rationale for study design and selection of dose.........................................................46
5.8.1
Study design.........................................................................................................46
5.8.2
Dose selection......................................................................................................47
6
SELECTION AND WITHDRAWAL OF SUBJECTS...................................................47
6.1
Inclusion criteria ..........................................................................................................47
6.2
Exclusion criteria .........................................................................................................48
6.3
Eligibility for the OLE Period......................................................................................51
6.4
Eligibility for the OLE2 Period....................................................................................52
6.4.1
All subjects (OLE2 Groups A and B)..................................................................52
6.4.2
OLE2 Period Group A subjects ...........................................................................52
6.4.3
OLE2 Period Group B subjects ...........................................................................52
6.5
Withdrawal criteria ......................................................................................................54
6.5.1
Potential drug-induced liver injury IMP discontinuation criteria........................56
7
STUDY TREATMENTS.................................................................................................57
7.1
Description of investigational medicinal products ......................................................57
7.2
Treatments to be administered.....................................................................................58
7.3
Packaging.....................................................................................................................63
7.4
Labeling .......................................................................................................................63
7.5
Handling and storage requirements .............................................................................63
7.6
Drug accountability......................................................................................................64
7.7
Procedures for monitoring subject compliance............................................................64
7.8
Concomitant medications/treatments...........................................................................65
7.8.1
Permitted concomitant treatments (medications and therapies) ..........................65
7.8.1.1
Topical medications ..................................................................................65
7.8.1.2
Other medications......................................................................................65
7.8.2
Prohibited concomitant treatments (medications and therapies) .........................65
7.8.2.1
Vaccines ....................................................................................................67
7.9
Blinding........................................................................................................................67
7.9.1
Procedures for maintaining and breaking the treatment blind.............................68
7.9.1.1
Maintenance of IMP blind.........................................................................68
7.9.1.2
Breaking the treatment blind in an emergency situation...........................68
7.10
Randomization and numbering of subjects..................................................................68
8
STUDY PROCEDURES BY VISIT ...............................................................................69
8.1
Screening Visit (2 to 5 weeks).....................................................................................70
8.2
Treatment Period..........................................................................................................71
8.2.1
Baseline Visit.......................................................................................................71
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01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 7 of 263
8.2.2
Week 1 and Week 2 Visits (±3 days relative to Baseline)...................................72
8.2.3
Week 3 Visit (±3 days relative to Baseline) ........................................................73
8.2.4
Week 4 Visit (±3 days relative to Baseline) ........................................................73
8.2.5
Week 8 and Week 12 Visits (±3 days relative to Baseline) ................................74
8.2.6
Week 16 Visit (±3 days relative to Baseline) ......................................................75
8.2.7
Week 20 (±3 days relative to Baseline) and Week 28 Visits (±7 days relative to 
Baseline) ..............................................................................................................76
8.2.8
Week 24 Visit (±3 days relative to Baseline) ......................................................76
8.2.9
Week 32 Visit (±7 days relative to Baseline) ......................................................77
8.2.10
Week 36 Visit (±7 days relative to Baseline) ......................................................78
8.2.11
Week 40 Visit (±7 days relative to Baseline) ......................................................79
8.2.12
Week 44 Visit (±7 days relative to Baseline) ......................................................79
8.2.13
Week 48 Visit (±7 days relative to Baseline) ......................................................80
8.3
OLE Period ..................................................................................................................81
8.3.1
Week 48 Visit (±7 days relative to Baseline) ......................................................81
8.3.2
Week 52 Visit (±7 days relative to Baseline) ......................................................81
8.3.3
Week 56 Visit (±7 days relative to Baseline) ......................................................82
8.3.4
Self-injection at home (Weeks 60, 68, 76, 80, 88, 92, 100, 104, 112, 116, 124, 
128, 136, and 140) ...............................................................................................83
8.3.5
Week 64 (±7 days relative to Baseline), Week 84, Week 108, Week 132 Visits 
(±14 days relative to Baseline) ............................................................................83
8.3.6
Week 72 (±7 days relative to Baseline) and Week 120 Visits (±14 days relative 
to Baseline) ..........................................................................................................85
8.3.7
Week 96 Visit (±14 days relative to Baseline) ....................................................86
8.3.8
Week 144 Visit (±14 days relative to Baseline) ..................................................87
8.4
OLE2 Period ................................................................................................................89
8.4.1
OLE2 Screening (up to 4 weeks) – applicable for OLE2 Group B only.............89
8.4.2
OLE2 Baseline Visit............................................................................................90
8.4.3
Self-injection at home (OLE2 Weeks 4, 8, 16, 32, and 40).................................91
8.4.4
OLE2 Week 12, Week 24, and Week 36 Visits (±14 days relative to OLE2 
Baseline) ..............................................................................................................92
8.4.5
OLE2 Week 48 Visit (±14 days relative to OLE2 Baseline)...............................93
8.5
Premature End of Treatment Visit ...............................................................................94
8.6
Safety Follow-Up Visit (20 weeks after final dose up to Week 144, ±7 days) ...........94
8.7
Safety Follow-Up Visit 2 (20 weeks after final dose in the OLE2 Period, ±7 days)...95
8.8
Unscheduled Visit........................................................................................................95
9
ASSESSMENT OF EFFICACY......................................................................................95
9.1
Psoriasis Area Severity Index......................................................................................95
9.2
Investigator’s Global Assessment................................................................................96
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01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 8 of 263
9.3
Dermatology Life Quality Index..................................................................................97
9.4
Scalp IGA.....................................................................................................................97
9.5
mNAPSI.......................................................................................................................98
9.6
pp-IGA.........................................................................................................................98
9.7
European Quality-of-Life 5-Dimensions 3-Level Questionnaire ................................99
9.8
Patient Global Assessment of psoriasis .......................................................................99
9.9
Itch, pain, and scaling numerical rating scale..............................................................99
9.10
PASE questionnaire .....................................................................................................99
9.11
PGADA for arthritis visual analog scale ...................................................................100
9.12
Photographs................................................................................................................100
9.13
WPAI-SHP V2.0........................................................................................................100
10
ASSESSMENT OF PHARMACOKINETIC VARIABLES.........................................101
10.1
Pharmacokinetic variables .........................................................................................101
11
ASSESSMENT OF IMMUNOLOGICAL VARIABLES.............................................101
12
ASSESSMENT OF SAFETY........................................................................................101
12.1
Adverse events...........................................................................................................101
12.1.1
Definitions .........................................................................................................101
12.1.1.1
Adverse event..........................................................................................101
12.1.1.2
Serious adverse event ..............................................................................102
12.1.1.3
Adverse events of special interest ...........................................................103
12.1.1.4
Other safety topics of interest..................................................................103
12.1.2
Procedures for reporting and recording adverse events.....................................103
12.1.2.1
Description of adverse events..................................................................104
12.1.2.2
Rule for repetition of an adverse event....................................................104
12.1.2.3
Additional procedures for reporting serious adverse events ...................104
12.1.3
Follow up of adverse events ..............................................................................105
12.1.4
Pregnancy ..........................................................................................................105
12.1.5
Suspected transmission of an infectious agent via a medicinal product............106
12.1.6
Overdose of investigational medicinal product .................................................106
12.1.7
Safety signal detection.......................................................................................106
12.2
Laboratory measurements..........................................................................................107
12.2.1
Evaluation of PDILI ..........................................................................................108
12.2.1.1
Consultation with Medical Monitor and local hepatologist ....................112
12.2.1.2
Immediate action: determination of IMP discontinuation.......................112
12.2.1.3
Testing: identification/exclusion of alternative etiology.........................113
12.2.1.4
Follow-up evaluation...............................................................................115
12.3
Other safety measurements........................................................................................115
12.3.1
Assessment and management of TB and TB risk factors..................................115
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01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 9 of 263
12.3.1.1
Tuberculosis assessment by IGRA..........................................................118
12.3.1.2
Chest x-ray for tuberculosis ....................................................................118
12.3.1.3
Tuberculosis questionnaire......................................................................118
12.3.1.4
Tuberculosis management.......................................................................118
12.3.2
Pregnancy testing...............................................................................................119
12.3.3
Vital signs ..........................................................................................................119
12.3.4
12-lead electrocardiograms................................................................................120
12.3.5
Physical examination.........................................................................................120
12.3.6
Height and body weight.....................................................................................120
12.3.7
Assessment of suicidal ideation and behavior...................................................120
12.3.8
Patient Health Questionnaire-9..........................................................................120
12.4
Other study measurements.........................................................................................121
12.4.1
Demographic information..................................................................................121
12.4.2
Medical history ..................................................................................................121
12.4.3
Psoriasis history.................................................................................................121
12.4.4
Data Monitoring and Adjudication Committees................................................121
13
STUDY MANAGEMENT AND ADMINISTRATION...............................................121
13.1
Adherence to protocol................................................................................................121
13.2
Monitoring .................................................................................................................121
13.2.1
Definition of source data ...................................................................................122
13.2.2
Source data verification .....................................................................................122
13.3
Data handling.............................................................................................................123
13.3.1
Case Report Form completion...........................................................................123
13.3.2
Database entry and reconciliation......................................................................123
13.3.3
Subject Screening and Enrollment log/Subject Identification Code list............123
13.4
Termination of the study............................................................................................123
13.5
Archiving and data retention......................................................................................124
13.6
Audit and inspection ..................................................................................................124
13.7
Good Clinical Practice ...............................................................................................124
14
STATISTICS .................................................................................................................124
14.1
Definition of analysis sets..........................................................................................124
14.2
General statistical considerations...............................................................................125
14.3
Planned efficacy analyses ..........................................................................................126
14.3.1
Analysis of the primary efficacy variable..........................................................126
14.3.1.1
Sensitivity analyses .................................................................................127
14.3.2
Other efficacy analyses......................................................................................128
14.3.2.1
Analysis of the secondary efficacy variables ..........................................128
14.3.2.2
Analysis of the other efficacy variables ..................................................128
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Bimekizumab
PS0015
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14.4
Subgroup analyses .....................................................................................................130
14.5
Planned safety and other analyses..............................................................................130
14.5.1
Safety analyses...................................................................................................130
14.5.2
Pharmacokinetic analyses..................................................................................130
14.5.3
Immunogenicity analyses ..................................................................................130
14.6
Handling of protocol deviations.................................................................................130
14.7
Handling of dropouts or missing data........................................................................131
14.8
Planned interim analysis ............................................................................................132
14.9
Determination of sample size.....................................................................................132
15
ETHICS AND REGULATORY REQUIREMENTS....................................................132
15.1
Informed consent .......................................................................................................132
15.2
Subject identification cards........................................................................................133
15.3
Institutional Review Boards and Independent Ethics Committees............................133
15.4
Subject privacy...........................................................................................................134
15.5
Protocol amendments.................................................................................................134
16
FINANCE, INSURANCE, AND PUBLICATION.......................................................134
17
REFERENCES ..............................................................................................................134
18
APPENDICES ...............................................................................................................137
18.1
Protocol Amendment 1 ..............................................................................................137
18.2
Protocol Amendment 1.1 ...........................................................................................160
18.3
Protocol Amendment 2 ..............................................................................................161
18.4
Protocol Amendment 3 ..............................................................................................209
18.5
Protocol Amendment 3.1 ...........................................................................................209
18.6
Protocol Amendment 4 ..............................................................................................213
18.7
Protocol Amendment 5 ..............................................................................................217
18.8
Protocol Amendment 5.1 ...........................................................................................217
18.9
Protocol Amendment 5.4 ...........................................................................................230
19
DECLARATION AND SIGNATURE OF INVESTIGATOR .....................................262
20
SPONSOR DECLARATION ........................................................................................263
LIST OF TABLES
Table 5‒1:
Schedule of study assessments, Screening and double-blind Treatment 
Periods..............................................................................................................33
Table 5‒2:
Schedule of study assessments, OLE Period ...................................................37
Table 5-3:
Schedule of study assessments, OLE2 Period .................................................40
Table 7‒1:
Dosing scheme, double-blind Treatment Period..............................................59
Table 7‒2:
Dosing scheme, OLE Period............................................................................60
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Bimekizumab
PS0015
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Table 7‒3:
Dosing scheme, OLE2 Period..........................................................................62
Table 7‒4:
Prohibited psoriasis medications......................................................................66
Table 9‒1:
Body areas for calculation of percent BSA for PASI ......................................96
Table 9‒2:
Five-point IGA.................................................................................................97
Table 9‒3:
Scalp IGA.........................................................................................................98
Table 9‒4:
pp-IGA.............................................................................................................99
Table 12‒1:
Anticipated serious adverse events for the population of subjects with 
moderate to severe chronic plaque psoriasis..................................................103
Table 12‒2:
Laboratory measurements..............................................................................108
Table 12‒3:
Required investigations and follow up for PDILI..........................................110
Table 12‒4:
PDILI laboratory measurements....................................................................114
Table 12‒5:
PDILI information to be collected .................................................................115
LIST OF FIGURES
Figure 5‒1:
Schematic diagram, Screening and double-blind Treatment Period 
(through Week 48)...........................................................................................44
Figure 5‒2:
Schematic diagram, OLE Period (Week 48 through Week 144).....................45
Figure 12-1:
Schematic diagram of TB test results and study eligibility ...........................117
Figure 14‒1:
Hypothesis testing..........................................................................................126
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01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 12 of 263
LIST OF ABBREVIATIONS
AE
adverse event
AESI
adverse event of special interest
ALP
alkaline phosphatase
ALT
alanine aminotransferase
AST
aspartate aminotransferase
AUC
area under the curve
axSpA
axial spondyloarthritis
BA
bioavailability
BCG
Bacillus Calmette-Guerin
BP
blood pressure
BSA
body surface area
cAMP
cyclic adenosine monophosphate
CDC
Centers for Disease Control
CDMS
clinical data management system
CI
confidence interval
CMH
Cochran-Mantel-Haenszel
CPM
Clinical Project Manager
CPMP
Committee for Proprietary Medicinal Products
CRO
contract research organization
CSR
Clinical Study Report
CTCAE
Common Terminology Criteria for Adverse Events
DLQI
Dermatology Life Quality Index
DMC
Data Monitoring Committee
ECG
electrocardiogram
eCRF
electronic Case Report Form
eC-SSRS
electronic Columbia Suicide Severity Rating Scale
ePRO
Electronic Patient-Reported Outcome
EQ-5D-3L
European Quality-of-Life 5-Dimensions 3-Level
EudraCT
European Union Drug Regulating Authorities Clinical Trials
FAS
Full Analysis Set
GCP
Good Clinical Practice
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01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 13 of 263
GMP
Good Manufacturing Practice
HCV
hepatitis C virus
HCV Ab
hepatitis C antibody
HIV
human immunodeficiency virus
HLT
High Level Term
IB
Investigator’s Brochure
IBD
inflammatory bowel disease
ICF
Informed Consent Form
ICH
International Council for Harmonisation
IEC
Independent Ethics Committee
Ig
immunoglobulin
IGA
Investigator’s Global Assessment
IGRA
interferon-gamma release assay
IL
interleukin
IMP
investigational medicinal product
IND
Investigational New Drug
IRB
Institutional Review Board
IRT
interactive response technology
iv
intravenous(ly)
LOCF
last observation carried forward
LTB
latent tuberculosis
LTBI
latent tuberculosis infection
mAb
monoclonal antibody
MI
multiple imputation
mNAPSI
Modified Nail Psoriasis Severity Index 
MS
Maintenance Set
NRI
nonresponder imputation
NSAID
nonsteroidal anti-inflammatory drug
NTMB
nontuberculous mycobacterium
OLE
open-label extension
OL2S
OLE2 Period Set
OLS
Open-Label Set
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01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 14 of 263
PASE
Psoriatic Arthritis Screening and Evaluation
PASI
Psoriasis Area Severity Index
PD
pharmacodynamic(s)
PDE
phosphodiesterase 
PDILI
potential drug-induced liver injury
PEOT
Premature End of Treatment
PFS
prefilled syringe
PGADA
Patient's Global Assessment of Disease Activity
PHQ-9
Patient Health Questionnaire-9
PK
pharmacokinetic(s)
PK-PPS
Pharmacokinetics Per-Protocol Set
pp-IGA
palmoplantar Investigator’s Global Assessment
PPS
Per-Protocol Set
PS
Patient Safety
PsA
psoriatic arthritis
PSO
psoriasis
PT
preferred term
Q4W
every 4 weeks
Q8W
every 8 weeks
QOL
quality of life
RS
Randomized Set
SAE
serious adverse event
SAP
Statistical Analysis Plan
sc
subcutaneous(ly)
scalp IGA
scalp-specific Investigator’s Global Assessment
SFU
Safety Follow-Up
SOP
Standard Operating Procedure
SS
Safety Set
TB
tuberculosis
TEAE
treatment-emergent adverse event
TNF
tumor necrosis factor
ULN
upper limit of normal
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01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 15 of 263
VAS
visual analog scale
WPAI-SHP
Work Productivity and Activity Impairment Questionnaire-specific 
health problem
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof. 


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01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 16 of 263
1
SUMMARY
This is a Phase 3b, multicenter, randomized, double-blind, active comparator-controlled, 
parallel-group study to evaluate the efficacy and safety of bimekizumab compared with 
secukinumab in adult subjects with moderate to severe chronic plaque psoriasis (PSO).
The study population consists of adult subjects (≥18 years of age) with a diagnosis of moderate 
to severe chronic plaque PSO (Baseline Psoriasis Area Severity Index [PASI] score ≥12 and 
body surface area [BSA] affected by PSO ≥10% and Investigator’s Global Assessment [IGA] 
score ≥3 [on a 5-point scale]) who are a candidate for secukinumab, or for systemic PSO therapy 
and/or phototherapy.
Approximately 935 subjects will be screened in order to have 700 subjects randomized in the 
study. For each subject, the study will last a maximum of 165 weeks and will consist of 
5 periods: a Screening Period (2 to 5 weeks), a double-blind Treatment Period (48 weeks; final 
dose at Week 44), an Open-Label Extension (OLE) Period (96 weeks; final dose at Week 136 for 
subjects receiving bimekizumab 320mg Q8W and at Week 140 for subjects receiving 
bimekizumab 320mg Q4W) followed by a Safety Follow-Up (SFU) Period (20 weeks after the 
final dose of investigational medicinal product [IMP] depending on subject’s participation in the 
second OLE Period [OLE2 Period]; see paragraph below). 
Subjects participating in the OLE2 Period (implemented as part of Protocol Amendment #5.4)
will enter the OLE2 Period after completing the OLE Period (at Week 144), including subjects in 
the SFU period and subjects who have completed the SFU Period. The OLE2 Period will be a 
48-week treatment period with final visit at OLE2 Week 48, followed by a SFU Period (SFU2, 
20 weeks after the final dose of IMP administered in the OLE2 Period). 
During the first 16 weeks of the double-blind Treatment Period, eligible subjects will be 
randomized 1:1 to receive one of the following blinded IMP regimens:
x
Bimekizumab 320mg administered subcutaneously (sc) every 4 weeks (Q4W)
x
Secukinumab 300mg administered sc at Baseline and Weeks 1, 2, 3, and 4 followed by 
dosing Q4W
Subjects receiving bimekizumab 320mg will receive placebo sc on Weeks 1, 2, and 3 in order to 
maintain the blind. 
Approximately 350 subjects will be randomized to bimekizumab 320mg and approximately 
350 subjects will be randomized to secukinumab. Investigational medicinal product will be 
administered at Baseline, Weeks 1, 2, 3, and 4 and then Q4W thereafter, until Week 44 (double-
blind Treatment Period). All doses will be administered in the clinic.
At Week 16 subjects in the bimekizumab 320mg treatment arm will be re-randomized 1:2 to 
receive bimekizumab 320mg Q4W or bimekizumab 320mg every 8 weeks (Q8W). To maintain 
the blind after re-randomization, subjects in the bimekizumab 320mg Q8W treatment arm will 
receive placebo at Weeks 20, 28, 36, and 44. Subjects in the secukinumab arm will continue to 
receive secukinumab 300mg Q4W.
At the completion of the Week 48 visit assessments, subjects may receive open-label 
bimekizumab treatment for an additional 96 weeks during the OLE Period. All subjects enrolling 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 17 of 263
in the OLE Period will, after signing a new ICF, be evaluated for eligibility, be randomized, and 
receive their first dose of bimekizumab in the OLE Period. 
During the OLE Period, eligible subjects will receive the following IMP regimens as determined 
by the subject’s treatment regimen and PASI response in the double-blind Treatment Period. 
At Week 48, subjects receiving:
x
Bimekizumab 320mg Q4W who achieve PASI90 at Week 48 of the double-blind Treatment 
Period will be randomized 1:1 to receive bimekizumab 320mg Q4W or bimekizumab 320mg 
Q8W.
x
Bimekizumab 320mg Q4W who do not achieve PASI90 at Week 48 of the double-blind 
Treatment Period will receive bimekizumab 320mg Q4W.
x
Bimekizumab 320mg Q8W who do not achieve PASI90 at Week 48 of the double-blind 
Treatment Period will receive bimekizumab 320mg Q4W.
x
Bimekizumab 320mg Q8W who achieve PASI90 at Week 48 of the double-blind Treatment 
Period will receive bimekizumab 320mg Q8W.
x
Secukinumab who do not achieve PASI90 at Week 48 of the double-blind Treatment Period
will receive bimekizumab 320mg Q4W.
x
Secukinumab who achieve PASI90 at Week 48 of the double-blind Treatment Period will be 
randomized 1:1 to receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W.
During the OLE Period, subjects will attend study visits at Weeks 52, 56, 64, and 72, and then 
every 12 weeks. 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 64 or at the next scheduled clinic visit after implementation 
of Protocol Amendment #5.1 if the subject has already completed Week 64.
All subjects not enrolling in the OLE Period will have the Week 48 study assessments and will 
enter the SFU Period.
Subjects withdrawing early from the study will undergo the Premature End of Treatment (PEOT) 
Visit assessments and will enter the SFU Period.
After the implementation of Protocol Amendment #5.4 (addition of a 48-week treatment period, 
ie, OLE2 Period), subjects will be invited to continue or reinitiate their treatment as per the 
following OLE2 Groups:
x
OLE2 Group A: Subjects in the treatment phase of the OLE Period at the time of Protocol 
Amendment #5.4 implementation will attend the Week 144 Visit and directly roll over to the 
OLE2 Period. These subjects will continue receiving bimekizumab 320mg Q8W for 
40 additional weeks, starting from the first treatment visit of the OLE2 Period (ie, Week 
144/OLE2 Baseline Visit; the Week 144 Visit will coincide with the Week 144/OLE2 
Baseline Visit and data collected at this visit will be used as baseline data for subjects 
entering the OLE2 Period).
x
OLE2 Group B: Eligible subjects who have completed the Week 144 Visit and are in the 
SFU or have completed the SFU of the OLE Period at the time of Protocol Amendment #5.4
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 18 of 263
implementation, will reinitiate their treatment in the OLE2 Period after having undergone 
Screening assessments during a 4-week OLE2 Screening Period. The first dose will be 
administered at the Week 144/OLE2 Baseline Visit and data collected at this visit will be 
used as baseline data for the OLE2 Period. Subjects in OLE2 Group B with an IGA score ≥3 
at the Week 144/OLE2 Baseline Visit will be treated with bimekizumab Q4W for the first 16 
weeks, and then will switch to bimekizumab 320mg Q8W. Subjects in OLE2 Group B with 
an IGA score <3 at the Week 144/OLE2 Baseline Visit will be treated with bimekizumab 
Q8W from the Week 144/OLE2 Baseline Visit.
During the OLE2 Period (Week 144/OLE2 Baseline to OLE2 Week 48), all subjects will attend 
study visits every 12 weeks. All subjects will be treated until OLE2 Week 40 (last dose of 
bimekizumab 320mg Q8W).
Following completion or early withdrawal from the OLE2 Period, subjects will undergo the SFU 
of the OLE2 Period (SFU2) and will return for the SFU2 Visit 20 weeks after the last dose of 
IMP administration.
The primary objective of the study is to compare the efficacy of bimekizumab administered sc 
for 16 weeks versus secukinumab at achieving complete clearance (PASI100) in subjects with 
moderate to severe chronic plaque PSO. The secondary objectives of the study are listed in 
Section 3.2.
The primary efficacy variable is the PASI100 response, defined as complete clearance from 
Baseline in the PASI score, at Week 16. The secondary efficacy variables are listed in 
Section 4.2.
Pharmacokinetic variables are listed in Section 4.3.3. The immunological variable is listed in 
Section 4.3.4.
Pharmacokinetic and immunological variables will be evaluated to assess their relationship to 
treatment response.
Safety variables to be assessed are adverse events (AEs), vital signs, electrocardiograms (ECGs), 
and measurements of laboratory parameters.
2
INTRODUCTION
2.1
Psoriasis
Psoriasis is a common, chronic inflammatory disease characterized by a series of linked cellular 
changes in the skin: hyperplasia of epidermal keratinocytes, vascular hyperplasia and ectasia, and 
infiltration of T-lymphocytes, neutrophils, and other types of leukocytes in affected skin. Though 
the pathophysiology of PSO is not fully understood, the importance of T-cells and inflammatory 
cytokines has been demonstrated by the clinical benefit provided by therapies directed at these 
targets (Krueger and Ellis, 2005).
There are a variety of forms of PSO including plaque, guttate, inverse, pustular, and 
erythrodermic. Plaque PSO is the most common, comprising approximately 80% to 90% of all 
cases. Approximately 17% of those with PSO have moderate to severe disease 
(Kurd et al, 2008).
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In addition to the impact on skin, PSO has a multitude of psychosocial and emotional effects on 
patients, including increased self-consciousness, frustration, fatigue, depression, and suicidal 
ideation. As a result, patients frequently report sleeping problems, difficulties at work, problems 
interacting with family members, disrupted leisure activities, and sexual difficulties 
(Dowlatshahi et al, 2014; Gottlieb, 2005; Mukhtar et al, 2004; Ortonne, 2004; 
Krueger et al, 2001).
A number of comorbidities have been associated with PSO, especially with more severe PSO. 
Psoriatic arthritis (PsA), cardiovascular disease, metabolic syndrome, chronic pulmonary 
disease, peptic ulcer disease, renal disease, and diabetes have all been demonstrated to have an 
increased prevalence in PSO patients (Yeung et al, 2013; Christophers et al, 2010;
Gisondi et al, 2007; Gelfand et al, 2006).
2.1.1
Global epidemiology of psoriasis
Psoriasis affects approximately 3% of the US adult population (Rachakonda et al, 2014;
Kurd and Gelfand, 2009) and its onset can begin at any age (Augustin et al, 2010;
Icen et al, 2009). The reported worldwide incidence and prevalence of PSO varies greatly 
depending on age, gender, ethnicity, and geography primarily due to genetic and environmental 
factors. Estimates of incidence and prevalence include all types of PSO. Plaque PSO is the most 
common form of the disease; therefore, reported estimates of the magnitude of this condition are 
likely weighted heavily by this subtype. Both the incidence and prevalence of PSO are higher 
among Caucasians and those living at higher latitudes. Psoriasis affects approximately 2% to 4% 
of the population of western countries. Geographical differences are also influenced by case 
definition, study design, and the definition of prevalence (Parisi et al, 2013; Langley et al, 2005;
Raychaudhuri and Gross, 2000).
2.1.2
Current treatments for psoriasis
Therapy for patients with PSO varies according to the severity of disease. Limited or mild 
disease is often treated with topical therapies such as corticosteroids and vitamin D analogs. 
Patients with more severe disease are often treated with phototherapy, methotrexate, 
cyclosporine, the oral phosphodiesterase (PDE) 4 inhibitor apremilast, or biologic agents, such as 
tumor necrosis factor (TNF) antagonists, interleukin (IL) 12/23 inhibitors, IL-23p19 inhibitors, 
and IL-17A inhibitors. The effectiveness of TNF inhibitors in the treatment of PSO has been 
demonstrated in many Phase 3 clinical studies and has led to the approval of multiple TNF 
inhibitors for use in patients with moderate to severe PSO. Interleukin inhibitors approved for 
this indication include the IL-12/23 antagonist ustekinumab, the IL-23p19 antagonist 
guselkumab, the IL-17A inhibitors secukinumab and ixekizumab, and the IL-17 receptor 
antagonist brodalumab. 
Standard therapies for PSO are listed below:
x
Topical steroids (eg, triamcinolone, mometasone, clobetasol, betamethasone, and 
hydrocortisone) are generally used as first-line treatment of PSO. High-strength steroids are 
typically reserved for use on the arms and legs. Areas such as the face and skin folds 
(axillary, inguinal regions, etc) are usually treated with a low-potency steroid. Chronic use of 
topical steroids can lead to corticosteroid-related side effects and is generally discouraged.
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UCB
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x
Vitamin D analogs (eg, calcipotriol and tacalcitol) are commonly used to treat 
mild-to-moderate PSO, and work best within the mild patients. They are safe but lack 
efficacy for more severe disease.
x
Phototherapy is a frequent option for moderate to severe patients, but the inconvenience of 
multiple treatment visits and varying efficacy limits its use in the market.
x
Methotrexate is a systemic immunosuppressant and is used in moderate to severe PSO 
patients. Toxicity concerns, particularly in older patients, are a major drawback.
x
Cyclosporine is a systemic immunosuppressant used in patients with severe, recalcitrant PSO 
who have failed at least one systemic therapy or in whom other systemic therapies are 
contraindicated. In recommended dosages cyclosporine can cause systemic hypertension and 
nephrotoxicity, therefore, renal function must be monitored during therapy.
x
Apremilast is an oral small-molecule inhibitor of PDE4 that is also approved for treatment of 
adults with moderate to severe plaque PSO. Phosphodiesterase 4 inhibitors work 
intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators. 
Phosphodiesterase 4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the 
dominant PDE in inflammatory cells. Phosphodiesterase 4 inhibition elevates intracellular 
cAMP levels, which in turn down-regulates the inflammatory response by modulating the 
expression of TNFα, IL-23, IL-17, and other inflammatory cytokines.
x
Biologics, including TNFα inhibitors (adalimumab, etanercept, and infliximab), 
IL-12/23 inhibitors (ustekinumab), the IL-23p19 antagonist (guselkumab), IL-17A inhibitors 
(secukinumab and ixekizumab), and the IL-17 receptor antagonist brodalumab are the 
treatment options of choice for patients with moderate to severe plaque PSO who are 
candidates for systemic therapy or phototherapy. These products are injected sc or delivered 
via intravenous (iv) infusion. Different from the traditional systemic drugs that impact the 
entire immune system, biologics target specific parts of the immune system and offer reduced 
multi-organ toxicity and adverse effects associated with traditional treatments.

TNFα inhibitors, while effective, come with boxed warnings including the risk of serious 
infections and reports of lymphoma and malignancy in children and adolescent patients. 
The efficacy of TNFα inhibitors in treating PSO is attributed to their inhibition of 
Th17-T cells.

Ustekinumab has been approved in the US and the EU for the treatment of patients with 
moderate to severe plaque psoriasis who are candidates for phototherapy or systemic 
therapy. Ustekinumab is a human immunoglobulin (Ig) G1κ monoclonal antibody (mAb) 
that binds with specificity to the p40 protein subunit used by both the IL-12 and IL-23
cytokines, naturally occurring cytokines that are involved in inflammatory and immune 
responses, such as natural killer cell activation and CD4+ T-cell differentiation and 
activation.

Secukinumab and ixekizumab have been approved in the US and the EU for the treatment 
of moderate to severe plaque PSO in adult patients who are candidates for systemic 
therapy or phototherapy. Secukinumab is a human IgG1 mAb that selectively binds to the 
IL-17A cytokine and inhibits its interaction with the IL-17 receptor. Ixekizumab is a 
humanized IgG4 mAb that selectively binds with the IL-17A cytokine and inhibits its 
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UCB
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interaction with the IL-17 receptor. Interleukin-17A is a naturally occurring cytokine that 
is involved in normal inflammatory and immune responses. Both drugs inhibit the release 
of pro-inflammatory cytokines and chemokines.
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Guselkumab has been approved in the US and EU for the treatment of adult patients with 
moderate to severe plaque PSO who are candidates for systemic therapy or phototherapy. 
It is a human monoclonal IgG1λ antibody that selectively binds to the p19 subunit of 
IL-23 and inhibits its interaction with the IL-23 receptor. Interleukin-23 is a naturally 
occurring cytokine that is involved in normal inflammatory and immune responses. 
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Brodalumab has been approved in the US for the treatment of moderate to severe plaque 
psoriasis in adult patients who are candidates for systemic therapy or phototherapy and 
have failed to respond or have lost response to other systemic therapies. In the EU, 
brodalumab is indicated for the treatment of moderate to severe plaque PSO in adult 
patients who are candidates for systemic therapy. Brodalumab is a human monoclonal 
IgG2 antibody that selectively binds to human IL-17RA and inhibits its interactions with 
cytokines IL-17A, IL-17F, IL-17C, IL-17A/F heterodimer, and IL-25. Blocking IL-17RA 
inhibits IL-17 cytokine-induced responses including the release of pro-inflammatory 
cytokines and chemokines. Brodalumab has a black box warning regarding suicidal 
ideation and behavior.
2.2
Bimekizumab
Bimekizumab (UCB4940) is an engineered, humanized, full-length mAb of IgG1 subclass of 
approximately 150,000 Daltons which is expressed in a genetically engineered Chinese hamster 
ovary cell line. Bimekizumab has high affinity for human IL-17A and human IL-17F and 
selectively and potently inhibits the activity of both isoforms in vitro. Interleukin-17A and 
IL-17F are key pro-inflammatory cytokines believed to play important roles in autoimmune and 
inflammatory diseases. Bimekizumab is being developed for the treatment of patients with 
inflammatory diseases such as PsA, PSO, and axial spondyloarthritis (axSpA).
While anti-IL-17A antibodies have demonstrated efficacy in patients with PSO, PsA, and 
ankylosing spondylitis, as yet, no therapeutic approach selectively and potently inhibits the 
activity of both IL-17A and IL-17F isoforms in vitro. Bimekizumab has been designed to inhibit 
the activity of IL-17A and IL-17F subtypes of IL-17. This property makes bimekizumab 
distinctly different from the other IL-17-targeting agents, like secukinumab and ixekizumab 
(selective anti-IL-17-A mAb) or brodalumab (anti-IL-17 receptor mAb).
Overexpression of IL-17A, IL-17C, and IL-17F in lesion tissue suggests that broader IL-17
blockade may be more beneficial in the treatment of plaque PSO. However, blocking all IL-17
isoforms (including the IL-17E isoform, also known as IL-25) may not be the optimal approach. 
The role of IL-25 in PSO and other IL-17 mediated diseases has not been well established; 
however, it has been suggested that IL-25 may play a beneficial role in inflammatory conditions 
associated with type 1 T helper mediated immune responses, such as PSO (as opposed to type 2
T helper mediated) (Valizadeh et al, 2015). Thus, it can be hypothesized that inhibition of both 
IL-17A and IL-17F is associated with additional benefits in PSO compared with selective 
IL-17A inhibition or a broader IL-17 blockade.
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UCB
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2.2.1
Clinical
2.2.1.1
Completed studies
Five clinical studies of bimekizumab have been completed: UP0008 in 39 subjects with mild to 
moderate plaque PSO, RA0124 in 30 healthy volunteers, PA0007 in 53 subjects with PsA, 
UP0031 in 12 healthy volunteers, and UP0042 in 48 healthy volunteers. 
UP0008 was a Phase 1, single ascending dose study in adults with mild-to-moderate PSO 
affecting ≤5% BSA. In this blinded study, single doses of up to 640mg (approximately 8mg/kg 
in an 80kg adult) were evaluated without any safety concerns. A total of 26 subjects with PSO 
with less than 5% of body surface involvement were treated with a range of single iv doses from 
8mg to 640mg. There were no clinically relevant safety findings identified at any dose and all 
doses were well tolerated. The pre-specified exploratory assessment of disease activity showed 
clinically relevant and statistically significant improvements at the higher doses studied.
RA0124 was a Phase 1, open-label, parallel-group, single-dose study in healthy subjects. The 
primary objective of this study was to determine the absolute bioavailability (BA) of single sc 
doses of bimekizumab (80mg and 160mg). The secondary objectives were to evaluate the dose 
proportionality of bimekizumab 80mg and 160mg sc, and to evaluate the safety and tolerability 
of these sc doses and 160mg given by iv infusion. In RA0124, the absolute BA was similar for 
the 2 doses tested (0.656 and 0.631 for the bimekizumab 80mg and 160mg sc doses, 
respectively). The pharmacokinetics (PK) of bimekizumab was linear in the tested dose range 
and the median half-life following sc administration was similar to that following iv 
administration (27.81 days and 28.25 days for bimekizumab 160mg sc and 160mg iv, 
respectively).
Bimekizumab has also been investigated in a Phase 1b, proof of concept, randomized, placebo 
controlled, multiple dose study (PA0007). The primary objective of PA0007 was to assess the 
safety and PK of multiple dose administration of iv bimekizumab in subjects with PsA. Four 
active doses and a placebo were tested. Drug was administered as a loading dose at Week 0, and 
2 additional doses were administered at Week 3 and Week 6. In each treatment group, subjects 
received a total of 3 doses of bimekizumab, administered every 3 weeks as shown below:
x
80mg loading dose followed by 40mg at Weeks 3 and 6
x
160mg loading dose followed by 80mg at Weeks 3 and 6
x
240mg loading dose followed by 160mg at Weeks 3 and 6
x
560mg loading dose followed by 320mg at Weeks 3 and 6
The results of this study demonstrated that all doses of bimekizumab were well tolerated and 
there were no unexpected clinically relevant safety findings.
Infections (mostly nasopharyngitis) were the most commonly reported events in both the active 
treatment and the placebo group. None of the infections were considered serious or required 
treatment with antibiotics. Two subjects in the active treatment group experienced 1 local 
candida infection each (oropharyngitis and vulvovaginitis, respectively) that were nonserious and 
resolved with topical therapy. There was a potential reduction in mean neutrophil count in the 
active treatment group, although this drop was not clinically relevant and a clear relationship 
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UCB
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Bimekizumab
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with dose or time was not evident. Some increases in liver function tests were reported, but none 
had a convincing relationship to exposure to IMP. The exploratory analysis showed clinically 
relevant improvement in activity of PsA and in skin involvement in those subjects with 
concomitant active psoriatic lesions.
UP0031 was a Phase 1, open-label, parallel-group, randomized, single-dose study to evaluate the 
BA, PK, and tolerability of 2 different formulations of bimekizumab in healthy subjects. Subjects 
receiving Formulation A (histidine-based) were administered two 1mL injections of 80mg each 
of bimekizumab and subjects receiving Formulation B (acetate-based) were administered a 
single injection of bimekizumab 160mg given as a 1mL injection. Six subjects were randomized 
to each bimekizumab formulation. The geometric means for area under the curve (AUC) were 
similar between bimekizumab 2x80mg and 1x160mg groups and the relative BA for 
Formulation B vs Formulation A was 96.1% (95% confidence interval [CI]: 72.7%, 127.0%). 
Administration of the 2 formulations of bimekizumab used in this study identified no new safety 
issues. There were no treatment-emergent adverse events (TEAEs) leading to discontinuation, 
and no serious adverse events (SAEs) or fatalities were reported. The only preferred term (PT) 
experienced by more than 1 subject in either treatment group was injection site pain (5 subjects 
[83.3%] and 3 subjects [50%] in the 2x80mg and 1x160mg groups, respectively). The most 
frequently reported TEAE considered related to the IMP was injection site pain, experienced by 
5 subjects (83.3%) and 3 subjects (50.0%) in the 2x80mg and 1x160mg groups, respectively. 
There were no clinically significant laboratory values reported in the study.
UP0042 was a randomized double-blind, placebo-controlled, single-dose, parallel-group study to 
evaluate the safety, tolerability, and pharmacokinetics of bimekizumab administered as 
subcutaneous injection to Japanese and Caucasian healthy subjects. This study demonstrated that 
the PK profiles following single administration of 80mg, 160mg, and 320mg with sc injection 
were dose proportional with a linear elimination in both Japanese and Caucasian subjects and 
that the PK profiles of Japanese and Caucasian subjects were considered to be generally similar. 
A single dose of bimekizumab (80mg, 160mg, or 320mg) administered as sc injection was 
generally 
and well tolerated in healthy Japanese and Caucasian subjects and no major 
differences in safety findings were observed between Japanese and Caucasian subjects.
Additional information on completed studies is available in the Investigator’s Brochure (IB).
2.2.1.2
Ongoing studies
All ongoing studies at the time of Protocol Amendment #5.4 implementation are presented and 
described in the current version of the IB.
2.2.2
Nonclinical
Parallel inhibition of IL-17A and IL-17F has been shown to be efficacious in a variety of animal 
models of inflammatory disease. Intravenously administered bimekizumab was well tolerated in 
repeat dose toxicology studies in Cynomolgus monkeys with a no adverse effect level of 
200mg/kg/week. The findings of note in toxicity studies were diarrhea related to infectious 
enteritis (observed in the single dose study) and asymptomatic mild colonic ulceration in a 
proportion of animals (in the repeat dose study); this latter finding was not associated with 
hematology abnormalities. Data suggest that bimekizumab has induced primary lesions to the 
mucosa associated lymphoid tissue via a pharmacologically related mechanism. In a second 
repeat-dose study, none of the minor apoptosis/necrosis findings observed in gut associated 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 24 of 263
lymph nodes were revealed. In animals given the highest dose of bimekizumab in the study 
(20mg/kg/week), a slightly higher number of protozoa (Balantidium coli) was observed in the 
cecum and colon as compared to the control animals and low dose animals. Therefore, gut 
associated lymph node lesions observed in the first study are considered to be accidental and/or 
linked to exaggerated pharmacology and proliferation of Balantidium coli and are considered the 
consequence of a change in local mucosal immunity. To date, similar findings have not been 
seen in studies in humans.
Additional information on the nonclinical data for bimekizumab is available in the current 
version of the IB.
3
STUDY OBJECTIVES
3.1
Primary objective
The primary objective of this study is to compare the efficacy of bimekizumab administered sc 
for 16 weeks versus secukinumab at achieving complete clearance (PASI100) in subjects with 
moderate to severe chronic plaque PSO.
3.2
Secondary objectives
The secondary objectives of the study are to:
x
Evaluate the efficacy of bimekizumab compared with secukinumab after 4 weeks, 16 weeks, 
and 48 weeks of treatment.
x
Assess TEAEs, SAEs, and TEAEs leading to withdrawal adjusted by duration of subject 
exposure to IMP.
3.3
Other objectives
The other objectives of the study are to demonstrate the effects of bimekizumab on the following 
aspects of the disease:
x
Assess the efficacy of bimekizumab over time
x
Assess the change of skin-related quality of life (QOL)
x
Assess the change of general health-related QOL
x
Assess the change in nail PSO over time in subjects with nail PSO at Baseline
x
Assess the change in psoriatic scalp disease over time in subjects with scalp PSO at Baseline
x
Assess the change in psoriatic palmoplantar disease over time in subjects with palmoplantar 
PSO at Baseline
x
Assess the change in patient global assessment PSO score
x
Assess the change in symptoms of PSO (itch, pain, and scaling) as reported by subjects 
x
Assess work productivity status
x
Assess the safety and tolerability of bimekizumab
x
Assess the PK of bimekizumab
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 25 of 263
x
Assess the immunogenicity of bimekizumab
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Assess the maintenance of efficacy of bimekizumab dosing Q4W versus Q8W
x
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secukinumab in the double-blind Treatment Period
4
STUDY VARIABLES
4.1
Primary efficacy variable
The primary efficacy variable is the PASI100 response, defined as complete clearance from 
Baseline in the PASI score, at Week 16.
4.2
Secondary variables
4.2.1
Secondary efficacy variables
The secondary efficacy variables are:
x
PASI75 response at Week 4
x
PASI90 response at Week 16
x
PASI100 response at Week 48
x
IGA response (0/1) (defined as Clear or Almost Clear with at least a 2-category improvement 
relative to Baseline) at Week 16
4.2.2
Secondary safety variables
The secondary safety variables are:
x
TEAEs adjusted by duration of subject exposure to IMP
x
SAEs adjusted by duration of subject exposure to IMP
x
TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment
4.3
Other variables
The other variables are listed below and will be evaluated according to the planned assessments 
(Table 5‒1, Table 5‒2, and Table 5-3).
4.3.1
Other efficacy variables
The other efficacy variables are listed below and will be evaluated according to the planned 
assessments (Table 5‒1, Table 5‒2, and Table 5-3). This excludes the time points for the primary 
and secondary variables specified above in Section 4.1 and Section 4.2.1, respectively.
The other efficacy variables are:
x
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x
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 26 of 263
x
IGA response (Clear)
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Baseline)
x
Shift from Baseline in IGA score
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x
Change from Baseline in Dermatology Life Quality Index (DLQI)
x
Percent of subjects achieving a DLQI total score of 0 or 1
x
Percent of subjects achieving a minimal clinically important difference (improvement from 
Baseline of 4 or more) in the DLQI
x
Change from Baseline in the Patient's Global Assessment of Disease Activity (PGADA) for 
the arthritis visual analog scale (VAS) in subjects with PsA at Baseline
x
Change from Baseline in Patient Global Assessment of PSO score
x
Change from Baseline in symptoms of PSO (itch, pain, and scaling)
x
Change from Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) score for 
subjects with nail PSO at Baseline
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Percent of subjects achieving mNAPSI75, mNAPSI90, and mNAPSI100 for subjects with 
nail PSO at Baseline
x
Scalp-specific Investigator’s Global Assessment (scalp IGA) response (Clear or Almost 
Clear with at least 2-category improvement relative to Baseline) for subjects with scalp PSO 
at Baseline
x
Palmoplantar Investigator’s Global Assessment (pp-IGA) response (Clear or Almost Clear 
with at least 2-category improvement relative to Baseline) for subjects with palmoplantar 
PSO at Baseline
x
Responses to the European Quality-of-Life 5-Dimensions 3-Level (EQ-5D-3L) dimensions, 
absolute and changes from Baseline in EQ-5D-3L VAS scores
x
Change from Baseline in Work Productivity and Activity Impairment Questionnaire-specific 
health problem (WPAI-SHP) V2.0 adapted to PSO scores
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Change from Baseline in the Psoriatic Arthritis Screening and Evaluation (PASE) 
questionnaire scores (function score, symptom score, and total score)
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Shift from Baseline in PASE score suggestive of PsA (<47 versus ≥47)
4.3.2
Other safety variables
Other safety variables to be assessed are:
x
Severity and frequency of AEs
x
Change from Baseline in vital signs
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 27 of 263
x
ECG results
x
Change from Baseline in clinical laboratory values (chemistry, hematology, and urinalysis)
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Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) scores
Physical examination findings considered clinically significant changes since the physical 
examination at the Screening Visit will be recorded as AEs.
4.3.3
Pharmacokinetic variable
The PK variable is the plasma concentration of bimekizumab.
4.3.4
Immunological variable
The immunological variable is the anti-bimekizumab antibody level prior to and following IMP 
administration.
5
STUDY DESIGN
5.1
Study description
PS0015 is a randomized, double-blind, secukinumab-controlled, parallel-group study to evaluate 
the efficacy and safety of bimekizumab administered sc to subjects with moderate to severe 
chronic plaque PSO. To be eligible to participate in this study, subjects must be adults with a 
diagnosis of moderate to severe plaque PSO (PASI ≥12 and BSA ≥10% and IGA score ≥3 [on a 
5-point scale]) who are candidates for secukinumab, or for systemic PSO therapy and/or 
phototherapy.
5.2
Study periods
This study will include the following periods: 
x
A Screening Period (2 to 5 weeks) 
x
A double-blind Treatment Period (48 weeks; final dose at Week 44) 
x
An optional OLE Period (96 weeks; final dose at Week 136 for subjects receiving 
bimekizumab 320mg Q8W and at Week 140 for subjects receiving bimekizumab 320mg 
Q4W) followed by a SFU Period (20 weeks after the final dose of IMP administered in the 
OLE Period depending upon subject’s participation in the OLE2 Period), and 
x
An optional 48-week OLE2 Period followed by a SFU Period (SFU2, 20 weeks after the final 
dose of IMP administered in the OLE2 Period).
The OLE2 Period was added as per Protocol Amendment #5.4 at the time when subjects will still 
be treated in the OLE (prior to Week 144 Visit) or will have finished treatment in the OLE (after 
completing Week 144 Visit):
x
Subjects in the treatment phase of the OLE Period at the time of Protocol Amendment #5.4
implementation will attend the Week 144 Visit and directly roll over to the OLE2 Period. 
These subjects will continue receiving bimekizumab 320mg Q8W for 40 additional weeks, 
starting from the first treatment visit of the OLE2 Period (ie, Week 144/OLE2 Baseline Visit; 
the Week 144 Visit will coincide with the Week 144/OLE2 Baseline Visit and data collected 
at this visit will be used as baseline data for subjects entering the OLE2 Period).
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 28 of 263
x
Eligible subjects who have completed the Week 144 Visit and are in the SFU or have 
completed the SFU of the OLE Period at the time of Protocol Amendment #5.4
implementation, will reinitiate their treatment in the OLE2 Period after having undergone 
Screening assessments during a 4-week OLE2 Screening Period. The first dose will be 
administered at the Week 144/OLE2 Baseline Visit and data collected at this visit will be 
used as baseline data for the OLE2 Period. Subjects in OLE2 Group B with an IGA score ≥3 
at the Week 144/OLE2 Baseline Visit will be treated with bimekizumab Q4W for the first 16 
weeks, and will then switch to bimekizumab 320mg Q8W. Subjects in OLE2 Group B with 
an IGA score <3 at the Week 144/OLE2 Baseline Visit will be treated with bimekizumab 
Q8W from the Week 144/OLE2 Baseline Visit.
During the OLE2 Period (Week 144/OLE2 Baseline to OLE2 Week 48), all subjects will attend 
study visits every 12 weeks. All subjects will be treated until OLE2 Week 40 (last dose of 
bimekizumab 320mg Q8W).
Following completion or early withdrawal from the OLE2 Period, subjects will undergo the SFU 
of the OLE2 Period (SFU2) and will return for the SFU2 Visit 20 weeks after the last dose of 
IMP administration.
The end of the study is defined as the date of the last visit of the last subject in the study.
5.2.1
Screening Period
The Screening Period will last 2 weeks, but can be extended up to a total of 5 weeks in cases 
where a laboratory assessment needs to be repeated or to allow washout of prohibited 
medications. During this time, eligible subjects will be informed about the study and sign the 
Informed Consent Form (ICF), laboratory data (hematology, urine, and biochemistry tests) will 
be obtained, and the doses of medications used to treat PsA (if applicable) will be verified as 
stable. The Screening Period will also enable washout of any medications not permitted for use 
during the study. Subjects who require prophylaxis for latent tuberculosis (LTB) infection must 
be on treatment for at least 8 weeks prior to their first dose of IMP. These subjects may be 
rescreened once they have completed the first 8 weeks of prophylaxis treatment.
One rescreening may be allowed after consultation with the Medical Monitor.
The assessments to be performed at the Screening Visit are presented in Table 5‒1.
5.2.2
Treatment Period
During the first 16 weeks of the 48-week double-blind Treatment Period, approximately 700 
subjects will be randomized 1:1 to receive the following blinded IMP regimens:
x
Bimekizumab 320mg administered sc Q4W (350 subjects)
x
Secukinumab 300mg administered sc at Baseline and Weeks 1, 2, 3, and 4 followed by 
dosing Q4W (350 subjects)
Subjects receiving bimekizumab 320mg will receive placebo sc on Weeks 1, 2, and 3 in order to 
maintain the blind. 
At Week 16 subjects in the bimekizumab 320mg treatment arm will be re-randomized 1:2 to 
receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. To maintain the blind after re-
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 29 of 263
randomization, subjects in the bimekizumab 320mg Q8W treatment arm will receive placebo at 
Weeks 20, 28, 36, and 44. Subjects in the secukinumab arm will continue to receive 
secukinumab 300mg Q4W.
Investigational medicinal product will be administered in the clinic by sc injection at the time 
points specified in the schedule of assessments (Table 5‒1).
Subjects withdrawing early from the study will undergo the PEOT Visit assessments and will 
enter the SFU Period.
The assessments to be performed at each double-blind Treatment Period Visit are presented in 
Table 5‒1.
5.2.3
OLE Period
After completion of the Week 48 visit assessments, subjects will be allowed to enroll in the OLE 
Period. All subjects enrolling in the OLE Period will sign a new ICF, and then receive the 
following IMP regimens as determined by the subject’s treatment regimen and PASI response in 
the double-blind Treatment Period. 
At Week 48, subjects receiving:
x
Bimekizumab 320mg Q4W who achieve PASI90 at Week 48 of the double-blind Treatment 
Period will be randomized 1:1 to receive bimekizumab 320mg Q4W or bimekizumab 320mg 
Q8W.
x
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Treatment Period will receive bimekizumab 320mg Q4W.
x
Bimekizumab 320mg Q8W who do not achieve PASI90 at Week 48 of the double-blind 
Treatment Period will receive bimekizumab 320mg Q4W.
x
Bimekizumab 320mg Q8W who achieve PASI90 at Week 48 of the double-blind Treatment 
Period will receive bimekizumab 320mg Q8W.
x
Secukinumab who do not achieve PASI90 at Week 48 of the double-blind Treatment Period
will receive bimekizumab 320mg Q4W.
x
Secukinumab who achieve PASI90 at Week 48 of the double-blind Treatment Period will be 
randomized 1:1 to receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W.
During the OLE Period, subjects will attend study visits at Weeks 52, 56, 64, and 72, and then 
every 12 weeks. At study visits, IMP will be administered in the clinic by sc injection as 
applicable. In between study visits, subjects will self-inject IMP at home.
The subject’s dosing interval will change from bimekizumab 320mg Q4W to bimekizumab 
320mg Q8W at Week 64, or at the next scheduled clinic visit after implementation of 
Protocol Amendment #5.1 if the subject has already completed Week 64. 
The last dose bimekizumab 320mg Q8W in the OLE Period will be administered at Week 136. 
The End of Treatment Visit of the OLE Period will be the Week 144 Visit.
All subjects not enrolling in the open-label study will have the Week 48 study assessments and 
will enter the SFU Period.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 30 of 263
The assessments to be performed at each OLE Period visit are presented in Table 5‒2.
5.2.4
OLE2 Period
Subjects enrolled as per Protocol Amendment #5.1 will be treated in the OLE Period until Week 
136 (last dose of bimekizumab 320mg Q8W) and will be followed in a SFU Period for 20 weeks 
after attending the Week 144 Visit (see Section 5.2.3). After the implementation of Protocol 
Amendment #5.4 (addition of a 48-week treatment period, ie, OLE2 Period), subjects will be 
invited to continue or reinitiate their treatment as per the following OLE2 Groups:
x
OLE2 Group A: Subjects in the treatment phase of the OLE Period at the time of Protocol 
Amendment #5.4 implementation will attend the Week 144 Visit and directly roll over to the 
OLE2 Period. These subjects will continue receiving bimekizumab 320mg Q8W for 
40 additional weeks, starting from the first treatment visit of the OLE2 Period (ie, Week 
144/OLE2 Baseline Visit; the Week 144 Visit will coincide with the Week 144/OLE2 
Baseline Visit and data collected at this visit will be used as baseline data for subjects 
entering the OLE2 Period).
x
OLE2 Group B: Eligible subjects who have completed the Week 144 Visit and are in the 
SFU or have completed the SFU of the OLE Period at the time of Protocol Amendment #5.4
implementation, will reinitiate their treatment in the OLE2 Period after having undergone 
Screening assessments during a 4-week OLE2 Screening Period. The first dose will be 
administered at the Week 144/OLE2 Baseline Visit and data collected at this visit will be 
used as baseline data for the OLE2 Period. Subjects in OLE2 Group B with an IGA score ≥3 
at the Week 144/OLE2 Baseline Visit will be treated with bimekizumab Q4W for the first 16 
weeks, and then will switch to bimekizumab 320mg Q8W. Subjects in OLE2 Group B with 
an IGA score <3 at the Week 144/OLE2 Baseline Visit will be treated with bimekizumab 
Q8W from the Week 144/OLE2 Baseline Visit. 
During the OLE2 Period (Week 144/OLE2 Baseline to OLE2 Week 48), all subjects will attend 
study visits every 12 weeks. All subjects will be treated until OLE2 Week 40 (last dose of 
bimekizumab 320mg Q8W).
Following completion or early withdrawal from the OLE2 Period, subjects will undergo the SFU 
of the OLE2 Period (SFU2) and will return for the SFU2 Visit 20 weeks after the last dose of 
IMP administration.
The assessments to be performed at each visit of the OLE2 Period are presented in Table 5-3.
5.2.5
Safety Follow-Up Periods
The assessments for the SFU Visits are presented in Table 5‒1, Table 5‒2, and Table 5-3.
Two SFU Periods are considered since Protocol Amendment #5.4 implementation: a first SFU 
following the OLE Period and a second SFU (SFU2) following the OLE2 Period (added as per 
Protocol Amendment #5.4 implementation).
Subjects having completed Week 144 Visit and who are in the SFU or have completed the SFU 
will be invited to reinitiate their treatment in the OLE2 Period. 
Subjects still being treated in the OLE Period (not having attended Week 144 yet) will have the 
opportunity to directly roll over in the OLE2 Period without participating in the first SFU.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 31 of 263
Subjects who decide not to participate in OLE2 Period will undergo the first SFU period for 
20 weeks after their last dose in the OLE Period.
All subjects who have completed treatment in the OLE2 Period (ie, have completed the OLE2 
Week 48 Visit), or have withdrawn from IMP during the OLE2 Period before OLE2 Week 48,
will have a SFU2 Visit 20 weeks after their final dose of IMP administered up to OLE2 
Week 48.
5.2.6
Premature End of Treatment
Subjects withdrawing early from the study will undergo PEOT Visit assessments (see 
Section 8.5) and will enter the SFU or SFU2 Period depending on when subjects withdraw.
5.3
Study duration per subject
For each subject, the study will last a maximum of up to 165 weeks, as follows:
x
Screening Period: 2 to 5 weeks
x
Double-blind Treatment Period: 48 weeks (final dose at Week 44)
x
OLE Period: 96 weeks (final dose at Week 136 for subjects receiving bimekizumab 320mg 
Q8W and at Week 140 for subjects receiving bimekizumab 320mg Q4W) followed by a 
Safety Follow-Up Period: a SFU Visit is planned 20 weeks after the final dose of IMP visit in 
the OLE Period (this SFU will not apply to subjects directly rolling over from the OLE to the 
OLE2 Period [see Section 5.2.5])
Subjects eligible for the OLE2 Period (added as part of Protocol Amendment #5.4) will enter the 
OLE2 Period after completing Week 144 of the OLE Period. The OLE2 Period will include a 
48-week treatment period with a final visit at OLE2 Week 48 and a SFU Period (SFU2) of 
20 weeks after the final dose of IMP administered in the OLE2 Period. 
For the subjects in the OLE2 Period, maximum study duration will depend on the time between 
their participation in the OLE until Week 144 and the start of the OLE2 Period:
x
209 weeks for subjects still being treated in the OLE Period and who will directly roll over to 
the OLE2 Period at Week 144
x
225 weeks for subjects who have completed Week 144 and the SFU; these subjects will have 
a 4-week Screening Period before reinitiating treatment in the OLE2 Period. Note: for these 
subjects, the study duration will not be continuous.
x
Between 209 and 225 weeks for subjects who have completed Week 144 and are
participating the in the SFU. For these subjects, the maximum study duration will depend 
upon when they stop the 20-week SFU period to enter the 4-week OLE2 Screening Period.
5.4
Planned number of subjects and sites
Approximately 935 subjects will be screened in order to have 700 subjects randomized in the 
study. There will be approximately 350 subjects in the bimekizumab 320mg treatment arm and 
350 subjects in the secukinumab 300mg treatment arm. The planned number of study sites is 
approximately 86. Every eligible subject who signs an ICF will be randomized.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 32 of 263
5.5
Anticipated regions and countries
The regions planned for study conduct are North America, Western Europe, and Central/Eastern 
Europe, with possible extension to other regions and countries.
5.6
Schedule of study assessments
The schedule of study assessments is presented in Table 5‒1 for the Screening and double-blind 
Treatment Periods, in Table 5‒2 for the OLE Period, and in Table 5-3 for the OLE2 Period. At 
each visit, all study assessments should be performed prior to administration of IMP.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 33 of 263
Table 5‒1:
Schedule of study assessments, Screening and double-blind Treatment Periods
Visita/
Week
Protocol activity
Screening
Treatment Period
SFUb
Baseline 
(first dose)
1
2
3
4
8
12
16
20
24
28
32
36
40
44
48/
PEOT
Informed consent
X
Inclusion/exclusion
X
Xc
Urine drug screen
X
Demographic data
X
Psoriasis history
X
eC-SSRS
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Significant past medical history 
and concomitant diseases
X
Xd
Physical examc, e
X
X
X
X
X
X
Height
X
Body weight
X
X
X
X
X
Vital signsf
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Hematology and biochemistry 
X
X
X
X
X
X
X
X
X
X
X
X
X
Urinalysis
X
X
X
X
X
X
X
X
ECG
X
X
X
X
Pregnancy testingg
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Hepatitis B and C testingh
X
HIV testingi
X
Chest x-rayj
X
IGRA tuberculosis test
X
X
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 34 of 263
Table 5‒1:
Schedule of study assessments, Screening and double-blind Treatment Periods
Visita/
Week
Protocol activity
Screening
Treatment Period
SFUb
Baseline 
(first dose)
1
2
3
4
8
12
16
20
24
28
32
36
40
44
48/
PEOT
Tuberculosis questionnaire
X
X
X
X
X
X
X
PASI
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Percentage of BSA
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Blood sample for 
bimekizumab/secukinumab 
plasma concentrationsk
X
X
X
X
X
X
X
X
X
X
X
X
Blood sample for 
anti-bimekizumab antibodiesk
X
X
X
X
X
X
X
X
X
X
X
X
IGA
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
DLQI
X
X
X
X
X
X
X
Patient Symptoms (itch, pain, 
and scaling)
X
X
X
X
X
X
X
PHQ-9
X
X
X
X
X
X
X
X
X
X
X
X
X
X
scalp IGAl
X
Xl
Xl
Xl
Xl
Xl
Xl
Xl
Xl
mNAPSIm
X
Xm
Xm
Xm
pp-IGAn
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Xn
Xn
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Patient Global Assessment of 
psoriasis
X
X
X
X
X
X
X
PASE
X
X
PGADA
X
Xo
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 35 of 263
Table 5‒1:
Schedule of study assessments, Screening and double-blind Treatment Periods
Visita/
Week
Protocol activity
Screening
Treatment Period
SFUb
Baseline 
(first dose)
1
2
3
4
8
12
16
20
24
28
32
36
40
44
48/
PEOT
Photographs of skin and nails 
(subset of sites)
X
X
X
X
X
X
X
X
X
EQ-5D-3L
X
X
X
X
X
Concomitant medication
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Adverse events
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Randomization
X
X
IRTp
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
IMP administrationq
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
BSA=body surface area; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eCRF=electronic Case Report Form; eC-SSRS=electronic 
Columbia Suicide Severity Rating Scale; EQ-5D-3L=European Quality-of-Life 5-Dimensions 3-Level; HCV=hepatitis C virus; HIV=human 
immunodeficiency virus; IGA=Investigator’s Global Assessment; IGRA=interferon-gamma release assay; IMP=investigational medicinal product; 
IRT=interactive response technology; mNAPSI=Modified Nail Psoriasis Severity Index; PASE=Psoriatic Arthritis Screening and Evaluation; PASI=Psoriasis 
Area Severity Index; PEOT=Premature End of Treatment; PGADA=Patient’s Global Assessment of Disease Activity; PHQ-9=Patient Health Questionnaire-9; 
pp-IGA=palmoplantar Investigator’s Global Assessment; PsA=psoriatic arthritis; scalp IGA=scalp-specific Investigator’s Global Assessment; SFU=Safety 
Follow-Up; TB=tuberculosis; WPAI-SHP=Work Productivity and Activity Impairment Questionnaire-specific health problem
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 36 of 263
Table 5‒1:
Schedule of study assessments, Screening and double-blind Treatment Periods
Visita/
Week
Protocol activity
Screening
Treatment Period
SFUb
Baseline 
(first dose)
1
2
3
4
8
12
16
20
24
28
32
36
40
44
48/
PEOT
a Visit windows of ±3 days from the first dose from the Week 1 visit to the Week 24 visit. Visit windows of ±7 days from Week 28 through Week 48/PEOT. 
The SFU Visit window is ±7 days relative to the scheduled visit date.
b The SFU Visit will occur 20 weeks after the final dose if subject does not enroll in the OLE Period.
c Includes evaluation of signs and symptoms of active TB and risk for exposure to TB.
d Ensure no significant changes in medical history.
e The physical examination will be performed as per Section 12.3.5.
f Vital signs (blood pressures, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable.
g Pregnancy testing will consist of serum testing at the Screening. Urine pregnancy testing will be performed at all other visits.
h Subjects who have evidence of or test positive for hepatitis B by any of the following criteria: 1) positive for hepatitis B surface antigen; 2) positive for 
anti-hepatitis B core antibody are excluded. A positive test for HCV is defined as: 1) positive for hepatitis C antibody, and 2) positive via a confirmatory test 
for HCV (for example, HCV polymerase chain reaction) are also excluded. Subjects will also be tested for anti-hepatitis B surface antibody.
i The HIV test results will not be recorded in the eCRF.
j Screening chest x-ray must occur within 3 months prior to Screening Visit.
k All blood samples taken prior to dosing.
l The scalp IGA will be assessed only for those subjects with scalp involvement (scalp IGA score >0) at Baseline.
m The mNAPSI will be assessed only in subjects with nail involvement (mNAPSI score >0) at Baseline.
n The pp-IGA will be assessed only in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline.
o The PGADA is assessed for all subjects at Baseline. At all subsequent visits, the PGADA is only for subjects with PsA at Baseline (defined as a past medical 
history of PsA or PASE ≥47).
p IMP administration is based on randomization.
q The dosing window from Baseline through Week 4 is ±2 days relative to the scheduled dosing visit. From Week 8 through Week 24, the dosing window is 
±3 days relative to the scheduled dosing visit. From Week 28 through Week 48, the dosing window is ±7 days relative to the scheduled dosing visit.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 37 of 263
Table 5‒2:
Schedule of study assessments, OLE Period
Visita/
Week
Protocol activity
48 (1st OLE dose)
Year 2
Year 3
SFUb
52
56
60
64
68
72
76
80
84
88
92
96
100
104
108
112
116
120
124
128
132
136
140
144/PEOT
C
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H
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H
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Informed consent
X
Eligibilityc
X
eC-SSRS
X
X
X
X
X
X
X
X
X
X
X
Physical examd,e
X
X
X
X
X
X
X
X
X
Body weight
X
X
Vital signsf
X
X
X
X
X
X
X
X
X
X
X
Hematology and biochemistry 
X
X
X
X
X
X
X
X
X
X
X
Urinalysis
X
X
X
X
X
X
X
X
X
ECG
X
X
Pregnancy testing (urine)g
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
IGRA tuberculosis test
X
X
Tuberculosis questionnaire
X
X
X
X
X
X
X
X
X
X
PASI
X
X
X
X
X
X
X
X
X
X
Percentage of BSA
X
X
X
X
X
X
X
X
X
X
Blood sample for bimekizumab 
plasma concentrationsh
X
X
X
X
X
Blood sample for anti‑bimekizumab 
antibodiesh
X
X
X
X
X
IGA
X
X
X
X
X
X
X
X
X
X
DLQI
X
X
X
X
Patient Symptoms (itch, pain, and 
scaling)
X
X
X
X
X
X
X
X
X
PHQ-9
X
X
X
X
X
X
X
X
X
X
scalp IGAi
X
X
X
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mNAPSIj
X
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112
112
116
16
eo
eo
thereo


UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 38 of 263
Table 5‒2:
Schedule of study assessments, OLE Period
Visita/
Week
Protocol activity
48 (1st OLE dose)
Year 2
Year 3
SFUb
52
56
60
64
68
72
76
80
84
88
92
96
100
104
108
112
116
120
124
128
132
136
140
144/PEOT
C
C
C
H
C
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
H
C
C
pp-IGAk
X
X
X
X
EQ-5D-3L
X
X
X
X
PASE
X
X
PGADAl
X
X
WPAI-SHP V2.0
X
X
Concomitant medication
X
X
X
X
X
X
X
X
X
X
X
Adverse events
X
X
X
X
X
X
X
X
X
X
X
Randomization
X
IRTm
X
X
X
X
X
X
X
X
X
X
X
X
IMP administration – Q4W n, o, p
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
IMP administration – Q8W n, o
X
X
X
X
X
X
X
X
X
X
X
X
BSA=body surface area; C=clinic; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eCRF=electronic Case Report Form; eC-
SSRS=electronic Columbia Suicide Severity Rating Scale; EQ-5D-3L=European Quality-of-Life 5-Dimensions 3-Level; H=home; HCV=hepatitis C virus; 
HIV=human immunodeficiency virus; IGA=Investigator’s Global Assessment; IGRA=interferon-gamma release assay; IMP=investigational medicinal
product; IRT=interactive response technology; mNAPSI=Modified Nail Psoriasis Severity Index; PASE=Psoriatic Arthritis Screening and Evaluation; 
PASI=Psoriasis Area Severity Index; PEOT=Premature End of Treatment; PGADA=Patient’s Global Assessment of Disease Activity; PHQ-9=Patient 
Health Questionnaire-9; pp IGA=palmoplantar Investigator’s Global Assessment; PsA=psoriatic arthritis; scalp IGA=scalp-specific Investigator’s Global 
Assessment; SFU=Safety Follow-Up; TB=tuberculosis; WPAI SHP=Work Productivity and Activity Impairment Questionnaire-specific health problem
a Visit windows of ±7 days from Week 48 through Week 72. Visit windows of ±14 days from Week 76 through Week 144. The SFU Visit window is ±7 days 
relative to the scheduled visit date.
b The SFU Visit will occur 20 weeks after the final dose.
c Criteria for OLE Period, Section 6.3.
d Includes evaluation of signs and symptoms of active TB and risk for exposure to TB.
e The physical examination will be performed as per Section 12.3.5.
f Vital signs (blood pressures, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable.
g Pregnancy testing will consist of urine pregnancy testing at all visits. Home pregnancy test kits will be provided to participants for use between clinic visits.
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16
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 39 of 263
Table 5‒2:
Schedule of study assessments, OLE Period
Visita/
Week
Protocol activity
48 (1st OLE dose)
Year 2
Year 3
SFUb
52
56
60
64
68
72
76
80
84
88
92
96
100
104
108
112
116
120
124
128
132
136
140
144/PEOT
C
C
C
H
C
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
H
C
C
h All blood samples taken prior to dosing.
i The scalp IGA will be assessed only for those subjects with scalp involvement (scalp IGA score >0) at Baseline.
j The mNAPSI will be assessed only in subjects with nail involvement (mNAPSI score >0) at Baseline.
k The pp-IGA will be assessed only in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline.
l The PGADA is assessed only for subjects with PsA at Baseline (defined as a past medical history of PsA or PASE ≥47).
m IMP administration is based on randomization.
n From Week 48 through Week 72, the dosing window is ±7 days relative to the scheduled dosing visit. From Week 76 through the Week 140 Visit, the dosing 
window is ±14 days relative to the scheduled dosing visit. 
o If self-injected at home, the subject/caregiver will document the date, body location, kit number and time point of administration of study medication. All 
used syringes will be disposed of by subjects/caregivers as determined by the Investigator in an acceptable disposal (sharps) container directly after the 
administration. The subjects/caregivers return the documentation together with any used/unused containers at the next scheduled clinic visit.
p Q4W IMP administration only applies to those subjects who have not yet changed to Q8W at Week 64, or at the next scheduled clinic visit (ie, Week 72, 
Week 84, Week 96, Week 108, Week 120, or Week 132) if the subject has already completed the Week 64 visit after implementation of 
Protocol Amendment #5.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 40 of 263
Table 5-3:
Schedule of study assessments, OLE2 Period
Visit a/
Week
OLE2 Period
OLE2 Screening b
W144/OLE2 
Baseline
OLE2 W4
OLE2 W8
OLE2 W12
OLE2 W16
OLE2 W24
OLE2 W32
OLE2 W36
OLE2 W40
OLE2W48/
PEOT
SFU2 c
C
H
H
C
H
C
H
C
H
C
C
Protocol activity
OLE2 Groups A + B
Informed consent
Group B
Group A
Eligibility
Group B
Group A+B
Urine drug screen
Group B
Significant past medical history 
and concomitant diseases d
Group B
Physical exam e
Group B
Group Af + B
X
X
X
X
X
Body weight
Group Af + B
X
Vital signs g
Group B
Group Af + B
X
X
X
X
X
Hematology and chemistry
Group B
Group Af + B
X
X
X
Urinalysis
Group B
Group Af + B
X
X
X
Pregnancy testing (urine) h
Group B
Group Af + B
X
X
X
X
X
X
X
X
X
X
Hepatitis B and C testing
Group B
HIV testing i
Group B
IGRA TB test
Group A f
X
Tuberculosis questionnaire
Group B
Group Af + B
X
X
X
X
PASI
Group B
Group Af + B
X
X
X
X
Percentage of BSA
Group B
Group Af + B
X
X
X
X
IGA
Group B
Group Af + B
X
X
X
X
DLQI
Group Af + B
X
X
X
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 41 of 263
Table 5-3:
Schedule of study assessments, OLE2 Period
Visit a/
Week
OLE2 Period
OLE2 Screening b
W144/OLE2 
Baseline
OLE2 W4
OLE2 W8
OLE2 W12
OLE2 W16
OLE2 W24
OLE2 W32
OLE2 W36
OLE2 W40
OLE2W48/
PEOT
SFU2 c
C
H
H
C
H
C
H
C
H
C
C
Protocol activity
OLE2 Groups A + B
Patient Symptoms (itch, pain, 
and scaling)
Group Af + B
X
X
X
X
PHQ-9
Group B
Group Af + B
X
X
X
X
ECG
Group A f
Blood sample for bimekizumab 
plasma concentrations j
Group A f
Blood sample for 
anti‑bimekizumab antibodies j
Group A f
scalp IGA
Group A f
mNAPSI
Group A f
pp-IGA
Group A f
EQ-5D-3L
Group A f
PASE
Group A f
PGADA
Group A f
WPAI-SHP V2.0
Group A f
eC-SSRS
Group B
Group Af + B
X
X
X
X
X
Concomitant medication
Group B
Group Af + B
X
X
X
X
X
Adverse events
Group B k
Group Af + B
X
X
X
X
X
IRT
X
Group Af + B
X
X
X
X
X
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 42 of 263
Table 5-3:
Schedule of study assessments, OLE2 Period
Visit a/
Week
OLE2 Period
OLE2 Screening b
W144/OLE2 
Baseline
OLE2 W4
OLE2 W8
OLE2 W12
OLE2 W16
OLE2 W24
OLE2 W32
OLE2 W36
OLE2 W40
OLE2W48/
PEOT
SFU2 c
C
H
H
C
H
C
H
C
H
C
C
Protocol activity
OLE2 Groups A + B
Bimekizumab administration 
Q4W/Q8W l, m, n
Group B l
X
X
X
X
X
X
X
Bimekizumab administration 
Q8W m, n
Group A+B l
X
X
X
X
X
BSA=body surface area; C=clinic; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide Severity Rating Scale; 
IGA=Investigator’s Global Assessment; H=home; IMP=investigational medicinal product; IRT=interactive response technology; OLE=open label extension; PASI=Psoriasis 
Area Severity Index; PHQ-9=Patient Health Questionnaire-9; PSO=psoriasis; Q4W=every 4 weeks; Q8W=every 8 weeks; SFU2=Safety Follow-Up #2; TB=tuberculosis; 
W=Week.
Note: Subjects may self-inject IMP at home; self-injection training will be provided to the subject/caregivers by qualified site personnel. 
a
Visit windows of ±14 days from the first dose at all visits except SFU2. The SFU2 Visit window is ±7 days from final dose.
b
Assessment for the OLE2 Screening is applicable to subjects in OLE2 Group B, ie, subjects who agreed to reinitiate their treatment after having completed the Week 144 
Visit. 
c
The SFU2 Visit will occur 20 weeks after the final dose.
d
Only applicable for subjects who completed the SFU period; only new or modified medical history since completing SFU will be entered in eCRF.
e
The physical examination will be performed as per Section 12.3.5.
f
These tests are performed as part of Week 144 visit (the Week 144 Visit coincides with the Week 144/OLE2 Baseline Visit for subjects in Group A, ie, direct enroller from 
OLE to OLE2 Period).
g
Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable.
h
Urine pregnancy testing will be performed at all visits. Pregnancy test results must be negative prior to administering IMP. Home pregnancy test kits will be provided to 
participants for use between clinic visits.
i
The HIV test results will not be recorded in the eCRF.
j
All blood samples taken prior to dosing.
k
Collected only from subjects in the SFU.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 43 of 263
Table 5-3:
Schedule of study assessments, OLE2 Period
Visit a/
Week
OLE2 Period
OLE2 Screening b
W144/OLE2 
Baseline
OLE2 W4
OLE2 W8
OLE2 W12
OLE2 W16
OLE2 W24
OLE2 W32
OLE2 W36
OLE2 W40
OLE2W48/
PEOT
SFU2 c
C
H
H
C
H
C
H
C
H
C
C
Protocol activity
OLE2 Groups A + B
l
Q4W IMP administration only applies to those subjects who have entered the OLE2 Period as part of Group B, and had an IGA ≥3 upon entry of OLE2 Period. These 
subjects will receive Q4W dosing for 16 weeks, then will change from Q4W to Q8W dosing. Subjects who have entered the OLE2 Period as part of Group B with an IGA 
<3 upon entry of OLE2 Period will receive Q8W dosing from the W144/OLE2 Screening Visit onwards.
m The dosing window is ±14 days relative to the Week 144/OLE2 Baseline Visit.
n
If self-injected at home, the subject/caregiver will document the date, body location, kit number and time point of administration of study medication. All used syringes will 
be disposed of by subjects/caregivers as determined by the Investigator in an acceptable disposal (sharps) container directly after the administration. The subjects/caregivers 
return the documentation together with any used/unused containers at the next scheduled clinic visit.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 44 of 263
5.7
Schematic diagram
The study schematic diagram for PS0015 from Screening through Week 48 is presented in 
Figure 5‒1, from Week 48 through Week 144 is presented in Figure 5‒2, and from Week OLE2 
Screening to the OLE2 Week 48 Visit is presented in Figure 5‒3.
Figure 5‒1: Schematic diagram, Screening and double-blind Treatment Period 
(through Week 48)
Screening
Treatment period (double-blind) 
Safety follow-up 
visit 20 weeks 
after last dose
Baseline
16
Week
SFU visit 20 
weeks after 
last dose
4
8
Dosing
12
20
24
28
32
36
40
44
48
Primary endpoint
PASI100 response
2–5 weeks
Dosing
Dosing
Dosing
Dosing
Dosing
Dosing
Dosing
Dosing
Dosing
Dosing
Dosing
Dosing
(SEC or 
PBO)
Open-label 
extension 
period
Bimekizumab 320mg Q4W
N=700
Secukinumab 300mg Q4W
n=350
n=350
Bimekizumab 320mg Q8W
Bimekizumab 320mg Q4W
1:2 re-
randomization
Open-label
extension
period
or
IGA=Investigator’s Global Assessment; IMP=investigational medicinal product; PASI100=Psoriasis Area Severity 
Index complete response; PBO=placebo; Q4W=every 4 weeks; Q8W=every 8 weeks; SEC=secukinumab; 
SFU=safety follow-up 
Note: At Week 28 and all following visits, subjects on continuous treatment for at least 12 weeks with a persistent 
IGA score ≥3 over at least a 4-week period are defined as nonresponders and should discontinue IMP.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 45 of 263
Figure 5‒2: Schematic diagram, OLE Period (Week 48 through Week 144)
PASI=Psoriasis Area Severity Index; PASI90=90% improvement in the PASI score; Q4W=every 4 weeks; 
Q8W=every 8 weeks
Note: The subject’s dosing interval will change from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W at 
Week 64, or at the next scheduled clinic visit (ie, Week 72, Week 84, Week 96, Week 108, Week 120, or Week 
132) if the subject has already completed the Week 64 visit prior to implementation of Protocol Amendment #5.1.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 46 of 263
Figure 5‒3: Schematic diagram, OLE2 period (from OLE2 Screening through 
OLE2 Week 48)
IGA=Investigator’s Global Assessment; IMP=investigational medicinal product; OLE=Open Label Extension; 
Q4W=every 4 weeks; Q8W=every 8 weeks; SFU2=Safety follow-up; W=week
Note: Q4W/Q8W IMP administration only applies to those subjects who have entered the OLE2 Period as part of 
Group B, and had an IGA ≥3 upon entry of OLE2 Period. These subjects will receive Q4W dosing for 16 weeks, 
then will change from Q4W to Q8W dosing.
5.8
Rationale for study design and selection of dose
5.8.1
Study design
A randomized, double-blind, active comparator-controlled study design has been selected to 
demonstrate efficacy and safety of bimekizumab relative to secukinumab. The study population 
will include adults with moderate to severe chronic plaque PSO and allow subjects who have 
received previous biologic treatment as well as those who are biologic treatment naïve. The 
primary efficacy outcome measure (based on PASI) and other efficacy assessments included in 
this study are consistent with those used for other PSO studies and are considered appropriate for 
establishing efficacy of bimekizumab. A treatment period of 48 weeks (final dose at Week 44)
will be used to demonstrate the superiority of bimekizumab versus secukinumab based on 
PASI100 at Week 16, along with the maintenance of efficacy of bimekizumab at Week 48.
The addition of the OLE Period will allow collection of long-term efficacy and safety data from 
eligible subjects on open-label bimekizumab for an additional 96 weeks.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 47 of 263
The OLE2 Period will 1) collect additional long-term safety data; 2) explore safety data in
subjects who have temporarily stopped bimekizumab and could have been exposed to other 
treatments; and 3) provide an additional 48-week treatment period for subjects continuing their 
current treatment or reinitiating treatment at the Week 144/OLE2 Baseline Visit.
5.8.2
Dose selection
Bimekizumab doses ranging from 64mg to 480mg were evaluated in the Phase 2b multicenter, 
randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study PS0010. 
Bimekizumab 320mg was found to have an acceptable safety profile, only required 2 injections 
per treatment administration, and achieved significant PASI responses at Week 12 (summarized 
in the IB). Furthermore, data from the Phase 2a multicenter, randomized, subject-blind, 
investigator-blind study PS0016 and PK/PD modeling in this PSO population indicates improved 
responses through Week 16. Therefore, a bimekizumab dose of 320mg Q4W through Week 16
was selected for this study.
Based on pooled data from the Phase 3 studies (PS0008, PS0009, and PS0013), during the
maintenance period bimekizumab 320mg Q8W provided efficacy results similar to 
bimekizumab 320mg Q4W. Therefore, at Week 64, subjects receiving 
bimekizumab 320mg Q4W will switch to receive bimekizumab 320mg Q8W. Subjects who are 
receiving bimekizumab 320mg Q4W treatment who already completed the Week 64 visit at the 
time of implementation of Protocol Amendment #5.1 will be switched to 
bimekizumab 320mg Q8W at the next scheduled clinic visit. This change in dosing interval will 
reduce subject and site burden, while allowing collection of more long-term safety data on the 
bimekizumab 320mg Q8W dosing regimen.
Subjects who are participating in the OLE Period can directly roll over to the OLE2 Period and 
continue receiving bimekizumab 320mg Q8W. Eligible subjects who are in the SFU of the OLE 
Period or who have completed the SFU at the time of Protocol Amendment #5.4 implementation 
can reinitiate their treatment in the OLE2 Period based on their current disease activity, as 
measured by IGA: subjects with IGA score <3 will receive bimekizumab 320mg Q8W, whereas 
subjects with IGA score ≥3 will receive 16 weeks of bimekizumab 320mg Q4W, in line with the 
original initial treatment period, followed by 320mg Q8W for the remaining dosing timepoints of 
the OLE2 Period.
6
SELECTION AND WITHDRAWAL OF SUBJECTS
6.1
Inclusion criteria
To be eligible to participate in this study, all of the following criteria must be met at Screening 
and be reconfirmed at the Baseline Visit:
1. Subject has provided informed consent. 
2. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand 
and complete diaries), visit schedule, or medication intake according to the judgment of the 
Investigator.
3. Male or female at least 18 years of age.
4. Subject must have had chronic plaque PSO for at least 6 months prior to the Screening visit.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 48 of 263
5. Subject must have PASI ≥12 and BSA affected by PSO ≥10% and IGA score ≥3 on a 5-point 
scale.
6. Subject must be a candidate for systemic PSO therapy and/or phototherapy.
7. Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for 
treatment with secukinumab per regional labeling and has no contraindications to receive 
secukinumab as per the local label.
8. Female subjects must be:

Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for 
which there is no other obvious pathological or physiological cause.

Or, permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)

Or, if of childbearing potential (and engaged in sexual activity that could result in 
procreation), must be willing to use a highly effective method of contraception 
throughout the duration of the study until 20 weeks after last administration of IMP, and 
have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose. 
The following methods are considered highly effective when used consistently and 
correctly:
◦
Combined (estrogen and progestogen) hormonal contraception associated with 
inhibition of ovulation (oral, intravaginal, or transdermal)
◦
Progestogen-only hormonal contraception associated with inhibition of ovulation 
(oral, injectable, implantable)
◦
Intrauterine device 
◦
Intrauterine hormone-releasing system 
◦
Vasectomized partner
◦
Abstinence as a form of birth control is generally not allowed in the study unless 
abstinence is in accordance with a subject’s preferred and common lifestyle. Study 
personnel must confirm the continued use of abstinence is still in accordance with the 
subject’s lifestyle at regular intervals during the study.
9. Subject agrees not to change their usual sun exposure during the course of the study and to 
use ultraviolet A/ultraviolet B (UVA/UVB) sunscreens if unavoidable exposure occurs.
6.2
Exclusion criteria
Subjects are not permitted to enroll in this study if any of the following criteria are met:
1. Female subject who is breastfeeding, pregnant, or plans to become pregnant during the study 
or within 20 weeks following the final dose of IMP.
2. Subject previously participated in a bimekizumab clinical study and received at least 1 dose 
of the IMP (including placebo).
3. Subject is currently participating in another study of a medication (systemic) under 
investigation. Subject must be washed out of the medication for 12 weeks or at least 5 half-
lives prior to the Baseline Visit, whichever is greater.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 49 of 263
4. Subject is currently participating in another study of a topical medication under investigation. 
Subject must be washed out of the medication for 4 weeks prior to the Baseline Visit.
5. Subject is currently, or was within the 4 weeks prior to the Baseline Visit, participating in 
another study of a medical device under investigation.
6. Subject has a known hypersensitivity to any excipients of bimekizumab or secukinumab.
7. Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and 
guttate PSO or drug-induced PSO).
8. Subject has an active infection or history of infection(s) as follows:

Any active infection (except common cold) within 14 days prior to Baseline

A serious infection, defined as requiring hospitalization or iv anti-infective(s) within 
2 months prior to the Baseline visit

A history of opportunistic, recurrent, or chronic infections that, in the opinion of the 
Investigator, might cause this study to be detrimental to the subject. Opportunistic
infections are infections caused by uncommon pathogens (eg, pneumocystis jirovecii, 
cryptococcosis) or unusually severe infections caused by common pathogens 
(eg, cytomegalovirus, herpes zoster)
9. Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency 
virus (HIV) infection. Subjects who have evidence of, or tested positive for hepatitis B or 
hepatitis C are excluded. A positive test for the hepatitis B virus is defined as: (1) positive for 
hepatitis B surface antigen or (2) positive for anti-hepatitis B core antibody. A positive test 
for the hepatitis C virus (HCV) is defined as: (1) positive for hepatitis C antibody (HCV Ab) 
and (2) positive via a confirmatory test for HCV (for example, HCV polymerase chain 
reaction).
10. Subject has received any live (includes attenuated) vaccination within the 8 weeks prior to 
the Baseline visit (eg, inactivated influenza and pneumococcal vaccines are allowed, but 
nasal influenza vaccination is not permitted).
11. Subject has received Bacillus Calmette-Guerin (BCG) vaccinations within 1 year prior to the 
Baseline Visit.
12. Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or 
has current or history of nontuberculous mycobacterium (NTMB) infection. A subject with 
LTB (a positive interferon-gamma release assay [IGRA] and diagnosis confirmed by TB 
specialist) may be rescreened once and enrolled after receiving at least 8 weeks of 
appropriate LTB infection therapy and if no evidence of therapy-related hepatotoxicity has 
occurred prior to the first injection (alanine aminotransferase [ALT]/aspartate 
aminotransferase [AST] remain ≤3 times the upper limit of normal [ULN]).
Subject has a past history of active TB involving any organ system unless adequately treated 
according to World Health Organization/Centers for Disease Control (CDC) therapeutic 
guidance and proven to be fully recovered upon consult with a TB specialist.
Refer to Section 12.3.1 for details on determining full TB exclusion criteria.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 50 of 263
13. Subject has a history of a lymphoproliferative disorder including lymphoma or current signs 
and symptoms suggestive of lymphoproliferative disease.
14. Subject has any active malignancy or history of malignancy within 5 years prior to the 
Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell 
carcinoma, or in situ cervical cancer.
15. Subject has a diagnosis of inflammatory conditions other than PSO or PsA, including but not 
limited to rheumatoid arthritis, sarcoidosis, or systemic lupus erythematosus. Subjects with a 
diagnosis of Crohn’s disease or ulcerative colitis are allowed as long as they have no active 
symptomatic disease at Screening or Baseline.
16. Subject has had major surgery (including joint surgery) within the 3 months prior to the 
Baseline Visit, or has planned major surgery within 6 months after entering the study.
17. Subject has any systemic disease (ie, cardiovascular, neurological, renal, liver, metabolic, 
gastrointestinal, hematological, immunological, etc) considered by the Investigator to be 
uncontrolled, unstable, or likely to progress to a clinically significant degree during the 
course of the study.
18. Subject has had myocardial infarction or stroke within the 6 months prior to the Screening 
Visit.
19. Subject has laboratory abnormalities at Screening, including any of the following:
a.
≥3.0x ULN of any of the following: ALT, AST, alkaline phosphatase (ALP); or >ULN 
total bilirubin (≥1.5xULN total bilirubin if known Gilbert’s syndrome).
b. White blood cell count <3.00x103/μL
c.
Absolute neutrophil count <1.5x103/μL
d. Lymphocyte count <500 cells/μL
e.
Hemoglobin <8.5g/dL
f.
Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent
the subject from completing the study or will interfere with the interpretation of the study 
results.
Individual screening tests for which the results are in error, borderline, or indeterminate for 
inclusion in the study can be repeated once for confirmation during the Screening Period.
Upon retesting, subjects whose results remain outside this threshold should not be 
randomized.
20. Subject has any other condition, including medical or psychiatric, which, in the Investigator's 
judgment, would make the subject unsuitable for inclusion in the study.
21. Subject has previous exposure to secukinumab.
22. Subject has experienced primary failure (no response within 12 weeks) to one or more IL-17
biologic response modifiers (ie, brodalumab, ixekizumab), or to more than one biologic 
response modifier other than an IL-17.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 51 of 263
23. Subject is taking PsA medications other than stable doses (ie, stable for at least 1 week prior 
to the Screening Visit) of nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics (see 
Section 7.8.1.2).
24. Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening as 
evaluated by the Investigator based on medical history, site interview, and/or results of the 
specified urine drug screen.
25a. Presence of active suicidal ideation, or positive suicide behavior using the "Screening" 
version of the electronic Columbia Suicide Severity Rating Scale (eC-SSRS) and with either 
of the following criteria:

History of a suicide attempt within the 5 years prior to the Screening Visit. Subjects with 
a history of a suicide attempt more than 5 years ago should be evaluated by a mental 
healthcare professional (eg, locally licensed psychiatrist, psychologist, or master’s level 
therapist) before enrolling into the study.

Suicidal ideation in the past month prior to the Screening Visit as indicated by a positive 
response ("Yes") to either Question 4 or Question 5 of the "Screening" version of the 
eC-SSRS.
26. Subject has presence of moderately severe major depression or severe major depression, 
indicated by a score ≥15 using the screening PHQ-9. Medication used to treat depression 
should be stable for 8 weeks prior to baseline.
27. Subject is a member of Investigator site personnel directly affiliated with this study and/or 
their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, 
whether biological or legally adopted.
28. Subject is a UCB employee or employee of third-party organizations involved in the study.
29. Subject is taking or has taken prohibited psoriasis medications without meeting the 
mandatory washout period relative to the Baseline Visit (Table 7‒2).
6.3
Eligibility for the OLE Period
Prior to entering the OLE Period, subjects on double-blind study treatment must complete all of 
the Week 48 visit assessments. Prior to initiating the OLE Period assessments, all subjects will 
be asked to read and sign a separate ICF. To be eligible to participate in the OLE Period of this 
study, the subject must have completed the double-blind Treatment Period without meeting any 
withdrawal criteria and have been compliant with the ongoing clinical study requirements. 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 52 of 263
6.4
Eligibility for the OLE2 Period
Prior to initiating the OLE2 Period assessments, all subjects will be asked to read and sign a 
separate ICF. 
6.4.1
All subjects (OLE2 Groups A and B)
To be eligible to participate in the OLE2 Period, all of the following inclusion criteria must be 
confirmed for all subjects:
1. Subject provided informed consent. 
2. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand 
and complete diaries), visit schedule, and medication intake according to the judgment of the 
Investigator.
3. Subject completes the OLE Period to Week 144 without meeting any withdrawal criteria 
defined in Section 6.5.
6.4.2
OLE2 Period Group A subjects
To participate in the OLE2 Period, subjects still treated in the OLE Period and who completed 
the Week 144 Visit by the time of the implementation of Protocol Amendment #5.4 will not need 
to fulfil other eligibility criteria than those listed in Section 6.4.1 and will continue their 
treatment from the Week 144/OLE2 Baseline Visit if they do not meet any of the withdrawal 
criteria defined in Section 6.5.
6.4.3
OLE2 Period Group B subjects
Inclusion criteria
To be eligible to participate in the OLE2 Period, all of the additional following inclusion criteria 
must be confirmed during the OLE2 Screening Period for subjects who have attended Week 144 
and are in the SFU or have completed the SFU before Protocol Amendment #5.4
implementation:
1. Female subjects must be:

Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for 
which there is no other obvious pathological or physiological cause.

Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)

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procreation), must be willing to use a highly effective method of contraception 
throughout the duration of the study until 20 weeks after last administration of IMP, and 
have a negative pregnancy test at OLE2 Screening. The following methods are 
considered highly effective when used consistently and correctly
o
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inhibition of ovulation (oral, intravaginal, or transdermal)
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 53 of 263
o
Intrauterine hormone-releasing system 
o
Vasectomized partner
o
Abstinence as a form of birth control is generally not allowed in the study unless 
abstinence is in accordance with a subject’s preferred and common lifestyle. Study 
personnel must confirm the continued use of abstinence is still in accordance with the 
subject’s lifestyle at regular intervals during the study.
2. Subjects with a diagnosis of Crohn’s disease or ulcerative colitis are allowed as long as they 
have no active symptomatic disease.
Exclusion criteria
Subjects in the OLE2 Group B are not permitted to enroll in the OLE2 Period if any of the 
following exclusion criteria is met:
1. Female subjects who plan to become pregnant during the OLE2 Period or within 20 weeks 
following final dose of study medication.
2. Subject has developed any medical or psychiatric condition that, in the opinion of the 
Investigator, could jeopardize or would compromise the subject’s ability to participate in the 
OLE2 Period.
3. Any subjects with an ongoing SAE, or a history of serious infections, the Medical Monitor 
must be consulted prior to the subject’s entry in the OLE2 Period, although the decision on 
whether to enroll the subject remains with the Investigator.
4. Subject had a positive or indeterminate IGRA in the OLE study to Week 144, unless 
appropriately evaluated and treated as per Section 12.3.1.
5. Subject may not participate in another study of a medicinal product or device under 
investigation 
6. Subject has a history of chronic alcohol or drug abuse within 6 months prior to reentry as 
assessed by medical history, site interview, and/or results of the urine drug screen.
7. Subjects who have used systemic treatments after Week 144 must have stopped this 
treatment 1 month prior to receiving the first bimekizumab injection in the OLE2 Period (See
Section 7.8.2 regarding prohibited medications).
8. Subject has erythrodermic, guttate, or pustular form of PSO.
9. Subject is noncompliant with the study procedures or medications in the opinion of the 
Investigator.
10. Subject has a clinical laboratory value meeting any of the following criteria:
a.
≥3.0x ULN of any of the following: ALT, AST, alkaline phosphatase (ALP); or >ULN 
total bilirubin (≥1.5xULN total bilirubin if known Gilbert’s syndrome)
b. A laboratory value meeting any of the following criteria:
◦
Absolute neutrophil count <1.0x103/μL
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 54 of 263
◦
Absolute lymphocyte count <0.2x103/μL
Subjects may enter the OLE2 Period if the result is transient. If a retest is required, it must be 
done within 1 to 2 weeks.
11. Subject has concurrent acute or chronic viral hepatitis B or C or HIV infection. Subjects who 
have evidence of, or tested positive for hepatitis B or hepatitis C are excluded. A positive test 
for the hepatitis B virus is defined as: (1) positive for hepatitis B surface antigen or (2) 
positive for anti-hepatitis B core antibody. A positive test for the hepatitis C virus (HCV) is 
defined as: (1) positive for hepatitis C antibody (HCV Ab) and (2) positive via a 
confirmatory test for HCV (for example, HCV polymerase chain reaction).
12. There is confirmation of a pregnancy, as evidenced by a positive pregnancy test (see 
Section 12.1.4 for more information regarding pregnancies).
13. Subjects showing:
x
Suicidal ideation in the past month prior to the OLE2 Screening Visit as indicated by a 
positive response ("Yes") to either Question 4 or Question 5 of the eC-SSRS.
x
Any suicidal behavior since last visit.
14. Subject has presence of moderately severe or severe major depression, indicated by a score 
≥15 on the PHQ-9. Medication used to treat depression should be stable for 4 weeks prior to
Week 144/OLE2 Baseline.
15. Subject has developed any active malignancy or history of malignancy prior to the OLE2 
Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell 
carcinoma, or in situ cervical cancer.
16. Subject has received any live (includes attenuated) vaccination within the 8 weeks prior to 
the Week 144/OLE2 Baseline Visit.
6.5
Withdrawal criteria
Subjects are free to withdraw from the study at any time, without prejudice to their continued 
care. Subjects who withdraw from the study should complete the PEOT Visit (see Section 8.5).
Subjects should be withdrawn from the study and will be encouraged to come back for the SFU
Visit 20 weeks after final dose of IMP if the subject withdraws his/her consent or the Sponsor or 
a regulatory agency requests withdrawal of the subject.
A subject should be withdrawn from IMP and will be asked to come back for the SFU visit 
20 weeks after final dose of IMP if any of the following events occur:
1. Subject develops an illness that in the opinion of the Investigator would interfere with his/her 
continued participation if the risk of continuing IMP outweighs the potential benefit.
2. Subject develops erythrodermic, guttate, or pustular form of PSO.
3. Subject is noncompliant with the study procedures or medications in the opinion of the 
Investigator.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 55 of 263
4. Subject uses prohibited concomitant medications, with the exception of topicals, as defined 
in this protocol (Section 7.8.2), that may present a risk to the safety of the subject or the 
integrity of the study data, in the opinion of the Investigator and/or the Medical Monitor.
5. Subject has a clinical laboratory value meeting any of the following criteria:
a.
Hepatotoxicity as described in Section 6.5.1
b. A laboratory value meeting any of the following criteria:
◦
Absolute neutrophil count <1.0x103/μL
◦
Absolute lymphocyte count <0.2x103/μL
Subjects may remain in the study if the result is transient. A retest is required within 1 to 
2 weeks at a scheduled or unscheduled visit. If the repeat absolute neutrophil count or 
absolute lymphocyte count is still below the allowable values, the subject must be 
withdrawn. If the repeat absolute neutrophil count or absolute lymphocyte count is above the 
allowable values, the subject may continue in the study.
6. The subject experiences a severe AE, an SAE, or a clinically significant change in a 
laboratory value that, in the opinion of the Investigator, merits the discontinuation of the 
investigational product and appropriate measures being taken.
7. There is confirmation of a pregnancy during the study, as evidenced by a positive pregnancy 
test (see Section 12.1.4 for more information regarding pregnancies).
8b. At Week 28 and all following visits, subjects on continuous treatment for at least 12 weeks 
with a persistent IGA score ≥3 over at least a 4-week period are defined as nonresponders 
and should discontinue IMP. 
9a. A subject considered as having either a suspected new latent tuberculosis infection (LTBI) or 
who develops active TB or pulmonary NTMB infection during the study (including but not 
limited to, conversion demonstrated by IGRA or other diagnostic means) must be 
immediately discontinued from IMP.
The subject must be permanently withdrawn if further examinations result in a diagnosis of 
pulmonary NTMB, active TB, or if the subject is diagnosed with LTBI with no initiation of 
prophylactic treatment, prematurely discontinues prophylactic treatment, or, in the opinion of 
the Investigator or Sponsor, is noncompliant with prophylactic TB therapy.
Confirmed active TB is an SAE and must be captured on an SAE Report Form and provided 
to the Sponsor in accordance with SAE reporting requirements. As with all SAEs, periodic 
follow-up reports should be completed as per protocol requirements until such time as the TB 
infection resolves.
Additional information on TB policies is provided in Section 12.3.1.
10. Subjects with newly diagnosed inflammatory bowel disease (IBD) or with IBD flares during 
the study must:

Be referred, as appropriate, to a health care professional treating IBD, such as a 
gastroenterologist

Discontinue IMP and be followed-up until resolution of active IBD symptoms
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 56 of 263
If IBD flares increase in severity or frequency during the study, the Investigator should use 
clinical judgement in deciding whether the subject should continue in the study and contact 
the Medical Monitor and UCB study physician to confirm the subject’s suitability for 
continued participation in the study.
11a. Subjects must be referred immediately to a mental healthcare professional (eg, locally 
licensed psychiatrist, psychologist, or master’s level therapist) and may be withdrawn from 
the study based upon the Investigator’s judgment of benefit/risk for:

Active suicidal ideation as indicated by a positive response (“Yes”) to Question 4 of the 
“Since Last Visit” version of the eC-SSRS.

Moderately severe major depression as indicated by a PHQ-9 score of 15 to 19 if this 
represents an increase of 3 points compared to last visit.
12a. Subjects must be referred immediately to a mental healthcare professional (eg, locally 
licensed psychiatrist, psychologist, or master’s level therapist) and must be withdrawn for:

Active suicidal ideation as indicated by a positive response (“Yes”) to Question 5 of the 
“Since Last Visit” version of the eC-SSRS

Any suicidal behavior since last visit

Severe major depression as indicated by a PHQ-9 score ≥20
The mental health consultation must be recorded in source documentation.
Investigators should attempt to obtain information on subjects in the case of withdrawal or
discontinuation. For subjects considered as lost to follow-up, the Investigator should make an 
effort (at least 1 phone call and 1 written message to the subject), and document his/her effort 
(date and summary of the phone call and copy of the written message in the source documents), 
to complete the final evaluation. All results of these evaluations and observations, together with a 
narrative description of the reason(s) for removing the subject, must be recorded in the source 
documents. The electronic Case Report Form (eCRF) must document the primary reason for 
withdrawal or discontinuation.
Investigators should contact the Medical Monitor, whenever possible, to discuss the withdrawal 
of a subject in advance.
6.5.1
Potential drug-induced liver injury IMP discontinuation criteria
Subjects with potential drug-induced liver injury (PDILI) must be assessed to determine if IMP 
must be discontinued. In addition, all concomitant medications and herbal supplements that are 
not medically necessary should also be discontinued.
The PDILI criteria below require immediate and permanent discontinuation of IMP for subjects 
with either of the following:
x
ALT or AST ≥ 8xULN
x
ALT or AST ≥3xULN and coexisting total bilirubin ≥2xULN
The PDILI criterion below requires immediate discontinuation of IMP for:
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 57 of 263
x
Subjects with ALT or AST ≥3xULN who exhibit temporally associated symptoms of 
hepatitis or hypersensitivity. Hepatitis symptoms include fatigue, nausea, vomiting, right 
upper quadrant pain or tenderness. Hypersensitivity symptoms include fever (without clear 
alternative cause), rash, or eosinophilia (ie, >5%).
If a nondrug-related cause for the symptoms can be confirmed, these subjects may resume 
IMP administration after discussion with the responsible UCB physician, but only when the
requirements for rechallenge with IMP as provided in Section 12.2.1.2.1 are followed.
The PDILI criterion below allows for subjects to continue on IMP at the discretion of the 
Investigator.
x
Subjects with ALT or AST ≥5xULN and <8xULN, total bilirubin <2xULN, and no 
eosinophilia (ie, ≤5%), with no fever, rash, or symptoms of hepatitis (eg, fatigue, nausea, 
vomiting, right upper quadrant pain or tenderness).
Evaluation of PDILI must be initiated as described in Section 12.2.1 with repeat tests 
performed in two weeks. Upon re-test, if ALT or AST values have reduced to <5xULN, the 
subject can continue with the study. However, if ALT or AST remains ≥5xULN and 
<8xULN after re-test, IMP should be temporarily withheld and subject should undergo a 
repeat test in two weeks. If ALT or AST values remain ≥5xULN even after the second 
re-test, then the subject should be permanently withdrawn from the study and should be 
followed for possible drug-induced liver injury.
If subjects are unable to comply with the applicable monitoring schedule, IMP must be 
discontinued immediately.
Investigators should attempt to obtain information on subjects in the case of IMP discontinuation 
to complete the final evaluation. Subjects with PDILI should not be withdrawn from the study 
until investigation and monitoring are complete. All results of these evaluations and 
observations, as well as the reason(s) for IMP discontinuation and subject withdrawal (if 
applicable), must be recorded in the source documents. The eCRF must document the primary 
reason for IMP discontinuation.
7
STUDY TREATMENTS
7.1
Description of investigational medicinal products
The IMPs used in this study are bimekizumab, secukinumab, and placebo.
x
Bimekizumab will be supplied in a 1mL prefilled syringe (PFS) at a concentration of 
160mg/mL (55mM sodium acetate, 220mM glycine, 0.04% polysorbate 80 at pH 5.0) for sc 
injection.
x
Secukinumab is commercially available and will be supplied as a 150mg/mL single-use PFS 
for sc injection.
x
Placebo will be supplied as 0.9% sodium chloride aqueous solution (physiological saline, 
preservative free) of pharmacopeia (US Pharmacopeia/European Pharmacopeia) quality in a 
1mL PFS for sc injection.
Further details of the IMPs and their specifications are provided in the IMP Handling Manual.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 58 of 263
7.2
Treatments to be administered
Unblinded study staff will be responsible for preparation of the clinical trial material, including 
recording the administration information on source documents, and administration of the IMP as 
sc injections. The unblinded personnel will not be involved in the study in any way other than 
assuring the medication is taken from the correct kit and administering the drug to the subjects.
Suitable areas for sc injections are the lateral abdominal wall, upper outer thigh, or upper arm. 
During each dosing visit, each of the injections should be administered at a separate injection 
site. Injection sites should be rotated at each visit and injections should not be given into a PSO 
plaque or areas where the skin is tender, bruised, erythematous, or indurated. The injection 
should last approximately 10 to 15 seconds.
An IMP Handling Manual will be provided to each site containing instructions regarding drug 
preparation and dosing.
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 64 or at the next scheduled clinic visit after implementation 
of Protocol Amendment #5.1 if the subject has already completed the Week 64 visit. 
The dosing scheme for Baseline through Week 44 is depicted in Table 7‒1. The dosing scheme 
from Week 48 through Week 140 is depicted in Table 7‒2.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 59 of 263
Table 7‒1:
Dosing scheme, double-blind Treatment Period
Week
Dose Assignment
Baseline 
(first dose)
1
2
3
4
8
12
16a
20
24
28
32
36
40
44
Bimekizumab 
320mg
●●
○○
○○
○○
●●
●●
●●
Q4W
●●
●●
●●
●●
●●
●●
●●
●●
Q8W
●●
○○
●●
○○
●●
○○
●●
○○
Secukinumab 
300mg 
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
Q4W=every 4 weeks; Q8W=every 8 weeks
Notes: A bimekizumab 160mg injection is depicted by a black circle (●). A placebo injection is depicted by a white circle (○). A secukinumab 150mg injection 
is depicted by a black triangle (▲). 
a Subjects in the bimekizumab 320mg treatment arm will be re-randomized 1:2 to receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 60 of 263
Table 7‒2:
Dosing scheme, OLE Period
Week
Dose 
Assignment
48 (1st 
OLE) 
Year 2
Year 3
52
56
60
64a,b
68
72a,b
76
80
84a,c
88
92
96a,b
100
104
108a,c
112
116
120a,b
124
128
132a,c
136
140
C
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Bimekizumab 
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●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
Bimekizumab 
320mg Q8W
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
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C=clinic; H=home; OLE=Open-Label Extension; Q4W=every 4 weeks; Q8W=every 8 weeks
Notes: A bimekizumab 160mg injection is depicted by a black circle (●).
a The subject’s dosing interval will change from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W at Week 64 or at the next scheduled clinic visit (ie, 
Week 72, Week 84, Week 96, Week 108, Week 120, or Week 132) after implementation of Protocol Amendment #5.1 if the subject has already completed 
the Week 64 visit.
b Subjects whose dosing interval is changed to bimekizumab 320mg Q8W should be dosed at this visit and will receive kits for home administration 8 weeks 
later.
c Subjects whose dosing interval is changed to bimekizumab 320mg Q8W should NOT be dosed at this visit and will receive kits for home administration 4
weeks later.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 61 of 263
During the OLE Period, IMP administration on weeks with no scheduled clinic visit should 
primarily be performed by subjects at home. Self-injection training will be provided to the 
subject/caregiver by qualified site personnel at Week 48 (upon signature of the ICF). Additional 
training may be provided by site staff at subsequent clinic visits as needed. At Week 48 and 
subsequent clinic visits, the subject/caregiver will perform self-administration under the 
supervision of the site staff to ensure that study medication is being properly and safely injected. 
After the implementation of Protocol Amendment #5.4 (addition of a 48-week treatment period, 
ie, OLE2 Period), subjects will be invited to continue or reinitiate their treatment as per the 
following OLE2 Groups:
x
OLE2 Group A: Subjects in the treatment phase of the OLE Period at the time of Protocol 
Amendment #5.4 implementation will attend the Week 144 Visit and directly roll over to the 
OLE2 Period. These subjects will continue receiving bimekizumab 320mg Q8W for 
40 additional weeks, starting from the first treatment visit of the OLE2 Period (ie, Week 
144/OLE2 Baseline Visit; the Week 144 Visit will coincide with the Week 144/OLE2 
Baseline Visit and data collected at this visit will be used as baseline data for subjects 
entering the OLE2 Period).
x
OLE2 Group B: Eligible subjects who have completed the Week 144 Visit and are in the 
SFU or have completed the SFU of the OLE Period at the time of Protocol Amendment #5.4
implementation, will reinitiate their treatment in the OLE2 Period after having undergone 
Screening assessments during a 4-week OLE2 Screening Period. The first dose will be 
administered at the Week 144/OLE2 Baseline Visit and data collected at this visit will be 
used as baseline data for the OLE2 Period. Subjects in OLE2 Group B with an IGA score 
≥3 at the Week 144/OLE2 Baseline Visit will be treated with bimekizumab Q4W for the first 
16 weeks, then will switch to bimekizumab 320mg Q8W. Subjects in OLE2 Group B with an 
IGA score <3 at the Week 144/OLE2 Baseline Visit will be treated with bimekizumab Q8W 
from the Week 144/OLE2 Baseline Visit. 
During the OLE2 Period (Week 144/OLE2 Baseline to OLE2 Week 48), all subjects will attend 
study visits every 12 weeks. All subjects will be treated until OLE2 Week 40 (last dose of 
bimekizumab 320mg Q8W).
The dosing scheme from Week 144/OLE2 Baseline through OLE2 Week 40 is depicted in 
Table 7‒3.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 62 of 263
Table 7‒3:
Dosing scheme, OLE2 Period
Visits/Week
Dose Assignment
OLE2 Period
Week 144/OLE2
Baseline
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Notes: A bimekizumab 160mg injection is depicted by a black circle (●).
a Subjects will receive kits for home administration 4 weeks later.
b Subjects will receive kits for home administration 8 weeks later.
c Subjects should NOT be dosed at this visit and will receive kits for home administration 4 weeks later.
d Q4W/Q8W IMP administration only applies to those subjects who have entered the OLE2 Period as part of Group B, and had an IGA ≥3 upon entry of 
OLE2 Period. These subjects will receive Q4W dosing for 16 weeks until OLE2 Week 16, then will change from Q4W to Q8W and will receive their next 
dose at the scheduled clinic visit OLE2 Week 24.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 63 of 263
Once subjects/caregivers as determined by the Investigator (or designee) have been trained, the 
study medication may be administered at home. The subject will receive the required number of 
syringes for injections at each visit needed to perform the Q4W or Q8W administrations at home. 
Subjects who are unable to or decide not to self-inject IMP or those without a family 
member/friend/caregiver who can help, will not be discontinued, but may continue to visit the 
site for unscheduled visits for IMP administration only. 
If administered at home, the subject/caregiver will document the date, body location, kit number 
and time point of administration of study medication. 
All used syringes will be disposed of by subjects/caregivers as determined by the Investigator in 
an acceptable disposal (sharps) container directly after the administration. The 
subjects/caregivers return the documentation together with any used/unused containers at the 
next scheduled clinic visit. 
7.3
Packaging
The IMPs will be packaged and labeled according to Good Manufacturing Practice (GMP) 
guidelines and applicable laws or regulations. They will be suitably packaged in such a way as to 
protect the product from deterioration during transport and storage. Further information 
regarding storage and transport conditions are provided in the IMP Handling Manual.
7.4
Labeling
The IMPs will be labeled in accordance with the current International Council for Harmonisation 
(ICH) guidelines on Good Clinical Practice (GCP) and GMP and will include any locally 
required statements. If necessary, labels will be translated into the local language.
7.5
Handling and storage requirements
Refer to the IMP Handling Manual for the storage conditions of the IMP.
The Investigator (or designee) is responsible for the safe and proper storage of IMP at the site. 
Investigational medicinal product stored by the Investigator is to be kept in a secured area with 
limited access according to the storage conditions mentioned on the label.
Appropriate storage conditions must be ensured either by controlling the temperature (eg, room,
refrigeration unit) or by completion of a temperature log in accordance with local requirements 
on a regular basis (eg, once a week), showing actual and minimum/maximum temperatures 
reached over the time interval.
In case an out of range temperature is noted, it must be immediately reported as per instructions 
contained in the IMP Handling Manual.
The IMP will be shipped to the study sites in temperature controlled containers. Out-of-range 
shipping or storage conditions must be brought to the attention of the sponsor or designee, 
immediately. Authorization to use any out-of-range IMP must be documented and received prior 
to dispensing or administering the IMP at the study site.
In addition, the Investigator (or designee) will instruct the subject/caregiver on how to handle the 
IMP during transport, and how to store the IMP following the instruction guide. Cooler bags 
with freezer packs will be provided to the subjects/caregivers. Specific attention will be put on 
the transport from site to home using cold bags, and the subject/caregiver will be instructed to 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 64 of 263
put the IMP as quickly as possible into his/her refrigerator. In case of broken refrigerator, or 
broken or lost syringes, the subject will inform the site immediately and new IMP will be 
supplied. All efforts should be made to follow the treatment scheme as per protocol.
7.6
Drug accountability
A Drug Accountability form will be used to record IMP dispensing and return information on a 
by subject basis and will serve as source documentation during the course of the study. Details of 
any IMP lost, damaged (eg, due to breakage or wastage), not used, partially used, disposed of at 
the study site, or returned to the sponsor or designee must also be recorded on the appropriate 
forms. All supplies and pharmacy documentation must be made available throughout the study 
for UCB (or designee) to review.
In order to maintain the blind, all IMP documentation (eg, shipping receipts, drug accountability 
logs, interactive response technology [IRT] randomization materials) must be maintained and 
accessed by unblinded, trained site personnel only. Designated, unblinded site personnel must be 
appropriately trained and licensed (per country guidelines) to administer injections.
Unblinded study staff will be responsible for receipt, inventory, and destruction of used kits. The 
packaging identifies each kit by a unique number, but due to the commercial packaging of the 
comparator, the unblinded study staff will be responsible to maintain the blind. Unblinded study 
staff will be responsible for preparation (breaking tamper proof sticker on kit, etc) of the clinical 
trial material, including recording the administration information on source document.
The OLE2 Period will be unblinded and blinding precautions will not be applicable.
The Investigator (or designee) is responsible for retaining all used, unused, and partially used 
containers of IMP until returned or destroyed.
The Investigator should assign some of the Investigator’s duties for drug accountability at the 
study site to an appropriate pharmacist/designee.
The Investigator must ensure that the IMP is used only in accordance with the protocol.
Periodically, and/or after completion of the clinical phase of the study, all used (including empty 
containers)/partially used, unused, damaged, and/or expired IMP must be reconciled and either 
destroyed at the site according to local laws, regulations, and UCB Standard Operating 
Procedures (SOPs) or returned to UCB (or designee). Investigational medicinal product intended 
for the study cannot be used for any other purpose than that described in this protocol.
7.7
Procedures for monitoring subject compliance
During the double-blind Treatment Period (up to Week 44), investigational medicinal product 
will be administered in the clinic and compliance will be determined at the visit by study 
personnel. Drug accountability must be recorded on the Drug Accountability Form.
After Week 48, self-injection at home will be possible at the following weeks: Weeks 60, 68, 76, 
80, 88, 92, 100, 104, 112, 116, 124, 128, 136, 140, and at the OLE2 Weeks 4, 8, 16, 32, and 40.
Dates, body locations, kit numbers and time of self-injection will be captured using a home 
administration form. All used syringes will be disposed of by subjects/caregivers as determined 
by the Investigator in an acceptable disposal (sharps) container directly after the administration. 
The subjects/caregivers return the documentation together with any used/unused containers at the 
next scheduled clinic visit.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 65 of 263
Completed home administration forms should be reviewed by the Investigator with the subject. If 
a subject is noncompliant with the study procedures or medications that may present a risk to the 
safety of the subject in the opinion of the Investigator, then the subject should be withdrawn as 
described in Section 6.5.
7.8
Concomitant medications/treatments
Any treatment administered from the time of informed consent to the final study visit will be 
considered concomitant medication. This includes medications that were started before the study 
and are ongoing during the study.
7.8.1
Permitted concomitant treatments (medications and therapies)
The following concomitant medications are permitted during the study.
7.8.1.1
Topical medications
Subjects may continue to use topical moisturizers or emollients, bath oils, or oatmeal bath 
preparations for skin conditions during the study, as needed. Over-the-counter shampoos for the 
treatment of PSO of the scalp are also permitted.
In the double-blind Treatment Period, mild and low potency topical steroids will be permitted for 
use limited to the face, axilla, and/or genitalia, as needed. These topical medications should not 
be used within approximately 24 hours prior to study visits requiring IGA and PASI measures.
In the OLE and OLE2 Periods, the medications listed as permitted for the double-blind 
Treatment Period will be allowed. In addition, any topical steroids and vitamin D analog 
ointment will be permitted for use, as needed. These topical medications should not be used 
within approximately 24 hours prior to study visits requiring IGA and PASI measures.
7.8.1.2
Other medications
Subjects may take pain relievers (acetaminophen/paracetamol, NSAIDs, opiates) as needed for 
pain but preferably not within 24 hours of the Baseline and Week 48 Visits. Intraarticular 
injections (eg, steroids or hyaluronic acid) are permitted and must be carefully recorded in the 
eCRF.
Subjects who are receiving an established regimen for depression should remain on stable dosing 
prior to Baseline and throughout the study. 
7.8.2
Prohibited concomitant treatments (medications and therapies)
Table 7‒4 presents the list of prohibited PSO medications.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 66 of 263
Table 7‒4:
Prohibited psoriasis medications
Drug
Washout period relative to Baseline Visit
Topicals except for those permitted (Section 7.8.1.1)
2 weeks
Systemic retinoids
1 month 
Systemic treatment (non-biological), eg:
systemic immunosuppressant agents (eg, methotrexate, 
cyclosporine, azathioprine, thioguanine)
fumaric acid esters specifically used for the treatment of 
PSO 
systemic corticosteroids
phototherapy 
1 month
Anti-TNFs, eg:
etanercept (including biosimilar)
infliximab (including biosimilar), golimumab, certolizumab 
pegol, adalimumab (including biosimilar)
1 month for etanercept
3 months for everything other than etanercept
Other biologics and other systemic therapies, eg:
ustekinumab
6 months for ustekinumab
apremilast, tofacitinib
2 weeks for apremilast and tofacitinib
alefacept, efalizumab, guselkumab 
3 months for alefacept, efalizumab, and 
guselkumab
tildrakizumab, risankizumab
5 months for tildrakizumab, risankizumab
briakinumab
6 months for briakinumab
rituximab
12 months for rituximab
Anti-IL-17 therapies, eg:
brodalumab
ixekizumab
3 months
(any prior exposure to secukinumab or 
bimekizumab is excluded [see Section 6.2])
Any other antipsoriatic agent (systemic) under investigation (or 
approved after the protocol is approved)
3 months or 5 half-lives, whichever is greater
Any other antipsoriatic agent (topical) under investigation
1 month
IL-17=interleukin 17; PSO=psoriasis; TNF=tumor necrosis factor
Up to Week 144
Subjects who take prohibited medications may be withdrawn from IMP but followed until the 
SFU Visit. The decision to withdraw a subject for taking prohibited medications should be made 
in consultation with the Medical Monitor.
Post Week 144 (OLE2 Period)
Subjects who have used systemic treatments after Week 144 must have stopped this treatment 
1 month prior to receiving the first bimekizumab injection in the OLE2 Period. Subjects 
receiving systemic immunomodulatory medications for an indication other than PSO must have
their eligibility confirmed by the Medical Monitor prior to enrollment in the OLE2 Period.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 67 of 263
7.8.2.1
Vaccines
Administration of live (including attenuated) vaccines is not allowed during the conduct of the 
study and for 20 weeks after the final dose of IMP (see Exclusion Criterion #10, Section 6.2).
Administration of inactivated vaccines is allowed during the study at the discretion of the 
Investigator.
7.9
Blinding
Due to differences in presentation between the bimekizumab and secukinumab, special 
precautions will be taken to ensure study blinding during the double-blind Treatment Period and 
study sites will have blinded and unblinded personnel.
For subjects receiving bimekizumab, bimekizumab will be administered at Baseline; placebo will 
be administered at Week 1, Week 2, and Week 3; their second dose of bimekizumab will be at 
Week 4; and bimekizumab doses Q4W through Week 16. At Week 16 subjects in the 
bimekizumab 320mg treatment arm will be re-randomized 1:2 to receive bimekizumab 320mg 
Q4W or bimekizumab 320mg Q8W. To maintain the blind, subjects in the bimekizumab 320mg 
Q8W treatment arm will receive placebo at Weeks 20, 28, 36, and 44. Secukinumab subjects will 
receive secukinumab at Baseline, Week 1, Week 2, Week 3, Week 4, and Q4W thereafter.
All Sponsor and Investigator site personnel involved in the study will be blinded to the 
randomized IMP assignment with the following exceptions:
x
Unblinded study staff will be responsible for preparation (breaking tamper proof sticker on 
kit, etc) of the clinical trial material, including recording the administration information on 
source documents, and administration of the IMP as sc injections. The unblinded personnel 
will not be involved in the study in any way other than assuring the medication is taken from 
the correct kit and administering the drug to the subjects.
x
Bioanalytical staff analyzing blood samples for bimekizumab and anti-bimekizumab 
antibody determination.
During the double-blind Treatment Period of the study, the Sponsor will provide blinded and 
unblinded site monitors for the purposes of verifying safety, efficacy, and drug administration 
and documentation records. Unblinded study site personnel need to be available in order to 
resolve queries. Study monitors and study site personnel, blinded to treatment assignment, will 
not discuss or have access to any drug related information. This will continue at least until all 
subjects have completed the double-blind Treatment Period of the study.
Study sites will be required to have a written blinding plan in place, signed by the Principal 
Investigator, which will detail the site’s steps for ensuring that the double-blind nature of the 
study is maintained. Sites will be instructed to keep study subjects blind to the IMP as detailed in 
the site blinding plan.
After all subjects have completed the double-blind Treatment Period of the study and the interim 
analysis has occurred, unblinded study site personnel can perform assessments in the OLE and 
OLE2 Period(s) of the study.
Further details are provided in the study manual and site blinding plan.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 68 of 263
7.9.1
Procedures for maintaining and breaking the treatment blind
7.9.1.1
Maintenance of IMP blind
All subject treatment details (bimekizumab or secukinumab) will be allocated and maintained by 
the IRT system.
7.9.1.2
Breaking the treatment blind in an emergency situation
The integrity of this clinical study must be maintained by observing the treatment blind. In the 
event of an emergency for which the appropriate treatment for a subject cannot be made without 
knowing the treatment assignment, it will be possible to determine to which treatment arm and 
dose the subject has been allocated by contacting the IRT. All sites will be provided with details 
of how to contact the system for code breaking at the start of the study. The Medical Monitor or 
equivalent should be consulted prior to unblinding, whenever possible.
The Clinical Project Manager (CPM) will be informed immediately via the IRT when a code is 
broken, but will remain blinded to specific treatment information. Any unblinding of the IMP 
performed by the Investigator must be recorded in the source documents and on the Study 
Termination eCRF page.
7.10
Randomization and numbering of subjects
An IRT will be used for assigning eligible subjects to a treatment regimen based on a 
predetermined production randomization and/or packaging schedule provided by UCB (or 
designee). The randomization schedule will be produced by the IRT vendor. The IRT will 
generate individual assignments for subject kits of IMP, as appropriate, according to the visit 
schedule. Subject treatment assignment will be stratified by region and prior biologic exposure 
(yes/no). The IRT will generate individual assignments for subject kits of IMP, as appropriate, 
according to the visit schedule. 
At Screening, each subject will be assigned a 5-digit number that serves as the subject identifier 
throughout the study. The subject number will be required in all communication between the 
Investigator or designee and the IRT regarding a particular subject.
At the Baseline Visit, a subject will be randomized into the study. The Investigator or designee 
will use the IRT for randomization. The IRT will automatically inform the Investigator or 
designee of the subject’s identification number. The IRT will allocate kit numbers to the subject 
based on the subject number during the course of the study. The kits are blinded.
At Week 16 subjects in the bimekizumab 320mg treatment arm will be re-randomized 1:2 to 
receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. To maintain the blind after 
re-randomization, subjects in the bimekizumab 320mg Q8W treatment arm will receive placebo 
at Weeks 20, 28, 36, and 44. Subjects in the secukinumab arm will continue to receive 
secukinumab 300mg Q4W.
In the OLE Period, subjects:
x
Who received bimekizumab 320mg Q4W and achieved PASI90 at Week 48 of the double-
blind Treatment Period will be randomized 1:1 to receive bimekizumab 320mg Q4W or 
bimekizumab 320mg Q8W.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 69 of 263
x
Who received bimekizumab 320mg Q4W and who did not achieve PASI90 at Week 48 of 
the double-blind Treatment Period will receive bimekizumab 320mg Q4W.
x
Who received bimekizumab 320mg Q8W and who did not achieve PASI90 at Week 48 of 
the double-blind Treatment Period will receive bimekizumab 320mg Q4W.
x
Who received bimekizumab 320mg Q8W and who achieved PASI90 at Week 48 of the 
double-blind Treatment Period will receive bimekizumab 320mg Q8W.
x
Who received secukinumab and who did not achieve PASI90 at Week 48 of the double-blind 
Treatment Period will receive bimekizumab 320mg Q4W.
x
Who received secukinumab and who achieved PASI90 at Week 48 of the double-blind 
Treatment Period will be randomized 1:1 to receive bimekizumab 320mg Q4W or 
bimekizumab 320mg Q8W.
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 64, or at the next scheduled clinic visit after implementation
of Protocol Amendment #5.1 if the subject has already completed Week 64. 
Subjects who roll over directly from the OLE Period into the OLE2 Period will continue 
receiving bimekizumab 320mg Q8W and will keep their unique 5-digit identification number. 
Subjects who reinitiate bimekizumab after having completed treatment (subjects in the SFU of 
the OLE Period or who have completed the SFU of the OLE Period) will receive either 
bimekizumab 320mg Q4W/Q8W or bimekizumab 320mg Q8W depending on their disease 
activity at time of reentry (bimekizumab 320mg Q4W/Q8W for subjects with IGA score ≥3 or 
bimekizumab 320mg Q8W for subjects with IGA score <3). For these subjects, the same unique 
5-digit identification number used in the study will be reused.
Subject numbers and kit numbers will be tracked via the IRT during the double-blind Treatment 
Period, the OLE Period, and the OLE2 Period.
8
STUDY PROCEDURES BY VISIT
Table 5‒1, Table 5‒2, and Table 5-3 provide a general overview of study assessments during the 
double-blind Treatment Period, the OLE Period, and the OLE2 Period, respectively. A list of 
procedures to be completed at each visit is described below.
x
Visit windows of ±3 days on either side of the scheduled dosing are permitted up to and 
including Week 24; however, the Investigator should try to keep the subjects on the original 
dosing schedule. From the Week 28 Visit through the Week 72 Visit, visit windows of 
±7 days on either side of the scheduled dosing are permitted; however, the Investigator 
should try to keep the subjects on the original dosing schedule. From the Week 76 Visit 
through the Week 144/PEOT Visit, visit windows of ±14 days on either side of the scheduled 
dosing are permitted; however, the Investigator should try to keep the subjects on the original 
dosing schedule. The visit window is relative to Baseline and applicable for all subsequent 
visits up to Week 144/OLE2 Baseline Visit. From the Week 144/OLE2 Baseline Visit 
through the OLE2 Week 48/PEOT Visit, visit windows of ±14 days relative to the Week 
144/OLE2 Baseline Visit on either side of the scheduled dosing are permitted; however, the 
Investigator should try to keep the subjects on the original dosing schedule. Changes to the 
dosing schedule outside the visit window must be discussed with the Medical Monitor.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 70 of 263
x
The dosing window from Baseline through Week 4 is ±2 days relative to the scheduled 
dosing visit. From Week 8 through Week 24, the dosing window is ±3 days relative to the 
scheduled dosing visit. From Week 28 through the Week 72 Visit, the dosing window is 
±7 days relative to the scheduled dosing visit. From the Week 76 Visit through the OLE2 
Week 40 Visit, the dosing window is ±14 days relative to the scheduled dosing visit.
x
For the SFU and SFU2 Visits (20 weeks after the final dose), the visit window is ±7 days 
relative to the scheduled visit date.
8.1
Screening Visit (2 to 5 weeks)
Prior to any study specific activities, subjects will be asked to read, sign, and date an ICF that has 
been approved by the Sponsor and an Institutional Review Board (IRB)/Independent Ethics 
Committee (IEC), and that complies with regulatory requirements. Subjects will be given 
adequate time to consider any information concerning the study given to them by the Investigator 
or designee. As part of the informed consent procedure, subjects will be given the opportunity to 
ask the Investigator any questions regarding potential risks and benefits of participation in the 
study.
The following procedures/assessments will be performed at the Screening Visit:
x
Informed consent
x
Inclusion/exclusion
x
Urine drug screen
x
Demographic data (age, gender, race and ethnicity [according to local regulations])
x
Psoriasis history including the date of onset and past treatments
x
Significant past medical history including clinically relevant past or coexisting medical 
conditions and surgeries
x
Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB
x
Vital signs (sitting systolic and diastolic blood pressure [BP], pulse rate, and body 
temperature) should be obtained prior to blood sampling
x
Collection of blood and urine samples for the following clinical laboratory tests:

Hematology and biochemistry
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Urinalysis
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Serum pregnancy test

Hepatitis B and Hepatitis C

HIV
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IGRA tuberculosis test
x
Record 12-lead ECG
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 71 of 263
x
Chest x-ray (not necessary if performed within 3 months prior to Screening Visit and report 
is available)
x
Tuberculosis questionnaire
x
PASI
x
Percentage of BSA
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IGA
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x
Concomitant medication
x
AEs
x
Contact IRT 
8.2
Treatment Period
8.2.1
Baseline Visit
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
x
Inclusion/exclusion (includes evaluation of signs and symptoms of active TB and risk for 
exposure to TB)
x
Significant past medical history and concomitant diseases to ensure no significant changes 
since Screening
x
Height
x
Body weight
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Hematology and biochemistry

Urinalysis

Urine pregnancy test

Bimekizumab/secukinumab plasma concentrations

Anti-bimekizumab antibodies
x
Tuberculosis questionnaire
x
PASI
x
Percentage of BSA
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 72 of 263
x
IGA
x
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x
Patient symptoms (itch, pain, and scaling)
x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
Upon confirmation of subject’s eligibility, randomization will occur
x
Contact IRT 
After completion of the above-mentioned procedures, IMP administration will occur.
8.2.2
Week 1 and Week 2 Visits (±3 days relative to Baseline)
The following procedures/assessments will be performed/recorded:
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood samples for the following tests should be obtained prior to dosing:

Hematology and biochemistry
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Bimekizumab/secukinumab plasma concentrations

Anti-bimekizumab antibodies
x
PASI
x
Percentage of BSA
x
IGA
x
scalp IGA for subjects with scalp involvement at Baseline
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 73 of 263
x
Photographs of skin and nails (subjects consenting to sub-study in participating centers only)
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8.2.3
Week 3 Visit (±3 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Concomitant medication
x
AEs
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Contact IRT
After completion of the above-mentioned procedures, administration of IMP will occur.
8.2.4
Week 4 Visit (±3 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

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Urine pregnancy test
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Bimekizumab/secukinumab plasma concentrations
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Anti-bimekizumab antibodies
x
PASI
x
Percentage of BSA
x
IGA
x
DLQI
x
Patient symptoms (itch, pain, and scaling)
x
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x
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 74 of 263
x
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x
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x
Patient Global Assessment of psoriasis
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After completion of the above-mentioned procedures, administration of IMP will occur.
8.2.5
Week 8 and Week 12 Visits (±3 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
x
Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB (Week 12 only)
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

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Urine pregnancy test

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
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x
Tuberculosis questionnaire (Week 12 only)
x
PASI
x
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DLQI
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x
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x
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x
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x
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x
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 75 of 263
x
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After completion of the above-mentioned procedures, administration of IMP will occur.
8.2.6
Week 16 Visit (±3 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
x
Body weight
x
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 76 of 263
x
Concomitant medication
x
AEs
x
Contact IRT
At Week 16 subjects in the bimekizumab 320mg treatment arm will be re-randomized 1:2 to 
receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. After completion of the 
above-mentioned procedures, administration of IMP will occur.
8.2.7
Week 20 (±3 days relative to Baseline) and Week 28 Visits (±7 days 
relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Urine pregnancy test

Bimekizumab/secukinumab plasma concentrations (Week 20 only)

Anti-bimekizumab antibodies (Week 20 only)
x
PASI
x
Percentage of BSA
x
IGA
x
PHQ-9
x
eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
After completion of the above-mentioned procedures, administration of IMP will occur.
8.2.8
Week 24 Visit (±3 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
x
Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB
x
Body weight
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 77 of 263
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Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:
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Hematology and biochemistry 
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IGA
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PHQ-9
x
eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
After completion of the above-mentioned procedures, administration of IMP will occur.
8.2.9
Week 32 Visit (±7 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Hematology and biochemistry
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Urinalysis

Urine pregnancy test
x
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x
PASI
x
Percentage of BSA
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IGA
x
DLQI
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 78 of 263
x
Patient symptoms (itch, pain, and scaling)
x
PHQ-9
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eC-SSRS
x
scalp IGA for subjects with scalp involvement at Baseline
x
mNAPSI for subjects with nail involvement at Baseline
x
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x
Patient Global Assessment of psoriasis
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PGADA (only for subjects with PsA)
x
WPAI-SHP V2.0
x
Photographs of skin and nails (subjects consenting to sub-study in participating centers only)
x
EQ-5D-3L
x
Concomitant medication
x
AEs
x
Contact IRT
After completion of the above-mentioned procedures, administration of IMP will occur.
8.2.10
Week 36 Visit (±7 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
x
Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB
x
Body weight
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Urine pregnancy test

Bimekizumab/secukinumab plasma concentrations

Anti-bimekizumab antibodies
x
Tuberculosis questionnaire
x
PASI
x
Percentage of BSA
x
IGA
x
PHQ-9
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 79 of 263
x
eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
After completion of the above-mentioned procedures, administration of IMP will occur.
8.2.11
Week 40 Visit (±7 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Hematology and biochemistry

Urinalysis

Urine pregnancy test
x
PASI
x
Percentage of BSA
x
IGA
x
PHQ-9
x
eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
After completion of the above-mentioned procedures, administration of IMP will occur.
8.2.12
Week 44 Visit (±7 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained at this visit:

Urine pregnancy test

IGRA tuberculosis test
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 80 of 263
x
PASI
x
Percentage of BSA
x
IGA
x
PHQ-9
x
eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
After completion of the above-mentioned procedures, administration of IMP will occur.
8.2.13
Week 48 Visit (±7 days relative to Baseline)
The following procedures/assessments will be performed/recorded:
x
Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB
x
Body weight
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained at this visit:

Hematology and biochemistry

Urinalysis

Urine pregnancy test

Bimekizumab/secukinumab plasma concentrations

Anti-bimekizumab antibodies
x
Record 12-lead ECG
x
Tuberculosis questionnaire
x
PASI
x
Percentage of BSA
x
IGA
x
DLQI
x
Patient symptoms (itch, pain, and scaling)
x
PHQ-9
x
scalp IGA for subjects with scalp involvement at Baseline
x
mNAPSI for subjects with nail involvement at Baseline
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 81 of 263
x
pp-IGA for subjects with palmoplantar involvement at Baseline
x
Patient Global Assessment of psoriasis
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PASE
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PGADA (only for subjects with PsA)
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WPAI-SHP V2.0
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EQ-5D-3L
x
eC-SSRS
x
Concomitant medication
x
AEs
8.3
OLE Period
8.3.1
Week 48 Visit (±7 days relative to Baseline)
The following procedures/assessments will be performed/recorded after completion of 
assessments listed for Week 48 (Section 8.2.13) and prior to administration of IMP:
x
Sign a separate ICF for the OLE Period
x
Inclusion/exclusion: Confirm that subject completed the double-blind Treatment Period 
without meeting any withdrawal criteria and has been compliant with the ongoing clinical 
study requirements
x
Upon confirmation of subject’s eligibility, randomization will occur
x
Contact IRT
Self-injection training will be provided to the subject/caregiver by qualified site personnel to 
allow self-injection to be performed at home after Week 48. Additional training may be provided 
by site staff at subsequent clinic visits as needed (see Section 7.2).
After completion of the above-mentioned procedures, IMP administration will occur, preferably 
by self-injection under supervision of the site personnel.
8.3.2
Week 52 Visit (±7 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Hematology and biochemistry

Urine pregnancy test
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 82 of 263
x
PASI
x
Percentage of BSA
x
IGA
x
PHQ-9
x
eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
After completion of the above-mentioned procedures, administration of IMP will occur for 
subjects on bimekizumab 320mg Q4W dosing only, preferably by self-injection under 
supervision of the site personnel.
8.3.3
Week 56 Visit (±7 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Hematology and biochemistry

Urine pregnancy test
x
Tuberculosis questionnaire
x
PASI
x
Percentage of BSA
x
IGA
x
Patient symptoms (itch, pain, and scaling)
x
PHQ-9
x
eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
After completion of the above-mentioned procedures, administration of IMP will occur, 
preferably by self-injection under supervision of the site personnel.
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 83 of 263
8.3.4
Self-injection at home (Weeks 60, 68, 76, 80, 88, 92, 100, 104, 112, 
116, 124, 128, 136, and 140)
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 64 or at the next scheduled clinic visit (ie, Week 72, Week 
84, Week 96, Week 108, Week 120, or Week 132) after implementation of 
Protocol Amendment #5.1 if the subject has already completed the Week 64 visit. 
Subjects receiving bimekizumab 320mg Q4W will be given the opportunity for self-injection of 
bimekizumab at home on the following weeks: Weeks 60, 68, 76, 80, 88, 92, 100, 104, 112, 116, 
124, 128, 136, and 140. This only applies to those subjects who have not yet changed to 
bimekizumab 320mg Q8W.
Subjects receiving bimekizumab 320mg Q8W will be given the opportunity for self-injection of
bimekizumab at home on the following weeks: Weeks 80, 88, 104, 112, 128, and 136.
Subjects of childbearing potential should conduct a home pregnancy test every 4 weeks. In case 
of a scheduled home self-injection the pregnancy test needs to be performed immediately prior to
self-injecting bimekizumab at home. If the pregnancy test result is positive, IMP should not be 
administered and the site should be contacted.
x
Adverse events will be captured spontaneously if the subject decides to visit the site to 
receive the bimekizumab administration. 
x
All used syringes will be disposed of by subjects/caregivers as determined by the Investigator 
in an acceptable disposal (sharps) container directly after the administration. The 
subjects/caregivers return the documentation together with any used/unused containers at the 
next scheduled clinic visit.
8.3.5
Week 64 (±7 days relative to Baseline), Week 84, Week 108, Week 132 
Visits (±14 days relative to Baseline)
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W as follows:
x
At Week 64 if the subject has not completed the Week 64 visit prior to implementation of 
Protocol Amendment #5.1.
x
At Week 84 if the subject has already completed the Week 72 visit prior to implementation 
of Protocol Amendment #5.1.
x
At Week 108 if the subject has already completed the Week 96 visit prior to implementation 
of Protocol Amendment #5.1.
x
At Week 132 if the subject has already completed the Week 120 visit prior to implementation 
of Protocol Amendment #5.1.
Subjects whose dosing interval is being changed to bimekizumab 320mg Q8W will receive kits 
for home administration as follows:
x
Subjects whose dosing interval is being changed to bimekizumab 320mg Q8W at Week 64 
should be dosed at this visit, and will receive kits for home administration 8 weeks later 
(Table 7‒2).
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 84 of 263
x
Subjects whose dosing interval is being changed to bimekizumab 320mg Q8W at Week 84,
Week 108, or Week 132 should NOT be dosed at that visit, and will receive kits for home 
administration 4 weeks later (Table 7‒2).
The following procedures/assessments will be performed/recorded. If IMP is administered on 
site during this visit, they need to be performed/recorded prior to administration of IMP:
x
Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Hematology and biochemistry

Urinalysis

Urine pregnancy test
x
Tuberculosis questionnaire
x
PASI
x
Percentage of BSA
x
IGA
x
Patient symptoms (itch, pain, and scaling)
x
PHQ-9
x
eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
After completion of the above-mentioned procedures, administration of IMP will occur:
x
At each of these visits for subjects on bimekizumab 320mg Q4W dosing, preferably by 
self-injection under supervision of the site personnel. This only applies to those subjects who 
have not yet changed to Q8W after implementation of Protocol Amendment #5.1.
x
At Week 64 only for those subjects on bimekizumab 320mg Q8W dosing, preferably by self-
injection under supervision of the site personnel.
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. Home pregnancy tests will be provided for 
testing every 4 weeks as appropriate (Table 5‒2).
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 85 of 263
8.3.6
Week 72 (±7 days relative to Baseline) and Week 120 Visits (±14 days 
relative to Baseline)
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W as follows:
x
At Week 72 if the subject has already completed the Week 64 visit prior to implementation 
of Protocol Amendment #5.1.
x
At Week 120 if the subject has already completed the Week 108 visit prior to implementation 
of Protocol Amendment #5.1.
As depicted in Table 7‒2, subjects whose dosing interval is being changed to 
bimekizumab 320mg Q8W at one of these visits should be dosed at this visit and will receive kits 
for home administration 8 weeks later.
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
x
Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Hematology and biochemistry

Urinalysis

Urine pregnancy test

Bimekizumab plasma concentrations

Anti-bimekizumab antibodies
x
Tuberculosis questionnaire
x
PASI
x
Percentage of BSA
x
IGA
x
DLQI
x
Patient symptoms (itch, pain, and scaling)
x
PHQ-9
x
scalp IGA for subjects with scalp involvement at Baseline
x
mNAPSI for subjects with nail involvement at Baseline
x
pp-IGA for subjects with palmoplantar involvement at Baseline
x
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 86 of 263
x
eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
x
After completion of the above-mentioned procedures, administration of IMP will occur, 
preferably by self-injection under supervision of the site personnel.
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. Home pregnancy tests will be provided for 
testing every 4 weeks as appropriate (Table 5‒2).
8.3.7
Week 96 Visit (±14 days relative to Baseline)
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 96 if the subject has already completed the Week 84 visit 
prior to implementation of Protocol Amendment #5.1. As depicted in Table 7‒2, subjects whose 
dosing interval is being changed to bimekizumab 320mg Q8W at Week 96 should be dosed at 
this visit, and will receive kits for home administration 8 weeks later.
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
x
Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB
x
Body weight
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Hematology and biochemistry

Urinalysis

Urine pregnancy test

IGRA tuberculosis test

Bimekizumab plasma concentrations

Anti-bimekizumab antibodies
x
Record 12-lead ECG
x
Tuberculosis questionnaire
x
PASI
x
Percentage of BSA
x
IGA
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 87 of 263
x
DLQI
x
Patient symptoms (itch, pain, and scaling)
x
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x
scalp IGA for subjects with scalp involvement at Baseline
x
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x
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x
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x
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x
EQ-5D-3L
x
eC-SSRS
x
Concomitant medication
x
AEs
x
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At Week 96, after completion of the above-mentioned procedures, administration of IMP will 
occur, preferably by self-injection under supervision of the site personnel
Distribution of IMP and accountability activities for home administration to be performed as
described in Section 7.2, Section 7.5, and Section 7.7. Home pregnancy tests will be provided for 
testing every 4 weeks as appropriate (Table 5‒2).
8.3.8
Week 144 Visit (±14 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration of
IMP:
x
Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB
x
Body weight
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Hematology and biochemistry

Urinalysis

Urine pregnancy test
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IGRA tuberculosis test
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Bimekizumab plasma concentrations
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 88 of 263

Anti-bimekizumab antibodies
x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
AEs
x
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Return of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7.
If Protocol Amendment #5.4 is implemented at the time subjects are treated in the OLE Period 
(ie, up to Week 144; OLE2 Group A subjects), these subjects will be invited to participate in the 
OLE2 Period and may directly roll over and continue their treatment from the Week 144/OLE2 
Baseline Visit as long as they do not meet any of the withdrawal criteria and have provided 
informed consent.
If Protocol Amendment #5.4 is implemented at the time subjects have completed the Week 144 
Visit and are in the SFU Period of the OLE Period or have completed the SFU of the OLE Period 
(Group B subjects), these subjects will be invited to enter the OLE2 Period to reinitiate their 
treatment in the OLE2 Period. However, before receiving the first dose at the Week 144/OLE2 
Baseline Visit, they will first undergo screening during the 4-week OLE2 Screening Period 
(Section 8.4.1).
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 89 of 263
8.4
OLE2 Period
8.4.1
OLE2 Screening (up to 4 weeks) – applicable for OLE2 Group B only
Prior to any study specific activities of the OLE2 Period, subjects who completed the Week 144 
Visit and are in the SFU or have completed the SFU of the OLE Period (OLE2 Group B 
subjects) will undergo screening. Subjects who have used systemic treatments after Week 144 
must have stopped this treatment 1 month prior to receiving the first bimekizumab injection in 
the OLE2 Period. Screening procedures may be performed during this time. Subjects receiving 
systemic immunomodulatory medications for an indication other than PSO must have their 
eligibility confirmed by the Medical Monitor prior to enrollment in the OLE2 Period.
At the Screening Visit of the OLE2 Period (OLE2 Screening Visit), subjects will be asked to 
read, sign, and date an ICF that has been approved by the Sponsor and an IRB/IEC and that 
complies with regulatory requirements. Subjects will be given adequate time to consider any 
information concerning the study given to them by the Investigator or designee. As part of the 
informed consent procedure, subjects will be given the opportunity to ask the Investigator any 
questions regarding potential risks and benefits of continued participation in the study.
The following procedures/assessments will be performed at the OLE2 Screening Visit for 
subjects in the OLE2 Group B:
x
Informed consent
x
Inclusion/exclusion
x
Urine drug screen
x
Significant past medical history including clinically relevant past or coexisting medical 
conditions and surgeries (only applicable for subjects who completed the SFU, only new or 
modified medical history since completing the SFU should be entered in eCRF)
x
AEs (only for subjects in the SFU)
x
Physical exam
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following clinical laboratory tests:

Hematology and biochemistry

Urinalysis

Urine pregnancy test

Hepatitis B and Hepatitis C

HIV
x
Tuberculosis questionnaire
x
PASI
x
Percentage of BSA
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 90 of 263
x
IGA
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SFU)
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8.4.2
OLE2 Baseline Visit
Subjects who will still be treated in the OLE Period at the time of implementing Protocol 
Amendment #5.4 (OLE2 Group A subjects) will attend Week 144 Visit and directly roll over to 
the OLE2 Period to continue their treatment (bimekizumab 320mg Q8W). They will undergo all 
study assessments of the Week 144 Visit and will receive bimekizumab 320mg Q8W at this visit, 
which will also coincide with the first visit of the OLE2 Period, ie, the Week 144/OLE2 Baseline 
Visit.
Subjects who have completed Week 144 Visit and are in the SFU of the OLE or have completed 
the SFU Period at the time of Protocol Amendment #5.4 implementation (OLE2 Group B 
subjects) will reinitiate their treatment at the Week 144/OLE2 Baseline Visit, and will be 
assigned a treatment regimen based on their disease severity at the Week 144/OLE2 Baseline 
Visit (bimekizumab 320mg Q4W/Q8W for subjects with IGA score ≥3 or bimekizumab 320mg 
Q8W for subjects with IGA score <3).
Applicable for OLE2 Groups A and B:
x
Physical exam
x
Body weight
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following clinical laboratory tests:

Hematology and biochemistry

Urinalysis

Urine pregnancy test
x
eC-SSRS
x
Tuberculosis questionnaire
x
PASI
x
Percentage of BSA
x
IGA
x
PHQ-9
x
DLQI
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 91 of 263
x
Patient symptoms (itch, pain, and scaling)
x
Concomitant medication
x
AEs
x
Contact IRT
Additional Procedures/assessments applicable for OLE2 Group A 
x
Informed Consent 
x
ECG
x
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x
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x
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x
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x
PASE
x
PGADA
x
WPAI-SHP V2.0
At the Week 144/OLE2 Baseline Visit, after completion of the above-mentioned procedures, 
administration of IMP will occur, preferably by self-injection under supervision of the site 
personnel.
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7.
8.4.3
Self-injection at home (OLE2 Weeks 4, 8, 16, 32, and 40)
Subjects receiving bimekizumab 320mg Q8W will be given the opportunity for self-injection of 
bimekizumab at home on the following weeks: OLE2 Weeks 8, 16, 32, and 40.
Subjects receiving bimekizumab 320mg Q4W/Q8W will be given the opportunity for self-
injection of bimekizumab at home on the following weeks: OLE2 Weeks 4, 8, and 16. At OLE2 
Week 16, subjects receiving bimekizumab 320mg Q4W/Q8W will switch to bimekizumab 
320mg Q8W regimen and will be given the opportunity for self-injection of bimekizumab at 
home dosed at OLE2 Weeks 32 and 40.
Subjects of childbearing potential should conduct a home pregnancy test every 4 weeks. In case 
of a scheduled home self-injection the pregnancy test needs to be performed immediately prior to 
self-injecting bimekizumab at home. If the pregnancy test result is positive, IMP should not be 
administered and the site should be contacted.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 92 of 263
Adverse events will be captured spontaneously if the subject decides to visit the site to receive 
the bimekizumab administration. 
All used syringes will be disposed of by subjects/caregivers as determined by the Investigator in 
an acceptable disposal (sharps) container directly after the administration. The
subjects/caregivers return the documentation together with any used/unused containers at the 
next scheduled clinic visit.
8.4.4
OLE2 Week 12, Week 24, and Week 36 Visits (±14 days relative to 
OLE2 Baseline)
As depicted in Table 7‒3, subjects receiving bimekizumab 320mg Q4W/Q8W should receive 
IMP at the OLE2 Week 12 Visit, and all subjects will receive kits for home administration 
4 weeks later at OLE2 Week 16. All subjects will receive IMP administration at the OLE2 Week 
24 Visit, and will receive kits for home administration 8 weeks later. At the OLE2 Week 36 
Visit, subjects will not be dosed and will receive kits for home administration 4 weeks later at 
OLE2 Week 40.
The following procedures/assessments will be performed/recorded at every clinic visit prior to 
administration of IMP:
x
Physical exam
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Urine pregnancy test, for applicable subjects
x
Tuberculosis questionnaire 
x
PASI
x
Percentage of BSA 
x
IGA
x
Patient symptoms (itch, pain, and scaling)
x
PHQ-9
x
eC-SSRS 
x
Concomitant medication 
x
AEs 
x
Contact IRT 
The following will be additional assessments will be performed / recorded every 24 weeks (ie, 
OLE2Weeks 24 and 48) prior to administration of IMP
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Hematology and biochemistry
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 93 of 263

Urinalysis
x
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At the OLE2 Week 12 and Week 24 Visit, after completion of the above-mentioned procedures, 
administration of IMP will occur, preferably by self-injection under supervision of the site 
personnel.
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. Home pregnancy tests will be provided for 
testing every 4 weeks as appropriate (Table 5‒2 and Table 5-3).
8.4.5
OLE2 Week 48 Visit (±14 days relative to OLE2 Baseline)
The following procedures/assessments will be performed/recorded:
x
Physical exam
x
Body weight
x
Vital signs (sitting systolic BP and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing:

Hematology and chemistry

Urinalysis

Urine pregnancy test

IGRA TB test
x
Tuberculosis questionnaire
x
PASI
x
Percentage of BSA
x
IGA
x
DLQI
x
Patient symptoms (itch, pain, and scaling)
x
PHQ-9
x
eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
Return of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 94 of 263
8.5
Premature End of Treatment Visit
If a subject is withdrawn from the study during the OLE Period (up to Week 144):
x
If the subject will be withdrawn from IMP prior to the Week 48 visit of the double-blind 
Treatment Period, the subject will undergo the same assessments as the Week 48 visit (see
Section 8.2.13), and will enter the SFU Period.
x
If the subject will be withdrawn from IMP prior to the Week 144 visit of the OLE Period, the 
subject will undergo the same assessments as the Week 144 visit (see Section 8.3.8), and will 
enter the SFU Period.
x
The subject will be encouraged to return for the SFU Visit (20 weeks after the last received 
dose; see Section 8.6).
If a subject is withdrawn from the study during the OLE2 Period:
x
The subject will be withdrawn from IMP, will undergo the same assessments as the OLE2 
Week 48 Visit (see Section 8.4.5) and will enter the SFU2 Period.
x
The subject will be encouraged to return for the SFU2 Visit (20 weeks after the last received 
dose; see Section 8.7).
8.6
Safety Follow-Up Visit (20 weeks after final dose up to Week 
144, ±7 days)
The following procedures/assessments will be performed/recorded:
x
Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained at this visit:

Hematology and biochemistry

Urinalysis

Urine pregnancy test

Bimekizumab (secukinumab for subjects not entering the OLE Period) plasma 
concentrations 

Anti-bimekizumab antibodies
x
Tuberculosis questionnaire
x
eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 95 of 263
8.7
Safety Follow-Up Visit 2 (20 weeks after final dose in the OLE2 
Period, ±7 days)
The following procedures/assessments will be performed/recorded:
x
Physical exam 
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained at this visit:

Hematology and biochemistry

Urinalysis

Urine pregnancy test
x
eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
8.8
Unscheduled Visit
At the Investigator’s discretion, an Unscheduled Visit may be completed at any time during the 
study but prior to the SFU Visit or SFU2 Visit (depending on which period, OLE or OLE2, the 
participant is in), if deemed necessary for the subject’s safety and well-being.
If an Unscheduled Visit is conducted due to safety or efficacy reasons, an eC-SSRS assessment 
will be performed with the subject during the visit. If an Unscheduled Visit is conducted for 
reasons other than safety or efficacy concerns (eg, repeated collection of a laboratory specimen 
due to collection or analysis issues, injection for subjects not making use of home self-
injections), an eC-SSRS will not be required at these visits.
At this visit, any assessment may be performed, as needed, depending on the reason for the visit.
9
ASSESSMENT OF EFFICACY
The PASI, BSA, IGA, scalp IGA, mNAPSI, and pp-IGA should be performed by the 
Investigator, another delegated physician, or an appropriately qualified medical professional 
(based on local requirements) who has had documented training on how to perform these 
assessments correctly. The same assessor should evaluate the subject at each assessment.
9.1
Psoriasis Area Severity Index
The PASI is the most commonly used and validated assessment for grading the severity of PSO 
in clinical studies (Feldman, 2004). The PASI quantifies the severity and extent of the disease 
and weighs these with the percentage of BSA involvement.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 96 of 263
The percent area of involvement (BSA%) is estimated across 4 body areas; head, upper 
extremities, trunk, and lower extremities. Assessors will enter the degree of involvement for a 
given region on a scale of 0 to 6 (0=none; 1=1% to <10% affected, 2=10% to <30% affected, 
3=30% to <50% affected, 4=50% to <70% affected, 5=70% to <90% affected, 6=90% to 100% 
affected) (Table 9‒1).
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body 
area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked.
The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Table 9‒1:
Body areas for calculation of percent BSA for PASI
Body area
Details of area
BSA
Degree of 
involvement of 
body areaa
Head
Face, back of head
10%
0 to 6
Upper extremities 
Left, right, upper lower, flexor surface, 
extensor surface
20%
0 to 6
Trunk
Front, back, groin
30%
0 to 6
Lower extremities 
Left, right, upper lower, flexor surface, 
extensor surface, including buttocks
40%
0 to 6
Total
100%
BSA=body surface area; PASI=Psoriasis Area and Severity Index
a Where 0=none; 1=1% to <10% affected; 2=10% to <30% affected; 3=30% to <50% affected; 4=50% to <70% 
affected; 5=70% to <90% affected; 6=90% to 100% affected
The PASI75, PASI90, and PASI100 responses are based on at least 75%, 90%, and 100% 
improvement in the PASI score, respectively.
The total BSA affected by PSO will be entered as a percentage from 0 to 100.
The PASI will be completed at the visits specified in Table 5‒1, Table 5‒2, and Table 5-3.
9.2
Investigator’s Global Assessment
A static IGA for PSO will be used to assess disease severity in all subjects during the study. The 
IGA will be completed at the visits specified in Table 5‒1,Table 5‒2, and Table 5-3.
The Investigator will assess the overall severity of PSO using the following 5-point scale 
presented in Table 9‒2.
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UCB
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Bimekizumab
PS0015
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Table 9‒2:
Five-point IGA
Score
Short Descriptor
Detailed Descriptor
0
Clear
No signs of PSO; post-inflammatory hyperpigmentation may be present
1
Almost clear
No thickening; normal to pink coloration; no to minimal focal scaling
2
Mild
Just detectable to mild thickening; pink to light red coloration; 
predominately fine scaling
3
Moderate
Clearly distinguishable to moderate thickening; dull to bright red; moderate 
scaling
4
Severe
Severe thickening with hard edges; bright to deep dark red coloration; 
severe/coarse scaling covering almost all or all lesions
IGA=Investigator’s Global Assessment; PSO=psoriasis
9.3
Dermatology Life Quality Index
The DLQI is a questionnaire designed for use in adult subjects with PSO. The DLQI is a skin 
disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect 
subjects’ health related QOL. This instrument asks subjects about symptoms and feelings, daily 
activities, leisure, work and school, personal relationships, and treatment. It has been shown to 
be valid and reproducible in subjects with PSO. The DLQI score ranges from 0 to 30 with higher 
scores indicating lower health-related QOL. A 4-point change in the DLQI score (DLQI 
response) has been reported to be meaningful for the subject (within-subject minimal important 
difference); while a DLQI absolute score of 0 or 1 indicates no or small impact of the disease on 
health related QOL. Subjects will be asked to complete the DLQI as outlined in the Schedule of 
Study Assessments (Table 5‒1, Table 5‒2, and Table 5-3).
9.4
Scalp IGA
A static IGA for scalp PSO will be used to assess disease severity on the scalp.
All subjects will complete the scalp IGA at Baseline. Only subjects with scalp involvement at 
Baseline will complete the scalp IGA at the other visits specified in Table 5‒1 and Table 5‒2.
Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at 
Baseline.
Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using 
a 5-point scale (Table 9‒3).
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 98 of 263
Table 9‒3:
Scalp IGA
Score
Short Descriptor
Detailed Descriptor
0
Clear
Scalp has no signs of PSO; post-inflammatory hyperpigmentation may be 
present
1
Almost clear
Scalp has no thickening; normal to pink coloration; no to minimal focal scaling
2
Mild
Scalp has just detectable to mild thickening; pink to light red coloration; 
predominately fine scaling
3
Moderate
Scalp has clearly distinguishable to moderate thickening; dull to bright red, 
moderate scaling
4
Severe
Scalp has severe thickening with hard edges; bright to deep dark red 
coloration; severe/coarse scaling covering almost all or all lesions
PSO=psoriasis; scalp IGA=scalp-specific Investigator’s Global Assessment
9.5
mNAPSI
Nail PSO will be evaluated using the mNAPSI. All affected nails will be scored (0 to 3) for 
onycholysis/oil drop dyschromia, nail plate crumbling, and pitting and will be scored (0 for “no” 
or 1 for “yes”) for leukonychia, nail bed hyperkeratosis, splinter hemorrhages and red spots in 
the lunula. The score for an individual nail ranges from 0 to 13 with higher scores indicative of 
more severe nail PSO. The total mNAPSI score is the sum of the scores for each individual nail. 
If a nail is unaffected, it will be recorded as such and will not contribute to the total mNAPSI 
score. Subjects with nail PSO at Baseline are defined as those with a mNAPSI score >0 at 
Baseline.
Only subjects with nail involvement at Baseline will complete the mNAPSI at the other visits 
specified in Table 5‒1 and Table 5‒2.
9.6
pp-IGA
A static IGA for palmoplantar PSO will be used to assess palmoplantar disease severity.
All subjects will complete the pp-IGA at Baseline. Only subjects with palmoplantar involvement 
at Baseline will complete the pp-IGA at the other visits specified in Table 5‒1 and Table 5‒2.
Subjects with palmoplantar involvement at Baseline are defined as those with a pp-IGA score >0 
at Baseline.
Palmoplantar disease will be assessed in terms of clinical signs of redness, thickness, and 
scaliness using a 5-point scale (Table 9‒4).
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UCB
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Bimekizumab
PS0015
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Page 99 of 263
Table 9‒4:
pp-IGA
Score
Short Descriptor
Detailed Descriptor
0
Clear
Palmoplantar areas have no signs of PSO; post-inflammatory 
hyperpigmentation may be present
1
Almost clear
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minimal focal scaling
2
Mild
Palmoplantar areas have just detectable to mild thickening; pink to light red 
coloration; predominately fine scaling
3
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Palmoplantar areas have clearly distinguishable to moderate thickening; dull to 
bright red and clearly distinguishable coloration; moderate scaling
4
Severe
Palmoplantar areas have severe thickening with hard edges; bright to deep dark 
red coloration; severe/coarse scaling covering almost all or all lesions; 
numerous fissures
pp-IGA=palmoplantar Investigator’s Global Assessment; PSO=psoriasis
9.7
European Quality-of-Life 5-Dimensions 3-Level Questionnaire
The EQ-5D-3L health questionnaire provides a descriptive profile and a single index value for 
health status. The instrument is comprised of a 5-item health status measure and a VAS. The 
EQ-5D-3L VAS records the respondent’s self-rated health status on a vertical 20cm scale, 
graduated from 0 to 100 (0=worst imaginable health status, 100=best imaginable health status).
The EQ-5D-3L will be assessed at the visits specified in Table 5‒1 and Table 5‒2.
9.8
Patient Global Assessment of psoriasis
The Patient Global Assessment of PSO is a PSO-specific item in which the patient responds to 
the multiple-choice question, “How severe are your psoriasis-related symptoms right now?” 
Possible responses to the question are “no symptoms,” “mild symptoms,” “moderate symptoms,” 
“severe symptoms,” or “very severe symptoms.”
The Patient Global Assessment of psoriasis will be performed at the visits specified in Table 5‒1.
9.9
Itch, pain, and scaling numerical rating scale
UCB developed and validated a new Patient Reported Outcome measure, in the form of a patient 
symptom diary, which is used to assess key symptoms relevant to subjects with moderate to 
severe chronic plaque PSO. In this study itch, pain, and scaling items from the diary will be used 
to assess the patient-reported level of these symptoms over time. The items will be administered 
on an electronic site tablet, during visits, as specified in Table 5‒1, Table 5‒2, and Table 5-3).
9.10
PASE questionnaire
The Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire is a self-administered 
tool to screen for active PsA in patients with PSO (Husni et al, 2014). The questionnaire consists 
of 15 items that are divided into a 7-item symptoms subscale and an 8-item functions subscale. 
Standardized responses are based on 5 categories relating to agreement (strongly agree [5], 
agree [4], no idea [3], disagree [2], and strongly disagree [1]). The total maximum score is 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 100 of 263
75 points (symptom score: 35 points and function score: 40 points). Psoriatic Arthritis Screening 
and Evaluation questionnaire scores ≥47 points are indicative of active PsA.
If a subject with a PASE score ≥47 points is referred to a rheumatologist, the referral will be 
recorded in the eCRF. Subjects with PsA, defined as a past medical history of PsA or PASE ≥47, 
are required to receive the additional PsA assessments (PGADA) as noted in Section 9.11.
The PASE questionnaire will be completed at the visits specified in Table 5‒1 and Table 5‒2.
9.11
PGADA for arthritis visual analog scale
The PGADA for the arthritis VAS will be used to provide an overall evaluation of arthritis 
disease symptoms. Subjects will respond to the question, “Considering all the ways your arthritis 
affects you, please mark a vertical line on the scale below to show how you are feeling today,” 
using a VAS where 0 is “very good, no symptoms” and 100 is “very poor, severe symptoms.
All subjects will complete the PGADA at Baseline. Subjects with PsA at Baseline (defined as a 
past medical history of PsA or PASE ≥47) will complete the PGADA at the visits specified in 
Table 5‒1 and Table 5‒2.
9.12
Photographs
At certain clinical sites, representative photographs of the changes in skin and nail appearance 
will be captured. Subjects who consent to the procedure will have full body (anterior and 
posterior views) photographs taken. Only those subjects with nail disease at Baseline will have 
nail photographs taken. Only those subjects with palmoplantar disease at Baseline will have 
photographs of their palms or soles of their feet taken. Only those subjects with scalp disease at 
Baseline will have scalp photographs taken. Photographs will be anonymized and will be used 
for publication purposes.
Study sites selected for photography will be trained and receive standardized photographic 
equipment by a centralized photographic vendor. Photographs will be electronically transferred 
from the site to the vendor.
At the end of the study, the site will receive an electronic file of all subject photographs for 
archiving.
The central photography vendor will tabulate and transfer all subject photos to the Sponsor at the 
end of the study.
9.13
WPAI-SHP V2.0
The WPAI-SHP V2.0 is a patient-reported questionnaire that assesses subject’s employment 
status, work absenteeism, work impairment while working (presenteeism), overall work, and 
daily activity impairment attributable to a specific health problem (WPAI-SHP) 
(Reilly et al, 1993). It has been used in several clinical studies of biologic therapy in subjects 
with plaque PSO (Kimball et al, 2012; Vender et al, 2012).
Five out of 6 items of the WPAI-SHP are regrouped into the 4 dimensions, with scores expressed 
as percentage, where higher numbers indicate greater impairment and less productivity, ie, worse 
outcomes, as described in the WPAI-SHP scoring rules.
The WPAI-SHP V2.0 will be assessed at the visits specified in Table 5‒1 and Table 5‒2.
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UCB
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Bimekizumab
PS0015
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10
ASSESSMENT OF PHARMACOKINETIC VARIABLES
10.1
Pharmacokinetic variables
Blood samples for measurement of PK assessments (Section 4.3.3) will be collected at the time 
points specified in the schedule of study assessments (Table 5‒1 and Table 5‒2). Blood samples 
for the measurement of PK assessments will not be collected in the OLE2 Period.
At dosing visits, blood samples will be drawn prior to dosing, and will be drawn at the same time
of the sampling for clinical laboratory tests. The time and date of collection will be recorded in 
the eCRF.
Instructions pertaining to sample collection, processing, storage, labeling, and shipping are 
provided in the laboratory manual for this study. Detailed information on sample analysis will be 
provided in a bioanalytical report.
Pharmacokinetic samples from subjects receiving secukinumab will not be analyzed, but stored 
for potential future PK analysis and anti-drug antibody determination.
11
ASSESSMENT OF IMMUNOLOGICAL VARIABLES
Blood samples for measurement of antibodies to bimekizumab will be collected at the visits 
specified in Table 5‒1 and Table 5‒2. The threshold for antibody positivity will be defined prior 
to analysis. Blood samples for the measurement of antibodies to bimekizumab will not be 
collected in the OLE2 Period.
At dosing visits, blood samples will be drawn prior to dosing, and will be drawn at the same time 
of the sampling for clinical laboratory tests. The time and date of collection will be recorded in 
the eCRF.
Instructions pertaining to sample collection, processing, storage, labeling, and shipping are 
provided in the laboratory manual for this study. The presence of antibodies to bimekizumab will 
be determined using a validated bioanalytical method. Detailed information on sample analysis 
will be provided in a bioanalytical report.
12
ASSESSMENT OF SAFETY
12.1
Adverse events
12.1.1
Definitions
12.1.1.1
Adverse event
An AE is any untoward medical occurrence in a patient or clinical investigation subject 
administered a pharmaceutical product that does not necessarily have a causal relationship with 
this treatment. An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease temporally associated with the use of a 
medicinal (investigational) product, whether or not related to the medicinal (investigational) 
product.
In order to ensure complete safety data collection, all AEs occurring during the study (ie, after 
the signing of the ICF), including any pretreatment and posttreatment periods required by the 
protocol, must be reported in the eCRF even if no IMP was taken but specific study procedures 
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UCB
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Bimekizumab
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were conducted. This includes all AEs not present prior to the initial visit and all AEs that 
recurred or worsened after the initial visit.
Signs or symptoms of the condition/disease for which the IMP is being studied should be
recorded as AEs only if their nature changes considerably or their frequency or intensity 
increases in a clinically significant manner as compared to the clinical profile known to the 
Investigator from the subject’s history or the Baseline Period.
12.1.1.2
Serious adverse event
Once it is determined that a subject experienced an AE, the seriousness of the AE must be 
determined. An SAE must meet 1 or more of the following criteria:
x
Death
x
Life-threatening
(Life-threatening does not include a reaction that might have caused death had it occurred in 
a more severe form)
x
Significant or persistent disability/incapacity
x
Congenital anomaly/birth defect (including that occurring in a fetus)
x
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patient or subject and may require medical or surgical intervention to prevent 1 of the other 
outcomes listed in the definition of serious
(Important medical events may include, but are not limited to, potential Hy’s Law [see 
Section 12.1.1.3], allergic bronchospasm requiring intensive treatment in an emergency room 
or at home, blood dyscrasias that do not result in inpatient hospitalization, or the 
development of drug dependency or drug abuse)
x
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(A patient admitted to a hospital, even if he/she is released on the same day, meets the 
criteria for the initial inpatient hospitalization. An emergency room visit that results in 
admission to the hospital would also qualify for the initial inpatient hospitalization criteria. 
However, emergency room visits that do not result in admission to the hospital would not 
qualify for this criteria and, instead, should be evaluated for 1 of the other criteria in the 
definition of serious [eg, life-threatening adverse experience, important medical event].
Hospitalizations for reasons not associated with the occurrence of an AE [eg, preplanned 
surgery or elective surgery for a pre-existing condition that has not worsened or manifested 
in an unusual or uncharacteristic manner] do not qualify for reporting. For example, if a 
subject has a condition recorded on his/her medical history and later has a preplanned surgery 
for this condition, it is not appropriate to record the surgery or hospitalization as an SAE, 
since there is no AE upon which to assess the serious criteria. Please note that, if the 
pre-existing condition has worsened or manifested in an unusual or uncharacteristic manner, 
this would then qualify as an AE and, if necessary, the seriousness of the event would need to 
be determined)
Confirmed active TB must be reported as an SAE. The Investigator is to complete and submit the 
TB Follow-Up Form provided.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 103 of 263
12.1.1.2.1
Anticipated serious adverse events
The following Anticipated SAEs are anticipated to occur in the population studied in this 
protocol at some frequency that is independent of drug exposure.
This list does not change the Investigator’s obligation to report all SAEs (including Anticipated 
SAEs) as detailed in Section 12.1.2.3.
Table 12‒1: Anticipated serious adverse events for the population of subjects 
with moderate to severe chronic plaque psoriasis
MedDRA® system order class
MedDRA preferred term
Skin and subcutaneous tissue disorders
Any psoriatic condition HLT
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
HLT=High Level Term; MedDRA=Medical Dictionary for Regulatory Activities; SAE=serious adverse event
Note: Exception: Listed events will not be regarded as anticipated SAEs if they are life threatening or if they 
result in the death of the study subject.
12.1.1.3
Adverse events of special interest
An AE of special interest (AESI) is any AE that a regulatory authority has mandated be reported 
on an expedited basis, regardless of the seriousness, expectedness, or relatedness of the AE to the 
administration of a UCB product/compound.
Potential Hy’s Law, defined as ≥3xULN ALT or AST with coexisting ≥2xULN total bilirubin in 
the absence of ≥2xULN ALP, with no alternative explanation for the biochemical abnormality, 
must ALWAYS be reported to UCB as an AESI (ie, without waiting for any additional etiologic 
investigations to have been concluded). Follow-up information should then be reported if an 
alternative etiology is identified during investigation and monitoring of the subject.
12.1.1.4
Other safety topics of interest
Pre-specified safety topics of interest for the study are: infections (serious, opportunistic, fungal, 
and TB), neutropenia, hypersensitivity, suicidal ideation and behavior, depression, major 
cardiovascular events, liver function test changes/enzyme elevations, malignancies, and 
inflammatory bowel diseases (with gastroenterology referral, as appropriate). This is based on 
findings from the IMP clinical program to date, potential risks generally associated with biologic 
immunomodulators, or findings from other medicines with a related mechanism of action. There 
are no specific AE reporting requirements for these topics, however special monitoring, 
additional data collection activities, and/or enhanced signal detection activities (within UCB) are 
in place.
12.1.2
Procedures for reporting and recording adverse events
The subject will be given the opportunity to report AEs spontaneously. A general prompt will 
also be given at each study visit to detect AEs. For example:
“Did you notice anything unusual about your health (since your last visit)?”
In addition, the Investigator should review any self-assessment procedures (eg, diary cards) 
employed in the study.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 104 of 263
12.1.2.1
Description of adverse events
When recording an AE, the Investigator should use the overall diagnosis or syndrome using 
standard medical terminology, rather than recording individual symptoms or signs. The eCRF 
and source documents should be consistent. Any discrepancies between the subject’s own words 
on his/her own records (eg, diary card) and the corresponding medical terminology should be 
clarified in the source documentation.
When recording the severity of an AE in the eCRF (ie, mild, moderate, or severe), the 
Investigator may refer to the Common Terminology Criteria for Adverse Events (CTCAE) 
Version 4 (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm) for 
additional guidance as needed. Details for completion of the Adverse Event eCRF (including
judgment of relationship to IMP) are described in the eCRF Completion Guidelines.
12.1.2.2
Rule for repetition of an adverse event
An increase in the intensity of an AE should lead to the repetition of the AE being reported with:
x
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the same as the start date of the repeated AE, and the outcome of “worsening”
x
The AE verbatim term being the same for the first and repeated AE, so that the repeated AE 
can be easily identified as the worsening of the first one
12.1.2.3
Additional procedures for reporting serious adverse events
If an SAE is reported, UCB must be informed within 24 hours of receipt of this information by 
the site (see contact information for SAE reporting listed in the Serious Adverse Event Reporting 
section at the front of the protocol). The Investigator must forward to UCB (or its representative) 
a duly completed “Investigator SAE Report Form for Development Drug” (SAE report form) 
provided by UCB, even if the data are incomplete, or if it is obvious that more data will be 
needed in order to draw any conclusions. Information recorded on this form will be entered into 
the global safety database.
An Investigator SAE report form will be provided to the Investigator. The Investigator SAE 
Report form must be completed in English.
It is important for the Investigator, when completing the SAE report form, to include the 
assessment as to a causal relationship between the SAE and the IMP administration. This insight 
from the Investigator is very important for UCB to consider in assessing the safety of the IMP 
and in determining whether the SAE requires reporting to the regulatory authorities in an 
expedited manner.
Additional information (eg, autopsy or laboratory reports) received by the Investigator must be 
provided within 24 hours. All documents in the local language must be accompanied by a 
translation in English, or the relevant information included in the same document must be 
summarized in the Investigator SAE report form.
The Investigator is specifically requested to collect and report to UCB (or its representative) any 
SAEs (even if the Investigator is certain that they are in no way associated with the IMP), up to 
30 days from the end of the study for each subject, and to also inform participating subjects of 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 105 of 263
the need to inform the Investigator of any SAE within this period. Serious AEs that the 
Investigator thinks may be associated with the IMP must be reported to UCB regardless of the 
time between the event and the end of the study.
Upon receipt of the SAE report form, UCB will perform an assessment of expectedness of the 
reported SAE. The assessment of the expectedness of the SAE is based on the IB.
12.1.3
Follow up of adverse events
An AE should be followed until it has resolved, has a stable sequelae, the Investigator 
determines that it is no longer clinically significant, or the subject is lost to follow up. This 
follow-up requirement applies to AEs, SAEs, and AESIs; further details regarding follow up of 
PDILI events is provided in Section 12.2.1.4.
If an AE is ongoing at the end of the study for a subject, follow up should be provided until 
resolution/stable level of sequelae is achieved, or until the Investigator no longer deems that it is 
clinically significant, or until the subject is lost to follow up. If no follow up is provided, the 
Investigator must provide a justification. The follow up will usually be continued for 20 weeks 
after the subject has discontinued his/her IMP.
Information on SAEs obtained after clinical database lock will be captured through the Patient 
Safety (PS) database without limitation of time.
12.1.4
Pregnancy
If an Investigator is notified that a subject has become pregnant after the first intake of any IMP, 
the Investigator must immediately notify UCB’s PS department by providing the completed 
Pregnancy Report and Outcome form (for contact details see Serious Adverse Event reporting 
information at the beginning of this protocol). The subject should be withdrawn from the study 
as soon as pregnancy is known (by positive pregnancy test), and the following should be 
completed:
x
The subject should return for an early discontinuation visit.
x
The subject should immediately stop the intake of the IMP.
x
A SFU Visit should be scheduled 20 weeks after the subject has discontinued her IMP.
The Investigator must inform the subject of information currently known about potential risks 
and about available treatment alternatives.
The pregnancy will be documented on the Pregnancy Report and Outcome form provided to the 
Investigator. The progression of the pregnancy and the eventual birth (if applicable) must be 
followed up using the Pregnancy Report and Outcome form in which the Investigator has to 
report on the health of the mother and of the child. Every reasonable attempt should be made to 
follow the health of the child for 30 days after birth for any significant medical issues. In certain 
circumstances, UCB may request that follow up is continued for a period longer than 30 days. If 
the subject is lost to follow up and/or refuses to give information, written documentation of 
attempts to contact the subject need to be provided by the Investigator and filed at the site. 
UCB’s PS department is the primary contact for any questions related to the data collection for 
the pregnancy, eventual birth, and follow up.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 106 of 263
In cases where the partner of a male subject enrolled in a clinical study becomes pregnant, the 
Investigator or designee is asked to contact the subject to request consent of the partner via the 
Partner Pregnancy Consent form that has been approved by the responsible IRB/IEC and should 
be available in the Investigator site file. In case of questions about the consent process, the 
Investigator may contact the UCB/contract research organization (CRO) contract monitor for the 
study. The Investigator will complete the Pregnancy Report and Outcome form and send it to 
UCB’s PS department (for contact details see Serious Adverse Event reporting information at the 
beginning of this protocol) only after the partner has agreed that additional information can be 
captured and has provided the signed Partner Pregnancy Consent form. UCB’s PS department is 
also the primary contact for any questions related to the data collection for the partner pregnancy, 
eventual birth, and follow up.
A pregnancy becomes a SAE in the following circumstances: miscarriage, elective abortion 
when medically indicated (eg, when pregnancy is endangering life or health of woman or when 
fetus will be born with severe abnormalities), unintended pregnancy after hormonal 
contraceptive failure (if the hormonal contraceptive was correctly used), ectopic pregnancy, fetal 
demise, or any congenital anomaly/birth defect of the baby. Those SAEs must be additionally 
reported using the Investigator SAE Report form.
Should a subject become pregnant while participating in the study, the subject may be offered the 
option to enroll in a separate observational pregnancy follow-up study sponsored by UCB and 
conducted independently from study PS0015. If the study is available locally, the PS0015 PI will 
be provided with the locally approved information about the observational pregnancy follow-up
study to inform the subject at the time the pregnancy is reported. Participation in this separate 
study will be voluntary and will not impact therapeutic management of the subject nor interfere 
with termination and follow-up procedures as described in study protocol PS0015.
12.1.5
Suspected transmission of an infectious agent via a medicinal 
product
For the purposes of reporting, any suspected transmission of an infectious agent via a medicinal 
product should be considered as an SAE; such cases must be reported immediately, recorded in 
the AE module of the eCRF, and followed as any other SAE. Any organism, virus, or infectious 
particle (eg, prion protein transmitting transmissible spongiform encephalopathy), pathogenic or 
nonpathogenic, is considered an infectious agent.
12.1.6
Overdose of investigational medicinal product
Excessive dosing (beyond that prescribed in the protocol and including overdose) should be 
recorded in the eCRF. Any SAE or nonserious AE associated with excessive dosing must be 
followed as any other SAE or nonserious AE. These events are only considered AEs or SAEs if 
there are associated clinical signs and symptoms or if the act of taking the excess medicine itself 
is an AE or SAE (eg, suicide attempt).
12.1.7
Safety signal detection
Selected data from this study will be reviewed periodically to detect as early as possible any 
safety concern(s) related to the IMP so that Investigators, clinical study subjects, regulatory 
authorities, and IRBs/IECs will be informed appropriately and as early as possible.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 107 of 263
In addition, an independent Data Monitoring Committee (DMC) will periodically review and 
monitor safety data from this study and advise UCB. Details are provided in the DMC Charter. 
Cardiovascular and Neuropsychiatric Adjudication Committees will also periodically review and 
monitor safety data from this study and advise UCB. Details are provided in the Adjudication 
Committee Charters.
The Study Physician or medically qualified designee/equivalent will conduct an ongoing review 
of SAEs and perform ongoing SAE reconciliations in collaboration with the PS representative.
As appropriate for the stage of development and accumulated experience with the IMP, 
medically qualified personnel at UCB may identify additional safety measures (eg, AEs, vital 
signs, laboratory or ECG results) for which data will be periodically reviewed during the course 
of the study.
12.2
Laboratory measurements
Clinical laboratory assessments consist of serum chemistry, hematology, and urinalysis. A 
centralized laboratory will be used to supply all laboratory test supplies and analyze all blood 
and urine samples for hematology, biochemistry, and urinalysis measurements. Any unscheduled 
laboratory testing should also be collected using the central laboratory. If tests are done locally, a 
concurrent sample should also be sent to the central laboratory whenever possible. Testing to 
rule out hepatitis B, hepatitis C, and HIV (see Exclusion Criterion #9, Section 6.2) and a urine 
drug screen will be performed at Screening in addition to those measurements listed in Table 12‒
2.
Specific details regarding the handling and processing of serum chemistry, hematology, and 
urinalysis samples are provided in the study laboratory manuals.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 108 of 263
The following laboratory parameters will be measured:
Table 12‒2: Laboratory measurements
Hematology
Chemistry
Urinalysis dipsticka
Basophils
Calcium
pH
Eosinophils
Chloride
Albumin (protein)
Lymphocytes
Magnesium
Glucose
Monocytes
Potassium
Blood
Neutrophils
Sodium
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Glucose
Nitrite
Hemoglobin
BUN
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MCH
Creatinine
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MCHC
ALP
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AST
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ALT
RBC count
GGT
WBC count
Total bilirubin
LDH
CRPb
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NT-proBNPb
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ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea 
nitrogen; CRP=C-reactive protein; GGT=gamma glutamyltransferase; LDH=lactate dehydrogenase; 
MCH=mean corpuscular hemoglobin; MCHC=mean corpuscular hemoglobin concentration; MCV=mean 
corpuscular volume; NT-proBNP=N-terminal pro B-type natriuretic peptide; RBC=red blood cell; WBC=white 
blood cell
a A urine microscopic examination will be performed if the result for albumin (protein), leukocyte esterase, blood 
or nitrite is abnormal. A urine microscopic examination will include: WBC, RBC, epithelial cells (squamous, 
transitional and renal tubular), hyaline casts, WBC casts, RBC casts, waxy casts, granular casts, calcium oxalate 
crystals, uric acid crystals, triphosphate crystals, yeast, bacteria, amorphous urates, and amorphous phosphates.
b Assessments of NT-proBNP and CRP will not be performed during any OLE Period; in addition, lipid panel 
will not be performed during OLE2 Period.
c Pregnancy testing will consist of serum testing at the initial Screening. Urine pregnancy testing will be 
performed at all other visits.
12.2.1
Evaluation of PDILI
The PDILI IMP discontinuation criteria for this study are provided in Section 6.5.1, with the 
accompanying required follow-up investigation and monitoring detailed below. All PDILI events 
must be reported as an AE and reported to the study site and sponsor within 24 hours of learning 
of their occurrence. Any PDILI event that meets the criterion for potential Hy’s Law must be 
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UCB
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Bimekizumab
PS0015
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Page 109 of 263
reported as an AESI (see Section 12.1.1.3), and, if applicable, also reported as an SAE (see 
Section 12.1.1.2).
Evaluation of PDILI consists of the diagnostic testing and continued monitoring included in 
Table 12‒3 (specific tests dependent on laboratory results and corresponding symptoms) and 
consultation with a local hepatologist (if applicable; discussed in Section 12.2.1.1). The local 
hepatologist is the expert usually consulted by the treating physician for assessment and 
management of potential hepatic disease. This would usually be a hepatologist, but may be a 
gastroenterologist. Additional investigation and monitoring may be required and adapted based 
on the diagnosis after the cause of the liver injury/abnormality is confirmed (details in 
Section 12.2.1.4).
The results of all monitoring, including laboratory testing and other testing, should be made 
available to the study site and sponsor.
All initial tests resulting in abnormal hepatic laboratory values need to be repeated, but 
appropriate medical action must not be delayed waiting for the repeat result.
If tests are done locally for more rapid results, a concurrent sample should also be sent to the 
central laboratory whenever possible. Medical care decisions are to be made initially using the 
most rapidly available results and a conservative approach must be taken if the results from the 
2 laboratory tests are significantly different. Data from the local and central laboratory are to be 
recorded on the applicable eCRF pages.
When IMP is discontinued, all concomitant medications and herbal supplements that are not 
medically necessary should also be discontinued. In these cases, the Investigator should also 
consider dose reduction for medically necessary concomitant medication and consider changing 
any medically required concomitant medication known to be hepatotoxic to a suitable 
alternative.
When IMP is stopped due to PDILI (as described in Section 6.5.1), IMP must be permanently 
discontinued unless a subsequent alternative diagnosis fully explains the hepatic findings. If a 
subsequent alternative diagnosis fully explains the hepatic findings, and the requirements 
provided in Section 12.2.1.2.1 are met, rechallenge with IMP may be appropriate.
Table 12‒3 summarizes the approach to investigate PDILI.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 110 of 263
Table 12‒3: Required investigations and follow up for PDILI
Laboratory value
Immediate
Follow up
ALT or 
AST
Total 
bilirubin
Symptomsa of 
hepatitis or 
hypersensitivity
Consultation 
requirements
Actions
Testing
Evaluation
≥3xULN
≥2xULNb
NA
Hepatology consultc
Medical Monitor must 
be notified within 
24 hours (eg, by 
laboratory alert) and 
subject discussed with 
Medical Monitor ASAP.
Immediate, permanent 
IMP discontinuation.e
Essential: Must have 
repeat liver chemistry 
values and additional 
testing completed 
ASAP (see 
Section 12.2.1.3); 
recommended to occur 
at the site with HCP.
Monitoring of liver 
chemistry values at least 
twice per week until values 
normalize, stabilize, or 
return to within baseline 
values. d
≥3xULN
NA
Yes
≥8xULN
NA
NA
Hepatology consult.
Medical Monitor must 
be notified within 
24 hours (eg, by 
laboratory alert) and 
subject discussed with 
Medical Monitor ASAP.
Immediate, permanent 
IMP discontinuation.
≥5xULN 
and 
<8xULN
<2xULN
No
Discussion with Medical 
Monitor required.
Consider need for 
hepatology consult if 
there is no evidence of 
resolution (see Follow 
up requirements). c
Further investigation –
immediate IMP 
discontinuation not 
required (see 
Section 12.2.1.2).
IMP discontinuation 
required if any of the 
following occur:
Subject cannot comply 
with monitoring 
schedule.
Liver chemistry values 
continue to increase
Liver chemistry values 
remain ≥5xULN after 
Essential: Every 
attempt must be made 
to have repeat liver 
chemistry values and 
additional testing 
completed within 
48 hours at the site 
with HCP (see 
Section 12.2.1.3).
Monitoring of liver 
chemistry values at least 
twice per week for 2 weeks.d
x
Immediate IMP 
discontinuation required 
if liver chemistry values 
continue to increase.
After 2 weeks of monitoring 
liver chemistry values:
x
ALT or AST remains 
≥5xULN <8xULN, IMP 
should be temporarily 
withheld and subject 
should undergo repeat 
test in 2 weeks.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 111 of 263
Table 12‒3: Required investigations and follow up for PDILI
Laboratory value
Immediate
Follow up
ALT or 
AST
Total 
bilirubin
Symptomsa of 
hepatitis or 
hypersensitivity
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discontinuation 
required.
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values normalize, stabilize, 
or return to within baseline 
values.d
ALP=alkaline phosphatase; ALT=alanine aminotransferase; ASAP=as soon as possible; AST=aspartate aminotransferase; HCP=healthcare practitioner; 
IMP=investigational medicinal product; NA=not applicable; PDILI=potential drug-induced liver injury; ULN=upper limit of normal
a Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or tenderness; hypersensitivity symptoms include eosinophilia (>5%), 
rash, and fever (without clear alternative cause).
b If the subject also has ≥2xULN ALP, the possibility of an indication of biliary obstruction should be discussed with the Medical Monitor.
c Details provided in Section 12.2.1.1. The local hepatologist is the expert usually consulted by the treating physician for assessment and management of 
potential hepatic disease. This would usually be a hepatologist, but may be a gastroenterologist.
d Unless an alternative monitoring schedule is agreed by the Investigator and UCB responsible physician. Determination of stabilization is at the discretion of the 
Investigator in consultation with the hepatologist (as applicable) and UCB responsible physician, as needed.
e Details provided in Section 12.2.1.2.1.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 112 of 263
12.2.1.1
Consultation with Medical Monitor and local hepatologist
Potential drug-induced liver injury events require notification of the Medical Monitor within 
24 hours (eg, by laboratory alert), and the subject must be discussed with the Medical Monitor as 
soon as possible. If required, the subject must also be discussed with the local hepatologist. The 
local hepatologist is the expert usually consulted by the treating physician for assessment and 
management of potential hepatic disease. This would usually be a hepatologist, but may be a 
gastroenterologist. If determined necessary, this discussion should be followed by a full 
hepatology assessment (see Section 12.2.1.3) and SAE report (if applicable).
12.2.1.2
Immediate action: determination of IMP discontinuation
All PDILI events require immediate action, testing, and monitoring.
The immediate action is dependent on the laboratory values and symptoms of hepatitis or 
hypersensitivity and ranges from continuation of IMP (followed by immediate investigation) to 
immediate and permanent discontinuation (see Section 6.5.1 and Table 12‒3 for details).
When IMP is discontinued, all concomitant medications and herbal supplements that are not 
medically necessary should also be discontinued. The Investigator should also consider dose 
reduction for medically necessary concomitant medication and consider changing any medically 
required concomitant medication known to be hepatotoxic to a suitable alternative.
12.2.1.2.1
IMP restart/rechallenge
Subjects who are immediately discontinued from IMP due to having met certain criteria for 
PDILI (as described in Section 6.5.1 and Table 12‒3), but for whom an alternative diagnosis is 
confirmed, ie, drug-induced liver injury is excluded, can rarely restart IMP.
Rechallenge with IMP can occur only if ALL of the following requirements are met at the time 
of the rechallenge.
x
The results of additional testing and monitoring described in Section 12.2.1.3 and 
Section 12.2.1.4 confirm a nondrug-related cause for the abnormal hepatic laboratory 
parameters and any associated symptoms (ie, a subsequent alternative diagnosis fully 
explains the hepatic findings).
x
The subject has shown clear therapeutic benefit from the IMP.
x
Subject’s ALT or AST elevations do not exceed ≥5xULN.
x
Subject’s total bilirubin is <2xULN.
x
Subject has no signs or symptoms of hypersensitivity or hepatitis.
x
During the double-blind Treatment Period, the rechallenge is approved by the UCB 
responsible physician, DMC, and a hepatologist. 
x
During the OLE and OLE2 Periods, the rechallenge is approved by the UCB responsible 
physician. 
x
Subject agrees to the Investigator-recommended monitoring plan.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 113 of 263
12.2.1.3
Testing: identification/exclusion of alternative etiology
The measurements and additional information required for the assessment of PDILI events when 
there is a reasonable possibility that they may have been caused by the IMP are detailed in 
Table 12‒4 (laboratory measurements) and Table 12‒5 (additional information). Results of the 
laboratory measurements and information collected are to be submitted to the sponsor on the 
corresponding eCRF. If the medical history of the subject indicates a requirement for other 
assessments not included below, these additional assessments should be completed and 
submitted, as applicable.
All blood samples should be stored, if possible. If tests are done locally for more rapid results, a 
concurrent sample must also be sent to the central laboratory.
The following measurements are to be assessed: 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 114 of 263
Table 12‒4: PDILI laboratory measurements
Virology-related
Hepatitis A IgM antibody
HBsAg
Hepatitis E IgM antibody
HBcAb-IgM
Hepatitis C RNA
Cytomegalovirus IgM antibody
Epstein-Barr viral capsid antigen IgM antibody (if unavailable, obtain heterophile 
antibody or monospot testing)
Immunology
Anti-nuclear antibody (qualitative and quantitative)
Anti-smooth muscle antibody (qualitative and quantitative)
Type 1 anti-liver kidney microsomal antibodies (qualitative and quantitative)
Hematology
Eosinophil count
Urinalysis
Urine drug screen a
Chemistry
Amylase
Sodium, potassium, chloride, glucose, BUN, creatinine
Total bilirubin, ALP, AST, ALT, GGT, total cholesterol, albumin
If total bilirubin ≥1.5xULN, obtain fractionated bilirubin to obtain % direct bilirubin
Serum CPK and LDH to evaluate possible muscle injury causing transaminase
elevation
Additional
Prothrombin time/INR b
Serum pregnancy test c
PK
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea 
nitrogen; CPK=creatine phosphokinase; GGT=gamma glutamyltransferase; HBcAb-IgM=hepatitis B core 
antibody-IgM; HBsAg=hepatitis B surface antigen; IgM=immunoglobulin M; INR=international normalized 
ratio; LDH=lactate dehydrogenase; PDILI=potential drug-induced liver injury; PK=pharmacokinetic; 
RNA=ribonucleic acid; ULN=upper limit of normal
a Tests in addition to the specified analytes may be performed based on the Investigator’s medical judgment and 
subject history.
b Measured only for subjects with ALT >8xULN, elevations in total bilirubin, and symptoms of hepatitis or 
hypersensitivity. Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or 
tenderness; hypersensitivity symptoms include eosinophilia (>5%), rash, and fever (without clear alternative 
cause).
c For women of childbearing potential.
The following additional information is to be collected:
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 115 of 263
Table 12‒5: PDILI information to be collected
New or updated information
Concomitant prescription and over-the-counter medications (eg, acetaminophen, herbal remedies, vitamins); 
dosages and dates should be included.
Pertinent medical history, including the following:
x
History of liver disease (eg, autoimmune hepatitis, nonalcoholic steatohepatitis or other “fatty liver disease”)
x
Adverse reactions to drugs
x
Allergies
x
Relevant family history or inheritable disorders (eg, Gilbert’s syndrome, alpha-1 antitrypsin deficiency)
x
Recent travel
Progression of malignancy involving the liver (Note: Metastatic disease to the liver, by itself, should not be used 
as an explanation for significant AST and/or ALT elevations)
The appearance or worsening of clinical symptoms of hepatitis or hypersensitivity (eg, fatigue, nausea, vomiting, 
right upper quadrant pain or tenderness, decreased appetite, abdominal pain, jaundice, fever, or rash)
Recent clinically significant hypotension or hypoxemia with compromised cardiopulmonary function
Alcohol and illicit drug use
Results of liver imaging or liver biopsy, if done
Results of any specialist or hepatology consult, if done
Any postmortem/pathology reports
ALT=alanine aminotransferase; AST=aspartate aminotransferase; PDILI=potential drug-induced liver injury
12.2.1.4
Follow-up evaluation
Potential drug-induced liver injury events require follow-up monitoring as described in 
Table 12‒3. Monitoring should continue until liver chemistry values normalize, stabilize, or 
return to baseline. Determination of stabilization is at the discretion of the Investigator in 
consultation with the hepatologist (as applicable) and UCB responsible physician, as needed.
12.3
Other safety measurements
12.3.1
Assessment and management of TB and TB risk factors
All subjects will be assessed for TB at Screening and at the time points specified in the Schedule 
of Assessments (Table 5‒1, Table 5‒2, and Table 5-3) through physical examination for signs 
and symptoms of TB, chest x-ray (Section 12.3.1.2), laboratory testing (Section 12.3.1.1), and 
subject questionnaire (Section 12.3.1.3).
For the purposes of this study, TB definitions are as follows:
c.
Known TB infection:
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Active TB infection or clinical signs and symptoms suspicious for TB (pulmonary or 
extra-pulmonary).
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 116 of 263

History of active TB infection involving any organ system or findings in other organ 
systems consistent with TB infection, unless adequately treated and proven to be fully 
recovered upon consult with a TB specialist.

Any evidence by radiography or other imaging modalities consistent with previously 
active TB infection that is not reported in the subject’s medical history.
d. High risk of acquiring TB infection:

Known close exposure to another person with active TB infection within the 3 months 
prior to Screening.

Time spent in a healthcare delivery setting or institution where individuals infected with 
TB are housed and where the risk of transmission of infection is high.
e.
Latent TB infection (unless appropriate prophylaxis is initiated at least 8 weeks prior to IMP 
dosing and continued to completion of prophylaxis):

The absence of signs, symptoms, or physical findings suggestive of TB infection with a 
positive IGRA test (or 2 indeterminate IGRA test results) and a chest x-ray (or other 
imaging) without evidence of TB infection. If the result of the IGRA test is 
indeterminate, the particular IGRA test previously performed may be repeated once; if 
positive or indeterminate on retest, the subject may not be randomized to IMP without 
further evaluation by a TB specialist and discussion with the Study Physician, if LTBI is 
identified. The retest must be done during the protocol-defined Screening window.
Note: If available, respiratory or other specimens must also be smear and culture negative 
for TB (CDC diagnosis of LTBI) http://www.cdc.gov/TB/topic /testing/default.htm).
f.
NTMB infection is defined as a clinical infection caused by mycobacterial species other than 
those belonging to the Mycobacterium tuberculosis complex.
g. Tuberculosis test conversion:

A positive IGRA result for the current test when previous IGRA test results were 
negative. All subjects with TB test conversion must immediately stop IMP administration 
and be referred to a TB specialist for further evaluation. Confirmed TB test conversions 
should be classified as due to LTBI, active TB infection, or NTMB, and reported to the 
UCB PS function.
Subject eligibility, retesting requirements, and treatment requirements are depicted in 
Figure 12-1.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 117 of 263
Figure 12-1: Schematic diagram of TB test results and study eligibility
IGRA TB test
IGRA TB test 
negative
IGRA TB test 
indeterminate 
IGRA TB test 
positive
Repeat IGRA TB 
testa
IGRA TB test 
negative
IGRA TB test 
indeterminate 
IGRA TB test 
positive
Subject eligible for 
study
Subject eligible for 
study
Evaluation by TB 
specialist
Latent or active 
TB negative
Latent TB 
positive
Active TB 
positive
Subject eligible for 
study
TB treatment 
initiated
No TB treatment 
initiated
Subject eligible for 
studyb
Subject NOT 
eligible for study
Subject NOT 
eligible for study
IGRA=interferon-gamma release assay; TB=tuberculosis
a IGRA retest must be done during the protocol-defined Screening window
b Subjects with LTBI may enter the study only after they have completed at least 8 weeks of appropriate 
prophylactic therapy and thereafter, will continue and complete the entire regimen.
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Bimekizumab
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12.3.1.1
Tuberculosis assessment by IGRA
During conduct of the study, the TB assessment by IGRA (QuantiFERON TB test is 
recommended) will be performed as described in Table 5‒1, Table 5‒2, and Table 5-3 for all 
subjects. The test results will be reported as positive, negative, or indeterminate. Positive and 
indeterminate TB test results must be reported as an AE and appropriately updated once the final 
diagnosis is known (eg, active TB, latent TB, or false positive TB test). UCB also recommends
that a TB specialist be consulted where TB (latent or active) is suspected or if there are doubts 
regarding test results. If active TB is identified, subject must undergo appropriate study-specified 
withdrawal procedures. The retest during Screening must be done during the protocol-defined 
Screening window.
12.3.1.2
Chest x-ray for tuberculosis
A plain posteroanterior chest x-ray must be performed in the Screening Period unless one has 
been performed within 3 months prior to the Screening Visit. The chest x-ray (or, if done, 
computed axial tomography of the chest) must be clear of signs of TB infection (previous or 
current) before first IMP administration. All chest imaging (particularly x-rays) should be 
available for review by the Investigator before randomization of the subject. The chest x-ray 
reading should be repeated if the TB test was confirmed positive. If the second read of the 
pretreatment chest x-ray is confirmed to be clear, the patient may be included in the study 
8 weeks after the start of the TB prophylactic treatment. If the pretreatment chest x-ray is not 
available for a re-read, it should be repeated after notification to the radiologist that this patient is 
IGRA positive, and confirmed to be clear for signs of TB.
The chest imaging must be negative for any old or recent TB infection as determined by a 
qualified radiologist and/or pulmonary physician. Any new clinically significant findings post 
Baseline on chest x-ray must be documented in the source documents and the eCRF as an AE.
12.3.1.3
Tuberculosis questionnaire
The questionnaire “Evaluation of signs and symptoms of tuberculosis” should be used as a 
source document. The questionnaire will be completed as described in Table 5‒1, Table 5‒2, and 
Table 5-3. The questionnaire will assist with the identification of subjects who may require 
therapy for TB. A subject who answers “Yes” to the question “Has the subject been in close 
contact with an individual with active TB, or an individual who has recently been treated for 
TB?” at Screening is excluded. A “Yes” response to any of the other questions within the 
questionnaire at Screening should trigger further careful assessment to determine if subject has 
LTB or active TB (see Exclusion Criterion #12, Section 6.2). A “Yes” response to any of the 
questions during the study should trigger further assessments to determine if the subject has 
either LTB or active TB infection.
12.3.1.4
Tuberculosis management
LTBI and active TB identified during study
During the study, subjects who develop evidence of LTBI or active TB must immediately stop 
further administration of IMP and will be referred to an appropriate TB specialist (pulmonologist 
or infectious disease specialist) for further evaluation. Evidence of LTBI is defined as subject’s 
IGRA test converts to positive or indeterminate (and confirmed indeterminate on repeat), or the 
subject’s questionnaire or history and physical indicates that TB infection or exposure may have 
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UCB
01 Oct 2021
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Bimekizumab
PS0015
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Page 119 of 263
occurred. Evidence of active TB includes, in addition to the aforementioned tests, signs and 
symptoms of organ involvement. In either situation, the subject should be carefully assessed by a 
TB specialist for active TB. Subjects diagnosed with active TB must be withdrawn from the 
study and receive appropriate TB therapy.
If a TB specialist excludes an active TB infection the subject can proceed with the IMP no earlier 
than 4 weeks after the start of an appropriate prophylactic therapy.
Any presumptive diagnosis or diagnosis of a TB infection is a reportable event. Confirmed active 
TB must be reported as an SAE. The Investigator is to complete and submit the TB Follow-Up
Form provided.
The subject should be transferred to the care of his/her physician and managed according to the 
best available standard of care. Subjects identified as having converted to active TB during the 
study must be withdrawn and scheduled to return for the PEOT Visit as soon as possible but no 
later than the next scheduled study visit and complete all PEOT Visit assessments.
The subject should be encouraged to complete a SFU Visit (20 weeks after the final dose of 
IMP).
If infection with NTMB is identified during the study, the same procedure as for active TB 
acquired during the study must be followed.
12.3.2
Pregnancy testing
Pregnancy testing will consist of serum testing at the initial Screening. The pregnancy test will 
be urine at other visits, including at the OLE2 Screening Visit.
The Screening Visit serum pregnancy testing results must be negative and received and reviewed 
prior to randomization.
A negative urine pregnancy test result should be obtained immediately prior to each 
administration of IMP at the visits specified in Table 5‒1, Table 5‒2, and Table 5-3. Pregnancy 
tests should be administered to all female subjects of childbearing potential, regardless of their 
use of birth control.
Subjects of childbearing potential should conduct a home pregnancy test every 4 weeks. Home
pregnancy tests will be provided to participants for use at Weeks 60, 68, 76, 80, 88, 92, 100, 104,
112, 116, 124, 128, 136, 140, and at the OLE2 Weeks 4, 8, 16, 32, and 40. At weeks on which 
IMP dosing is scheduled (specified in Table 5‒1, Table 5‒2, and Table 5-3), a negative urine 
pregnancy test result should be obtained immediately prior to the administration of IMP. In the 
case of a positive pregnancy test result, IMP should not be administered and the site should be 
contacted.
12.3.3
Vital signs
Vital signs will be collected at every visit and will include systolic and diastolic BP, pulse rate, 
and body temperature (oral, axillary, or otic). Subjects should be sitting for 5 minutes before and 
during vital signs assessments.
Vital signs are to be measured prior to blood sampling, and prior to dosing, where applicable.
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Bimekizumab
PS0015
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12.3.4
12-lead electrocardiograms
Twelve-lead standard ECGs will be recorded at the visits specified in Table 5‒1 and Table 5‒2,
and read by a central ECG reader.
Full details of ECG recording will be provided in the ECG Manual.
12.3.5
Physical examination
A physical examination will be performed at the visits specified in Table 5‒1, Table 5‒2, and 
Table 5-3. The physical examination will include general appearance; ear, nose, and throat; eyes, 
hair, and skin; respiratory; cardiovascular; gastrointestinal; musculoskeletal; and hepatic. 
Findings considered clinically significant changes since the physical examination at the 
Screening Visit will be recorded as AEs.
12.3.6
Height and body weight
Height will be measured at Baseline only.
Body weight will be measured at the visits specified in Table 5‒1, Table 5‒2, and Table 5-3.
12.3.7
Assessment of suicidal ideation and behavior
Suicidal ideation and behavior will be assessed by using the eC-SSRS; the questionnaire will be 
self-administered by the subject and assessed by trained study personnel. This scale will be used 
to assess suicidal ideation and behavior that may occur during the study. The visits at which the 
eC-SSRS assessments will be performed are specified in the schedule of study assessments 
(Table 5‒1, Table 5‒2, and Table 5-3).
The eC-SSRS is a standardized and validated instrument developed for the assessment of the 
severity and frequency of suicidal ideation and behavior (Posner et al, 2011; Mundt et al, 2010). 
Subjects respond to standardized clinical questions that are presented in a uniform fashion. The 
eC-SSRS defines 5 subtypes of suicidal ideation and behavior in addition to self-injurious 
behavior with no suicidal intent. The eC-SSRS takes approximately 3 to 10 minutes to complete.
Refer to Section 6.5 for eC-SSRS-related withdrawal criteria.
12.3.8
Patient Health Questionnaire-9
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring 
the severity of depression (Kroenke et al, 2001). The PHQ-9 scores for depression range from 
0 to 27, with higher scores indicating worse state. A score of 5 to 9 is considered to be minimal 
symptoms of depression. A score of 10 to 14 is considered minor depression, dysthymia, or mild 
major depression. A score of 15 to 19 is considered to indicate moderately severe major 
depression, and a score ≥20 is considered to be severe major depression.
The PHQ-9 will be assessed at the visits specified in Table 5‒1, Table 5‒2, and Table 5-3.
Refer Section 6.5 for PHQ-9-related withdrawal criteria.
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Bimekizumab
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12.4
Other study measurements
12.4.1
Demographic information
Demographic information will be collected in all subjects and include age, gender, race and 
ethnicity. Information on demographics will be collected according to local rules and regulations. 
Demographic information will be recorded in the eCRF.
12.4.2
Medical history
A complete medical history will be collected as part of the initial Screening assessment and 
include all clinically relevant past or coexisting medical conditions and surgeries. Findings will 
be recorded in the eCRF. 
For OLE2 Group B, only new or modified medical history since completing the SFU will be 
collected at OLE2 Screening and entered in eCRF.
12.4.3
Psoriasis history
A detailed history of each subject’s PSO history will be collected and include the date of onset 
and past treatments for PSO.
12.4.4
Data Monitoring and Adjudication Committees
The DMC membership includes experienced clinicians and a statistician, all of whom have 
expertise in clinical trials. Cardiovascular and Neuropsychiatric Adjudication Committees will 
also periodically review data from this trial. Both Data Monitoring and Adjudication Committee 
members may not participate in the study as principal or co-Investigators, or as study subject 
care physicians. The DMC will monitor the study through the last subject completing the Week 
48 and SFU visit (for subjects not participating in the OLE period). 
The Cardiovascular and Neuropsychiatric Adjudication Committees will monitor the study 
through the last subject completing the OLE, SFU, OLE2, and SFU2 Periods for PS0015. 
Detailed role, scope, responsibilities, and complete procedures, as well as the identity of 
members, are described in the separate committee charters.
13
STUDY MANAGEMENT AND ADMINISTRATION
13.1
Adherence to protocol
The Investigator should not deviate from the protocol. However, the Investigator should take any 
measure necessary in deviation from or not defined by the protocol in order to protect clinical 
study subjects from any immediate hazard to their health and safety. In this case, this action 
should be taken immediately, without prior notification of the regulatory authority, IRB/IEC, or 
sponsor.
After implementation of such measure, the Investigator must notify the CPM of the sponsor 
within 24 hours and follow any local regulatory requirements.
13.2
Monitoring
UCB (or designee) will monitor the study to meet the sponsor’s monitoring SOPs, ICH-GCP 
guideline, and applicable regulatory requirements, and to ensure that study initiation, conduct, 
and closure are adequate. Monitoring of the study may be delegated by UCB to a CRO or a 
contract monitor.
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Bimekizumab
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The Investigator and his/her staff are expected to cooperate with UCB (or designee) and to be 
available during the monitoring visits to answer questions sufficiently and to provide any 
missing information. The Investigator(s)/institution(s) will permit direct access to source 
data/documents for study-related monitoring, audits, IRB/IEC review, and regulatory 
inspection(s).
The Investigator will allow UCB (or designee) to periodically review all eCRFs and 
corresponding source documents (eg, hospital and laboratory records for each subject). 
Monitoring visits will provide UCB (or designee) with the opportunity to evaluate the progress 
of the study, verify the accuracy and completeness of eCRFs, ensure that all protocol 
requirements, applicable authorities regulations, and Investigator’s obligations are being 
fulfilled, and resolve any inconsistencies in the study records.
13.2.1
Definition of source data
All source documents must be accurate, clear, unambiguous, permanent, and capable of being 
audited. They should be made using some permanent form of recording (ink, typing, printing, 
optical disc). They should not be obscured by correction fluid or have temporary attachments 
(such as removable self-stick notes). Photocopies and/or printouts of eCRFs are not considered 
acceptable source documents.
Source documents are original records in which raw data are first recorded. These may include 
hospital/clinic/general practitioner records, charts, diaries, x-rays, laboratory results, printouts, 
pharmacy records, care records, ECG or other printouts, completed scales, or QOL 
questionnaires, for example. Source documents should be kept in a secure, limited access area.
Source documents that are computer generated and stored electronically must be printed for 
review by the monitor (eg, ECG reports). Once printed, these copies should be signed and dated 
by the Investigator and become a permanent part of the subject’s source documents. The 
Investigator will facilitate the process for enabling the monitor to compare the content of the 
printout and the data stored in the computer to ensure all data are consistent.
Electronic data records, such as Holter monitor records or electroencephalogram records, must 
be saved and stored as instructed by UCB (or designee).
Electronic Patient-Reported Outcome (ePRO) measures (eg, DLQI, EQ-5D-3L, Patient Global 
Assessment of PSO, and PGADA) will be completed by each subject and will be collected 
electronically.
The data collection and database management system will be supplied by a vendor and will be 
compliant with the relevant regulations. The data collected on the ePROs will be uploaded to a
central server database and will be sent electronically to UCB (or a designated CRO).
13.2.2
Source data verification
Source data verification ensures accuracy and credibility of the data obtained. During monitoring 
visits, reported data are reviewed with regard to being accurate, complete, and verifiable from 
source documents (eg, subject files, recordings from automated instruments, tracings [ECG], 
x-ray films, laboratory notes). All data reported on the eCRF should be supported by source 
documents, unless otherwise specified in Section 13.2.1.
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Bimekizumab
PS0015
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13.3
Data handling
13.3.1
Case Report Form completion
The Investigator is responsible for prompt reporting of accurate, complete, and legible data in the 
electronic eCRFs and in all required reports.
Any change or correction to the eCRF after saving must be accompanied by a reason for the 
change.
Corrections made after the Investigator’s review and approval (by means of a 
password/electronic signature) will be reapproved by the Investigator.
The Investigator should maintain a list of personnel authorized to enter data into the electronic 
eCRF.
Detailed instructions will be provided in the eCRF Completion Guidelines.
13.3.2
Database entry and reconciliation
Case Report Forms/external electronic data will be entered/loaded into a validated electronic 
database using a clinical data management system (CDMS). Computerized data cleaning checks 
will be used in addition to manual review to check for discrepancies and to ensure consistency of 
the data. This study is performed using Electronic Data Capture: the data are entered into the 
eCRFs once and are subsequently verified. An electronic audit trail system will be maintained 
within the CDMS to track all data changes in the database once the data have been saved initially 
into the system or electronically loaded. Regular backups of the electronic data will be 
performed.
13.3.3
Subject Screening and Enrollment log/Subject Identification Code list
The subject’s screening and enrollment will be recorded in the Subject Screening and Enrollment 
Log.
The Investigator will keep a Subject Identification Code list. This list remains with the 
Investigator and is used for unambiguous identification of each subject.
The subject’s consent and enrollment in the study must be recorded in the subject’s medical 
record. These data should identify the study and document the dates of the subject’s 
participation.
13.4
Termination of the study
UCB reserves the right to temporarily suspend or prematurely discontinue this study either at a 
single site, multiple sites, or at all sites at any time for reasons including, but not limited to, 
safety or ethical issues, inaccurate or incomplete data recording, noncompliance, or 
unsatisfactory enrollment with respect to quality or quantity.
If the study is prematurely terminated or suspended, UCB (or its representative) will inform the 
Investigators/institutions and the regulatory authority(ies) of the termination or suspension and 
the reason(s) for the termination or suspension, in accordance with applicable regulatory 
requirement(s). The IRB/IEC should also be informed and provided with reason(s) for the 
termination or suspension by the sponsor or by the Investigator/institution, as specified by the 
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Bimekizumab
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applicable regulatory requirement(s). In addition, arrangements will be made for the return of all 
unused IMP and other material in accordance with UCB procedures for the study.
13.5
Archiving and data retention
The Investigator will maintain adequate records for the study, including eCRFs, medical records, 
laboratory results, Informed Consent documents, drug dispensing and disposition records, safety 
reports, information regarding subjects who discontinued, and other pertinent data.
All essential documents are to be retained by the Investigator until at least 2 years after the last 
approval of a marketing application in an ICH region and until there are no pending or 
contemplated marketing applications in an ICH region, or at least 2 years have elapsed since the 
formal discontinuation of clinical development of the IMP. These documents should be retained 
for a longer period, however, if required by the applicable regulatory requirement(s) or by an 
agreement with UCB (Committee for Proprietary Medicinal Products [CPMP]/ICH/135/95, 2002 
[Section 4.9.5]). The Investigator will contact UCB for authorization prior to the destruction of 
any study records or in the event of accidental loss or destruction of any study records. The 
Investigator will also notify UCB should he/she relocate or move the study-related files to a 
location other than that specified in the sponsor’s trial master file.
13.6
Audit and inspection
The Investigator will permit study-related audits mandated by UCB, after reasonable notice, and 
inspections by domestic or foreign regulatory authorities.
The main purposes of an audit or inspection are to confirm that the rights and well-being of the 
subjects enrolled have been protected, that enrolled subjects (ie, signing consent and undergoing 
study procedures) are appropriate for the study, and that all data relevant for the evaluation of the 
IMP have been processed and reported in compliance with the planned arrangements, the 
protocol, investigational site, and IRB/IEC SOPs, ICH GCP, and applicable regulatory 
requirements.
The Investigator will provide direct access to all study documents, source records, and source 
data. If an inspection by a regulatory authority is announced, the Investigator will immediately 
inform UCB (or designee).
13.7
Good Clinical Practice
Noncompliance with the protocol, ICH-GCP, or local regulatory requirements by the 
Investigator, institution, institution staff, or designees of the sponsor will lead to prompt action 
by UCB to secure compliance. Continued noncompliance may result in the termination of the 
site’s involvement in the study.
14
STATISTICS
A description of statistical methods follows and will be described in more detail in the Statistical 
Analysis Plan (SAP).
14.1
Definition of analysis sets
The Enrolled Set will consist of all subjects who have given informed consent.
The Randomized Set (RS) will consist of all randomized subjects.
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UCB
01 Oct 2021
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Bimekizumab
PS0015
Confidential
Page 125 of 263
The Safety Set (SS) will consist of all subjects that received at least 1 dose of the IMP.
The Pharmacokinetics Per-Protocol Set (PK-PPS) consists of all randomized subjects who 
received at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration 
postdose without important protocol deviations that would affect the concentration.
The Full Analysis Set (FAS) will consist of all subjects in the RS that receive at least 1 dose of 
the IMP and have a valid PASI measurement at Baseline.
The Maintenance Set (MS) will consist of all subjects that receive at least 1 dose of IMP at Week 
16 or later in the double-blind Treatment Period (including the Week 16 dose).
The Open-label Set (OLS) will consist of all subjects that receive at least 1 dose of IMP at Week 
48 or later in the OLE Period (including the Week 48 dose).
The OLE2 Period Set (OL2S) will consist of all subjects that receive at least 1 dose of IMP at the
Week 144/OLE2 Baseline or later in the OLE2 Period (including the Week 144/OLE2 Baseline 
dose).
The Per-Protocol Set (PPS) will consist of all subjects in the RS who had no important protocol 
deviations affecting the primary efficacy variable. Important protocol deviations will be 
predefined and subjects with important protocol deviations will be evaluated during ongoing data 
cleaning meetings prior to unblinding of the data.
14.2
General statistical considerations
Summary statistics will consist of frequency tables for categorical variables. For continuous 
variables, summary statistics will consist of the number of available observations, arithmetic 
mean, standard deviation, median, minimum, and maximum unless stated otherwise.
The statistical analysis of the primary efficacy variable and selected secondary efficacy variables 
will account for multiplicity and control the familywise Type I error rate at a 2-sided alpha level 
of 0.05 by using a fixed sequence testing procedure. 
The hypotheses (H1, H2, H3, H4, H5, and H6) comparing bimekizumab vs secukinumab will be 
tested at a 2-sided alpha level of 0.05.
The first 2 hypotheses (H1 and H2) test whether bimekizumab is non-inferior and superior, 
respectively, to secukinumab for PASI100 response at Week 16. These are the hypothesis tests 
corresponding to the primary endpoint. If these hypotheses are rejected at a 2-sided alpha level of 
0.05, that alpha will be passed to the next test in the sequence, allowing the testing procedure to 
proceed.
The hypotheses associated with the subsequent tests are for selected secondary efficacy 
endpoints and are based on testing for superiority relative to secukinumab. Figure 14‒1 presents 
the details on this procedure.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 126 of 263
Figure 14‒1:Hypothesis testing
BKZ=bimekizumab; PASI=Psoriasis Area Severity Index; Q4W=every 4 weeks; Q8W=every 8 weeks
Note: Tests for H1, H2, H3, and H4 are based on all subjects initially randomized to bimekizumab compared to 
secukinumab. For H5 and H6, testing is based on the subjects re-randomized at Week 16 to bimekizumab 320mg 
Q4W, and bimekizumab 320mg Q8W, respectively, compared to secukinumab.
14.3
Planned efficacy analyses
14.3.1
Analysis of the primary efficacy variable
The analysis of the primary efficacy variable (PASI100 at Week 16) will be based on the RS. A 
stratified Cochran-Mantel-Haenszel (CMH) test will be performed, where region and prior 
biologic exposure (yes/no) will be used as stratification variables. Region and prior biologic 
exposure have been selected as stratification variables in the analysis because they are 
stratification variables in the randomization and because they may have an impact on efficacy. 
Treatment comparisons between bimekizumab and secukinumab will be made based on the 
CMH test using the p-value for the general association. For the assessment of non-inferiority, a 
non-inferiority margin of 10% will be used and evaluated based on the CI for the stratified 
Mantel-Haenszel risk difference between bimekizumab and secukinumab. A non-inferiority 
margin of 10% has been selected as this is considered to be a clinically relevant difference that 
could influence the choice of interventions used to treat chronic plaque PSO. Therefore, a 
difference within the 10% non-inferiority margin would suggest a similar impact on efficacy 
between the treatments.
Nonresponder imputation (NRI) will be used to account for missing data in the primary analysis. 
Specifically, any subject who withdraws from IMP prior to Week 16 or who has missing data for 
the primary efficacy variables at the Week 16 time point will be considered a nonresponder. 
Based on previous studies of biologics in subjects with moderate to severe chronic plaque PSO, 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
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Page 127 of 263
it is expected that the number of subjects who discontinue prior to Week 16 will be low. For the 
small percentage of subjects for whom primary endpoint data are unavailable at Week 16, this 
lack of data is suggestive of an ineffective IMP, thereby supporting the imputation of 
nonresponse. Therefore, NRI is considered an appropriate method for handling missing data 
since achieving the clinical response and making it through 16 weeks of IMP are both critical 
components of the primary outcome.
14.3.1.1
Sensitivity analyses
The primary efficacy analysis described in Section 14.3.1 will be repeated based on the FAS and 
the PPS.
As a sensitivity analysis to the primary analysis method, logistic regression based on the RS will 
be used. The odds ratio of the responder rates at Week 16 will be estimated and tested between 
treatment groups using a logistic regression model with factors of treatment group, region, and 
prior biologic exposure (yes/no). The odds ratio, associated CI, and p-value based on the Wald 
test will be presented. If the logistic regression model is unable to converge, then prior biologic 
exposure may be dropped from the model to facilitate convergence. If the model is still unable to 
converge, then region may be removed from the model as well. As with the primary analysis, 
missing data will be handled using NRI.
The center-by-treatment interaction will be tested by replacing region with center in the logistic 
regression model described above and adding a center-by-treatment interaction term. In the 
model, center will be based on the original centers prior to pooling. However, if the model is 
unable to converge due to a low number of subjects at a given center, a pooling (to be further 
described in the SAP) will be applied in order to allow the model to converge.
In order to obtain reasonable estimates of variability for a treatment arm at a given center, a 
minimum of 10 subjects will be considered acceptable for a center to be included in the model 
without pooling. Given the 1:1 randomization allocation scheme at the start of the study, this 
should provide a minimum of about 5 subjects in the bimekizumab arm and 5 subjects in the 
secukinumab arm. Centers with fewer than 10 subjects will be eligible for pooling. The 
following center pooling algorithm will be used for each geographic region:
x
If a center has 10 or more subjects, then no pooling will be done for that center.
x
Centers with fewer than 10 subjects will be ordered from largest to smallest with pooling 
proceeding in the following manner:
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Two or more centers will be combined until the cumulative subject total is at least 10.
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fashion for the subsequent centers in the ordered list, where a new pooled center begins 
each time at least 10 subjects has been reached in the previous pool.
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pooled center has fewer than 10 subjects, then the subjects from the centers in that pool 
will be combined with the pooled center formed in the previous iteration.
This procedure is only to be performed within a geographic region – there will be no pooling of 
centers across regions.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 128 of 263
If the center-by-treatment interaction is not found to be significant (α=0.10), then no further
analyses will be performed. On the other hand, if the interaction is significant, further analyses 
will be conducted to determine which center or centers may be the source of the interaction. This 
will be done by running the logistic regression model (including the interaction term) where each 
center will be systematically removed from the model. The impact of a given center will be 
based on the change in the interaction p-value when that center is removed. The center or centers 
that appear to be driving the significant interaction effect will then be removed from the model to 
verify that conclusions remain the same with or without the influential center(s). 
Additional sensitivity analyses to evaluate varying assumptions related to the handling of 
missing data will also be performed and are described in greater detail in Section 14.7.
14.3.2
Other efficacy analyses
14.3.2.1
Analysis of the secondary efficacy variables
The secondary efficacy variables will be analyzed for all subjects in the RS.
All secondary efficacy variables are binary. Therefore, the stratified CMH test (as specified for 
the primary analysis) will be implemented to test for superiority. As in the primary analysis, NRI 
will be used to account for missing data. Sensitivity analyses for handling missing data on 
secondary endpoints are outlined in Section 14.7.
PASI75 response at Week 4 will be analyzed for all subjects in the RS based on the randomized 
treatment group at Baseline.
Additionally, PASI100 at Week 48 will be evaluated as a secondary efficacy variable. The way 
the analysis for this variable is conducted will depend on which comparison is being made. The 
planned comparisons are as follows:
x
Compare all subjects initially randomized to bimekizumab (regardless of re-randomization 
assignment at Week 16) to all subjects initially randomized to secukinumab based on the RS 
(H4)
x
Compare subjects who were assigned to bimekizumab 320mg Q4W at Week 16 to 
secukinumab based on the MS (H5)
x
Compare subjects who were assigned to bimekizumab 320mg Q8W at Week 16 to 
secukinumab based on the MS (H6)
14.3.2.2
Analysis of the other efficacy variables
Other efficacy variables will be summarized by treatment and visit and will generally be 
summarized based on imputed data (NRI and multiple imputation [MI] for binary and continuous 
variables, respectively, unless otherwise stated in the SAP). In some cases, variables may also be 
summarized based on observed case data (ie, subjects with missing data or who have 
prematurely discontinued IMP are treated as missing). There may be cases where the multiple 
imputation model fails to converge. In such situations, the last observation carried forward 
(LOCF) approach will instead be used to impute the missing data. If LOCF is used instead of 
multiple imputation for this reason, this will be clearly specified in the corresponding table 
summary. Should there be no missing data for a study variable, then only observed case data will 
be presented. Note that for LOCF imputation, any missing data or data collected following 
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UCB
01 Oct 2021
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Bimekizumab
PS0015
Confidential
Page 129 of 263
discontinuation of IMP will be imputed with the most recent previous value. See Section 14.7 for 
further details.
Time to PASI75/90/100 response will be estimated and presented using the Kaplan-Meier 
product-limit method based on the RS by initially randomized treatment groups (Bimekizumab 
vs secukinumab). This could make the interpretation of the data challenging given that there are 
two different bimekizumab dosing regimens starting at Week 16, but it is anticipated that most 
responses will be observed by Week 16 when all bimekizumab subjects are on the same regimen. 
Time to a given response will be defined as the length in days from the first dose of IMP until the 
first date when the response is achieved. Subjects who discontinue IMP prior to achieving a 
response will be censored at the date of IMP discontinuation. Subjects who reach the Week 48
Visit without achieving the given PASI response will be censored at the date of the Week 48
Visit. The median time to response, including the 2-sided 95% CI, will be calculated for each 
treatment. Between group differences (bimekizumab vs secukinumab) will be analyzed with the 
log-rank statistic.
In general, data will be summarized by visit through Week 48 in the double-blind Treatment 
Period and then by visit in the OLE Period and OLE2 Period separately. All summaries of data 
up to Week 16 will be based on the RS for the 2 randomized treatment groups (bimekizumab and 
secukinumab). For visits after Week 16 in the double-blind Treatment Period, by-visit summaries 
will be prepared for the following 3 groups of subjects:
1. Subjects in the MS summarized by the 3 maintenance treatment groups (bimekizumab 
320mg Q4W, bimekizumab 320mg Q8W, and secukinumab). Note that while the MS is
primarily defined for the evaluation of data after Week 16, these summary tables will include 
data at all visits (Baseline to Week 48) to provide a comprehensive summary of subjects by 
maintenance treatment group for the MS.
2. A subset of Group 1 above. Specifically, this will include only those subjects who are 
responders at Week 16 for the variable being summarized. This will provide an assessment of 
how efficacy is maintained among Week 16 responders.
3. Subjects in the RS summarized by the 2 randomized treatment groups (bimekizumab and 
secukinumab). Data from Baseline to Week 48 will be included in these tables. This provides 
an intent-to-treat analysis among all randomized subjects in the study through Week 48.
All efficacy variables in the double-blind Treatment Period will be summarized in the manner 
described for Group 1 and 3 above. Summaries for Groups 2 will be done only for a subset of 
efficacy variables, namely, PASI75/90/100, IGA Clear or Almost Clear, Scalp IGA Clear or 
Almost Clear, pp-IGA Clear or Almost Clear, mNAPSI75/90/100, and DLQI 0/1.
In the OLE Period, efficacy variables of interest generally will be summarized descriptively by 
the combined treatment regimen in the double-blind Treatment Period and re-randomized 
treatment in the OLE.
In general, efficacy variables will be summarized using descriptive statistics by treatment group 
and scheduled visit during the OLE Period based on Baseline at beginning of the study unless 
otherwise specified. 
In the OLE2 Period, selected efficacy variables of interest will be summarized descriptively by 
OLE2 Period Treatment Group during the OLE2 Period.
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UCB
01 Oct 2021
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Bimekizumab
PS0015
Confidential
Page 130 of 263
Further details on the above analyses including analysis in the OLE Period and OLE2 Period will 
be provided in the SAP.
14.4
Subgroup analyses
Subgroup analyses will be performed on the primary and secondary efficacy variables that are 
part of the fixed sequence testing procedure described in Section 14.2. The following variables 
for subgroup analyses will be defined: age, gender, disease duration, region, weight, body mass 
index, prior systemic chemotherapy or phototherapy, prior biologic exposure, prior primary 
failure to biologics, prior systemic therapy of any kind, Baseline disease severity, and antibody 
positivity. These summaries will be based on imputed data (NRI) and will include descriptive 
statistics only.
14.5
Planned safety and other analyses
14.5.1
Safety analyses
Safety variables will be analyzed for all subjects in the SS. This will include all subjects who 
took at least one dose of study medication. Selected analyses will also be presented for MS, 
OLS, and OL2S. Adverse events will be coded according to the Medical Dictionary for 
Regulatory Activities. Adverse events will be summarized descriptively by treatment group, 
primary system organ class, High Level Term (HLT), and PT. Additional tables will summarize 
AEs by intensity and relationship to IMP, AEs leading to withdrawal from the study, SAEs, and 
deaths. Safety topics of interest will be summarized and will be described in greater detail in the 
SAP. 
Laboratory values (including markedly abnormal laboratory values), urinary values, vital signs, 
and extent of exposure will be presented descriptively by treatment group. Definitions for 
markedly abnormal laboratory values will be provided in the SAP.
14.5.2
Pharmacokinetic analyses
Pharmacokinetic variables will be analyzed for all subjects in the PK-PPS. Bimekizumab plasma 
concentrations will be summarized for each treatment at each scheduled visit where samples are 
collected. 
14.5.3
Immunogenicity analyses
Anti-bimekizumab antibodies will be assessed using a tiered approach: screening, confirmatory, 
and titer assays will be used. Anti-bimekizumab antibodies (including positivity) will be 
summarized by treatment at each scheduled visit at which samples are collected.
14.6
Handling of protocol deviations
Important protocol deviations are deviations from the protocol which potentially could have a 
meaningful impact on study conduct, or on the primary efficacy, key safety, or PK/PD outcomes 
for an individual subject. The criteria for identifying important protocol deviations will be 
defined within the appropriate protocol-specific document at study start. Important protocol 
deviations will be reviewed as part of the ongoing data cleaning process and all important 
deviations will be identified and documented prior to unblinding to confirm exclusion from 
analysis sets.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 131 of 263
14.7
Handling of dropouts or missing data
Study variables with multiple components may have rules to account for partial missing data of 
1 or more components. Such rules will be defined in the SAP. The following rules are outlined 
for cases where variables are completely missing, including partial missing data where the data 
handling rules conclude that the variable should be treated as completely missing.
The analysis of the primary efficacy variable will use NRI for handling of missing data. That is, 
subjects with missing data or who have discontinued IMP prior to Week 16 will be considered as 
nonresponders for the primary analysis.
The following sensitivity analyses for the primary efficacy variable will be performed:
1. Missing data will be addressed by using MI (Markov-Chain Monte Carlo method for 
intermittent missing data, followed by monotone regression for monotone missing data) to 
evaluate the effect of the method for handling missing data on the analysis. The actual PASI 
scores will be imputed and then dichotomized to obtain the response status. The treatment 
differences for each imputed data set will subsequently be evaluated using the stratified 
CMH test as used in the primary analysis. The results from each of the imputed data sets will 
be combined for overall inference using Rubin’s rules, which account for the uncertainty 
associated with the imputed values (Rubin, 1987). This will be done using SAS PROC 
MIANALYZE. This procedure assumes a missing at random pattern of missingness and 
corresponds to an estimand of the difference in outcome improvement if all subjects tolerated 
or adhered to treatment (Mallinckrodt et al, 2012). This is an estimand of efficacy to evaluate 
the de jure hypothesis. 
2. Another sensitivity analysis will be based on observed data at Week 16. Subjects with 
missing data or who have prematurely discontinued IMP will be treated as missing. The same 
stratified CMH test as in the primary efficacy analysis will be used.
Further details on the MI procedures will be provided in the SAP.
Missing data for the secondary efficacy variables (which are all binary) will be imputed using 
NRI. Additionally, the 2 missing data-handling approaches described above for the primary 
efficacy variable will be used for the secondary efficacy variables. Additional missing data 
handling approaches may be described in the SAP.
For other continuous efficacy variables, MI will be used to impute missing data when possible. If 
the imputation model cannot converge, LOCF will be used. The MI procedure will be similar to 
sensitivity analysis #1 described above with the following differences: (1) the imputation model 
will use the change from Baseline (instead of actual) values by visit and no dichotomization will 
be necessary; (2) instead of using the stratified CMH test, the imputed data sets will be combined 
and simple means and standard errors will be calculated using Rubin’s rules (via SAS PROC 
MIANALYZE). For calculation of other descriptive statistics such as the median, minimum and 
maximum, Rubin's rules do not apply. Multiple imputation estimates will be computed by simply 
averaging the estimates from the multiple repetitions of the imputation algorithm. 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 132 of 263
14.8
Planned interim analysis 
An interim analysis is planned at Week 48 and Week 144, details of which will be documented 
in the SAP. Additional interim analyses may be performed (details of which will be documented 
in the SAP). Corresponding interim Clinical Study Reports (CSRs) may be written. A final 
analysis and updated final CSR will be prepared once all data through the OLE2 Period and 
SFU2 Visit have been collected. 
14.9
Determination of sample size
A total of 700 subjects will be randomly assigned in a 1:1 ratio at Baseline to one of the 
following treatment groups:
x
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x
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The primary efficacy analysis is based on the comparison of bimekizumab to secukinumab for 
the primary efficacy variable of PASI100 response at Week 16. The assumed responder rates for 
PASI100 at Week 16 are 60% and 44% for bimekizumab and secukinumab, respectively. The 
assumed responder rate for bimekizumab is based on the Phase 2b PS0010 data. The 
assumptions related to the responder rates for secukinumab are based on those observed in the 
CLEAR study (Thaçi et al, 2015). The power to show statistical superiority of bimekizumab 
relative to secukinumab under these assumptions is 98% for the primary endpoint. The power for 
the non-inferiority comparison (with 10% non-inferiority margin) under these assumptions is 
>99%.
15
ETHICS AND REGULATORY REQUIREMENTS
15.1
Informed consent
Subject’s informed consent must be obtained and documented in accordance with local 
regulations, ICH-GCP requirements, and the ethical principles that have their origin in the 
principles of the Declaration of Helsinki.
Prior to obtaining informed consent, information should be given in a language and at a level of 
complexity understandable to the subject in both oral and written form by the Investigator (or 
designee). Each subject will have the opportunity to discuss the study and its alternatives with 
the Investigator.
Prior to participation in the study, the ICF should be signed and personally dated by the subject 
and by the person who conducted the informed consent discussion (Investigator or designee). 
The subject must receive a copy of the signed and dated ICF. As part of the consent process, 
each subject must consent to direct access to his/her medical records for study-related 
monitoring, auditing, IRB/IEC review, and regulatory inspection.
All subjects enrolling in the OLE Period will sign a new ICF. Similarly, all subjects enrolling in 
the OLE2 Period will sign a new ICF.
If the ICF is amended during the study, the Investigator (or the sponsor, if applicable) must 
follow all applicable regulatory requirements pertaining to the approval of the amended ICF by 
the IRB/IEC and use of the amended form.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 133 of 263
All studies conducted at centers in the United States must include the use of a Health Insurance 
Portability and Accountability Act Authorization form.
The subject may withdraw his/her consent to participate in the study at any time. A subject is 
considered as enrolled in the study when he/she has signed the ICF. An eCRF must not be 
started, nor may any study specific procedure be performed for a given subject, without having 
obtained his/her written consent to participate in the study.
15.2
Subject identification cards
Upon signing the Informed Consent and Assent form (as applicable), the subject will be provided 
with a subject identification card in the language of the subject. The Investigator will fill in the 
subject identifying information and medical emergency contact information. The Investigator 
will instruct the subject to keep the card with him/her at all times.
15.3
Institutional Review Boards and Independent Ethics 
Committees
The study will be conducted under the auspices of an IRB/IEC, as defined in local regulations, 
ICH-GCP, and in accordance with the ethical principles that have their origin in the Declaration 
of Helsinki.
The Investigator/UCB will ensure that an appropriately constituted IRB/IEC that complies with 
the requirements of the current ICH-GCP version or applicable country-specific regulations will 
be responsible for the initial and continuing review and approval of the clinical study. Prior to 
initiation of the study, the Investigator/UCB will forward copies of the protocol, ICF, IB, 
Investigator’s curriculum vitae (if applicable), advertisement (if applicable), and all other 
subject-related documents to be used for the study to the IRB/IEC for its review and approval.
Before initiating a study, the Investigator will have written and dated full approval from the 
responsible IRB/IEC for the protocol.
The Investigator will also promptly report to the IRB/IEC all changes in the study, all 
unanticipated problems involving risks to human subjects or others, and any protocol deviations, 
to eliminate immediate hazards to subjects.
The Investigator will not make any changes in the study or study conduct without IRB/IEC 
approval, except where necessary to eliminate apparent immediate hazards to the subjects. For 
minor changes to a previously approved protocol during the period covered by the original 
approval, it may be possible for the Investigator to obtain an expedited review by the IRB/IEC as 
allowed.
As part of the IRB/IEC requirements for continuing review of approved studies, the Investigator 
will be responsible for submitting periodic progress reports to the IRB/IEC (based on IRB/IEC 
requirements), at intervals appropriate to the degree of subject risk involved, but no less than 
once per year. The Investigator should provide a final report to the IRB/IEC following study 
completion.
UCB (or its representative) will communicate safety information to the appropriate regulatory 
authorities and all active Investigators in accordance with applicable regulatory requirements. 
The appropriate IRB/IEC will also be informed by the Investigator or the sponsor, as specified 
by the applicable regulatory requirements in each concerned country. Where applicable, 
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UCB
01 Oct 2021
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Bimekizumab
PS0015
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Page 134 of 263
Investigators are to provide the sponsor (or its representative) with evidence of such IRB/IEC 
notification.
15.4
Subject privacy
UCB staff (or designee) will affirm and uphold the subject’s confidentiality. Throughout this 
study, all data forwarded to UCB (or designee) will be identified only by the subject number 
assigned at Screening.
The Investigator agrees that representatives of UCB, its designee, representatives of the relevant 
IRB/IEC, or representatives of regulatory authorities will be allowed to review that portion of the 
subject’s primary medical records that directly concerns this study (including, but not limited to, 
laboratory test result reports, ECG reports, admission/discharge summaries for hospital 
admissions occurring during a subject’s study participation, and autopsy reports for deaths 
occurring during the study).
15.5
Protocol amendments
Protocol changes may affect the legal and ethical status of the study and may also affect the 
statistical evaluations of sample size and the likelihood of the study fulfilling its primary 
objective.
Significant changes to the protocol will only be made as an amendment to the protocol and must 
be approved by UCB, the IRB/IEC, and the regulatory authorities (if required), prior to being 
implemented.
16
FINANCE, INSURANCE, AND PUBLICATION
Insurance coverage will be handled according to local requirements.
Finance, insurance, and publication rights are addressed in the Investigator and/or CRO 
agreements, as applicable.
17
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Bimekizumab
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 137 of 263
18
APPENDICES
18.1
Protocol Amendment 1
Rationale for the amendment
The primary rationale for this amendment was to incorporate a re-randomization at Week 16 for 
subjects in the bimekizumab 320mg treatment arm. At Week 16 subjects in the bimekizumab 
320mg treatment arm will be re-randomized 1:2 to receive bimekizumab 320mg Q4W or 
bimekizumab 320mg Q8W.
The following additional changes were also made:
x
Add the number of subjects included in the summary of the completed study UP0042
x
Clarify the scalp IGA and pp-IGA efficacy response criteria
x
Move the PHQ-9 variable from an other safety variable to an other efficacy variable
x
Added percent of subjects achieving mNAPSI75, mNAPSI90, and mNAPSI100 for subjects 
with nail PSO at Baseline as an other efficacy variable
x
Clarify that all study assessments should be performed prior to administration of IMP
x
Clarify the study visit windows
x
Clarify that the PGADA should be performed on all subjects at Baseline
x
Define mental healthcare professional
x
Clarify the assessment and management of TB wording
x
Clarify the drug accountability wording
x
Revise the systemic retinoid washout period
x
Clarify that the same assessor should evaluate the subject at each assessment
x
Remove the requirement for a rheumatologist evaluation for subjects with a PASE ≥47
x
Clarify the IMP restart/rechallenge requirements in case of PDILI
x
Add the definition of the Enrolled Set and Maintenance Set
x
Revise the statistical analysis based on the addition of re-randomization at Week 16
Minor spelling, editorial, and formatting changes were also made, and the List of Abbreviations 
was updated.
Modifications and changes
Change #1
Section 1 Summary
During the Treatment Period, eligible subjects will be randomized 1:1 to receive one of the 
following blinded IMP regimens:
x
Bimekizumab 320mg administered subcutaneously (sc) every 4 weeks (Q4W)
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 138 of 263
x
Secukinumab 300mg administered sc at Baseline and Weeks 1, 2, 3, and 4 followed by
dosing Q4W
Subjects receiving bimekizumab 320mg will receive placebo sc on Weeks 1, 2, and 3 in order to 
maintain the blind. 
Approximately 350 subjects will be randomized to bimekizumab 320mg and approximately 
350 subjects will be randomized to secukinumab. Investigational medicinal product will be 
administered at Baseline, Weeks 1, 2, 3, and 4 and then Q4W thereafter, until Week 44
(Treatment Period). All doses will be administered in the clinic.
Has been changed to:
During the first 16 weeks of the Treatment Period, eligible subjects will be randomized 1:1 to 
receive one of the following blinded IMP regimens:
x
Bimekizumab 320mg administered subcutaneously (sc) every 4 weeks (Q4W)
x
Secukinumab 300mg administered sc at Baseline and Weeks 1, 2, 3, and 4 followed by 
dosing Q4W
Subjects receiving bimekizumab 320mg will receive placebo sc on Weeks 1, 2, and 3 in order to 
maintain the blind. 
Approximately 350 subjects will be randomized to bimekizumab 320mg and approximately 
350 subjects will be randomized to secukinumab. Investigational medicinal product will be 
administered at Baseline, Weeks 1, 2, 3, and 4 and then Q4W thereafter, until Week 44
(Treatment Period). All doses will be administered in the clinic.
At Week 16 subjects in the bimekizumab 320mg treatment arm will be re-randomized 1:2 
to receive bimekizumab 320mg Q4W or bimekizumab 320mg every 8 weeks (Q8W). To 
maintain the blind after re-randomization, subjects in the bimekizumab 320mg Q8W 
treatment arm will receive placebo at Weeks 20, 28, 36, and 44. Subjects in the 
secukinumab arm will continue to receive secukinumab 300mg Q4W.
Change #2
Section 2.2.1.1 Completed studies
Five clinical studies of bimekizumab have been completed: UP0008 in 39 subjects with mild to 
moderate plaque PSO, RA0124 in 30 healthy volunteers, PA0007 in 53 subjects with PsA, 
UP0031 in 12 healthy volunteers, and UP0042 in healthy volunteers. 
Has been changed to:
Five clinical studies of bimekizumab have been completed: UP0008 in 39 subjects with mild to 
moderate plaque PSO, RA0124 in 30 healthy volunteers, PA0007 in 53 subjects with PsA, 
UP0031 in 12 healthy volunteers, and UP0042 in 48 healthy volunteers. 
Change #3 
Section 2.2.1.2 Ongoing studies
Seven additional studies of bimekizumab in the treatment of PSO are ongoing.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 139 of 263
x
PS0008 is a Phase 3, multicenter, randomized, double-blind, parallel-group, active-
comparator-controlled study to evaluate the efficacy and safety of bimekizumab in adult 
subjects with moderate to severe chronic plaque PSO.
x
PS0009 is a Phase 3 randomized, double-blind, placebo- and active comparator-controlled 
study to evaluate the efficacy and safety of bimekizumab administered sc to adult subjects 
with moderate to severe plaque PSO.
x
PS0010 is a Phase 2b, double-blind, placebo-controlled, dose ranging study to evaluate the 
safety, efficacy, PK, and pharmacodynamics (PD) of bimekizumab in adult subjects with 
moderate to severe chronic plaque PSO.
x
PS0011 is a long-term extension study for subjects who completed PS0010 to assess the 
long-term safety, tolerability, and efficacy of bimekizumab.
x
PS0013 is a Phase 3, multicenter, randomized withdrawal, double-blind, placebo-controlled 
study to evaluate the efficacy and safety of bimekizumab in adult subjects with moderate to 
severe chronic plaque PSO.
x
PS0016 is a Phase 2a, subject-blind, investigator-blind study to evaluate the time course of 
PD response, safety, and PK of bimekizumab in adult subjects with moderate to severe 
chronic plaque PSO.
x
PS0018 is a long-term extension study for eligible subjects from PS0016 to assess the safety, 
tolerability, and efficacy of bimekizumab.
x
PS0014 is a Phase 3, multicenter, open-label study to assess the long-term safety, tolerability, 
and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque 
psoriasis.
Has been changed to:
Eightseven additional studies of bimekizumab in the treatment of PSO are ongoing.
x
PS0008 is a Phase 3, multicenter, randomized, double-blind, parallel-group, active-
comparator-controlled study to evaluate the efficacy and safety of bimekizumab in adult 
subjects with moderate to severe chronic plaque PSO.
x
PS0009 is a Phase 3 randomized, double-blind, placebo- and active comparator-controlled 
study to evaluate the efficacy and safety of bimekizumab administered sc to adult subjects 
with moderate to severe plaque PSO.
x
PS0010 is a Phase 2b, double-blind, placebo-controlled, dose ranging study to evaluate the 
safety, efficacy, PK, and pharmacodynamics (PD) of bimekizumab in adult subjects with 
moderate to severe chronic plaque PSO.
x
PS0011 is a long-term extension study for subjects who completed PS0010 to assess the 
long-term safety, tolerability, and efficacy of bimekizumab.
x
PS0013 is a Phase 3, multicenter, randomized withdrawal, double-blind, placebo-controlled 
study to evaluate the efficacy and safety of bimekizumab in adult subjects with moderate to 
severe chronic plaque PSO.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 140 of 263
x
PS0014 is a Phase 3, multicenter, open-label study to assess the long-term safety, 
tolerability, and efficacy of bimekizumab in adult subjects with moderate to severe 
chronic plaque psoriasis.
x
PS0016 is a Phase 2a, subject-blind, investigator-blind study to evaluate the time course of 
PD response, safety, and PK of bimekizumab in adult subjects with moderate to severe 
chronic plaque PSO.
x
PS0018 is a long-term extension study for eligible subjects from PS0016 to assess the safety, 
tolerability, and efficacy of bimekizumab.
Change #4
Section 4.3.1 Other efficacy variables
The following bullet has been added:
x
Percent of subjects achieving mNAPSI75, mNAPSI90, and mNAPSI100 for subjects with 
nail PSO at Baseline
Change #5
Section 4.3.1 Other efficacy variables
x
Scalp-specific Investigator’s Global Assessment (scalp IGA) response (0/1 and 0) at 
Week 16 for subjects with scalp PSO at Baseline
x
Scalp IGA response (0/1 and 0) for subjects with scalp PSO at Baseline
x
Palmoplantar Investigator’s Global Assessment (pp-IGA) response (0/1 and 0) for subjects 
with palmoplantar PSO at Baseline
Has been changed to:
x
Scalp-specific Investigator’s Global Assessment (scalp IGA) response (0/1 and 0Clear or 
Almost Clear with at least 2 category improvement relative to Baseline) at Week 16 for 
subjects with scalp PSO at Baseline
x
Scalp IGA response (0/1 and 0) for subjects with scalp PSO at Baseline
x
Palmoplantar Investigator’s Global Assessment (pp-IGA) response (0/1 and 0 Clear or 
Almost Clear with at least 2 category improvement relative to Baseline) for subjects with 
palmoplantar PSO at Baseline
Change #6
Section 4.3.1 Other efficacy variables
The following bullet has been added:
x
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) scores
Change #7
Section 4.3.2 Other safety variables
The following bullet has been removed:
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 141 of 263
x
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) scores
Change #8
Section 5.2.2 Treatment Period
During the 48-week Treatment Period, approximately 700 subjects will be randomized 1:1 to 
receive the following blinded IMP regimens:
x
Bimekizumab 320mg administered sc Q4W (350 subjects)
x
Secukinumab 300mg administered sc at Baseline and Weeks 1, 2, 3, and 4 followed by 
dosing Q4W (350 subjects)
Subjects receiving bimekizumab 320mg will receive placebo sc on Weeks 1, 2, and 3 in order to 
maintain the blind.
Has been changed to:
During the first 16 weeks of the 48-week Treatment Period, approximately 700 subjects will be 
randomized 1:1 to receive the following blinded IMP regimens:
x
Bimekizumab 320mg administered sc Q4W (350 subjects)
x
Secukinumab 300mg administered sc at Baseline and Weeks 1, 2, 3, and 4 followed by 
dosing Q4W (350 subjects)
Subjects receiving bimekizumab 320mg will receive placebo sc on Weeks 1, 2, and 3 in order to 
maintain the blind. 
At Week 16 subjects in the bimekizumab 320mg treatment arm will be re-randomized 1:2 
to receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. To maintain the blind 
after re-randomization, subjects in the bimekizumab 320mg Q8W treatment arm will 
receive placebo at Weeks 20, 28, 36, and 44. Subjects in the secukinumab arm will continue 
to receive secukinumab 300mg Q4W.
Change #9
Section 5.6 Schedule of study assessments
The schedule of study assessments is presented in Table 5‒1.
Has been changed to:
The schedule of study assessments is presented in Table 5‒1. At each visit, all study 
assessments should be performed prior to administration of IMP.
Change #10
Table 5‒1 Schedule of study assessments
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 142 of 263
Physical examd, e
X
X
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X
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Change #11
Table 5‒1 Schedule of study assessments, footnotes a through d, o, and q
a Visit windows of ±3 days from the first dose from the Week 1 visit to the Week 24 visit. Visit 
windows of ±7 days from Week 28 through Week 48/PEOT. The SFU Visit window is -3 and +7 
days from the last dose.
b The SFU Visit will occur 20 weeks after the last dose.
c Ensure no significant changes in medical history.
d Includes evaluation of signs and symptoms of active TB and risk for exposure to TB.
o The PGADA is assessed only for subjects with PsA at Baseline (defined as a past medical 
history of PsA or PASE ≥47).
q The dosing window from Baseline through Week 4 is ±2 days relative to the scheduled dosing 
visit. From Week 8 through Week 24, the dosing window is ±3 days relative to the scheduled 
dosing visit. From Week 28 through the end of the study, including the SFU visit, the dosing 
window is ±7 days relative to the scheduled dosing visit.
Have been changed to:
a Visit windows of ±3 days from the first dose from the Week 1 visit to the Week 24 visit. Visit 
windows of ±7 days from Week 28 through Week 48/PEOT. The SFU Visit window is -3 and +
±7 days from the last doserelative to the scheduled visit date.
b The SFU Visit will occur 20 weeks after the lastfinal dose.
c Ensure no significant changes in medical history.Includes evaluation of signs and 
symptoms of active TB and risk for exposure to TB.
dIncludes evaluation of signs and symptoms of active TB and risk for exposure to 
TB.Ensure no significant changes in medical history.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 143 of 263
o The PGADA is assessed onlyfor all subjects with PsAat Baseline (defined as a past medical 
history of PsA or PASE ≥47). At all subsequent visits, the PGADA is only for subjects with 
PsA at Baseline (defined as a past medical history of PsA or PASE ≥47).
q The dosing window from Baseline through Week 4 is ±2 days relative to the scheduled dosing 
visit. From Week 8 through Week 24, the dosing window is ±3 days relative to the scheduled 
dosing visit. From Week 28 through the end of the study, including the SFU visit,the dosing 
window is ±7 days relative to the scheduled dosing visit.
Change #12
Figure 5‒1: Schematic diagram
PASI100=Psoriasis Area Severity Index complete response; PBO=placebo; Q4W=every 4 weeks; 
SEC=secukinumab; w=Week
Note: At Week 28 and all following visits, subjects on continuous treatment for at least 12 weeks with a persistent 
IGA score ≥3 over at least a 4-week period are defined as nonresponders and should discontinue IMP.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 144 of 263
Has been changed to:
IGA=Investigator’s Global Assessment; IMP=investigational medicinal product; PASI100=Psoriasis Area 
Severity Index complete response; PBO=placebo; Q4W=every 4 weeks; Q8W=every 8 weeks;
SEC=secukinumab; w=Week
Note: At Week 28 and all following visits, subjects on continuous treatment for at least 12 weeks with a persistent 
IGA score ≥3 over at least a 4-week period are defined as nonresponders and should discontinue IMP.
Change #13
Section 5.8.2 Dose selection
Bimekizumab doses ranging from 64mg to 480mg were evaluated in the Phase 2b multicenter, 
randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study PS0010. 
Bimekizumab 320mg was found to have an acceptable safety profile, only required 2 injections 
per treatment administration, and achieved significant PASI responses at Week 12 (summarized 
in the IB). Furthermore, data from the Phase 2a multicenter, randomized, subject-blind, 
investigator-blind study PS0016 and PK/PD modeling in this PSO population indicates improved 
responses through Week 16. Therefore, a bimekizumab dose of 320mg Q4W was selected for 
this study.
Has been changed to:
Bimekizumab doses ranging from 64mg to 480mg were evaluated in the Phase 2b multicenter, 
randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study PS0010. 
Bimekizumab 320mg was found to have an acceptable safety profile, only required 2 injections
per treatment administration, and achieved significant PASI responses at Week 12 (summarized 
in the IB). Furthermore, data from the Phase 2a multicenter, randomized, subject-blind, 
investigator-blind study PS0016 and PK/PD modeling in this PSO population indicates improved 
responses through Week 16. Therefore, a bimekizumab dose of 320mg Q4W through Week 16 
and 320mg Q4W or Q8W thereafter was selected for this study.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 145 of 263
Change #14
Section 6.2 Exclusion criteria
25. Presence of active suicidal ideation, or positive suicide behavior using the "Screening" 
version of the electronic Columbia Suicide Severity Rating Scale (eC-SSRS) and with either 
of the following criteria:

History of a suicide attempt within the 5 years prior to the Screening Visit. Subjects with
a history of a suicide attempt more than 5 years ago should be evaluated by a mental 
healthcare practitioner before enrolling into the study.

Suicidal ideation in the past month prior to the Screening Visit as indicated by a positive 
response ("Yes") to either Question 4 or Question 5 of the "Screening" version of the 
eC-SSRS.
Has been changed to:
25a. Presence of active suicidal ideation, or positive suicide behavior using the "Screening" 
version of the electronic Columbia Suicide Severity Rating Scale (eC-SSRS) and with either 
of the following criteria:

History of a suicide attempt within the 5 years prior to the Screening Visit. Subjects with 
a history of a suicide attempt more than 5 years ago should be evaluated by a mental 
healthcare practitionerprofessional (eg, locally licensed psychiatrist, psychologist, or 
master’s level therapist) before enrolling into the study.

Suicidal ideation in the past month prior to the Screening Visit as indicated by a positive 
response ("Yes") to either Question 4 or Question 5 of the "Screening" version of the 
eC-SSRS.
Change #15
Section 6.3 Withdrawal criteria
9. A subject considered as having either a suspected new latent tuberculosis infection (LTBI) or 
who develops active TB or NTMB infection during the study (including but not limited to, 
conversion demonstrated by IGRA or other diagnostic means) must be immediately 
discontinued from IMP and a PEOT Visit must be scheduled as soon as possible, but not later 
than the next regular visit.
The subject must be permanently withdrawn if further examinations result in a diagnosis of 
active TB, or if the subject is diagnosed with LTBI with no initiation of prophylactic 
treatment, prematurely discontinues prophylactic treatment, or, in the opinion of the 
Investigator or Sponsor, is noncompliant with prophylactic TB therapy.
Confirmed active TB is an SAE and must be captured on an SAE Report Form and provided 
to the Sponsor in accordance with SAE reporting requirements. As with all SAEs, periodic 
follow-up reports should be completed as per protocol requirements until such time as the TB 
infection resolves.
Additional information on TB policies is provided in Section 12.3.1.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 146 of 263
Has been changed to:
9a. A subject considered as having either a suspected new latent tuberculosis infection (LTBI) or 
who develops active TB or pulmonary NTMB infection during the study (including but not 
limited to, conversion demonstrated by IGRA or other diagnostic means) must be 
immediately discontinued from IMP and a PEOT Visit must be scheduled as soon as 
possible, but not later than the next regular visit.
The subject must be permanently withdrawn if further examinations result in a diagnosis of 
pulmonary NTMB, active TB, or if the subject is diagnosed with LTBI with no initiation of 
prophylactic treatment, prematurely discontinues prophylactic treatment, or, in the opinion of 
the Investigator or Sponsor, is noncompliant with prophylactic TB therapy.
Confirmed active TB is an SAE and must be captured on an SAE Report Form and provided 
to the Sponsor in accordance with SAE reporting requirements. As with all SAEs, periodic 
follow-up reports should be completed as per protocol requirements until such time as the TB 
infection resolves.
Additional information on TB policies is provided in Section 12.3.1.
Change #16
Section 6.3 Withdrawal criteria
11. Subjects must be referred immediately to a mental healthcare professional and may be 
withdrawn from the study based upon the Investigator’s judgment of benefit/risk for:

Active suicidal ideation as indicated by a positive response (“Yes”) to Question 4 of the 
“Since Last Visit” version of the eC-SSRS.

Moderately severe major depression as indicated by a PHQ-9 score of 15 to 19 if this 
represents an increase of 3 points compared to last visit.
Has been changed to:
11a. Subjects must be referred immediately to a mental healthcare professional (eg, locally 
licensed psychiatrist, psychologist, or master’s level therapist) and may be withdrawn 
from the study based upon the Investigator’s judgment of benefit/risk for:

Active suicidal ideation as indicated by a positive response (“Yes”) to Question 4 of the 
“Since Last Visit” version of the eC-SSRS.

Moderately severe major depression as indicated by a PHQ-9 score of 15 to 19 if this 
represents an increase of 3 points compared to last visit.
Change #17
Section 6.3 Withdrawal criteria
12. Subjects must be referred immediately to a mental healthcare professional and must be 
withdrawn for:

Active suicidal ideation as indicated by a positive response (“Yes”) to Question 5 of the 
“Since Last Visit” version of the eC-SSRS

Any suicidal behavior since last visit.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 147 of 263

Severe major depression as indicated by a PHQ-9 score ≥20
Has been changed to:
12a. Subjects must be referred immediately to a mental healthcare professional (eg, locally 
licensed psychiatrist, psychologist, or master’s level therapist) and must be withdrawn for:

Active suicidal ideation as indicated by a positive response (“Yes”) to Question 5 of the 
“Since Last Visit” version of the eC-SSRS

Any suicidal behavior since last visit

Severe major depression as indicated by a PHQ-9 score ≥20
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 148 of 263
Change #18 
Table 7‒1: Dosing scheme
Week
Dose Assignment
Baseline 
(first dose)
1
2
3
4
8
12
16
20
24
28
32
36
40
44
Bimekizumab 
320mg
●●
○○
○○
○○
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
Secukinumab 
300mg 
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
Notes: A bimekizumab 160mg injection is depicted by a black circle (●). A placebo injection is depicted by a white circle (○). A secukinumab 150mg
injection is depicted by a black triangle (▲).
Has been changed to:
Week
Dose Assignment
Baseline 
(first dose)
1
2
3
4
8
12
16a
20
24
28
32
36
40
44
Bimekizumab 
320mg
●●
○○
○○
○○
●●
●●
●●
Q4W
●●
●●
●●
●●
●●
●●
●●
●●
Q8W
●●
○○
●●
○○
●●
○○
●●
○○
Secukinumab 
300mg 
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
Q4W=every 4 weeks; Q8W=every 8 weeks
Notes: A bimekizumab 160mg injection is depicted by a black circle (●). A placebo injection is depicted by a white circle (○). A secukinumab 150mg
injection is depicted by a black triangle (▲). 
a Subjects in the bimekizumab 320mg treatment arm will be re-randomized 1:2 to receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 149 of 263
Change #19
Section 7.6 Drug accountability
Blinded study staff may be delegated the responsibility to receive, inventory, and destroy the 
used kits. The packaging identifies each kit by a unique number that does not correlate to the 
contents and therefore, does not unblind study site staff. Unblinded study staff will be 
responsible for preparation (breaking tamper proof sticker on kit, etc) of the clinical trial 
material, including recording the administration information on source document.
Has been changed to:
Blinded study staff may be delegated the responsibility to receive, inventory, and destroy 
the used kits. Unblinded study staff will be responsible for receipt, inventory, and 
destruction of used kits. The packaging identifies each kit by a unique number that does not 
correlate to the contents and therefore, does not unblind study site staff, but due to the 
commercial packaging of the comparator, the unblinded study staff will be responsible to 
maintain the blind. Unblinded study staff will be responsible for preparation (breaking tamper 
proof sticker on kit, etc) of the clinical trial material, including recording the administration 
information on source document.
Change #20
Section 7.6 Drug accountability
The Investigator may assign some of the Investigator’s duties for drug accountability at the study 
site to an appropriate pharmacist/designee.
Has been changed to:
The Investigator mayshould assign some of the Investigator’s duties for drug accountability at 
the study site to an appropriate pharmacist/designee.
Change #21
Table 7-2 Prohibited psoriasis medications
Systemic retinoids
3 months 
Has been changed to:
Systemic retinoids
31 months
Change #22
Section 7.9 Blinding
For subjects receiving bimekizumab, bimekizumab will be administered at Baseline; placebo will 
be administered at Week 1, Week 2, and Week 3; their second dose of bimekizumab will be at 
Week 4; and bimekizumab doses Q4W thereafter. Secukinumab subjects will receive 
secukinumab at Baseline, Week 1, Week 2, Week 3, Week 4, and Q4W thereafter.
Has been changed to:
For subjects receiving bimekizumab, bimekizumab will be administered at Baseline; placebo will 
be administered at Week 1, Week 2, and Week 3; their second dose of bimekizumab will be at 
the Inve
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 150 of 263
Week 4; and bimekizumab doses Q4W thereafterthrough Week 16. At Week 16 subjects in 
the bimekizumab 320mg treatment arm will be re-randomized 1:2 to receive bimekizumab 
320mg Q4W or bimekizumab 320mg Q8W. To maintain the blind, subjects in the 
bimekizumab 320mg Q8W treatment arm will receive placebo at Weeks 20, 28, 36, and 44.
Secukinumab subjects will receive secukinumab at Baseline, Week 1, Week 2, Week 3, Week 4,
and Q4W thereafter.
Change #23
Section 7.10 Randomization and numbering of subjects
The following was added:
At Week 16 subjects in the bimekizumab 320mg treatment arm will be re-randomized 1:2 to 
receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. To maintain the blind after 
re-randomization, subjects in the bimekizumab 320mg Q8W treatment arm will receive placebo 
at Weeks 20, 28, 36, and 44. Subjects in the secukinumab arm will continue to receive 
secukinumab 300mg Q4W.
Change #24
Section 8 Study procedures by visit
x
The dosing window from Baseline through Week 4 is ±2 days relative to the scheduled 
dosing visit. From Week 8 through Week 24, the dosing window is ±3 days relative to the 
scheduled dosing visit. From Week 28 through the end of the study, including the SFU visit,
the dosing window is ±7 days relative to the scheduled dosing visit.
x
For the SFU Visit (20 weeks after the final dose), the visit should occur no more than 3 days 
prior to the scheduled visit date and within 7 days after the scheduled visit date 
(-3 days/+7 days).
Has been changed to:
x
The dosing window from Baseline through Week 4 is ±2 days relative to the scheduled 
dosing visit. From Week 8 through Week 24, the dosing window is ±3 days relative to the 
scheduled dosing visit. From Week 28 through the end of the study, including the SFU visit,
the dosing window is ±7 days relative to the scheduled dosing visit.
x
For the SFU Visit (20 weeks after the final dose), the visit should occur no more than 
3 days prior to the scheduled visit date and within 7 days after the scheduled visit date 
(-3 days/+7 days)window is ±7 days relative to the scheduled visit date.
Change #25
Section 8.2.1 Baseline Visit
x
Inclusion/exclusion 
Has been changed to:
x
Inclusion/exclusion (includes evaluation of signs and symptoms of active TB and risk for 
exposure to TB)
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 151 of 263
Change #26
Section 8.2.1 Baseline Visit
After completion of the above-mentioned procedures, bimekizumab or secukinumab 
administration will occur.
Has been changed to:
After completion of the above-mentioned procedures, bimekizumab or secukinumabIMP
administration will occur.
Change #27
Section 8.2.2 Week 1 and Week 2 Visits (±3 days relative to Baseline)
After completion of the above-mentioned procedures, placebo or secukinumab administration 
will occur.
Has been changed to:
After completion of the above-mentioned procedures, IMPplacebo or secukinumab 
administration will occur.
Change #28
Section 8.2.3 Week 4 Visit (±3 days relative to Baseline)
After completion of the above-mentioned procedures, administration of placebo or secukinumab 
will occur.
Has been changed to:
After completion of the above-mentioned procedures, administration of IMPplacebo or 
secukinumab will occur.
Change #29
Sections 8.2.4 Week 4 Visit (±3 days relative to Baseline), 8.2.5 Week 8 and Week 12 Visits 
(±3 days relative to Baseline), 8.2.7 Week 20 (±3 days relative to Baseline) and Week 28
Visits (±7 days relative to Baseline), 8.2.8 Week 24 Visit (±7 days relative to Baseline), 8.2.9 
Week 32 Visit (±7 days relative to Baseline), 8.2.10 Week 36 Visit (±7 days relative to 
Baseline), 8.2.11 Week 40 Visit (±7 days relative to Baseline), 8.2.12 Week 44 Visit (±7 days 
relative to Baseline)
After completion of the above-mentioned procedures, administration of bimekizumab or 
secukinumab will occur.
Has been changed to:
After completion of the above-mentioned procedures, administration of IMPbimekizumab or 
secukinumab will occur.
Change #30
Section 8.2.6 Week 16 Visit (±3 days relative to Baseline)
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 152 of 263
After completion of the above-mentioned procedures, administration of bimekizumab or 
secukinumab will occur.
Has been changed to:
At Week 16 subjects in the bimekizumab 320mg treatment arm will be re-randomized 1:2 
to receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. After completion of the 
above-mentioned procedures, administration of IMPbimekizumab or secukinumab will occur.
Change #31
Section 8.4 Safety Follow-Up Visit (20 weeks after final dose, -3 days/+7 days), section title
8.4 Safety Follow-Up Visit (20 weeks after final dose, -3 days/+7 days)
Has been changed to:
8.4 Safety Follow-Up Visit (20 weeks after final dose, -3 days/+±7 days)
Change #32
Section 9 Assessment of efficacy
The PASI, BSA, IGA, scalp IGA, mNAPSI, and pp-IGA should be performed by the 
Investigator, another delegated physician, or an appropriately qualified medical professional 
(based on local requirements) who has had documented training on how to perform these 
assessments correctly. Preferably the same assessor should evaluate the subject at each 
assessment.
Has been changed to:
The PASI, BSA, IGA, scalp IGA, mNAPSI, and pp-IGA should be performed by the 
Investigator, another delegated physician, or an appropriately qualified medical professional 
(based on local requirements) who has had documented training on how to perform these
assessments correctly. Preferably tThe same assessor should evaluate the subject at each 
assessment.
Change #33
Section 9.11 PASE questionnaire
The Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire is a self-administered 
tool to screen for active PsA in patients with PSO (Husni et al, 2014). The questionnaire consists 
of 15 items that are divided into a 7-item symptoms subscale and an 8-item functions subscale. 
Standardized responses are based on 5 categories relating to agreement (strongly agree [5], 
agree [4], no idea [3], disagree [2], and strongly disagree [1]). The total maximum score is 
75 points (symptom score: 35 points and function score: 40 points). Psoriatic Arthritis Screening 
and Evaluation questionnaire scores ≥47 points are indicative of active PsA. Subjects with scores 
≥47 should be referred to a rheumatologist for evaluation.
Has been changed to:
The Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire is a self-administered 
tool to screen for active PsA in patients with PSO (Husni et al, 2014). The questionnaire consists 
of 15 items that are divided into a 7-item symptoms subscale and an 8-item functions subscale. 
Standardized responses are based on 5 categories relating to agreement (strongly agree [5], 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 153 of 263
agree [4], no idea [3], disagree [2], and strongly disagree [1]). The total maximum score is 
75 points (symptom score: 35 points and function score: 40 points). Psoriatic Arthritis Screening 
and Evaluation questionnaire scores ≥47 points are indicative of active PsA. Subjects with 
scores ≥47 should be referred to a rheumatologist for evaluation.
Change #34
Section 12.2.1.2.1 IMP restart/rechallenge
x
The rechallenge is approved by the UCB responsible physician, DMC, and a hepatologist. 
The hepatologist must be external to UCB but may be a member of the DMC. It is 
recommended that the hepatologist be a local hepatology expert or the hepatologist treating 
the subject.
Has been changed to:
The rechallenge is approved by the UCB responsible physician, DMC, and a hepatologist. The 
hepatologist must be external to UCB but may be a member of the DMC. It is 
recommended that the hepatologist be a local hepatology expert or the hepatologist treating 
the subject.
Change #35
Section 12.3.1 Assessment and management of TB and TB risk factors
b. High risk of acquiring TB infection:

Known exposure to another person with active TB infection within the 3 months prior to 
Screening.

Time spent in a healthcare delivery setting or institution where individuals infected with 
TB are housed and where the risk of transmission of infection is high.
c.
Latent TB infection (unless appropriate prophylaxis is initiated at least 8 weeks prior to IMP 
dosing and continued to completion of prophylaxis):

The absence of signs, symptoms, or physical findings suggestive of TB infection with a 
positive IGRA test (or 2 indeterminate IGRA test results) and a chest x-ray (or other 
imaging) without evidence of TB infection. If the result of the IGRA test is 
indeterminate, the particular IGRA test previously performed may be repeated once; if 
positive or indeterminate on retest, the subject may not be randomized to IMP without 
further evaluation by a TB specialize and discussion with the Study Physician, if LTBI is 
identified. The retest must be done during the protocol-defined Screening window.
Note: If available, respiratory or other specimens must also be smear and culture negative 
for TB (CDC diagnosis of LTBI) http://www.cdc.gov/TB/topic /testing/default.htm).
Has been changed to:
b. High risk of acquiring TB infection:

Known close exposure to another person with active TB infection within the 3 months 
prior to Screening.
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UCB
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Clinical Study Protocol
Bimekizumab
PS0015
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Page 154 of 263

Time spent in a healthcare delivery setting or institution where individuals infected with 
TB are housed and where the risk of transmission of infection is high.
c.
Latent TB infection (unless appropriate prophylaxis is initiated at least 8 weeks prior to IMP 
dosing and continued to completion of prophylaxis):

The absence of signs, symptoms, or physical findings suggestive of TB infection with a 
positive IGRA test (or 2 indeterminate IGRA test results) and a chest x-ray (or other 
imaging) without evidence of TB infection. If the result of the IGRA test is 
indeterminate, the particular IGRA test previously performed may be repeated once; if 
positive or indeterminate on retest, the subject may not be randomized to IMP without 
further evaluation by a TB specialistze and discussion with the Study Physician, if LTBI 
is identified. The retest must be done during the protocol-defined Screening window.
Note: If available, respiratory or other specimens must also be smear and culture negative 
for TB (CDC diagnosis of LTBI) http://www.cdc.gov/TB/topic /testing/default.htm).
Change #36
Section 12.3.1.1 Tuberculosis assessment by IGRA
If latent or active TB is identified, subject must undergo appropriate study-specified withdrawal 
procedures. 
Has been changed to:
If latent or active TB is identified, subject must undergo appropriate study-specified withdrawal 
procedures. 
Change #37
Section 12.3.1.3 Tuberculosis questionnaire
The following sentence was deleted:
Subjects with a latent or active TB infection must be withdrawn from the study.
Change #38
Section 12.3.1.4 Tuberculosis management
During the study, subjects who develop evidence of LTBI or active TB must immediately stop 
further administration of IMP and will be referred to an appropriate TB specialist (pulmonologist 
or infectious disease specialist) for further evaluation. Evidence of LTBI is defined as subject’s 
IGRA test converts to positive or indeterminate (and confirmed indeterminate on repeat), or the 
subject’s questionnaire or history and physical indicates that TB infection or exposure may have 
occurred. Evidence of active TB includes, in addition to the aforementioned tests, signs and
symptoms of organ involvement. In either situation, the subject should be carefully assessed by a 
TB specialist for active TB. Subjects diagnosed with active TB or LTBI should be withdrawn 
from the study and receive appropriate TB or prophylaxis therapy.
Has been changed to:
During the study, subjects who develop evidence of LTBI or active TB must immediately stop 
further administration of IMP and will be referred to an appropriate TB specialist (pulmonologist 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 155 of 263
or infectious disease specialist) for further evaluation. Evidence of LTBI is defined as subject’s 
IGRA test converts to positive or indeterminate (and confirmed indeterminate on repeat), or the 
subject’s questionnaire or history and physical indicates that TB infection or exposure may have 
occurred. Evidence of active TB includes, in addition to the aforementioned tests, signs and 
symptoms of organ involvement. In either situation, the subject should be carefully assessed by a 
TB specialist for active TB. Subjects diagnosed with active TB or LTBI should must be 
withdrawn from the study and receive appropriate TB or prophylaxistherapy.
Change #39
Section 14.1 Definition of analysis sets
The following sentence has been added:
The Enrolled Set will consist of all subjects who have given informed consent.
Change #40
Section 14.1 Definition of analysis sets
The following sentence has been added:
The Maintenance Set (MS) will consist of all subjects that receive at least 1 dose of IMP at Week 
16 or later in the Treatment Period (including the Week 16 dose).
Change #41
Figure 14-1 Hypotheses testing of secondary efficacy endpoints
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UCB
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Bimekizumab
PS0015
Confidential
Page 156 of 263
Has been changed to:
BKZ=bimekizumab; PASI=Psoriasis Area Severity Index; Q4W=every 4 weeks; Q8W=every 8 weeks
Note: Tests for H1, H2, H3, and H4 are based on all subjects initially randomized to bimekizumab compared to 
secukinumab. For H5 and H6, testing is based on the subjects re-randomized at Week 16 to bimekizumab 
320mg Q4W, and bimekizumaba 320mg Q8W, respectively, compared to secukinumab.
Change #42
Section 14.3.1.1 Sensitivity analysis
In order to obtain reasonable estimates of variability for a treatment arm at a given center, a 
minimum of 10 subjects will be considered acceptable for a center to be included in the model 
without pooling. Given the 1:1 randomization allocation scheme, this should provide a minimum 
of about 5 subjects in the bimekizumab arm and 5 subjects in the secukinumab arm. Centers with 
fewer than 10 subjects will be eligible for pooling. The following center pooling algorithm will 
be used for each geographic region:
Has been changed to:
In order to obtain reasonable estimates of variability for a treatment arm at a given center, a 
minimum of 10 subjects will be considered acceptable for a center to be included in the model 
without pooling. Given the 1:1 randomization allocation scheme at the start of the study, this 
should provide a minimum of about 5 subjects in the bimekizumab arm and 5 subjects in the 
secukinumab arm. Centers with fewer than 10 subjects will be eligible for pooling. The 
following center pooling algorithm will be used for each geographic region:
Change #43
Section 14.3.2.1 Analysis of the secondary efficacy variables
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 157 of 263
The following has been added:
PASI75 response at Week 4 will be analyzed for all subjects in the RS based on the randomized 
treatment group at Baseline.
Additionally, PASI100 at Week 48 will be evaluated as a secondary efficacy variable. The way 
the analysis for this variable is conducted will depend on which comparison is being made. The 
planned comparisons are as follows:
x
Compare all subjects initially randomized to bimekizumab (regardless of re-randomization 
assignment at Week 16) to all subjects initially randomized to secukinumab based on the RS 
(H4)
x
Compare subjects who were assigned to bimekizumab 320mg Q4W at Week 16 to 
secukinumab based on the MS (H5)
x
Compare subjects who were assigned to bimekizumab 320mg Q8W at Week 16 to 
secukinumab based on the MS (H6)
Change #44
Section 14.3.2.2 Analysis of the other efficacy variables
Other efficacy variables will be summarized by treatment and visit and will generally be 
summarized based on imputed data (NRI and multiple imputation [MI] for binary and continuous 
variables, respectively, unless otherwise stated in the SAP). In some cases, variables may also be 
summarized based on observed case data (ie, subjects with missing data or who have 
prematurely discontinued IMP are treated as missing). There may be cases where the multiple 
imputation model fails to converge. In such situations, the last observation carried forward 
(LOCF) approach will instead be used to impute the missing data. If LOCF is used instead of 
multiple imputation for this reason, this will be clearly specified in the corresponding table 
summary. Should there be no missing data for a study variable, then only observed case data will 
be presented. Note that for LOCF imputation, any missing data or data collected following 
discontinuation of IMP will be imputed with the most recent previous value. See Section 14.7 for 
further details.
Time to PASI75/90/100 response will be estimated and presented using the Kaplan-Meier 
product-limit method for each treatment. Time to a given response will be defined as the length 
in days from the first dose of IMP until the first date when the response is achieved. Subjects 
who discontinue IMP prior to achieving a response will be censored at the date of IMP 
discontinuation. Subjects who reach the Week 48 Visit without achieving the given PASI 
response will be censored at the date of the Week 48 Visit. The median time to response, 
including the 2-sided 95% CI, will be calculated for each treatment. Between group differences 
(bimekizumab vs secukinumab) will be analyzed with the log-rank statistic.
In general, data will be summarized by visit through Week 48. However, for PASI responder 
variables (PASI75, PASI90, PASI100) and IGA responder variables (IGA 0/1, IGA 0), as well as 
selected other efficacy variables, summaries will be prepared for time points between Weeks 16
and 48 among those subjects who were responders at Week 16. Further details will be provided 
in the SAP.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 158 of 263
Other efficacy variables will be summarized by treatment and visit and will generally be 
summarized based on imputed data (NRI and multiple imputation [MI] for binary and continuous 
variables, respectively, unless otherwise stated in the SAP). In some cases, variables may also be 
summarized based on observed case data (ie, subjects with missing data or who have 
prematurely discontinued IMP are treated as missing). There may be cases where the multiple 
imputation model fails to converge. In such situations, the last observation carried forward 
(LOCF) approach will instead be used to impute the missing data. If LOCF is used instead of 
multiple imputation for this reason, this will be clearly specified in the corresponding table 
summary. Should there be no missing data for a study variable, then only observed case data will 
be presented. Note that for LOCF imputation, any missing data or data collected following 
discontinuation of IMP will be imputed with the most recent previous value. See Section 14.7 for 
further details.
Time to PASI75/90/100 response will be estimated and presented using the Kaplan-Meier 
product-limit method for each treatment. Time to a given response will be defined as the 
length in days from the first dose of IMP until the first date when the response is achieved. 
Subjects who discontinue IMP prior to achieving a response will be censored at the date of 
IMP discontinuation. Subjects who reach the Week 48 Visit without achieving the given 
PASI response will be censored at the date of the Week 48 Visit. The median time to 
response, including the 2-sided 95% CI, will be calculated for each treatment. Between 
group differences (bimekizumab vs secukinumab) will be analyzed with the log-rank 
statistic.
In general, data will be summarized by visit through Week 48. However, for PASI 
responder variables (PASI75, PASI90, PASI100) and IGA responder variables (IGA 0/1, 
IGA 0), as well as selected other efficacy variables, summaries will be prepared for time 
points between Weeks 16 and 48 among those subjects who were responders at Week 16.
Further details will be provided in the SAP.
Time to PASI75/90/100 response will be estimated and presented using the Kaplan-Meier 
product-limit method based on the RS by initially randomized treatment groups 
(Bimekizumab vs secukinumab). This could make the interpretation of the data 
challenging given that there are two different bimekizumab dosing regimens starting at 
Week 16, but it is anticipated that most responses will be observed by Week 16 when all 
bimekizumab subjects are on the same regimen. Time to a given response will be defined as 
the length in days from the first dose of IMP until the first date when the response is 
achieved. Subjects who discontinue IMP prior to achieving a response will be censored at 
the date of IMP discontinuation. Subjects who reach the Week 48 Visit without achieving 
the given PASI response will be censored at the date of the Week 48 Visit. The median time 
to response, including the 2-sided 95% CI, will be calculated for each treatment. Between 
group differences (bimekizumab vs secukinumab) will be analyzed with the log-rank 
statistic.
In general, data will be summarized by visit through Week 48. All summaries of data up to 
Week 16 will be based on the RS for the 2 randomized treatment groups (bimekizumab 
and secukinumab). For visits after Week 16, by-visit summaries will be prepared for the 
following 3 groups of subjects:
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 159 of 263
1. Subjects in the MS summarized by the 3 maintenance treatment groups (bimekizumab 
320mg Q4W, bimekizumab 320mg Q8W, and secukinumab). Note that while the MS is
primarily defined for the evaluation of data after Week 16, these summary tables will 
include data at all visits (Baseline to Week 48) to provide a comprehensive summary of 
subjects by maintenance treatment group for the MS.
2. A subset of Group 1 above. Specifically, this will include only those subjects who are 
responders at Week 16 for the variable being summarized. This will provide an 
assessment of how efficacy is maintained among Week 16 responders.
3. Subjects in the RS summarized by the 2 randomized treatment groups (bimekizumab 
and secukinumab). Data from Baseline to Week 48 will be included in these tables. This 
provides an intent-to-treat analysis among all randomized subjects in the study through 
Week 48.
All efficacy variables will be summarized in the manner described for Group 1 above. 
Summaries for Groups 2 and 3 will be done only for a subset of efficacy variables, namely, 
PASI75/90/100, IGA Clear or Almost Clear, Scalp IGA Clear or Almost Clear, pp-IGA 
Clear or Almost Clear, mNAPSI75/90/100, and DLQI 0/1. Further details on these analyses 
will be provided in the SAP.
Change #45
Section 14.7 Handling of dropouts or missing data
Missing data for the secondary efficacy variables (which are all binary) will be imputed using 
NRI. Additionally, the 2 additional approaches described above for the primary efficacy variable 
will be used for the secondary efficacy variables.
Has been changed to:
Missing data for the secondary efficacy variables (which are all binary) will be imputed using 
NRI. Additionally, the 2 additionalmissing data-handling approaches described above for the 
primary efficacy variable will be used for the secondary efficacy variables.
Change #46
Section 14.9 Determination of sample size
A total of 700 subjects will be randomly assigned in a 1:1 ratio to one of the following treatment 
groups:
x
Bimekizumab 320mg (350 subjects)
x
Secukinumab (350 subjects)
Has been changed to:
A total of 700 subjects will be randomly assigned in a 1:1 ratio at Baseline to one of the 
following treatment groups:
x
Bimekizumab 320mg (350 subjects)
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Bimekizumab
PS0015
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x
Secukinumab (350 subjects)
18.2
Protocol Amendment 1.1
Rationale for the amendment
The primary rationale for this local amendment was to incorporate the use of photographs of skin 
and nails during Schedule of study assessments only for sites in the US, Australia, Belgium, 
Poland, and Germany and only for patients who consent (see Table 5‒1).
Modifications and changes
Specific changes
Change #1 
Section 5 Study Design, Table 5‒1.
The specific assessment requiring the taking of photographs of skin and nails during Baseline, 
Weeks 1, 2, 4, 8, 12, 16, 32, and 48/EOT was added as stated below (table header used for 
clarification and was not changed):
Visita/
Week
Protocol 
activity
Screening
Treatment Period
SFUb
Baseline 
(first
1
2
3
4
8
12
16
20
24
28
32
36
40
44
48/
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Photographs of 
skin and nails 
(subset of sites)
X
X
X
X
X
X
X
X
X
Change #2
Section 8.1
Added the following text: “In case subjects agree to participate in the photography sub-study 
(see Section 9.12) they will need to sign a separate informed consent form.”
Change #3
Section 8.2 Treatment Period
Added text referring to the assessment requiring photographs of skin and nails during the 
following time points:
x
Baseline
x
Week 1
x
Week 2
x
Week 4
x
Week 8
x
Week 12
x
Week 16
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Clinical Study Protocol
Bimekizumab
PS0015
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x
Week 32
x
Week 48/EOT
Change #4
Section 9.12 Photographs
The following text was added as subsection 9.14
At certain clinical sites, representative photographs of the changes in skin and nail appearance 
will be captured. Subjects who consent to the procedure will have full body (anterior and 
posterior views) photographs taken. Only those subjects with nail disease at Baseline will have 
nail photographs taken. Only those subjects with palmoplantar disease at Baseline will have 
photographs of their palms or soles of their feet taken. Only those subjects with scalp disease at 
Baseline will have scalp photographs taken. Photographs will be anonymized and will be used 
for publication purposes.
Study sites selected for photography will be trained and receive standardized photographic 
equipment by a centralized photographic vendor. Photographs will be electronically transferred 
from the site to the vendor.
At the end of the study, the site will receive an electronic file of all subject photographs for 
archiving.
The central photography vendor will tabulate and transfer all subject photos to the Sponsor at the 
end of the study.
18.3
Protocol Amendment 2
No subjects were enrolled under this amendment.
Rationale for the amendment
The protocol has been amended for the following reasons:
x
Extended the study duration for an additional 96 weeks in an Open-Label Extension Period. 
Changes include addition of a new schedule of assessments for the additional 96 weeks, 
additional other objectives and endpoints, and updates to Section 8, Study procedures by 
visit.
x
Added planned re-randomization by treatment regimens and PASI response at Week 48 in
the OLE Period.
x
Clarified secondary efficacy variable for IGA response at Week 16, and added other efficacy 
variables for IGAxBSA and PASE score suggestive of PsA.
x
Modified the text in Section 7 to include guidance for allowing subjects the option to 
self-inject IMP at home after Week 48.
x
Updated Section 12.2.1 (Evaluation of PDILI) for improved clarity and consistency with 
other Phase 3 studies of bimekizumab in subjects with PSO.
x
Added statistical analyses for the OLE Period.
Modifications and changes
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 162 of 263
Global changes:
The following changes were made throughout the protocol:
x
The maximum duration of the study has been changed from 69 weeks to 165 weeks 
throughout the document.
x
Cross references to the new schedule of assessments (Table 5-2) for the 2-year extension 
have been made throughout the document. 
x
The term “Treatment Period” has been changed to “double-blind Treatment Period” 
throughout the document to clearly distinguish it from the OLE Period.
x
The list of abbreviations was updated accordingly.
x
Minor spelling, editorial, and formatting changes were made throughout the document.
Change #1
Section 1 Summary, third and fourth paragraphs: 
Approximately 935 subjects will be screened in order to have 700 subjects randomized in the 
study. For each subject, the study will last a maximum of 69 weeks and will consist of 3 periods, 
a Screening Period (2 to 5 weeks), a double-blind Treatment Period (48 weeks; final dose at 
44 weeks), and a Safety Follow-Up (SFU) Period (20 weeks after the final dose of 
investigational medicinal product [IMP]).
During the first 16 weeks of the Treatment Period, eligible subjects will be randomized 1:1 to 
receive one of the following blinded IMP regimens:
Has been changed to:
Approximately 935 subjects will be screened in order to have 700 subjects randomized in the 
study. For each subject, the study will last a maximum of 69165 weeks and will consist of 
34 periods, a Screening Period (2 to 5 weeks), a double-blind Treatment Period (48 weeks; final 
dose at 44 weeks),Week 44), an Open-Label Extension (OLE) Period (96 weeks; final dose 
at Week 136 for subjects receiving bimekizumab 320mg Q8W and at Week 140 for subjects 
receiving bimekizumab 320mg Q4W); and a Safety Follow-Up (SFU) Period (20 weeks after 
the final dose of investigational medicinal product [IMP]).
During the first 16 weeks of the double-blind Treatment Period, eligible subjects will be 
randomized 1:1 to receive one of the following blinded IMP regimens:
Change #2
Section 1 Summary, 8th through 11th paragraphs: 
At Week 48, all subjects will undergo the Week 48 study assessments and will enter the SFU 
Period. 
Has been changed to:
At the completion of the Week 48, allvisit assessments, subjects may receive open-label 
bimekizumab treatment for an additional 96 weeks. All subjects enrolling in the OLE 
Period will undergo, after signing a new ICF, be evaluated for eligibility, be randomized, 
and receive their first dose of bimekizumab in the OLE Period. 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 163 of 263
During the OLE Period eligible subjects will receive the following IMP regimens as 
determined by the subject’s treatment regimen and PASI response in the double-blind 
Treatment Period. 
At Week 48, subjects receiving:
x
Bimekizumab 320mg Q4W who achieve PASI90 at Week 48 of the double-blind 
Treatment Period will be randomized 1:1 to receive bimekizumab 320mg Q4W or 
bimekizumab 320mg Q8W.
x
Bimekizumab 320mg Q4W who do not achieve PASI90 at Week 48 of the double-blind 
Treatment Period will receive bimekizumab 320mg Q4W.
x
Bimekizumab 320mg Q8W who do not achieve PASI90 at Week 48 of the double-blind 
Treatment Period will receive bimekizumab 320mg Q4W.
x
Bimekizumab 320mg Q8W who achieve PASI90 at Week 48 of the double-blind 
Treatment Period will receive bimekizumab 320mg Q8W.
x
Secukinumab who do not achieve PASI90 at Week 48 of the double-blind Treatment 
Period will receive bimekizumab 320mg Q4W.
x
Secukinumab who achieve PASI90 at Week 48 of the double-blind Treatment Period
will be randomized 1:1 to receive bimekizumab 320mg Q4W or bimekizumab 320mg 
Q8W.
At Week 96, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
subject’s dosing interval will change from 320mg Q4W to 320mg Q8W (default), unless, 
based on medical judgment, the Investigator decides differently.
During the OLE Period, subjects will attend study visits at Weeks 52, 56, 64, and 72, and 
then every 12 weeks. 
All subjects not enrolling in the OLE Period will have the Week 48 study assessments and 
will enter the SFU Period.
Change #3
Section 3.3 Other objectives: 
The following text was added:
x
Assess the maintenance of efficacy of bimekizumab dosing Q4W versus Q8W
x
Assess the safety and efficacy of initiating bimekizumab therapy in subjects who 
received secukinumab in the double-blind Treatment Period
Change #4
Section 4.2.1 Secondary efficacy variables: 
x
IGA response (0/1) (defined as Clear or Almost Clear with at least a 2-category improvement 
relative to Baseline) at Week 16
Has been changed to:
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 164 of 263
x
IGA response (0/1) at Week 16(defined as Clear or Almost Clear with at least a 2-
category improvement relative to Baseline) at Week 16
Change #5
Section 4.3.1 Other efficacy variables: 
The following text has been added:
x
Absolute and percent change from Baseline in the product of IGA and BSA (IGAxBSA)
x
Shift from Baseline in PASE score suggestive of PsA (<47 versus ≥47)
Change #6
Section 5.2 Study periods: 
This study will include 3 periods, a Screening Period (2 to 5 weeks), a double-blind Treatment 
Period (48 weeks; final dose at 44 weeks), and a SFU Period (20 weeks after the final dose of 
IMP). The end of the study is defined as the date of the last visit of the last subject in the study.
Has been changed to:
This study will include 34 periods, a Screening Period (2 to 5 weeks), a double-blind Treatment 
Period (48 weeks; final dose at Week 44), an optional OLE Period (96 weeks),; final dose at 
Week 136 for subjects receiving bimekizumab 320mg Q8W and at Week 140 for subjects 
receiving bimekizumab 320mg Q4W), and an SFU Period (20 weeks after the final dose of 
IMP). The end of the study is defined as the date of the last visit of the last subject in the study.
Change #7
The following section has been added:
5.2.3 OLE Period
After completion of the Week 48 visit assessments, subjects will be allowed to enroll in the 
OLE Period. All subjects enrolling in the OLE Period will sign a new ICF, and then receive 
the following IMP regimens as determined by the subject’s treatment regimen and PASI 
response in the double-blind Treatment Period. 
At Week 48, subjects receiving:
x
Bimekizumab 320mg Q4W who achieve PASI90 at Week 48 of the double-blind 
Treatment Period will be randomized 1:1 to receive bimekizumab 320mg Q4W or 
bimekizumab 320mg Q8W.
x
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Treatment Period will receive bimekizumab 320mg Q4W.
x
Bimekizumab 320mg Q8W who do not achieve PASI90 at Week 48 of the double-blind 
Treatment Period will receive bimekizumab 320mg Q4W.
x
Bimekizumab 320mg Q8W who achieve PASI90 at Week 48 of the double-blind 
Treatment Period will receive bimekizumab 320mg Q8W.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 165 of 263
x
Secukinumab who do not achieve PASI90 at Week 48 of the double-blind Treatment 
Period will receive bimekizumab 320mg Q4W.
x
Secukinumab who achieve PASI90 at Week 48 of the double-blind Treatment Period
will be randomized 1:1 to receive bimekizumab 320mg Q4W or bimekizumab 320mg 
Q8W.
At Week 96, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
subject’s dosing interval will change from 320mg Q4W to 320mg Q8W (default), unless, 
based on medical judgment, the Investigator decides differently.
During the OLE Period, subjects will attend study visits at Weeks 52, 56, 64, and 72, and 
then every 12 weeks. At study visits, IMP will be administered in the clinic by sc injection 
as applicable. In between study visits, subjects will self-inject IMP at home.
All subjects not enrolling in the open-label study will have the Week 48 study assessments 
and will enter the SFU Period.
The assessments to be performed at each OLE Period visit are presented in Table 5-2.
Change #8
Section 5.3 Study duration per subject:
For each subject, the study will last a maximum of up to 69 weeks, as follows:
x
Screening Period: 2 to 5 weeks
x
Double-blind Treatment Period: 48 weeks (final dose at Week 44)
x
Safety Follow-Up Period: a SFU Visit is planned 20 weeks after the final dose of IMP 
Has been changed to:
For each subject, the study will last a maximum of up to 69165 weeks, as follows:
x
Screening Period: 2 to 5 weeks
x
Double-blind Treatment Period: 48 weeks (final dose at Week 44)
x
OLE Period: 96 weeks (final dose at Week 136 for subjects receiving bimekizumab 
320mg Q8W and at Week 140 for subjects receiving bimekizumab 320mg Q4W)
x
Safety Follow-Up Period: a SFU Visit is planned 20 weeks after the final dose of IMP visit
Change #9
Section 5.6 Schedule of study assessments
The schedule of study assessments is presented in Table 5-1. At each visit, all study assessments 
should be performed prior to administration of IMP.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 166 of 263
Table 5-1:
Schedule of study assessments
Visita/
Week
Protocol activity
Screening
Treatment Period
SFUb
Baseline 
(first 
1
2
3
4
8
12
16
20
24
28
32
36
40
44
48/
PEOT
Informed consent
X
Inclusion/exclusion
X
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Urine drug screen
X
Demographic data
X
Psoriasis history
X
eC-SSRS
X
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X
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Height
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Body weight
X
X
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X
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X
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 167 of 263
Table 5-1:
Schedule of study assessments
Visita/
Week
Protocol activity
Screening
Treatment Period
SFUb
Baseline 
(first 
1
2
3
4
8
12
16
20
24
28
32
36
40
44
48/
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HIV testingi
X
Chest x-rayj
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X
X
Tuberculosis questionnaire
X
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PASI
X
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Percentage of BSA
X
X
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bimekizumab/secukinumab 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 168 of 263
Table 5-1:
Schedule of study assessments
Visita/
Week
Protocol activity
Screening
Treatment Period
SFUb
Baseline 
(first 
1
2
3
4
8
12
16
20
24
28
32
36
40
44
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psoriasis
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X
X
X
X
X
X
X
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X
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Adverse events
X
X
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BSA=body surface area; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eCRF=electronic Case Report Form; eC-SSRS=electronic 
Columbia Suicide Severity Rating Scale; EQ-5D-3L=European Quality-of-Life 5-Dimensions 3-Level; HCV=hepatitis C virus; HIV=human 
immunodeficiency virus; IGA=Investigator’s Global Assessment; IGRA=interferon-gamma release assay; IMP=investigational medicinal product; 
IRT=interactive response technology; mNAPSI=Modified Nail Psoriasis Severity Index; PASE=Psoriatic Arthritis Screening and Evaluation; 
PASI=Psoriasis Area Severity Index; PEOT=Premature End of Treatment; PGADA=Patient’s Global Assessment of Disease Activity; PHQ-9=Patient 
Health Questionnaire-9; pp-IGA=palmoplantar Investigator’s Global Assessment; PsA=psoriatic arthritis; scalp IGA=scalp-specific Investigator’s Global 
Assessment; SFU=Safety Follow-Up; TB=tuberculosis; WPAI-SHP=Work Productivity and Activity Impairment Questionnaire-specific health problem
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 169 of 263
Table 5-1:
Schedule of study assessments
Visita/
Week
Protocol activity
Screening
Treatment Period
SFUb
Baseline 
(first 
1
2
3
4
8
12
16
20
24
28
32
36
40
44
48/
PEOT
a Visit windows of ±3 days from the first dose from the Week 1 visit to the Week 24 visit. Visit windows of ±7 days from Week 28 through Week 48/PEOT. 
The SFU Visit window is ±7 days relative to the scheduled visit date.
b The SFU Visit will occur 20 weeks after the final dose.
c Includes evaluation of signs and symptoms of active TB and risk for exposure to TB.
d Ensure no significant changes in medical history.
e The physical examination will be performed as per Section 12.3.5.
f Vital signs (blood pressures, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable.
g Pregnancy testing will consist of serum testing at the Screening. Urine pregnancy testing will be performed at all other visits.
h Subjects who have evidence of or test positive for hepatitis B by any of the following criteria: 1) positive for hepatitis B surface antigen; 2) positive for 
anti-hepatitis B core antibody are excluded. A positive test for HCV is defined as: 1) positive for hepatitis C antibody, and 2) positive via a confirmatory test 
for HCV (for example, HCV polymerase chain reaction) are also excluded. Subjects will also be tested for anti-hepatitis B surface antibody.
i The HIV test results will not be recorded in the eCRF.
j Screening chest x-ray must occur within 3 months prior to Screening Visit.
k All blood samples taken prior to dosing.
l The scalp IGA will be assessed only for those subjects with scalp involvement (scalp IGA score >0) at Baseline.
m The mNAPSI will be assessed only in subjects with nail involvement (mNAPSI score >0) at Baseline.
n The pp-IGA will be assessed only in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline.
o The PGADA is assessed for all subjects at Baseline. At all subsequent visits, the PGADA is only for subjects with PsA at Baseline (defined as a past medical 
history of PsA or PASE ≥47).
p IMP administration is based on randomization.
q The dosing window from Baseline through Week 4 is ±2 days relative to the scheduled dosing visit. From Week 8 through Week 24, the dosing window is 
±3 days relative to the scheduled dosing visit. From Week 28 through the end of the study, the dosing window is ±7 days relative to the scheduled dosing 
visit.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 170 of 263
Has been changed to:
The schedule of study assessments is presented in Table 5-1 for the Screening and double-
blind Treatment Periods, and in Table 5-2 for the OLE Period. At each visit, all study 
assessments should be performed prior to administration of IMP.
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof. 


UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 171 of 263
Table 5-1:
Schedule of study assessments, Screening and double-blind Treatment Periods
Visita/
Week
Protocol activity
Screening
Treatment Period
SFUb
Baseline 
(first 
1
2
3
4
8
12
16
20
24
28
32
36
40
44
48/
PEOT
Informed consent
X
Inclusion/exclusion
X
Xc
Urine drug screen
X
Demographic data
X
Psoriasis history
X
eC-SSRS
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Significant past medical history 
and concomitant diseases
X
Xd
Physical examc, e
X
X
X
X
X
X
Height
X
Body weight
X
X
X
X
X
Vital signsf
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Hematology and biochemistry 
X
X
X
X
X
X
X
X
X
X
X
X
X
Urinalysis
X
X
X
X
X
X
X
X
ECG
X
X
X
X
Pregnancy testingg
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Hepatitis B and C testingh
X
HIV testingi
X
Chest x-rayj
X
IGRA tuberculosis test
X
X
PUBLIC 
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32
32
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 172 of 263
Table 5-1:
Schedule of study assessments, Screening and double-blind Treatment Periods
Visita/
Week
Protocol activity
Screening
Treatment Period
SFUb
Baseline 
(first 
1
2
3
4
8
12
16
20
24
28
32
36
40
44
48/
PEOT
Tuberculosis questionnaire
X
X
X
X
X
X
X
PASI
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Percentage of BSA
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Blood sample for 
bimekizumab/secukinumab 
plasma concentrationsk
X
X
X
X
X
X
X
X
X
X
X
X
Blood sample for 
anti-bimekizumab antibodiesk
X
X
X
X
X
X
X
X
X
X
X
X
IGA
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
DLQI
X
X
X
X
X
X
X
Patient Symptoms (itch, pain, 
and scaling)
X
X
X
X
X
X
X
PHQ-9
X
X
X
X
X
X
X
X
X
X
X
X
X
X
scalp IGAl
X
Xl
Xl
Xl
Xl
Xl
Xl
Xl
Xl
mNAPSIm
X
Xm
Xm
Xm
pp-IGAn
X
Xn
Xn
Xn
Patient Global Assessment of 
psoriasis
X
X
X
X
X
X
X
PASE
X
X
PGADA
X
Xo
Xo
Xo
WPAI-SHP V2.0
X
X
X
X
X
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32
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he
of
th


UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 173 of 263
Table 5-1:
Schedule of study assessments, Screening and double-blind Treatment Periods
Visita/
Week
Protocol activity
Screening
Treatment Period
SFUb
Baseline 
(first 
1
2
3
4
8
12
16
20
24
28
32
36
40
44
48/
PEOT
EQ-5D-3L
X
X
X
X
X
Concomitant medication
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Adverse events
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Randomization
X
X
IRTp
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
IMP administrationq
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
BSA=body surface area; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eCRF=electronic Case Report Form; eC-SSRS=electronic 
Columbia Suicide Severity Rating Scale; EQ-5D-3L=European Quality-of-Life 5-Dimensions 3-Level; HCV=hepatitis C virus; HIV=human 
immunodeficiency virus; IGA=Investigator’s Global Assessment; IGRA=interferon-gamma release assay; IMP=investigational medicinal product; 
IRT=interactive response technology; mNAPSI=Modified Nail Psoriasis Severity Index; PASE=Psoriatic Arthritis Screening and Evaluation; 
PASI=Psoriasis Area Severity Index; PEOT=Premature End of Treatment; PGADA=Patient’s Global Assessment of Disease Activity; PHQ-9=Patient 
Health Questionnaire-9; pp-IGA=palmoplantar Investigator’s Global Assessment; PsA=psoriatic arthritis; scalp IGA=scalp-specific Investigator’s Global 
Assessment; SFU=Safety Follow-Up; TB=tuberculosis; WPAI-SHP=Work Productivity and Activity Impairment Questionnaire-specific health problem
X
IC
; ECG=e
ECG=e
ean Quali
an Quali
essment; 
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fied Nail 
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32
32
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th


UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 174 of 263
Table 5-1:
Schedule of study assessments, Screening and double-blind Treatment Periods
Visita/
Week
Protocol activity
Screening
Treatment Period
SFUb
Baseline 
(first 
1
2
3
4
8
12
16
20
24
28
32
36
40
44
48/
PEOT
a Visit windows of ±3 days from the first dose from the Week 1 visit to the Week 24 visit. Visit windows of ±7 days from Week 28 through Week 48/PEOT. 
The SFU Visit window is ±7 days relative to the scheduled visit date.
b The SFU Visit will occur 20 weeks after the final dose if subject does not enroll in the OLE Period.
c Includes evaluation of signs and symptoms of active TB and risk for exposure to TB.
d Ensure no significant changes in medical history.
e The physical examination will be performed as per Section 12.3.5.
f Vital signs (blood pressures, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable.
g Pregnancy testing will consist of serum testing at the Screening. Urine pregnancy testing will be performed at all other visits.
h Subjects who have evidence of or test positive for hepatitis B by any of the following criteria: 1) positive for hepatitis B surface antigen; 2) positive for 
anti-hepatitis B core antibody are excluded. A positive test for HCV is defined as: 1) positive for hepatitis C antibody, and 2) positive via a confirmatory test 
for HCV (for example, HCV polymerase chain reaction) are also excluded. Subjects will also be tested for anti-hepatitis B surface antibody.
i The HIV test results will not be recorded in the eCRF.
j Screening chest x-ray must occur within 3 months prior to Screening Visit.
k All blood samples taken prior to dosing.
l The scalp IGA will be assessed only for those subjects with scalp involvement (scalp IGA score >0) at Baseline.
m The mNAPSI will be assessed only in subjects with nail involvement (mNAPSI score >0) at Baseline.
n The pp-IGA will be assessed only in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline.
o The PGADA is assessed for all subjects at Baseline. At all subsequent visits, the PGADA is only for subjects with PsA at Baseline (defined as a past medical 
history of PsA or PASE ≥47).
p IMP administration is based on randomization.
q The dosing window from Baseline through Week 4 is ±2 days relative to the scheduled dosing visit. From Week 8 through Week 24, the dosing window is 
±3 days relative to the scheduled dosing visit. From Week 28 through the end of the studyWeek 48, the dosing window is ±7 days relative to the scheduled 
dosing visit.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 175 of 263
Table 5-2:
Schedule of study assessments, OLE Period
Visita/
Week
Protocol activity
48 (1st OLE dose)
Year 2
Year 3
SFUb
52
56
60
64
68
72
76
80
84
88
92
96
100
104
108
112
116
120
124
128
132
136
140
144/PEOT
C
C
C
H
C
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
H
C
C
Informed consent
X
Eligibilityc
X
eC-SSRS
X
X
X
X
X
X
X
X
X
X
X
Physical examd,e
X
X
X
X
X
X
X
X
X
Body weight
X
X
Vital signsf
X
X
X
X
X
X
X
X
X
X
X
Hematology and biochemistry 
X
X
X
X
X
X
X
X
X
X
X
Urinalysis
X
X
X
X
X
X
X
X
X
ECG
X
X
Pregnancy testing (urine)h
X
X
X
X
X
X
X
X
X
X
X
IGRA tuberculosis test
X
X
Tuberculosis questionnaire
X
X
X
X
X
X
X
X
X
X
PASI
X
X
X
X
X
X
X
X
X
X
Percentage of BSA
X
X
X
X
X
X
X
X
X
X
Blood sample for bimekizumab 
plasma concentrationsh
X
X
X
X
X
Blood sample for anti‑bimekizumab 
antibodiesh
X
X
X
X
X
IGA
X
X
X
X
X
X
X
X
X
X
DLQI
X
X
X
X
Patient Symptoms (itch, pain, and 
scaling)
X
X
X
X
X
X
X
X
X
PHQ-9
X
X
X
X
X
X
X
X
X
X
scalp IGAi
X
X
X
X
mNAPSIj
X
X
X
X
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 176 of 263
Table 5-2:
Schedule of study assessments, OLE Period
Visita/
Week
Protocol activity
48 (1st OLE dose)
Year 2
Year 3
SFUb
52
56
60
64
68
72
76
80
84
88
92
96
100
104
108
112
116
120
124
128
132
136
140
144/PEOT
C
C
C
H
C
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
H
C
C
pp-IGAk
X
X
X
X
EQ-5D-3L
X
X
X
X
Patient Global Assessment of PSO
PASE
X
X
PGADAl
X
X
WPAI-SHP V2.0
X
X
Concomitant medication
X
X
X
X
X
X
X
X
X
X
X
Adverse events
X
X
X
X
X
X
X
X
X
X
X
Randomization
X
IRTm
X
X
X
X
X
X
X
X
X
X
X
X
IMP administration – Q4W n, o
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
IMP administration – Q8W n, o
X
X
X
X
X
X
X
X
X
X
X
X
BSA=body surface area; C=clinic; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eCRF=electronic Case Report Form; eC-
SSRS=electronic Columbia Suicide Severity Rating Scale; EQ-5D-3L=European Quality-of-Life 5-Dimensions 3-Level; H=home; HCV=hepatitis C virus; 
HIV=human immunodeficiency virus; IGA=Investigator’s Global Assessment; IGRA=interferon-gamma release assay; IMP=investigational medicinal
product; IRT=interactive response technology; mNAPSI=Modified Nail Psoriasis Severity Index; PASE=Psoriatic Arthritis Screening and Evaluation; 
PASI=Psoriasis Area Severity Index; PEOT=Premature End of Treatment; PGADA=Patient’s Global Assessment of Disease Activity; PHQ-9=Patient 
Health Questionnaire-9; pp IGA=palmoplantar Investigator’s Global Assessment; PsA=psoriatic arthritis; scalp IGA=scalp-specific Investigator’s Global 
Assessment; SFU=Safety Follow-Up; TB=tuberculosis; WPAI SHP=Work Productivity and Activity Impairment Questionnaire-specific health problem
a Visit windows of ±7 days from Week 48 through Week 72. Visit windows of ±14 days from Week 76 through Week 144. The SFU Visit window is ±7 days 
relative to the scheduled visit date.
b The SFU Visit will occur 20 weeks after the final dose.
c Criteria for OLE Period, Section 6.3.
d Includes evaluation of signs and symptoms of active TB and risk for exposure to TB.
e The physical examination will be performed as per Section 12.3.5.
f Vital signs (blood pressures, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 177 of 263
Table 5-2:
Schedule of study assessments, OLE Period
Visita/
Week
Protocol activity
48 (1st OLE dose)
Year 2
Year 3
SFUb
52
56
60
64
68
72
76
80
84
88
92
96
100
104
108
112
116
120
124
128
132
136
140
144/PEOT
C
C
C
H
C
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
H
C
C
g Pregnancy testing will consist of urine pregnancy testing at all visits.
h All blood samples taken prior to dosing.
i The scalp IGA will be assessed only for those subjects with scalp involvement (scalp IGA score >0) at Baseline.
j The mNAPSI will be assessed only in subjects with nail involvement (mNAPSI score >0) at Baseline.
k The pp-IGA will be assessed only in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline.
l The PGADA is assessed only for subjects with PsA at Baseline (defined as a past medical history of PsA or PASE ≥47).
m IMP administration is based on randomization.
n From Week 48 through Week 72, the dosing window is ±7 days relative to the scheduled dosing visit. From Week 76 through the Week 144/PEOT visit, the 
dosing window is ±14 days relative to the scheduled dosing visit.
o If self-injected at home, the subject/caregiver will document the date, body location, kit number and time point of administration of study medication. All 
used syringes will be disposed of by subjects/caregivers as determined by the Investigator in an acceptable disposal (sharps) container directly after the 
administration. The subjects/caregivers return the documentation together with any used/unused containers at the next scheduled clinic visit.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 178 of 263
Change #10
Section 5.7 Schematic diagram:
The study schematic diagram for PS0015 is presented in Figure 5-1.
Figure 5-1:
Schematic diagram
IGA=Investigator’s Global Assessment; IMP=investigational medicinal product; PASI100=Psoriasis Area Severity 
Index complete response; PBO=placebo; Q4W=every 4 weeks; Q8W=every 8 weeks; SEC=secukinumab 
Note: At Week 28 and all following visits, subjects on continuous treatment for at least 12 weeks with a persistent 
IGA score ≥3 over at least a 4-week period are defined as nonresponders and should discontinue IMP.
Has been changed to:
The study schematic diagram for PS0015 from Screening through Week 48 is presented in 
Figure 5-1, and from Week 48 through Week 144 is presented in Figure 5-2.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 179 of 263
Figure 5-1:
Schematic diagram, Screening and double-blind Treatment Period 
(through Week 48)
Screening
Treatment period (double-blind) 
Safety follow-up 
visit 20 weeks 
after last dose
Baseline
16
Week
SFU visit 20 
weeks after 
last dose
4
8
Dosing
12
20
24
28
32
36
40
44
48
Primary endpoint
PASI100 response
2–5 weeks
Dosing
Dosing
Dosing
Dosing
Dosing
Dosing
Dosing
Dosing
Dosing
Dosing
Dosing
Dosing
(SEC or 
PBO)
Open-label 
extension 
period
Bimekizumab 320mg Q4W
N=700
Secukinumab 300mg Q4W
n=350
n=350
Bimekizumab 320mg Q8W
Bimekizumab 320mg Q4W
1:2 re-
randomization
Open-label
extension
period
or
IGA=Investigator’s Global Assessment; IMP=investigational medicinal product; PASI100=Psoriasis Area Severity 
Index complete response; PBO=placebo; Q4W=every 4 weeks; Q8W=every 8 weeks; SEC=secukinumab 
Note: At Week 28 and all following visits, subjects on continuous treatment for at least 12 weeks with a persistent 
IGA score ≥3 over at least a 4-week period are defined as nonresponders and should discontinue IMP.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 180 of 263
Figure 5-2:
Schematic diagram, OLE Period (Week 48 through Week 144)
1:1 re-
randomization
≥PASI90
<PASI90
≥PASI90
20 weeks 
after last 
dose
Week 48
Open-label extension period
Safety follow-up 
visit 20 weeks 
after last dose
52
84
Week
60
68
76
92
100
108
116
124
132
140
56
88
64
72
80
96
104
112
120
128
136
144
Bimekizumab 320mg Q4W
Bimekizumab 320mg Q8W
Secukinumab
300mg Q4W
Bimekizumab 
320mg Q4W
Bimekizumab 
320mg Q8W
Secukinumab
300mg Q4W
Bimekizumab 
320mg Q4W
Bimekizumab 
320mg Q8W
≥PASI90
All Q4W All Q4W All
All
All
All*
Q4W
Q4W
Q4W
Q4W
Q4W
Q4W
Q4W
Q4W
Q4W
All
All
All
All
All
Q4W
Dosing
Q4W=every 4 weeks; Q8W=every 8 weeks; PASI=Psoriasis Area Severity Index; PASI90=90% improvement 
in the PASI score
*At Week 96, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the subject’s dosing 
interval will change from 320mg Q4W to 320mg Q8W (default), unless, based on medical judgment, the 
Investigator decides differently.
Change #11
Section 5.8.1 Study design:
The following text was added:
The addition of the OLE Period will allow collection of long-term efficacy and safety data 
from eligible subjects on open-label bimekizumab for an additional 96 weeks. 
Change #12
The following section was added:
Section 6.3 Eligibility for the OLE Period:
Prior to entering the OLE Period, subjects on double-blind study treatment must complete 
all of the Week 48 visit assessments. Prior to initiating the OLE Period assessments, all 
subjects will be asked to read and sign a separate ICF. To be eligible to participate in the 
OLE Period of this study, the subject must have completed the double-blind Treatment 
Period without meeting any withdrawal criteria and have been compliant with the ongoing 
clinical study requirements. 
Change #13
Section 6.4 Withdrawal criteria:
8. At Week 28 and all following visits, subjects on continuous treatment for at least 12 weeks 
with a persistent IGA score ≥3 over at least a 4-week period are defined as nonresponders 
and should discontinue IMP. 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 181 of 263
Has been changed to:
8a. At Week 28 and all following visits up to Week 48, subjects on continuous treatment for at 
least 12 weeks with a persistent IGA score ≥3 over at least a 4-week period are defined as 
nonresponders and should discontinue IMP.
Change #14
Section 7.2 Treatments to be administered, from 4th paragraph to end:
The dosing scheme is depicted in Table 7-1.
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof. 


UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 182 of 263
Table 7-1:
Dosing scheme, double-blind Treatment Period
Week
Dose Assignment
Baseline 
(first dose)
1
2
3
4
8
12
16a
20
24
28
32
36
40
44
Bimekizumab 
320mg
●●
○○
○○
○○
●●
●●
●●
Q4W
●●
●●
●●
●●
●●
●●
●●
●●
Q8W
●●
○○
●●
○○
●●
○○
●●
○○
Secukinumab 
300mg 
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
Q4W=every 4 weeks; Q8W=every 8 weeks
Notes: A bimekizumab 160mg injection is depicted by a black circle (●). A placebo injection is depicted by a white circle (○). A secukinumab 150mg injection 
is depicted by a black triangle (▲). 
a Subjects in the bimekizumab 320mg treatment arm will be re-randomized 1:2 to receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 183 of 263
Has been changed to:
The dosing scheme for Baseline through Week 44 is depicted in Table 7-1. The dosing scheme 
from Week 48 through Week 140 is depicted in Table 7-2.
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof. 


UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 184 of 263
Table 7-1:
Dosing scheme, double-blind Treatment Period
Week
Dose Assignment
Baseline 
(first dose)
1
2
3
4
8
12
16a
20
24
28
32
36
40
44
Bimekizumab 
320mg
●●
○○
○○
○○
●●
●●
●●
Q4W
●●
●●
●●
●●
●●
●●
●●
●●
Q8W
●●
○○
●●
○○
●●
○○
●●
○○
Secukinumab 
300mg 
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
Q4W=every 4 weeks; Q8W=every 8 weeks
Notes: A bimekizumab 160mg injection is depicted by a black circle (●). A placebo injection is depicted by a white circle (○). A secukinumab 150mg injection 
is depicted by a black triangle (▲). 
a Subjects in the bimekizumab 320mg treatment arm will be re-randomized 1:2 to receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W.
Table 7-2:
Dosing scheme, OLE Period
Week
Dose 
Assignment
48 (1st 
OLE 
Year 2
Year 3
52
56
60
64
68
72
76
80
84
88
92
96
100
104
108
112
116
120
124
128
132
136
140
Bimekizumab 
320mg Q4W
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
Bimekizumab 
320mg Q8W
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
Q4W=every 4 weeks; OLE=Open-Label Extension; Q8W=every 8 weeks
Notes: A bimekizumab 160mg injection is depicted by a black circle (●).
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 185 of 263
During the OLE Period, IMP administration on weeks with no scheduled clinic visit should
primarily be performed by subjects at home. Self-injection training will be provided to the 
subject/caregiver by qualified site personnel at Week 40 and Week 44. At Week 48 and 
subsequent clinic visits, the subject/caregiver will perform self-administration under the 
supervision of the site staff to ensure that study medication is being properly and safely 
injected. 
Once subjects/caregivers as determined by the Investigator (or designee) have been trained, 
the study medication may be administered at home. The subject will receive the required 
number of syringes for injections at each visit needed to perform the Q4W or Q8W 
administrations at home. Subjects who are unable to or decide not to self-inject IMP or 
those without a family member/friend/caregiver who can help, will not be discontinued, but 
may continue to visit the site for unscheduled visits for IMP administration only. 
If administered at home, the subject/caregiver will document the date, body location, kit 
number and time point of administration of study medication. 
All used syringes will be disposed of by subjects/caregivers as determined by the 
Investigator in an acceptable disposal (sharps) container directly after the administration. 
The subjects/caregivers return the documentation together with any used/unused 
containers at the next scheduled clinic visit. 
Change # 15
Section 7.5 Handling and storage requirements:
The following text has been added:
In addition, the Investigator (or designee) will instruct the subject on how to handle the 
IMP during transport, and how to store the IMP following the instruction guide. Cooler 
bags with freezer packs will be provided to the subjects. Specific attention will be put on 
the transport from site to home using cold bags, and the subject will be instructed to put 
the IMP as quickly as possible into his/her refrigerator. In case of broken refrigerator, or 
broken or lost syringes, the subject will inform the site immediately and new IMP will be 
supplied. All efforts should be made to follow the treatment scheme as per protocol.
Change #16
Section 7.7 Procedures for monitoring subject compliance:
Investigational medicinal product will be administered in the clinic and compliance will be 
determined at the visit by study personnel. Drug accountability must be recorded on the Drug 
Accountability Form.
Has been changed to:
InvestigationalDuring the double-blind Treatment Period (up to Week 44), investigational
medicinal product will be administered in the clinic and compliance will be determined at the 
visit by study personnel. Drug accountability must be recorded on the Drug Accountability 
Form.
After Week 48, self-injection at home will be possible at the following weeks: Weeks 60, 68, 
76, 80, 88, 92, 100, 104, 112, 116, 124, 128, 136, and 140. Dates, body locations, kit numbers 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 186 of 263
and time of self-injection will be captured using a home administration form. All used 
syringes will be disposed of by subjects/caregivers as determined by the Investigator in an 
acceptable disposal (sharps) container directly after the administration. The 
subjects/caregivers return the documentation together with any used/unused containers at 
the next scheduled clinic visit.
Completed home administration forms should be reviewed by the Investigator with the 
subject. If a subject is noncompliant with the study procedures or medications that may 
present a risk to the safety of the subject in the opinion of the Investigator, then the subject 
should be withdrawn as described in Section 6.4.
Change #17
Section 7.8.1.1 Topical medications, 2nd paragraph:
Mild and low potency topical steroids will be permitted for use limited to the face, axilla, and/or 
genitalia, as needed. These topical medications should not be used within approximately 24 
hours prior to study visits requiring IGA and PASI measures.
Has been changed to:
MildIn the double-blind Treatment Period, mild and low potency topical steroids will be 
permitted for use limited to the face, axilla, and/or genitalia, as needed. These topical 
medications should not be used within approximately 24 hours prior to study visits requiring 
IGA and PASI measures.
In the OLE Period, the medications listed as permitted for the double-blind Treatment 
Period will be allowed. In addition, topical steroids and vitamin D analog ointment will be 
permitted for use, as needed.
Change #18
Section 7.9 Blinding, first paragraph, 3rd paragraph, and last paragraph:
Due to differences in presentation between the bimekizumab and secukinumab, special 
precautions will be taken to ensure study blinding and study sites will have blinded and 
unblinded personnel.
During the study the Sponsor will provide blinded and unblinded site monitors for the purposes 
of verifying safety, efficacy, and drug administration and documentation records. Unblinded 
study site personnel need to be available in order to resolve queries. Study monitors and study 
site personnel, blinded to treatment assignment, will not discuss or have access to any drug 
related information.
Has been changed to:
Due to differences in presentation between the bimekizumab and secukinumab, special 
precautions will be taken to ensure study blinding during the double-blind Treatment Period
and study sites will have blinded and unblinded personnel.
During the double-blind Treatment Period of the study, the Sponsor will provide blinded and 
unblinded site monitors for the purposes of verifying safety, efficacy, and drug administration 
and documentation records. Unblinded study site personnel need to be available in order to 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 187 of 263
resolve queries. Study monitors and study site personnel, blinded to treatment assignment, will 
not discuss or have access to any drug related information.
For subjects participating in the OLE Period, there will be no blinding and the blinding 
procedures described above will no longer apply.
Change #19
Section 7.10 Randomization and numbering of subjects, last paragraph:
Subject numbers and kit numbers will be tracked via the IRT.
Has been changed to:
In the OLE Period, subjects:
x
Who received bimekizumab 320mg Q4W and achieved PASI90 at Week 48 of the 
double-blind Treatment Period will be randomized 1:1 to receive bimekizumab 320mg 
Q4W or bimekizumab 320mg Q8W.
x
Who received bimekizumab 320mg Q4W and who did not achieve PASI90 at Week 48 
of the double-blind Treatment Period will receive bimekizumab 320mg Q4W.
x
Who received bimekizumab 320mg Q8W and who did not achieve PASI90 at Week 48 
of the double-blind Treatment Period will receive bimekizumab 320mg Q4W.
x
Who received bimekizumab 320mg Q8W and who achieved PASI90 at Week 48 of the 
double-blind Treatment Period will receive bimekizumab 320mg Q8W.
x
Who received secukinumab and who did not achieve PASI90 at Week 48 of the double-
blind Treatment Period will receive bimekizumab 320mg Q4W.
x
Who received secukinumab and who achieved PASI90 at Week 48 of the double-blind 
Treatment Period will be randomized 1:1 to receive bimekizumab 320mg Q4W or 
bimekizumab 320mg Q8W.
At Week 96, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
subject’s dosing interval will change from 320mg Q4W to 320mg Q8W (default), unless, 
based on medical judgment, the Investigator decides differently.
Subject numbers and kit numbers will be tracked via the IRT during the double-blind 
Treatment Period and the OLE Period.
Change #20
Section 8 Study procedures by visit:
Table 5-1 (Schedule of study assessments) provides a general overview of study assessments. A 
list of procedures to be completed at each visit is described below.
x
Visit windows of ±3 days on either side of the scheduled dosing are permitted up to and 
including Week 24; however, the Investigator should try to keep the subjects on the original 
dosing schedule. From the Week 28 Visit through the Week 48/PEOT Visit, visit windows of 
±7 days on either side of the scheduled dosing are permitted; however, the Investigator 
should try to keep the subjects on the original dosing schedule. The visit window is relative 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 188 of 263
to Baseline and applicable for all subsequent visits. Changes to the dosing schedule outside 
the visit window must be discussed with the Medical Monitor.
x
The dosing window from Baseline through Week 4 is ±2 days relative to the scheduled
dosing visit. From Week 8 through Week 24, the dosing window is ±3 days relative to the 
scheduled dosing visit. From Week 28 through the end of the study the dosing window is ±7 
days relative to the scheduled dosing visit.
Has been changed to:
Table 5-1 (Schedule of study assessments) providesand Table 5-2 provide a general overview 
of study assessments during the double-blind Treatment Period and the OLE Period, 
respectively. A list of procedures to be completed at each visit is described below.
x
Visit windows of ±3 days on either side of the scheduled dosing are permitted up to and 
including Week 24; however, the Investigator should try to keep the subjects on the original 
dosing schedule. From the Week 28 Visit through the Week 48/PEOT72 Visit, visit
windows of ±7 days on either side of the scheduled dosing are permitted; however, the 
Investigator should try to keep the subjects on the original dosing schedule. From the Week 
76 Visit through the Week 144/PEOT Visit, visit windows of ±14 days on either side of 
the scheduled dosing are permitted; however, the Investigator should try to keep the 
subjects on the original dosing schedule. The visit window is relative to Baseline and 
applicable for all subsequent visits. Changes to the dosing schedule outside the visit window 
must be discussed with the Medical Monitor.
x
The dosing window from Baseline through Week 4 is ±2 days relative to the scheduled 
dosing visit. From Week 8 through Week 24, the dosing window is ±3 days relative to the 
scheduled dosing visit. From Week 28 through the end ofthrough the studyWeek 72 Visit,
the dosing window is ±7 days relative to the scheduled dosing visit. From Week 76 Visit 
through the Week 144/PEOT, the dosing window is ±14 days relative to the scheduled 
dosing visit.
Change #21
The following sections have been added: 
Section 8.3
OLE Period
Section 8.3.1 Week 48 Visit (±7 days relative to Baseline)
The following procedures/assessments will be performed/recorded after completion of 
assessments listed for Week 48 (Section 8.2.13) and prior to administration of IMP:
x
Sign a separate ICF for the OLE Period
x
Inclusion/exclusion: Confirm that subject completed the double-blind Treatment Period 
without meeting any withdrawal criteria and has been compliant with the ongoing 
clinical study requirements
x
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x
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 189 of 263
After completion of the above-mentioned procedures, IMP administration will occur, 
preferably by self-injection under supervision of the site personnel.
Section 8.3.2 Week 52 Visit (±7 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration 
of IMP:
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should 
be obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Hematology and biochemistry

Urine pregnancy test
x
PASI
x
Percentage of BSA
x
IGA
x
PHQ-9
x
eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
After completion of the above-mentioned procedures, administration of IMP will occur for 
subjects on bimekizumab 320mg Q4W dosing only, preferably by self-injection under 
supervision of the site personnel.
Section 8.3.3 Week 56 Visit (±7 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration 
of IMP:
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should 
be obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Hematology and biochemistry

Urine pregnancy test
x
Tuberculosis questionnaire
x
PASI
x
Percentage of BSA
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 190 of 263
x
IGA
x
Patient symptoms (itch, pain, and scaling)
x
PHQ-9
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Concomitant medication
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AEs
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Contact IRT
After completion of the above-mentioned procedures, administration of IMP will occur, 
preferably by self-injection under supervision of the site personnel.
Distribution of IMP and accountability activities for home administration to be performed 
as described in Section 7.2, Section 7.5, and Section 7.7.
Section 8.3.4 Self-injection at home (Weeks 60, 68, 76, 80, 88, 92, 100, 104, 112, 
116, 124, 128, 136 and 140)
Subjects receiving bimekizumab 320mg Q4W will be given the opportunity for self-
injection of bimekizumab at home on the following weeks: Weeks 60, 68, 76, 80, 88, 92, 100, 
104, 112, 116, 124, 128, 136 and 140.
Subjects receiving bimekizumab 320mg Q8W will be given the opportunity for self-
injection of bimekizumab at home on the following weeks: Weeks 80, 88, 104, 112, 128, and 
136.
x
Adverse events will be captured spontaneously if the subject decides to visit the site to 
receive the bimekizumab administration. 
x
All used syringes will be disposed of by subjects/caregivers as determined by the 
Investigator in an acceptable disposal (sharps) container directly after the 
administration. The subjects/caregivers return the documentation together with any 
used/unused containers at the next scheduled clinic visit.
Section 8.3.5 Week 64, Week 84, Week 108, Week 132 Visits (±14 days relative to 
Baseline)
The following procedures/assessments will be performed/recorded prior to administration 
of IMP:
x
Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should 
be obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Hematology and biochemistry

Urinalysis
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 191 of 263

Urine pregnancy test
x
Tuberculosis questionnaire
x
PASI
x
Percentage of BSA
x
IGA
x
Patient symptoms (itch, pain, and scaling)
x
PHQ-9
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eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
After completion of the above-mentioned procedures, administration of IMP will occur
x
at each of these visits for subjects on bimekizumab 320mg Q4W dosing, preferably by 
self-injection under supervision of the site personnel
x
at Week 64 for subjects on bimekizumab 320mg Q8W dosing, preferably by self-
injection under supervision of the site personnel
Distribution of IMP and accountability activities for home administration to be performed 
as described in Section 7.2, Section 7.5, and Section 7.7.
Section 8.3.6 Week 72 and Week 120 Visits (±14 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration 
of IMP:
x
Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should 
be obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Hematology and biochemistry
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Urinalysis

Urine pregnancy test

Bimekizumab plasma concentrations

Anti-bimekizumab antibodies
x
Tuberculosis questionnaire
x
PASI
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 192 of 263
x
Percentage of BSA
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DLQI
x
Patient symptoms (itch, pain, and scaling)
x
PHQ-9
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Distribution of IMP and accountability activities for home administration to be 
performed as described in Section 7.2, Section 7.5, and Section 7.7.
Section 8.3.7 Week 96 Visit (±14 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration 
of IMP:
x
Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB
x
Body weight
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should 
be obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:
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Hematology and biochemistry
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Urinalysis
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Urine pregnancy test
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IGRA tuberculosis test

Bimekizumab plasma concentrations
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Anti-bimekizumab antibodies
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 193 of 263
x
Record 12-lead ECG
x
Tuberculosis questionnaire
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PASI
x
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IGA
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DLQI
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Patient symptoms (itch, pain, and scaling)
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will occur, preferably by self-injection under supervision of the site personnel
Distribution of IMP and accountability activities for home administration to be performed 
as described in Section 7.2, Section 7.5, and Section 7.7.
Section 8.3.8 Week 144 Visit (±14 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration 
of IMP:
x
Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB
x
Body weight
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should 
be obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 194 of 263

Hematology and biochemistry

Urinalysis

Urine pregnancy test

IGRA tuberculosis test

Bimekizumab plasma concentrations
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Anti-bimekizumab antibodies
x
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x
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x
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x
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x
eC-SSRS
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Return of IMP and accountability activities for home administration to be performed as 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 195 of 263
Change #21
Section 8.4 Premature End of Treatment Visit:
The following bullet has been added:

If the subject will be withdrawn from IMP prior to the Week 144 visit of the OLE 
Period, the subject will undergo the same assessments as the Week 144 visit (see
Section 8.3.8), and will enter the SFU Period.
Change #22
Section 8.5 Safety Follow-Up Visit (20 weeks after final dose, ±7 days)

Bimekizumab/ secukinumab plasma concentrations 
Has been changed to:

Bimekizumab/ (secukinumab for subjects not entering the OLE Period) plasma 
concentrations 
Change #23
Section 8.6 Unscheduled visit, 2nd paragraph:
If an Unscheduled Visit is conducted due to safety or efficacy reasons, an eC-SSRS assessment 
will be performed with the subject during the visit. If an Unscheduled Visit is conducted for 
reasons other than safety or efficacy concerns (eg, repeated collection of a laboratory specimen 
due to collection or analysis issues), an eC-SSRS will not be required at these visits.
Has been changed to:
If an Unscheduled Visit is conducted due to safety or efficacy reasons, an eC-SSRS assessment 
will be performed with the subject during the visit. If an Unscheduled Visit is conducted for 
reasons other than safety or efficacy concerns (eg, repeated collection of a laboratory specimen 
due to collection or analysis issues, injection for subjects not making use of home self-
injections), an eC-SSRS will not be required at these visits.
Change #24
Section 12.2 Laboratory measurements, Table 12-2
Table 18‒6: Laboratory measurements
Hematology
Chemistry
Urinalysis dipsticka
Basophils
Calcium
pH
Eosinophils
Chloride
Albumin (protein)
Lymphocytes
Magnesium
Glucose
Monocytes
Potassium
Blood
Neutrophils
Sodium
Leukocyte esterase
Hematocrit
Glucose
Nitrite
Hemoglobin
BUN
Urine dipstick for pregnancy testingb
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 196 of 263
Table 18‒6: Laboratory measurements
Hematology
Chemistry
Urinalysis dipsticka
MCH
Creatinine
MCHC
ALP
MCV
AST
Platelet count
ALT
RBC count
GGT
WBC count
Total bilirubin
LDH
CRP
Lipid panel
NT-proBNP
Serum pregnancy testingb
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea 
nitrogen; CRP=C-reactive protein; GGT=gamma glutamyltransferase; LDH=lactate dehydrogenase; 
MCH=mean corpuscular hemoglobin; MCHC=mean corpuscular hemoglobin concentration; MCV=mean 
corpuscular volume; NT-proBNP=N-terminal pro B-type natriuretic peptide; RBC=red blood cell; WBC=white 
blood cell
a A urine microscopic examination will be performed if the result for albumin (protein), leukocyte esterase, blood 
or nitrite is abnormal. A urine microscopic examination will include: WBC, RBC, epithelial cells (squamous, 
transitional and renal tubular), hyaline casts, WBC casts, RBC casts, waxy casts, granular casts, calcium oxalate 
crystals, uric acid crystals, triphosphate crystals, yeast, bacteria, amorphous urates, and amorphous phosphates.
b Pregnancy testing will consist of serum testing at the Screening. Urine pregnancy testing will be performed at 
all other visits.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 197 of 263
Table 18‒7: Laboratory measurements
Hematology
Chemistry
Urinalysis dipsticka
Basophils
Calcium
pH
Eosinophils
Chloride
Albumin (protein)
Lymphocytes
Magnesium
Glucose
Monocytes
Potassium
Blood
Neutrophils
Sodium
Leukocyte esterase
Hematocrit
Glucose
Nitrite
Hemoglobin
BUN
Urine dipstick for pregnancy testingb
MCH
Creatinine
Urine drug screen
MCHC
ALP
MCV
AST
Platelet count
ALT
RBC count
GGT
WBC count
Total bilirubin
LDH
CRPb
Lipid panel
NT-proBNPb
Serum pregnancy testingc
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea 
nitrogen; CRP=C-reactive protein; GGT=gamma glutamyltransferase; LDH=lactate dehydrogenase; 
MCH=mean corpuscular hemoglobin; MCHC=mean corpuscular hemoglobin concentration; MCV=mean 
corpuscular volume; NT-proBNP=N-terminal pro B-type natriuretic peptide; RBC=red blood cell; WBC=white 
blood cell
a A urine microscopic examination will be performed if the result for albumin (protein), leukocyte esterase, blood 
or nitrite is abnormal. A urine microscopic examination will include: WBC, RBC, epithelial cells (squamous, 
transitional and renal tubular), hyaline casts, WBC casts, RBC casts, waxy casts, granular casts, calcium oxalate 
crystals, uric acid crystals, triphosphate crystals, yeast, bacteria, amorphous urates, and amorphous phosphates.
b Assessments of NT-proBNP and CRP will not be performed during the OLE Period.
c Pregnancy testing will consist of serum testing at the Screening. Urine pregnancy testing will be performed at 
all other visits.
Change #25
Section 12.2.1 Evaluation of PDILI, Table 12-3:
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 198 of 263
Table 12-3: Required investigations and follow up for PDILI
Laboratory value
Immediate
Follow up
ALT or 
AST
Total 
bilirubin
Symptomsa of 
hepatitis of 
hypersensitivity
Consultation 
requirements
Actions
Testing
Evaluation
≥3xULN
≥2xULNb
NA
Hepatology consultc
Medical Monitor must 
be notified within 
24 hours (eg, by 
laboratory alert) and 
subject discussed with 
Medical Monitor ASAP.
Immediate, permanent 
IMP discontinuation.
Essential: Must have 
repeat liver chemistry 
values and additional 
testing completed 
ASAP (see 
Section 12.2.1.3); 
recommended to occur 
at the site with HCP.
Monitoring of liver 
chemistry values at least 
twice per week until values 
normalize, stabilize, or 
return to within baseline 
values. d
≥3xULN
NA
Yes
≥8xULN
NA
NA
Need for hepatology 
consult to be discussed 
(required if ALT or AST 
≥8xULN).
Medical Monitor must 
be notified within 
24 hours (eg, by 
laboratory alert) and 
subject discussed with 
Medical Monitor ASAP.
Immediate, permanent 
IMP discontinuation.
≥5xULN 
(and ≥2x 
baseline) 
and 
<8xULN
<2xULN
No
Discussion with Medical 
Monitor required.
Consider need for 
hepatology consult if 
there is no evidence of 
resolution (see Follow 
up requirements). c
Further investigation –
immediate IMP 
discontinuation not 
required (see 
Section 12.2.1.2).
IMP discontinuation 
required if any of the 
following occur:
Subject cannot comply 
with monitoring 
schedule.
Essential: Every 
attempt must be made 
to have repeat liver 
chemistry values and 
additional testing 
completed within 
48 hours at the site 
with HCP (see 
Section 12.2.1.3).
Monitoring of liver 
chemistry values at least 
twice per week for 2 weeks.
d
Immediate IMP 
discontinuation required if 
liver chemistry values 
continue to increase.
After 2 weeks of monitoring 
liver chemistry values:
ALT or AST remains 
≥5xULN <8xULN, IMP 
should be temporarily 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 199 of 263
Table 12-3: Required investigations and follow up for PDILI
Laboratory value
Immediate
Follow up
ALT or 
AST
Total 
bilirubin
Symptomsa of 
hepatitis of 
hypersensitivity
Consultation 
requirements
Actions
Testing
Evaluation
Liver chemistry values 
continue to increase
Liver chemistry values 
remain ≥5xULN (and 
≥2x baseline) after 
4 weeks of monitoring 
without evidence of
resolution
withheld and subject should 
undergo repeat test in 2 
weeks.
Continue IMP if ALT or 
AST values <5xULN; 
continue to monitor at least 
twice per week until values 
normalize, stabilize, or 
return to within baseline 
values.
If ALT or AST remains 
≥5xULN after second 
re-test, immediate, 
permanent IMP 
discontinuation required.
Continue to monitor until 
values normalize, stabilize, 
or return to within baseline 
values. d
ALP=alkaline phosphatase; ALT=alanine aminotransferase; ASAP=as soon as possible; AST=aspartate aminotransferase; HCP=healthcare practitioner; 
IMP=investigational medicinal product; NA=not applicable; PDILI=potential drug-induced liver injury; ULN=upper limit of normal
a Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or tenderness; hypersensitivity symptoms include eosinophilia (>5%), 
rash, and fever (without clear alternative cause).
b If the subject also has ≥2xULN ALP, the possibility of an indication of biliary obstruction should be discussed with the Medical Monitor.
c Details provided in Section 12.2.1.1. The local hepatologist is the expert usually consulted by the treating physician for assessment and management of 
potential hepatic disease. This would usually be a hepatologist, but may be a gastroenterologist.
d Unless an alternative monitoring schedule is agreed by the Investigator and UCB responsible physician. Determination of stabilization is at the discretion of the 
Investigator in consultation with the hepatologist (as applicable) and UCB responsible physician, as needed.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 200 of 263
Table 12-3: Required investigations and follow up for PDILI
Laboratory value
Immediate
Follow up
ALT or 
AST
Total 
bilirubin
Symptomsa of 
hepatitis of 
hypersensitivity
Consultation 
requirements
Actions
Testing
Evaluation
≥3xULN
≥2xULNb
NA
Hepatology consultc
Medical Monitor must 
be notified within 
24 hours (eg, by 
laboratory alert) and 
subject discussed with 
Medical Monitor ASAP.
Immediate, permanent 
IMP discontinuation.e
Essential: Must have 
repeat liver chemistry 
values and additional 
testing completed 
ASAP (see 
Section 12.2.1.3); 
recommended to 
occur at the site with 
HCP.
Monitoring of liver 
chemistry values at least 
twice per week until values 
normalize, stabilize, or 
return to within baseline 
values. d
≥3xULN
NA
Yes
≥8xULN
NA
NA
Need for hepatology 
consult to be discussed 
(required if ALT or 
AST ≥8xULN).
Hepatology consult.
Medical Monitor must 
be notified within 
24 hours (eg, by 
laboratory alert) and 
subject discussed with 
Medical Monitor ASAP.
Immediate, permanent 
IMP discontinuation.
≥5xULN 
(and ≥2x 
baseline) 
and 
<8xULN
<2xULN
No
Discussion with Medical 
Monitor required.
Consider need for 
hepatology consult if 
there is no evidence of 
resolution (see Follow 
up requirements). c
Further investigation –
immediate IMP 
discontinuation not 
required (see 
Section 12.2.1.2).
IMP discontinuation 
required if any of the 
following occur:
Subject cannot comply 
with monitoring 
schedule.
Essential: Every 
attempt must be made 
to have repeat liver 
chemistry values and 
additional testing 
completed within 
48 hours at the site 
with HCP (see 
Section 12.2.1.3).
Monitoring of liver 
chemistry values at least
twice per week for 
2 weeks.d
x
Immediate IMP 
discontinuation 
required if liver 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 201 of 263
Table 12-3: Required investigations and follow up for PDILI
Laboratory value
Immediate
Follow up
ALT or 
AST
Total 
bilirubin
Symptomsa of 
hepatitis of 
hypersensitivity
Consultation 
requirements
Actions
Testing
Evaluation
Liver chemistry values 
continue to increase
Liver chemistry values 
remain ≥5xULN (and 
≥2x baseline) after 
4 weeks of monitoring 
without evidence of 
resolution
chemistry values 
continue to increase.
After 2 weeks of monitoring 
liver chemistry values:
x
ALT or AST remains 
≥5xULN <8xULN, 
IMP should be 
temporarily withheld 
and subject should 
undergo repeat test in 2 
weeks.
Continue IMP if ALT 
or AST values 
<5xULN; continue to 
monitor at least twice 
per week until values 
normalize, stabilize, or 
return to within 
baselineBaseline
values.
If ALT or AST remains 
≥5xULN after second 
re-test, immediate, 
permanent IMP 
discontinuation 
required.
Continue to monitor until 
values normalize, stabilize, 
or return to within baseline 
values.d
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 202 of 263
Table 12-3: Required investigations and follow up for PDILI
Laboratory value
Immediate
Follow up
ALT or 
AST
Total 
bilirubin
Symptomsa of 
hepatitis of 
hypersensitivity
Consultation 
requirements
Actions
Testing
Evaluation
ALP=alkaline phosphatase; ALT=alanine aminotransferase; ASAP=as soon as possible; AST=aspartate aminotransferase; HCP=healthcare practitioner; 
IMP=investigational medicinal product; NA=not applicable; PDILI=potential drug-induced liver injury; ULN=upper limit of normal
a Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or tenderness; hypersensitivity symptoms include eosinophilia (>5%), 
rash, and fever (without clear alternative cause).
b If the subject also has ≥2xULN ALP, the possibility of an indication of biliary obstruction should be discussed with the Medical Monitor.
c Details provided in Section 12.2.1.1. The local hepatologist is the expert usually consulted by the treating physician for assessment and management of 
potential hepatic disease. This would usually be a hepatologist, but may be a gastroenterologist.
d Unless an alternative monitoring schedule is agreed by the Investigator and UCB responsible physician. Determination of stabilization is at the discretion of 
the Investigator in consultation with the hepatologist (as applicable) and UCB responsible physician, as needed.
e Details provided in Section 12.2.1.2.1
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 203 of 263
Change #26
Section 12.2.1.2.1 IMP restart/rechallenge:
Rechallenge with IMP can occur only if ALL of the following requirements are met:
x
The results of additional testing and monitoring described in Section 12.2.1.3 and 
Section 12.2.1.1 confirm a nondrug-related cause for the abnormal hepatic laboratory 
parameters and any associated symptoms (ie, a subsequent alternative diagnosis fully 
explains the hepatic findings).
x
The subject has shown clear therapeutic benefit from the IMP.
x
Subject’s ALT or AST elevations do not exceed ≥5xULN.
x
Subject’s total bilirubin is <2xULN.
x
Subject has no signs or symptoms of hypersensitivity or hepatitis.
x
The rechallenge is approved by the UCB responsible physician, DMC, and a hepatologist. 
x
Subject agrees to the Investigator-recommended monitoring plan.
Has been changed to:
Subjects who are immediately discontinued from IMP due to having met certain criteria 
for PDILI (as described in Section 6.4.1 and Table 12-3), but for whom an alternative 
diagnosis is confirmed, ie, drug-induced liver injury is excluded, can rarely restart IMP.
Rechallenge with IMP can occur only if ALL of the following requirements are met at the time 
of the rechallenge:
x
The results of additional testing and monitoring described in Section 12.2.1.3 and 
Section 12.2.1.4 confirm a nondrug-related cause for the abnormal hepatic laboratory 
parameters and any associated symptoms (ie, a subsequent alternative diagnosis fully 
explains the hepatic findings).
x
The subject has shown clear therapeutic benefit from the IMP.
x
Subject’s ALT or AST elevations do not exceed ≥5xULN.
x
Subject’s total bilirubin is <2xULN.
x
Subject has no signs or symptoms of hypersensitivity or hepatitis.
x
TheDuring the double-blind Treatment Period, the rechallenge is approved by the UCB 
responsible physician, DMC, and a hepatologist.
x
During the OLE Period, the rechallenge is approved by the UCB responsible physician.
x
Subject agrees to the Investigator-recommended monitoring plan.
Change #27
Section 12.4.4 Data Monitoring and Adjudication Committees
The DMC membership includes experienced clinicians and a statistician, all of whom have 
expertise in clinical trials. Cardiovascular and Neuropsychiatric Adjudication Committees will 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 204 of 263
also periodically review data from this trial. Both Data Monitoring and Adjudication Committee 
members may not participate in the study as principal or co-Investigators, or as study subject 
care physicians. The duration of membership for the committees will be inclusive of planned 
analyses for PS0015. Detailed role, scope, responsibilities, and complete procedures, as well as 
the identity of members, are described in the separate committee charters.
Has been changed to:
The DMC membership includes experienced clinicians and a statistician, all of whom have 
expertise in clinical trials. Cardiovascular and Neuropsychiatric Adjudication Committees will 
also periodically review data from this trial. Both Data Monitoring and Adjudication Committee 
members may not participate in the study as principal or co-Investigators, or as study subject 
care physicians. The duration of membership for the committees will be inclusive of planned 
analysesdata through the last subject completing the Week 48 Visit for PS0015. Detailed
role, scope, responsibilities, and complete procedures, as well as the identity of members, are 
described in the separate committee charters.
Change #28
Section 14.1 Definition of analysis sets:
The following text has been added:
The Open-label Set (OLS) will consist of all subjects that receive at least 1 dose of IMP at 
Week 48 or later in the OLE Period (including the Week 48 dose).
Change #29
Section 14.2 General statistical considerations, second and fifth paragraphs and title of 
figure 14-1:
The statistical analysis of the primary efficacy variable and secondary efficacy variables will 
account for multiplicity and control the familywise Type I error rate at a 2-sided alpha level of 
0.05 by using a fixed sequence testing procedure. 
The hypotheses associated with the subsequent tests are for secondary efficacy endpoints and are 
based on testing for superiority relative to secukinumab. Figure 14-1 presents the details on this 
procedure.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 205 of 263
Figure 14 1: Hypotheses testing of secondary efficacy endpoints
BKZ=bimekizumab; PASI=Psoriasis Area Severity Index; Q4W=every 4 weeks; Q8W=every 8 weeks
Note: Tests for H1, H2, H3, and H4 are based on all subjects initially randomized to bimekizumab compared to 
secukinumab. For H5 and H6, testing is based on the subjects re-randomized at Week 16 to bimekizumab 320mg 
Q4W, and bimekizumab 320mg Q8W, respectively, compared to secukinumab.
Has been changed to:
The statistical analysis of the primary efficacy variable and selected secondary efficacy variables 
will account for multiplicity and control the familywise Type I error rate at a 2-sided alpha level 
of 0.05 by using a fixed sequence testing procedure. 
The hypotheses associated with the subsequent tests are for selected secondary efficacy 
endpoints and are based on testing for superiority relative to secukinumab. Figure 14-1 presents 
the details on this procedure.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 206 of 263
Figure 14 1: HypothesesHypothesis testing of secondary efficacy endpoints
BKZ=bimekizumab; PASI=Psoriasis Area Severity Index; Q4W=every 4 weeks; Q8W=every 8 weeks
Note: Tests for H1, H2, H3, and H4 are based on all subjects initially randomized to bimekizumab compared to 
secukinumab. For H5 and H6, testing is based on the subjects re-randomized at Week 16 to bimekizumab 320mg 
Q4W, and bimekizumab 320mg Q8W, respectively, compared to secukinumab.
Change #30
Section 14.3.2.2 Analysis of the other efficacy variables, third paragraph through end of 
section:
In general, data will be summarized by visit through Week 48. All summaries of data up to Week 
16 will be based on the RS for the 2 randomized treatment groups (bimekizumab and 
secukinumab). For visits after Week 16, by-visit summaries will be prepared for the following 3 
groups of subjects:
4. Subjects in the MS summarized by the 3 maintenance treatment groups (bimekizumab 
320mg Q4W, bimekizumab 320mg Q8W, and secukinumab). Note that while the MS is 
primarily defined for the evaluation of data after Week 16, these summary tables will include 
data at all visits (Baseline to Week 48) to provide a comprehensive summary of subjects by 
maintenance treatment group for the MS.
5. A subset of Group 1 above. Specifically, this will include only those subjects who are 
responders at Week 16 for the variable being summarized. This will provide an assessment of 
how efficacy is maintained among Week 16 responders.
6. Subjects in the RS summarized by the 2 randomized treatment groups (bimekizumab and 
secukinumab). Data from Baseline to Week 48 will be included in these tables. This provides
an intent-to-treat analysis among all randomized subjects in the study through Week 48.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 207 of 263
All efficacy variables will be summarized in the manner described for Group 1 above. 
Summaries for Groups 2 and 3 will be done only for a subset of efficacy variables, namely, 
PASI75/90/100, IGA Clear or Almost Clear, Scalp IGA Clear or Almost Clear, pp-IGA Clear or 
Almost Clear, mNAPSI75/90/100, and DLQI 0/1. Further details on these analyses will be 
provided in the SAP.
Has been changed to:
In general, data will be summarized by visit through Week 48 in the double-blind Treatment 
Period and then by visit in the OLE Period separately. All summaries of data up to Week 16 
will be based on the RS for the 2 randomized treatment groups (bimekizumab and secukinumab). 
For visits after Week 16 in the double-blind Treatment Period, by-visit summaries will be 
prepared for the following 3 groups of subjects:
7. Subjects in the MS summarized by the 3 maintenance treatment groups (bimekizumab 
320mg Q4W, bimekizumab 320mg Q8W, and secukinumab). Note that while the MS is 
primarily defined for the evaluation of data after Week 16, these summary tables will include 
data at all visits (Baseline to Week 48) to provide a comprehensive summary of subjects by 
maintenance treatment group for the MS.
8. A subset of Group 1 above. Specifically, this will include only those subjects who are 
responders at Week 16 for the variable being summarized. This will provide an assessment of 
how efficacy is maintained among Week 16 responders.
9. Subjects in the RS summarized by the 2 randomized treatment groups (bimekizumab and 
secukinumab). Data from Baseline to Week 48 will be included in these tables. This provides 
an intent-to-treat analysis among all randomized subjects in the study through Week 48.
All efficacy variables in the double-blind Treatment Period will be summarized in the manner 
described for Group 1 and 3 above. Summaries for Groups 2 and 3 will be done only for a 
subset of efficacy variables, namely, PASI75/90/100, IGA Clear or Almost Clear, Scalp IGA 
Clear or Almost Clear, pp-IGA Clear or Almost Clear, mNAPSI75/90/100, and DLQI 0/1.
In the OLE treatment period, efficacy variables of interest generally will be summarized 
descriptively by the combined treatment regimen in the double-blind treatment period and 
re-randomized treatment in the OLE,
In general, efficacy variables will be summarized using descriptive statistics by treatment 
group and scheduled visit during the OLE Period based on Baseline at beginning of the 
study unless otherwise specified. 
Further details on thesethe above analyses including analysis in the OLE Period will be 
provided in the SAP.
Change #31
Section 14.4 Subgroup analyses:
Subgroup analyses will be performed on the primary and secondary efficacy variables that are 
part of the fixed sequence testing procedure described in Section 14.2. The following variables 
for subgroup analyses will be defined: age, gender, disease duration, region, weight, body mass 
index, prior systemic chemotherapy or phototherapy, prior biologic exposure, prior systemic 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 208 of 263
therapy of any kind, Baseline disease severity, and antibody positivity. These summaries will be 
based on imputed data (NRI) and will include descriptive statistics only.
Has been changed to:
Subgroup analyses will be performed on the primary and secondary efficacy variables that are 
part of the fixed sequence testing procedure described in Section 14.2. The following variables 
for subgroup analyses will be defined: age, gender, disease duration, region, weight, body mass 
index, prior systemic chemotherapy or phototherapy, prior biologic exposure, prior primary 
failure to biologics, prior systemic therapy of any kind, Baseline disease severity, and antibody 
positivity. These summaries will be based on imputed data (NRI) and will include descriptive 
statistics only.
Change #32
Section 14.5.1 Safety analyses, first paragraph:
Safety variables will be analyzed for all subjects in the SS. This will include all subjects who 
took at least one dose of study medication. Adverse events will be coded according to the 
Medical Dictionary for Regulatory Activities. Adverse events will be summarized descriptively 
by treatment group, primary system organ class, High Level Term (HLT), and PT. Additional 
tables will summarize AEs by intensity and relationship to IMP, AEs leading to withdrawal from 
the study, SAEs, and deaths. Safety topics of interest will be summarized and will be described 
in greater detail in the SAP. 
Has been changed to:
Safety variables will be analyzed for all subjects in the SS. This will include all subjects who 
took at least one dose of study medication. Selected analyses will also be presented for MS 
and OLS. Adverse events will be coded according to the Medical Dictionary for Regulatory 
Activities. Adverse events will be summarized descriptively by treatment group, primary system 
organ class, High Level Term (HLT), and PT. Additional tables will summarize AEs by intensity 
and relationship to IMP, AEs leading to withdrawal from the study, SAEs, and deaths. Safety 
topics of interest will be summarized and will be described in greater detail in the SAP. 
Change #33
Section 14.8 Planned interim analysis:
After the final Week 48 Visit, an interim analysis will be performed based on all data available at 
that time. Further details related to this interim analysis will be outlined in the SAP. A final 
analysis and final clinical study report will be prepared once all data (through the SFU Visit) 
have been collected.
Has been changed to:
After the final Week 48 Visit, anAn interim analysis will be performed based on all data 
availableis planned at that time. FurtherWeek 48, details related to this interim analysisof 
which will be outlineddocumented in the SAP. Additional interim analyses may be 
performed (details of which will be documented in the SAP). Corresponding interim 
Clinical Study Reports (CSRs) may be written. A final analysis and updated final clinical 
study reportCSR will be prepared once all data (through the SFU Visitvisit and including the 
OLE Period) have been collected.
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UCB
01 Oct 2021
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Bimekizumab
PS0015
Confidential
Page 209 of 263
18.4
Protocol Amendment 3
This was a global amendment. The changes are detailed below in Amendment 3.1.
18.5
Protocol Amendment 3.1
Rationale for the amendment
The protocol has been amended for the following reasons:
x
Moved subject self-injection training into the start of the OLE Period at Week 48.
x
Added the description of the Patient Global Assessment of PSO, which was inadvertently 
deleted in global Protocol Amendment #2, back into Section 9.
x
Updated the name and contact information of the Clinical Trial Biostatistician.
Global changes:
Minor spelling, editorial, and formatting changes were made throughout the document.
Specific changes:
Change #1
Clinical Trial Biostatistician
Name:
Address:
UCB Biosciences
8010 Arco Corporate Drive, Raleigh, NC 27617, USA
Phone:
Fax:
Has been changed to: 
Name:
Address:
UCB
208 Bath Road, Slough, SL1 3WE, UK
Phone:
Fax:
Change #2
Table 5‒2:
Schedule of study assessments, OLE Period
Table Footnote “n”
n
From Week 48 through Week 72, the dosing window is ±7 days relative to the scheduled 
dosing visit. From Week 76 through the Week 144/PEOT visit, the dosing window is ±14 
days relative to the scheduled dosing visit.
Has been changed to:
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 210 of 263
n
From Week 48 through Week 72, the dosing window is ±7 days relative to the scheduled 
dosing visit. From Week 76 through the Week 140 Visit, the dosing window is ±14 days 
relative to the scheduled dosing visit. 
Change #3
Section 7.2
Treatments to be administered, paragraph 5
During the OLE Period, IMP administration on weeks with no scheduled clinic visit should 
primarily be performed by subjects at home. Self-injection training will be provided to the 
subject/caregiver by qualified site personnel at Week 40 and Week 44. At Week 48 and 
subsequent clinic visits, the subject/caregiver will perform self-administration under the 
supervision of the site staff to ensure that study medication is being properly and safely injected. 
Has been changed to:
During the OLE Period, IMP administration on weeks with no scheduled clinic visit should 
primarily be performed by subjects at home. Self-injection training will be provided to the 
subject/caregiver by qualified site personnel at Week 40 and Week 44 Week 48. Additional 
training may be provided by site staff at subsequent clinic visits as needed. At Week 48 and 
subsequent clinic visits, the subject/caregiver will perform self-administration under the 
supervision of the site staff to ensure that study medication is being properly and safely injected. 
Change #4
Section 7.5
Handling and storage requirements; paragraph 6
In addition, the Investigator (or designee) will instruct the subject on how to handle the IMP 
during transport, and how to store the IMP following the instruction guide. Cooler bags with 
freezer packs will be provided to the subjects. Specific attention will be put on the transport from 
site to home using cold bags, and the subject will be instructed to put the IMP as quickly as 
possible into his/her refrigerator. In case of broken refrigerator, or broken or lost syringes, the 
subject will inform the site immediately and new IMP will be supplied. All efforts should be 
made to follow the treatment scheme as per protocol.
Has been changed to:
In addition, the Investigator (or designee) will instruct the subject/caregiver on how to handle 
the IMP during transport, and how to store the IMP following the instruction guide. Cooler bags 
with freezer packs will be provided to the subjects/caregivers. Specific attention will be put on 
the transport from site to home using cold bags, and the subject/caregiver will be instructed to 
put the IMP as quickly as possible into his/her refrigerator. In case of broken refrigerator, or 
broken or lost syringes, the subject will inform the site immediately and new IMP will be 
supplied. All efforts should be made to follow the treatment scheme as per protocol.
Change #5
Section 7.8.1.1
Topical medications; paragraph 3
In the OLE Period, the medications listed as permitted for the double-blind Treatment Period 
will be allowed. In addition, topical steroids and vitamin D analog ointment will be permitted for 
use, as needed. 
Has been changed to:
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 211 of 263
In the OLE Period, the medications listed as permitted for the double-blind Treatment Period 
will be allowed. In addition, any topical steroids and vitamin D analog ointment will be 
permitted for use, as needed. These topical medications should not be used within 
approximately 24 hours prior to study visits requiring IGA and PASI measures.
Change #6
Section 7.9
Blinding; paragraphs 4-7
During the double-blind Treatment Period of the study, the Sponsor will provide blinded and 
unblinded site monitors for the purposes of verifying safety, efficacy, and drug administration 
and documentation records. Unblinded study site personnel need to be available in order to 
resolve queries. Study monitors and study site personnel, blinded to treatment assignment, will 
not discuss or have access to any drug related information.
Study sites will be required to have a written blinding plan in place, signed by the Principal 
Investigator, which will detail the site’s steps for ensuring that the double-blind nature of the 
study is maintained. Sites will be instructed to keep study subjects blind to the IMP as detailed in 
the site blinding plan.
Further details are provided in the study manual and site blinding plan.
For subjects participating in the OLE Period, there will be no blinding and the blinding 
procedures described above will no longer apply.
Has been changed to:
During the double-blind Treatment Period of the study, the Sponsor will provide blinded and 
unblinded site monitors for the purposes of verifying safety, efficacy, and drug administration 
and documentation records. Unblinded study site personnel need to be available in order to 
resolve queries. Study monitors and study site personnel, blinded to treatment assignment, will 
not discuss or have access to any drug related information. This will continue at least until all 
subjects have completed the double-blind Treatment Period of the study.
During the double-blind Treatment Period of the study, the Sponsor will provide blinded and 
unblinded site monitors for the purposes of verifying safety, efficacy, and drug administration 
and documentation records. Unblinded study site personnel need to be available in order to 
resolve queries. Study monitors and study site personnel, blinded to treatment assignment, will 
not discuss or have access to any drug related information.
Study sites will be required to have a written blinding plan in place, signed by the Principal 
Investigator, which will detail the site’s steps for ensuring that the double-blind nature of the 
study is maintained. Sites will be instructed to keep study subjects blind to the IMP as detailed in 
the site blinding plan.
Further details are provided in the study manual and site blinding plan.
For subjects participating in the OLE Period, there will be no blinding and the blinding 
procedures described above will no longer apply.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 212 of 263
Change #7
Section 8 STUDY PROCEDURES BY VISIT; paragraph 1, second bullet
x
The dosing window from Baseline through Week 4 is ±2 days relative to the scheduled 
dosing visit. From Week 8 through Week 24, the dosing window is ±3 days relative to the 
scheduled dosing visit. From Week 28 through the Week 72 Visit, the dosing window is 
±7 days relative to the scheduled dosing visit. From the Week 76 Visit through the 
Week 144/PEOT, the dosing window is ±14 days relative to the scheduled dosing visit.
Has been changed to:
x
The dosing window from Baseline through Week 4 is ±2 days relative to the scheduled 
dosing visit. From Week 8 through Week 24, the dosing window is ±3 days relative to the 
scheduled dosing visit. From Week 28 through the Week 72 Visit, the dosing window is 
±7 days relative to the scheduled dosing visit. From the Week 76 Visit through the Week 140
VisitWeek 144/PEOT, the dosing window is ±14 days relative to the scheduled dosing visit.
Change #8
Section 8.3.1 Week 48 Visit (±7 days relative to Baseline); paragraph 1
The following procedures/assessments will be performed/recorded after completion of 
assessments listed for Week 48 (Section 8.2.13) and prior to administration of IMP:
Has been changed to:
The following procedures/assessments will be performed/recorded after completion of 
assessments listed for Week 48 of the double-blind Treatment Period (Section 8.2.13) and 
prior to administration of IMP:
And the following paragraph regarding subject self-injection was added:
Self-injection training will be provided to the subject/caregiver by qualified site personnel 
to allow self-injection to be performed at home after Week 48. Additional training may be 
provided by site staff at subsequent clinic visits as needed (see Section 7.2).
Change #9
Section 8.3.5 Week 64, Week 84, Week 108, Week 132 Visits (±14 days relative to Baseline)
Has been changed to:
Section 8.3.5 Week 64 (±7 days relative to Baseline), Week 84, Week 108, Week 132 Visits 
(±14 days relative to Baseline)
Change #10
Section 8.3.6 Week 72 and Week 120 Visits (±14 days relative to Baseline)
Has been changed to:
Section 8.3.6 Week 72 (±7 days relative to Baseline) and Week 120 Visits (±14 days relative 
to Baseline)
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 213 of 263
Change #11
The following subsection was inadvertently deleted from global Protocol Amendment #2. 
The subsection has been added back and subsequent subsections were renumbered.
Section 9.9
Patient Global Assessment of psoriasis
The Patient Global Assessment of PSO is a PSO-specific item in which the patient responds 
to the multiple-choice question, “How severe are your psoriasis-related symptoms right 
now?” Possible responses to the question are “no symptoms,” “mild symptoms,” “moderate 
symptoms,” “severe symptoms,” or “very severe symptoms.”
The Patient Global Assessment of psoriasis will be performed at the visits specified 
Table 5‒1.
Change #12
Section 15.1
Informed consent
The following sentence was added:
All subjects enrolling in the OLE Period will sign a new ICF.
18.6
Protocol Amendment 4
Rationale for the amendment
The protocol has been amended for the following reasons:
x
Change the sponsor company name from “UCB Biopharma SPRL” to “UCB Biopharma 
SRL” since the name of the legal form of the entity UCB Biopharma has changed into 
“société à responsabilité limitée” abbreviated “SRL”.
x
Update the name and contact information for the Study Physician.
x
Update withdrawal criterion to be valid through the entire study, not just up to Week 48.
x
Moved the PHQ-9 variable from an other efficacy variable to an other safety variable
x
Moved the PHQ-9 description from the assessment of efficacy section to the assessment of 
safety section
x
Clarify duration of monitoring for the DMC and the Cardiovascular and Neuropsychiatric 
Adjudication Committee.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 214 of 263
Specific changes:
Change #1
Change #1
Sponsor name on the cover page 
Sponsor
UCB Biopharma SPRL
Allée de la Recherche 60
1070 Brussels
BELGIUM
Has been changed to:
Sponsor
UCB Biopharma SRL
Allée de la Recherche 60
1070 Brussels
BELGIUM
Change #2
Sponsor name on the title page in the study contact information
Sponsor
UCB Biopharma SPRL
Allée de la Recherche 60
1070 Brussels BELGIUM
Has been changed to:
Sponsor
UCB Biopharma SRL
Allée de la Recherche 60
1070 Brussels BELGIUM
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or variations thereof. 


UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 215 of 263
Change #3
Study Physician
Name:
Address:
UCB Biosciences
8010 Arco Corporation Drive
Raleigh, NC 27617
USA
Phone:
Fax:
Has been changed to: 
Name:
Address:
UCB Biopharma SRL
Chemin du Foriest
B-1420 Braine-l’Alleud
Belgium
Phone:
Fax:
Change #4
Section 4.3.1 Other efficacy variables
The following bullet has been deleted
x
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) scores
Change #5
Section 4.3.2 Other safety variables
The following bullet has been added:
x
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) scores
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 216 of 263
Change #6
Section 6.4
Withdrawal criteria
8a. At Week 28 and all following visits up to Week 48, subjects on continuous treatment for at 
least 12 weeks with a persistent IGA score ≥3 over at least a 4-week period are defined as 
nonresponders and should discontinue IMP. 
Has been changed to:
8b. At Week 28 and all following visits, subjects on continuous treatment for at least 12 weeks 
with a persistent IGA score ≥3 over at least a 4-week period are defined as nonresponders 
and should discontinue IMP. 
Change #7
Section 9.4
Patient Health Questionnaire-9
This subsection has been moved to Section 12.3.8
Change #8
Section 12.3.8 – Patient Health Questionnaire-9
A new subsection has been added (moved from Section 9.4):
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and 
measuring the severity of depression (Kroenke et al, 2001). The PHQ-9 scores for 
depression range from 0 to 27, with higher scores indicating worse state. A score of 5 to 9 is 
considered to be minimal symptoms of depression. A score of 10 to 14 is considered minor 
depression, dysthymia, or mild major depression. A score of 15 to 19 is considered to 
indicate moderately severe major depression, and a score ≥20 is considered to be severe 
major depression.
The PHQ-9 will be assessed at the visits specified in Table 5-1 and Table 5-2.
Refer Section 6.4 for PHQ-9-related withdrawal criteria.
Change #9
Section 12.4.4
Data Monitoring and Adjudication Committees
The DMC membership includes experienced clinicians and a statistician, all of whom have 
expertise in clinical trials. Cardiovascular and Neuropsychiatric Adjudication Committees will 
also periodically review data from this trial. Both Data Monitoring and Adjudication Committee 
members may not participate in the study as principal or co-Investigators, or as study subject 
care physicians. The duration of membership for the committees will be inclusive of data 
through the last subject completing the Week 48 Visit for PS0015. Detailed role, scope, 
responsibilities, and complete procedures, as well as the identity of members, are described in 
the separate committee charters.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 217 of 263
Has been changed to:
The DMC membership includes experienced clinicians and a statistician, all of whom have 
expertise in clinical trials. Cardiovascular and Neuropsychiatric Adjudication Committees will 
also periodically review data from this trial. Both Data Monitoring and Adjudication Committee 
members may not participate in the study as principal or co-Investigators, or as study subject 
care physicians. The DMC will monitor the study through the last subject completing the 
Week 48 and SFU visit (for subjects not participating in the OLE period). The 
Cardiovascular and Neuropsychiatric Adjudication Committees will monitor the study 
through the last subject completing the OLE and SFU Periods for PS0015. Detailed role, 
scope, responsibilities, and complete procedures, as well as the identity of members, are 
described in the separate committee charters.
18.7
Protocol Amendment 5
This was a global amendment. The changes are detailed below in Amendment 5.1.
18.8
Protocol Amendment 5.1
Rationale for the amendment
Change the dose regimen at Week 64 (or at the next scheduled clinic visit after implementation 
of Protocol Amendment #5.1 if the subject has already completed the Week 64 visit) from 
bimekizumab 320mg Q4W to bimekizumab 320mg Q8W, based on pooled data from the Phase 3 
studies (PS0008, PS0009, and PS0013), which demonstrated that during the maintenance period 
bimekizumab 320mg Q8W provided essentially the same efficacy as bimekizumab 320mg Q4W.
Add pregnancy tests every 4 weeks during the OLE Period.
Corrected the visit window for the Week 24 visit from 7 days to 3 days.
Added provision for collecting a concurrent sample for central laboratory testing if laboratory 
tests are performed locally.
In addition, minor corrections, including typographical/grammatical errors, have been made.
Modifications and changes
Global changes
No global changes have been made.
Specific changes
Change #1
Section 1, Summary; Section 5.2.3, OLE Period; Section 7.10, Randomization and 
numbering of subjects 
At Week 96, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
subject’s dosing interval will change from 320mg Q4W to 320mg Q8W (default), unless, based 
on medical judgment, the Investigator decides differently.
Has been changed to:
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 218 of 263
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 64 or at the next scheduled clinic visit after 
implementation of Protocol Amendment #5.1 if the subject has already completed Week 64.
Change #2
Section 5.6, Schedule of study assessments
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof. 


UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 219 of 263
Table 5-2:
Schedule of study assessments, OLE Period
Visita/
Week
Protocol activity
48 (1st OLE dose)
Year 2
Year 3
SFUb
52
56
60
64
68
72
76
80
84
88
92
96
100
104
108
112
116
120
124
128
132
136
140
144/PEOT
C
C
C
H
C
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
H
C
C
Pregnancy testing (urine)g
X
X
X
X
X
X
X
X
X
X
X
IMP administration – Q4W n, o
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
IMP administration – Q8W n, o
X
X
X
X
X
X
X
X
X
X
X
X
g Pregnancy testing will consist of urine pregnancy testing at all visits. 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 220 of 263
Has been changed to:
Table 5-2:
Schedule of study assessments, OLE Period
Visita/
Week
Protocol activity
48 (1st OLE dose)
Year 2
Year 3
SFUb
52
56
60
64
68
72
76
80
84
88
92
96
100
104
108
112
116
120
124
128
132
136
140
144/PEOT
C
C
C
H
C
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
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C
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Pregnancy testing (urine)g
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
IMP administration – Q4W n, o, p
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
IMP administration – Q8W n, o
X
X
X
X
X
X
X
X
X
X
X
X
g Pregnancy testing will consist of urine pregnancy testing at all visits. Home pregnancy test kits will be provided to participants for use between clinic
visits.
p Q4W IMP administration only applies to those subjects who have not yet changed to Q8W at Week 64, or at the next scheduled clinic visit (ie, Week 
72, Week 84, Week 96, Week 108, Week 120, or Week 132) if the subject has already completed the Week 64 visit after implementation of 
Protocol Amendment #5.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 221 of 263
Change #3
Section 5.7, Schematic diagram
Figure 5-2:
Schematic diagram, OLE Period (Week 48 through Week 144)
1:1 re-
randomization
≥PASI90
<PASI90
≥PASI90
20 weeks 
after last 
dose
Week 48
Open-label extension period
Safety follow-up 
visit 20 weeks 
after last dose
52
84
Week
60
68
76
92
100
108
116
124
132
140
56
88
64
72
80
96
104
112
120
128
136
144
Bimekizumab 320mg Q4W
Bimekizumab 320mg Q8W
Secukinumab
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Bimekizumab 
320mg Q4W
Bimekizumab 
320mg Q8W
Secukinumab
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Bimekizumab 
320mg Q4W
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Q4W
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PASI=Psoriasis Area Severity Index; PASI90=90% improvement in the PASI score; Q4W=every 4 weeks; 
Q8W=every 8 weeks
*At Week 96, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the subject’s dosing interval 
will change from 320mg Q4W to 320mg Q8W (default), unless, based on medical judgment, the Investigator 
decides differently.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 222 of 263
Has been changed to:
Figure 5-2:
Schematic diagram, OLE Period (Week 48 through Week 144)
PASI=Psoriasis Area Severity Index; PASI90=90% improvement in the PASI score; Q4W=every 4 weeks; 
Q8W=every 8 weeks
Note: The subject’s dosing interval will change from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W 
at Week 64, or at the next scheduled clinic visit (ie, Week 72, Week 84, Week 96, Week 108, Week 120, or 
Week 132) if the subject has already completed the Week 64 visit prior to implementation of 
Protocol Amendment #5.1.
Change #4
Section 5.8.2, Dose selection
Therefore, a bimekizumab dose of 320mg Q4W through Week 16 and 320mg Q4W or Q8W 
thereafter was selected for this study.
Has been changed to:
Therefore, a bimekizumab dose of 320mg Q4W through Week 16 was selected for this study.
Based on pooled data from the Phase 3 studies (PS0008, PS0009, and PS0013), during the 
maintenance period bimekizumab 320mg Q8W provided efficacy results similar to 
bimekizumab 320mg Q4W. Therefore, at Week 64, subjects receiving 
bimekizumab 320mg Q4W will switch to receive bimekizumab 320mg Q8W. Subjects who 
are receiving bimekizumab 320mg Q4W treatment who already completed the Week 64 
visit at the time of implementation of Protocol Amendment #5.1 will be switched to 
bimekizumab 320mg Q8W at the next scheduled clinic visit. This change in dosing interval 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 223 of 263
will reduce subject and site burden, while allowing collection of more long-term safety data 
on the bimekizumab 320mg Q8W dosing regimen.
Change #5
Section 7.2, Treatments to be administered
The following text has been added:
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 64 or at the next scheduled clinic visit after 
implementation of Protocol Amendment #5.1 if the subject has already completed the 
Week 64 visit. 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 224 of 263
The following table:
Table 7-2:
Dosing scheme, OLE Period
Week
Dose 
Assignment
48 (1st 
OLE 
Year 2
Year 3
52
56
60
64
68
72
76
80
84
88
92
96
100
104
108
112
116
120
124
128
132
136
140
Bimekizumab 
320mg Q4W
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
Bimekizumab 
320mg Q8W
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
OLE=Open-Label Extension; Q4W=every 4 weeks; Q8W=every 8 weeks
Notes: A bimekizumab 160mg injection is depicted by a black circle (●).
Has been changed to:
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 225 of 263
Table 7-2:
Dosing scheme, OLE Period
Week
Dose 
Assignment
48 (1st 
OLE) 
Year 2
Year 3
52
56
60
64a,b
68
72a,b
76
80
84a,c
88
92
96a,b
100
104
108a,c
112
116
120a,b
124
128
132a,c
136
140
C
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H
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H
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H
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Bimekizumab 
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●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
Bimekizumab 
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●●
●●
●●
●●
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●●
●●
●●
●●
●●
●●
●●
C=clinic; H=home; OLE=Open-Label Extension; Q4W=every 4 weeks; Q8W=every 8 weeks
Notes: A bimekizumab 160mg injection is depicted by a black circle (●).
a The subject’s dosing interval will change from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W at Week 64 or at the next scheduled clinic 
visit (ie, Week 72, Week 84, Week 96, Week 108, Week 120, or Week 132) after implementation of Protocol Amendment #5.1 if the subject has 
already completed the Week 64 visit.
b Subjects whose dosing interval is changed to bimekizumab 320mg Q8W should be dosed at this visit and will receive kits for home administration 8 
weeks later.
c Subjects whose dosing interval is changed to bimekizumab 320mg Q8W should NOT be dosed at this visit and will receive kits for home 
administration 4 weeks later.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 226 of 263
Change #6
Section 7.9, Blinding
The following text has been added:
After all subjects have completed the double-blind Treatment Period of the study and the 
interim analysis has occurred, unblinded study site personnel can perform assessments in 
the OLE Period of the study.
Change #7
Section 8.2.8, Week 24 Visit (±7 days relative to Baseline)
Has been changed to:
Section 8.2.8, Week 24 Visit (±3 days relative to Baseline)
Change #8
Section 8.3.4, Self-injection at home (Weeks 60, 68, 76, 80, 88, 92, 100, 104, 112, 116, 124, 
128, 136 and 140)
Subjects receiving bimekizumab 320mg Q4W will be given the opportunity for self-injection of 
bimekizumab at home on the following weeks: Weeks 60, 68, 76, 80, 88, 92, 100, 104, 112, 116, 
124, 128, 136 and 140.
Subjects receiving bimekizumab 320mg Q8W will be given the opportunity for self-injection of
bimekizumab at home on the following weeks: Weeks 80, 88, 104, 112, 128, and 136.
Has been changed to:
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 64 or at the next scheduled clinic visit (ie, Week 72, 
Week 84, Week 96, Week 108, Week 120, or Week 132) after implementation of 
Protocol Amendment #5.1 if the subject has already completed the Week 64 visit. 
Subjects receiving bimekizumab 320mg Q4W will be given the opportunity for self-injection of 
bimekizumab at home on the following weeks: Weeks 60, 68, 76, 80, 88, 92, 100, 104, 112, 116, 
124, 128, 136, and 140. This only applies to those subjects who have not yet changed to 
bimekizumab 320mg Q8W.
Subjects receiving bimekizumab 320mg Q8W will be given the opportunity for self-injection of
bimekizumab at home on the following weeks: Weeks 80, 88, 104, 112, 128, and 136.
Subjects of childbearing potential should conduct a home pregnancy test every 4 weeks. In 
case of a scheduled home self-injection the pregnancy test needs to be performed 
immediately prior to self-injecting bimekizumab at home. If the pregnancy test result is 
positive, IMP should not be administered and the site should be contacted.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 227 of 263
Change #9
Section 8.3.5, Week 64 (±7 days relative to Baseline), Week 84, Week 108, Week 132 Visits 
(±14 days relative to Baseline)
The following procedures/assessments will be performed/recorded prior to administration of 
IMP:
Has been changed to:
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W as follows:
x
At Week 64 if the subject has not completed the Week 64 visit prior to implementation 
of Protocol Amendment #5.1.
x
At Week 84 if the subject has already completed the Week 72 visit prior to 
implementation of Protocol Amendment #5.1.
x
At Week 108 if the subject has already completed the Week 96 visit prior to 
implementation of Protocol Amendment #.15.
x
At Week 132 if the subject has already completed the Week 120 visit prior to 
implementation of Protocol Amendment #5.1.
Subjects whose dosing interval is being changed to bimekizumab 320mg Q8W will receive 
kits for home administration as follows:
x
Subjects whose dosing interval is being changed to bimekizumab 320mg Q8W at Week 
64 should be dosed at this visit, and will receive kits for home administration 8 weeks 
later (Table 7-2).
x
Subjects whose dosing interval is being changed to bimekizumab 320mg Q8W at 
Week 84, Week 108, or Week 132 should NOT be dosed at that visit, and will receive 
kits for home administration 4 weeks later (Table 7-2).
The following procedures/assessments will be performed/recorded. If IMP is administered on 
site during this visit, they need to be performed/recorded prior to administration of IMP:
Change #10
Section 8.3.5, Week 64 (±7 days relative to Baseline), Week 84, Week 108, Week 132 Visits
(±14 days relative to Baseline)
After completion of the above-mentioned procedures, administration of IMP will occur
x
at each of these visits for subjects on bimekizumab 320mg Q4W dosing, preferably by self-
injection under supervision of the site personnel
x
at Week 64 for subjects on bimekizumab 320mg Q8W dosing, preferably by self-injection 
under supervision of the site personnel.
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 228 of 263
x
Has been changed to:
After completion of the above-mentioned procedures, administration of IMP will occur:
x
At each of these visits for subjects on bimekizumab 320mg Q4W dosing, preferably by 
self-injection under supervision of the site personnel. This only applies to those subjects 
who have not yet changed to Q8W after implementation of Protocol Amendment #5.
x
At Week 64 only for those subjects on bimekizumab 320mg Q8W dosing, preferably by 
self-injection under supervision of the site personnel.
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. Home pregnancy tests will be provided 
for testing every 4 weeks as appropriate (Table 5‒2).
Change #11
Section 8.3.6, Week 72 (±7 days relative to Baseline) and Week 120 Visits (±14 days relative 
to Baseline)
The following text has been added:
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W as follows:
x
At Week 72 if the subject has already completed the Week 64 visit prior to 
implementation of Protocol Amendment #5.1.
x
At Week 120 if the subject has already completed the Week 108 visit prior to 
implementation of Protocol Amendment #5.1.
As depicted in Table 7-2, subjects whose dosing interval is being changed to 
bimekizumab 320mg Q8W at one of these visits should be dosed at this visit and will 
receive kits for home administration 8 weeks later.
Change #12
Section 8.3.6, Week 72 (±7 days relative to Baseline) and Week 120 Visits (±14 days relative 
to Baseline)
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7.
Has been changed to:
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. Home pregnancy tests will be provided 
for testing every 4 weeks as appropriate (Table 5‒2).
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 229 of 263
Section 8.3.7, Week 96 Visit (±14 days relative to Baseline) 
The following text has been added:
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 96 if the subject has already completed the Week 84 
visit prior to implementation of Protocol Amendment #5.1. As depicted in Table 7-2,
subjects whose dosing interval is being changed to bimekizumab 320mg Q8W at Week 96
should be dosed at this visit, and will receive kits for home administration 8 weeks later.
Change #13
Section 8.3.7, Week 96 Visit (±14 days relative to Baseline) 
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7.
Has been changed to:
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. Home pregnancy tests will be provided 
for testing every 4 weeks as appropriate (Table 5‒2).
Change #14
Section 12.2, Laboratory measurements 
Clinical laboratory assessments consist of serum chemistry, hematology, and urinalysis. A 
centralized laboratory will be used to supply all laboratory test supplies and analyze all blood 
and urine samples for hematology, biochemistry, and urinalysis measurements. Any unscheduled 
laboratory testing should also be collected using the central laboratory. 
Has been changed to: 
Clinical laboratory assessments consist of serum chemistry, hematology, and urinalysis. A 
centralized laboratory will be used to supply all laboratory test supplies and analyze all blood 
and urine samples for hematology, biochemistry, and urinalysis measurements. Any unscheduled 
laboratory testing should also be collected using the central laboratory. If tests are done locally, 
a concurrent sample should also be sent to the central laboratory whenever possible.
Change #15
Section 12.3.2, Pregnancy testing
The following text has been added:
Subjects of child-bearing potential should conduct a home pregnancy test every 4 weeks. 
Home pregnancy tests will be provided to participants for use at Weeks 60, 68, 76, 80, 88, 
92, 100, 104, 112, 116, 124, 128, 136, and 140. At weeks on which IMP dosing is scheduled 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 230 of 263
(specified in Table 5-1 and Table 5-2), a negative urine pregnancy test result should be 
obtained immediately prior to the administration of IMP. In the case of a positive 
pregnancy test result, IMP should not be administered and the site should be contacted.
Change #16
Section 14.7, Handling of dropouts or missing data
Missing data for the secondary efficacy variables (which are all binary) will be imputed using 
NRI. Additionally, the 2 missing data-handling approaches described above for the primary 
efficacy variable will be used for the secondary efficacy variables.
Has been changed to: 
Missing data for the secondary efficacy variables (which are all binary) will be imputed using 
NRI. Additionally, the 2 missing data-handling approaches described above for the primary 
efficacy variable will be used for the secondary efficacy variables. Additional missing data 
handling approaches may be described in the SAP.
18.9
Protocol Amendment 5.4
Rationale for the amendment
The protocol has been amended for the following reasons:
x
To collect additional long-term safety data, 
x
To explore safety data with subjects who have temporarily stopped bimekizumab and could 
have been exposed to other treatments, and 
x
To provide an additional 48-week treatment period for subjects continuing their current 
treatment or reinitiating treatment at the Week 144/OLE2 Baseline Visit.
Modifications and changes
Global changes
The following global changes were made throughout the protocol:
x
An additional 48-week open label treatment period was added (OLE2 Period).
x
The maximum duration of the study has been changed. For the subjects in the OLE2 Period, 
maximum study duration will depend on the time between their participation in the OLE until 
Week 144 and the start of the OLE2 Period; ie, 209 weeks for subjects still being treated in 
the OLE Period and who will directly roll over to the OLE2 Period at Week 144; 225 weeks 
for subjects who have completed Week 144 and the SFU; these subjects will have a 4-week 
Screening Period before reinitiating treatment in the OLE2 Period; Between 209 and 225 
weeks for subjects who have completed Week 144 and are participating the in the SFU (for 
these subjects, the maximum study duration will depend upon when they stop the 20-week 
SFU period to enter the 4-week OLE2 Screening Period).
x
Implementation of a new schedule of assessments (Table 5-3) for the OLE2 Period have been 
made. 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 231 of 263
x
Schematic diagram (Figure 5-3) for the for the 4-year extension have been made
x
A list of inclusion and exclusion criteria has been added for participating in OLE2 Period
x
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treatment to be administered in OLE2 Period. A new dosing scheme from Week 144/OLE2 
Baseline through OLE2 Week 40 has been added (Table 7‒3).
x
Addition of the study procedures by visit has been made for the OLE2 Period (Section 8.4)
Specific changes
Change #1
Section 1, Summary 
Approximately 935 subjects will be screened in order to have 700 subjects randomized in the 
study. For each subject, the study will last a maximum of 165 weeks and will consist of 
4 periods, a Screening Period (2 to 5 weeks), a double-blind Treatment Period (48 weeks; final 
dose at Week 44), an Open-Label Extension (OLE) Period (96 weeks; final dose at Week 136 for 
subjects receiving bimekizumab 320mg Q8W and at Week 140 for subjects receiving 
bimekizumab 320mg Q4W); and a Safety Follow-Up (SFU) Period (20 weeks after the final dose 
of investigational medicinal product [IMP
Has been changed to: 
Approximately 935 subjects will be screened in order to have 700 subjects randomized in the 
study. For each subject, the study will last a maximum of 165 weeks and will consist of 
5 periods: a Screening Period (2 to 5 weeks), a double-blind Treatment Period (48 weeks; final 
dose at Week 44), an Open-Label Extension (OLE) Period (96 weeks; final dose at Week 136 for 
subjects receiving bimekizumab 320mg Q8W and at Week 140 for subjects receiving 
bimekizumab 320mg Q4W) followed by a Safety Follow-Up (SFU) Period (20 weeks after the 
final dose of investigational medicinal product [IMP] depending on subject’s participation in 
the second OLE Period [OLE2 Period]; see paragraph below).
And the following paragraph was added
Subjects participating in the OLE2 Period (implemented as part of Protocol amendment 
5.4) will enter the OLE2 Period after completing the OLE Period (at Week 144), including 
subjects in the SFU period and subjects who have completed the SFU Period. The OLE2 
Period will be a 48-week treatment period with final visit at OLE2 Week 48, followed by a 
SFU Period (SFU2, 20 weeks after the final dose of IMP administered in the OLE2 Period). 
Change #2
Section 1, Summary 
The following text was added
After the implementation of Protocol Amendment #5.4 (addition of a 48-week treatment 
period, ie, OLE2 Period), subjects will be invited to continue or reinitiate their treatment as 
per the following OLE2 Groups:
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 232 of 263
x
OLE2 Group A: Subjects in the treatment phase of the OLE Period at the time of 
Protocol Amendment #5.4 implementation will attend the Week 144 Visit and directly 
roll over to the OLE2 Period. These subjects will continue receiving bimekizumab 
320mg Q8W for 40 additional weeks, starting from the first treatment visit of the OLE2 
Period (ie, Week 144/OLE2 Baseline Visit; the Week 144 Visit will coincide with the 
Week 144/OLE2 Baseline Visit and data collected at this visit will be used as baseline 
data for subjects entering the OLE2 Period).
x
OLE2 Group B: Eligible subjects who have completed the Week 144 Visit and are in 
the SFU or have completed the SFU of the OLE Period at the time of Protocol 
Amendment #5.4 implementation, will reinitiate their treatment in the OLE2 Period 
after having undergone Screening assessments during a 4-week OLE2 Screening 
Period. The first dose will be administered at the Week 144/OLE2 Baseline Visit and 
data collected at this visit will be used as baseline data for the OLE2 Period. Subjects in 
OLE2 Group B with an IGA score ≥3 at the Week 144/OLE2 Baseline Visit will be 
treated with bimekizumab Q4W for the first 16 weeks, and then will switch to 
bimekizumab 320mg Q8W. Subjects in OLE2 Group B with an IGA score <3 at the 
Week 144/OLE2 Baseline Visit will be treated with bimekizumab Q8W from the Week 
144/OLE2 Baseline Visit. 
During the OLE2 Period (Week 144/OLE2 Baseline to OLE2 Week 48), all subjects will 
attend study visits every 12 weeks. All subjects will be treated until OLE2 Week 40 (last 
dose of bimekizumab 320mg Q8W).
Following completion or early withdrawal from the OLE2 Period, subjects will undergo the 
SFU of the OLE2 Period (SFU2) and will return for the SFU2 Visit 20 weeks after the last 
dose of IMP administration.
Change #3
2.2.1.2 Ongoing studies
Eight additional studies of bimekizumab in the treatment of PSO are ongoing.
x
PS0008 is a Phase 3, multicenter, randomized, double-blind, parallel-group, active-
comparator-controlled study to evaluate the efficacy and safety of bimekizumab in adult 
subjects with moderate to severe chronic plaque PSO.
x
PS0009 is a Phase 3 randomized, double-blind, placebo- and active comparator-controlled 
study to evaluate the efficacy and safety of bimekizumab administered sc to adult subjects 
with moderate to severe plaque PSO.
x
PS0010 is a Phase 2b, double-blind, placebo-controlled, dose ranging study to evaluate the 
safety, efficacy, PK, and pharmacodynamics (PD) of bimekizumab in adult subjects with 
moderate to severe chronic plaque PSO.
x
PS0011 is a long-term extension study for subjects who completed PS0010 to assess the 
long-term safety, tolerability, and efficacy of bimekizumab.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 233 of 263
x
PS0013 is a Phase 3, multicenter, randomized withdrawal, double-blind, placebo-controlled 
study to evaluate the efficacy and safety of bimekizumab in adult subjects with moderate to 
severe chronic plaque PSO.
x
PS0014 is a Phase 3, multicenter, open-label study to assess the long-term safety, tolerability, 
and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque 
psoriasis.
x
PS0016 is a Phase 2a, subject-blind, investigator-blind study to evaluate the time course of 
PD response, safety, and PK of bimekizumab in adult subjects with moderate to severe 
chronic plaque PSO.
x
PS0018 is a long-term extension study for eligible subjects from PS0016 to assess the safety, 
tolerability, and efficacy of bimekizumab.
Bimekizumab is also being evaluated in the treatment of other indications (eg, PsA, axSpA, 
hidradenitis suppurativa). Additional information on the clinical data for bimekizumab is 
available in the current version of the IB. 
was changed to:
All ongoing studies at the time of Protocol Amendment #5.4 implementation are presented
and described in the current version of the IB. 
Change #4
Section 5.2 Study periods
Screening Period (2 to 5 weeks), a double-blind Treatment Period (48 weeks; final dose at Week 
44), an optional OLE Period (96 weeks; final dose at Week 136 for subjects receiving 
bimekizumab 320mg Q8W and at Week 140 for subjects receiving bimekizumab 320mg Q4W), 
and an SFU Period (20 weeks after the final dose of IMP). 
Was changes to:
This study will include the following periods: 
x
A Screening Period (2 to 5 weeks) 
x
A double-blind Treatment Period (48 weeks; final dose at Week 44) 
x
An optional OLE Period (96 weeks; final dose at Week 136 for subjects receiving 
bimekizumab 320mg Q8W and at Week 140 for subjects receiving bimekizumab 320mg 
Q4W) followed by a SFU Period (20 weeks after the final dose of IMP administered in the 
OLE Period depending upon subject’s participation in the OLE2 Period), and 
x
An optional 48-week OLE2 Period followed by a SFU Period (SFU2, 20 weeks after the 
final dose of IMP administered in the OLE2 Period).
The OLE2 Period was added as per Protocol Amendment #5.4 at the time when subjects 
will still be treated in the OLE (prior to Week 144 Visit) or will have finished treatment in 
the OLE (after completing Week 144 Visit):
x
Subjects in the treatment phase of the OLE Period at the time of Protocol Amendment 
#5.4 implementation will attend the Week 144 Visit and directly roll over to the OLE2 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 234 of 263
Period. These subjects will continue receiving bimekizumab 320mg Q8W for 40 
additional weeks, starting from the first treatment visit of the OLE2 Period (ie, Week 
144/OLE2 Baseline Visit; the Week 144 Visit will coincide with the Week 144/OLE2 
Baseline Visit and data collected at this visit will be used as baseline data for subjects 
entering the OLE2 Period).
x
Eligible subjects who have completed the Week 144 Visit and are in the SFU or have 
completed the SFU of the OLE Period at the time of Protocol Amendment #5.4
implementation, will reinitiate their treatment in the OLE2 Period after having 
undergone Screening assessments during a 4-week OLE2 Screening Period. The first 
dose will be administered at the Week 144/OLE2 Baseline Visit and data collected at 
this visit will be used as baseline data for the OLE2 Period. Subjects in OLE2 Group B 
with an IGA score ≥3 at the Week 144/OLE2 Baseline Visit will be treated with 
bimekizumab Q4W for the first 16 weeks, and will then switch to bimekizumab 320mg 
Q8W. Subjects in OLE2 Group B with an IGA score <3 at the Week 144/OLE2 
Baseline Visit will be treated with bimekizumab Q8W from the Week 144/OLE2 
Baseline Visit.
During the OLE2 Period (Week 144/OLE2 Baseline to OLE2 Week 48), all subjects will
attend study visits every 12 weeks. All subjects will be treated until OLE2 Week 40 (last 
dose of bimekizumab 320mg Q8W).
Following completion or early withdrawal from the OLE2 Period, subjects will undergo the 
SFU of the OLE2 Period (SFU2) and will return for the SFU2 Visit 20 weeks after the last 
dose of IMP administration.
Change #5
Section 5.2.3 OLE Period
The following sentence was added:
The last dose bimekizumab 320mg Q8W in the OLE Period will be administered at Week 
136. The End of Treatment Visit of the OLE Period will be the Week 144 Visit.
Change #6
The following section was added:
Section 5.2.5 OLE2 Period
Subjects enrolled as per Protocol Amendment #5.1 will be treated in the OLE Period until 
Week 136 (last dose of bimekizumab 320mg Q8W) and will be followed in a SFU Period for 
20 weeks after attending the Week 144 Visit (see Section 5.2.3). After the implementation of 
Protocol Amendment #5.4 (addition of a 48-week treatment period, ie, OLE2 Period), 
subjects will be invited to continue or reinitiate their treatment as per the following OLE2 
Groups:
x
OLE2 Group A: Subjects in the treatment phase of the OLE Period at the time of 
Protocol Amendment #5.4 implementation will attend the Week 144 Visit and directly 
roll over to the OLE2 Period. These subjects will continue receiving bimekizumab 
320mg Q8W for 40 additional weeks, starting from the first treatment visit of the OLE2 
PUBLIC
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 235 of 263
Period (ie, Week 144/OLE2 Baseline Visit; the Week 144 Visit will coincide with the 
Week 144/OLE2 Baseline Visit and data collected at this visit will be used as baseline 
data for subjects entering the OLE2 Period).
x
OLE2 Group B: Eligible subjects who have completed the Week 144 Visit and are in 
the SFU or have completed the SFU of the OLE Period at the time of Protocol 
Amendment #5.4 implementation, will reinitiate their treatment in the OLE2 Period 
after having undergone Screening assessments during a 4-week OLE2 Screening 
Period. The first dose will be administered at the Week 144/OLE2 Baseline Visit and 
data collected at this visit will be used as baseline data for the OLE2 Period. Subjects in 
OLE2 Group B with an IGA score ≥3 at the Week 144/OLE2 Baseline Visit will be 
treated with bimekizumab Q4W for the first 16 weeks, and then will switch to 
bimekizumab 320mg Q8W. Subjects in OLE2 Group B with an IGA score <3 at the 
Week 144/OLE2 Baseline Visit will be treated with bimekizumab Q8W from the Week 
144/OLE2 Baseline Visit. 
During the OLE2 Period (Week 144/OLE2 Baseline to OLE2 Week 48), all subjects will 
attend study visits every 12 weeks. All subjects will be treated until OLE2 Week 40 (last 
dose of bimekizumab 320mg Q8W).
Following completion or early withdrawal from the OLE2 Period, subjects will undergo the 
SFU of the OLE2 Period (SFU2) and will return for the SFU2 Visit 20 weeks after the last 
dose of IMP administration.
The assessments to be performed at each visit of the OLE2 Period are presented in
Table 5-3.
Change #7
Section 5.2.5 Safety Follow-up
All subjects, including those withdrawn from IMP, will have a SFU Visit 20 weeks after their 
final dose of IMP.
The assessments for the SFU are presented in Table 5‒1 and Table 5‒2.
Was changes to:
Section 5.2.5 Safety Follow-up Period
The assessments for the SFU Visits are presented in Table 5‒1, Table 5‒2, and Table 5-3.
Two SFU Periods are considered since Protocol Amendment #5.4 implementation: a first 
SFU following the OLE Period and a second SFU (SFU2) following the OLE2 Period 
(added as per Protocol Amendment #5.4 implementation).
Subjects having completed Week 144 Visit and who are in the SFU or have completed the 
SFU will be invited to reinitiate their treatment in the OLE2 Period. 
Subjects still being treated in the OLE Period (not having attended Week 144 yet) will have 
the opportunity to directly roll over in the OLE2 Period without participating in the first 
SFU.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 236 of 263
Subjects who decide not to participate in OLE2 Period will undergo the first SFU period 
for 20 weeks after their last dose in the OLE Period.
All subjects who have completed treatment in the OLE2 Period (ie, have completed the 
OLE2 Week 48 Visit), or have withdrawn from IMP during the OLE2 Period before OLE2 
Week 48, will have a SFU2 Visit 20 weeks after their final dose of IMP administered up to 
OLE2 Week 48.
Change #8
Section 5.4 Study duration per subject
For each subject, the study will last a maximum of up to 165 weeks, as follows:
x
Screening Period: 2 to 5 weeks
x
Double-blind Treatment Period: 48 weeks (final dose at Week 44)
x
OLE Period: 96 weeks (final dose at Week 136 for subjects receiving bimekizumab 320mg 
Q8W and at Week 140 for subjects receiving bimekizumab 320mg Q4W)
Safety Follow-Up Period a SFU Visit is planned 20weeks after the final dose of IMP visit
Was changed to:
For each subject, the study will last a maximum of up to 165 weeks, as follows:
x
Screening Period: 2 to 5 weeks
x
Double-blind Treatment Period: 48 weeks (final dose at Week 44)
x
OLE Period: 96 weeks (final dose at Week 136 for subjects receiving bimekizumab 320mg 
Q8W and at Week 140 for subjects receiving bimekizumab 320mg Q4W) followed by a 
Safety Follow-Up Period: a SFU Visit is planned 20 weeks after the final dose of IMP 
visit in the OLE Period (this SFU will not apply to subjects directly rolling over from 
the OLE to the OLE2 Period [see Section 5.2.5])
Subjects eligible for the OLE2 Period (added as part of Protocol Amendment #5.4) will 
enter the OLE2 Period after completing Week 144 of the OLE Period. The OLE2 Period 
will include a 48-week treatment period with a final visit at OLE2 Week 48 and a SFU 
Period (SFU2) of 20 weeks after the final dose of IMP administered in the OLE2 Period. 
For the subjects in the OLE2 Period, maximum study duration will depend on the time 
between their participation in the OLE until Week 144 and the start of the OLE2 Period:
x
209 weeks for subjects still being treated in the OLE Period and who will directly roll 
over to the OLE2 Period at Week 144
x
225 weeks for subjects who have completed Week 144 and the SFU; these subjects will 
have a 4-week Screening Period before reinitiating treatment in the OLE2 Period. Note: 
for, these subjects the study duration will not be continuous.
x
Between 209 and 225 weeks for subjects who have completed Week 144 and are 
participating the in the SFU. For these subjects, the maximum study duration will 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 237 of 263
depend upon when they stop the 20-week SFU period to enter the 4-week OLE2 
Screening Period.
Change #9
Section 5.6 Schedule of study assessments
Table 5-3 Schedule of study assessments, OLE2 Period, was added:
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof. 


UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 238 of 263
Table 5-3 Schedule of study assessments, OLE2 Period
Visit a/
Week
OLE2 Period
OLE2 Screening b
W144/OLE2 
Baseline
OLE2 W4
OLE2 W8
OLE2 W12
OLE2 W16
OLE2 W24
OLE2 W32
OLE2 W36
OLE2 W40
OLE2W48/
PEOT
SFU2 c
C
H
H
C
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C
H
C
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C
C
Protocol activity
OLE2 Groups A + B
Informed consent
Group B
Group A
Eligibility
Group B
Group A+B
Urine drug screen
Group B
Significant past medical history 
and concomitant diseases d
Group B
Physical exam e
Group B
Group Af + B
X
X
X
X
X
Body weight
Group Ae + B
X
Vital signs g
Group B
Group Af + B
X
X
X
X
X
Hematology and chemistry
Group B
Group Af + B
X
X
X
Urinalysis
Group B
Group Af + B
X
X
X
Pregnancy testing (urine) h
Group B
Group Af + B
X
X
X
X
X
X
X
X
X
X
Hepatitis B and C testing
Group B
HIV testing i
Group B
IGRA TB test
Group A f
X
Tuberculosis questionnaire
Group B
Group Af + B
X
X
X
X
PASI
Group B
Group Af + B
X
X
X
X
Percentage of BSA
Group B
Group Af + B
X
X
X
X
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 239 of 263
Table 5-3 Schedule of study assessments, OLE2 Period
Visit a/
Week
OLE2 Period
OLE2 Screening b
W144/OLE2 
Baseline
OLE2 W4
OLE2 W8
OLE2 W12
OLE2 W16
OLE2 W24
OLE2 W32
OLE2 W36
OLE2 W40
OLE2W48/
PEOT
SFU2 c
C
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Protocol activity
OLE2 Groups A + B
IGA
Group B
Group Af + B
X
X
X
X
DLQI
Group Af + B
X
X
X
Patient Symptoms (itch, pain, 
and scaling)
Group Af + B
X
X
X
X
PHQ-9
Group B
Group Af + B
X
X
X
X
ECG
Group A f
Blood sample for bimekizumab 
plasma concentrations j
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Blood sample for 
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Group A f
scalp IGA
Group A f
mNAPSI
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Group A f
PASE
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PGADA
Group A f
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Group B
Group Af + B
X
X
X
X
X
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Group B
Group Af + B
X
X
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01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 240 of 263
Table 5-3 Schedule of study assessments, OLE2 Period
Visit a/
Week
OLE2 Period
OLE2 Screening b
W144/OLE2 
Baseline
OLE2 W4
OLE2 W8
OLE2 W12
OLE2 W16
OLE2 W24
OLE2 W32
OLE2 W36
OLE2 W40
OLE2W48/
PEOT
SFU2 c
C
H
H
C
H
C
H
C
H
C
C
Protocol activity
OLE2 Groups A + B
Adverse events
Group B k
Group Af + B
X
X
X
X
X
IRT
Group B
Group Af + B
X
X
X
X
X
Bimekizumab administration 
Q4W/Q8W l, m, n
Group B l
X
X
X
X
X
X
X
Bimekizumab administration 
Q8W m, n
Group A+B l
X
X
X
X
X
BSA=body surface area; C=clinic; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide Severity Rating Scale; 
IGA=Investigator’s Global Assessment; H=home; IMP=investigational medicinal product; IRT=interactive response technology; OLE=open label extension; PASI=Psoriasis 
Area Severity Index; PHQ-9=Patient Health Questionnaire-9; PSO=psoriasis; Q4W=every 4 weeks; Q8W=every 8 weeks; SFU2=Safety Follow-Up #2; TB=tuberculosis; 
W=Week.
Note: Subjects may self-inject IMP at home; self-injection training will be provided to the subject/caregivers by qualified site personnel. 
a
Visit windows of ±14 days from the first dose at all visits except SFU2. The SFU2 Visit window is ±7 days from final dose.
b
Assessment for the OLE2 Screening is applicable to subjects in OLE2 Group B, ie, subjects who agreed to reinitiate their treatment after having completed the Week 144 Visit. 
c
The SFU2 Visit will occur 20 weeks after the final dose.
d
Only applicable for subjects who completed the SFU period; only new or modified medical history since completing SFU will be entered in eCRF.
e
The physical examination will be performed as per Section 12.3.5.
f
These tests are performed as part of Week 144 visit (the Week 144 Visit coincides with the Week 144/OLE2 Baseline Visit for subjects in Group A, ie, direct enroller from 
OLE to OLE2 Period).
g
Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable.
h
Urine pregnancy testing will be performed at all visits. Pregnancy test results must be negative prior to administering IMP. Home pregnancy test kits will be provided to 
participants for use between clinic visits.
i
The HIV test results will not be recorded in the eCRF.
j
All blood samples taken prior to dosing.
k
Collected only from subjects in the SFU.
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01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 241 of 263
Table 5-3 Schedule of study assessments, OLE2 Period
Visit a/
Week
OLE2 Period
OLE2 Screening b
W144/OLE2 
Baseline
OLE2 W4
OLE2 W8
OLE2 W12
OLE2 W16
OLE2 W24
OLE2 W32
OLE2 W36
OLE2 W40
OLE2W48/
PEOT
SFU2 c
C
H
H
C
H
C
H
C
H
C
C
Protocol activity
OLE2 Groups A + B
l
Q4W IMP administration only applies to those subjects who have entered the OLE2 Period as part of Group B, and had an IGA ≥3 upon entry of OLE2 Period. These 
subjects will receive Q4W dosing for 16 weeks, then will change from Q4W to Q8W dosing. Subjects who have entered the OLE2 Period as part of Group B with an IGA 
<3 upon entry of OLE2 Period will receive Q8W dosing from the W144/OLE2 Screening Visit onwards.
m The dosing window is ±14 days relative to the Week 144/OLE2 Baseline Visit.
n
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be disposed of by subjects/caregivers as determined by the Investigator in an acceptable disposal (sharps) container directly after the administration. The subjects/caregivers 
return the documentation together with any used/unused containers at the next scheduled clinic visit.
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01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 242 of 263
Change #10
Section 5.7 Schematic diagram
Figure 5-3 was added:
Figure 5-3 Schematic diagram, OLE2 period (from OLE2 Screening through OLE2 
Week 48)
IGA=Investigator’s Global Assessment; IMP=investigational medicinal product; OLE=Open Label Extension; 
Q4W=every 4 weeks; Q8W=every 8 weeks; SFU2=Safety follow-up; W=week
Note: Q4W/Q8W IMP administration only applies to those subjects who have entered the OLE2 Period as part of 
Group B, and had an IGA ≥3 upon entry of OLE2 Period. These subjects will receive Q4W dosing for 16 weeks, 
then will change from Q4W to Q8W dosing.
Change #11
Section 
5.8 Rationale for study design and selection of dose
5.8.1
Study design
The following paragraph was added:
The OLE2 Period will 1) collect additional long-term safety data; 2) explore safety data in 
subjects who have temporarily stopped bimekizumab and could have been exposed to other 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 243 of 263
treatments; and 3) provide an additional 48-week treatment period for subjects continuing 
their current treatment or reinitiating treatment at the Week 144/OLE2 Baseline Visit.
Change #12
5.8.2
Dose selection
The following paragraph was added:
Subjects who are participating in the OLE Period can directly roll over to the OLE2 Period 
and continue receiving bimekizumab 320mg Q8W. Eligible subjects who are in the SFU of 
the OLE Period or who have completed the SFU at the time of Protocol Amendment #5.4
implementation can reinitiate their treatment in the OLE2 Period based on their current 
disease activity, as measured by IGA: subjects with IGA score <3 will receive bimekizumab 
320mg Q8W, whereas subjects with IGA score ≥3 will receive 16 weeks of bimekizumab 
320mg Q4W, in line with the original initial treatment period, followed by 320mg Q8W for 
the remaining dosing timepoints of the OLE2 Period. 
Change #13
The following sections were added:
6.4 Eligibility for the OLE2 Period
Prior to initiating the OLE2 Period assessments, all subjects will be asked to read and sign 
a separate ICF. 
6.4.1
All subjects (OLE2 Groups A and B)
To be eligible to participate in the OLE2 Period, all of the following inclusion criteria must 
be confirmed for all subjects:
10. Subject provided informed consent. 
11. Subject is considered reliable and capable of adhering to the protocol (eg, able to 
understand and complete diaries), visit schedule, and medication intake according to 
the judgment of the Investigator.
12. Subject completes the OLE Period to Week 144 without meeting any withdrawal 
criteria defined in Section 6.5.
6.4.2
OLE2 Period Group A subjects
To participate in the OLE2 Period, subjects still treated in the OLE Period and who 
completed the Week 144 Visit by the time of the implementation of Protocol Amendment 
#5.4 will not need to fulfil other eligibility criteria than those listed in Section 6.4.1 and will 
continue their treatment from the Week 144/OLE2 Baseline Visit if they do not meet any of 
the withdrawal criteria defined in Section 6.5.
6.4.3
OLE2 Period Group B subjects
Inclusion criteria
To be eligible to participate in the OLE2 Period, all of the additional following inclusion 
criteria must be confirmed during the OLE2 Screening Period for subjects who have 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 244 of 263
attended Week 144 and are in the SFU or have completed the SFU before Protocol 
Amendment #5.4 implementation:
13. Female subjects must be:

Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, 
for which there is no other obvious pathological or physiological cause.

Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)

Or, if of childbearing potential (and engaged in sexual activity that could result in 
procreation), must be willing to use a highly effective method of contraception 
throughout the duration of the study until 20 weeks after last administration of 
IMP, and have a negative pregnancy test at OLE2 Screening. The following methods 
are considered highly effective when used consistently and correctly
o
Combined (estrogen and progestogen) hormonal contraception associated with 
inhibition of ovulation (oral, intravaginal, or transdermal)
o
Progestogen-only hormonal contraception associated with inhibition of ovulation 
(oral, injectable, implantable)
o
Intrauterine device 
o
Intrauterine hormone-releasing system 
o
Vasectomized partner
o
Abstinence as a form of birth control is generally not allowed in the study unless 
abstinence is in accordance with a subject’s preferred and common lifestyle. 
Study personnel must confirm the continued use of abstinence is still in 
accordance with the subject’s lifestyle at regular intervals during the study.
14. Subjects with a diagnosis of Crohn’s disease or ulcerative colitis are allowed as long as 
they have no active symptomatic disease.
Exclusion criteria
Subjects in the OLE2 Group B are not permitted to enroll in the OLE2 Period if any of the 
following exclusion criteria is met:
15. Female subjects who plan to become pregnant during the OLE2 Period or within 
20 weeks following final dose of study medication.
16. Subject has developed any medical or psychiatric condition that, in the opinion of the 
Investigator, could jeopardize or would compromise the subject’s ability to participate 
in the OLE2 Period.
17. Any subjects with an ongoing SAE, or a history of serious infections, the Medical 
Monitor must be consulted prior to the subject’s entry in the OLE2 Period, although 
the decision on whether to enroll the subject remains with the Investigator.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 245 of 263
18. Subject had a positive or indeterminate IGRA in the OLE study to Week 144, unless 
appropriately evaluated and treated as per Section 12.3.1.
19. Subject may not participate in another study of a medicinal product or device under 
investigation
20. Subject has a history of chronic alcohol or drug abuse within 6 months prior to reentry 
as assessed by medical history, site interview, and/or results of the urine drug screen.
21. Subjects who have used systemic treatments after Week 144 must have stopped this 
treatment 1 month prior to receiving the first bimekizumab injection in the OLE2 
Period (See Section 7.8.2 regarding prohibited medications).
22. Subject has erythrodermic, guttate, or pustular form of PSO.
23. Subject is noncompliant with the study procedures or medications in the opinion of the 
Investigator.
24. Subject has a clinical laboratory value meeting any of the following criteria:
h. ≥3.0x ULN of any of the following: ALT, AST, alkaline phosphatase (ALP); or 
>ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert’s syndrome)
i.
A laboratory value meeting any of the following criteria:
◦
Absolute neutrophil count <1.0x103/μL
◦
Absolute lymphocyte count <0.2x103/μL
Subjects may enter the OLE2 Period if the result is transient. If a retest is required, it 
must be done within 1 to 2 weeks.
25. Subject has concurrent acute or chronic viral hepatitis B or C or HIV infection. 
Subjects who have evidence of, or tested positive for hepatitis B or hepatitis C are 
excluded. A positive test for the hepatitis B virus is defined as: (1) positive for 
hepatitis B surface antigen or (2) positive for anti-hepatitis B core antibody. A positive 
test for the hepatitis C virus (HCV) is defined as: (1) positive for hepatitis C antibody 
(HCV Ab) and (2) positive via a confirmatory test for HCV (for example, HCV 
polymerase chain reaction).
26. There is confirmation of a pregnancy, as evidenced by a positive pregnancy test (see 
Section 12.1.4 for more information regarding pregnancies).
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 246 of 263
27. Subjects showing:
x
Suicidal ideation in the past month prior to the OLE2 Screening Visit as indicated 
by a positive response ("Yes") to either Question 4 or Question 5 of the eC-SSRS.
x
Any suicidal behavior since last visit.
28. Subject has presence of moderately severe or severe major depression, indicated by a 
score ≥15 on the PHQ-9. Medication used to treat depression should be stable for 
4 weeks prior to Week 144/OLE2 Baseline.
29. Subject has developed any active malignancy or history of malignancy prior to the 
OLE2 Screening Visit EXCEPT treated and considered cured cutaneous squamous or 
basal cell carcinoma, or in situ cervical cancer.
30. Subject has received any live (includes attenuated) vaccination within the 8 weeks prior 
to the Week 144/OLE2 Baseline Visit.
Change #13
Section 7.2 Treatments to be administered
The following text and Table 7-3 were added:
After the implementation of Protocol Amendment #5.4 (addition of a 48-week treatment 
period, ie, OLE2 Period), subjects will be invited to continue or reinitiate their treatment as 
per the following OLE2 Groups:
x
OLE2 Group A: Subjects in the treatment phase of the OLE Period at the time of 
Protocol Amendment #5.4 implementation will attend the Week 144 Visit and directly 
roll over to the OLE2 Period. These subjects will continue receiving bimekizumab 
320mg Q8W for 40 additional weeks, starting from the first treatment visit of the OLE2 
Period (ie, Week 144/OLE2 Baseline Visit; the Week 144 Visit will coincide with the 
Week 144/OLE2 Baseline Visit and data collected at this visit will be used as baseline 
data for subjects entering the OLE2 Period).
x
OLE2 Group B: Eligible subjects who have completed the Week 144 Visit and are in 
the SFU or have completed the SFU of the OLE Period at the time of Protocol 
Amendment #5.4 implementation, will reinitiate their treatment in the OLE2 Period 
after having undergone Screening assessments during a 4-week OLE2 Screening 
Period. The first dose will be administered at the Week 144/OLE2 Baseline Visit and 
data collected at this visit will be used as baseline data for the OLE2 Period. Subjects in 
OLE2 Group B with an IGA score ≥3 at the Week 144/OLE2 Baseline Visit will be 
treated with bimekizumab Q4W for the first 16 weeks, then will switch to bimekizumab 
320mg Q8W. Subjects in OLE2 Group B with an IGA score <3 at the Week 144/OLE2 
Baseline Visit will be treated with bimekizumab Q8W from the Week 144/OLE2 
Baseline Visit. 
During the OLE2 Period (Week 144/OLE2 Baseline to OLE2 Week 48), all subjects will 
attend study visits every 12 weeks. All subjects will be treated until OLE2 Week 40 (last 
dose of bimekizumab 320mg Q8W).
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 247 of 263
The dosing scheme from Week 144/OLE2 Baseline through OLE2 Week 40 is depicted in 
Table 7‒3.
COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof. 


UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 248 of 263
Table 7-3  Dosing scheme, OLE2 Period
Visits/Week
Dose Assignment
OLE2 Period
Week 144/OLE2 
Baseline
OLE2 W4
OLE2 W8
OLE2 W12 a
OLE2 W16
OLE2 W24 b
OLE2 W32
OLE2 W36 c
OLE2 W40
C
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Bimekizumab 320mg Q4W/Q8W d
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Bimekizumab 320mg Q8W
●●
●●
●●
●●
●●
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C=Clinic; H=home; IGA=Investigator’s Global Assessment; IMP=investigational medicinal product; Q4W/Q8W=every 4 weeks for 16 weeks, followed by 
every 8 weeks; Q8W=every 8 weeks; OLE=Open Label Extension; W=week
Notes: A bimekizumab 160mg injection is depicted by a black circle (●).
a Subjects will receive kits for home administration 4 weeks later.
b Subjects will receive kits for home administration 8 weeks later.
c Subjects should NOT be dosed at this visit and will receive kits for home administration 4 weeks later.
d Q4W/Q8W IMP administration only applies to those subjects who have entered the OLE2 Period as part of Group B, and had an IGA ≥3 upon entry of 
OLE2 Period. These subjects will receive Q4W dosing for 16 weeks until OLE2 Week 16, then will change from Q4W to Q8W and will receive their next 
dose at the scheduled clinic visit OLE2 Week 24.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 249 of 263
Change #13
Section 7.6 Dug accountability 
The following sentence was added:
The OLE2 Period will be unblinded and blinding precautions will not be applicable.
Change #14
Section 7.7
Procedures for monitoring subject compliance
After Week 48, self-injection at home will be possible at the following weeks: Weeks 60, 68, 76, 
80, 88, 92, 100, 104, 112, 116, 124, 128, 136, and 140. Dates, body locations, kit numbers and 
time of self-injection will be captured using a home administration form. All used syringes will 
be disposed of by subjects/caregivers as determined by the Investigator in an acceptable disposal 
(sharps) container directly after the administration. The subjects/caregivers return the 
documentation together with any used/unused containers at the next scheduled clinic visit.
Was changes to:
After Week 48, self-injection at home will be possible at the following weeks: Weeks 60, 68, 76,
80, 88, 92, 100, 104, 112, 116, 124, 128, 136, 140, and at the OLE2 Weeks 4, 8, 16, 32, and 
40. Dates, body locations, kit numbers and time of self-injection will be captured using a home 
administration form. All used syringes will be disposed of by subjects/caregivers as determined 
by the Investigator in an acceptable disposal (sharps) container directly after the administration. 
The subjects/caregivers return the documentation together with any used/unused containers at the 
next scheduled clinic visit.
Change #14
Section 7.8.1.1
Topical medications
In the OLE Period, the medications listed as permitted for the double-blind Treatment Period 
will be allowed. In addition, any topical steroids and vitamin D analog ointment will be 
permitted for use, as needed. These topical medications should not be used within approximately 
24 hours prior to study visits requiring IGA and PASI measures.
Was changed to:
In the OLE and OLE2 Periods, the medications listed as permitted for the double-blind 
Treatment Period will be allowed. In addition, any topical steroids and vitamin D analog 
ointment will be permitted for use, as needed. These topical medications should not be used 
within approximately 24 hours prior to study visits requiring IGA and PASI measures.
Change #15
Section 7.8.2 Prohibited concomitant treatments (medications and therapies)
Subjects who take prohibited medications may be withdrawn from IMP but followed until the 
SFU Visit. The decision to withdraw a subject for taking prohibited medications should be made 
in consultation with the Medical Monitor.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 250 of 263
Was changed to:
Up to Week 144
Subjects who take prohibited medications may be withdrawn from IMP but followed until the 
SFU Visit. The decision to withdraw a subject for taking prohibited medications should be made 
in consultation with the Medical Monitor.
Post Week 144 (OLE2 Period)
Subjects who have used systemic treatments after Week 144 must have stopped this 
treatment 1 month prior to receiving the first bimekizumab injection in the OLE2 Period. 
Subjects receiving systemic immunomodulatory medications for an indication other than 
PSO must have their eligibility confirmed by the Medical Monitor prior to enrollment in 
the OLE2 Period.
Change #16
Section 7.10
Randomization and numbering of subjects
The following paragraph was added:
Subjects who roll over directly from the OLE Period into the OLE2 Period will continue 
receiving bimekizumab 320mg Q8W and will keep their unique 5-digit identification 
number. Subjects who reinitiate bimekizumab after having completed treatment (subjects 
in the SFU of the OLE Period or who have completed the SFU of the OLE Period) will 
receive either bimekizumab 320mg Q4W/Q8W or bimekizumab 320mg Q8W depending on 
their disease activity at time of reentry (bimekizumab 320mg Q4W/Q8W for subjects with 
IGA score ≥3 or bimekizumab 320mg Q8W for subjects with IGA score <3). For these 
subjects, the same unique 5-digit identification number used in the study will be reused.
Change #17
Section 8 STUDY PROCEDURES BY VISIT
Table 5‒1 and Table 5‒2 provide a general overview of study assessments during the double-
blind Treatment Period and the OLE Period, respectively. A list of procedures to be completed at 
each visit is described below.
x
Visit windows of ±3 days on either side of the scheduled dosing are permitted up to and 
including Week 24; however, the Investigator should try to keep the subjects on the original 
dosing schedule. From the Week 28 Visit through the Week 72 Visit, visit windows of 
±7 days on either side of the scheduled dosing are permitted; however, the Investigator 
should try to keep the subjects on the original dosing schedule. From the Week 76 Visit 
through the Week 144/PEOT Visit, visit windows of ±14 days on either side of the scheduled 
dosing are permitted; however, the Investigator should try to keep the subjects on the original 
dosing schedule. The visit window is relative to Baseline and applicable for all subsequent 
visits Changes to the dosing schedule outside the visit window must be discussed with the 
Medical Monitor.
x
The dosing window from Baseline through Week 4 is ±2 days relative to the scheduled
dosing visit. From Week 8 through Week 24, the dosing window is ±3 days relative to the 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 251 of 263
scheduled dosing visit. From Week 28 through the Week 72 Visit, the dosing window is 
±7 days relative to the scheduled dosing visit. From the Week 76 Visit through the Week 140
Visit the dosing window is ±14 days relative to the scheduled dosing visit.
x
For the SFU Visit (20 weeks after the final dose), the visit window is ±7 days relative to the 
scheduled visit date.
Was changed to:
Table 5‒1, Table 5‒2, Table 5-3 provide a general overview of study assessments during the 
double-blind Treatment Period, the OLE Period, and the OLE2 Period, respectively. A list of 
procedures to be completed at each visit is described below.
x
Visit windows of ±3 days on either side of the scheduled dosing are permitted up to and 
including Week 24; however, the Investigator should try to keep the subjects on the original 
dosing schedule. From the Week 28 Visit through the Week 72 Visit, visit windows of 
±7 days on either side of the scheduled dosing are permitted; however, the Investigator 
should try to keep the subjects on the original dosing schedule. From the Week 76 Visit 
through the Week 144/PEOT Visit, visit windows of ±14 days on either side of the scheduled 
dosing are permitted; however, the Investigator should try to keep the subjects on the original 
dosing schedule. The visit window is relative to Baseline and applicable for all subsequent 
visits up to Week 144/OLE2 Baseline Visit. From the Week 144/OLE2 Baseline Visit 
through the OLE2 Week 48/PEOT Visit, visit windows of ±14 days relative to the Week 
144/OLE2 Baseline Visit on either side of the scheduled dosing are permitted; however, 
the Investigator should try to keep the subjects on the original dosing schedule. Changes 
to the dosing schedule outside the visit window must be discussed with the Medical Monitor. 
x
The dosing window from Baseline through Week 4 is ±2 days relative to the scheduled 
dosing visit. From Week 8 through Week 24, the dosing window is ±3 days relative to the 
scheduled dosing visit. From Week 28 through the Week 72 Visit, the dosing window is 
±7 days relative to the scheduled dosing visit. From the Week 76 Visit through the OLE2 
Week 40 Visit, the dosing window is ±14 days relative to the scheduled dosing visit.
x
For the SFU and SFU2 Visits (20 weeks after the final dose), the visit window is ±7 days 
relative to the scheduled visit date.
Change #18
Section 8.3.8 Week 144 Visit (±14 days relative to Baseline)
The following paragraphs were added:
If Protocol Amendment #5.4 is implemented at the time subjects are treated in the OLE 
Period (ie, up to Week 144; OLE2 Group A subjects), these subjects will be invited to 
participate in the OLE2 Period and may directly roll over and continue their treatment 
from the Week 144/OLE2 Baseline Visit as long as they do not meet any of the withdrawal 
criteria and have provided informed consent.
If Protocol Amendment #5.4 is implemented at the time subjects have completed the Week 
144 Visit and are in the SFU Period of the OLE Period or have completed the SFU of the 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 252 of 263
OLE Period (Group B subjects), these subjects will be invited to enter the OLE2 Period to
reinitiate their treatment in the OLE2 Period. However, before receiving the first dose at 
the Week 144/OLE2 Baseline Visit, they will first undergo screening during the 4-week 
OLE2 Screening Period (Section 8.4.1).
Change #19
The following sections were added
8.4 OLE2 Period
8.4.1
OLE2 Screening (up to 4 weeks) – applicable for OLE2 Group B only
Prior to any study specific activities of the OLE2 Period, subjects who completed the Week 
144 Visit and are in the SFU or have completed the SFU of the OLE Period (OLE2 Group 
B subjects) will undergo screening. Subjects who have used systemic treatments after Week 
144 must have stopped this treatment 1 month prior to receiving the first bimekizumab 
injection in the OLE2 Period. Screening procedures may be performed during this time. 
Subjects receiving systemic immunomodulatory medications for an indication other than 
PSO must have their eligibility confirmed by the Medical Monitor prior to enrollment in 
the OLE2 Period.
At the Screening Visit of the OLE2 Period (OLE2 Screening Visit), subjects will be asked to 
read, sign, and date an ICF that has been approved by the Sponsor and an IRB/IEC and 
that complies with regulatory requirements. Subjects will be given adequate time to 
consider any information concerning the study given to them by the Investigator or 
designee. As part of the informed consent procedure, subjects will be given the opportunity 
to ask the Investigator any questions regarding potential risks and benefits of continued 
participation in the study.
The following procedures/assessments will be performed at the OLE2 Screening Visit for 
subjects in the OLE2 Group B:
x
Informed consent
x
Inclusion/exclusion
x
Urine drug screen
x
Significant past medical history including clinically relevant past or coexisting medical 
conditions and surgeries (only applicable for subjects who completed the SFU, only new 
or modified medical history since completing the SFU should be entered in eCRF)
x
AEs (only for subjects in the SFU)
x
Physical exam
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should 
be obtained prior to blood sampling
x
Collection of blood and urine samples for the following clinical laboratory tests:

Hematology and biochemistry
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 253 of 263

Urine pregnancy test

Hepatitis B and Hepatitis C

HIV
x
Tuberculosis questionnaire
x
PASI
x
Percentage of BSA
x
IGA
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PHQ-9
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eC-SSRS
x
Prior and concomitant medication (including new or modified medications initiated 
after SFU)
x
Contact IRT
8.4.2
OLE2 Baseline Visit
Subjects who will still be treated in the OLE Period at the time of implementing Protocol 
Amendment #5.4 (OLE2 Group A subjects) will attend Week 144 Visit and directly roll 
over to the OLE2 Period to continue their treatment (bimekizumab 320mg Q8W). They 
will undergo all study assessments of the Week 144 Visit and will receive bimekizumab 
320mg Q8W at this visit, which will also coincide with the first visit of the OLE2 Period, ie, 
the Week 144/OLE2 Baseline Visit.
Subjects who have completed Week 144 Visit and are in the SFU of the OLE or have 
completed the SFU Period at the time of Protocol Amendment #5.4 implementation (OLE2 
Group B subjects) will reinitiate their treatment at the Week 144/OLE2 Baseline Visit, and 
will be assigned a treatment regimen based on their disease severity at the Week 144/OLE2 
Baseline Visit (bimekizumab 320mg Q4W/Q8W for subjects with IGA score ≥3 or 
bimekizumab 320mg Q8W for subjects with IGA score <3).
Applicable for OLE2 Groups A and B:
x
Physical exam
x
Body weight
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should 
be obtained prior to blood sampling
x
Collection of blood and urine samples for the following clinical laboratory tests:
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Hematology and biochemistry

Urinalysis
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x
eC-SSRS
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 254 of 263
x
Tuberculosis questionnaire
x
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Patient symptoms (itch, pain, and scaling)
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x
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x
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x
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x
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x
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procedures, administration of IMP will occur, preferably by self-injection under 
supervision of the site personnel.
Distribution of IMP and accountability activities for home administration to be performed 
as described in Section 7.2, Section 7.5, and Section 7.7.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 255 of 263
8.4.3
Self-injection at home (OLE2 Weeks 4, 8, 16, 32, and 40)
Subjects receiving bimekizumab 320mg Q8W will be given the opportunity for self-
injection of bimekizumab at home on the following weeks: OLE2 Weeks 8, 16, 32, and 40.
Subjects receiving bimekizumab 320mg Q4W/Q8W will be given the opportunity for self-
injection of bimekizumab at home on the following weeks: OLE2 Weeks 4, 8, and 16. At 
OLE2 Week 16, subjects receiving bimekizumab 320mg Q4W/Q8W will switch to 
bimekizumab 320mg Q8W regimen and will be given the opportunity for self-injection of 
bimekizumab at home dosed at OLE2 Weeks 32 and 40.
Subjects of childbearing potential should conduct a home pregnancy test every 4 weeks. In 
case of a scheduled home self-injection the pregnancy test needs to be performed 
immediately prior to self-injecting bimekizumab at home. If the pregnancy test result is 
positive, IMP should not be administered and the site should be contacted.
Adverse events will be captured spontaneously if the subject decides to visit the site to 
receive the bimekizumab administration. 
All used syringes will be disposed of by subjects/caregivers as determined by the 
Investigator in an acceptable disposal (sharps) container directly after the administration. 
The subjects/caregivers return the documentation together with any used/unused 
containers at the next scheduled clinic visit.
8.4.4
OLE2 Week 12, Week 24, and Week 36 Visits (±14 days relative to OLE2 Baseline)
As depicted in Table 7‒3, subjects receiving bimekizumab 320mg Q4W/Q8W should 
receive IMP at the OLE2 Week 12 Visit, and all subjects will receive kits for home 
administration 4 weeks later at OLE2 Week 16. All subjects will receive IMP 
administration at the OLE2 Week 24 Visit, and will receive kits for home administration 
8 weeks later. At the OLE2 Week 36 Visit, subjects will not be dosed and will receive kits 
for home administration 4 weeks later at OLE2 Week 40.
The following procedures/assessments will be performed/recorded at every clinic visit prior 
to administration of IMP:
x
Physical exam
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should 
be obtained prior to blood sampling
x
Urine pregnancy test, for applicable subjects
x
Tuberculosis questionnaire 
x
PASI
x
Percentage of BSA 
x
IGA
x
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x
PHQ-9
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 256 of 263
x
Concomitant medication 
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The following will be additional assessments will be performed / recorded every 24 weeks 
(ie, OLE2Weeks 24 and 48) prior to administration of IMP
x
Collection of blood and urine samples for the following tests should be obtained prior to 
dosing:

Hematology and biochemistry

Urinalysis
x
DLQI 
At the OLE2 Week 12 and Week 24 Visit, after completion of the above-mentioned 
procedures, administration of IMP will occur, preferably by self-injection under 
supervision of the site personnel.
Distribution of IMP and accountability activities for home administration to be performed 
as described in Section 7.2, Section 7.5, and Section 7.7. Home pregnancy tests will be 
provided for testing every 4 weeks as appropriate (Table 5‒2 and Table 5-3).
8.4.5
OLE2 Week 48 Visit (±14 days relative to OLE2 Baseline)
The following procedures/assessments will be performed/recorded:
x
Physical exam
x
Body weight
x
Vital signs (sitting systolic BP and diastolic BP, pulse rate, and body temperature) 
should be obtained prior to blood sampling
x
Collection of blood and urine samples for the following clinical laboratory tests should 
be obtained prior to dosing:

Hematology and chemistry

Urinalysis

Urine pregnancy test

IGRA TB test
x
Tuberculosis questionnaire
x
PASI
x
Percentage of BSA
x
IGA
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 257 of 263
x
DLQI
x
Patient symptoms (itch, pain, and scaling)
x
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x
eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
Return of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7.
Change #20
Section 8.5
Premature End of Treatment Visit
The following text was added:
If a subject is withdrawn from the study during the OLE2 Period:
x
The subject will be withdrawn from IMP, will undergo the same assessments as the 
OLE2 Week 48 Visit (see Section 8.4.5) and will enter the SFU2 Period.
x
The subject will be encouraged to return for the SFU2 Visit (20 weeks after the last 
received dose; see Section 8.7).
Change #21
The following section was added:
8.7 Safety Follow-Up Visit 2 (20 weeks after final dose in the OLE2 Period, ±7 days)
The following procedures/assessments will be performed/recorded:
x
Physical exam 
x
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should 
be obtained prior to blood sampling
x
Collection of blood and urine samples for the following tests should be obtained at this 
visit:

Hematology and biochemistry

Urinalysis

Urine pregnancy test
x
eC-SSRS
x
Concomitant medication
x
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 258 of 263
x
Contact IRT
Change #22
Section 8.8
Unscheduled Visit
At the Investigator’s discretion, an Unscheduled Visit may be completed at any time during the 
study but prior to the SFU Visit, if deemed necessary for the subject’s safety and well-being.
Was changed to:
At the Investigator’s discretion, an Unscheduled Visit may be completed at any time during the 
study but prior to the SFU Visit or SFU2 Visit (depending on which period, OLE or OLE2, 
the participant is in), if deemed necessary for the subject’s safety and well-being.
Change #23
Section 10.1
Pharmacokinetic variables
The following sentence was added:
Blood samples for the measurement of PK assessments will not be collected in the OLE2 
Period.
Change #24
Section 11ASSESSMENT OF IMMUNOLOGICAL VARIABLES
The following sentence was added:
Blood samples for the measurement of antibodies to bimekizumab will not be collected in 
the OLE2 Period.
Change #25
Section 12.2
Laboratory measurements
Table 12-2  Laboratory measurements
Hematology
Chemistry
Urinalysis dipsticka
Lipid panel
NT-proBNPb
Serum pregnancy testingc
b Assessments of NT-proBNP and CRP will not be performed during the OLE Period.
c Pregnancy testing will consist of serum testing at the Screening. Urine pregnancy testing will be performed at 
all other visits.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 259 of 263
Was changed to:
Table 12-2  Laboratory measurements
Hematology
Chemistry
Urinalysis dipsticka
Lipid panelb
NT-proBNPb
Serum pregnancy testingc
b Assessments of NT-proBNP and CRP will not be performed during any OLE Period; in addition, lipid panel 
will not be performed during OLE2 Period.
c Pregnancy testing will consist of serum testing at the initial Screening. Urine pregnancy testing will be 
performed at all other visits.
Change #26
Section 12.3.2Pregnancy testing
Pregnancy testing will consist of serum testing at the Screening. The pregnancy test will be urine 
at other visits.
The Screening Visit serum pregnancy testing results must be negative and received and reviewed 
prior to randomization.A negative urine pregnancy test result should be obtained immediately 
prior to each administration of IMP as specified in Table 5‒1 and Table 5‒2. Pregnancy tests 
should be administered to all female subjects of childbearing potential, regardless of their use of 
birth control.
Subjects of childbearing potential should conduct a home pregnancy test every 4 weeks. Home 
pregnancy tests will be provided to participants for use at Weeks 60, 68, 76, 80, 88, 92, 100, 104, 
112, 116, 124, 128, 136, and 140. At weeks on which IMP dosing is scheduled (specified in 
Table 5‒1 and Table 5‒2), a negative urine pregnancy test result should be obtained immediately 
prior to the administration of IMP. In the case of a positive pregnancy test result, IMP should not
be administered and the site should be contacted.
Was changed to:
Pregnancy testing will consist of serum testing at the initial Screening. The pregnancy test will 
be urine at other visits, including at the OLE2 Screening Visit.
The Screening Visit serum pregnancy testing results must be negative and received and reviewed 
prior to randomization.
A negative urine pregnancy test result should be obtained immediately prior to each 
administration of IMP at the visits specified in Table 5‒1, Table 5‒2, and Table 5-3. Pregnancy 
tests should be administered to all female subjects of childbearing potential, regardless of their 
use of birth control.
Subjects of childbearing potential should conduct a home pregnancy test every 4 weeks. Home 
pregnancy tests will be provided to participants for use at Weeks 60, 68, 76, 80, 88, 92, 100, 104, 
112, 116, 124, 128, 136, and 140, and at the OLE2 Weeks 4, 8, 16, 32, and 40. At weeks on 
which IMP dosing is scheduled (specified in Table 5‒1, Table 5‒2, and Table 5-3), a negative 
urine pregnancy test result should be obtained immediately prior to the administration of IMP. In 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 260 of 263
the case of a positive pregnancy test result, IMP should not be administered and the site should 
be contacted.
Change #27
Section 12.4.2Medical history
A complete medical history will be collected as part of the Screening assessment and include all 
clinically relevant past or coexisting medical conditions and surgeries. Findings will be recorded 
in the eCRF.
Was changed to:
A complete medical history will be collected as part of the initial Screening assessment and
include all clinically relevant past or coexisting medical conditions and surgeries. Findings will 
be recorded in the eCRF. 
For OLE2 Group B, only new or modified medical history since completing the SFU will be 
collected at OLE2 Screening and entered in eCRF.
Change #28
Section 12.4.4Data Monitoring and Adjudication Committees
The Cardiovascular and Neuropsychiatric Adjudication Committees will monitor the study 
through the last subject completing the OLE and SFU Periods for PS0015.
Was changed to:
The Cardiovascular and Neuropsychiatric Adjudication Committees will monitor the study 
through the last subject completing the OLE, SFU, OLE2, and SFU2 Periods for PS0015.
Change #29
Section 14.1
Definition of analysis sets
The following paragraph was added:
The OLE2 Period Set (OL2S) will consist of all subjects that receive at least 1 dose of IMP 
at the Week 144/OLE2 Baseline or later in the OLE2 Period (including the Week 
144/OLE2 Baseline dose).
Change #30
Section 14.3.2.2
Analysis of the other efficacy variables
In general, data will be summarized by visit through Week 48 in the double-blind Treatment 
Period and then by visit in the OLE Period separately. All summaries of data up to Week 16 will 
be based on the RS for the 2 randomized treatment groups (bimekizumab and secukinumab). For 
visits after Week 16 in the double-blind Treatment Period, by-visit summaries will be prepared 
for the following 3 groups of subjects:
Was changed to:
In general, data will be summarized by visit through Week 48 in the double-blind Treatment 
Period and then by visit in the OLE Period and OLE2 Period separately. All summaries of data 
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 261 of 263
up to Week 16 will be based on the RS for the 2 randomized treatment groups (bimekizumab and 
secukinumab). For visits after Week 16 in the double-blind Treatment Period, by-visit summaries 
will be prepared for the following 3 groups of subjects:
And the folloing sentence was added:
In the OLE2 Period, selected efficacy variables of interest will be summarized descriptively 
by OLE2 Period Treatment Group during the OLE2 Period.
Change #31
Section 14.5.1Safety analyses
Safety variables will be analyzed for all subjects in the SS. This will include all subjects who 
took at least one dose of study medication. Selected analyses will also be presented for MS and 
OLS.
Was changed to
Safety variables will be analyzed for all subjects in the SS. This will include all subjects who 
took at least one dose of study medication. Selected analyses will also be presented for MS, 
OLS, and OL2S.
Change #32
Section 14.8
Planned interim analysis
An interim analysis is planned at Week 48, details of which will be documented in the SAP. 
Additional interim analyses may be performed (details of which will be documented in the SAP). 
Corresponding interim Clinical Study Reports (CSRs) may be written. A final analysis and 
updated final CSR will be prepared once all data through the SFU visit and including the OLE
Period have been collected.
Was changed to
An interim analysis is planned at Week 48 and Week 144, details of which will be documented 
in the SAP. Additional interim analyses may be performed (details of which will be documented 
in the SAP). Corresponding interim Clinical Study Reports (CSRs) may be written. A final 
analysis and updated final CSR will be prepared once all data through the OLE2 Period and 
SFU2 Visit have been collected.
Change #33
Section 15.1
Informed consent
All subjects enrolling in the OLE Period will sign a new ICF.
Was changed to
All subjects enrolling in the OLE Period will sign a new ICF. Similarly, all subjects enrolling 
in the OLE2 Period will sign a new ICF.
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 262 of 263
19
DECLARATION AND SIGNATURE OF INVESTIGATOR
I confirm that I have carefully read and understood this protocol and agree to conduct this 
clinical study as outlined in this protocol, according to current GCP and local laws and 
requirements.
I will ensure that all subinvestigators and other staff members read and understand all aspects of 
this protocol.
I have received and read all study-related information provided to me.
The objectives and content of this protocol as well as the results deriving from it will be treated 
confidentially, and will not be made available to third parties without prior authorization by 
UCB.
All rights of publication of the results reside with UCB, unless other agreements were made in a 
separate contract.
Investigator:
Printed name
Date/Signature
PUBLIC COPY 
CO
This document cannot be used to support 
Date/Sign
ate/Sig
rtrt any marketing 
o
reements 
emen
authorization 
s of 
of 
will be tr
ill be 
orizatio
rizatio
application and any extensions or 
ature
ature
variations 
va
thereof. 
ea
n by 
by 
s were m
 were m


UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 263 of 263
20
SPONSOR DECLARATION
I confirm that I have carefully read and understand this protocol and agree to conduct this 
clinical study as outlined in this protocol and according to current GCP.
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof. 


Approval Signatures
Name:
ps0015-protocol-amend-5.4
Version:
1. 0
Document Number:
CLIN-000178914
Title:
ps0015-protocol-amend-5.4
Approved Date:
01 Oct 2021
Document Approvals
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 01-Oct-2021 16:11:46 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 01-Oct-2021 16:11:56 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 01-Oct-2021 16:12:05 GMT+0000
UBLIC 
PU
COPY 
O
ument 
ment
C
This document cann
nnot 
nn
be used 
u
to 
to
to
port
Approv
Appro
suppo
po
p
Na
any marketing authorization 
application and 
n
y
any y
sions
s
: 
pacity
Date 
extensisi
ns
e
s or
als
al
or 
or
o variations 
va
ls
thereof. 

SAP_001.pdf: 
UCB 
 
14-Mar-2022 
Statistical Analysis Plan 
Bimekizumab 
PS0015 
 
 
 
Confidential 
Page 1 of 205 
 
STATISTICAL ANALYSIS PLAN 
 
 
Study: PS0015 
Product: Bimekizumab 
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, SECUKINUMAB-CONTROLLED, 
PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 
BIMEKIZUMAB IN ADULT SUBJECTS WITH MODERATE TO SEVERE CHRONIC 
PLAQUE PSORIASIS 
SAP/Amendment Number Date  
Final SAP 
29-Mar-2019 
Amendment 1 
21-Feb-2020 
Amendment 2 
Amendment 3 
15-Jun-2020 
21-Jan-2021 
Amendment 4 
14-Mar-2022 
Confidentiality Statement 
Confidential 
This document is the property of UCB and may not – in full or in part – be passed on, 
reproduced, published, or otherwise used without the express permission of UCB. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.


UCB 
 
14-Mar-2022 
Statistical Analysis Plan 
Bimekizumab 
PS0015 
 
 
 
Confidential 
Page 2 of 205 
TABLE OF CONTENTS 
LIST OF ABBREVIATIONS .................................................................................................... 8 
1 
INTRODUCTION ........................................................................................................... 11 
2 
PROTOCOL SUMMARY ............................................................................................... 11 
2.1 
Study objectives ........................................................................................................... 11 
2.1.1 
Primary objectives ............................................................................................... 11 
2.1.2 
Secondary objectives ........................................................................................... 11 
2.1.3 
Other objectives ................................................................................................... 11 
2.2 
Study variable(s) .......................................................................................................... 12 
2.2.1 
Efficacy variable(s) .............................................................................................. 12 
2.2.1.1 
Primary efficacy variable .......................................................................... 12 
2.2.1.2 
Secondary efficacy variables ..................................................................... 12 
2.2.1.3 
Other efficacy variables ............................................................................. 12 
2.2.2 
Pharmacokinetic/pharmacodynamic variable ...................................................... 13 
2.2.3 
Safety variable(s) ................................................................................................. 13 
2.2.3.1 
Secondary safety variables ........................................................................ 13 
2.2.3.2 
Other safety variables ................................................................................ 14 
2.2.4 
Immunological variable ....................................................................................... 14 
2.3 
Study design and conduct ............................................................................................ 14 
2.3.1 
Study description ................................................................................................. 14 
2.3.2 
Study periods ....................................................................................................... 14 
2.3.2.1 
Screening Period ........................................................................................ 15 
2.3.2.2 
Initial Treatment Period ............................................................................. 16 
2.3.2.3 
Maintenance Treatment Period.................................................................. 16 
2.3.2.4 
OLE Period ................................................................................................ 16 
2.3.2.5 
OLE2 Period .............................................................................................. 17 
2.3.2.6 
Safety Follow-Up ...................................................................................... 18 
2.3.2.7 
Premature End of Treatment ..................................................................... 18 
2.3.3 
Study duration per subject ................................................................................... 18 
2.3.4 
Planned number of subjects and sites .................................................................. 19 
2.3.5 
Anticipated regions and countries ....................................................................... 19 
2.4 
Determination of sample size ....................................................................................... 19 
3 
DATA ANALYSIS CONSIDERATIONS ...................................................................... 19 
3.1 
General presentation of summaries and analyses ........................................................ 19 
3.2 
Definition of Baseline values ....................................................................................... 21 
3.3 
Mapping of data from early withdrawal visits ............................................................. 21 
3.4 
Protocol deviations....................................................................................................... 22 
3.5 
Analysis sets................................................................................................................. 22 
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Statistical Analysis Plan 
Bimekizumab 
PS0015 
 
 
 
Confidential 
Page 3 of 205 
3.5.1 
Enrolled Set ......................................................................................................... 22 
3.5.2 
Randomized Set ................................................................................................... 22 
3.5.3 
Safety Set ............................................................................................................. 22 
3.5.4 
Full Analysis Set .................................................................................................. 22 
3.5.5 
Maintenance Set ................................................................................................... 22 
3.5.6 
Open-Label Set .................................................................................................... 22 
3.5.7 
Open-Label Set 2 ................................................................................................. 23 
3.5.8 
Per Protocol Set ................................................................................................... 23 
3.5.9 
Pharmacokinetics Per-Protocol Set ...................................................................... 23 
3.5.10 
Bimekizumab Set ................................................................................................. 23 
3.6 
Treatment assignment and treatment groups ............................................................... 23 
3.7 
Center pooling strategy ................................................................................................ 25 
3.8 
Coding dictionaries ...................................................................................................... 25 
3.9 
Relative day ................................................................................................................. 26 
3.10 
Changes to protocol-defined analyses ......................................................................... 26 
3.10.1 
Changes related to COVID-19 ............................................................................. 27 
4 
STATISTICAL/ANALYTICAL ISSUES ....................................................................... 27 
4.1 
Adjustments for covariates .......................................................................................... 27 
4.2 
Handling of dropouts or missing data .......................................................................... 27 
4.2.1 
Handling of missing data for efficacy variables .................................................. 27 
4.2.1.2 
Handling missing data for the secondary efficacy variables ..................... 28 
4.2.1.3 
Handling missing data for the other efficacy variables ............................. 28 
4.2.1.4 
Handling missing data for subgroup analyses ........................................... 28 
4.2.1.5 
Missing data overview and summary ........................................................ 29 
4.2.1.6 
Missing data algorithm – MI – MCMC / Monotone Regression .............. 29 
4.2.1.7 
Missing data methods for assessing impact of COVID-19 ....................... 33 
4.2.2 
Handling missing data for safety variables .......................................................... 35 
4.3 
Interim analyses and data monitoring .......................................................................... 36 
4.4 
Multicenter studies ....................................................................................................... 36 
4.5 
Multiple comparisons/multiplicity ............................................................................... 37 
4.6 
Use of an efficacy subset of subjects ........................................................................... 38 
4.7 
Active-control studies intended to show equivalence .................................................. 38 
4.8 
Examination of subgroups ........................................................................................... 38 
5 
STUDY POPULATION CHARACTERISTICS ............................................................. 39 
5.1 
Subject disposition ....................................................................................................... 39 
5.2 
Protocol deviations....................................................................................................... 40 
6 
DEMOGRAPHICS AND OTHER BASELINE CHARACTERISTICS ........................ 40 
6.1 
Demographics .............................................................................................................. 40 
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6.2 
Other Baseline characteristics ...................................................................................... 41 
6.3 
Medical history and concomitant diseases ................................................................... 42 
6.4 
Prior and concomitant medications .............................................................................. 43 
7 
MEASUREMENTS OF TREATMENT COMPLIANCE ............................................... 43 
8 
EFFICACY ANALYSES ................................................................................................ 47 
8.1 
Statistical analysis of the primary efficacy variable .................................................... 47 
8.1.1 
Derivations of primary efficacy variable ............................................................. 47 
8.1.1.1 
Psoriasis Area and Severity Index (PASI) ................................................ 47 
8.1.1.2 
PASI100 Response at Week 16 ................................................................. 48 
8.1.2 
Primary analysis of the primary efficacy variable ............................................... 48 
8.1.3 
Supportive and sensitivity analyses of the primary efficacy variable ................. 49 
8.1.3.1 
Sensitivity Analysis #1 .............................................................................. 49 
8.1.3.2 
Sensitivity Analysis #2 .............................................................................. 49 
8.1.3.3 
Sensitivity Analysis #3 .............................................................................. 50 
8.1.3.4 
Sensitivity Analysis #4 .............................................................................. 50 
8.1.3.5 
Sensitivity Analysis #5 .............................................................................. 50 
8.1.3.6 
Sensitivity Analysis #6 .............................................................................. 50 
8.2 
Statistical analysis of the secondary efficacy variables ............................................... 51 
8.2.1 
Derivations of secondary efficacy variables ........................................................ 51 
8.2.1.2 
PASI90 Responder at Week 16 ................................................................. 51 
8.2.1.3 
PASI100 Responder at Week 48 ............................................................... 51 
8.2.1.4 
IGA Response (0/1) at Week 16 ................................................................ 51 
8.2.2 
Primary analysis of the secondary efficacy variables .......................................... 51 
8.2.3 
Sensitivity analyses of the secondary efficacy variables ..................................... 52 
8.3 
Analysis of other efficacy variables ............................................................................. 52 
8.3.1 
PASI ..................................................................................................................... 53 
8.3.1.1 
PASI75, PASI90 and PASI100 response rates .......................................... 53 
8.3.1.2 
Time to PASI75, PASI90 and PASI100 response ..................................... 53 
8.3.1.3 
PASI score ................................................................................................. 54 
8.3.2 
IGA response ....................................................................................................... 54 
8.3.3 
Body Surface Area (BSA) ................................................................................... 56 
8.3.4 
Product of IGA and BSA (IGAxBSA) ................................................................ 56 
8.3.5 
Dermatology Life Quality Index (DLQI) ............................................................ 56 
8.3.6 
Patient’s Global Assessment of Disease Activity (PGADA) for arthritis visual 
analog scale (VAS) .............................................................................................. 58 
8.3.7 
Patient Global Assessment of PSO ...................................................................... 58 
8.3.8 
Symptoms of PSO (Itch, pain, and scaling) ......................................................... 59 
8.3.9 
Modified Nail Psoriasis Severity Index (mNAPSI) score ................................... 59 
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8.3.10 
Psoriatic Arthritis Screening and Evaluation (PASE) ......................................... 60 
8.3.11 
Euro-Quality of Life 5-Dimensions, 3 levels (EQ-5D-3L) ................................. 60 
8.3.12 
Work Productivity and Activity Impairment Questionnaire – Specific Health 
Problem (WPAI-SHP) ......................................................................................... 61 
8.4 
Additional Statistical Analysis of other Efficacy Variables ........................................ 62 
9 
PHARMACOKINETICS AND PHARMACODYNAMICS .......................................... 63 
9.1 
Pharmacokinetics ......................................................................................................... 64 
9.2 
Pharmacodynamics ...................................................................................................... 64 
9.3 
Immunogenicity ........................................................................................................... 65 
9.3.1 
Anti-nuclear antibodies ........................................................................................ 65 
9.3.2 
Anti-bimekizumab antibodies .............................................................................. 65 
10 SAFETY ANALYSES ..................................................................................................... 69 
10.1 
Extent of exposure ....................................................................................................... 69 
10.1.1 
Exposure during the Initial Treatment Period for SS .......................................... 70 
10.1.2 
Exposure during the Maintenance Treatment Period for MS .............................. 71 
10.1.3 
Exposure during the Initial and Maintenance Treatment Period for SS .............. 72 
10.1.3.1 
For subjects who do not switch study treatments ...................................... 72 
10.1.3.2 
For subjects who switch from BKZ 320mg Q4W to Q8W at Week 16: ... 73 
10.1.4 
Exposure during the Open-Label Extension Period based on OLS ..................... 73 
10.1.4.1 
For subjects who do not switch study treatments ...................................... 73 
10.1.4.2 
For subjects who switch from BKZ 320mg Q4W to Q8W during Open-
Label Extension Period ............................................................................. 74 
10.1.5 
Exposure during the Double-blind and Open-Label Extension Period based on 
BKZ set ................................................................................................................ 76 
10.1.5.1 
For subjects who do not switch dose ......................................................... 76 
10.1.5.2 
For subjects who switch dose .................................................................... 76 
10.1.6 
Exposure during the OLE2 Period based on OLE2 set ....................................... 79 
10.1.6.1 
Group A: Subjects who roll over directly from OLE to OLE2 ................. 79 
10.1.6.2 
Group B: Subjects who reinitiate bimekizumab ........................................ 79 
10.2 
Adverse events ............................................................................................................. 81 
10.2.1 
Data considerations .............................................................................................. 81 
10.2.1.1 
COVID-19 related data considerations ..................................................... 83 
10.2.2 
AE summaries ...................................................................................................... 84 
10.2.3 
Other Safety topics of interest ............................................................................. 87 
10.2.3.1 
Infections (serious, opportunistic, fungal and Tuberculosis [TB]) ........... 87 
10.2.3.2 
Malignancies ............................................................................................. 90 
10.2.3.3 
Cardiac events ........................................................................................... 90 
10.2.3.4 
Neutropenia ............................................................................................... 92 
10.2.3.5 
Suicidal Ideation and Behavior (SIB) ....................................................... 92 
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10.2.3.6 
Inflammatory bowel disease ...................................................................... 93 
10.2.3.7 
Hypersensitivity (including anaphylaxis) .................................................. 95 
10.2.3.8 
Hepatic events ........................................................................................... 95 
10.3 
Clinical laboratory evaluations .................................................................................... 96 
10.4 
Vital signs, physical findings, and other observations related to safety ...................... 99 
10.4.1 
Vital signs ............................................................................................................ 99 
10.4.2 
Physical examination ......................................................................................... 100 
10.4.3 
Electrocardiograms ............................................................................................ 100 
10.4.4 
Other safety variables ........................................................................................ 101 
10.4.4.1 
Assessment and management of TB and TB risk factors ........................ 101 
10.4.4.2 
Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) ............ 101 
10.4.4.3 
Pregnancy testing .................................................................................... 102 
10.4.4.4 
Childbearing potential and Lifestyle ....................................................... 102 
10.4.4.5 
Patient Health Questionnaire 9 (PHQ-9) ................................................. 102 
11 REFERENCES .............................................................................................................. 104 
12 APPENDICES ............................................................................................................... 105 
12.1 
Appendix A: MedDRA algorithmic approach to anaphylaxis ................................... 105 
12.2 
Appendix B: Definition of CTCAE grades ................................................................ 109 
12.3 
Appendix C: Week 96 interim analyses..................................................................... 110 
12.4 
Appendix D: Efficacy analyses by data cut visit ....................................................... 112 
13 AMENDMENT(S) TO THE STATISTICAL ANALYSIS PLAN (SAP) .................... 114 
13.1 
Amendment 1 ............................................................................................................. 114 
13.2 
Amendment 2 ............................................................................................................. 132 
13.3 
Amendment 3 ............................................................................................................. 138 
13.4 
Amendment 4 ............................................................................................................. 157 
STATISTICAL ANALYSIS PLAN SIGNATURE PAGE ................................................... 205 
 
LIST OF TABLES 
Table 4‒1: 
Missing data handling approach by variable priority and type ........................ 29 
Table 4‒2: 
Allowable ranges for imputation by variable................................................... 31 
Table 7‒1: 
Dosing scheme ................................................................................................. 45 
Table 7‒2: 
Dosing scheme, OLE Period ............................................................................ 45 
Table 7‒3: 
Dosing scheme, OLE2 Period .......................................................................... 46 
Table 8‒1: 
Investigator’s Global Assessment .................................................................... 51 
Table 8‒2: 
Scalp IGA......................................................................................................... 54 
Table 8‒3: 
Palmoplantar IGA ............................................................................................ 55 
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Table 8‒4: 
Dermatology Life Quality Index ...................................................................... 57 
Table 10‒1: 
Definitions of Markedly Abnormal Liver Function Values ............................ 97 
Table 10‒2: 
Definitions of Markedly Abnormal Biochemistry Values ............................... 97 
Table 10‒3: 
Definitions of Markedly Abnormal Hematology Values ................................. 98 
Table 10‒4: 
Definitions of Markedly Abnormal Blood Pressure Values .......................... 100 
Table 12‒1: 
Definitions of CTCAE grades by biochemistry parameter ............................ 109 
Table 12‒2: 
Definitions of CTCAE grades by hematology parameter .............................. 110 
Table 12‒3: 
Efficacy analyses reporting ............................................................................ 112 
 
 
 
 
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LIST OF ABBREVIATIONS 
ACP 
above cut point 
ADAb 
anti-drug antibodies 
AE 
adverse event 
AH 
abnormal high 
AL 
abnormal low 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
ATC 
Anatomical Therapeutic Chemical 
BCP 
below cut point 
BMI 
body mass index 
BSA 
body surface area 
CI 
confidence interval 
CMH 
Cochran-Mantel-Haenszel 
COVID-19 
Coronavirus Disease 2019 
CP 
confirmed positive 
CSR 
Clinical Study Report 
CTCAE 
Common Terminology Criteria for Adverse Events 
CV 
coefficient of variation 
CV-CAC 
Cardiovascular Clinical Event Adjudication Committee 
DILI 
drug-induced liver injury 
DLQI 
Dermatology Life Quality Index 
DMC 
Data Monitoring Committee 
EAER 
exposure adjusted event rate 
EAIR 
exposure adjusted incidence rate 
ECG 
electrocardiogram 
eC-SSRS 
electronic Columbia Suicide Severity Rating Scale 
EQ-5D-3L 
European Quality-of-Life 5-Dimensions 3-Level 
EudraCT 
European Union Drug Regulating Authorities Clinical Trials 
GGT 
gamma-glutamyltransferase 
FAS 
Full Analysis Set 
HLT 
High Level Term 
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IGA 
Investigator’s Global Assessment 
IGRA 
interferon-gamma release assay 
IMP 
investigational medicinal product 
LOCF 
last observation carried forward 
MACE 
Major adverse cardiac events 
MAR 
missing at random 
MCID 
minimally important clinical difference 
MCMC 
Markov-Chain Monte Carlo 
MedDRA 
Medical Dictionary for Regulatory Activities 
MI 
multiple imputation 
mNAPSI 
MS 
Modified Nail Psoriasis Severity Index  
Maintenance Set 
NCP 
not confirmed positive 
NRI 
nonresponder imputation 
OLE 
open-label extension 
OLE2 
open-label extension 2 
OLS 
open-label set 
OLS2 
open-label set 2 
OC 
Observed case 
PASE 
Psoriatic Arthritis Screening and Evaluation 
PASI 
Psoriasis Area Severity Index 
PD 
pharmacodynamic(s) 
pDILI 
potential drug induced liver injury 
PEOT 
Premature End of Treatment 
PGA 
Patients Global Assessment 
PGADA 
Patient's Global Assessment of Disease Activity 
PHQ-9 
Patient Health Questionnaire-9 
PK 
pharmacokinetic(s) 
PK-PPS 
Pharmacokinetics Per-Protocol Set 
pp-IGA 
palmoplantar Investigator’s Global Assessment 
PPS 
Per-Protocol Set 
PsA 
psoriatic arthritis 
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PSD 
patient symptom diary 
PSO 
psoriasis 
PT 
preferred term 
Q4W 
every 4 weeks 
Q8W 
every 8 weeks 
QOL 
quality of life 
RS 
Randomized Set 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
SAS 
Statistical Analysis Software 
sc 
subcutaneous(ly) 
scalp IGA 
scalp-specific Investigator’s Global Assessment 
SD 
standard deviation 
SFU 
Safety Follow-Up 
SFU2 
Safety Follow-Up 2 
SIB 
suicidal ideation and behavior 
SMQ 
Standardized MedDRA Query 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
SS 
Safety Set 
TB 
tuberculosis 
TEAE 
treatment-emergent adverse event 
ULN 
upper limit of normal 
VAS 
visual analog scale 
WBC 
white blood cell 
WHO-DD 
World Health Organization Drug Dictionary 
WPAI-SHP 
Work Productivity and Activity Impairment Questionnaire-specific 
health problem 
 
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1 
INTRODUCTION 
This statistical analysis plan (SAP) defines the scope of statistical analyses and provides a 
detailed description of statistical methodology for the statistical analyses to support the final 
clinical study report. The SAP is based on the following study documents: Protocol Amendments 
5.4 (US) 01 Oct 2021, and 5.5 (Canada) 08 Dec 2021. 
2 
PROTOCOL SUMMARY 
2.1 
Study objectives 
2.1.1 
Primary objectives 
The primary objective of this study is to compare the efficacy of bimekizumab administered 
subcutaneously (sc) for 16 weeks versus secukinumab at achieving complete clearance 
(PASI100) in subjects with moderate to severe chronic plaque psoriasis (PSO). 
2.1.2 
Secondary objectives 
The secondary objectives of the study are to: 
• Evaluate the efficacy of bimekizumab compared with secukinumab after 4 weeks, 16 weeks, 
and 48 weeks of treatment. 
• Assess treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and 
TEAEs leading to withdrawal adjusted by duration of subject exposure to investigational 
medicinal product (IMP). 
2.1.3 
Other objectives 
The other objectives of the study are to demonstrate the effects of bimekizumab on the following 
aspects of the disease: 
• Assess the efficacy of bimekizumab over time 
• Assess the change of skin-related quality of life (QOL) 
• Assess the change of general health-related QOL 
• Assess the change in nail PSO over time in subjects with nail PSO at Baseline 
• Assess the change in psoriatic scalp disease over time in subjects with scalp PSO at Baseline 
• Assess the change in psoriatic palmoplantar disease over time in subjects with palmoplantar 
PSO at Baseline 
• Assess the change in patient global assessment PSO score 
• Assess the change in symptoms of PSO (itch, pain, and scaling) as reported by subjects 
• Assess work productivity status 
• Assess the safety and tolerability of bimekizumab 
• Assess the pharmacokinetics (PK) of bimekizumab 
• Assess the immunogenicity of bimekizumab 
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• Assess the maintenance of efficacy of bimekizumab dosing Q4W versus Q8W 
• Assess the safety and efficacy of initiating bimekizumab therapy in subjects who received 
secukinumab in the double-blind Treatment Period 
2.2 
Study variable(s) 
2.2.1 
Efficacy variable(s) 
2.2.1.1 
Primary efficacy variable 
The primary efficacy variable is the PASI100 response, defined as complete clearance from 
Baseline in the Psoriasis Area Severity Index (PASI) score, at Week 16. 
2.2.1.2 
Secondary efficacy variables 
The secondary efficacy variables are: 
• PASI75 response at Week 4 
• PASI90 response at Week 16 
• PASI100 response at Week 48 
• Investigators Global Assessment (IGA) response (Clear or Almost Clear with at least 2-
category improvement relative to Baseline) at Week 16 
2.2.1.3 
Other efficacy variables 
The other efficacy variables are: 
• PASI75, PASI90, and PASI100 response 
• Time to PASI75, PASI90, and PASI100 response 
• Absolute and percent change from Baseline in PASI 
• Percentage of subjects with PASI ≤1, ≤2, ≤3, and ≤5 
• IGA response (Clear with at least 2 category improvement relative to Baseline) 
• IGA response (Clear or Almost Clear with at least 2 category improvement relative to 
Baseline) 
• Shift from Baseline in IGA score 
• Absolute and percent change from Baseline in the body surface area (BSA) affected by PSO 
• Percent of subjects with absolute BSA=0%, ≤1%, ≤3% and ≤5% 
• Absolute and percent change from Baseline in the product of IGA and BSA (IGAxBSA) 
• Change from Baseline in Dermatology Life Quality Index (DLQI) total score 
• Percent of subjects achieving a DLQI total score of 0 or 1 
• Percent of subjects achieving a minimal clinically important difference (MCID) 
(improvement from Baseline of 4 or more) in the DLQI total score 
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• Change from Baseline in the Patient's Global Assessment of Disease Activity (PGADA) for 
the arthritis visual analog scale (VAS) in subjects with psoriatic arthritis (PsA) at Baseline 
• Shift from Baseline in Patient Global Assessment of PSO score 
• Change from Baseline in symptoms of PSO (itch, pain, and scaling) 
• Patient Symptom Diary responses for itch, pain, and scaling 
• Change from Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) score for 
subjects with nail PSO at Baseline 
• mNAPSI75 response (defined as a subject that achieves at least a 75% reduction from 
Baseline in the mNAPSI score) for subjects with nail PSO at Baseline 
• mNAPSI90 response (defined as a subject that achieves at least a 90% reduction from 
Baseline in the mNAPSI score) for subjects with nail PSO at Baseline 
• mNAPSI100 response (defined as a subject that achieves a 100% reduction from Baseline in 
the mNAPSI score) for subjects with nail PSO at Baseline 
• Scalp IGA response (clear or almost clear with at least a two-category improvement from 
Baseline) for subjects with scalp PSO at Baseline 
• Palmoplantar Investigator’s Global Assessment (pp-IGA) response (clear or almost clear 
with at least a two-category improvement from Baseline) for subjects with palmoplantar PSO 
at Baseline 
• Responses to the European Quality-of-Life 5-Dimensions 3-Level (EQ-5D-3L) dimensions, 
absolute and changes from Baseline in EQ-5D-3L VAS scores 
• Change from Baseline in Work Productivity and Activity Impairment Questionnaire-specific 
health problem (WPAI-SHP) V2.0 adapted to PSO scores 
• Change from Baseline in the Psoriatic Arthritis Screening and Evaluation (PASE) 
questionnaire scores (function score, symptom score, and total score) 
• Shift from Baseline in PASE score suggestive of PsA (<47 versus ≥47) 
2.2.2 
Pharmacokinetic/pharmacodynamic variable 
The PK variable is the plasma concentration of bimekizumab. Pharmacokinetic samples from 
subjects receiving secukinumab will not be analyzed, but stored for potential future PK analysis 
and anti-drug antibody determination. 
No assessment of pharmacodynamics will be done. 
2.2.3 
Safety variable(s) 
2.2.3.1 
Secondary safety variables 
The secondary safety variables include the following treatment emergent adverse events 
(TEAEs) and serious adverse events (SAEs). 
• TEAEs adjusted by duration of subject exposure to IMP 
• SAEs adjusted by duration of subject exposure to IMP 
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• TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment 
2.2.3.2 
Other safety variables 
Other safety variables to be assessed are: 
• Severity and frequency of adverse events (AEs) (including serious AEs) 
• Change from Baseline in vital signs 
• Electrocardiogram (ECG) results 
• Change from Baseline in clinical laboratory values (chemistry and hematology) 
• Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) scores 
Physical examination findings considered clinically significant changes since the physical 
examination at the Screening Visit will be recorded as AEs. 
2.2.4 
Immunological variable 
The immunological variable is the anti-bimekizumab antibody level prior to and following IMP 
administration. 
2.3 
Study design and conduct 
2.3.1 
Study description 
PS0015 is a randomized, double-blind, secukinumab-controlled, parallel-group study to evaluate 
the efficacy and safety of bimekizumab administered sc to subjects with moderate to severe 
chronic plaque PSO. To be eligible to participate in this study, subjects must be adults with a 
diagnosis of moderate to severe plaque PSO (PASI ≥12 and BSA ≥10% and IGA score ≥3 [on a 
5-point scale]) who are candidates for secukinumab, or for systemic PSO therapy and/or 
phototherapy. 
2.3.2 
Study periods 
This study will include 5 periods, a Screening Period (2 to 5 weeks), a double-blind Treatment 
Period (48 weeks; final dose at Week 44), an optional open-label extension (OLE) Period (96 
weeks, final dose at Week 136 for subjects receiving bimekizumab 320mg Q8W and at Week 
140 for subjects receiving bimekizumab 320mg Q4W, followed by a safety follow-up (SFU) 
Period (20 weeks after the final dose of IMP). Eligible subjects from US and Canada sites who 
have completed the OLE Period (at Week 144), including subjects in the SFU period and 
subjects who have completed the SFU Period will have the option to enroll in the 48-week 
Open-Label Extension 2 (OLE2) Period followed by a SFU Period (SFU2, 20 weeks after the 
final dose of IMP administered in the OLE2).  
The double-blind treatment Period will be separated into an Initial Treatment Period (16 weeks) 
and a Maintenance Treatment Period (32 weeks). The end of the study is defined as the date of 
the last visit of the last subject in the study. 
Subjects withdrawing early from the study will undergo the premature end of treatment (PEOT) 
Visit assessments and will enter the SFU Period. Following completion or early withdrawal from 
the OLE2 Period, subjects will undergo the SFU of the OLE2 Period (SFU2) and will return for 
the SFU2 Visit 20 weeks after the last dose of IMP administration in the OLE2 treatment period. 
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The following study periods are defined for the classification by study period: 
• Screening Period: Prior to the date of first dose of study drug 
• Initial Treatment Period is defined as the time from the first study drug administration up to 
the start of the Maintenance Treatment Period 
• Maintenance Treatment Period starts with the first study drug administration at or after the 
Week 16 visit 
• Open-Label Extension Period starts with the first study drug administration at or after the 
Week 48 visit 
• SFU Period is 20 weeks after the final dose of IMP in the double-blind Treatment Period or 
Open-Label Extension Period 
• Open-Label Extension 2 Period starts with the first study drug administration at or after the 
Week 144/OLE2 Baseline visit 
• SFU2 Period is 20 weeks after the final dose of IMP in the OLE2. 
The Double-blind Treatment Period ends either at the Week 48 visit for subjects completing the 
double-blind Treatment Period, or at PEOT Visit for subjects who discontinued early during the 
double-blind Treatment Period. If a subject does not have a Week 48/PEOT visit, then the date of 
the last scheduled or unscheduled visit during the double-blind Treatment Period will define the 
end date of the double-blind Treatment Period. 
The Open-Label Treatment Period ends either at the Week 144 visit for subjects completing the 
Open-Label Treatment Period, or at PEOT Visit for subjects who discontinued early during the 
Open-Label Treatment Period. If a subject does not have a Week 144/PEOT visit, then the date 
of the last scheduled or unscheduled visit during the Open-Label Treatment Period will define 
the end date of the Open-Label Treatment Period. 
The OLE2 Treatment Period ends either at the OLE2 Week 48 visit for subjects completing the 
OLE2 Period, or at PEOT Visit for subjects who discontinued early during the OLE2 Period. If a 
subject does not have an OLE2 Week 48/PEOT visit, then the date of the last scheduled or 
unscheduled visit during the OLE2 Period will define the end date of the OLE2 Period. 
2.3.2.1 
Screening Period 
The Screening Period will last 2 weeks but can be extended up to a total of 5 weeks in cases 
where a laboratory assessment needs to be repeated or to allow washout of prohibited 
medications. During this time, eligible subjects will be informed about the study and sign the 
Informed Consent Form, laboratory data (hematology, urine, and biochemistry tests) will be 
obtained, and the doses of medications used to treat PsA (if applicable) will be verified as stable. 
The Screening Period will also enable washout of any medications not permitted for use during 
the study. Subjects who require prophylaxis for latent tuberculosis infection must be on treatment 
for at least 8 weeks prior to their first dose of IMP. These subjects may be rescreened once they 
have completed the first 8 weeks of prophylaxis treatment. 
One rescreening may be allowed after consultation with the Medical Monitor. 
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2.3.2.2 
Initial Treatment Period 
During the first 16 weeks of the 48-week double-blind Treatment Period, approximately 700 
subjects will be randomized 1:1 to receive the following blinded IMP regimens: 
• Bimekizumab 320mg administered sc every 4 weeks (Q4W) (350 subjects) 
• Secukinumab 300mg administered sc at Baseline and Weeks 1, 2, 3, and 4 followed by 
dosing Q4W (350 subjects) 
Subjects receiving bimekizumab 320mg will receive placebo sc on Weeks 1, 2, and 3 in order to 
maintain the blind. 
Subjects will be classified as completing the initial treatment period if they complete the Week 
16 Visit without early withdrawal from the study or if they start treatment in the maintenance 
treatment period. The start of the maintenance treatment period marks the end of the initial 
treatment period. 
2.3.2.3 
Maintenance Treatment Period 
At Week 16 subjects in the bimekizumab 320mg treatment arm will be re-randomized 1:2 to 
receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. To maintain the blind after re-
randomization, subjects in the bimekizumab 320mg Q8W treatment arm will receive placebo at 
Weeks 20, 28, 36, and 44. Subjects in the secukinumab arm will continue to receive 
secukinumab 300mg Q4W. 
Subjects will be classified as completing the maintenance treatment period if they complete the 
Week 48 Visit without early withdrawal from the study or if they start treatment in the Open-
Label period. The start of the Open-Label extension period marks the end of the maintenance 
treatment period for subjects opting to participate in the OLE period. Otherwise the end of the 
maintenance period is marked by the Week 48 visit. 
2.3.2.4 
OLE Period 
After completion of the Week 48 visit assessments, subjects will be allowed to enroll in the OLE 
Period. All subjects enrolling in the OLE Period will sign a new ICF, and then receive the 
following IMP regimens as determined by the subject’s treatment regimen and PASI response in 
the double-blind Treatment Period. 
At Week 48, subjects receiving: 
• Bimekizumab 320mg Q4W who achieve PASI90 at Week 48 of the double-blind Treatment 
Period will be randomized 1:1 to receive bimekizumab 320mg Q4W or bimekizumab 320mg 
Q8W. 
• Bimekizumab 320mg Q4W who do not achieve PASI90 at Week 48 of the double-blind 
Treatment Period will receive bimekizumab 320mg Q4W. 
• Bimekizumab 320mg Q8W who achieve PASI90 at Week 48 of the double-blind Treatment 
Period will receive bimekizumab 320mg Q8W. 
• Bimekizumab 320mg Q8W who do not achieve PASI90 at Week 48 of the double-blind 
Treatment Period will receive bimekizumab 320mg Q4W. 
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• Secukinumab who achieve PASI90 at Week 48 of the double-blind Treatment Period will be 
randomized 1:1 to receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. 
• Secukinumab who do not achieve PASI90 at Week 48 of the double-blind Treatment Period 
will receive bimekizumab 320mg Q4W. 
From Week 64 the subjects who are receiving bimekizumab 320mg Q4W at the time of 
implementation of protocol amendment 5.0 will have their dosing interval changed to 
bimekizumab 320mg Q8W at the next clinical site assessment as described on Table 7‒2 for 
subjects who are receiving bimekizumab 320mg Q4W and have reached Week 96 prior to the 
implementation of Protocol Amendment 5.0, if PASI90 is achieved, the subject’s dosing interval 
will change from 320mg Q4W to 320mg Q8W (default), unless, based on medical judgment, the 
Investigator decides differently. Otherwise, if PASI90 is not achieved they will have their dosing 
interval changed to bimekizumab 320mg Q8W at the next clinical site assessment after 
implementation of protocol amendment 5.0 as detailed above. 
During the OLE Period, subjects will attend study visits at Weeks 52, 56, 64, and 72, and then 
every 12 weeks. At study visits, IMP will be administered in the clinic by sc injection as 
applicable. In between study visits, subjects will self-inject IMP at home. Subjects who are 
unable to or decide not to self-inject IMP or those without a family member/friend/caregiver who 
can help, will not be discontinued, but may continue to visit the site for unscheduled visits for 
IMP administration only. 
All subjects not enrolling in the Open-Label study will have the Week 48 study assessments and 
will enter the SFU Period. 
2.3.2.5 
OLE2 Period 
After the implementation of Protocol Amendment #5.4 and 5.5 (with the addition of a 48-week 
Open-Label treatment period, ie, OLE2 Period), subjects from US and Canada sites will be 
invited to continue or reinitiate their treatment as per the following OLE2 Groups:  
• OLE2 Group A: Subjects in the treatment phase of the OLE Period at the time of Protocol 
Amendment #5.4 and 5.5 implementation will attend the Week 144 Visit and directly roll 
over to the OLE2 Period. These subjects will continue receiving bimekizumab 320mg Q8W 
for 40 additional weeks, starting from the first treatment visit of the OLE2 Period (ie, Week 
144/OLE2 Baseline Visit; the Week 144 Visit will coincide with the Week 144/OLE2 
Baseline Visit and data collected at this visit will be used as baseline data for the OLE2 
Period)  
• OLE2 Group B: Eligible subjects who have completed the Week 144 Visit and are in the 
SFU or have completed the SFU of the OLE Period at the time of Protocol Amendment #5.4 
and 5.5 implementation, will be eligible to reinitiate their treatment in the OLE2 Period after 
having undergone additional screening assessments during a 4-week OLE2 Screening Period 
− The first dose of the IMP will be administered at the OLE2 Baseline Visit and data 
collected at this visit will be used as baseline data for the OLE2 Period  
− Subjects in OLE2 Group B with an IGA score ≥3 at the OLE2 Baseline Visit will receive 
bimekizumab Q4W for the first 16 weeks, and then will switch to bimekizumab 320mg 
Q8W  
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− Subjects in OLE2 Group B with an IGA score <3 at the OLE2 Baseline Visit will receive 
bimekizumab Q8W from the OLE2 Baseline Visit. 
Following completion or early withdrawal from the OLE2 Period, subjects will enter the SFU2 
and will return for the SFU2 Visit 20 weeks after the last dose of IMP administration. 
2.3.2.6 
Safety Follow-Up 
All subjects, including those withdrawn from IMP, will have a SFU Visit 20 weeks after their 
final dose of IMP. 
Two SFU Periods are considered following the implementation of Protocol Amendments #5.4 
and #5.5:  
• SFU following the OLE Period following the initial, maintenance, and OLE treatment 
periods  
• SFU2 following the OLE2 treatment period.  
2.3.2.7 
Premature End of Treatment 
Subjects withdrawing early from the study will undergo PEOT Visit assessments and will enter 
the SFU Period or SFU2 Period depending on when subjects withdraw from the study. 
2.3.3 
Study duration per subject 
For each subject not entering the OLE2 treatment period, the study will last a maximum of up to 
165 weeks, as follows: 
• Screening Period: 2 to 5 weeks 
• Double-blind Treatment Period: 48 weeks (final dose at Week 44) 
• OLE Period: 96 weeks (final dose at Week 136 for subjects receiving bimekizumab 320mg 
Q8W and at Week 140 for subjects receiving bimekizumab 320mg Q4W) 
• Safety Follow-Up Period: an SFU Visit is planned 20 weeks after the final dose of IMP 
during the OLE period (this SFU will not apply to subjects directly rolling over from the 
OLE to the OLE2 Period). 
The OLE2 Period will include a 48-week treatment period with a final visit at OLE2 Week 48 
and a SFU2 period of 20 weeks after the final dose of IMP administered in the OLE2 Period.  
For the subjects in the OLE2 Period, maximum study duration will depend on the time between 
their participation in the OLE until Week 144 and the start of the OLE2 Period:  
• 209 weeks for subjects still being treated in the OLE Period and who will directly roll over to 
the OLE2 Period at Week 144 visit 
• 225 weeks for subjects who have completed Week 144 and the SFU; these subjects will have 
a 4-week Screening Period before reinitiating treatment in the OLE2 Period. Note: for these 
subjects, the study duration will not be continuous 
• Between 209 and 225 weeks for subjects who have completed Week 144 and are ongoing in 
the SFU. For these subjects, the maximum study duration will depend upon when they stop 
the 20-week SFU period to enter the 4-week OLE2 Screening Period. 
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2.3.4 
Planned number of subjects and sites 
Approximately 935 subjects will be screened in order to have 700 subjects randomized in the 
study. There will be approximately 350 subjects in the bimekizumab 320mg treatment arm and 
350 subjects in the secukinumab 300mg treatment arm. The planned number of study sites is 
approximately 86 from approximately 11 countries and 4 geographical regions. 
2.3.5 
Anticipated regions and countries 
The regions and countries planned for study conduct are North America (Canada, USA), 
Western Europe (Belgium, France, Germany, Netherlands, Spain, United Kingdom), 
Central/Eastern Europe (Poland), Asia/Australia (Australia, Turkey).  
An additional OLE2 will be conducted in US and Canada only. 
2.4 
Determination of sample size 
A total of 700 subjects will be randomly assigned in a 1:1 ratio at Baseline to one of the 
following treatment groups: 
• Bimekizumab 320mg (350 subjects) 
• Secukinumab 300mg (350 subjects). 
The primary efficacy analysis is based on the comparison of bimekizumab to secukinumab for 
the primary efficacy variable of PASI100 response at Week 16. The assumed responder rates for 
PASI100 at Week 16 are 60% and 44% for bimekizumab and secukinumab, respectively. The 
assumed responder rate for bimekizumab is based on the Phase 2b PS0010 data. The 
assumptions related to the responder rates for secukinumab are based on those observed in the 
CLEAR study (Thaçi et al, 2015). The power to show statistical superiority of bimekizumab 
relative to secukinumab under these assumptions is 98% for the primary endpoint. The power for 
the non-inferiority comparison (with 10% non-inferiority margin) under these assumptions is 
>99%. 
3 
DATA ANALYSIS CONSIDERATIONS 
3.1 
General presentation of summaries and analyses 
Statistical analysis and generation of tables, figures, subject data listings, and statistical output 
will be performed using Statistical Analysis Software (SAS) Version 9.3 or higher. All tables and 
listings will use Courier New font size 9. 
Descriptive statistics will be displayed to provide an overview of the study results. For 
continuous variables, descriptive statistics will include number of subjects with available 
measurements (n), mean, standard deviation (SD), median, minimum, and maximum. 
For categorical variables, the number and percentage of subjects in each category will be 
presented. Unless otherwise noted, the denominator for percentages should be based on the 
number of subjects included in the respective analysis set. Subjects with missing data can 
generally be accounted for using either of the following approaches: 
• For summaries of demographics and Baseline characteristics: summarize percentages based 
on all subjects in the analysis set and include a “Missing” category (corresponding to subjects 
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with missing data for the variable being summarized) as the last row in the list of categories 
being summarized. 
• For summaries of efficacy and safety endpoints, unless otherwise specified: summarize 
percentages based only on those subjects with observed data for the variable being 
summarized. As the denominator may be different from the number of subjects in the 
analysis set being considered, the denominator should be displayed in the table. The general 
format for displaying this will be “n/Nsub (%).” 
Percentages will be presented to 1 decimal place. If the percentage is 100%, do not present a 
decimal. If the percentage is 0, do not present the percentage. Typically, the % sign should be 
presented in the column header, but not with each individual value. 
For bimekizumab PK concentrations, summary statistics will include geometric mean, geometric 
coefficient of variation (CV), 95% confidence intervals for geometric mean, arithmetic mean, 
SD, median, minimum, and maximum. All summaries of PK variables will be based on the 
observed values. No imputation will be used. 
Decimal places for descriptive statistics will always apply the following rules: 
• “n” will be an integer 
• Mean, SD, and median will use one additional decimal place compared to the original data 
• CV [%] will be presented with one decimal place 
• Minimum and maximum will have the same number of decimal places as the original value. 
Derived variables in general will display the mean, SD and median to 1 more decimal place than 
the variables used in the derivation. If the number of decimal places reported in the raw data is 
varied then use either the maximum raw number of reported decimal places or 3, whichever is 
the lowest, as a guide for the descriptive statistics. 
Statistical tests of efficacy variables will be presented as two-sided p-values rounded to three 
decimal places. P-values less than 0.001 will be presented as “<0.001” and p-values greater than 
0.999 will be presented as “>0.999.” Statistical comparisons will be two-sided and will be 
performed at the 0.05 level of significance. 
Per protocol, visit windows of ±3 days from the first dose to Week 24, ±7 days from Week 28 to 
Week 72 and ±14 days from Week 76 to Week 144 are permissible. For the SFU Visit, visit 
window is 20 weeks ±7 days from final dose.  
Per protocol, visit windows of ±14 days from the first OLE2 dose at all OLE2 visits except SFU2 
are permissible, the SFU2 visit window is 20 weeks ±7 days from final dose in OLE2. 
All by-visit summaries will contain nominal (i.e. scheduled) visits only. Unscheduled visits will 
not be mapped to scheduled visits except for assessments that occur within a 3-day time window 
of a scheduled visit. In that case, the assessment will be mapped to the corresponding scheduled 
visit and will be used for the analysis. This will only occur for some vendor data. 
A complete set of data listings containing all documented data as well as calculated data (e.g. 
change from Baseline) will be generated. Separate data listings will be generated for the OLE2 
period. 
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3.2 
Definition of Baseline values 
A Baseline value for a subject is defined as the latest measurement for that subject up to and 
including the day of administration of first study medication, unless otherwise stated. If a 
Baseline assessment is taken on the same day as first administration of study medication, it is 
eligible to be used as the Baseline value, even in the case that the time of the assessment is 
recorded as taking place after the time of first study medication administration. This is 
considered acceptable as this measurement is still the best representation of the Baseline value of 
the given assessment since it is highly unlikely that the study medication could have an impact 
on any measurement in such a short period of time. However, such cases should be rare as study 
center personnel are instructed to do all assessments at the Baseline visit prior to administering 
study medication. One exception to this rule is plasma concentration. If Baseline plasma 
concentration is measured at a time after the first administration of study medication, then it 
should not be eligible to be considered as a Baseline plasma concentration. Such cases should be 
discussed with the quantitative clinical pharmacologist. 
If a Baseline measurement is missing or not collected, and a Screening value is available, the 
Screening value will be utilized as Baseline instead. 
Baseline values for component scores should be computed using components from the same visit 
where the relevant measurements were recorded prior to dosing. For example, if the Screening 
visit has all of the components, but the Baseline visit is missing one or more components, the 
Baseline value for the component score should be calculated using the Screening visit values. 
When the time of first dose is derived, it should be based on the first injection of study treatment, 
regardless of whether or not it is an active treatment. 
Unless specified otherwise, the process laid out above will always be followed to determine 
Baseline. An additional Baseline value for the OLE Period will be defined for anti-bimekizumab 
antibodies for subjects initially randomized to secukinumab and for selected summaries of 
laboratory evaluations. This baseline for the OLE Period is the latest measurement on/prior to the 
day of first dose in the OLE Period for subjects switching from secukinumab to bimekizumab. 
Note that for any laboratory value that occurs on the day of treatment switch, that lab value will 
be attributed and summarized for the treatment the subjects were on previously. 
For subjects enrolled in OLE2, the OLE2 first dose will be administered at the Week 144/OLE2 
Baseline Visit and data collected at this visit will be used as baseline data for safety data in the 
OLE2 Period. Efficacy data will continue to use the Week 0 Visit as Baseline. 
3.3 
Mapping of data from early withdrawal visits 
If the early withdrawal visit (PEOT visit) occurs at a scheduled visit as outlined in the schedule 
of assessments, then no mapping is necessary and any early withdrawal assessments should 
correspond to that scheduled visit. Premature visits that occur between scheduled visits will be 
assigned to the next scheduled visit. This approach means that there is a chance that data 
collected will be mapped to a visit where the given assessment would not have been collected as 
per the protocol schedule of assessments. Such data would not be summarized in by-visit tables 
(though it would be available in the listings). 
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The only exception to the above rule is for anti-bimekizumab antibody assessments, in which all 
early withdrawal visit assessments will be assigned to the next scheduled visit at which 
anti-bimekizumab antibody are assessed. 
All by-visit summaries will contain scheduled visits only. Unscheduled visits will not be mapped 
to scheduled visits. Note that based on the early withdrawal mapping conventions described 
above, a mapped early withdrawal visit is considered as observed at that visit and should be 
summarized as such in the tables. 
3.4 
Protocol deviations 
Important protocol deviations are deviations from the protocol which potentially could have a 
meaningful impact on study conduct, or on the primary efficacy, key safety, or PK outcomes for 
an individual subject. The criteria for identifying important protocol deviations will be defined 
within the appropriate protocol-specific document at study start. Important protocol deviations 
will be reviewed as part of the ongoing data cleaning process. Important protocol deviations 
including those that lead to exclusion from the analysis sets will be identified and documented 
prior to unblinding. 
Deviations related to the Coronavirus Disease 2019 (COVID-19) global pandemic are 
unavoidable deviations from the protocol due to confirmed COVID-19 infection, suspected 
COVID-19 infection, general circumstances around COVID-19 without infection or any other 
deviation from the protocol due to COVID-19. COVID-19 protocol deviations will also be 
reviewed separately as part of the ongoing data cleaning process. 
3.5 
Analysis sets 
3.5.1 
Enrolled Set 
The Enrolled Set (ES) will consist of all subjects who have given informed consent. 
3.5.2 
Randomized Set 
The Randomized Set (RS) will consist of all randomized subjects. 
3.5.3 
Safety Set 
The Safety Set (SS) will consist of all subjects that received at least 1 dose of IMP. 
3.5.4 
Full Analysis Set 
The Full Analysis Set (FAS) will consist of all subjects in the RS that receive at least 1 dose of 
the IMP and have a valid PASI measurement at Baseline. 
3.5.5 
Maintenance Set 
The Maintenance Set (MS) will consist of all subjects that receive at least 1 dose of IMP at Week 
16 or later in the double-blind Treatment Period (including the Week 16 dose). 
3.5.6 
Open-Label Set 
The Open-label Set (OLS) will consist of all subjects that received at least 1 dose of 
bimekizumab at Week 48 or later in the OLE Period (including the Week 48 dose). 
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3.5.7 
Open-Label Set 2 
The Open-label Set 2 (OLS2) will consist of all subjects that received at least 1 dose of 
bimekizumab at Week 144/OLE2 Baseline Visit or later in the OLE2 Period. 
3.5.8 
Per Protocol Set 
The Per-Protocol Set (PPS) will consist of all subjects in the RS who had no important protocol 
deviations affecting the primary efficacy variable. Important protocol deviations will be 
predefined and subjects with important protocol deviations will be evaluated during ongoing data 
cleaning meetings prior to unblinding of the data. 
3.5.9 
Pharmacokinetics Per-Protocol Set 
The Pharmacokinetics Per-Protocol Set (PK-PPS) consists of all randomized subjects who 
received at least 1 dose of the IMP and provided at least 1 quantifiable post-dose plasma 
concentration without important protocol deviations that would affect the concentration. 
3.5.10 
Bimekizumab Set 
The Bimekizumab Set (BKZ Set) consists of all randomized subjects who received at least 1 
dose of bimekizumab in the double-blind or Open-Label extension treatment period. 
3.6 
Treatment assignment and treatment groups 
It is expected that subjects receive treatment as randomized and hence safety analyses will be 
based on the SS, as randomized. However, if after unblinding it is determined that subjects 
randomized to a treatment arm had never received such treatment, then for safety analysis, these 
subjects will be reallocated to the appropriate received treatment groups, unless otherwise 
specified. 
If subjects randomized to secukinumab received bimekizumab at any time, then for safety 
analyses these subjects will be reallocated to the appropriate bimekizumab treatment group, 
unless otherwise specified. Subjects randomized to bimekizumab will only be reallocated to the 
secukinumab treatment group if they never received bimekizumab. 
Efficacy analyses should be performed according to randomized treatment and not actual 
treatment received. 
Randomized treatment groups are Bimekizumab 320mg Q4W and Secukinumab 300mg Q4W. 
Maintenance treatment groups are Bimekizumab 320mg Q4W, Bimekizumab 320mg Q8W, and 
Secukinumab 300mg Q4W. 
Re-randomized (Open-Label extension) treatment groups are Bimekizumab 320mg Q4W and 
Bimekizumab 320mg Q8W. Unless otherwise specified, the OLE period will be summarized by 
treatment sequence comprising randomized treatment at Baseline and OLE period treatment at 
Week 48.  
The following treatment sequences will be used to summarize efficacy data and specific safety 
data related to laboratory, ECG, PHQ-9, eC-SSRS, and vital signs assessments: 
• Subjects receiving bimekizumab in the double-blind treatment period: 
− Initiating OLE on bimekizumab Q8W 
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− Initiating OLE on bimekizumab Q4W 
• Subjects receiving secukinumab in the double-blind treatment period 
− Initiating OLE on bimekizumab Q8W 
− Initiating OLE on bimekizumab Q4W 
• All Subjects 
Adverse event data (including for a subgroup of subjects who switched from Q4W to Q8W 
during OLE period) and study compliance data will be summarized in 2 treatment groups based 
on the dose most recently received prior to the date of the event or assessment  
• Bimekizumab 320mg Q8W 
• Bimekizumab 320mg Q4W 
• Bimekizumab Total 
In addition, the following key efficacy variables: 
•  PASI90 response  
•  PASI100 response  
•  IGA Clear or Almost Clear (with at least a 2-category improvement from Baseline) 
•  IGA Clear (with at least a 2-category improvement from Baseline)  
will be summarized for the Open-Label Extension treatment period by the following randomized 
treatment sequences: 
• Bimekizumab Q4W/Q8W/Q4W for non-responder at Week 48 (<PASI90) 
• Bimekizumab Q4W/Q4W/Q4W for non-responder at Week 48 (<PASI90) 
• Secukinumab / Bimekizumab Q4W for non-responder at Week 48 (<PASI90)  
• Bimekizumab Q4W/Q8W/Q8W for responder at Week 48 (>=PASI90) 
• Bimekizumab Q4W/Q4W/Q8W for responder at Week 48 (>=PASI90) 
• Bimekizumab Q4W/Q4W/Q4W for responder at Week 48 (>=PASI90) 
• Secukinumab / Bimekizumab Q8W for responder at Week 48 (>=PASI90) 
• Secukinumab / Bimekizumab Q4W for responder at Week 48 (>=PASI90) 
Safety and efficacy assessments for the OLE2 period will only include subjects who entered the 
OLE2 period and will be summarized based on OLS2, by the assigned treatment as follows: 
• Subjects who enroll directly from the OLE treatment period: Group A 
− Bimekizumab Q8W Group A 
• Subjects in Group B who reinitiate bimekizumab after having completed treatment in the 
OLE and have an IGA <3 upon entry to the OLE2: Group B 
− Bimekizumab Q8W Group B 
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• Subjects in Group B who reinitiate bimekizumab after having completed treatment in the 
OLE and have an IGA ≥3 upon entry to the OLE2: Group B 
− Bimekizumab Q4W/Q8W Group B 
• For safety summaries only 
− BKZ Total. 
3.7 
Center pooling strategy 
Centers will be pooled into regions for analysis purposes. Geographic regions will be categorized 
as North America, Western Europe, Central/Eastern Europe, and Asia/Australia. Below is a table 
of geographic regions with corresponding countries. 
Region 
Countries 
North America 
Canada, United States 
Western Europe 
Belgium, France, Germany, Netherlands, Spain, United 
Kingdom 
Central /Eastern Europe 
Poland 
Asia/Australia 
Australia, Turkey 
For a sensitivity analysis to test center-by-treatment interaction (see Section 8.1.3.6), the 
following center pooling algorithm might be used for each geographic region: 
• If a center has 10 or more subjects, then no pooling will be done for that center. 
• Centers with fewer than 10 subjects will be ordered from largest to smallest with pooling 
proceeding in the following manner: 
− Two or more centers will be combined until the cumulative subject total is at least 10. 
− Once a pooled center has at least 10 subjects, the process will continue in an iterative 
fashion for the subsequent centers in the ordered list, where a new pooled center begins 
each time at least 10 subjects has been reached in the previous pool. 
− If this iterative process reaches the end of the ordered list of centers where the final 
pooled center has fewer than 10 subjects, then the subjects from the centers in that pool 
will be combined with the pooled center formed in the previous iteration. 
This procedure is only to be performed within a geographic region –there will be no pooling of 
centers across regions. 
In the event that the percentage of randomized subjects is less than 10% in either of the 
Asia/Australia or Western Europe region, the two regions will be combined as a geographic 
region stratum for all efficacy modeling, so that there are no modeling convergence issues across 
efficacy variables. 
3.8 
Coding dictionaries 
All medications other than study drug will be classified by WHO Anatomical Therapeutic 
Chemical (ATC) Classification, presenting Anatomical Main Group (ATC Level 1), 
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Pharmacological Subgroup (ATC level 3), and preferred term, using World Health Organization 
Drug Dictionary (WHO-DD) version SEP/2015 for Week 48 and Week 96 analysis, and version 
MAR 2021 for Week 144 and Final analysis, according to UCB standard operating procedures 
(SOP). 
All AEs will be classified by primary system organ class (SOC), high level term (HLT) and 
preferred term (PT) using version 19.0 of Medical Dictionary for Regulatory Activities 
(MedDRA®) according to UCB SOPs. 
Previous and ongoing medical history will be classified by version 19.0 of MedDRA® SOC and 
PT. 
3.9 
Relative day 
Relative day will be calculated the following way 
• for days on or after the day of first dose of study drug and prior to or on the day of last study 
drug dose: 
− the current date minus the date of first dose of study drug plus 1 (e.g., the day of first 
dose will be Day 1). 
• for days prior to the first dose of study drug: 
− date of first dose of study drug minus the current date (e.g., the day prior to first dose will 
be Day -1). 
• For days after the last dose of study drug: 
− the current date minus the date of last dose of study drug including a “+” to denote 
posttreatment days (e.g., the day after the last dose will be Day +1). 
Relative day will only be computed for fully completed dates and will be missing for partial 
dates.  Two relative days will be used as follows: 
• Compared to the first dose of study drug in the Initial Treatment Period for all subjects 
• Compared to the first dose of study drug in the Open-Label Extension 2 Period for subjects in 
OLS2 only. 
3.10 
Changes to protocol-defined analyses 
The following endpoints are not listed in the protocol, but have been added to the SAP in order 
to achieve consistency with other studies from the program: 
• Percent of subjects with absolute BSA=0%, ≤1%, ≤3% and ≤5% 
• Patient Symptom Diary responses for itch, pain, and scaling 
The log-rank statistic for time to PASI response as described in Section 8.3.1.2 will be produced 
by region and prior biologic exposure although this is not specifically stated in the protocol. 
The Treatment Period is further divided into two sub periods -Initial Treatment Period and 
Maintenance Treatment Period- to aid different analysis summaries and help keep consistency 
with other studies. 
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The protocol states that subgroup analyses will be performed on the primary and secondary 
efficacy variables that are part of the fixed sequence testing procedure. However, subgroup 
analyses will not only be done for PASI75 and PASI100 but also for PASI90. Additionally, 
subgroup analyses to assess predictability will also use IGA Response (0/1) (see Section 4.8). 
Urinalysis will not be analysed in summary tables but will only be included in listings. 
Section 14.7 of the protocol describes how multiple imputation should be used to analyse other 
efficacy endpoints. It is mentioned that the imputation model will use the change from Baseline 
(instead of actual) values by visit. This statement was omitted from SAP Section 4.2.1.3 as actual 
values will be used in the imputation algorithm and change from baseline will be calculated 
based on the imputed values. 
3.10.1 
Changes related to COVID-19 
The following changes have been introduced due to the COVID-19 pandemic: 
• COVID-19 protocol deviations have been defined in Section 3.4 and the presentation of 
COVID-19 protocol deviations is described in Section 5.2 
• COVID-19 impact on study visits has been assessed and are described in Section 5.1 
• COVID-19 Disposition assessments are described in Section 5.1  
• Missing data methods for assessing the impact of COVID-19 are described in Section 4.2.1.7  
• Data considerations for assessing the impact of COVID-19 on TEAEs including COVID-19 
vaccine AEs are described in Section 10.2.1.1 and the associated analysis is described in 
Section 10.2.2. 
4 
STATISTICAL/ANALYTICAL ISSUES 
4.1 
Adjustments for covariates 
The primary efficacy analyses and selected secondary analyses will be adjusted for the following 
covariates: 
• Prior biologic exposure 
• Region 
4.2 
Handling of dropouts or missing data 
4.2.1 
Handling of missing data for efficacy variables 
Based on previous studies of biologics in subjects with moderate to severe chronic plaque 
psoriasis, it is expected that the number of subjects who discontinue prior to Week 16 will be 
low. For the small percentage of subjects for whom primary endpoint data are unavailable at 
Week 16, this lack of data is suggestive of an ineffective study treatment, thereby supporting the 
imputation of nonresponse. Achieving the clinical response and making it through 16 weeks of 
study treatment are both critical components of the primary outcome. Therefore, non-responder 
imputation (NRI) is considered an appropriate method for handling missing data. 
If a subject discontinues early from the study, all efficacy data that are collected later than 35 
days after the last administration of study treatment will be treated as missing and subject to 
imputation as applicable. 
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Study variables with multiple components may have rules to account for partial missing data of 1 
or more components. Such rules will be defined in section 8 for applicable endpoints. The 
following rules are outlined for cases where variables are completely missing, including partial 
missing data where the data handling rules conclude that the variable should be treated as 
completely missing. 
4.2.1.1 
Handling missing data for the primary efficacy variable 
The analysis of the primary efficacy variable will use NRI for handling of missing data. That is, 
subjects with missing data or who have discontinued IMP prior to Week 16 will be considered as 
non-responders for the primary analysis. 
In addition, sensitivity analyses using multiple imputation (Markov-Chain Monte Carlo method) 
(MI-MCMC)/monotone regression, last observation carried forward (LOCF) and observed case 
(OC) method will be performed which will assess the impact of different methods of handling 
missing data. These methods are described in Section 8.1.3.1 to Section 8.1.3.4. 
4.2.1.2 
Handling missing data for the secondary efficacy variables 
Missing data for the secondary efficacy variables (which are all binary) will be imputed using 
NRI. Additionally, MI-MCMC/monotone regression and OC methods will be performed as 
sensitivity analysis. If the imputation model cannot converge, LOCF will be used. The same 
analyses are detailed in the analysis for the primary efficacy variable in Section 8.1.3.1 and 
Section 8.1.3.2. 
Additional methods for handling missing data to assess the impact of the COVID-19 global 
pandemic on planned statistical analyses are detailed in Section 4.2.1.7. 
4.2.1.3 
Handling missing data for the other efficacy variables 
For other binary efficacy variables, missing data will be imputed using NRI as primary method. 
For other continuous efficacy variables, multiple imputation (MI) will be used to impute missing 
data when possible. If the imputation model cannot converge, last observation carried forward 
(LOCF) will be used. The MI procedure will be similar to sensitivity analysis #1 described in 
Section 8.1.3.1 with the following differences: 
1. No dichotomization will be necessary. 
2. Instead of using the stratified Cochran-Mantel-Haenszel (CMH) test, the imputed data sets 
will be combined, and simple means and standard errors will be calculated using Rubin’s 
rules (via SAS PROC MIANALYZE). For calculation of other descriptive statistics such as 
the median, minimum and maximum, Rubin's rules do not apply. Multiple imputation 
estimates will be computed by simply averaging the estimates from the multiple repetitions 
of the imputation algorithm. 
For other ordinal variables (IGA score, EQ-5D-3L and Patient Global Assessment of PSO), OC 
method will be applied as the primary analysis method. No imputation is applied. 
4.2.1.4 
Handling missing data for subgroup analyses 
For subgroup analyses specified in Section 4.8, NRI will be used for responder variables. Only 
descriptive statistics will be provided. 
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4.2.1.5 
Missing data overview and summary 
In summary, the approaches listed below will be used in this study for handling missing data for 
efficacy variables as appropriate: 
• NRI: Subjects who have missing data at the time point of interest are treated as though they 
did not respond to the treatment. 
• MI –MCMC / Monotone Regression: Using multiple imputation methodology, intermittent 
missing data are imputed based on the MCMC method, and monotone missing data are 
imputed using monotone regression. Note: for all analyses and summaries using MI, subjects 
with missing baseline value will be excluded. 
• LOCF: Post-Baseline missing data are imputed by carrying forward the last available 
observation (including Baseline). 
• OC: Missing data are not imputed. Only subjects with available data who have not 
discontinued study treatment at the given time point are considered. 
The following table depicts which missing data handling approaches should be used based on 
variable priority (primary, secondary, other) and variable type (responder, continuous, ordinal). 
Table 4‒1: 
Missing data handling approach by variable priority and type 
Variable 
Priority 
Variable 
Type 
NRI 
MI (MCMC/ 
Monotone 
Regression) 
LOCF 
OC 
Primary 
Responder 
P 
Sa 
S 
S 
Secondary 
Responder 
P 
Sa 
B 
S 
Other 
Responder 
P 
 
 
Sb,c 
Continuouse 
 
P 
B 
 
Ordinal 
 
 
 
Pd 
P=Primary method, S=Sensitivity method, B=Backup method, NRI=Nonresponder imputation, MI=Multiple 
imputation, MCMC=Markov Chain Monte Carlo, LOCF=Last observation carried forward, OC=Observed Case 
Note: Backup method is only applicable when the primary/secondary method is unable to converge due to 
challenges with the imputation model. 
 Note: Additional missing data handling approaches are detailed in Section 4.2.1.7 for assessing the impact of 
COVID-19 on the secondary efficacy variable PASI100 response at Week 48. 
a Imputation method is applied on continuous data, and responder variable is derived from the continuous variable 
based on complete data set. 
b Only applies to by-visit summaries of variables that are in the multiplicity-controlled testing procedure. 
c Includes IGA Responses, PASI75, PASI90 and PASI100. 
d Includes IGA score, Patient Global Assessment of PSO and EQ-5D-3L. 
e For PASE, OC is the primary analysis method. 
4.2.1.6 
Missing data algorithm – MI – MCMC / Monotone Regression 
Investigators will be given discretion to discontinue study treatment for subjects not responding 
in order to provide them with alternative therapy to treat the condition. Therefore, in many cases, 
missing efficacy data due to study treatment discontinuation should be dependent on the 
observed efficacy scores, but independent of unobserved data. This would be consistent with a 
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missing at random (MAR) pattern of missingness. To investigate the efficacy results under the 
assumption of data being MAR, a multiple imputation method will be applied as follows 
(exemplary for PASI100 at Week 16): 
1. Create a data set, one for each treatment group (note that a separate imputation procedure 
must be invoked in SAS for each treatment group as the seed cannot be set for by groups 
beyond the first when using a by statement, see notes below about treatment groups to 
use for different analysis sets), of subjects with observed values and those needing 
estimation by multiple imputation. The intermittent missing PASI/IGA values in each 
data set (i.e., missing values for a given subject that has available data before and after 
the missing time point) will be filled in using the MCMC method, with a total of 100 sets 
of imputations being performed. The seed used for these imputations will be 852 (note 
that all other multiple imputation procedures described in this SAP related to 
MCMC/Monotone Regression analyses will use this same seed as well). For monotone 
missing data (i.e., where all subject data is missing after a given time point), monotone 
regression will be used to impute missing data. Again, this will be based on the 100 sets 
of imputations already created using the MCMC method such that there will be 100 
imputations in total. In both cases, biologic exposure, geographic region and PASI/IGA 
values at Baseline and at each post-Baseline visit (in chronological order, see notes below 
about visits to include for different analysis sets) will be included in the imputation 
model. Note that PASI scores at earlier visits will also be used as predictors for the model 
of PASI at later visits. The resulting data sets for each treatment arm will be combined 
into one complete data set based on each of the 100 imputations. 
Note: The imputation model will only allow continuous variables. Therefore, prior 
biologic exposure and region will be re-coded as indicator variables. For prior biologic 
exposure, this will simply be 0 for biologic-naïve subjects and 1 for biologic-exposed 
subjects. For region, which has 4 levels, one indicator variable will be defined as 0 for 
regions other than North America and 1 for North America. Two more indicator variables 
will be defined similarly replacing North America with Central/Eastern Europe, and 
Western Europe respectively. An indicator variable for Asia/Australia is not needed as 
the fourth region will be adequately represented by the other region indicator variables all 
being 0. In the event that the percentage of randomized subjects is less than 10% in either 
of the Asia/Australia or Western Europe region, the two regions will be combined as a 
geographic region stratum for efficacy modeling, so that there are no modeling 
convergence issues across efficacy variables. In order to achieve model convergence, 
prior biologic exposure may be dropped from the model. If convergence is still not 
obtained, then region may also be dropped from the model. 
2. For each complete imputed data set, the dichotomous responder variable (PASI100) 
based on the PASI scores will be computed. Each complete imputed data set will then be 
analyzed based on the stratified CMH test. 
Note: For derivation of PASI100 response, the PASI value at Week 16 in the imputed 
data sets will be compared directly to the observed Baseline PASI value to determine 
whether or not a reduction of 100% was achieved. If values outside of the pre-defined 
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range of values for PASI (0-72) are imputed, they will be cut off as appropriate after the 
multiple imputation procedure but before deriving the responder variable. For example, 
an imputed PASI value of -0.5 would be changed to 0 before deriving the PASI100 
responder variable. 
Note: Standard rounding rules will be applied to the imputed IGA values in order to 
derive the binary IGA 0/1 responder variable. In addition, if values outside of the pre-
defined range of values for IGA (0-4) are imputed, they will be cut off as appropriate 
after the multiple imputation procedure but before deriving the responder variable. For 
example, if a subject has an IGA score imputed as 1.4 (and assuming a Baseline IGA 
score of 3), this imputed value would be rounded down to 1, and the minimum change 
from Baseline of 2 would have been met. Therefore, this subject would be considered an 
IGA 0/1 responder. 
Additional ranges of values for other variables are defined in Table 4‒2. 
Table 4‒2: 
Allowable ranges for imputation by variable 
Variable 
Minimum value 
Maximum value 
Integer values only 
PASI 
0 
72 
No 
IGA 
0 
4 
Yes 
PSD items (itch, pain, 
scaling) 
0 
10 
No 
Scalp IGA 
0 
4 
Yes 
mNAPSI 
0 
130 
No 
BSA 
0 
100 
No 
IGAxBSA 
0 
400 
No 
DLQI 
0 
30 
Yes 
PGADA 
0 
100 
No 
EQ-5D-3L VAS 
0 
100 
Yes 
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Variable 
Minimum value 
Maximum value 
Integer values only 
WPAI dimension 
scores 
0 
100 
No for variables: 
“Percent work time 
missed due to problem” 
and “Percent overall 
work impairment due to 
problem”. 
Yes for variables: 
“Percent impairment 
while working due to 
problem” and “Percent 
activity impairment due 
to problem”. These two 
variables can only take 
values that are 
multiples of 10. 
PHQ-9 
0 
27 
Yes 
3. The Week 16 results from the specified statistical analysis (e.g. stratified CMH, logistic 
regression) of each of the 100 imputed data sets will be combined for overall inference 
using Rubin’s rules, which account for the uncertainty associated with the imputed values 
(Rubin, 1987). This will be done using SAS PROC MIANALYZE. 
Some key points to consider relative to the calculation of the odds ratios and corresponding 
confidence intervals are noted below: 
If stratified CMH or logistic regression are used, the estimates of the odds ratios from the logistic 
regression model in step 3 follow a log-normal distribution, and a log transformation is needed to 
normalize these estimates since the procedures for combining results from multiple imputed 
datasets are based on the assumption that the statistics estimated from each imputed dataset are 
normally distributed. Therefore, the log of the odds ratio estimates from the logistic regression 
model are used when combining into a single inference (the use of PROC MIANALYZE in step 
3). Appropriate transformations to the standard errors and p-values should also be made in order 
to get the correct confidence intervals, for the CMH test using the p-value for the general 
association the Wilson-Hilferty transformation should be used (Ratitch, 2013). 
For other continuous efficacy variables, MI will be used to impute missing data when possible 
(see Section 4.2.1.3). If the imputation model cannot converge, LOCF will be used. 
Further details about imputation for different analysis sets are below: 
Randomized Set: When programming multiple imputations based on the RS, PROC MI will be 
used with a separate data set for each of the 2 randomized treatment groups (bimekizumab 
320mg Q4W and secukinumab) including all scheduled assessment visits from Baseline to Week 
48. 
Maintenance Set: When programming multiple imputation based on the MS, PROC MI will be 
used with a separate data set for each of the 3 Maintenance Period treatment groups 
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(bimekizumab 320mg Q8W, bimekizumab 320mg Q4W, secukinumab) including all scheduled 
assessment visits from Baseline to Week 48. 
Open-Label Set: When programming multiple imputations based on the OLS, PROC MI will be 
used with a separate data set for each of the 6 treatment sequences based on the combination of 
randomized treatment at Baseline, Maintenance Period treatment and OLE period treatment at 
Week 48 including all scheduled assessment visits from Baseline to Week 144. However, the 
summary values for the 4 treatment sequences based on the combination of randomized 
treatment at Baseline and OLE period treatment at Week 48 will be computed after the 
imputation steps 
The Open-label Set 2: The analyses will be based on OC. Multiple imputation methods described 
above will not be applied.  
4.2.1.7 
Missing data methods for assessing impact of COVID-19 
In order to assess the impact of the COVID-19 global pandemic on planned statistical analysis, 
additional sensitivity analyses will be performed for the secondary efficacy variable PASI100 
response at Week 48. The sensitivity analyses in Section 8.2.3 will also still be performed, 
Assessments for the primary efficacy variable and for other secondary efficacy variables are at 
timepoints prior to Week 48 and will have been performed prior to the pandemic, therefore 
additional supplementary analyses of these variables are not necessary. 
As described in Section 4.2.1, if a subject discontinues early from the study, all efficacy data that 
are collected later than 35 days after the last administration of study treatment will be treated as 
missing and subject to imputation as applicable. Thus if a subject discontinues from the study 
due to COVID-19 (general circumstances related to the COVID-19 pandemic or due to 
confirmed or suspected infection with the novel coronavirus) and the PASI assessment at 
Week 48 is later than 35 days after the last administration of study treatment, this will also be 
treated as missing. 
If the PASI assessment at Week 48 is conducted by video call or telephone, this will be treated as 
missing since the validity and exchangeability of these assessment modalities has not been 
established. This will be determined according to collection of COVID-19 protocol deviations 
(including COVID-19 impact assessment) (see Section 3.4 for further details). 
4.2.1.7.1 
Hybrid approach for assessing impact of COVID-19 
The main sensitivity analysis method to assess the impact of the COVID-19 pandemic on 
planned statistical analysis uses a hybrid approach and will be applied to the analysis of PASI100 
response at Week 48 based on both the RS and the MS. If study subjects have missing PASI 
score at Week 48, then the imputation method is dependent on the reason for missingness as 
follows: 
• If the data is missing due to COVID-19 then MI-MCMC/monotone regression will be 
implemented following the method described in Step 1 of Section 4.2.1.6 to impute the 
missing PASI score at Week 48. 
• If the data is missing due to other reasons, then PASI100 response at Week 48 will be 
imputed as a non-response using NRI. 
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MI-MCMC/monotone regression will be implemented as described in Step 1 of Section 4.2.1.6 
for all subjects in the respective analysis set. However when data is missing or the subject 
discontinued from the study due to other reasons than COVID-19, they will be considered as 
PASI100 non-responders at Week 48 for each imputation during Step 2 regardless of their MI-
MCMC/monotone regression imputed value. Then Step 3 of Section 4.2.1.6 using stratified 
CMH can be applied for the PASI100 response at Week 48. If the PROC MIANALYZE leads to 
non-calculable results (ie, if there are a low amount of data missing or subjects dropped out due 
to COVID-19), this analysis will not be reported. 
4.2.1.7.2 
Subgroup approach for assessing the impact of COVID-19 
A supplementary sensitivity analysis method to assess the impact of the COVID-19 pandemic on 
PASI100 response at Week 48 will use a subgroup analysis approach and will be based on the 
MS. The COVID-19 pandemic subgroups are defined as: 
• Week 48 visit date before COVID-19 pandemic start date (ie, prior to COVID-19 pandemic) 
• Week 48 visit date on or after COVID-19 pandemic start date (ie, during COVID-19 
pandemic) 
Where: 
− COVID-19 pandemic start date is 11 March 2020. (The date is chosen as the date the 
World Health Organization declared COVID-19 as a pandemic.) 
− For subjects with a Week 48 visit, the actual date of the Week 48 PASI assessment will 
be used to determine subgroup inclusion. 
− For subjects without a Week 48 visit, the scheduled Week 48 visit date will be used to 
determine subgroup inclusion, where: 
◦ 
Scheduled Week 48 visit date = date of first dose of study drug + 336 days. 
Note: 
• It is not anticipated that there will be any Week 48 visits post-pandemic for this study. 
• Although the COVID-19 pandemic subgroups are determined based on an event occurring 
after randomization, the inclusion of a subject in the applicable subgroup is independent of 
their PASI assessment at Week 48 and is independent of the subject’s Baseline 
characteristics. 
This subgroup analysis for PASI100 at Week 48 will include descriptive statistics with missing 
data imputed using NRI. 
4.2.1.7.3 
Approach to assess the impact of out of window assessments due to 
COVID-19 
Another supplementary sensitivity analysis method to assess the impact of the COVID-19 
pandemic on the planned statistical analyses will treat PASI assessments that are out of window 
at Week 48 due to COVID-19 as missing. A window of ±21 days relative to the scheduled 
Week 48 visit will be evaluated. This will be applied to the analysis of PASI100 response at 
Week 48 based on both the RS and the MS. 
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The PASI assessment at Week 48 will therefore be determined as out of window due to 
COVID-19 if the following criteria are both met: 
• There is a corresponding out of window COVID-19 protocol deviation (see Section 3.4 for 
further details) 
• Date of first dose of study drug + 315 days > Week 48 PASI assessment date or Week 48 
PASI assessment date > date of first dose of study drug + 357 days 
A hybrid approach will then be applied as in Section 4.2.1.7.1 such that if the data is missing due 
to COVID-19 then MI-MCMC/monotone regression will be implemented and if data is missing 
due to other reasons, then PASI100 response at Week 48 will be imputed as a non-response 
using NRI. If the PROC MIANALYZE leads to non-calculable results, this analysis will not be 
reported. 
4.2.2 
Handling missing data for safety variables 
For analyses of AEs and concomitant medication usage, a complete date must be established in 
order to correctly identify the AE or medication as occurring during treatment or not. For 
purposes of imputing missing components of partially-reported or missing start and stop dates 
for AEs and for medication use, the algorithms listed below will be followed. Start and stop dates 
of AEs or concomitant medication will be displayed as reported in the subject data listings (i.e., 
no imputed values will be displayed in data listings). 
Partial or missing AE and concomitant medication start dates will be imputed as follows: 
Imputation of Partial or Missing Start Dates 
• If only the month and year are specified and the month and year of first dose is not the same 
as the month and year of the start date, then use the 1st of the month 
• If only the month and year are specified and the month and year of first dose is the same as 
the month and year of the start date, then use the date of first dose 
• If only the year is specified, and the year of first dose is not the same as the year of the start 
date, then use the 1st of January of the year of the start date 
• If only the year is specified, and the year of first dose is the same as the year of the start date, 
then use the date of first dose 
• If the start date is completely unknown and the stop date is unknown or not prior to the date 
of first dose, then use the date of first dose 
• If the start date is completely unknown and the stop date is prior to the date of first dose of 
IMP, then set the start date to the 1st of January of the year of the stop date. 
Imputation of Partial Stop Dates 
• If only the month and year are specified, then use the last day of the month 
• If only the year is specified, then use December 31st of that year 
• If the stop date is completely unknown, do not impute the stop date. 
If the stop date or imputed stop date is prior to the imputed start date: 
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• If the year of imputed start date is the same as the year of first dose and the stop date is after 
the date of first dose, then set the start date to the date of first dose 
• If the month and year of imputed start date is the same as the year and month of the first dose 
and the same as the year and month of the stop date, and the stop date is prior to the date of 
first dose then set the start date to the 1st of the month  
• Otherwise, set the start date to the 1st of January of the year of the start date. 
In the event of ambiguity or incomplete data which makes it impossible to determine whether a 
medication was concomitant, or an adverse event was treatment emergent, the medication will be 
considered as concomitant or the adverse event will be considered treatment emergent. 
4.3 
Interim analyses and data monitoring 
The following data cuts will occur, and corresponding interim analyses will be performed:  
• After the final Week 48 visit, an interim analysis will be performed and a corresponding 
Week 48 interim clinical study report (CSR) will be written. For subjects that participate in 
the OLE period, data will be cut at the day of their Week 48 study drug administration. Data 
from the OLE will not be included in this interim analysis.  
• An additional Week 96 data cut will occur approximately after the last Week 96 visit. A 
Week 96 analysis will be performed for the Open-Label treatment period using this Week 96 
data cut. Selected tables, figures, and listings based on Week 96 data cut will be produced for 
these analyses as detailed in Section 12.3 (Appendix C). No corresponding CSR for these 
analyses was planned. 
• In addition, a Week 144 data cut will occur after Week 144 visit and SFU. A Week 144 
analysis will be performed using Week 144 and SFU data cut and a corresponding Week 144 
interim CSR will be written.  
• A final analysis will be conducted when all data for the double-blind, OLE (including SFU), 
and OLE2 (including SFU2) treatment periods have been collected and final CSR will be 
written. 
An independent Data Monitoring Committee (DMC) will periodically review and monitor the 
safety data from the Double-blind treatment period of this study and advise UCB.  
Cardiovascular, Inflammatory bowel disease (IBD), and Neuropsychiatric Adjudication 
Committees will also periodically review and monitor safety data from this study including two 
Open-label Extension (OLE and OLE2) treatment periods and advise UCB. Details will be 
provided in the DMC Charter and in the Adjudication Committee Charters. 
Further details related to the DMC will be outlined in a separate analysis plan. 
4.4 
Multicenter studies 
The center-by-treatment interaction will be tested by replacing region with center in the logistic 
regression model used for the sensitivity analysis (Section 8.1.3.6 and adding a center-by-
treatment interaction term. In the model, center will be based on the original centers prior to 
pooling (Section 3.7). However, if the model is unable to converge due to a low number of 
subjects at a given center, a pooling by center will be considered. Detailed strategy from 
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Section 3.7 will be applied in order to allow the model to converge. If convergence is still not 
achieved, a pooling by region will be applied. If convergence still cannot be achieved, this 
analysis will not be performed. 
4.5 
Multiple comparisons/multiplicity 
The statistical analysis of the primary efficacy variable and selected secondary efficacy variables 
will account for multiplicity and control the familywise Type I error rate at a 2-sided alpha level 
of 0.05 by using a fixed sequence testing procedure. 
The hypotheses (H1, H2, H3, H4, H5, and H6) comparing bimekizumab vs secukinumab will be 
tested at a 2-sided alpha level of 0.05. 
The first 2 hypotheses (H1 and H2) test whether bimekizumab is non-inferior and superior, 
respectively, to secukinumab for PASI100 response at Week 16. These are the hypothesis tests 
corresponding to the primary endpoint. 
If these hypotheses are rejected at a 2-sided alpha level of 0.05, that alpha will be passed to the 
next test in the sequence, allowing the testing procedure to proceed. If a hypothesis can not be 
rejected, p-values for subsequent hypotheses will not be calculated. A combined table will 
present all hypotheses together with all p-values that were calculated. 
The hypotheses associated with the subsequent tests are for secondary efficacy endpoints and are 
based on testing for superiority relative to secukinumab. Figure 4‒1 presents the details on this 
procedure. 
Figure 4‒1: Fixed sequence of hypothesis testing procedure 
 
BKZ=bimekizumab; PASI=Psoriasis Area Severity Index; Q4W=every 4 weeks; Q8W=every 8 weeks 
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Note: Tests for H1, H2, H3, and H4 are based on all subjects initially randomized to bimekizumab compared to 
secukinumab. For H5 and H6, testing is based on the subjects re-randomized at Week 16 to bimekizumab 320mg 
Q4W, and bimekizumab 320mg Q8W, respectively, compared to secukinumab. 
A table will be produced containing the results for all hypotheses. P-values or confidence 
intervals only will be shown as appropriate. 
Other tables will include p-values of primary and secondary endpoints. These p-values should 
not be considered to evaluate hypotheses as they are not controlled for multiplicity. 
4.6 
Use of an efficacy subset of subjects 
The primary efficacy analysis (described in Section 8.1.2) will be repeated based on FAS and 
PPS as a sensitivity analysis (see Section 8.1.3.4). 
4.7 
Active-control studies intended to show equivalence 
A non-inferiority margin of 10% has been selected as this is considered to be a clinically relevant 
difference that could influence the choice of interventions used to treat chronic plaque PSO. 
4.8 
Examination of subgroups 
Subgroup analyses will be based on data up to Week 48 only. These analyses will be performed 
on the PASI75/90/100 response rates, using by visit summaries only. The following subgroups 
for analysis will be determined for the RS using baseline data: 
• Age (<40 years, 40 to <65 years, ≥65 years) 
• Gender (male, female) 
• Disease duration (<median, ≥median) 
• Region (North America, Western Europe, Central/Eastern Europe, Asia/Australia) 
• Weight (≤100 kg, >100 kg) 
• Body mass index (BMI) (<25 kg/m2, 25 to <30 kg/m2, ≥30 kg/m2) 
• Prior systemic phototherapy or chemotherapy (yes, no) 
• Prior biologic exposure (yes, no) 
• Prior primary failure to biologic (yes/no) 
• Prior systemic therapy of any kind (yes, no) 
• Baseline disease severity (PASI<20, PASI≥20) 
• Antibody positivity (negative, positive) 
Antibody positivity is the only subgroup that is not determined by Baseline data (described in 
Section 9.3.2). It will be presented in a separate table. 
The definition of prior systemic therapy of any kind is if a subject received previous biologic 
therapy, previous systemic therapy (non-biologic), or previous systemic chemotherapy or 
phototherapy. Subjects who never received previous biologic therapy, previous systemic therapy 
(non-biologic), or previous systemic chemotherapy or phototherapy will be classified as not 
receiving prior systemic treatment for psoriasis. 
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In addition, in order to assess whether an early response to treatment is predictive of response at 
later time points, subgroup analyses will be performed for PASI90/100 and IGA over time using 
the following early response subgroups: 
• PASI75 response (OC) at Week 4 (yes, no) to predict PASI90/100 and IGA (clear or almost 
clear) (NRI) through Week 48 based on RS 
• PASI90 response (OC) at Week 16 (yes, no) to predict PASI100 (NRI) through Week 48 
based on RS 
• PASI90 response (OC) at Week 48 (yes, no) to predict PASI90 (NRI) during the OLE based 
on OLS 
• PASI90 response (OC) at Week 48 (yes, no) to predict PASI100 (NRI) during the OLE based 
on OLS 
• PASI90 response (OC) at Week 48 (yes, no) to predict IGA responder rates (clear) and IGA 
responder (clear or almost clear) during the OLE based on OLS. 
All summaries will be based on imputed data as appropriate and will include descriptive statistics 
only. 
Additional subgroup analyses are described in Section 4.2.1.7.2 to assess the impact of the 
COVID-19 pandemic on planned statistical analysis of PASI100 response at Week 48. 
5 
STUDY POPULATION CHARACTERISTICS 
5.1 
Subject disposition 
Summaries of reasons for screen failures (for all subjects screened), disposition of subjects (for 
all subjects screened), disposition of analysis sets (for RS, MS, OLS, and OLS2), disposition and 
discontinuation reasons (for RS, MS, OLS, and OLS2), as well as for the subjects who 
discontinued due to AEs (for RS, MS, OLS, and OLS2) will be produced. The disposition of 
subjects for all subjects screened will include the number of subjects included in each analysis 
set (RS, SS, FAS, MS, OLS, OLS2, BKZ Set, PPS, and PK-PPS) overall and by site. 
The following listings for subject disposition will be provided: subjects who did not meet study 
eligibility criteria (all subjects screened), subject disposition (all subjects screened), study 
discontinuation (for RS), visit dates (for RS), subjects excluded from efficacy analysis (RS).  
Summaries of visits at which subjects initiated the switch from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W dosing interval in the Open-Label Extension period will be 
presented. Similar listings will be provided separately for the OLE and the OLE2 treatment 
periods. 
In addition, the following COVID-19 impact categories will be summarized by country and visit 
for the MS, OLS, and OLS2 (see Section 2.3.5 for list of countries). Separate listings of 
COVID-19 impact will be provided for the OLE and the OLE2 treatment periods. 
• Visit not done  
• Visit performed out of window 
• Home Visit 
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• Visit performed by video call 
• Visit performed by telephone 
• Investigational product shipped to study participant 
• Participant Home administration of investigational product by participant or caregiver 
• Home administration of investigational product by a healthcare professional 
• Missed study drug administration/dispensation 
• Temporary discontinuation of study drug 
• Permanent discontinuation of study drug 
• Termination of study participation 
• Other 
Note that home administration was permitted at certain visits (see Table 7‒2) and only home 
administration that was not per the protocol should be captured.  
A by-subject listing of COVID-19 impact categories will be provided separately for the OLE and 
the OLE2 treatment periods. 
5.2 
Protocol deviations 
A summary of number and percentage of subjects with an important protocol deviation 
(including a summary of subjects excluded from any analysis set due to important protocol 
deviations) by treatment group will be provided for the RS, MS,OLS, and OLS2. 
A by-subject listing of important protocol deviations will be provided separately for Initial and 
Maintenance treatment periods for RS. Similar listings will be provided separately for the OLE, 
and the OLE2 treatment periods. 
A summary of number and percentage of subjects with COVID-19 protocol deviations by 
treatment group and visit will be provided for the MS and OLS.  
A by-site, subject and visit listing of COVID-19 protocol deviations will be provided.  
Separate listings of subjects with COVID-19 protocol deviations will also be provided for the 
OLE and the OLE2 treatment periods. 
6 
DEMOGRAPHICS AND OTHER BASELINE 
CHARACTERISTICS 
All summaries detailed in this section will be performed on the RS by treatment group. 
Summaries for demographics and other Baseline characteristics will also be repeated on SS, MS, 
OLS, and OLS2. All these summaries (including the OLS and the OLS2 summaries) will use the 
Baseline value from Week 0 of the double-blind treatment period. If the RS and SS analysis sets 
are identical the summaries will not be repeated.  
6.1 
Demographics 
Demographic variables will be summarized by treatment group and overall. 
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The following continuous variables will be summarized using descriptive statistics (number of 
subjects, mean, SD, minimum, median and maximum). 
• Age at the time of study entry (years) 
• Height (cm) 
• Weight (kg) 
• BMI (kg/m2) 
BMI (kg/m2) will be calculated as: 
BMI = Weight (kg)
(Height (m))2 
The following categorical variables will be summarized using frequency counts and percentages. 
• Age group (18-<65, 65-<85, ≥85 years) 
• Age group (≤18, 19-<65, ≥65 years) 
• Age group (<40, 40-<65, ≥65 years) 
• Body Weight (≤100kg, >100kg) 
• BMI (<25 kg/m2, 25 to <30 kg/m2, ≥30 kg/m2) 
• Gender 
• Race 
• Ethnicity 
By-subject listings of demographics will be provided. 
6.2 
Other Baseline characteristics 
Baseline characteristics (including Baseline clinical measures) will be summarized by treatment 
group and overall. 
Generally, the following continuous variables will be summarized using descriptive statistics 
(number of subjects, mean, SD, minimum, median and maximum). 
• Psoriasis Body Surface Area (BSA; %) 
• Psoriasis Area and Severity Index (PASI) score 
• Modified Nail Psoriasis Severity Index (mNAPSI) total score 
• mNAPSI total score for subjects with nail involvement (i.e. mNAPSI>0) 
• Patient Global Assessment of Disease Activity (PGADA) for arthritis visual analogue scale 
(VAS) score 
• Dermatology Life Quality Index (DLQI) total score 
• PSD item scores: Pain, Itch, Scaling 
• Duration of disease (years) 
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Duration of disease (years) will be calculated as: 
𝐷𝑖𝑠𝑒𝑎𝑠𝑒 𝐷𝑢𝑟𝑎𝑡𝑖𝑜𝑛= (𝐷𝑎𝑡𝑒 𝑜𝑓 𝑟𝑎𝑛𝑑𝑜𝑚𝑖𝑧𝑎𝑡𝑖𝑜𝑛−𝐷𝑎𝑡𝑒 𝑜𝑓 𝑜𝑛𝑠𝑒𝑡 𝑜𝑓 𝑃𝑙𝑎𝑞𝑢𝑒 𝑃𝑠𝑜𝑟𝑖𝑎𝑠𝑖𝑠1)
365.25
 
1 If the date of onset of plaque psoriasis is partial, it should be imputed to the most recent feasible date (ie, last day 
of the month if only day is missing, or the last day of the year if day and month are missing). Note that if the date of 
randomization is missing then the duration of disease will be derived using the date of screening. 
The following categorical variables will be summarized using frequency counts and percentages. 
• Region (North America [Canada, USA], Western Europe [Belgium, France, Germany, 
Netherlands, Spain, United Kingdom], Eastern/Central Europe [Poland], Asia/ Australia 
[Australia, Turkey] 
• Country 
• PGADA score (=0, >0) 
• DLQI total score (=0, >0) 
• Duration of disease (<median, ≥median) 
• Investigator’s Global Assessment (IGA) score 
• Baseline disease severity (PASI<20, PASI≥20) 
• Nail involvement (yes, no) 
• Scalp involvement (yes, no) 
• Palmoplantar involvement (yes, no) 
• Prior biologic exposure (yes, no) 
• Prior primary failure to biologic (yes, no) 
• Prior anti-TNF therapy (yes, no) 
• Prior phototherapy or chemotherapy (yes, no) 
• Any prior systemic therapy (yes, no) 
Baseline nail, scalp, and palmoplantar involvement are based on the number of subjects 
achieving mNAPSI>0, Scalp IGA>0, and pp-IGA>0, respectively. The categorization of whether 
or not subjects had prior exposure to biologic therapy will be based on the Psoriasis Treatment 
History CRF module. Prior anti-TNFs include etanercept, adalimumab, infliximab, certolizumab 
pegol, and golimumab (or biosimilars of those treatments). 
By-subject listings of Baseline characteristics will be provided. 
6.3 
Medical history and concomitant diseases 
Previous and ongoing medical history will be summarized by treatment group(s), SOC and PT 
using MedDRA® version. Medical procedures are not coded. 
The following listings for medical history and concomitant diseases will be provided: medical 
history, psoriasis history, concomitant medical procedures, previous and ongoing medical history 
glossary, previous and ongoing medical history conditions, and procedure history. 
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For subjects enrolling in OLE2 Group B, any additional medical history collected during OLE2 
screening will be flagged in the medical history listing. 
6.4 
Prior and concomitant medications 
Medication start and stop dates will be compared to the date of first dose of treatment to allow 
medications to be classified as either Prior or Concomitant. 
Details of imputation methods for missing or partial dates are described in Section 4.2.1.7. 
Prior medications include any medications that started prior to the start date of study medication. 
Concomitant medications are medications taken at least one day in common with the study 
medication dosing period (defined as from first dose of study medication [including placebo] up 
to last dose of study medication + 28 days for the double-blind treatment period, and +28 days or 
+56 for Q4W and Q8W dosing respectively in the OLE period). Concomitant medications will 
be summarized separately for the double-blind Treatment Period (SS), the OLE treatment period 
(OLS). 
The number and percentage of subjects taking prior medications (excluding past psoriasis 
medications) will be summarized by treatment group, overall and by ATC class, presenting 
Anatomical Main Group (ATC Level 1), Pharmacological Subgroup (ATC level 3), and 
preferred term. The number and percentage taking concomitant medications will be summarized 
similarly. 
Past psoriasis medications will be captured separately and will also be summarized by treatment 
group. These medications are not subject to dictionary coding. In addition, subjects who failed 
past psoriasis biologic treatment will be summarized by reason of failure as captured on the 
Psoriasis Treatment History CRF module. 
The number and percentage of subjects with concomitant vaccines for COVID-19 will be 
summarized by treatment group, overall and by World Health Organization Drug Dictionary 
Standardized Drug Grouping (SDG), presenting SDG subgroup, and preferred term. The SDG 
subgroup Vaccines for COVID-19 will be used to identify vaccines for COVID-19 using the 
narrow scope; this subgroup is divided further into separate subgroups which is the level that will 
be presented. The number of individual occurrences of the vaccine for COVID-19 will also be 
summarized.  
By-subject listings of all Prior and Concomitant medications (including COVID-19 concomitant 
medications), prior and concomitant medications glossary, and psoriasis treatment history will be 
provided separately for OLE and OLE2 treatment periods. Ongoing concomitant medications 
from OLE to OLE2 treatment period will be flagged.  
An additional listing of concomitant vaccines for COVID-19 will be provided separately for 
OLE and OLE2 treatment periods.  
7 
MEASUREMENTS OF TREATMENT COMPLIANCE 
Due to the method of administration of the treatments, compliance will be examined in terms of 
completed injections and by treatment arm. 
Treatment compliance will be calculated as: 
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𝑡𝑜𝑡𝑎𝑙 𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑐𝑜𝑚𝑝𝑙𝑒𝑡𝑒𝑑 𝑖𝑛𝑗𝑒𝑐𝑡𝑖𝑜𝑛𝑠 
𝑡𝑜𝑡𝑎𝑙 𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑒𝑥𝑝𝑒𝑐𝑡𝑒𝑑 𝑖𝑛𝑗𝑒𝑐𝑡𝑖𝑜𝑛𝑠×  100 
where the total number of expected injections is derived relative to when the subject finishes 
treatment. In this study, bimekizumab, secukinumab, or placebo are administered according to 
the schedule in Table 7-1 below. 
If a subject discontinues early, then the number of expected injections is based on the time of 
early discontinuation relative to the dosing visits. For example, if a subject discontinues after 
Week 4 visit and prior to Week 8 visit, the total number of expected injections will be 10. 
A summary of percent treatment compliance categorized as <75% and ≥75% will be provided by 
treatment group and study periods (Initial Treatment Period for the SS, Maintenance Treatment 
Period for the SS, Initial and Maintenance Treatment Period for the SS, Open-Label Extension 
Period for the OLS, and Open-Label 2 Extension Period for the OLS2). 
A by-subject listing of treatment compliance will be provided. Separate listings of treatment 
compliance will be provided for the OLE and the OLE2 treatment periods. 
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Table 7‒1: 
Dosing scheme 
Week 
Dose 
Assignment 
Baseline 
(first dose) 
1 
2 
3 
4 
8 
12 
16a 
20 
24 
28 
32 
36 
40 
44 
Bimekizumab 
320mg 
●● 
○○ 
○○ 
○○ 
●● 
●● 
●● 
Q4W 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
Q8W 
●● 
○○ 
●● 
○○ 
●● 
○○ 
●● 
○○ 
Secukinumab 
300mg  
▲▲ 
▲▲ 
▲▲ 
▲▲ 
▲▲ 
▲▲ 
▲▲ 
▲▲ 
▲▲ 
▲▲ 
▲▲ 
▲▲ 
▲▲ 
▲▲ 
▲▲ 
Q4W=every 4 weeks; Q8W=every 8 weeks 
Notes: A bimekizumab 160mg injection is depicted by a black circle (●). A placebo injection is depicted by a white circle (○). A secukinumab 150mg injection is 
depicted by a black triangle (▲). 
a Subjects in the bimekizumab 320mg treatment arm will be re-randomized 1:2 to receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. 
Table 7‒2: 
Dosing scheme, OLE Period 
Week 
 
Dose 
Assignment 
48 (1st OLE 
dose) 
Year 2 
Year 3 
52 
56 
60 
64ab 
68 
72 ab 
76 
80 
84 ac 
88 
92 
96 ab 
100 
104 
108 ac 
112 
116 
120 ab 
124 
128 
132 ac 
136 
140 
Bimekizumab 
320mg Q4W 
●● 
●● ●● ●● ●● ●● ●● ●● ●● ●● ●● ●● ●● ●● ●● ●● ●● ●● ●● ●● ●● ●● ●● ●● 
Bimekizumab 
320mg Q8W 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
OLE=Open-Label Extension; Q4W=every 4 weeks; Q8W=every 8 weeks 
Notes: A bimekizumab 160mg injection is depicted by a black circle (●). 
  a The subject’s dosing interval will change from Q4W to Q8W at Week 64 or at the next scheduled clinic visit after implementation of Protocol Amendment 5.0    
  if the subject has already completed the Week 64 visit. 
  b Subjects whose dosing interval is changed to Q8W should be dosed at this visit and will receive kits for home administration 8 weeks later. 
  c Subjects whose dosing interval is changed to Q8W should NOT be dosed at this visit and will receive kits for home administration 4 weeks later. 
 
 
 
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Table 7‒3: 
Dosing scheme, OLE2 Period 
Visit/Week 
 
Dose Assignment 
OLE2 Period 
Week 144/OLE2 
Baseline 
OLE2 Week 4 
OLE2 Week 8 
OLE2 Week 12 a 
OLE2 Week 16 
OLE2 Week 24 b 
OLE2 Week 32 
OLE2 Week 36 c 
OLE2 Week 40 
OLE2 Week 48 
 
C 
H 
H 
C 
H 
C 
H 
C 
H 
C 
Bimekizumab 320mg Q4W/Q8Wd 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
 
●● 
 
Bimekizumab 320mg Q8W 
●● 
 
●● 
 
●● 
●● 
●● 
 
●● 
 
C=Clinic, H=home, IGA=Investigator's Global Assessment, IMP=investigational medication product, OLE=Open Label Extension, Q4W/Q8W=every 4 weeks 
for 16 weeks, followed by every 8 weeks, Q8W=every 8 week, W=week. 
Notes: A bimekizumab 160mg injection is depicted by black circle (●).  
a Subjects will receive kits for home administration 4 weeks later. 
b Subjects will receive kits for home administration 8 weeks later.  
c Subjects should NOT be dosed at this visit and will receive kits for home administration 4 weeks later.  
d Q4W/Q8W IMP administration only applies to those subjects who have entered the OLE2 Period as part of Group B and had an IGA ≥3 upon entry of OLE2 
Period. These subjects will receive Q4W dosing for 16 weeks until OLE2 Week 16, then will change from Q4W to Q8W and will receive their next dose at the 
scheduled clinic visit OLE2 Week 24. 
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8 
EFFICACY ANALYSES 
8.1 
Statistical analysis of the primary efficacy variable 
8.1.1 
Derivations of primary efficacy variable 
Unless otherwise specified, the Baseline value to be used in the analysis of efficacy endpoints 
will be the assessments from Week 0 of the double-blind treatment period of the study. A table 
of efficacy variables analyzed at each treatment period is provided in Section 12.4 (Appendix D). 
8.1.1.1 
Psoriasis Area and Severity Index (PASI) 
PASI100 is defined to be equal to 1 if the percentage improvement from Baseline in the PASI 
scores is 100% and 0 if the percentage improvement from Baseline is less than 100%. This 
definition is introduced for the purpose of identifying subjects who respond to the treatment (1 = 
responder, 0 = non-responder). 
PASI scoring of psoriatic plaques is based on three criteria: redness (R), thickness (T), and 
scaliness (S). Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 
4 for very marked involvement). The body is divided into four areas comprising the head (h), 
upper extremities (u), trunk (t), and lower extremities (l). In each of these areas, the fraction of 
total surface area affected is graded on a 0-6 scale (0 for no involvement; up to 6 for 90% - 100% 
involvement). 
The various body regions are weighted to reflect their respective proportion of BSA. The 
composite PASI score is then calculated by multiplying the sum of the individual-severity scores 
for each area by the weighted area-of-involvement score for that respective area, and then 
summing the four resulting quantities as follows (note for R, T, and S scores are as follows: 0 = 
none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked): 
PASI = (0.1 × (Rh + Th + Sh) × Ah) + (0.2 × (Ru + Tu + Su) × Au)
+ (0.3 × (Rt + Tt + St) × At) + (0.4 × (Rl + Tl + Sl) × Al) 
where 
Rh, Ru, Rt, Rl = redness score of plaques on the head, upper extremities, trunk, and lower 
extremities, scored 0-4 respectively; 
Th, Tu, Tt, Tl = thickness score of plaques on the head, upper extremities, trunk, and lower 
extremities, scored 0-4 respectively; 
Sh, Su, St, Sl = scaliness score of plaques on the head, upper extremities, trunk, and lower 
extremities, scored 0-4 respectively; 
Ah, Au, At, Al = numerical value translation of % area of psoriatic involvement score for the 
head, upper extremities, trunk, and lower extremities, respectively (where 0 = 0% [clear], 1 = 
>0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to <90%, and 6 
= 90% to 100%). 
The highest potential PASI score is 72 for severe disease; the lowest is 0 for no psoriasis lesions. 
PASI scores are treated as continuous. The percent improvement in PASI scores from Baseline 
will be computed as: 
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Percent improvement from Baseline = 100 × Baseline PASI −Post Baseline PASI
Baseline PASI
 
If a subject has experienced an improvement, this measure will be positive. If a subject has 
experienced a worsening in their condition, this measure will be negative. 
If a subject is missing 1 or 2 severity measurements for a certain region, the average of the 
remaining severity measurement(s) within that region will be utilized to substitute for the 
missing severity measurement(s) in that region. If the area of affected skin and/or all severity 
measurements for up to 2 regions are missing, then the missing (R+T+S) x A for a region will be 
substituted by the average of the available (R+T+S) x A. Otherwise, the PASI will be set to 
missing. 
8.1.1.2 
PASI100 Response at Week 16 
The primary efficacy variable, PASI100 at Week 16, is a categorical response variable and is 
defined to be equal to 1 if the percentage improvement from Baseline to Week 16 in the PASI 
scores is 100% and 0 if the percentage improvement from Baseline to Week 16 is less than 
100%. This definition is introduced for the purpose of identifying subjects who respond to the 
treatment (1 = responder, 0 = non-responder). The definition of percentage improvement from 
Baseline is given in Section 8.1.1.1. 
8.1.2 
Primary analysis of the primary efficacy variable 
The analysis of the primary efficacy variable (PASI100 at Week 16) will be based on the RS. A 
stratified Cochran-Mantel-Haenszel (CMH) test will be performed, where region and prior 
biologic exposure (yes/no) will be used as stratification variables. 
Treatment comparisons between bimekizumab and secukinumab will be made based on the 
CMH test using the p-value for the general association. For the assessment of non-inferiority, a 
non-inferiority margin of 10% will be used and evaluated based on the CI for the stratified 
Mantel-Haenszel risk difference between bimekizumab and secukinumab. The evaluation of 
superiority will use pairwise treatment comparisons based on the CMH test using the p-value for 
the general association. The odds ratio and associated confidence interval (CI) based on the Wald 
test will be presented. 
To calculate the stratified Mantel-Haenszel risk difference, the method of Greenland and Robins 
(1985) is used. For each combination of strata, a 2x2 table of treatment group and response is 
created. A theoretical 2x2 table for a given stratum is shown below, where n = a+b+c+d. 
Treatment Group 
Response 
Yes 
No 
Bimekizumab 
a 
c 
Secukinumab 
b 
d 
Given that structure, the stratified Mantel-Haenszel risk difference, standard error, and two-sided 
(1-α)*100% confidence interval may be written as follows: 
𝑅𝐷𝑀𝐻=
∑((𝑎𝑖∗(𝑏𝑖+ 𝑑𝑖)/𝑛𝑖) −(𝑏𝑖∗(𝑎𝑖+ 𝑐𝑖)/𝑛𝑖)
𝑖
∑((𝑎𝑖+ 𝑐𝑖) ∗(𝑏𝑖
𝑖
+ 𝑑𝑖))/𝑛𝑖
 
 
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𝑆𝐸𝑀𝐻= √
∑{[𝑎𝑖∗𝑐𝑖∗(𝑏𝑖+ 𝑑𝑖)3] + [𝑏𝑖∗𝑑𝑖∗(𝑎𝑖+ 𝑐𝑖)3]
(𝑎𝑖+ 𝑐𝑖) ∗(𝑏𝑖+ 𝑑𝑖) ∗𝑛𝑖
2
}
𝑖
{∑[(𝑎𝑖+ 𝑐𝑖) ∗(𝑏𝑖+ 𝑑𝑖)
𝑛𝑖
]
𝑖
}
2
 
 
𝐶𝐼𝑀𝐻= 𝑅𝐷𝑀𝐻± probit(1 −(𝛼2
⁄ )) ∗𝑆𝐸𝑀𝐻 
For the assessment of non-inferiority of bimekizumab to secukinumab, the lower 97.5% 
confidence limit for the stratified Mantel-Haenszel risk difference will be considered. If that 
value is greater than -10%, then non-inferiority will have been established. 
NRI will be used to account for missing data in the primary analysis. Specifically, any subject 
who withdraws from IMP prior to Week 16 or who has missing data for the primary efficacy 
variables at the Week 16 time point will be considered a nonresponder. 
The number and percentage of subjects who are PASI100 responders at Week 16 will be 
summarized. 
A line plot of the percentage improvement from Baseline in PASI score over time by treatment 
group will be produced by randomized treatment group for the RS and repeated for the MS. An 
additional plot will be produced for the OLS by OLE treatment groups. 
By-subject listings of PASI and PASI responder variables will be provided for the Initial and the 
Maintenance periods combined based on RS. This listing will also be provided separately for the 
OLE and the OLE2 treatment periods. 
8.1.3 
Supportive and sensitivity analyses of the primary efficacy variable 
The following sensitivity analyses for the primary efficacy variable will be performed to evaluate 
the assumptions related to the handling of missing data 
8.1.3.1 
Sensitivity Analysis #1 
Missing data will be addressed by using MI (MCMC) method for intermittent missing data, 
followed by monotone regression for monotone missing data (see Section 4.2.1.6) to evaluate the 
effect of the method for handling missing data on the analysis. The actual PASI scores will be 
imputed and then dichotomized to obtain the response status. The treatment differences for each 
imputed data set will subsequently be evaluated using the stratified CMH test as used in the 
primary analysis. The results from each of the imputed data sets will be combined for overall 
inference using Rubin’s rules, which account for the uncertainty associated with the imputed 
values (Rubin, 1987). This will be done using SAS PROC MIANALYZE. This procedure 
assumes a MAR pattern of missingness and corresponds to an estimand of the difference in 
outcome improvement if all subjects tolerated or adhered to treatment (Mallinckrodt et al, 2012). 
This is an estimand of efficacy to evaluate the de jure hypothesis. 
8.1.3.2 
Sensitivity Analysis #2 
This sensitivity analysis will be based on observed data at Week 16. Subjects with missing data 
or who have prematurely discontinued IMP will be treated as missing (see Section 4.2.1.5). The 
same stratified CMH test as in the primary efficacy analysis will be used. 
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8.1.3.3 
Sensitivity Analysis #3 
The primary efficacy analyses from Section 8.1.2 will be repeated using LOCF as the imputation 
method (see Section 4.2.1.5). 
8.1.3.4 
Sensitivity Analysis #4 
The primary efficacy analyses from Section 8.1.2 will be repeated based on the FAS and the 
PPS. 
8.1.3.5 
Sensitivity Analysis #5 
As a sensitivity analysis to the primary analysis method, logistic regression based on the RS will 
be used. The odds ratio of the responder rates at Week 16 will be estimated and tested between 
treatment groups using a logistic regression model with factors of treatment group, region, and 
prior biologic exposure (yes/no). The odds ratio, associated confidence interval (CI), and p-value 
based on the Wald test will be presented. If the logistic regression model is unable to converge, 
then prior biologic exposure may be dropped from the model to facilitate convergence. If the 
model is still unable to converge, then region may be removed from the model as well. In 
addition, if the logistic regression model cannot converge, then Fisher’s exact test will be used 
for inferential comparisons. As with the primary analysis, missing data will be handled using 
NRI. 
8.1.3.6 
Sensitivity Analysis #6 
The center-by-treatment interaction will be tested by replacing region with center in the logistic 
regression model described in Section 8.1.3.5 and adding a center-by-treatment interaction term. 
In the model, center will be based on the original centers prior to pooling. However, if the model 
is unable to converge due to a low number of subjects at a given center, a pooling (see 
Section 3.7) will be described in order to allow the model to converge. In order to obtain 
reasonable estimates of variability for a treatment arm at a given center, a minimum of 10 
subjects will be considered acceptable for a center to be included in the model without pooling. 
Given the 1:1 randomization allocation scheme at the start of the study, this should provide a 
minimum of about 5 subjects in each treatment group. Centers with fewer than 10 subjects will 
be eligible for pooling. The pooling algorithm used is described in Section 3.7. In order to 
achieve model convergence, region may be used instead of center or prior biologic exposure may 
be dropped from the model. If convergence still cannot be achieved, this analysis will not be 
performed. 
If the center-by-treatment interaction is not found to be significant (α=0.10), then no further 
analyses will be performed. On the other hand, if the interaction is significant, further analyses 
will be conducted to determine which center or centers may be the source of interaction. This 
will be done by running the logistic regression model (including the interaction term) where each 
center will be systematically removed from the model. This impact of a given center will be 
based on the change in the interaction p-value when that center is removed. The center or centers 
that appear to be driving the significant interaction effect will then be removed from the model to 
verify that conclusions remain the same with or without the influential center(s). This sensitivity 
analysis will be based on RS with NRI for missing data. 
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8.2 
Statistical analysis of the secondary efficacy variables 
8.2.1 
Derivations of secondary efficacy variables 
8.2.1.1 
PASI75 Responder at Week 4 
A categorical response variable, PASI75 at Week 4 is defined to be equal to 1 if the percentage 
improvement from Baseline to Week 4 in the PASI scores is 75% or greater and 0 if the 
percentage improvement from Baseline to Week 4 is less than 75%. The definition of percentage 
improvement from Baseline is given in Section 8.1.1.1. 
8.2.1.2 
PASI90 Responder at Week 16 
A categorical response variable, PASI90 at Week 16 is defined to be equal to 1 if the percentage 
improvement from Baseline to Week 16 in the PASI scores is 90% or greater and 0 if the 
percentage improvement from Baseline to Week 16 is less than 90%. 
The definition of percentage improvement from Baseline is given in Section 8.1.1.1. 
8.2.1.3 
PASI100 Responder at Week 48 
PASI100 response definition and derivation are outlined in Section 8.1.1.1 and Section 8.1.1.2. 
8.2.1.4 
IGA Response (0/1) at Week 16 
A static IGA for psoriasis will be used to assess disease severity in all subjects during the study. 
The Investigator will assess the overall severity of psoriasis using the following five-point scale: 
Table 8‒1: 
Investigator’s Global Assessment 
Score 
Short Descriptor 
Definition 
0 
Clear 
No signs of psoriasis; post-inflammatory hyperpigmentation may 
be present 
1 
Almost clear 
No thickening; normal to pink coloration; no to minimal focal 
scaling 
2 
Mild 
Just detectable to mild thickening; pink to light red coloration; 
predominately fine scaling 
3 
Moderate 
Clearly distinguishable to moderate thickening; dull to bright red, 
clearly distinguishable to moderate thickening; moderate scaling 
4 
Severe 
Severe thickening with hard edges; bright to deep dark red 
coloration; severe/coarse scaling covering almost all or all lesions 
IGA response at Week 16 is defined as clear [0] or almost clear [1] with at least a two-category 
improvement from Baseline at Week 16. 
8.2.2 
Primary analysis of the secondary efficacy variables 
All secondary efficacy variables are binary (responder) variables and will be summarized using 
frequency tables by randomized treatment group for each visit. Primary analysis for secondary 
efficacy variables will be summarized based on imputed data (NRI for binary variables) and for 
the RS, unless otherwise specified. A stratified CMH test will be performed, where region and 
prior biologic exposure (yes/no) will be used as stratification variables. 
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Treatment comparisons between bimekizumab and secukinumab will be made based on the 
CMH test using the p-value for the general association. PASI90 and IGA (clear or almost clear) 
at Week 16 are not in the closed testing procedure therefore the related p-values should only be 
considered descriptive statistics. 
PASI100 at Week 48 is the only secondary variable that is affected by the re-randomization at 
Week 16. The way the analysis for this variable is conducted will depend on which comparison 
is being made. The following comparisons will be performed: 
• Compare all subjects initially randomized to bimekizumab (regardless of re-randomization 
assignment at Week 16) to all subjects initially randomized to secukinumab based on the RS 
(H4) 
• Compare subjects who were assigned to bimekizumab 320mg Q4W at Week 16 to subjects 
on secukinumab based on the MS (H5) 
• Compare subjects who were assigned to bimekizumab 320mg Q8W at Week 16 to subjects 
on secukinumab based on the MS (H6) 
8.2.3 
Sensitivity analyses of the secondary efficacy variables 
For all secondary efficacy variables, sensitivity analyses #1 and #2 (Section 8.1.3.1 and 
Section 8.1.3.2) will be performed. In addition, for PASI100 response at Week 48, the sensitivity 
analyses described in Section 4.2.1.7 will be performed. 
8.3 
Analysis of other efficacy variables 
The other efficacy variables are listed below and will be evaluated according to the planned 
assessments in the protocol. This excludes the time points for the primary and secondary 
variables specified above in Section 8.1.1.2 and Section 8.2.1. 
Three different types of tables will be produced by visit through Week 48: 
1. Subjects in the MS summarized by the 3 maintenance treatment groups (bimekizumab 
320mg Q4W, bimekizumab 320mg Q8W, and secukinumab). 
2. A subset of Group 1 above. Specifically, this will include only those subjects who are 
responders at Week 16 for the variable being summarized. 
3. Subjects in the RS summarized by the 2 randomized treatment groups (bimekizumab and 
secukinumab). 
All efficacy variables will be summarized in the manner described for Group 1 and Group 3 
above. Summaries for Group 2 will be done only for a subset of efficacy variables, namely, 
PASI90/100 responder rate, IGA Clear or Almost Clear. Examination of subgroups will only be 
done for Group 3. 
Binary (responder) variables will be summarized using frequency tables by treatment group for 
each visit. Continuous variables will be summarized using descriptive statistics by treatment 
group for each visit. All variables will be summarized based on imputed data (NRI and 
MCMC/Monotone Regression for binary and continuous variables, respectively), unless 
otherwise specified. 
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For variables that are part of the sequence testing procedure, summaries based on observed case 
data will also be provided. There may be cases where the multiple imputation model fails to 
converge. In such situations, the LOCF approach will instead be used to impute the missing data. 
Selected efficacy variables will also be summarized by visit through Week 144 for the OLE 
Period for the OLS. Subjects will be summarized by treatment sequence comprising randomized 
treatment at Baseline and OLE period treatment at Week 48.  
The OC approach will be used to summarize the following efficacy variables for subjects in the 
OLE2 treatment period: PASI90, PASI100, IGA (0/1), IGA (0), DLQI (0/1), and PSD response. 
8.3.1 
PASI 
8.3.1.1 
PASI75, PASI90 and PASI100 response rates 
Categorical response variables, PASI75, PASI90 and PASI100 over time are defined to be equal 
to 1 if the percentage improvement from Baseline to visit time point in the PASI scores is 75%, 
90% and 100% respectively or greater and 0 if the percentage improvement from Baseline to 
visit time point is less than 75%, 90% and 100% respectively (1 = responder, 0 = non-responder). 
The definition of PASI score percentage improvement from Baseline is given in Section 8.1.1.1. 
A line plot of the PASI responder (PASI75, PASI90, and PASI100) rate over time, by treatment 
group will be produced for the RS and by randomized treatment groups. Additional plots will be 
produced separately for the MS by maintenance treatment groups, for the OLS and for the OLS2 
(excluding PASI75) by OLE and OLE2 treatment sequence respectively. 
8.3.1.2 
Time to PASI75, PASI90 and PASI100 response 
Time to PASI75, PASI90, and PASI100 response (in days) will each be calculated as: 
𝑀𝑖𝑛 (𝐷𝑎𝑡𝑒 𝑜𝑓 𝑓𝑖𝑟𝑠𝑡 𝑃𝐴𝑆𝐼𝑥𝑥 𝑟𝑒𝑠𝑝𝑜𝑛𝑠𝑒) –  𝐷𝑎𝑡𝑒 𝑜𝑓 𝐵𝑎𝑠𝑒𝑙𝑖𝑛𝑒 𝑣𝑖𝑠𝑖𝑡 +  1, 
where xx represents 75, 90, 100 respectively. All visits including unscheduled visits are 
considered. 
Subjects who discontinue study treatment without achieving a given PASI response prior to 
discontinuation will be censored at the date of the last observed PASI assessment on or prior to 
the date of treatment discontinuation. Subjects who reach the Week 48 Visit without achieving 
the given response will be censored at the date of the last observed PASI assessment on or prior 
to the Week 48 Visit. Subjects will be censored at Baseline if there is no Baseline PASI 
assessment or no Post Baseline PASI assessment 
Time to PASI75, PASI90, and PASI100 response during the initial and maintenance treatment 
period will each be estimated and presented using the Kaplan-Meier product-limit method based 
on the RS by initially randomized treatment groups (bimekizumab vs secukinumab). 
Time to a given response will be defined as the length in days from the first dose of IMP until the 
first date when the response is achieved. The median time to response, including the two-sided 
95% CI, will be calculated for each treatment. Between group differences (bimekizumab vs 
secukinumab) will be analyzed with the log-rank statistic by region and prior biologic exposure. 
Kaplan-Meier plots of time to PASI responses will also be presented by initially randomized 
treatment group. In these Kaplan-Meier plots, the line will start at 0 (since there are no 
responders at Week 0) and will increase over time, representing time to achieving the response. 
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Time to PASI75. PASI90, and PASI100 response analyses will not be conducted for the OLE 
and the OLE2 treatment periods. 
8.3.1.3 
PASI score 
Absolute and percent change from Baseline in PASI score is defined in Section 8.1.1.1. 
The percentage of subjects with absolute PASI score ≤1, ≤2, ≤3 and ≤5 will be presented over 
time using NRI for the RS, the MS, and the OLS. 
Absolute PASI score categories will not be summarized for the OLE2 treatment period. 
8.3.2 
IGA response 
• IGA response (Clear) is defined when IGA score is clear [0] (Table 8‒1) with at least a two-
category improvement from Baseline at visit time point. 
• IGA response (Clear or Almost Clear with at least 2 category improvements relative to 
Baseline) is defined as IGA score of clear [0] or almost clear [1] with at least a two-category 
improvement from Baseline at visit time point. 
• Shift from Baseline in IGA score is defined at each Post-Baseline visit time point relative to 
Baseline. 
• Scalp-specific IGA response 
A static IGA for scalp PSO will be used to assess disease severity on the scalp. 
All subjects will complete the scalp IGA at Baseline. Only subjects with scalp involvement at 
Baseline will complete the scalp IGA at the other visits specified in the protocol. Subjects with 
scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. 
Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using 
a 5-point scale as outlined in Table 8‒2 below. 
Table 8‒2: 
Scalp IGA 
Score Short Descriptor 
Detailed Descriptor 
0 
Clear 
Scalp has no signs of PSO; post-inflammatory hyperpigmentation may 
be present 
1 
Almost clear 
Scalp has no thickening; normal to pink coloration; no to minimal focal 
scaling 
2 
Mild 
Scalp has just detectable to mild thickening; pink to light red coloration; 
predominately fine scaling 
3 
Moderate 
Scalp has clearly distinguishable to moderate thickening; dull to bright 
red, moderate scaling 
4 
Severe 
Scalp has severe thickening with hard edges; bright to deep dark red 
coloration; severe/coarse scaling covering almost all or all lesions 
Scalp IGA response is defined as clear [0] or almost clear [1] with at least a two-category 
improvement from Baseline. For analysis purposes, the evaluation of scalp IGA will be limited 
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to subjects with a Baseline scalp IGA of at least 2. Therefore, if a subject has a score of 2 at 
Baseline, they can only be considered a responder if their IGA is 0 (thereby meeting the criterion 
for a two-category improvement from Baseline). Subjects with a Baseline scalp IGA of 1 will be 
assessed per the protocol but will not be part of the scalp IGA analysis. 
• pp-IGA response 
A static IGA for palmoplantar PSO will be used to assess palmoplantar disease severity. 
Only subjects with palmoplantar involvement at Baseline will complete the pp-IGA at the other 
visits specified in the protocol. Subjects with palmoplantar involvement at Baseline are defined 
as those with a pp-IGA score >0 at Baseline. 
Palmoplantar disease will be assessed in terms of clinical signs of redness, thickness, and 
scaliness using a 5-point scale as outlined in Table 8‒3 below. 
Table 8‒3: 
Palmoplantar IGA 
Score 
Short Descriptor 
Detailed Descriptor 
0 
Clear 
Palmoplantar has no signs of PSO; post-inflammatory 
hyperpigmentation may be present 
1 
Almost clear 
Palmoplantar has no thickening; normal to pink coloration; no to 
minimal focal scaling 
2 
Mild 
Palmoplantar has just detectable to mild thickening; pink to light red 
coloration; predominately fine scaling 
3 
Moderate 
Palmoplantar has clearly distinguishable to moderate thickening; dull to 
bright red and clearly distinguishable coloration; moderate scaling 
4 
Severe 
Palmoplantar has severe thickening with hard edges; bright to deep dark 
red coloration; severe/coarse scaling covering almost all or all lesions; 
numerous fissures 
PSO=psoriasis.  
Palmoplantar IGA response is defined as clear [0] or almost clear [1] with at least a two-category 
improvement from Baseline. For analysis purposes, the evaluation of pp-IGA will be limited to 
subjects with a Baseline pp-IGA of at least 2. Therefore, if a subject has a score of 2 at Baseline, 
they can only be considered a responder if their IGA is 0 (thereby meeting the criterion for a 
two-category improvement from Baseline). Subjects with a Baseline pp-IGA of 1 will be 
assessed per the protocol but will not be part of the palmoplantar IGA analysis. 
IGA response rate, Scalp IGA response rate, and Palmoplantar IGA response rate will be 
summarized for RS by treatment group and for OLS by treatment sequence and visit. 
A line plot of the IGA responder rates (both clear or almost clear and clear) over time, by 
treatment group will be produced for the RS and by randomized treatment groups. This plot will 
include assessments from the Initial and Maintenance Treatment Period. An additional plot will 
be produced by re-randomized maintenance treatment groups only for the Maintenance 
Treatment Period for the MS. Additional plots will be produced based on the OLS and the OLS2 
for IGA clear [0] and for IGA (clear [0] or almost clear [1] only by treatment sequence. 
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8.3.3 
Body Surface Area (BSA) 
• Absolute change from Baseline in the BSA affected by PSO is defined as Post Baseline BSA 
minus Baseline BSA affected by PSO. 
• Percent change from Baseline in BSA affected by PSO is defined as 
Percent change from Baseline = 100 × Post Baseline BSA −Baseline BSA
Baseline BSA 
 
The percent of subjects with absolute BSA=0%, ≤1%, ≤3% and ≤5% will be presented over time 
using NRI. 
BSA results will be listed but will not be summarized for the OLE2 treatment period. 
8.3.4 
Product of IGA and BSA (IGAxBSA) 
• Absolute change from Baseline in the product IGAxBSA is defined as Post Baseline 
IGAxBSA minus product of Baseline IGAxBSA. 
• Percent change from Baseline in the product of IGAxBSA is defined as 
Percent change from Baseline = 100 × Post Baseline IGAxBSA −Baseline IGAxBSA
Baseline  IGAxBSA  
 
The absolute and percentage change from baseline will be summarized for each study period 
(Initial randomized, Maintenance) by treatment group and visit. 
The product of IGA and BSA will not be summarized for the OLE2 treatment period. 
8.3.5 
Dermatology Life Quality Index (DLQI) 
The DLQI questionnaire is used for subjects with psoriasis and consists of 10-questions. This is a 
validated quality-of-life questionnaire that covers 6 domains including symptoms and feelings, 
daily activities, leisure, work and school, personal relationships, and treatment, as assessed over 
the past week. 
The scoring of each answer for the DLQI is as follows: 
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Table 8‒4: 
Dermatology Life Quality Index 
DLQI Scoring 
Response 
Score 
Very much 
3 
A lot 
2 
A little 
1 
Not at all 
0 
Not relevant 
0 
Question unanswered 
0 
Q7: ‘prevented work or studying’ = yes 
3 
The DLQI total score is calculated by adding the score of each question. The maximum score is 
30, and the minimum score is 0. The higher the score, the more quality of life is impaired. 
Meaning of DLQI Scores 
0-1 = no effect at all on patient’s life 
2-5 = small effect on patient’s life 
6-10 = moderate effect on patient’s life 
11-20 = very large effect on patient’s life 
21-30 = extremely large effect on patient’s life 
This categorization will not be utilized in the analysis. 
Because Q7 has a sub-question (referred to as Q7a here) after the leading yes/no question, some 
clarifying rules for scoring are provided: 
• If Q7 is marked as “yes”, a score of 3 is given regardless of the responses to Q7a. 
• If Q7 is marked as “no”, “not relevant”, or is missing and Q7a is “A lot”, a score of 2 is 
given. 
• If Q7 is marked as “no”, “not relevant”, or is missing and Q7a is “A little”, a score of 1 is 
given. 
• If Q7 is marked as “no”, “not relevant”, or is missing and Q7a is “Not at all”, a score of 0 is 
given. 
• If Q7 is marked as “no” or “not relevant” and Q7a is missing, a score of 0 is given. 
• If Q7 is missing and Q7a is missing, Q7 is considered unanswered (see below for details on 
how this impacts the overall DLQI score). 
If 1 question is left unanswered, this is scored 0 and the scores are summed and expressed as 
usual out of a maximum of 30. If 2 or more questions are left unanswered, the questionnaire is 
not scored. 
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A subject is considered to have achieved the minimally clinical important difference (MCID) if 
their individual improvement from Baseline score is > 4. A 4-point improvement in the DLQI 
total score (DLQI response) has been reported to be meaningful for the subject (within-subject 
MCID). 
The DLQI related efficacy variables are defined as follows: 
• Change from Baseline in DLQI total score is defined as Post-Baseline DLQI total score 
minus Baseline DLQI total score. 
• Percent of subjects achieving a DLQI total score of 0 or 1 is defined as the number of 
subjects with DLQI absolute score of 0 or 1 divided by the number of subjects in RS. 
• Percent of subjects achieving a MCID in DLQI is defined as the number of subjects with 
improvement from Baseline total score of 4 or more divided by the number of subjects in RS. 
Only subjects with a Baseline DLQI total score of 4 or greater will be considered for this 
analysis. 
The DLQI related efficacy variables will be summarized for the double-blind treatment visits 
separately for the RS and MS, and separately for OLS and OLS2 [DLQI(0/1) only] by treatment 
sequence respectively and visit. 
8.3.6 
Patient’s Global Assessment of Disease Activity (PGADA) for 
arthritis visual analog scale (VAS) 
The PGADA for arthritis VAS will be used to provide an overall evaluation of arthritis disease 
symptoms. Subjects will respond to the question, “Considering all the ways your arthritis affects 
you, please mark a vertical line on the scale below to show how you are feeling today,” using a 
VAS where 0 is “very good, no symptoms” and 100 is “very poor, severe symptoms. 
All subjects will complete the PGADA at Baseline. Subjects with PsA at Baseline (defined as a 
past medical history of PsA or PASE ≥47) will complete the PGADA at the visits specified in 
the protocol. Change from Baseline in PGADA is defined as Post-Baseline PGADA minus 
Baseline PGADA.  
The absolute and change from baseline in PGADA will be summarized for the double-blind 
treatment visits separately for the RS and MS and OLS by treatment sequence and visit.  
8.3.7 
Patient Global Assessment of PSO 
The Patient Global Assessment of PSO is a PSO-specific item in which the subject responds to 
the multiple-choice question, “How severe are your psoriasis-related symptoms right now?” 
Possible responses to the question are “no symptoms,” “mild symptoms,” “moderate symptoms,” 
“severe symptoms,” or “very severe symptoms.” 
The Patient Global Assessment of psoriasis will be summarized based on OC as the primary 
analysis. No imputation is applied. 
Shift from Baseline in Patient Global Assessment (PGA) of PSO score is defined to each Post-
Baseline visit time point relative to Baseline. 
The absolute value and shift from baseline in Patient Global Assessment (PGA) of PSO score 
will be summarized for each study period (Initial randomized, Maintenance) by treatment group.  
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8.3.8 
Symptoms of PSO (Itch, pain, and scaling) 
UCB has developed a new Patient Reported Outcome measure, in the form of a patient symptom 
diary (PSD), which is used to assess key signs, symptoms, and impacts relevant to subjects with 
moderate to severe chronic plaque PSO. In this study itch, pain, and scaling items from the diary 
will be used to assess the patient-reported level of these symptoms over time. The items will be 
administered on an electronic site tablet, during visits, as specified in the protocol. 
Each of the 3 items is measuring the severity of the symptom. Each item will be scored 
separately on a 0-10 scale with 0 meaning no symptom and 10 for very severe or worst symptom. 
• Change from Baseline in PSD item score for each item is defined as post Baseline PSD item 
score minus Baseline PSD item score. 
• Percent change from Baseline in PSD item score for each item is defined as 
Percent change from Baseline = 100 × Post Baseline PSD score - Baseline PSD score
Baseline PSD score
 
Absolute and percent changes from Baseline PSD item scores for each item will be summarized 
for each study period (Initial randomized, Maintenance) by treatment group.  
PSD response and the proportion of subjects with score of 0 (or 0/1) will be summarized for 
OLE Treatment Period by treatment sequence and visit. 
In addition, each of the 3 PSD scores will be characterized in terms of the percent of subjects 
demonstrating a 4-point improvement at each visit. Subjects with a missing score will be 
imputed using NRI. The analysis will be limited to subjects with a Baseline PSD score at or 
above the applicable threshold score.  
The PS0009 and PS0013 analyses determined a 4-point reduction as a marked within-subject 
clinically meaningful improvement in the weekly score each of these 3 PSD items that can be 
used to define different marked response to treatment over 16 weeks in patients with moderate-
to-severe plaque psoriasis. Such a threshold has also been used to support US label claims of 
other compounds approved in the same indication based on different PSO symptom diaries using 
an 11-point numeric response scale and was suggested in previous interactions with the FDA. 
Analyses conducted on blinded PS0015 data support the 4-point threshold as indicative of 
marked within-subject clinically meaningful improvement that can be used for responder 
definition. 
Cumulative distribution plots will also be provided for absolute change from Baseline PSD at 
Week 16 and Week 48 for each item. 
Listings of responses to individual questions of the patient diary will be provided separately for 
the Initial, Maintenance, OLE, and the OLE2 treatment periods. 
Summaries of PSD response (Itch, Pain, and Scaling symptoms) will be produced for the OLE2 
by treatment sequence as described in Section 3.6. 
8.3.9 
Modified Nail Psoriasis Severity Index (mNAPSI) score 
Psoriatic nail disease will be evaluated at the Baseline visit using the mNAPSI. All affected nails 
will be scored (0 to 3) for onycholysis/oil drop dyschromia, nail plate crumbling, and pitting and 
will be scored (0 for “no” or 1 for “yes”) for leukonychia, nail bed hyperkeratosis, splinter 
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haemorrhages and red spots in the lunula. The score for an individual nail ranges from 0 to 13 
with higher scores indicative of more severe nail disease. The total mNAPSI score is the sum of 
the scores for each individual nail. If a nail is unaffected, it will be recorded as such and will not 
contribute to the total mNAPSI score. 
If any of the 7 response items that contribute to mNAPSI is present, while other items are 
missing (ie, partial mNAPSI data), then the missing items are assumed to be 0 for the mNAPSI 
calculation. In some cases, the data may be captured in such a way that only non-zero component 
scores are present in the database. Again, those components that are not present are simply 
assumed to be 0 for the mNAPSI calculation. 
Change from Baseline in mNAPSI score for subjects with nail PSO at Baseline is defined as 
Post-Baseline mNAPSI score minus Baseline mNAPSI. 
An mNAPSI75 responder is defined as a subject who achieved at least a 75% improvement from 
Baseline in the mNAPSI score. mNAPSI90 and mNAPSI100 are defined accordingly. The 
proportion of mNAPSI75/90/100 responders for subjects with nail PSO at Baseline over time 
will be summarized for each study period (Initial randomized, Maintenance) by treatment group 
and OLE by treatment sequence.  
8.3.10 
Psoriatic Arthritis Screening and Evaluation (PASE) 
The PASE questionnaire is a self-administered tool to screen for active PsA in subjects with PSO 
(Husni et al, 2014). The questionnaire consists of 15 items that are divided into a 7-item 
symptoms subscale and an 8-item functions subscale. Standardized responses are based on 5 
categories relating to agreement (strongly agree [5], agree [4], no idea [3], disagree [2], and 
strongly disagree [1]). The total maximum score is 75 points (symptom score: 35 points and 
function score: 40 points). Psoriatic Arthritis Screening and Evaluation questionnaire scores ≥47 
points are indicative of active PsA. 
PASE will be collected at Baseline, Week 48/PEOT, Week 96 and Week 144/PEOT visits. 
PASE will be summarized based on OC only. No imputation is applied. 
• Change from Baseline in the PASE questionnaire scores (function score, symptom score, and 
total score) is defined as Post-Baseline PASE questionnaire score (function, symptom, and 
total) minus Baseline PASE questionnaire score (function, symptom, and total). 
• Shift from Baseline in PASE score suggestive of PsA (<47 versus ≥47) is defined to Week 
48/PEOT visit time point relative to Baseline. 
Change from Baseline in the PASE and Shift from Baseline in PASE will be summarized for 
each study period (Initial randomized, Maintenance) by treatment group and for OLE by 
treatment sequence and visit.  
8.3.11 
Euro-Quality of Life 5-Dimensions, 3 levels (EQ-5D-3L) 
The EQ-5D-3L health questionnaire provides a descriptive profile and a single index value for 
health status. The instrument is comprised of a 5-item health status measure and a VAS 
measurement. 
Responses to EQ-5D-3L are scored as 1 for “no problem”, 2 for “some or moderate problems”, 
and 3 for “extreme problems”. 
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Absolute EQ-5D-3L VAS score records the respondent’s self-rated health status on a vertical 
20cm scale, 0 to 100 graduated (0=worst imaginable health status, 100=best imaginable health 
status). 
Change from Baseline in EQ-5D-3L VAS scores is defined as Post-Baseline EQ-5D-3L VAS 
score minus Baseline EQ-5D-3L VAS score. 
Responses to EQ-5D-3L will be summarized for each study period (Initial randomized, 
Maintenance) by treatment group and for OLE by treatment sequence and visit. The analysis will 
be based on OC only as primary analysis. No imputation is applied to responses to EQ-5D-3L 
but is applied to EQ-5D-3L VAS scores.  
8.3.12 
Work Productivity and Activity Impairment Questionnaire – Specific 
Health Problem (WPAI-SHP) 
The WPAI-SHP is a subject-reported questionnaire that assesses subject’s employment status, 
work absenteeism, work impairment while working, overall work, and daily activity impairment 
attributable to a specific health problem. Five out of 6 items of the WPAI-SHP are regrouped 
into the 4 dimensions, with scores expressed as percentage, where higher numbers indicate 
greater impairment and less productivity, i.e., worse outcomes, as described in the WPAI-SHP 
scoring rules. 
The scoring rules for the WPAI-SHP are as follows: 
Questions: 
1 = currently employed 
2 = hours missed due to specified problem 
3 = hours missed other reasons 
4 = hours actually worked 
5 = degree problem affected productivity while working 
6 = degree problem affected regular activities 
Scores: 
• Percent work time missed due to problem: [Q2 hours/(Q2 hours +Q4 hours)]*100 
• Percent impairment while working due to problem: [Q5 score/10]*100 
• Percent overall work impairment due to problem: 
[Q2 hours/(Q2 hours +Q4 hours)+[(1-(Q2 hours/(Q2 hours +Q4 hours))x(Q5 score/10)] ] 
*100 
• Percent activity impairment due to problem: [Q6 score/10]*100 
Change from Baseline score is derived as post Baseline score minus Baseline score. A negative 
change score indicates a reduction in the score/improvement for the subject. 
The Change from Baseline in WPAI-SHP will be summarized for each study period (Initial 
randomized, Maintenance) by treatment group and for OLE by treatment sequence at each visit.  
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8.4 
Additional Statistical Analysis of other Efficacy Variables 
For selected other efficacy variables, it is of interest to perform statistical tests and to calculate 
inferential statistics. As these tests are not part of the multiplicity-controlled procedure, the 
associated p-values are considered nominal and are not controlled for multiplicity. For responder 
variables, the analysis will follow what was specified for the primary analysis. Specifically, a 
stratified Cochran-Mantel-Haenszel (CMH) test will be used, where region and prior biologic 
exposure (yes/no) will be stratification variables. The p-value will be based on the CMH test for 
a general association. Missing values will be imputed using NRI. For continuous variables, the 
MI – MCMC / Monotone Regression approach used for other continuous variables will be 
applied for the imputation model. The analysis model will be based on analysis of covariance 
(ANCOVA) with fixed effects of treatment, region, and prior biologic exposure and Baseline 
value as a covariate. Below is a list of variables for which these nominal p-values will be 
calculated (with the time points in parentheses). The results of these inferential tests will all be 
presented in a single table summarizing the testing performed outside of the multiplicity-
controlled testing procedure. 
• PASI90 
− Bimekizumab vs Secukinumab (Weeks 1, 2, 4, 8, 12, 16 and 48) 
• IGA Clear or Almost Clear 
− Bimekizumab vs Secukinumab (Weeks 1, 2, 4, 8, 12, 16 and 48) 
• PASI100 
− Bimekizumab vs Secukinumab (Weeks 4, 8, and 12) 
• IGA Clear 
− Bimekizumab vs Secukinumab (Weeks 4, 8, 12, 16, and 48) 
• PASI75 
− Bimekizumab vs Secukinumab (Weeks 1, 2, and 16) 
• Scalp IGA Clear or Almost Clear (subjects with Baseline Scalp IGA ≥2) 
− Bimekizumab vs Secukinumab (Weeks 16 and 48) 
• pp-IGA Clear or Almost Clear (subjects with Baseline pp-IGA ≥2) 
− Bimekizumab vs Secukinumab (Weeks 16 and 48) 
• mNAPSI75 response (subjects with Baseline mNAPSI>0) 
− Bimekizumab vs Secukinumab (Weeks 16 and 48) 
• mNAPSI90 response (subjects with Baseline mNAPSI>0) 
− Bimekizumab vs Secukinumab (Weeks 16 and 48) 
• mNAPSI100 response (subjects with Baseline mNAPSI>0) 
− Bimekizumab vs Secukinumab (Weeks 16 and 48) 
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• DLQI 0/1 response 
− Bimekizumab vs Secukinumab (Weeks 16 and 48) 
• PASI percentage change from Baseline 
− Bimekizumab vs Secukinumab (Weeks 1, 2, 4, 8, 12, 16, and 48)  
• PASI ≤1 response 
− Bimekizumab vs Placebo (Weeks 1, 2, 4, 8, 12, 16, and 48) 
• PASI ≤2 response 
− Bimekizumab vs Placebo (Weeks 1, 2, 4, 8, 12, 16, and 48)  
• PASI ≤3 response 
− Bimekizumab vs Placebo (Weeks 1, 2, 4, 8, 12, 16, and 48) 
• PASI ≤5 response 
− Bimekizumab vs Placebo (Weeks 1, 2, 4, 8, 12, 16, and 48) 
• Patient Symptom Diary responses for itch, pain, and scaling 
− Bimekizumab vs Secukinumab (Weeks 16, 32, 48) 
9 
PHARMACOKINETICS AND PHARMACODYNAMICS 
For the Week 48 interim the following treatment groups were summarized for the Initial and 
Maintenance Treatment Period. 
− Bimekizumab 320mg Q4W/Q8W with switch from Q4W to Q8W occurring at Week 16  
− Bimekizumab 320mg Q4W.  
PK and ADAb will also be summarized through to Week 144 by the following treatment 
sequence and by visit for Initial, Maintenance, and Open-Label Extension treatment period 
combined. No PK or ADAb samples will be collected in the OLE2 treatment period. 
• Subjects receiving bimekizumab in the double-blind treatment period until Week 144 or until 
treatment discontinuation: 
− Bimekizumab 320mg Q4W/Q8W with switch from Q4W to Q8W occurring at Week 16  
− Bimekizumab 320mg Q4W/Q8W with switch from Q4W to Q8W occurring at Week 48  
− Bimekizumab 320mg Q4W/Q8W with switch from Q4W to Q8W occurring at Week 72 
or 84  
− Bimekizumab 320mg Q4W/Q8W with switch from Q4W to Q8W occurring at Week 96 
or later  
− Bimekizumab Total (only for immunogenicity analyses). 
Subjects with any other treatment sequence groups (eg, Bimekizumab 320mg Q4W/Q8W/Q4W 
or Q4W/Q8W/Q4W/Q8W) will be allocated the "Bimekizumab Total" treatment sequence group 
for immunogenicity analysis only. All data will be included in the listings. 
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• Subjects receiving secukinumab in the double-blind treatment period: 
− Bimekizumab 320mg Q8W from Week 48 
− Bimekizumab 320mg Q4W/Q8W with switch from Q4W to Q8W occurring at Week 72 
or 84 
− Bimekizumab 320mg Q4W/Q8W with switch from Q4W to Q8W occurring at Week 96 
or later 
− Bimekizumab Total (only for immunogenicity analyses) 
Note that subjects who received Bimekizumab 320mg Q4W only, ie, those who discontinued 
before switching to Q8W, will be allocated to the corresponding Q4W/Q8W treatment sequence 
group depending on when the subject discontinued. For example, if a subject discontinued at 
week 68, they will be allocated to group Bimekizumab 320mg Q4W/Q8W, switch occurring at 
Week 72 for PK summary table and figure purposes. 
9.1 
Pharmacokinetics 
Pharmacokinetic variables will be analyzed for all subjects in the PK-PPS. Bimekizumab plasma 
concentrations will be summarized for each treatment sequence as described in Section 9, at each 
scheduled visit. A separate summary table will be created for the Open-Label Extension Period 
for subjects that are both in the PK-PPS and the OLS. 
PK summaries will be based on observed values. No imputation will be used however, if plasma 
concentration measurements are below the level of quantification (BLQ), then for calculation of 
the derived statistics the result will be set to 0.125 µg/ml, which is ½ of the lower level of 
quantification (LLOQ). Descriptive statistics including geometric mean, geometric coefficient of 
variation, and geometric mean 95% CI if applicable will be calculated if at least 2/3 of the values 
of interest are above the LLOQ. If this is not the case, only median, minimum, and maximum 
will be presented. In cases where n<3 only the minimum and maximum will be presented. 
In addition, geometric mean plasma concentration (with the 95% CI) will be plotted versus time 
on linear and semi-logarithmic scales by treatment sequence group. The summary table and 
figures will be repeated by cumulative antibody status for subjects randomized to bimekizumab. 
If a dose is +/- 21 days out of window, then the plasma concentration from that visit and all 
subsequent visits will be excluded from the PK summary tables and graphs. 
If the PK sampling date is >1 day after the dosing date, the plasma concentration at this visit will 
be excluded from the PK summary tables and figures, but not from the listing. 
If a subject misses an administration of bimekizumab, receives less or more than the intended 
dose, then the plasma concentration from the next scheduled visit will be excluded from PK 
summary tables and graphs. 
All PK concentration data will be listed. 
9.2 
Pharmacodynamics 
Not applicable. 
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9.3 
Immunogenicity 
The analysis of immunogenicity for the Week 48 Interim will be based on the SS All other 
analyses will be based on the BKZ Set. 
9.3.1 
Anti-nuclear antibodies 
Not applicable. 
9.3.2 
Anti-bimekizumab antibodies 
Anti-bimekizumab antibodies will be measured using a three tiered assay approach: screening 
assay, confirmatory assay and titration assay. Samples confirmed as positive within the 
confirmatory assay, will be further evaluated in a neutralizing assay to evaluate the potential of 
the ADAb to neutralize the activity of Bimekizumab (IL17A or IL17F, or both) in-vitro. Samples 
were taken at baseline, week 1, week 2, week 4, week 8, week 12, week 16, week 20, week 24, 
week 36, week 48, Week 72, Week 96, Week 120, Week144 (or PEOT) and at SFU which is 20 
weeks after the last dose. Due to the planned entry of some subjects to the OLE2 period, not all 
subjects will have an SFU period immediately following Week 144 with PK and 
immunogenicity samples.  
Anti-bimekizumab antibody samples are not analyzed when subjects are on a treatment other 
than bimekizumab. For subjects who switch from secukinumab to bimekizumab, samples are 
analyzed starting at the visit when the switch to bimekizumab occurs. The sample at the visit 
when the switch occurs will act as the Baseline for that treatment group. 
Screening, confirmatory and titer cut points of the respective assays will be determined by the 
bioanalytical laboratory based either on using commercially available drug-naïve samples or on 
the pre-dose samples of the study itself. The samples (or a subset) will also be subject to a 
neutralizing assay to evaluate whether the anti-bimekizumab antibody neutralizes the activity of 
bimekizumab (IL17 A or IL17F or both) in- vitro. 
The following definitions will be applied regarding ADAb status of each test samples: 
• An ADAb status will be confirmed as positive for any sample with an ADAb level that is 
positive screen and positive immunodepletion. 
• An ADAb status of negative will be concluded for any sample with an ADAb level that is 
either negative screen or (positive screen and negative immunodepletion). 
If the titer for an ADAb level that is positive screen and positive immunodepletion is missing, 
then a conservative approach will be used and ADAb status will be considered as positive. No 
imputation rules apply for the missing titer. If the ADAb level is positive screen but no 
confirmatory result could be determined, then a conservative approach will be used and ADAb 
status will be considered as positive. 
Anomalous values will be not included in summaries/analysis and will be reviewed and flagged 
by pharmacokinetic expert. 
For each subject an overall ADAb status in the treatment and OLE periods (Baseline to Week 
144) will be derived: 
• Overall Positive is defined as having at least one value that is confirmed positive during the 
treatment period. 
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• Overall Negative is defined as having no values that are confirmed positive at any time up to 
Week 144 and at least 2/3 of the protocol scheduled post-baseline assessments up to Week 
144 are evaluable (i.e. neither missing as per schedule nor inconclusive) 
• Overall Missing is defined as having no values that are confirmed positive at any visit in the 
treatment period, but the subject has 1/3 or more protocol scheduled post-baseline 
assessments missing (or inconclusive) up to Week 144.  
This differs from the Week 48 interim analysis where all subjects were defined as either overall 
positive or overall negative only (a missing category was not considered). As the time on 
treatment is protracted in this open label extension study (up to 144 Weeks), missing data or 
subject discontinuation may be more prevalent and is therefore considered for the final analysis 
• The double-blind and OLE treatment periods do not include Baseline/pre-treatment samples 
or SFU. 
Furthermore, the following subcategories for each subject will be derived: 
1. Pre anti-bimekizumab antibody negative – treatment emergent anti-bimekizumab 
antibody negative: Includes subjects who are negative at Baseline and antibody 
negative at all sampling points post treatment (excluding SFU) 
2. Pre anti-bimekizumab antibody negative – treatment emergent anti-bimekizumab 
antibody positive: Includes subjects who are negative at Baseline and antibody 
positive at any sampling point post treatment (excluding SFU). This group also includes 
subjects who have a missing pre-treatment sample (either missing or insufficient 
volume) at Baseline with one or more anti-bimekizumab antibody positive post-
treatment samples. 
3. Pre anti-bimekizumab antibody positive – treatment emergent reduced anti-
bimekizumab antibody: Includes subjects who are positive at Baseline, and antibody 
negative at all sampling points post treatment (excluding SFU). 
4. Pre anti-bimekizumab antibody positive – treatment emergent unaffected anti-
bimekizumab antibody positive: Includes subjects who are positive at Baseline and 
are positive at any sampling point post treatment (excluding SFU) with titer values of 
the same magnitude as Baseline (ie, less than a 2.07 fold difference from the Baseline 
value). 
5. Pre anti-bimekizumab antibody positive – treatment emergent anti-bimekizumab 
antibody boosted positive: Includes subjects who are positive at Baseline and are 
positive at any sampling point post treatment (excluding SFU) with increased titer 
values compared to baseline (greater than a 2.07 fold difference increase from Baseline 
value which will be defined within the validation of the assay). 
6. Inconclusive: Includes subjects who have a positive pre-treatment sample and some 
post-treatment samples are missing, while other post-treatment samples are anti-
bimekizumab antibody negative. 
7. Total treatment-emergent ADAb positivity (Category 7 [Categories 2 and 5 
combined]): Includes study participants who are pre ADAb negative – treatment-
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emergent ADAb positive (Category 2) and pre ADAb positive – treatment boosted 
ADAb positive (Category 5).  
8. Total prevalence of pre- ADAb positivity (Category 8 [Categories 3, 4 and 5 
combined]): Study participants that are tested ADAb positive at Baseline. 
9. Missing: Includes subjects who are antibody negative at baseline, are not positive at 
any post-baseline visit, and have at least one missing post-treatment scheduled 
assessment. Note this is also applicable to subjects who have missing baseline. 
For the Week 144 analysis, when all OLE and SFU data will be available, data from the OLE 
and SFU visits will be considered. That is, each instance of “excluding SFU” in the categories 
above, should be changed to “including SFU.” 
In the case that a sample is collected one or more days following the scheduled visit date in 
which the drug was administered, the anti-bimekizumab antibody results for that sample will be 
associated with the scheduled visit and summarized accordingly. Such samples will also be 
considered when anti-bimekizumab antibody results are summarized over a given study period. 
Analysis 
• Immunogenicity will be assessed through summary tables, figures, and listing of individual 
results by subject. The analysis of immunogenicity will be summarized by treatment 
sequence as described in Section 9 and visit. All analyses will be run on the safety 
population, unless specified otherwise. Summary of anti-bimekizumab antibody status 
overall and by each visit separated by treatment sequence 
• Summary of the time-point of the first occurrence of anti-bimekizumab antibody positivity 
during the treatment period by treatment sequence. A plot of the titer by time to first anti-
bimekizumab antibody positivity will be prepared 
• All individual subject-level anti-bimekizumab antibody results will be listed. 
• The number and percentage of subjects in each of the 8 anti-bimekizumab antibody 
categories during the treatment period by treatment sequence, with an additional category 
combining subjects in categories 2 and 5, summarized as total treatment emergent. In 
addition, the count and percentage of subjects who are pre anti-bimekizumab positive will be 
calculated (this is the sum of categories 3, 4, and 5) 
• The prevalence of immunogenicity, separated by treatment sequence, and defined 
subcategory, will be reported by visit, defined as (cumulative) proportion of subjects having 
confirmed positive anti-bimekizumab antibody samples at any visit up to and including that 
visit. Missing samples will not be included in the denominator 
• The time to achieving treatment-emergent anti-bimekizumab antibody positivity, separated 
by treatment sequence and defined sub-category, will be analyzed based on Kaplan-Meier 
methods. Subjects will be considered to have an event at the time point at which treatment 
emergent anti-bimekizumab antibody positive is first achieved. Subjects classified as 
treatment-emergent anti-bimekizumab antibody negative will be censored at the time of the 
last available anti-bimekizumab antibody result 
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• A summary of PASI 100 responders, separated by treatment sequence and defined sub-
category, at weeks 16, 48 and 144 as a function of ADAb titer will be presented graphically. 
This will be repeated for PASI 75 and 90 responders 
• Individual plots of Bimekizumab Concentrations/ anti-bimekizumab antibody titer and PASI 
score all plotted on the Y-axes by visit (x-axis) for the full treatment period (excluding SFU 
and OLE period for interim analyses and including SFU and OLE period for final analyses), 
where a patient has not progressed into the OLE. Plots should be labeled and grouped into 
the 7 sub-categories 
• Spaghetti plots of ADAb titer (y-axis) by visit (x-axis), separated by treatment sequence (as 
specified above) for all anti-bimekizumab antibody positive subjects, including Baseline 
positive subjects 
• Box plots Plot of ADAb titer (logscale) by time to first ADAb positivity by treatment 
sequence. 
For purposes of efficacy subgroup analyses based on anti-bimekizumab antibody status, two 
categories will be used: 
• Anti-bimekizumab antibody positive – This is defined as subjects who have anti-
bimekizumab antibody levels above the specified cut point on at least 2 time points while on 
treatment (ie, excluding Baseline, excluding SFU) 
• Anti-bimekizumab antibody negative – Subjects who are not defined as anti-bimekizumab 
positive (as described above) will be defined as anti-bimekizumab antibody negative. 
The groups for defining anti-bimekizumab antibody status for safety subgroup analyses are as 
follows: 
− AEs starting before first anti-bimekizumab antibody positive result 
− AEs starting on or after first anti-bimekizumab antibody positive result 
− AEs for subjects who were always anti-bimekizumab antibody negative. 
In addition to the anti-bimekizumab antibody classifications, subjects will be assigned an overall 
neutralizing anti-BKZ antibodies (NAb) classification for each NAb assay separately (IL-17AA 
and IL-17FF), inclusive of Baseline and post-Baseline results, on the NAb assay results. The 
classifications are as follows: 
− NAb negative: No NAb positive samples at Baseline or post-Baseline and did not 
discontinue prior to Week 144. Subject can have up to 1 missing sample. 
− NAb positive: One or more positive samples (IL-17AA positive, IL-17FF positive, or 
both) at Baseline or post-Baseline (regardless of missing samples). Subjects who are NAb 
positive will be further classified as follows: 
◦ 
Positive for IL-17AA only: one or more positive samples for IL-17AA at Baseline or 
post Baseline. No positive samples for IL-17FF 
◦ 
Positive for IL-17FF only: one or more positive samples for IL-17 FF at Baseline or 
post Baseline. No positive samples for IL-17AA 
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◦ 
Positive for both IL-17AA and IL-17FF: one or more positive samples for both IL-
17AA and IL-17FF at Baseline or post Baseline 
− NAb Missing: >1 relevant NAb samples are missing, eg, if subject had samples selected 
for NAb testing based on their anti-bimekizumab antibody levels, but there was 
insufficient sample left for NAb testing. 
A summary table covering the initial, maintenance and OLE periods combined by treatment 
sequence will be produced, in addition, to summarize the NAb status overall. 
A listing will be produced to summarize the NAb status by visit. The listing should be sorted by 
treatment sequence, subject identifier, and visit and would provide the following information for 
each subject: 
− Visit 
◦ 
Study week since first BKZ dose 
◦ 
Sample date and time 
◦ 
Time since previous dose (weeks) 
− NAb status and the corresponding bimekizumab plasma concentration (ug/mL) and the 
anti-bimekizumab antibody level titer at this visit 
− IL-17AA NAb status and corresponding IL-17AA signal/negative control result 
IL-17FF NAb status and corresponding IL-17FF signal/negative control result 
The tables will provide the following overall summary statistics by treatment group: 
− Total number and percentage of anti-bimekizumab antibody positive, anti-bimekizumab 
antibody negative and missing subjects at each visit 
− Number and percentage of subjects who are NAb positive, NAb negative and missing at 
each visit  
− The number and percentage of subjects who are IL-17AA NAb positive, IL-17FF NAb 
positive, or both. 
10 
SAFETY ANALYSES 
If not specified otherwise, all safety summaries and listings will be created using all subjects in 
the SS. 
10.1 
Extent of exposure 
Summaries for exposure will be provided for the SS, MS, OLS, OLS2, and BKZ set. These 
consist of a descriptive summary of study medication duration in days. In addition, total study 
medication duration and time at risk will be summarized in years by treatment group 
The cumulative study medication duration will be summarized for the SS for subjects exposed 
for given durations of time, the following categories for duration will be used: 
• >0 weeks 
• >=16 weeks 
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• >=24 weeks 
• >=48 weeks 
For the Week 144 analysis and for the final analysis, the table will also be created for the BKZ 
set and will include the above categories plus the below categories. A bimekizumab total column 
will also be displayed. 
• >=72 weeks 
• >=96 weeks 
• >=120 weeks 
• >=144 weeks 
In addition, the OLE2 exposure will be displayed separately as follow: 
• >0 weeks 
• >=16 weeks 
• >=24 weeks 
• >=48 weeks. 
Definitions for study medication duration and time at risk in days are provided below. Time at 
risk will be summarized in years. Time at risk in years is calculated by dividing the time at risk 
in days by 365.25. 
Throughout this section, date of last clinical contact for each subject is defined as the maximum 
of (last visit date including SFU or SFU2 visit, last imputed AE start date, date of study 
termination or completion, last date of study drug administration). 
10.1.1 
Exposure during the Initial Treatment Period for SS 
Definitions for study medication duration (days) and time at risk (days) during the Initial 
Treatment Period are provided as follows: 
Study medication duration (days) 
• Date of last active dose of IMP in the Initial Treatment Period – date of first dose + 28 days 
Note: If date of last active dose of IMP in the Initial Treatment Period + 28 days extends to a 
date beyond the final visit date (including PEOT, but not including SFU), then this 
calculation reverts to: 
• Final visit date (including PEOT, but not including SFU) – date of first dose + 1. 
Note: If date of last active dose of IMP in the Initial Period + 28 days extends to a date 
beyond the date of first dose in the Maintenance Treatment Period, then this calculation 
reverts to: 
− Date of first dose in the Maintenance Period – date of first dose in the Initial Treatment 
Period + 1. 
Note: For subjects who die, if date of last active dose of IMP in the Initial Treatment Period 
+ 28 days extends to a date beyond the date of death, then this calculation reverts to: 
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• Date of death – date of first dose + 1. 
Time at risk (days) 
• For subjects who die: 
− Date of death – date of first dose +1. 
• For subjects who complete the final visit of the Initial Period and continue to the 
Maintenance Period: 
− Date of first dose in the Maintenance Treatment Period – date of first dose in the Initial 
Treatment Period + 1. 
• For subjects who discontinue on or prior to the final visit of the Initial Period, use the 
minimum of the following: 
− Date of last active dose of IMP in the Initial Treatment Period– date of first dose + 140 
days. 
− The total number of days in the Initial Treatment Period (112 days). For AEs that 
emerged after 112 days but still within the 140 days window, those AEs would be 
classified as TEAE, but will be excluded from the output based on the Initial Treatment 
Period. However, these AEs will be included in the AE summaries for Initial Treatment 
Period and Maintenance Treatment Period combined. 
− Date of last clinical contact – date of first dose + 1. 
10.1.2 
Exposure during the Maintenance Treatment Period for MS 
Definitions for study medication duration (days) and time at risk (days) during the Maintenance 
Treatment Period are provided as follows: 
Study medication duration (days) 
• Date of last bimekizumab or secukinumab dose in the Maintenance Treatment Period – date 
of first dose in the Maintenance Treatment Period + 28 days (for subjects on Q4W dosing or 
secukinumab) 
• Date of last bimekizumab in the Maintenance Treatment Period – date of first dose in the 
Maintenance Treatment Period + 56 days (for subjects on Q8W dosing) 
Note: If date of last bimekizumab or secukinumab dose in the Maintenance Treatment Period 
+ 28 days (or 56 days for subjects on Q8W dosing) extends to a date beyond the final visit 
date (including PEOT, but not including SFU), then this calculation reverts to: 
− Final visit date (including PEOT, but not including SFU) – date of first dose in the 
Maintenance Treatment Period+ 1. 
Note: If date of last bimekizumab or secukinumab dose in the Maintenance Period + 28 (or 
56 days for subjects on Q8W dosing) days extends to a date beyond the date of first dose in 
the Open-Label Extension Period, then this calculation reverts to: 
− Date of first dose in the Open-Label Extension Period – date of first dose in the 
Maintenance Treatment Period + 1. 
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Note: For subjects who die, if date of last bimekizumab or secukinumab dose in the 
Maintenance Treatment Period + 28 days (or 56 days for subjects on Q8W dosing) extends to 
a date beyond the date of death, then this calculation reverts to: 
− Date of death – date of first dose in the Maintenance Treatment Period+ 1. 
Time at risk (days) 
• For subjects who die: 
− Date of death – date of first dose in the Maintenance Treatment Period+1. 
• For subjects who complete the final visit of the Maintenance Period and continue to the OLE 
Period: 
− Date of first dose in the OLE Period - date of first dose in the Maintenance Treatment 
Period + 1 day. 
• For subjects who discontinue on or prior to the final visit of the Maintenance Period, use the 
minimum of the following: 
− Date of last dose in the Maintenance Treatment Period – date of first dose in the 
Maintenance Treatment Period + 140 days. 
− Date of last clinical contact – date of first dose in the Maintenance Treatment Period + 1. 
10.1.3 
Exposure during the Initial and Maintenance Treatment Period for SS 
Definitions for study medication duration (days) and time at risk (days) during the Initial and 
Maintenance Treatment Period are provided as follows: 
10.1.3.1 
For subjects who do not switch study treatments 
Study medication duration (days) 
• Date of last active dose of IMP in the Initial and Maintenance Treatment Period – date of 
first dose + 28 days 
Note: If date of last active dose of IMP in the Initial and Maintenance Treatment Period + 28 
days extends to a date beyond the final visit date (including PEOT, but not including SFU), 
then this calculation reverts to: 
− Final visit date (including PEOT, but not including SFU) – date of first dose + 1. 
Note: If date of last bimekizumab or secukinumab dose in the Maintenance Period + 28 days 
extends to a date beyond the date of first dose in the Open-Label Extension Period, then this 
calculation reverts to: 
− Date of first dose in the Open-Label Extension Period – date of first dose + 1. 
Note: For subjects who die, if date of last dose in the Initial Treatment and Maintenance 
Period + 28 days extends to a date beyond the date of death, then this calculation reverts to: 
− Date of death – date of first dose + 1. 
Time at risk (days) 
• For subjects who continue into the OLE period: 
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− Date of first dose in the OLE Period – date of first dose + 1. 
• For subjects who die: Date of death – date of first dose +1. 
• For all other subjects, use the minimum of the following: 
− Date of last active dose of IMP in the Initial and Maintenance Treatment Period– date of 
first dose + 140 days. 
− Date of last clinical contact – date of first dose + 1. 
10.1.3.2 
For subjects who switch from BKZ 320mg Q4W to Q8W at Week 16: 
Study medication duration (days) 
• Initial Treatment Period (attributed to BKZ 320mg Q4W) 
− Date of last dose in the Initial Treatment Period – date of first dose + 28 days 
Note: If date of last dose in the Initial Treatment Period + 28 days extends to a date beyond 
the first dose in the Maintenance Treatment Period, then this calculation reverts to: 
− Date of first dose in the Maintenance Treatment Period – date of first dose + 1. 
• Maintenance Treatment Period (attributed to BKZ 320mg Q8W) 
− Use the study medication duration algorithm specified for the Maintenance Treatment 
Period in Section 10.1.2 
• Initial and Maintenance Treatment Period (attributed to Total BKZ) 
− Study medication duration in Initial Treatment Period + Study medication duration in 
Maintenance Treatment Period. 
Time at risk (days) 
• Initial Treatment Period (attributed to BKZ 320mg Q4W) 
− Date of first dose in the Maintenance Treatment Period - date of first dose + 1 day. 
• Maintenance Treatment Period (attributed to BKZ 320mg Q8W) 
− Use the time at risk algorithm specified for the Maintenance Treatment Period in 
Section 10.1.2 
• Initial and Maintenance Treatment Period (attributed to Total BKZ) 
− Use the time at risk algorithm specified for subjects who do not switch study treatments 
in Section 10.1.3.1 
10.1.4 
Exposure during the Open-Label Extension Period based on OLS 
Definitions for study medication duration (days) and time at risk (days) during the Open-Label 
Extension Period are provided as follows: 
10.1.4.1 
For subjects who do not switch study treatments 
Study medication duration (days) 
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• For subjects who receive Q4W in the Open-Label Extension Period (subjects who 
discontinue prior to switching to Q8W): 
− Date of last bimekizumab dose in the Open-Label Extension Period – date of first dose in 
the Open-Label Extension Period + 28 days (for subjects on Q4W dosing) 
• For subjects who receive Q8W in the Open-Label Extension Period use the minimum of: 
− Date of last bimekizumab dose in the Open-Label Extension Period – date of first dose in 
the Open-Label Extension Period + 56 days  
− First dose date in Open-Label Extension 2 Period  – date of first dose in the Open-Label 
Extension Period + 1 
Note: If date of last bimekizumab dose in the Open-Label Extension Period + 28 days (or 56 
days for subjects on Q8W dosing) extends to a date beyond the final visit date (including 
PEOT, but not including SFU), then this calculation reverts to: 
− Final visit date (including PEOT, but not including SFU) – date of first dose in the Open-
Label Extension Period+ 1. 
Note: For subjects who die, if date of last bimekizumab dose in the Open-Label Extension 
Period + 28 days (or 56 days for subjects on Q8W dosing) extends to a date beyond the date 
of death, then this calculation reverts to: 
− Date of death – date of first dose in the Open-Label Extension Period+ 1. 
Time at risk (days) 
• For all subjects, use the minimum of the following: 
− Date of last dose in the Open-Label Extension Period – date of first dose in the Open-
Label Extension Period + 140 days, 
− Date of first dose in OLE2 - date of first dose in the Open-Label Extension Period + 1 
day 
− Date of last clinical contact in OLE and SFU – date of first dose in the Open-Label 
Extension Period + 1. 
− Date of death – date of OLE first dose 
10.1.4.2 
For subjects who switch from BKZ 320mg Q4W to Q8W during Open-
Label Extension Period 
Following Protocol Amendment 5.0, subjects receiving Q4W should switch to Q8W during the 
Open-Label extension period. (see Section 2.3.2.4 for further details). 
Study medication duration (days) 
• Attributed to BKZ 320mg Q4W: 
− Date of last BKZ 320mg Q4W dose in the OLE Period – date of first BKZ 320mg Q4W 
dose in the OLE Period + 28 days 
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Note: If date of last BKZ 320mg Q4W dose in the OLE Period + 28 days extends to a date 
beyond the date of first BKZ 320mg Q8W dose in the OLE Period, then this calculation 
reverts to: 
− Date of first BKZ 320mg Q8W dose in the OLE Period – date of first BKZ 320mg Q4W 
dose in the OLE Period + 1. 
• Attributed to BKZ 320mg Q8W use the minimum of: 
− Date of last BKZ 320mg Q8W dose in the OLE Period – date of first BKZ 320mg Q8W 
dose in the OLE Period + 56 days. 
− First dose date in Open-Label Extension Period 2 – date of first BKZ 320mg Q8W dose 
in the Open-Label Extension Period+ 1. 
Note: If date of last bimekizumab dose in the Open-Label Extension Period + 56 days 
extends to a date beyond the final visit date (including PEOT, but not including SFU), then 
this calculation reverts to: 
− Final visit date (including PEOT, but not including SFU) – date of first BKZ 320mg 
Q8W dose in the OLE Period + 1. 
Note: For subjects who die, if date of last bimekizumab dose in the Open-Label Extension 
Period + 56 days extends to a date beyond the date of death, then this calculation reverts to: 
− Date of death – date of first BKZ 320mg Q8W dose in the OLE Period + 1. 
• Attributed to Total BKZ 
− Sum of study medication duration in OLE period attributed to BKZ 320mg Q4W and 
study medication duration in OLE period attributed to BKZ 320mg Q8W-1. 
Time at risk (days) 
• Attributed to BKZ 320mg Q4W: 
− Date of first BKZ 320mg Q8W dose in the OLE Period – date of last BKZ 320mg Q4W 
dose in the OLE Period + 1 day 
• Attributed to BKZ 320mg Q8W: 
− For all subjects, use the minimum of the following: 
◦ 
Date of last BKZ 320mg Q8W dose in the OLE Period – date of first BKZ 320mg 
Q8W dose in the OLE Period + 140 days. 
◦ 
Date of first BKZ 320mg Q8W dose in OLE2 - date of first BKZ 320mg Q8W dose 
in the Open-Label Extension Period + 1 day 
◦ 
Date of last clinical contact – date of first BKZ 320mg Q8W dose in the OLE Period 
+ 1. 
◦ 
Date of death – date of first BKZ 320mg Q8W dose in the OLE Period + 1. 
• Attributed to Total BKZ: 
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− Use the time at risk algorithm specified for subjects who do not switch study treatments 
in Section 10.1.4.1 
10.1.5 
Exposure during the Double-blind and Open-Label Extension Period 
based on BKZ set 
Definitions for study medication duration (days) and time at risk (days) during the double-blind 
and Open-Label Extension Period are provided as follows: 
10.1.5.1 
For subjects who do not switch dose 
For subjects randomized to bimekizumab 320mg Q4W at Baseline who continue on the Q4W 
dose schedule without switching: 
Study medication duration (days) 
• Date of last bimekizumab dose – date of first bimekizumab dose + 28 days 
• Note: If date of last bimekizumab dose + 28 days extends to a date beyond the final visit date 
(including PEOT, but not including SFU), then this calculation reverts to: 
− Final visit date (including PEOT, but not including SFU) – date of first dose + 1. 
Note: For subjects who die, if date of last bimekizumab dose + 28 days extends to a date 
beyond the date of death, then this calculation reverts to: 
− Date of death – date of first dose + 1. 
Time at risk (days) 
• For all subjects, use the minimum of the following: 
− Date of last dose – date of first + 140 days. 
− Date of last clinical contact – date of first dose + 1. 
− Date of death – date of first dose + 1. 
For subjects randomized to secukinumab at Baseline who initiate bimekizumab at Week 48 and 
continue on the same dose schedule in the OLE without switching, use the study medication 
duration and time at risk algorithms specified for subjects who do not switch study treatments in 
Section 10.1.4.1 
10.1.5.2 
For subjects who switch dose 
Subjects can switch bimekizumab 320mg dose schedule up to three times during the Double-
blind and Open-Label Extension Period. Switches can occur at Week 16, Week 48, and Week 96 
or at specific visits during the OLE following amendment 5.0. See Section 2.3.2 for further 
details regarding switching. 
Study medication duration (days) 
Total study medication duration attributed to each dose will be obtained by summing the study 
medication duration(s) at each specific dose in each individual study period. Total study 
medication duration attributed to BKZ Total will be obtained by summing the study medication 
durations in each individual study period and deducting n-1, where n is the number of periods 
covered that are being summed.  
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Study medication duration at each specific dose in each individual study period is calculated 
separately as follows: 
• Attributed to BKZ 320mg Q4W: 
− Date of last consecutive BKZ 320mg Q4W dose in current study period– date of first 
consecutive BKZ 320mg Q4W dose in current study period + 28 days 
Note: If date of last consecutive BKZ 320mg Q4W dose in current study period+ 28 days 
extends to a date beyond the date of first BKZ 320mg Q8W dose in the next study period, 
then this calculation reverts to: 
− Date of first BKZ 320mg Q8W dose in the next study period – date of first BKZ 320mg 
Q4W dose in the current study period. 
Note: If BKZ 320mg Q4W is the last dosing schedule received in the last study period the 
subject receives bimekizumab in and date of last consecutive BKZ 320mg Q4W dose in 
current study period+ 28 days extends to a date beyond the final visit date (including PEOT, 
but not including SFU), then this calculation reverts to: 
− Final visit date (including PEOT, but not including SFU) – date of first BKZ 320mg 
Q4W dose in the current study period + 1. 
Note: For subjects who die, where BKZ 320mg Q4W is the last dosing schedule received in 
the last study period the subject receives bimekizumab in and date of last consecutive BKZ 
320mg Q4W dose in current study period+ 28 days extends to a date beyond the date of 
death, then this calculation reverts to: 
− Date of death – date of first BKZ 320mg Q4W dose in the current study period + 1. 
• Attributed to BKZ 320mg Q8W 
− Date of last consecutive BKZ 320mg Q8W dose in current study period– date of first 
consecutive BKZ 320mg Q8W dose in current study period + 56 days 
Note: If date of last consecutive BKZ 320mg Q8W dose in current study period+ 56 days 
extends to a date beyond the date of first BKZ 320mg Q4W dose in the next study period, 
then this calculation reverts to: 
− Date of first BKZ 320mg Q4W dose in the next study period – date of first BKZ 320mg 
Q4W dose in the current study period. 
Note: If BKZ 320mg Q8W is the last dosing schedule received in the last study period the 
subject receives bimekizumab in and date of last consecutive BKZ 320mg Q8W dose in 
current study period+ 56 days extends to a date beyond the final visit date (including PEOT, 
but not including SFU), then this calculation reverts to: 
− Final visit date (including PEOT, but not including SFU) – date of first BKZ 320mg 
Q8W dose in the current study period + 1. 
Note: For subjects who progress into the OLE2, if date of last bimekizumab dose in the 
Open-Label Extension Period + 56 days extends to a date beyond the date of first dose in the 
Open-Label Extension 2 Period then this calculation reverts to: 
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− First dose date in Open-Label Extension 2 Period– date of first BKZ 320mg Q8W dose in 
the current study period + 1. 
Note: For subjects who die, where BKZ 320mg Q8W is the last dosing schedule received in 
the last study period the subject receives bimekizumab in and date of last consecutive BKZ 
320mg Q8W dose in current study period+ 56 days extends to a date beyond the date of 
death, then this calculation reverts to: 
− Date of death – date of first BKZ 320mg Q8W dose in the current study period + 1. 
Time at risk (days) 
Total time at risk attributed to each dose will be obtained by summing the time(s) at risk at each 
specific dose in each individual study period and deducting n-1, where n is the number of 
non-consecutive periods covered that are being summed. Total time at risk attributed to BKZ 
Total will be obtained by using the time at risk algorithms specified for subjects who do not 
switch study treatments in Section 10.1.5.1. 
• Time at risk at each specific dose in each individual study period is calculated separately as 
follows: 
− Attributed to BKZ 320mg Q4W: 
◦ 
Date of first BKZ 320mg Q8W dose in the next study period – date of first BKZ 
320mg Q4W dose in the current study period. 
Note: If BKZ 320mg Q4W is the last dosing schedule received in the last study period, 
then this calculation reverts to: 
◦ 
For all subjects, use the minimum of the following: 
◦ 
Date of last BKZ 320mg Q4W dose in the current study period – date of first BKZ 
320mg Q4W dose in the current study period + 140 days. 
◦ 
Date of first BKZ 320mg Q8W dose in OLE2 - date of first BKZ 320mg Q4W dose 
in the Open-Label Extension Period + 1 day. The OLE and The OLE2 treatment 
periods should not overlap by more than 1 day 
◦ 
Date of last clinical contact – date of first BKZ 320mg Q4W dose in the OLE Period 
+ 1. 
◦ 
Date of death – date of first BKZ 320mg Q4W dose in the current study period + 1 
− Attributed to BKZ 320mg Q8W: 
◦ 
Date of first BKZ 320mg Q4W dose in the next study period – date of first BKZ 
320mg Q8W dose in the current study period. 
Note: If BKZ 320mg Q8W is the last dosing schedule received in the last study period, 
then this calculation reverts to: 
◦ 
For subjects who die 
Date of death – date of first BKZ 320mg Q8W dose in the current study period + 1. 
For all other subjects, use the minimum of the following: 
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◦ 
Date of last BKZ 320mg Q8W dose in the current study period – date of first BKZ 
320mg Q8W dose in the current study period + 140 days. 
◦ 
Date of first dose in OLE2 - date of first BKZ 320mg Q8W dose in the Open-Label 
Extension Period + 1 day.  
◦ 
Date of last clinical contact – date of first BKZ 320mg Q8W dose in the OLE Period 
+ 1. 
10.1.6 
Exposure during the OLE2 Period based on OLE2 set 
Eligible subjects from sites in the US or Canada who have completed the Week 144 Visit or are 
in the SFU or have completed the SFU of the OLE Period can roll over to an additional OLE2 
period. 
Definitions for study medication duration (days) and time at risk (days) during the OLE2 Period 
will be provided for the following subjects: 
• Group A: Subjects who roll over directly from OLE to OLE2 
• Group B: Subjects who reinitiate bimekizumab and who were in the SFU or had completed 
the SFU of the OLE Period. 
10.1.6.1 
Group A: Subjects who roll over directly from OLE to OLE2 
Study medication duration (days) 
• Date of last bimekizumab dose in the OLE2 Period – date of first dose in the OLE2 Period + 
56 days 
Note: If date of last bimekizumab dose in the OLE2 Period + 56 days extends to a date 
beyond the final visit date (including PEOT, but not including SFU2), then this calculation 
reverts to: 
− Final visit date (including PEOT, but not including SFU2) – date of first dose in the 
OLE2 Period+ 1. 
Note: For subjects who die, if date of last bimekizumab dose in the OLE2 Period + 56 days 
extends to a date beyond the date of death, then this calculation reverts to: 
− Date of death – date of first dose in the OLE2 Period+ 1. 
Time at risk (days) 
• Use the minimum of the following: 
− Date of last dose in the OLE2 Period – date of first dose in the OLE2 Period + 140 days. 
− Date of last clinical contact – date of first dose in the Open-Label Extension Period + 1. 
− Date of death – date of first dose in the OLE2 Period+1. 
10.1.6.2 
Group B: Subjects who reinitiate bimekizumab 
10.1.6.2.1 
Subjects reinitiated to receive BKZ Q8W at OLE2 start 
• Study medication duration (days) 
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− Date of last bimekizumab dose in the OLE2 period– date of first bimekizumab dose in 
the OLE2 + 56 days 
Note: If date of last bimekizumab dose in the OLE2 + 56 days extends to a date beyond the 
final visit date (including PEOT, but not including SFU2), then this calculation reverts to: 
− Final visit date (including PEOT, but not including SFU2) – date of first dose in the 
OLE2 Period + 1. 
Note: For subjects who die, if date of last bimekizumab 320mg Q8W dose + 56 days extends 
to a date beyond the date of death, then this calculation reverts to: 
− Date of death – date of first dose in the OLE2 Period + 1. 
• Time at risk (days) 
− Use the minimum of the following: 
◦ 
Date of last dose – date of first dose in OLE2 + 140 days. 
◦ 
Date of last clinical contact – date of first dose in OLE2 + 1.Date of death – date of 
first dose + 1. 
10.1.6.2.2 
Subjects reinitiated to receive BKZ Q4W/Q8W at OLE2 start 
• Attributed to BKZ Q4W/Q8W 
− Date of last BKZ 320mg Q8W dose in the OLE2 Period – date of first BKZ 320mg Q4W 
dose in the OLE2 Period + 56 days. 
Note: If date of last bimekizumab dose in the OLE2 Period + 56 days extends to a date beyond 
the final visit date (including PEOT, but not including SFU2), then this calculation reverts to: 
− Final visit date (including PEOT, but not including SFU2) – date of first BKZ 320mg 
Q4W dose in the OLE2 Period + 1. 
Note: For subjects who die, if date of last bimekizumab dose in the OLE2 Period + 56 days 
extends to a date beyond the date of death, then this calculation reverts to: 
− Date of death – date of first dose in the OLE2 Period + 1 
• If the subject discontinued prior to the switch to Q8W then:  
− Date of last BKZ 320mg Q4W dose in the OLE2 Period – date of first BKZ 320mg Q4W 
dose in the OLE2 Period + 28 days. 
If date of last bimekizumab dose in the OLE2 Period + 28 days extends to a date beyond the final 
visit date (including PEOT, but not including SFU2), then this calculation reverts to: 
− Final visit date (including PEOT, but not including SFU2) – date of first BKZ 320mg 
Q4W dose in the OLE2 Period + 1. 
Note: For subjects who die prior to switch to Q8W, if date of last bimekizumab dose in the 
OLE2 Period + 28 days extends to a date beyond the date of death, then this calculation reverts 
to: 
− Date of death – date of first dose in the OLE2 Period + 1. 
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Time at risk (days) 
• Attributed to BKZ Q4W/Q8W: 
− Use the time at risk algorithm specified for subjects who do not switch study treatments 
in Section 10.1.6.1.   
10.2 
Adverse events 
An AE is any untoward medical occurrence in a subject or clinical investigation subject 
administered a pharmaceutical product that does not necessarily have a causal relationship with 
this treatment. An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease temporally associated with the use of a 
medicinal (investigational) product, whether or not related to the medicinal (investigational) 
product. 
Adverse events will be coded according to the MedDRA. AEs will be allocated to the respective 
randomized treatment arm. For subjects who switch treatment at Week 16, Week 48 or (on or 
after Week 64), any adverse events that occur after initiation of the new treatment are attributable 
to the new treatment. If an adverse event occurs on the date of a treatment switch, the event is 
attributed to the original treatment. The only exception to this is if the AE fulfills any of the 
criteria specified below: 
• Events that fulfill the anaphylaxis criteria for acute events 
• Events that fulfill the hypersensitivity criteria 
• Events with an HLT of “Administration site reactions NEC” 
• Events with an HLT of “Injection site reactions” 
For results disclosure on public registries (eg, ClinicalTrials.gov), treatment-emergent adverse 
events and treatment-emergent serious adverse events will be published. 
10.2.1 
Data considerations 
TEAEs are defined as those AEs that have a start date on or following the first dose of study 
treatment through the final dose of study treatment + 140 days (covering the 20-week SFU 
period). If it is not possible (due to partial dates) to determine whether or not an AE is treatment-
emergent then it will be assumed to be a TEAE. 
The rules for imputing partial start or stop dates are outlined in Section 4.2.1.7. 
If the intensity of an adverse event is unknown, it is considered as severe. If the relationship to 
study drug is missing, it is considered as related. 
AEs will be presented as “number of subjects (percentage of subjects) [number of events]”. In 
this style of output, “[number of events]” will include all cases of an AE including repeat 
occurrences in individual subjects, while “number of subjects” will count each subject only once. 
Subject time at risk represents the time a subject is at risk for having an AE. The definitions for 
subject time at risk (in days) are outlined in Section 10.1. These definitions will be used for 
exposure-adjusted AE summaries. 
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Selected AE summaries will include the exposure adjusted incidence rate (EAIR) with associated 
95% CI and the exposure adjusted event rate (EAER). 
The EAIR is defined as the number of subjects (n) with a specific AE adjusted for the exposure 
and will be scaled to 100 patient-years: 
 
EAIR = 100 × n/ ∑(TExp(i))
N
i=1
 
Where TExp(i) is the exposure time for the ith subject and N is the number of subjects at risk. 
If a subject has multiple events, the time of exposure is calculated to the first occurrence of the 
AE being considered. If a subject has no events, the total time at risk is used. 
Exact Poisson 95% confidence intervals for incidence rates are calculated using the relationship 
between the Poisson and the Chi-square distribution (Ulm, 1990; Fay and Feuer, 1997): 
 
 
 
 
where n is the number of subjects with a specific AE for the incidence rate of interest and is the 
basis for the number of the degrees of freedom for the chi-square quantile for the upper tail 
probability χ2. 
The EAER will be the number of AEs including repeat occurrences in individual subjects 
divided by the total time at risk scaled to 100 patient-years and calculated using: 
 
EAER = 100 × NAE/ ∑(TRisk(i))
N
i=1
 
where NAE is the total number of AEs, TRisk(i) is the time at risk for then ith subject, and N is the 
total number of subjects at risk. 
No confidence interval will be computed for EAER. 
Selected summaries, as specified in Section 10.2.2, will include the risk difference between 
bimekizumab and secukinumab. The risk difference is calculated as: 
𝑅𝐷= 𝐼𝑃𝐵𝐾𝑍−𝐼𝑃𝑆𝐸𝐶 
where 𝐼𝑃𝐵𝐾𝑍 is the incidence proportion for the bimekizumab-treated group and 𝐼𝑃𝑆𝐸𝐶 is the 
incidence proportion for the secukinumab group. Note that incidence proportion simply refers to 
the percentage of subjects within the specified treatment group that experienced a given adverse 
event. 
The standard error for the risk difference is calculated as follows: 
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𝑆𝐸𝑅𝐷= √(𝐼𝑃𝐵𝐾𝑍× (1 −𝐼𝑃𝐵𝐾𝑍
𝑛𝐵𝐾𝑍
)) + (𝐼𝑃𝑆𝐸𝐶× (1 −𝐼𝑃𝑆𝐸𝐶
𝑛𝑆𝐸𝐶
)) 
where 𝑛𝐵𝐾𝑍 is the number of subjects in the bimekizumab-treated group and 𝑛𝑆𝐸𝐶 is the number 
of subjects in the secukinumab group. 
The corresponding confidence interval for the risk difference is as follows: 
𝐶𝐼𝑅𝐷= 𝑅𝐷 ± 𝑍1−𝛼2
⁄ × (𝑆𝐸𝑅𝐷) 
where 𝑍1−𝛼2
⁄  is the 𝑍 statistic for the corresponding level of alpha. For the risk difference 
confidence intervals calculated in this SAP, 1.96 will be used (corresponding to a two-sided 
alpha of 0.05 and 95% confidence interval). 
Separate by-subject listings of all TEAEs for the OLE and the OLE2 treatment periods will be 
provided. 
10.2.1.1 
COVID-19 related data considerations 
In order to assess the impact of the COVID-19 global pandemic on TEAEs, an additional AE 
summary based on the BKZ set will be presented for the combined Initial, Maintenance, and 
OLE periods. The following data considerations are introduced to support this presentation by 
the following periods: 
• Prior to COVID-19 pandemic 
• During COVID-19 pandemic 
The COVID-19 pandemic start date is defined as 11 March 2020 as it is the date the World 
Health Organization declared COVID-19 as a pandemic, see also Section 4.2.1.7.2. Note that the 
Week 48 and Week 96 interim analyses will be conducted during the pandemic therefore a post 
COVID-19 pandemic period is not defined for these analyses. If WHO declares the COVID-19 
pandemic has ended prior to Week 144, then that date may be used to support presentation of a 
post COVID-19 pandemic period. 
Where a subject’s time at risk includes 11 March 2020, the subject is included in the 
denominator for both periods and their time at risk is split as follows: 
• Prior to COVID-19 pandemic: 
− Start of time at risk to 10 March 2020 
• During COVID-19 pandemic: 
− 11 March to end of time at risk 
Where a subject’s time at risk does not include 11 March 2020, the subject is only included in 
the denominator for the Prior to COVID-19 pandemic period and their time at risk would be 
included entirely in the Prior to COVID-19 pandemic period. 
Detailed definitions for subject time at risk are outlined in Section 10.1. 
AEs are assigned to the appropriate period according to start date: 
• Prior to COVID-19 pandemic: 
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− AE start date ≤ 10 March 2020 
• During COVID-19 pandemic: 
− AE start date ≥ 11 March 2020 
Incidence of COVID-19 TEAEs will be summarized for the OLE treatment periods based on the 
OLS by treatment group.  
The following PTs will be used to identify COVID-19 related TEAEs. These will include 
confirmed and suspected COVID-19 infection: 
• Corona virus infection 
• Coronavirus test positive  
By-subject listings of COVID-19 TEAEs will be produced separately for OLE and OLE2 
treatment periods. 
To assess the impact of COVID-19 mass vaccination on TEAEs, a sensitivity analysis will 
present all TEAEs excluding TEAEs assessed as exclusively related to COVID-19 vaccine by 
the investigator. TEAEs recorded as related to both study medication and COVID-19 vaccination 
should not be excluded. A complementary table of TEAEs related to COVID-19 vaccine will be 
presented.  
Another sensitivity analysis will present vaccine interval censored TEAEs, that is all TEAEs 
excluding TEAEs with start date on or up to 5 days after date of COVID-19 vaccine. Note that 
subjects may receive more than one administration of COVID-19 vaccine. A complementary 
table and listing of vaccine interval TEAEs, that is TEAEs with start date on or up to 5 days after 
date of COVID-19 vaccine will also be presented.  
Complementary listings of TEAEs related to COVID-19 vaccine will be presented for the OLE 
and the OLE2 treatment periods separately. 
10.2.2 
AE summaries 
AE summaries will be provided by actual treatment at the time of the adverse event. Separate AE 
summaries for OLE2 treatment period will be provided by treatment sequence as specified in 
Section 3.6  and will be based on OLS2. 
For subjects who discontinue on or prior to the final scheduled visit of the Initial Treatment 
Period, any AEs that emerged more than after 112 days relative to the first dose but still within 
the 140 days SFU window will be classified as TEAE. However, these AEs will be excluded 
from AE summaries based on the Initial Period but included in the AE summaries for Initial and 
Maintenance Treatment Period. See the description of time at risk in Section 10.1.1 for further 
details. 
The following selected outputs will be produced for the SS for the Initial Treatment Period, for 
the MS for the Maintenance Treatment Period, for the SS for the Initial and Maintenance 
Treatment Period, for the OLS for the Open-Label Extension Period:  
• Incidence of TEAEs – Overview 
• Incidence of TEAEs per 100 subject years by SOC, HLT, and PT  
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• Incidence of Serious TEAEs per 100 subject years by SOC, HLT, and PT 
• Incidence of TEAEs Leading to Discontinuation per 100 subject-years by SOC, HLT and PT 
• Incidence of TEAEs by decreasing frequency of PT 
The following summaries will be provided for the SS for the Initial Treatment Period, for the SS 
for the Initial and Maintenance Treatment Period: 
• Incidence of TEAEs Leading to Death by SOC, HLT, and PT 
• Incidence of TEAEs by Maximum Relationship by SOC, HLT, and PT 
• Incidence of Serious TEAEs by Relationship, SOC, HLT, and PT – Note: For European 
Union Drug Regulating Authorities Clinical Trials (EudraCT) reporting purposes 
• Incidence of Related Serious TEAEs by SOC, HLT, and PT 
• Incidence of TEAEs Leading to Death by Relationship by SOC, HLT, and PT – Note: For 
EudraCT reporting purposes 
• Incidence of TEAEs by Maximum Severity, SOC, HLT, and PT 
• Incidence of TEAEs Above Reporting Threshold of 5% by SOC and PT 
• Incidence of Non-Serious TEAEs by SOC, HLT, and PT 
• Incidence of Non-Serious TEAEs by Maximum Relationship SOC, HLT, and PT 
• Incidence of Non-Serious TEAEs Above Reporting Threshold of 5% by SOC and PT 
• Incidence of Non-Serious TEAEs Above Reporting Threshold of 5% by Relationship SOC 
and PT 
• Incidence of Related TEAEs by SOC, HLT, and PT 
• Incidence of Related TEAEs Above Reporting Threshold of 5% with Risk Differences by 
SOC and PT 
The following summary will be provided by treatment for the Initial and Maintenance Treatment 
Period (combined) for the SS (only subjects treated with BKZ, only Total BKZ will be 
summarized): 
• Incidence of TEAEs per 100 subject years by SOC, HLT, and PT and by Time of Onset 
Relative to Anti-bimekizumab Antibody Status 
Incidence of TEAEs per 100 subject years by SOC, HLT, and PT and by Time of Onset Relative 
to COVID-19 pandemic (prior to COVID-19 pandemic, during COVID-19 pandemic).  
The following summaries will be provided by treatment for the Initial Treatment Period (SS) as 
well as for Initial and Maintenance Treatment Period combined (SS): 
• Incidence of TEAEs Above Reporting Threshold of 5% with Risk Differences by SOC and 
PT 
• Incidence of Serious TEAEs and Risk Differences by SOC and PT 
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The tables with risk differences will also be accompanied by figures (dot plots) which show the 
incidence of the adverse events and corresponding 95% risk difference confidence intervals. 
These will be ordered by descending order of risk difference (bimekizumab vs secukinumab). 
The following selected AEs summaries will be provided separately for the Open-Label Extension 
Period. Separate AEs summaries will be provided for the OLE2 treatment period by treatment 
sequence as described in Section 3.6 and will be based on the OLS2: 
• Incidence of COVID-19 TEAEs  
• Incidence of TEAEs Overview 
• Incidence of TEAEs per 100 Subject-Years 
• Incidence of Serious TEAEs per 100 Subject-Years 
• Incidence of Serious TEAEs by Relationship  
• Incidence of TEAEs Leading to Discontinuation per 100 subject-years 
• Incidence of TEAEs Leading to Death 
• Incidence of Non-Serious TEAEs Above Reporting Threshold of 5% by SOC and PT 
• Incidence of Non-Serious TEAEs Above Reporting Threshold of 5% by Relationship SOC 
and PT 
In addition, the following AEs summaries will be provided for the Open-Label Extension Periods 
only, by treatment at the time of AE onset, and will be based separately on the OLS and OLS2. 
• Incidence of TEAEs Excluding TEAEs Exclusively Related to COVID-19 Vaccine by SOC, 
HLT, and PT  
• Incidence of TEAEs Exclusively Related to COVID-19 Vaccine by SOC, HLT, and PT  
• Incidence of COVID-19 Vaccine Interval Censored TEAEs by SOC, HLT, and PT  
• Incidence of COVID-19 Vaccine Interval TEAEs by SOC, HLT, and PT  
The following listings will be provided separately for the OLS and OLS2:  
• Listing of TEAEs Related to COVID-19 Vaccine  
• Listing of COVID-19 Vaccine Interval TEAEs  
The following summaries will be provided for the BKZ Set by treatment at the time of AE onset. 
These tables will include AEs from both the double-blind and Open-Label treatment period 
(excluding OLE2 treatment period). AEs that occurred while subjects received secukinumab will 
not be included. 
• Incidence of TEAEs Overview 
• Incidence of TEAEs per 100 Subject-Years 
• Incidence of Serious TEAEs per 100 Subject-Years 
• Incidence of TEAEs by decreasing frequency of PT  
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• Incidence of TEAEs per 100 subject years by SOC, HLT, and PT and by Time of Onset 
Relative to COVID-19 pandemic (prior to COVID-19 pandemic, during COVID-19 
pandemic). 
In addition, all summaries of TEAEs based on “100 subject years” will include EAIR (with 95% 
CI) and EAER. 
The following summaries will be presented for subjects who switched from secukinumab to 
bimekizumab at Week 48. The analyses will assign AEs according to the AE onset date relative 
to last secukinumab dose and accounting for approximately 5 times half-life (Onset ≤ 140 days 
from last secukinumab dose or Onset > 140 days from last secukinumab dose): 
• Incidence of TEAEs Overview 
• Incidence of TEAEs per 100 Subject-Years 
• Incidence of Serious TEAEs per 100 Subject-Years 
10.2.3 
Other Safety topics of interest 
The following summaries for AEs of other safety topics of interest will be provided by actual 
Treatment at the time of the adverse event. The following outputs will be produced separately for 
the SS for the initial treatment period, for the SS for the Initial and Maintenance Treatment 
Period, and for the OLS for the Open-Label Extension Period by treatment group (see 
Section 3.6). No safety topics of interest AE summaries will be produced for the Open-Label 
Extension 2 treatment period (OLS2). 
Similar outputs for hypersensitivity events and hepatic events will also be produced for the 
Maintenance Treatment Period for the MS.  
Additional analyses will be presented for subjects who switched from secukinumab to 
bimekizumab at Week 48 and the AEs will be assigned according to the onset date relative to last 
secukinumab dose and accounting for approximately 5 times half-life (Onset ≤ 140 days from 
last secukinumab dose or Onset > 140 days from last secukinumab dose). 
Along with the tables described, there will be tables which displays the risk difference and 95% 
confidence intervals for each of the topics of interest during the Initial Treatment Period (SS) as 
well as for Initial and Maintenance Treatment Period combined (SS). Corresponding figures 
(with dot plots) will be prepared. 
Listings of all treatment emergent adverse events of other safety topics of interest will be 
provided separately for the OLE and the OLE2 treatment periods. 
10.2.3.1 
Infections (serious, opportunistic, fungal and Tuberculosis [TB]) 
• Incidence of Serious Infection TEAEs per 100 subject years by SOC, HLT and PT 
Serious infections will be identified based on MedDRA classification (SOC “Infections and 
infestations”) using the “Any SAE” table. A separate table does not need to be produced to 
summarize these events. 
• Incidence of Fungal Infection TEAEs per 100 subject years by SOC, HLT and PT 
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Fungal infections will be summarized in a stand-alone table. The table will include all TEAEs 
(serious and non-serious) which code into the High Level Group Term (HLGT) “Fungal 
infectious disorders” 
• Incidence of Opportunistic Infection TEAEs per 100 subject years by SOC, HLT and 
PT 
Opportunistic infections (including tuberculosis) will be summarized in a stand-alone table. The 
table will include all opportunistic infection TEAEs identified using UCB-defined search criteria 
which were adjudicated as opportunistic infections.  
The following steps are followed for identifying and reviewing opportunistic infections: 
Identification Process 
The two steps below outline two ways in which opportunistic infections (or potential 
opportunistic infections) can be identified: 
Step 1: Refer to column B of the spreadsheet which identifies the Preferred Terms (PTs) to be 
classified as opportunistic infections using either a single ‘x’ or a double ‘xx’. 
• TEAEs which code to a PT flagged with a single ‘x’ need to also be serious to be considered 
an opportunistic infection. 
• All TEAEs which code to a PT flagged with a double ‘xx’ are considered to be an 
opportunistic infection, regardless of seriousness. 
Step 2: Refer to column C of the spreadsheet which identifies the PTs that need to be evaluated 
on a case-by-case basis by the study physician to determine whether or not it is an opportunistic 
infection. If Column C has a single ‘x’, then the corresponding preferred term should be flagged 
for case-by-case review by the study physician. 
Review Process 
Opportunistic infections for a given study will be reviewed on the following occasions: 
• At quarterly Infectious Disease Committee (IDC) Meetings, listings will be produced for 
each study (see details below) and reviewed by the corresponding study physician ahead of 
the IDC Meeting. These listings will be posted as part of the broader SSD deliverable to a 
folder named for the given quarter (eg, 2018Q4) on the SharePoint. They should be based on 
the same data cut as the one used for SSD and should be delivered at the same time as the 
SSD outputs. The IDC will then agree on the final adjudication for each potential 
opportunistic infection. 
• For each study, a final listing for opportunistic infections (in the format described below) will 
be produced and agreed upon between the study physician and the IDC prior to finalizing the 
database. 
In each of the circumstances described above, the study programming team will produce an 
Excel listing that will be provided to the project lead statistician, project lead programmer, and to 
the study physician (who will subsequently provide it to the IDC). The Excel listing will contain 
the following columns (using the descriptions below as the column headings in the Excel listing): 
• Study ID 
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• Unique Subject ID 
• AE Term (Verbatim) 
• AE Preferred Term 
• AE System Organ Class 
• AE High Level Term 
• AE Low Level Term 
• Date of Onset 
• Outcome of Adverse Event 
• Date of Outcome 
• TEAE Flag 
• Serious Adverse Event? 
• Relationship to Study Medication 
• Intensity 
• Action Taken with IMP 
• Opportunistic Infection – Automatic 
• Opportunistic Infection – Manual Review 
• Flag 
• Data Cut Date 
• Opportunistic Infection – Final Adjudication 
Note the following about the final 5 variables in this listing: 
• Opportunistic Infection – Automatic: This is flagged as “Y” if the criteria for automatic 
selection as described in “Step 1” of the identification process are met. 
• Opportunistic Infection – Manual Review: This is flagged as “Y” if the criteria for case-by-
case selection as described in “Step 2” of the identification process are met. 
• Flag – This has a value of either “NEW” or “OLD”. It is marked as “NEW” if the event is 
appearing for the first time in that run of the listing. Otherwise, if it has appeared previously, 
it is marked as “OLD”. Unique records are determined by USUBJID AESPID for purposes 
of identifying whether an event has been modified from a previous run. 
• Date – Only for cases where Flag is “NEW”, this field will be populated with the data cut 
date for that particular run of the listing. 
• Opportunistic Infection – Final Adjudication – For new events, this is always left blank by 
the programmers. It should be completed by the study physician/IDC for every event that 
appears in the listing. For events adjudicated as opportunistic, the field should be populated 
with a “Y”. 
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Following each review by the study physician and IDC, the Opportunistic Infection –Final 
Adjudication column will be completed (as described above), and the spreadsheets for each study 
will be returned to the study programming team via e-mail (coordinated by the IDC secretary). 
Then, for subsequent runs of the listing, the study programming teams will incorporate 
adjudications from previous runs. 
10.2.3.2 
Malignancies 
• Incidence of Malignant or Unspecified Tumours TEAEs per 100 subject years by SOC, 
HLT and PT 
These events will be presented in the following tables: 
− One table will be based on the criteria (SMQ) = “Malignant or unspecified tumours 
(SMQ)” 
− One table will be based on the criteria SMQ = ”Malignant tumours (SMQ)”. 
SMQ search should include all TEAEs which code to a PT included in the Scope=Narrow group 
within each SMQ. 
Note that the events included in the “Malignant tumours” table will be a subset of the events 
included in the “Malignant or unspecified tumours” table. While the “Malignant tumours 
(SMQ)” is most relevant, “Malignant or unspecified tumours (SMQ)” must be reviewed for 
potential malignancies. 
The output table will include 2 different overall incidence rows: 
− The first overall incidence row will summarize “Any malignancies” and this row will 
summarize the incidence of all AEs flagged for inclusion in the table (using the 
appropriate SMQ depending on the table), regardless of the High Level Term (HLT) it 
codes to 
− The second overall incidence row will summarize “Any malignancy excluding non-
melanomic skin cancers HLT” and this row will summarize the incidence of AEs flagged 
for inclusion in the table (using the appropriate SMQ depending on the table), excluding 
those which code to an HLT of “skin neoplasms malignant and unspecified (excl 
melanoma)”. 
10.2.3.3 
Cardiac events 
• Incidence of Major Adverse Cardiac Event (MACE) TEAEs per 100 subject years by 
SOC, HLT and PT 
Potential cardiovascular events are adjudicated by the independent Cardiovascular Event 
Adjudication Committee (CV-CAC) according to the CV-CAC Charter (version 6.0). 
Adjudicated events are classified by the CV-CAC to one of the event types as defined in the 
cardiovascular event classifications Table below. The classification of an event as a Major 
Adverse Cardiac Event (MACE) is also determined by the CV-CAC. Events which are classified 
by the CV-CAC as any of the event types identified in the third column of the table will be 
considered an extended MACE. Note that extended MACE is determined programmatically and 
includes a broader scope definition of MACE.  
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MACE as determined by the CV-CAC will be presented in a table and listing. Extended MACE 
will be presented separately in a table and listing. Additional listings of all MACE as determined 
by the CV-CAC will be presented separately for the OLE and the OLE2 treatment periods. 
Another table and listing will present the adjudicated cardiovascular events by type. For each 
cardiovascular event type, the individual PTs which fall within each event type will be 
summarized. This listing will indicate whether each event was determined to be a MACE and/or 
an extended MACE. Similar listings of the adjudicated cardiovascular events by type will be 
presented separately for the OLE and the OLE2 treatment periods. 
Additionally, a listing of all events identified for potential review by the CV-CAC will be 
produced. This listing will indicate whether each event was identified by the CV-CAC Chair for 
full committee review. Similar listings of all events identified for potential review by the CV-
CAC will be produced separately for the OLE and the OLE2 treatment periods. 
Cardiovascular event classifications 
Event 
Type 
Code 
Event Type 
Extended 
MACE 
1 
Non-Fatal Myocardial Infarction (MI) 
Yes 
2 
Non-Fatal Stroke: hemorrhagic 
Yes 
3 
Non-Fatal Stroke: ischemic 
Yes 
4 
Non-Fatal Stroke: embolic 
Yes 
5 
Non-Fatal Stroke: undeterminable 
Yes 
6 
Hospitalization or ER for Unstable Angina with urgent 
revascularization 
Yes 
7 
Hospitalization or ER for Unstable Angina without urgent 
revascularization 
No 
8 
Hospitalization for Heart Failure 
Yes 
9 
Transient Ischemic Attack (TIA) 
No 
10 
Coronary Revascularization Procedures (e.g. percutaneous coronary 
intervention, coronary artery bypass grafting) 
Yes 
11 
Urgent Revascularization Procedures (i.e. due to symptoms of brain 
ischemia or pending infarction) 
Yes 
12 
Arrhythmia (not associated with ischemia) 
No 
13 
Peripheral Arterial Event 
No 
14 
Venous Thromboembolic Event: pulmonary embolism (PE) 
No 
15 
Venous Thromboembolic Event: deep vein thrombosis (DVT) 
No 
16 
Venous Thromboembolic Event: PE and DVT 
No 
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Cardiovascular event classifications 
Event 
Type 
Code 
Event Type 
Extended 
MACE 
17 
Other CV Event 
No 
18 
Death due to Myocardial Infarction (MI) 
Yes 
19 
Death due to Stroke 
Yes 
20 
Sudden Cardiac Death 
Yes 
21 
Other CV Death (e.g. heart failure, pulmonary embolism, 
cardiovascular procedure-related) 
Yes 
22 
Cardiovascular: Undetermined Cause of Death (i.e. cause of death 
unknown) 
Yes 
23 
Non-Cardiovascular Death 
No 
24 
Non-Cardiovascular Event 
No 
99 
Inadequate information to adjudicate 
No 
CV=Cardiovascular; DVT=Deep Vein Thrombosis; ER=Emergency Room; MACE=Major Adverse Cardiac Event; 
MI=Myocardial Infarction; PE=Pulmonary Embolism; TIA=Transient Ischemic Attack. 
MACE is determined by the adjudication committee and is not identified programmatically based on event type. 
10.2.3.4 
Neutropenia 
• Incidence of Neutropenia TEAEs per 100 subject years by SOC, HLT and PT 
A table based on the following PTs (regardless of seriousness) will be produced: 
− Autoimmune neutropenia 
− Band neutrophil count decreased 
− Cyclic neutropenia 
− Febrile neutropenia 
− Idiopathic neutropenia 
− Neutropenia 
− Neutropenic infection 
− Neutropenic sepsis 
− Neutrophil count decreased 
10.2.3.5 
Suicidal Ideation and Behavior (SIB) 
• Incidence of SIB-Adjudicated Neuropsychiatric TEAEs per 100 subject years by SOC, 
HLT and PT 
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Potential neuropsychiatric events are adjudicated by the independent Neuropsychiatric 
Adjudication Committee according to the Neuropsychiatric Adjudication Committee (version 
8.0).  Adjudicated events are classified by the Committee as Suicidal or Non-suicidal. 
Adjudicated events are also further classified by the Committee to one of the event types as 
defined in neuropsychiatric event classifications Table below. Suicidal Ideation and Behavior 
(SIB) is defined as events classified by the Committee as Suicidal. 
A table and listing will present SIB events. This listing will also be provided separately for OLE 
and OLE2 treatment periods. 
Another table and listing will present the adjudicated neuropsychiatric events by type. For each 
neuropsychiatric event type, the individual PTs which fall within each event type will be 
summarized. This listing will indicate whether each event was determined to be Suicidal or Non-
Suicidal. For event type suicidal ideation, the listing will also indicate if intent was present and if 
the suicidal ideation was clinically significant. A similar listing of the adjudicated 
neuropsychiatric events by type will be presented. 
Additionally, a listing of all events identified for potential review by the Committee will be 
produced. This listing will indicate whether each event was identified by the Neuropsychiatric 
Event Adjudication Committee Chair for full committee review. Similar listings will be provided 
separately for the OLE and the OLE2 treatment periods. 
Neuropsychiatric event classifications 
Event 
Type 
Code 
Event 
Classification 
Event Type 
1 
Suicidal 
Suicidal events/completed suicide 
2 
Suicidal 
Suicide attempt 
3 
Suicidal 
Preparatory acts toward imminent suicidal behavior 
4 
Suicidal/Non-
suicidala 
Suicidal ideation 
7 
Non-suicidal 
Nonsuicidal Self-injurious behavior 
8 
Non-suicidal 
Nonsuicidal Other 
99 
Not applicable 
Inadequate information to adjudicate 
Suicidal ideation event types can be classified by the Neuropsychiatric Adjudication Committee as Suicidal or Non-
suicidal depending on whether intent to die was present 
10.2.3.6 
Inflammatory bowel disease 
• Incidence of Inflammatory Bowel Disease TEAEs per 100 subject years by SOC, HLT 
and PT 
Selected gastrointestinal events are adjudicated by the independent Inflammatory Bowel Disease 
(IBD) Adjudication Committee (IBD-CAC) according to the IBD-CAC Charter (version 3.0).  
Adjudicated events are classified by the IBD-CAC into one of the diagnostic types as defined in 
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the IBD event classifications Table below. The events will further be classified as definite, 
probable or possible IBD. 
An overview of adjudicated IBD events will be stratified by subjects with or without a previous 
medical history of IBD. Previous medical history of IBD will be determined using the 
information recorded on the Extra-Articular Assessment at Screening CRF page ("Does subject 
have a history of IBD?”). This overview table will present events adjudicated by the IBD-CAC 
as either possible, probable or definite IBD. Definite and probable IBD will also be aggregated 
and summarized in this table. In addition, this table will summarize each IBD event classification 
(possible, probable or definite) separately. 
Another table and listing will present the adjudicated IBD events by type. For each IBD event 
type, the individual PTs which fall within each event type will be summarized. Similar listings of 
the adjudicated IBD events by type will be presented separately for OLE and OLE2 treatment 
periods. 
Additionally, a listing of all events identified for potential review by the IBD-CAC will be 
produced. This listing will indicate whether each event was identified by the IBD-CAC Chair for 
full committee review. Similar listings of all events identified for potential review by the IBD-
CAC Chair for full committee review will be produced separately for the OLE and the OLE2 
treatment periods. 
A further supportive listing will present the individual diagnostic criteria met for each 
adjudicated IBD event. This listing will also be presented separately for the OLE and the OLE2 
treatment periods combined.  
IBD event classifications 
Event 
Type 
Code 
Event Type (Classification and diagnosis) 
Classification 
1 
Possible Inflammatory Bowel Disease – Crohn’s Disease 
Possible 
2 
Probable Inflammatory Bowel Disease – Crohn’s Disease 
Probable 
3 
Definite Inflammatory Bowel Disease – Crohn’s Disease 
Definite 
4 
Possible Inflammatory Bowel Disease – Ulcerative Colitis 
Possible 
5 
Probable Inflammatory Bowel Disease – Ulcerative Colitis 
Probable 
6 
Definite Inflammatory Bowel Disease – Ulcerative Colitis 
Definite 
7 
Possible Inflammatory Bowel Disease – type unclassified 
Possible 
8 
Probable Inflammatory Bowel Disease – type unclassified 
Probable 
9 
Definite Inflammatory Bowel Disease – type unclassified 
Definite 
10 
Symptoms not consistent with Inflammatory Bowel Disease 
Not applicable 
11 
Possible Inflammatory Bowel Disease – Microscopic Colitis 
Possible 
12 
Probable Inflammatory Bowel Disease – Microscopic Colitis 
Probable 
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IBD event classifications 
Event 
Type 
Code 
Event Type (Classification and diagnosis) 
Classification 
13 
Definite Inflammatory Bowel Disease – Microscopic Colitis 
Definite 
14 
Possible Inflammatory Bowel Disease – no further 
differentiation possible 
Possible 
15 
Probable Inflammatory Bowel Disease – no further 
differentiation possible 
Probable 
16 
Definite Inflammatory Bowel Disease – no further 
differentiation possible 
Definite 
99 
Not enough information to adjudicate 
Not applicable 
IBD=inflammatory bowel disease. 
Note: IBD diagnoses of “microscopic colitis” and “no further differentiation possible” were added in an adjudication 
charter amendment, accounting for the event type numbering. 
10.2.3.7 
Hypersensitivity (including anaphylaxis) 
• Incidence of Anaphylactic Reaction TEAEs per 100 subject years by SOC, HLT and PT 
A separate table will be prepared based on the MedDRA anaphylaxis Algorithm (see Appendix 
A) for acute anaphylactic events (reported on the same day as when an injection was 
administered or one day after). An AE glossary table will also be produced to summarize the 
MedDRA coding for these events. The glossary table will include the following fields: reported 
term, PT, LLT, HLT, and SOC. 
A separate table will be prepared to summarize hypersensitivity events, identified using the SMQ 
“Hypersensitivity (SMQ)”. All TEAEs which code to a PT included in the Scope=Narrow search 
will be included in this table. In addition, a separate table will be prepared to summarize serious 
hypersensitivity events, identified using the SMQ “Hypersensitivity (SMQ)”. All serious TEAEs 
which code to a PT included in the Scope=Narrow search will be included in this table. An AE 
glossary table will also be produced to summarize the MedDRA coding for these events. The 
glossary table will include the following fields: reported term, PT, LLT, HLT, and SOC. 
Furthermore, a separate table will be prepared to summarize injection site reactions, identified 
using the HLTs: “Administration site reactions NEC” and “Injection site reactions”. 
10.2.3.8 
Hepatic events 
• Incidence of hepatic events TEAEs per 100 subject years by SOC, HLT and PT 
A table for hepatic events will be created based on the SMQ of “Drug related hepatic disorders - 
comprehensive search (SMQ)”. However, these 2 sub-SMQs are to be excluded: “Liver 
neoplasms, benign (incl cysts and polyps) (SMQ)” and “Liver neoplasms, malignant and 
unspecified (SMQ)”. For each of the above SMQs, include all TEAEs which code to a PT 
included in the Scope=Broad and/or Scope=Narrow. 
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Note that all AEs meeting the above criteria are to be included. It should not be limited to events 
that the investigator determined to be related to study drug. 
Cases of Hy’s Law will be reported separately in a liver function test table.  
A by-subject listing of all AEs of safety topics of interest by type of safety topics of interest will 
be provided. 
10.3 
Clinical laboratory evaluations 
If not specified otherwise, laboratory values, including markedly abnormal laboratory values will 
be presented descriptively by treatment group for the SS. Tables presenting markedly abnormal 
values and those based on CTCAE grade only include selected laboratory variables. 
For tables where data are summarized by visit, unscheduled and repeat visits will not be 
summarized, but these data will be included in listings. For tables where multiple measurements 
over a period of time are considered (as in shift tables), unscheduled and repeat visits will be 
considered as long as they were collected in the period being summarized. All summaries will be 
presented in SI units and will be based on observed case values. In the case where laboratory 
values are below the lower limit of quantification, then these will be set to the midpoint between 
0 and the lower limit of quantification for the purpose of summarizing the data. The following 
summaries are required: 
• A summary of observed results and change from Baseline values in each laboratory variable 
by treatment group and visit 
• A summary of the number and percentage of subjects experiencing markedly abnormal 
values at any time while on treatment (assessment on or following the first dose of study 
treatment through the final dose of study treatment + 140 days) by laboratory variable and 
treatment group. Two separate tables will show results for the initial treatment period (for the 
SS) and the Initial and Maintenance Treatment Period (for the MS). An additional table for 
the OLE period will be provided for the OLS by treatment the subjects were receiving at the 
time of the assessment of the abnormal value. 
• A summary of the number and percentage of subjects with a given CTCAE grade (0, 1, 2, 3, 
or 4) based on minimum/maximum post-baseline value by laboratory variable and treatment 
group. Two separate tables will show results for the initial treatment period (for the SS) and 
the Initial and Maintenance Treatment Period (for the MS). An additional table for the OLE 
period will be provided for the OLS by treatment the subjects were receiving at the time of 
the assessment of the value with the given CTCAE grade. 
• A shift table of the number and percentage of subjects experiencing CTCAE grade 0, 1, 2, 3, 
or 4 values (as applicable) at Baseline to minimum/maximum post-Baseline CTCAE grade, 
by laboratory variable and treatment group. Two separate tables will show results for the 
initial treatment period (for the SS) and the Initial and Maintenance Treatment Period (for the 
MS). An additional table for the OLE period will be provided for the OLS by treatment the 
subjects were receiving at the time of the assessment of the value with the given CTCAE 
grade. A lipid profile table of treatment emergent markedly abnormal laboratory data will be 
provided for the Initial and Maintenance Treatment Period (SS) and the Open-label 
Extension treatment period (OLS) separately. 
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In addition, a shift table of number and percentage of subjects experiencing post-Baseline 
HDL Low risk (≥ 1.55 mmol/L), Intermediate risk ( ≥ 1.04 - < 1.55 mmol/L) and High risk 
(< 1.04 mmol/L) compared to baseline will be provided for the Initial and Maintenance 
Treatment Period (SS) and the  Open-Label Extension Treatment Period  (OLS). 
Shift laboratory summaries will use the Baseline for Open-Label Extension Period for subjects 
switching from secukinumab to Bimekizumab as described in Section 3.2. 
A figure of neutrophil values over time for subjects with at least one markedly abnormal 
neutrophil value (CTCAE Grade 3 or 4) will also be presented. 
A by-subject listing of all laboratory data (including urinalysis) will be provided. Separate 
by-subject listings for the OLE and the OLE2 treatment periods will be provided. These listings 
will be presented by treatment group and will include: center, subject identifier, age, sex, race, 
weight, visit, laboratory variable, result (with abnormal values flagged as “L” or “H” 
accordingly) and unit. 
Markedly abnormal values are defined as those with a severity of Grade 3 and above based on 
the common terminology criteria for adverse events (CTCAE) criteria (U.S. Department of 
Health and Human Services 2010). Definitions of markedly abnormal values using the Grade 3 
cut points are given in the tables below for age ranges of ≥17 years (Table 10‒1 for markedly 
abnormal liver function test values, Table 10‒2 for markedly abnormal biochemistry values and 
Table 10‒3 for markedly abnormal hematology values). Tables summarizing markedly abnormal 
values should include a summary (counts and percentages) of markedly abnormal labs observed 
at any time while on treatment (ie, treatment-emergent markedly abnormal [TEMA]). For this 
summary, Baseline values and values observed more than 140 days after the last administration 
of study medication are not considered. The laboratory results classified as Grade 3 or Grade 4 
will be summarized and listed separately. 
Table 10‒1: Definitions of Markedly Abnormal Liver Function Values 
Parameter 
Name 
Conventional 
Standard 
Abnormal 
Designation 
Unit 
Criteria 
Unit 
Criteria 
Alkaline 
Phosphatase 
U/L 
>5.0 x ULN 
U/L 
>5.0 x ULN 
AH 
ALT 
U/L 
>5.0 x ULN 
U/L 
>5.0 x ULN 
AH 
AST 
U/L 
>5.0 x ULN 
U/L 
>5.0 x ULN 
AH 
Total Bilirubin 
mg/dL 
>3.0 x ULN 
umol/L 
>3.0 x ULN 
AH 
GGT 
U/L 
>5.0 x ULN 
U/L 
>5.0 x ULN 
AH 
Table 10‒2: Definitions of Markedly Abnormal Biochemistry Values 
Parameter 
Name 
Conventional 
Standard 
Abnormal 
Designation 
Unit 
Criteria 
Unit 
Criteria 
Creatinine 
mg/dL 
>3.0 x ULN 
mmol/L 
>3.0 x ULN 
AH 
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Parameter 
Name 
Conventional 
Standard 
Abnormal 
Designation 
Unit 
Criteria 
Unit 
Criteria 
Glucose 
mg/dL 
<40 
>250 
mmol/L 
<1.7 
>13.9 
AL 
AH 
Calcium 
mg/dL 
>12.5 
<7.0 
mmol/L 
>3.1 
<1.75 
AH 
AL 
Magnesium 
mg/dL 
>3.0 
<0.9 
mmol/L 
>1.23 
<0.4 
AH 
AL 
Potassium 
mmol/L 
>6.0 
<3.0 
mmol/L 
>6.0 
<3.0 
AH 
AL 
Sodium 
mmol/L 
>155 
<130 
mmol/L 
>155 
<130 
AH 
AL 
Total 
Cholesterol 
mg/dL 
>400 
mmol/L 
>10.34 
AH 
HDL 
Cholesterol 
mg/dL 
<40 
mmol/L 
< 1.04 
AL 
LDL 
Cholesterol 
mg/dL 
≥190 
mmol/L 
≥ 4.90 
AH 
Triglycerides 
mg/dL 
>500 
mmol/L 
> 5.7 
AH 
 
Table 10‒3: Definitions of Markedly Abnormal Hematology Values 
Parameter Name Conventional 
Standard 
Abnormal 
Designation 
Unit 
Criteria 
Unit 
Criteria 
Hemoglobin 
g/dL 
<8.0 
>4.0 above 
ULN 
g/L 
<80 
>40 above 
ULN 
AL 
AH 
Lymphocytes 
Absolute 
109/L 
<0.5 
>20.0 
109/L 
<0.5 
>20.0 
AL 
AH 
Neutrophils 
Absolute 
109/L 
<1.0 
109/L 
<1.0 
AL 
Platelets 
109/L 
<50 
109/L 
<50 
AL 
WBC/Leukocytes 
109/L 
<2.0 
>100 
109/L 
<2.0 
>100 
AL 
AH 
Abbreviations: AH=abnormal high; AL=abnormal low; ALT= alanine aminotransferase; AST = aspartate 
aminotransferase; dL = deciliter; GGT: gamma-glutamyl transferase; L = liter; mg = milligram; mmol = millimoles; 
μg = microgram; ULN = upper limit of normal. 
The table for markedly abnormal liver function tests (LFTs) will contain data beyond the 
CTCAE Grade 3 thresholds outlined above in Table 10‒1 in order to allow for a more thorough 
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review of elevated LFTs. There will be one table which will list the count and percentage of 
subjects meeting the below criteria at any time during the study: 
• AST: >3xULN, >5xULN, >8xULN, >10xULN, >20xULN 
• ALT: >3xULN, >5xULN, >8xULN, >10xULN, >20xULN 
• AST or ALT: >3xULN, >5xULN, >8xULN, >10xULN, >20xULN 
• Bilirubin: >1.5xULN, >2xULN 
In addition, a table will be produced to summarize potential Hy’s Law cases. The following two 
definitions will be used in that table: 
•  [AST ≥3xULN or ALT ≥3xULN] and  
• Total Bilirubin ≥2xULN in the absence of ALP ≥2xULN 
In order to meet the above criteria, a subject must experience the elevation in bilirubin and ALT 
or AST (and the absence of ALP elevation, if applicable) at the same visit. For example, a 
subject who experiences a ≥2 x ULN elevation of bilirubin at one visit and a ≥3xULN elevation 
in ALT (or AST) at a subsequent visit has not fulfilled the Hy’s law criteria. 
Potential hepatotoxicity (meeting one of the pDILI or Hy’s law laboratory criteria at least once) 
will be considered with and without symptoms potentially associated with hepatitis or 
hypersensitivity according to the investigator (reported on the Symptoms of Hepatitis and 
Hypersensitivity CRF page)”. 
A table for potential drug induced liver injuries (pDILI) will be presented by treatment group for 
subjects with at least one post-Baseline liver laboratory assessment. Number and percentage of 
subjects meeting laboratory criteria for pDILI for at least 1 visit and reporting at least 1 symptom 
potentially associated with hepatitis or hypersensitivity according to the Investigator on the 
pDILI CRF will be presented. Subjects who potentially meet Hy’s law criteria at least 1 time 
during exposure must meet all criteria at the same visit to be counted as potential Hy’s Law. 
Spaghetti plots of AST values over time for the subset of subjects with at least one markedly 
abnormal AST value (CTCAE Grade 3 or 4) will also be presented. A similar set of plots will be 
produced for ALT values over time for the subset of subjects with at least one markedly 
abnormal ALT value (CTCAE Grade 3 or 4). 
10.4 
Vital signs, physical findings, and other observations related to 
safety 
10.4.1 
Vital signs 
The following vital signs variables should be summarized: systolic blood pressure (mmHg), 
diastolic blood pressure (mmHg), body temperature (°C) and heart rate (beats/min). The 
following summary will be provided for the Initial Treatment Period (SS) for Initial and 
Maintenance Treatment Period, and for the Open-Label Extension Period (OLS). Vital signs will 
not be summarized for the OLE2. 
• A summary of the absolute and change from Baseline value for each vital sign variable by 
treatment group and visit. 
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• A shift from Baseline to Post-Baseline systolic and diastolic blood pressure values based on 
the following categorization will be provided for the Initial and Maintenance Treatment 
Period (SS), and the Open-label Extension Period (OLS): 
− Hypotension: systolic blood pressure <90 mmHg or diastolic blood pressure <60 
− Normal: systolic blood pressure ≥90 and <120 mmHg and diastolic blood pressure ≥60 
and <80 mmHg 
− Elevated: systolic blood pressure between 120-129 mmHg and diastolic blood pressure 
<80 
− Stage 1: systolic blood pressure between 130-139 mmHg or diastolic blood pressure 
between 80-89 
− Stage 2: systolic blood pressure ≥140 and ≤180 mmHg or diastolic blood pressure ≥90 
and ≤120 mmHg 
− Hypertensive crisis: systolic blood pressure >180 mmHg and/or diastolic blood pressure 
>120 mmHg.  
The following summary will be provided for the Initial Treatment Period (SS), the Initial and 
Maintenance Treatment Period (SS), and the open-Label Extension Period (OLS): 
• A summary of the number and percentage of subjects experiencing at least one markedly 
abnormal value for a vital sign variable as defined in Table 10‒4, by treatment group. 
Table 10‒4: Definitions of Markedly Abnormal Blood Pressure Values 
Parameter (unit) 
Markedly Abnormal Low 
Markedly Abnormal High 
Systolic blood pressure (mmHg) 
<90 and a decrease from 
Baseline of ≥20 
>180 and an increase from 
Baseline of ≥20 
Diastolic blood pressure (mmHg) 
<50 and a decrease from 
Baseline of ≥15 
>105 and an increase from 
Baseline of ≥15 
A by-subject listing of all vital signs data will be provided. This listing will be presented by 
treatment group and will include center, subject identifier, age, sex, race, weight, visit, vital sign 
variable and result (with abnormal values flagged as “L” or “H” accordingly). This listing will 
also be provided separately for the OLE and the OLE2 treatment periods. 
10.4.2 
Physical examination 
Abnormal results of the physical examination together with details of abnormalities: abnormality 
clinically significant or not, will be listed by subject and visit separately for the Initial and 
Maintenance (SS), Open-Label Extension (OLS) and Open-Label Extension 2 (OLS2) treatment 
periods. 
10.4.3 
Electrocardiograms 
ECG data will be analyzed by treatment group and visit for the Initial Treatment Period (SS), the 
Initial and Maintenance Treatment Period (SS), and by treatment sequence for the Open-Label 
Extension Period (OLS). 
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A summary of the number and percentage of subjects with normal and abnormal ECG results, as 
determined by the central reader, will be presented for all applicable visits. 
The following ECG variables will be summarized (absolute values and change from Baseline) by 
visit: QTcF, RR, PR, QRS and QT. 
QTc outliers are defined as QTcF values following dosing that are greater than 450 ms or are 
increases from Baseline greater than 30 ms. QTcF outliers will be highlighted in the data listings 
and summarized using the following categories: 
• Values >450 ms, >480 ms, >500 ms 
• Increase from Baseline of >30 ms, increase from Baseline of >60 ms, increase from Baseline 
of >90 ms 
• Values >450 ms and increases of >30 ms. Values >500 ms and increases of >60 ms 
The number and percentage of subjects who meet the ECG outlier criteria at any assessment post 
first dose will be summarized. 
Two separate by-subject listing of all 12-lead ECG data will be provided based on interpretation 
from central reader and from site.  
10.4.4 
Other safety variables 
10.4.4.1 
Assessment and management of TB and TB risk factors 
A summary of the number and percentage of subjects with negative, positive, and indeterminate 
IGRA (Interferon-Gamma Release Assay) results at all applicable visits will be presented for the 
entire study. 
A by-subject listing of the “Evaluation of signs and symptoms of tuberculosis” questionnaire 
data and IGRA results will be provided. This listing will also be provided separately for the OLE 
and the OLE2 treatment periods. 
A by-subject listing of the result of chest x-ray for tuberculosis will be provided by treatment. 
10.4.4.2 
Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) 
eC-SSRS questionnaire will be self-administered by the subject and assessed by trained study 
personnel. This scale will be used to assess suicidal ideation and behavior that may occur during 
the study. Results of the eC-SSRS will be summarized using the number of subject and 
percentage with (i) events in suicide behavior, (ii) suicidal ideation, (iii) suicidal behavior and 
ideation, and (iv) self-injurious behavior without suicidal intent. 
Suicidal ideation is defined as an event in any of the following 5 categories: 
• Wish to be dead 
• Non-specific active suicidal thoughts 
• Active suicidal ideation with any methods (not plan), without intent to act 
• Active suicidal ideation with some intent to act, without specific plan 
• Active suicidal ideation with specific plan and intent 
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Suicidal behavior is defined as an event in any of the following 4 categories: 
• Actual attempt 
• Interrupted attempt 
• Aborted attempt 
• Preparatory acts or behavior 
Suicidal behavior or ideation is defined as an event in any of the above 9 categories. 
Self-injurious behavior without suicidal intent is defined as an event in the category non-suicidal 
self-injurious injuries. 
The incidence of subjects with suicidal ideation, suicidal behavior, suicidal ideation or behavior, 
and self-injurious behavior will be summarized by treatment group. For events that emerged after 
112 days but still within the 140 days window, those events would be classified as treatment 
emergent, but will be excluded from the output based on the Initial Treatment Period. However, 
these events will be included in the summaries for Initial Treatment Period and Maintenance 
Treatment Period combined. Similar summaries will be presented for the Open-Label Extension 
Period (OLS) by treatment sequence and visit. 
A by-subject listing of the eC-SSRS questionnaire data will be provided by treatment group. This 
listing will also be provided separately for the OLE and the OLE2 treatment periods. 
10.4.4.3 
Pregnancy testing 
Pregnancy testing will consist of serum testing at the Screening. The pregnancy test will be urine 
at all other visits. 
A by-subject listing of the pregnancy test data will be provided by treatment group.  
10.4.4.4 
Childbearing potential and Lifestyle 
Childbearing potential and lifestyle will be collected at Screening. A by-subject listing will be 
provided for all the subjects screened. 
10.4.4.5 
Patient Health Questionnaire 9 (PHQ-9) 
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring 
the severity of depression. The PHQ-9 scores for depression range from 0 to 27 with higher 
scores indicating worse state. A score of 5-9 is considered to be minimal symptoms of 
depression. A score of 10 to 14 is considered minor depression, dysthymia, or mild major 
depression. A score of 15 to 19 is considered to indicate moderately severe major depression, 
and a score ≥20 is considered to be severe major depression. If any of the 9 questions are 
missing, then the score is treated as missing. 
Change from Baseline in PHQ-9 is derived as post-Baseline score minus Baseline score and will 
be summarized by treatment group. 
Differently to other safety variables, PHQ-9 will be summarized using the MCMC/monotone 
regression approach described in Section 8.1.3.1. A table for the SS through Week 48 will be 
produced. An additional table will be produced for the OLS by treatment sequence and visit. 
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The number and percentage of subjects with a PHQ-9 score ≥ 15 at any point while on treatment 
and the number and percentage of subjects with a PHQ-9 score ≥ 20 at any point while on 
treatment will also be presented based on observed case data. 
A by-subject listing of PHQ-9 data will be provided separately for the OLE and the OLE2 
treatment periods. This listing will include site, subject number, visit, total score observed result, 
and total score change from Baseline value. 
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11 
REFERENCES 
Fay MP, Feuer EJ. Confidence intervals for directly standardized rates: A method based on the 
gamma distribution. Statistics in Medicine 1997; 16(7):791-801. 
Husni ME, Qureshi AA, Keonig AS, Pedersen R, Robertson D. Utility of the PASE 
questionnaire, psoriatic arthritis (PsA) prevalence and PsA improvement with anti-TNF therapy: 
results from the PRISTINE trial. J Dermatolog Treat. 2014;25(1):90-5. 
Greenland S, Robins JM. Estimation of common effect parameter from sparse follow up data. 
Biometrics 1985;41:55-68. 
Mallinckrodt CH, Lin Q, Lipkovich I, and Molenberghs G. A structured approach to choosing 
estimands and estimators in longitudinal clinical trials. Pharmaceutical Statistics 2012; 11:456-
61. 
Ratitch, B., Lipkovich, I., O’Kelly, M. Combining Analysis Results from Mutiply Imputed 
Categorical Data, PharmaSUG, 2013, SP03 
Rubin D.B. 1987. Multiple Imputation for Nonresponse in Surveys. New York: John Wiley and 
Sons. 
Thaçi D, Blauvelt A, Reich K, et al. Secukinumab is superior to ustekinumab in clearing skin of 
subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. 
J Am Acad Dermatol 2015;73:400-09. 
Ulm, K., A simple method to calculate the confidence interval of a standardized mortality ratio. 
American Journal of Epidemiology, 1990; 131(12), 373-375 
U.S. Department of Health and Human Services, Common Terminology Criteria for Adverse 
Events (CTCAE), Version 4.0, June 2010. 
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12 
APPENDICES 
12.1 
Appendix A: MedDRA algorithmic approach to anaphylaxis 
The SMQ Anaphylactic reaction consists of three parts: 
1. A narrow search containing PTs that represent core anaphylactic reaction terms  
• Category A – core anaphylactic reaction terms 
− Anaphylactic reaction 
− Anaphylactic shock 
− Anaphylactic transfusion reaction 
− Anaphylactoid reaction 
− Anaphylactoid shock 
− Circulatory collapse 
− Dialysis membrane reaction 
− Kounis syndrome 
− Procedural shock 
− Shock 
− Shock symptom 
− Type I hypersensitivity 
2. A broad search that contains additional terms that are added to those included in the narrow 
search. These additional terms are signs and symptoms possibly indicative of anaphylactic 
reaction and categorized in B, C, or D. 
• Category B (Upper Airway/Respiratory terms) 
− Acute respiratory failure 
− Asthma 
− Bronchial oedema 
− Bronchospasm 
− Cardio-respiratory distress 
− Chest discomfort 
− Choking 
− Choking sensation 
− Circumoral oedema 
− Cough 
− Cough variant asthma 
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− Cyanosis 
− Dyspnoea 
− Hyperventilation 
− Irregular breathing 
− Laryngeal dyspnoea 
− Laryngeal oedema 
− Laryngospasm 
− Laryngotracheal oedema 
− Mouth swelling 
− Nasal obstruction 
− Oedema mouth 
− Oropharyngeal oedema 
− Oropharyngeal spasm 
− Oropharyngeal swelling 
− Pharyngeal oedema 
− Pharyngeal swelling 
− Respiratory arrest 
− Respiratory distress 
− Respiratory failure 
− Reversible airways obstruction 
− Sensation of foreign body 
− Sneezing 
− Stridor 
− Swollen tongue 
− Tachypnoea 
− Throat tightness 
− Tongue oedema 
− Tracheal obstruction 
− Tracheal oedema 
− Upper airway obstruction 
− Wheezing 
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• Category C (Angioedema/Urticaria/Pruritus/Flush terms) 
− Acquired C1 inhibitor deficiency 
− Allergic oedema 
− Angioedema 
− Circumoral swelling 
− Erythema 
− Eye oedema 
− Eye pruritus 
− Eye swelling 
− Eyelid oedema 
− Face oedema 
− Flushing 
− Hereditary angioedema with C1 esterase inhibitor deficiency 
− Injection site urticaria 
− Lip oedema 
− Lip swelling 
− Nodular rash 
− Ocular hyperaemia 
− Oedema 
− Oedema blister 
− Periorbital oedema 
− Periorbital swelling 
− Pruritus 
− Pruritus allergic 
− Rash 
− Rash erythematous 
− Rash pruritic 
− Skin swelling 
− Swelling 
− Swelling face 
− Swelling of eyelid 
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− Urticaria 
− Urticaria papular 
• Category D (Cardiovascular/Hypotension terms) 
− Blood pressure decreased 
− Blood pressure diastolic decreased 
− Blood pressure systolic decreased 
− Cardiac arrest 
− Cardio-respiratory arrest 
− Cardiovascular insufficiency 
− Diastolic hypotension 
− Hypotension 
− Hypotensive crisis 
− Post procedural hypotension 
3. An algorithmic approach which combines a number of anaphylactic reaction symptoms in 
order to increase specificity. A case must include one of the following where both occur on 
either the same day as when an injection was administered or one day after, and for scenarios 
where two must have been reported, both events must have occurred within one day of each 
other: 
• A narrow term or a term from Category A 
• A term from Category B – (Upper Airway/Respiratory) AND a term from Category C – 
(Angioedema/Urticaria/Pruritus/Flush) 
• A term from Category D – (Cardiovascular/Hypotension) AND [a term from Category B – 
(Upper Airway/Respiratory) OR a term from Category C – 
(Angioedema/Urticaria/Pruritus/Flush) 
• Hypersensitivity events will be identified using the “Hypersensitivity (SMQ)”. All TEAEs 
which code to a PT included in the Scope=Narrow search will be included. 
 
 
 
 
 
 
 
 
 
 
 
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12.2 
Appendix B: Definition of CTCAE grades 
Table 12‒1: Definitions of CTCAE grades by biochemistry parameter 
Parameter (unit) 
Definition 
Unit 
Grade 1 
Grade 
2 
Grade 3 
Grade 4 
Alanine 
Aminotransferase               
High 
UL 
>ULN - 
3.0 x 
ULN 
>3.0 - 
5.0 x 
ULN 
>5.0 - 20.0 x 
ULN 
>20.0 x ULN 
Alkaline 
Phosphatase                                   
High 
UL 
>ULN - 
2.5 x 
ULN 
>2.5 - 
5.0 x 
ULN 
>5.0 - 20.0 x 
ULN 
>20.0 x ULN 
Aspartate 
Aminotransferase                       
High 
U/L 
>ULN - 
3.0 x 
ULN 
>3.0 - 
5.0 x 
ULN 
>5.0 - 20.0 x 
ULN 
>20.0 x ULN 
Bilirubin 
High 
umol/L 
>ULN - 
1.5 x 
ULN 
>1.5 - 
3.0 x 
ULN 
>3.0 - 10.0 x 
ULN 
>10.0 x ULN 
Gamma Glutamyl  
Transferase 
High 
U/L 
>ULN - 
2.5 x 
ULN 
>2.5 - 
5.0 x 
ULN 
>5.0 - 20.0 x 
ULN 
>20.0 x ULN 
Glucose                    
High 
mg/dL 
Fasting 
glucose 
value 
>ULN - 
160 
mg/dL;  
Fasting 
glucose 
value 
>160 - 
250 
mg/dL; 
>250 - 500 
mg/dL 
hospitalization 
indicated 
>500 mg/dL 
lifethreatening 
consequences 
Creatinine 
High 
mmol/L 
>ULN-
1.5 x 
ULN 
(>1.5 – 
3.0) x 
ULN 
(>3.0 – 6.0) x 
ULN 
6.0 x ULN 
Sodium 
Low 
mmol/L 
130-
<LLN 
N/A 
120-<130 
<120 
Sodium 
High 
mmol/L 
>ULN-
150 
>150-
155 
>155-160 
>160 
Potassium 
Low 
mmol/L 
3.0-
<LLN 
3.0-
<LLN 
2.5-<3.0 
<2.5 
Potassium 
High 
mmol/L 
>ULN-
5.5 
>5.5-
6.0 
>6.0-7.0 
>7.0 
Calcium 
Low 
mmol/L 
2.0-
<LLN 
1.75-
<2.0 
1.5-<1.75 
<1.5 
Calcium 
High 
mmol/L 
>ULN-
2.9 
>2.9-
3.1 
>3.1-3.4 
>3.4 
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Magnesium 
Low 
mmol/L 
0.5-
<LLN 
0.4-
<0.5 
0.3-<0.4 
<0.3 
Magnesium 
High 
mmol/L 
>ULN-
1.23 
N/A 
>1.23-3.30 
>3.30 
Total cholesterol 
High 
mmol/L 
>ULN-
7.75 
>7.75-
10.34 
>10.34-12.92 
>12.92 
Triglyceride 
High 
mmol/L 
1.71 - 
3.42 
>3.42 - 
5.7 
>5.7 - 11.4 
>11.4 
Table 12‒2: Definitions of CTCAE grades by hematology parameter 
Parameter (unit) 
Definition 
Unit 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Hemoglobin 
Low 
g/L 
100-<LLN 
80-<100 
<80 
N/A 
Hemoglobin 
High 
g/L 
>0-20 above 
ULN 
>20-40 
above ULN 
>40 above 
ULN 
N/A 
Platelets 
Low 
109/L 
75-<LLN 
50-<75 
25-<50 
<25 
WBC 
Low 
109/L 
3-<LLN 
2-<3 
1-<2 
<1 
WBC 
High 
109/L 
N/A 
N/A 
>100 
N/A 
Lymphocytes 
Low 
109/L 
0.8-<LLN 
0.5-<0.8 
0.2-<0.5 
<0.2 
Lymphocytes 
High 
109/L 
N/A 
>4-20 
>20 
N/A 
Neutrophils 
Low 
109/L 
1.5-<LLN 
1.0-<1.5 
0.5-<1.0 
<0.5 
12.3 
Appendix C: Week 96 interim analyses 
An additional data cut will occur approximately after the final Week 96 visit, an interim analysis 
will be performed focused on the Open-Label extension treatment period. 
The currently anticipated date for the final Week 96 visit is 19 March 2021. The interim analyses 
will include: 
• Efficacy data through the Week 96 visit. 
• Safety data through 19 March 2021. 
Selected tables, figures and listings will be produced for this Week 96 interim analysis. Study 
population characteristics, demographics, other baseline characteristics and measurements of 
treatment compliance will be presented for the OLS. The following efficacy variables will be 
presented for the Open-Label extension treatment period based on the OLS, this will include 
presentations based on the subgroup of participants switching from secukinumab to 
bimekizumab: 
• PASI90 response 
• PASI100 response 
• IGA Clear or Almost Clear (with at least a 2-category improvement from Baseline) 
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• IGA Clear (with at least a 2-category improvement from Baseline)  
• Scalp IGA Clear or Almost Clear (with at least 2 category improvement relative to Baseline)  
• Palmoplantar IGA Clear or Almost Clear (with at least a 2-category improvement from 
Baseline) 
• DLQI total score of 0 or 1  
• mNAPSI90, mNAPSI100  
• Absolute, change, and percent change from Baseline in PASI score 
• Absolute PASI scores of ≤1, ≤2, ≤3 
• Absolute and percent change from Baseline in BSA affected by PSO  
• Psoriasis BSA values of 0%, ≤1%, ≤3% 
• PSD response (itch, pain and scaling) 
• PSD 0 or 1 (itch, pain and scaling) 
• PSD 0 (itch, pain and scaling) 
The following safety variables will be presented for the Open-Label extension treatment period 
based on the OLS: 
• Extent of exposure 
• TEAEs including COVID-19 and safety topics of interest 
• Laboratory data focused on TEMA and CTCAE 
• e-CSSRS 
• PHQ-9 
• COVID-19 impact 
Selected analyses of TEAEs will be presented for the subgroup of participants switching from 
secukinumab to bimekizumab for the Open-Label extension treatment period based on the OLS. 
Selected analyses of TEAEs will also be presented for the BKZ Set by treatment at the time of 
AE onset. These tables will include AEs from both the double-blind and Open-Label treatment 
period. 
In addition, the following tables will be produced: 
• Past psoriasis medication 
• Impact of COVID-19 and COVID-19 protocol deviations for Maintenance Treatment Period 
based on MS 
• Main analysis of PASI100 Responder Rates at Week 48 plus sensitivity analyses of this 
variable based on hybrid approach for assessing impact of COVID-19 
Laboratory data for lipid panel (Total Cholesterol, HDL Cholesterol, LDL Cholesterol, 
Triglycerides) for combined Initial Treatment Period and Maintenance Treatment period based 
on SS. 
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12.4 
Appendix D: Efficacy analyses by data cut visit 
Table 12‒3: Efficacy analyses reporting 
Parameter 
Week 48 
Week 96 
Week 
144/OLEa 
Final/OL
E2b 
PASI100 
X 
X 
X 
X 
PAS90 
X 
X 
X 
X 
PASI75 
X 
 
X 
 
Absolute change and percent change from Baseline 
in PASI score 
X 
X 
X 
 
Absolute PASI scores of ≤1, ≤2, ≤3, ≤5, 
X 
X 
X 
 
Time to PASI100 response 
X 
 
 
 
Time to PASI90 response 
X 
 
 
 
Time to PASI75 response 
X 
 
 
 
IGA Clear  
X 
X 
X 
X 
IGA Clear or Almost Clear 
X 
X 
X 
X 
IGA Change from Baseline 
X 
 
 
 
Scalp IGA Clear or Almost Clear 
X 
X 
X 
 
Palmoplantar IGA Clear or Almost Clear 
X 
X 
X 
 
Change from Baseline in DLQI Total Score 
X 
X 
X 
 
DLQI Total Score of 0 or 1 
X 
X 
X 
X 
MCID ≥4 more in DLQI 
X 
X 
X 
 
mNAPSI100 
X 
X 
X 
 
mNAPSI90 
X 
X 
X 
 
mNAPSI75  
X 
X 
X 
 
Change from Baseline in mNAPSI score 
X 
X 
X 
 
Change from Baseline in Psoriasis BSA 
X 
X 
X 
 
Patient Global Assessment of PSO 
X 
 
 
 
Absolute and percent change from Baseline in BSA 
affected by PSO  
X 
X 
X 
 
Psoriasis BSA values of 0%, ≤1%, ≤3%, ≤5%, 
X 
X 
X 
 
Absolute and percent change from Baseline in the 
product of IGA and BSA 
X 
 
X 
 
PSD response (itch, pain and scaling) 
X 
X 
X 
X 
PSD 0 or 1 (itch, pain and scaling) 
X 
X 
X 
 
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Parameter 
Week 48 
Week 96 
Week 
144/OLEa 
Final/OL
E2b 
PSD 0 (itch, pain and scaling) 
X 
X 
X 
 
PGADA for arthritis analog scale 
X 
 
X 
 
PASE 
X 
 
X 
 
PASE (<47 versus ≥47) 
X 
 
 
 
EQ-5D-3L 
X 
 
X 
 
WPAI-SHP 
X 
 
X 
 
a All Week 48 analyses will also be re-run at Week 144/OLE. 
b All Week 48 and Week 144 analyses will also be rerun at Final/OLE2. 
 
 
 
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13 
AMENDMENT(S) TO THE STATISTICAL ANALYSIS PLAN 
(SAP) 
13.1 
Amendment 1 
Rationale of the Amendment 
The main purpose of this amendment is to align the SAP with protocol amendments 3 and 4 and 
to achieve consistency with other SAPs of the program. 
Specific Changes 
Change #1 
List of abbreviations 
The following abbreviations have been added: 
CSR 
Clinical Study Report 
OLE 
open-label extension 
OLS 
open-label set 
The following abbreviation has been removed: 
ADR 
adverse drug reaction 
 
Change #2 
1 Introduction 
The SAP is based on the following study document: Protocol Amendment 1, 17 October 2018. 
Has been changed to 
The SAP is based on the following study document: Protocol Amendment 4, 06 Feb 2020. 
 
Change #3 
2.1.3 Other objectives 
The following objectives have been added: 
• Assess the maintenance of efficacy of bimekizumab dosing Q4W versus Q8W 
• Assess the safety and efficacy of initiating bimekizumab therapy in subjects who 
received secukinumab in the double-blind Treatment Period 
 
Change #4 
2.2.1.3 Other efficacy variables 
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Patient Symptom Diary responses for itch, pain, and scaling has been added as a variable. 
Definition of IGA response (Clear with at least 2 category improvement relative to 
Baseline) and of DLQI total score has been clarified. 
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) scores was moved from 
this section to section 2.2.3.2 Other safety variables. 
 
2.2.3.2 Other safety variables 
Urinalysis has been removed as a variable. 
 
Change #5 
2.3.2 Study periods 
An Open-Label period has been added: 
o Open-Label Extension Period starts with the first study drug administration 
at or after the Week 48 visit 
Open-Label Treatment Period ends either at the Week 144 visit for subjects completing the 
Open-Label Treatment Period, or at PEOT Visit for subjects who discontinued early 
during the Open-Label Treatment Period. If a subject does not have a Week 144/PEOT 
visit, then the date of the last scheduled or unscheduled visit during the Open-Label 
Treatment Period will define the end date of the Open-Label Treatment Period. 
 
The title of section 2.3.2.2 was changed from Double-blind Treatment Period to Initial 
Treatment Period and a separate section 2.3.2.2 Maintenance Treatment Period was created. 
The following paragraphs were added: 
Subjects will be classified as completing the initial treatment period if they complete the 
Week 16 Visit without early withdrawal from the study or if they start treatment in the 
maintenance treatment period. The start of the maintenance treatment period marks the 
end of the initial treatment period. 
Subjects will be classified as completing the maintenance treatment period if they complete 
the Week 48 Visit without early withdrawal from the study or if they start treatment in the 
Open-Label extension period. The start of the Open-Label period marks the end of the 
maintenance treatment period. 
The following section has been added: 
2.3.2.4 OLE Period 
After completion of the Week 48 visit assessments, subjects will be allowed to enroll in the 
OLE Period. All subjects enrolling in the OLE Period will sign a new ICF, and then receive 
the following IMP regimens as determined by the subject’s treatment regimen and PASI 
response in the double-blind Treatment Period. 
At Week 48, subjects receiving: 
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• Bimekizumab 320mg Q4W who achieve PASI90 at Week 48 of the double-blind 
Treatment Period will be randomized 1:1 to receive bimekizumab 320mg Q4W or 
bimekizumab 320mg Q8W. 
• Bimekizumab 320mg Q4W who do not achieve PASI90 at Week 48 of the double-
blind Treatment Period will receive bimekizumab 320mg Q4W. 
• Bimekizumab 320mg Q8W who do not achieve PASI90 at Week 48 of the double-
blind Treatment Period will receive bimekizumab 320mg Q4W. 
• Bimekizumab 320mg Q8W who achieve PASI90 at Week 48 of the double-blind 
Treatment Period will receive bimekizumab 320mg Q8W. 
• Secukinumab who do not achieve PASI90 at Week 48 of the double-blind Treatment 
Period will receive bimekizumab 320mg Q4W. 
• Secukinumab who achieve PASI90 at Week 48 of the double-blind Treatment 
Period will be randomized 1:1 to receive bimekizumab 320mg Q4W or 
bimekizumab 320mg Q8W. 
At Week 96, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
subject’s dosing interval will change from 320mg Q4W to 320mg Q8W (default), unless, 
based on medical judgment, the Investigator decides differently. 
During the OLE Period, subjects will attend study visits at Weeks 52, 56, 64, and 72, and 
then every 12 weeks. At study visits, IMP will be administered in the clinic by sc injection 
as applicable. In between study visits, subjects will self-inject IMP at home. 
All subjects not enrolling in the Open-Label study will have the Week 48 study assessments 
and will enter the SFU Period. 
The following bullet point was added in section 2.3.3 Study duration per subject: 
• OLE Period: 96 weeks (final dose at Week 136 for subjects receiving bimekizumab 
320mg Q8W and at Week 140 for subjects receiving bimekizumab 320mg Q4W) 
 
Change #6 
3.1 General presentation of summaries and analyses 
The following section has been added: 
Per protocol, visit windows of ±3 days from the first dose to Week 24, ±7 days from Week 
28 to Week 72 and ±14 days from Week 76 to Week 144 are permissible. For the SFU Visit, 
visit window is 20 weeks ±7 days from final dose. All by-visit summaries will contain 
nominal (i.e. scheduled) visits only. Unscheduled visits will not be mapped to scheduled 
visits except for assessments that occur within a 3-day time window of a scheduled visit. In 
that case, the assessment will be mapped to the corresponding scheduled visit and will be 
used for the analysis. This will only occur for some vendor data. 
 
3.2 Definition of Baseline values 
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Unless specified otherwise, the process laid out above will always be followed to determine 
Baseline. An additional Baseline for the Maintenance Treatment Period will be defined for 
selected summaries of laboratory evaluations. This Baseline for the Maintenance Treatment 
Period is the latest measurement on/prior to the day of first dose in the Maintenance Treatment 
Period. 
Has been changed to: 
Unless specified otherwise, the process laid out above will always be followed to determine 
Baseline. An additional Baseline for the OLE Period will be defined for selected summaries 
of laboratory evaluations. This Baseline for the OLE Period is the latest measurement 
on/prior to the day of first dose in the OLE Period. 
Note that for any laboratory value that occurs on the day of treatment switch, that lab 
value will be attributed and summarized for the treatment they were on previously. 
 
Change #7 
The following sections have been added: 
3.5.6 Open-Label Set 
The Open-label Set (OLS) will consist of all subjects that receive at least 1 dose of IMP at 
Week 48 or later in the OLE Period (including the Week 48 dose). 
3.5.9 Bimekizumab Set 
The Bimekizumab Set (BKZ Set) consists of all randomized subjects who received at least 1 
dose of bimekizumab in the double-blind or Open-Label extension treatment period. 
 
Change #8 
3.6 Treatment assignment and treatment groups 
The following has been added: 
Re-randomized (Open-Label extension) treatment groups are Bimekizumab 320mg Q4W 
and Bimekizumab 320mg Q8W. 
 
Change #9 
3.10 
Changes to protocol-defined analyses 
 
The following has been removed as they have been updated in the latest protocol amendment are 
no longer changes to protocol-defined analyses: 
• Percent of subjects with absolute BSA=0%, ≤1%, ≤3% and ≤5% 
• Absolute and percent change from Baseline in the product of IGA and BSA (IGAxBSA) 
• Shift from Baseline in PASE score suggestive of PsA (<47 versus ≥47) 
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For the following secondary endpoint the definition of response was added in parentheses: 
• Investigators Global Assessment (IGA) response (Clear or Almost Clear with at least 2-
category improvement relative to Baseline) at Week 16 
All variables listed as other efficacy variables in Section 2.2.1.3 will be summarized for the RS 
as well as for the MS. This is a deviation from protocol Section 14.3.2.2 and is described in 
detail in Section 8.3. 
 
 
The following has been added: 
The protocol states that subgroup analyses will be performed on the primary and 
secondary efficacy variables that are part of the fixed sequence testing procedure. 
However, subgroup analyses will only be done for PASI75 and PASI100 as described in 
Section 4.8. Urinalysis will not be analysed in summary tables but will only be included in 
listings. 
Urinalysis will not be analysed in summary tables but will only be included in listings. 
Section 14.7 of the protocol describes how multiple imputation should be used to analyse 
other efficacy endpoints. It is mentioned that the imputation model will use the change 
from Baseline (instead of actual) values by visit. This statement was omitted from SAP 
Section 4.2.1.3 as actual values will be used in the imputation algorithm and change from 
baseline will be calculated based on the imputed values. 
Also, Patient Symptom Diary responses for itch, pain, and scaling has been added as an 
endpoint that is not listed in the protocol but was added into the SAP. 
 
Change #10 
4.2.1 Handling of missing data for efficacy variables 
 
The following has been added: 
If a subject discontinues early from the study, all efficacy data that are collected later than 
35 days after the last administration of study treatment will be treated as missing and 
subject to imputation as applicable. 
Additionally, MI-MCMC/reference based imputation has been removed as a method for 
sensitivity analyses and LOCF has been added instead. 
Change #11 
4.2.1.5 Missing data overview and summary 
The following has been added: 
Note: for all analyses and summaries using MI, subjects with missing baseline value will be 
excluded. 
 
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Change #12 
4.2.1.6 Missing data algorithm – MI – MCMC / Monotone Regression 
Some clarifications have been made without changing the logic of the imputation method. 
Additionally, the following sentence was added in order to deal with imputed values that are out 
of range: 
In addition, if values outside of the pre-defined range of values for IGA (0-4) are imputed, 
they will be cut off as appropriate after the multiple imputation procedure but before 
deriving the responder variable. 
Table 4‒2: Allowable ranges for imputation by variable has been added. 
Further details about imputation for different analysis sets have been added as below: 
Randomized Set: When programming multiple imputation based on the RS, PROC MI will 
be used with a separate data set for each of the 2 randomized treatment groups 
(bimekizumab 320mg Q4W and secukinumab) including all scheduled assessment visits 
from Baseline to Week 48. 
Maintenance Set: When programming multiple imputation based on the MS, PROC MI 
will be used with a separate data set for each of the 3 Maintenance Period treatment groups 
(bimekizumab 320mg Q8W, bimekizumab 320mg Q4W, secukinumab) including all 
scheduled assessment visits from Baseline to Week 56. 
Open-Label Set: When programming multiple imputation based on the OLS, PROC MI 
will be used with a separate data set for each of the 6 treatment sequences based on the 
combination of randomized treatment at Baseline, Maintenance Period treatment and OLE 
period treatment at Week 48 including all scheduled assessment visits from Baseline to 
Week 144. The summary values for the 4 treatment sequences based on the combination of 
randomized treatment at Baseline and OLE period treatment at Week 48 will be computed 
after the imputation steps 
 
Change #13 
4.3 Interim analyses and data monitoring 
The first paragraph has been updated to: 
After the final Week 48 visit, an interim analysis will be performed and a corresponding interim 
clinical study report (CSR) may be written, data from the OLE/analysis based on the OLS 
will not be included in this interim analysis. For subjects that participate in the OLE 
period, data will be cut at the day of their Week 48 study drug administration. A final 
analysis will be conducted when all data for the double-blind and OLE period (including 
SFU) will be collected. 
 
4.4 Multicenter studies 
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However, if the model is unable to converge due to a low number of subjects at a given center, a 
pooling by region will be considered. Detailed strategy from Section 3.7 will be applied in order 
to allow the model to converge. 
Has been changed to: 
However, if the model is unable to converge due to a low number of subjects at a given 
center, a pooling by center will be considered. Detailed strategy from Section 3.7 will be 
applied in order to allow the model to converge. If convergence is still not achieved, a 
pooling by region will be applied. If convergence still cannot be achieved, this analysis will 
not be performed. 
 
Change #14 
4.8 Examination of subgroups 
• 
PASI75 responders at Week 4 (yes, no) to predict PASI90/100 and IGA through Week 48 
• 
PASI90 responders at Week 16 (yes, no) to predict PASI100 through Week 48 
Has been changed to: 
• PASI75 response (OC) at Week 4 (yes, no) to predict PASI90/100 and IGA (NRI) 
through Week 48 
• PASI90 response (OC) at Week 16 (yes, no) to predict PASI100 (NRI) through Week 48 
 
Change #15 
6.2 Other Baseline characteristics 
The following has been added to the list of baseline characteristics: 
• PSD items: Pain, Itch, Scaling 
• PGADA score (=0, >0) 
• DLQI total score (=0, >0) 
 
Change #16 
7 MEASUREMENTS OF TREATMENT COMPLIANCE 
A summary of percent treatment compliance categorized as ≤75% and >75% will be provided by 
treatment group and study periods (Initial Treatment Period, Maintenance Treatment Period, and 
the Initial and Maintenance Treatment Period). 
Has been changed to: 
A summary of percent treatment compliance categorized as <75% and ≥75% will be 
provided by treatment group and study periods (Initial Treatment Period for the SS, 
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Maintenance Treatment Period for the SS, Initial and Maintenance Treatment Period for 
the SS, and Open-Label Extension Period for the OLS). 
 
Table 7.2 Dosing scheme, OLE Period has been added. 
 
Change #17 
8.1.2 Primary analysis of the primary efficacy variable 
The following has been added: 
The evaluation of superiority will use pairwise treatment comparisons based on the CMH 
test using the p-value for the general association. The odds ratio and associated confidence 
interval (CI) based on the Wald test will be presented. 
 
To calculate the stratified Mantel-Haenszel risk difference, the method of Greenland and 
Robins (1985) is used. For each combination of strata, a 2x2 table of treatment group and 
response is created. A theoretical 2x2 table for a given stratum is shown below, where n = 
a+b+c+d. 
Treatment Group 
Response 
Yes 
No 
Bimekizumab 
a 
c 
Secukinumab 
b 
d 
 
Given that structure, the stratified Mantel-Haenszel risk difference, standard error, and 
two-sided (1-α)*100% confidence interval may be written as follows: 
𝑹𝑫𝑴𝑯=
∑((𝒂𝒊∗(𝒃𝒊+ 𝒅𝒊)/𝒏𝒊) −(𝒃𝒊∗(𝒂𝒊+ 𝒄𝒊)/𝒏𝒊)
𝒊
∑((𝒂𝒊+ 𝒄𝒊) ∗(𝒃𝒊
𝒊
+ 𝒅𝒊))/𝒏𝒊
 
 
𝑺𝑬𝑴𝑯= √
∑{[𝒂𝒊∗𝒄𝒊∗(𝒃𝒊+ 𝒅𝒊)𝟑] + [𝒃𝒊∗𝒅𝒊∗(𝒂𝒊+ 𝒄𝒊)𝟑]
(𝒂𝒊+ 𝒄𝒊) ∗(𝒃𝒊+ 𝒅𝒊) ∗𝒏𝒊
𝟐
}
𝒊
{∑[(𝒂𝒊+ 𝒄𝒊) ∗(𝒃𝒊+ 𝒅𝒊)
𝒏𝒊
]
𝒊
}
𝟐
 
 
𝑪𝑰𝑴𝑯= 𝑹𝑫𝑴𝑯± probit(𝟏−(𝜶𝟐
⁄ )) ∗𝑺𝑬𝑴𝑯 
 
For the assessment of non-inferiority of bimekizumab to secukinumab, the lower 97.5% 
confidence limit for the stratified Mantel-Haenszel risk difference will be considered. If 
that value is greater than -10%, then non-inferiority will have been established. 
Also: An additional plot will be produced for the OLS by OLE treatment groups. 
Change #18 
8.1.3.6 Sensitivity Analysis #6 
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The following has been added: 
In order to achieve model convergence, region may be used instead of center or prior 
biologic exposure may be dropped from the model. If convergence still cannot be achieved, 
this analysis will not be performed. 
 
Change #19 
8.3 Analysis of other efficacy variables 
The following paragraph has been updated: 
All efficacy variables will be summarized in the manner described for Group 1 and Group 3 
above. Summaries for Group 2 will be done only for a subset of efficacy variables, namely, 
PASI90/100 responder rate, IGA Clear or Almost Clear. Examination of subgroups will only 
be done for Group 3. 
The following has been added: 
Selected endpoints will be summarized for OLE Period for the OLS. Imputation methods 
will be identical to the respective summary for the RS. 
 
8.3.8 Symptoms of PSO (Itch, pain, and scaling) 
The following section has been added: 
In addition, each of the 3 PSD scores will be characterized in terms of the percent of 
subjects demonstrating a specified point improvement at each visit. Subjects with a missing 
score will be imputed using NRI. The analysis will be limited to subjects with a Baseline 
PSD score at or above the applicable threshold score. The 3 threshold scores for itch, pain 
and scaling will be determined prior to unblinding of the data. 
Cumulative distribution plots will also be provided for absolute change from Baseline PSD 
at Week 16 for each item. 
 
Change #20 
8.3.1.2 Time to PASI75, PASI90 and PASI100 response 
The following has been added: 
All visits including unscheduled visits are considered. 
Subjects who discontinue study treatment without achieving a given PASI response prior 
to discontinuation will be censored at the date of the last observed PASI assessment on or 
prior to the date of treatment discontinuation. Subjects who reach the Week 48 Visit 
without achieving the given response will be censored at the date of the last observed PASI 
assessment on or prior to the Week 48 Visit. Subjects will be censored at Baseline if there is 
no Baseline PASI assessment or no Post Baseline PASI assessment 
 
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Change #21 
8.3.11 Euro-Quality of Life 5-Dimensions, 3 levels (EQ-5D-3L) 
The following clarification was added: 
Responses to EQ-5D-3L will be summarized based on OC only as primary analysis. No 
imputation is applied to responses to EQ-5D-3L but is applied to EQ-5D-3L VAS scores. 
 
Change #22 
 The following section has been added: 
8.4 Additional statistical analysis of other efficacy variables 
For selected other efficacy variables, it is of interest to perform statistical tests and to calculate 
inferential statistics. As these tests are not part of the multiplicity-controlled procedure, the 
associated p-values are considered nominal and are not controlled for multiplicity. For responder 
variables, the analysis will follow what was specified for the primary analysis. Specifically, a 
stratified Cochran-Mantel-Haenszel (CMH) test will be used, where region and prior biologic 
exposure (yes/no) will be stratification variables. The p-value will be based on the CMH test for 
a general association. Missing values will be imputed using NRI. For continuous variables, the 
MI – MCMC / Monotone Regression approach used for other continuous variables will be 
applied for the imputation model. The analysis model will be based on analysis of covariance 
(ANCOVA) with fixed effects of treatment, region, and prior biologic exposure and Baseline 
value as a covariate. Below is a list of variables for which these nominal p-values will be 
calculated (with the time points in parentheses). The results of these inferential tests will all be 
presented in a single table summarizing the testing performed outside of the multiplicity-
controlled testing procedure. 
• PASI90 
− Bimekizumab vs Secukinumab (Weeks 1, 2, 4, 8, 12, 16 and 48) 
• IGA Clear or Almost Clear 
− Bimekizumab vs Secukinumab (Weeks 1, 2, 4, 8, 12, 16 and 48) 
• PASI100 
− Bimekizumab vs Secukinumab (Weeks 4, 8, and 12) 
• IGA Clear 
− Bimekizumab vs Secukinumab (Weeks 4, 8, 12, 16, and 48) 
• PASI75 
− Bimekizumab vs Secukinumab (Weeks 1, 2, and 16) 
• Scalp IGA Clear or Almost Clear (subjects with Baseline Scalp IGA ≥2) 
− Bimekizumab vs Secukinumab (Weeks 16 and 48) 
• pp-IGA Clear or Almost Clear (subjects with Baseline pp-IGA ≥2) 
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− Bimekizumab vs Secukinumab (Weeks 16 and 48) 
• mNAPSI75 response (subjects with Baseline mNAPSI>0) 
− Bimekizumab vs Secukinumab (Weeks 16 and 48) 
• mNAPSI90 response (subjects with Baseline mNAPSI>0) 
− Bimekizumab vs Secukinumab (Weeks 16 and 48) 
• mNAPSI100 response (subjects with Baseline mNAPSI>0) 
− Bimekizumab vs Secukinumab (Weeks 16 and 48) 
• DLQI 0/1 response 
− Bimekizumab vs Secukinumab (Weeks 16 and 48) 
• PASI percentage change from Baseline 
− Bimekizumab vs Secukinumab (Weeks 1, 2, 4, 8, 12, 16, and 48) 
• Patient Symptom Diary responses for itch, pain, and scaling 
− Bimekizumab vs Secukinumab (Weeks 16, 32, 48) 
 
Change #23 
9.1 Pharmacokinetics 
The following clarifications have been added 
A separate summary table will be created for the Open-Label Extension Period for subjects 
that are both in the PK-PPS and the OLS. 
and 
A separate plot will be created for the Open-Label Extension Period for subjects that are 
both in the PK-PPS and the OLS. 
and 
If the PK sampling date is >1 day after the dosing date data points will be excluded from 
the PK summary tables and figures, but not from the listing. 
 
Change #24 
9.3.2 Anti-bimekizumab antibodies 
Visits during the OLE period have been added. 
The following paragraph has been added: 
Anti-bimekizumab antibody samples are not analyzed when subjects are on a treatment 
other than bimekizumab. For subjects who switch from secukinumab either placebo or an 
active comparator to bimekizumab, samples are analyzed starting at the visit when the 
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switch to bimekizumab occurs. The sample at the visit when the switch occurs will act as 
the Baseline for that treatment group. 
 
Additionally, adjustments in the Subject Classification section have been done and the rest of 
the section has been updated in order to align with UCB program conventions. A section about 
neutralizing antibodies has been added. 
 
Change #25 
10.1 
Extent of exposure 
The following has been added: 
For the final analysis (not the interim), an additional table will be created for the BKZ set 
with the above categories plus the below categories. A Bimekizumab total column will be 
displayed only. 
• >=72 weeks 
• >=96 weeks 
• >=120 weeks 
• >=144 weeks 
As the study was separated into three different periods, this section was re-written in order to 
provide definitions for exposure variables for the three periods and a combinations of initial and 
maintenance period. 
The following four sections have been added: 
10.1.1 Exposure during the Initial Treatment Period for SS 
10.1.2 Exposure during the Maintenance Treatment Period for MS 
10.1.3 Exposure during the Initial and Maintenance Treatment Period for SS 
10.1.3.1 
For subjects who do not switch study treatments 
10.1.3.2 
For subjects who switch from BKZ 320mg Q4W to Q8W at Week 16: 
10.1.4 Exposure during the Open-Label Extension Period based on OLS 
10.1.4.1 
For subjects who do not switch study treatments 
10.1.4.2 
For subjects who switch from BKZ 320mg Q4W to Q8W at Week 16: 
10.1.5 Exposure during the Double-blind and OLE Period based on BKZ set 
10.1.5.1 
For subjects who do not switch study treatments 
10.1.5.2 
For subjects who switch from BKZ 320mg Q4W to Q8W at Week 16: 
 
Change #26 
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10.2 
Adverse events 
The following has been added: 
For subjects who switch treatment at Week 16, Week 48, or Week 96, any adverse events 
that occur after initiation of the new treatment are attributable to the new treatment. If an 
adverse event occurs on the date of a treatment switch, the event is attributed to the 
original treatment. The only exception to this is if the AE fulfills any of the criteria 
specified below: 
• Events that fulfill the anaphylaxis criteria for acute events 
• Events that fulfill the hypersensitivity criteria 
• Events with an HLT of “Administration site reactions NEC” 
• Events with an HLT of “Injection site reactions” 
 
Change #27 
10.2.1 Data considerations 
A paragraph about adverse drug reactions has been removed and the following has been added: 
Selected summaries, as specified in Section 10.2.2, will include the risk difference between 
bimekizumab and secukinumab. The risk difference is calculated as: 
𝑹𝑫= 𝑰𝑷𝑩𝑲𝒁−𝑰𝑷𝑺𝑬𝑪 
where 𝑰𝑷𝑩𝑲𝒁 is the incidence proportion for the bimekizumab-treated group and 𝑰𝑷𝑺𝑬𝑪 is 
the incidence proportion for the secukinumab group. Note that incidence proportion 
simply refers to the percentage of subjects within the specified treatment group that 
experienced a given adverse event. 
The standard error for the risk difference is calculated as follows: 
𝑺𝑬𝑹𝑫= √(𝑰𝑷𝑩𝑲𝒁× (𝟏−𝑰𝑷𝑩𝑲𝒁
𝒏𝑩𝑲𝒁
)) + (𝑰𝑷𝑷𝑩𝑶× (𝟏−𝑰𝑷𝑺𝑬𝑪
𝒏𝑺𝑬𝑪
)) 
where 𝒏𝑩𝑲𝒁 is the number of subjects in the bimekizumab-treated group and 𝒏𝑺𝑬𝑪 is the 
number of subjects in the secukinumab group. 
The corresponding confidence interval for the risk difference is as follows: 
𝑪𝑰𝑹𝑫= 𝑹𝑫 ± 𝒁𝟏−𝜶𝟐
⁄ × (𝑺𝑬𝑹𝑫) 
where 𝒁𝟏−𝜶𝟐
⁄  is the 𝒁 statistic for the corresponding level of alpha. For the risk difference 
confidence intervals calculated in this SAP, 1.96 will be used (corresponding to a two-sided 
alpha of 0.05 and 95% confidence interval). 
 
Change #28 
10.2.2 AE summaries 
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The wording of Adverse drug reactions has been changed to related TEAEs 
The following has been added: 
The following summary will be provided by treatment for the Initial Treatment Period for 
the SS: 
• Incidence of TEAEs Above Reporting Threshold of 5% with Risk Differences by SOC 
and PT 
• Incidence of Serious TEAEs and Risk Differences by SOC and PT 
 
The following summary will be provided by treatment for the Open-Label Extension 
Period for the OLS. 
• Incidence of TEAEs Overview 
• Incidence of TEAEs per 100 Subject-Years 
Incidence of Serious TEAEs per 100 Subject-Years In addition, all summaries of TEAEs 
based on “100 subject years” will include EAIR (with 95% CI) and EAER. 
The tables with risk differences will also be accompanied by figures (dot plots) which show 
the incidence of the adverse events and corresponding 95% risk difference confidence 
intervals. These will be ordered by descending order of risk difference (bimekizumab vs 
secukinumab). 
 
Change #29 
10.2.3 Other Safety topics of interest 
The following has been added: 
The following outputs will be produced for the SS for the initial treatment period, for the SS for 
the Initial and Maintenance Treatment Period, and for the OLS for the Open-Label Extension 
Period. 
Along with the tables described, there will be a table which displays the risk difference and 
95% confidence intervals for each of the topics of interest during the Initial Treatment 
Period. A corresponding figure (with dot plots) will be prepared. 
 
Change #30 
10.2.3.1 
Infections (serious, opportunistic, fungal and Tuberculosis [TB]) 
The steps for the identification and review of opportunistic infections have been updated. 
 
Change #31 
10.2.3.3 
Major adverse cardiac event 
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• Incidence of Major Cardiac Event (MACE) TEAEs per 100 subject years by SOC, HLT and 
PT 
MACE will be presented in a table. The classification of an event as MACE is determined by an 
external cardiovascular event adjudication committee. 
Has been changed to: 
• Incidence of Major Adverse Cardiac Event (MACE) TEAEs per 100 subject years by 
SOC, HLT and PT 
Adjudicated MACE will be presented in a table. The classification of an event as MACE is 
determined by an external cardiovascular event adjudication committee. 
Extended MACE events will be presented in a separate table and listing. All events which 
are classified by the adjudication committee as any of the following events types will be 
considered an extended MACE event. 
Event Type Code Event Type 
1 
Non-Fatal Myocardial Infarction (MI) 
2 
Non-Fatal Stroke: hemorrhagic 
3 
Non-Fatal Stroke: ischemic 
4 
Non-Fatal Stroke: embolic 
5 
Non-Fatal Stroke: undeterminable 
6 
Hospitalization or ER for Unstable Angina with urgent revascularization 
8 
Hospitalization for Heart Failure 
10 
Coronary Revascularization Procedures (e.g. percutaneous coronary intervention, 
coronary artery bypass grafting) 
11 
Urgent Revascularization Procedures (i.e. due to symptoms of brain ischemia or 
pending infarction) 
18 
Death due to Myocardial Infarction (MI) 
19 
Death due to Stroke 
20 
Sudden Cardiac Death 
21 
Other CV Death (e.g. heart failure, pulmonary embolism, cardiovascular 
procedure-related) 
22 
Cardiovascular: Undetermined Cause of Death (i.e. cause of death unknown) 
 
A separate table and listing will present the TEAEs referred to the cardiovascular event 
adjudication committee by cardiovascular event type. For each cardiovascular event type 
(24 total), the individual PTs which fall within each event type will be summarized. 
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Additionally, a listing of all events identified for potential review by the cardiovascular 
event adjudication committee will be produced. This listing will indicate whether each 
event was escalated to the committee for formal review/adjudication. 
 
Change #32 
10.2.3.5 
Suicidal Ideation and Behavior (SIB) 
• Incidence of Neuropsychiatric TEAEs per 100 subject years by SOC, HLT and PT 
This table is based on the SMQ of “Depression and suicide/self-injury” (all TEAEs which code 
to a PT included in the Scope=Broad and/or Scope=Narrow). 
An external neuropsychiatric adjudication committee will evaluate potential neuropsychiatric 
events and determine whether any of those events were associated with suicidal ideation and 
behavior (SIB). If an event is adjudicated as SIB, further information will be provided. A 
separate listing for SIB events as determined by the adjudication committee will be included. 
Has been changed to: 
10.2.3.5 
Suicidal Ideation and Behavior (SIB) 
• 
Incidence of SIB-Adjudicated Neuropsychiatric TEAEs per 100 subject years by SOC, 
HLT and PT 
An external neuropsychiatric adjudication committee will evaluate potential 
neuropsychiatric events and determine whether any of those events were associated with 
suicidal ideation and behavior (SIB). If an event is adjudicated as SIB, further information 
will be provided. A separate listing for SIB events as determined by the adjudication 
committee will be included. Additionally, a listing of all events identified for potential 
review by the neuropsychiatric adjudication committee will be produced. This listing will 
indicate whether each event was escalated to the committee for formal review/adjudication. 
 
Change #33 
10.2.3.5 
Neuropsychiatric events (in particular depression and suicide) 
• 
Incidence of Neuropsychiatric TEAEs per 100 subject years by SOC, HLT and PT 
This table is based on the SMQ of “Depression and suicide/self-injury” (all TEAEs which code 
to a PT included in the Scope=Broad and/or Scope=Narrow). 
An external neuropsychiatric adjudication committee will evaluate potential neuropsychiatric 
events and determine whether any of those events were associated with suicidal ideation and 
behavior (SIB). If an event is adjudicated as SIB, further information will be provided. A 
separate listing for SIB events as determined by the adjudication committee will be included. 
has been changed to: 
10.2.3.5 
Suicidal Ideation and Behavior (SIB) 
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• 
Incidence of SIB-Adjudicated Neuropsychiatric TEAEs per 100 subject years by SOC, 
HLT and PT 
An external neuropsychiatric adjudication committee will evaluate potential 
neuropsychiatric events and determine whether any of those events were associated with 
suicidal ideation and behavior (SIB). If an event is adjudicated as SIB, further information 
will be provided. A separate listing for SIB events as determined by the adjudication 
committee will be included. Additionally, a listing of all events identified for potential 
review by the neuropsychiatric adjudication committee will be produced. This listing will 
indicate whether each event was escalated to the committee for formal review/adjudication. 
 
Change #34 
10.2.3.6 
Inflammatory bowel disease 
The following has been added: 
Inflammatory bowel disease events will be summarized stratified by subjects with or 
without a previous medical history of inflammatory bowel disease. Previous medical 
history of inflammatory bowel disease will be determined using the information recorded 
on the Extra-Articular Assessment at Screening CRF page (“Does subject have a history of 
IBD?”). 
 
Change #35 
10.2.3.7 
Anaphylactic reaction 
• 
Incidence of Anaphylactic Reaction TEAEs per 100 subject years by SOC, HLT and PT 
This table will be prepared based on the MedDRA anaphylaxis algorithm (refer to Appendix 1 in 
“Bimekizumab-Safety-Topics-of-Interest.docx”) for acute events (reported on the same day) and 
for treatment-emergent PTs including the term “hypersensitivity” reported at any time. 
Furthermore, injection site reactions will be evaluated based on the any TEAE table (no separate 
table needed) by looking under the following HLTs: “Administration site reactions NEC” and 
“Injection site reactions”. 
has been changed to: 
10.2.3.6 
Hypersensitivity (including anaphylaxis) 
• 
Incidence of Anaphylactic Reaction TEAEs per 100 subject years by SOC, HLT and PT 
A separate table will be prepared based on the MedDRA anaphylaxis Algorithm (see 
Appendix A) for acute anaphylactic events (reported on the same day as when an injection 
was administered or one day after). 
A separate table will be prepared to summarize hypersensitivity events, identified using the 
SMQ “Hypersensitivity (SMQ)”. All TEAEs which code to a PT included in the 
Scope=Narrow search will be included in this table. 
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Furthermore, injection site reactions will be evaluated based on the any TEAE table (no 
separate table needed) by looking under the following HLTs: “Administration site 
reactions NEC” and “Injection site reactions”. 
 
Change #36 
10.3 
Clinical laboratory evaluations 
The following has been added: 
• AST: >3xULN, >5xULN, >8xULN, >10xULN, >20xULN 
• ALT: >3xULN, >5xULN, >8xULN, >10xULN, >20xULN 
• AST or ALT: >3xULN, >5xULN, >8xULN, >10xULN, >20xULN 
• Bilirubin: >1.5xULN, >2xULN 
 
The following has been removed 
• AST: >2xULN, >3xULN, >5xULN, >10xULN, >20xULN 
• ALT: >2xULN, >3xULN, >5xULN, >10xULN, >20xULN 
• AST or ALT: >2xULN, >3xULN, >5xULN, >10xULN, >20xULN 
• Bilirubin: >1xULN, >1.5xULN 
• ALP: >2xULN 
and 
• [AST ≥3xULN or ALT ≥3xULN] and Total Bilirubin ≥2xULN 
 
Change #37 
10.4.1 Vital signs 
It was specified that a summary of absolute and change from baseline will be provided for the 
Initial Treatment Period and that a summary of markedly abnormal values will be provided for 
the Initial Treatment Period (SS), the Initial and Maintenance Treatment Period (SS), and 
the open-Label Extension Period (OLS). 
 
Change #38 
10.4.3 Electrocardiograms 
It was specified that two separate by-subject listing of all 12-lead ECG data will be provided 
based on interpretation from central reader and from site. 
 
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Change #39 
10.4.4.5 
Patient Health Questionnaire 9 (PHQ-9) 
This section has been moved to the safety section as it was previously included in the efficacy 
section. 
The following has been added: 
Change from Baseline in PHQ-9 is derived as post-Baseline score minus Baseline score and will 
be summarized by treatment group. 
Differently to other safety variables, PHQ-9 will be summarized using the 
MCMC/monotone regression approach described in section 8.1.3.1. A table for the SS 
through Week 48 will be produced. 
 
Change #40 
11 REFERENCES 
The following two references have been added: 
Greenland S, Robins JM. Estimation of common effect parameter from sparse follow up 
data. Biometrics 1985;41:55-68. 
Ratitch, B., Lipkovich, I., O’Kelly, M. Combining Analysis Results from Mutiply Imputed 
Categorical Data, PharmaSUG, 2013, SP03 
13.2 
Amendment 2 
Rationale of the Amendment 
The main purpose of this amendment is to prespecify sensitivity and supportive analyses to 
assess the impact of the COVID-19 pandemic on the statistical analyses methods. 
Global Changes 
Typographical errors were corrected and formatting was amended throughout the document. 
 
Specific Changes 
Change #1 
List of abbreviations 
The following abbreviations have been added: 
COVID-19 
Coronavirus Disease 2019 
CV-CAC 
Cardiovascular Clinical Event Adjudication Committee 
 
Change #2 
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3.4 Protocol deviations 
The following paragraph is added: 
Deviations related to the Coronavirus Disease 2019 (COVID-19) global pandemic are 
unavoidable deviations from the protocol due to confirmed COVID-19 infection, suspected 
COVID-19 infection, general circumstances around COVID-19 without infection or any 
other deviation from the protocol due to COVID-19. COVID-19 protocol deviations will 
also be reviewed separately as part of the ongoing data cleaning process. 
 
Change #3 
The following section has been added: 
3.10.1 Changes related to COVID-19 
 
Change #4 
4.2.1.2 Handling missing data for the secondary efficacy variables 
The following paragraph has been added: 
Additional methods for handling missing data to assess the impact of the COVID-19 global 
pandemic on planned statistical analyses are detailed in Section 4.2.1.7. 
 
Change #5 
Table 4-1 Missing data handling approach by variable priority and type 
The following footnote has been added: 
Note: Additional missing data handling approaches are detailed in Section 4.2.1.7 for 
assessing the impact of COVID-19 on the secondary efficacy variable PASI100 response at 
Week 48. 
 
Change #6 
The following section has been added: 
4.2.1.7 Missing data methods for  assessing impact of COVID-19 
 
Change #7 
4.8 Examination of subgroups 
The following paragraph has been added: 
Additional subgroup analyses are described in Section 4.2.1.7.2 to assess the impact of the 
COVID-19 pandemic on planned statistical analysis of PASI100 response at Week 48. 
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Change #8 
5.2 Protocol deviations 
The following paragraphs have been added: 
A summary of number and percentage of subjects with COVID-19 protocol deviations by 
treatment group and visit will be provided for the MS and OLS. This summary will also be 
repeated by country (see Section 2.3.5 for list of countries). 
A by-site, subject and visit listing of COVID-19 protocol deviations will be provided. 
 
Change #9 
8.2.3 Sensitivity analyses of the secondary efficacy variables 
The following sentence has been added: 
In addition, for PASI100 response at Week 48, the sensitivity analyses described in Section 
4.2.1.7 will be performed. 
 
Change #10 
8.3.2 IGA response 
The following text has been updated: 
• IGA response (Clear) is defined when IGA score is zero (Table 8‒1) with at least a two-
category improvement from Baseline at visit time point. 
To clarify as follows: 
• IGA response (Clear) is defined when IGA score is clear [0] (Table 8‒1) with at least a two-
category improvement from Baseline at visit time point. 
 
Change #11 
8.3.8 Symptoms of PSO (Itch, pain, and scaling) 
The following sentence has been deleted: 
The 3 threshold scores for itch, pain and scaling will be determined prior to unblinding of the 
data. 
The following paragraph has been added: 
The PS0009 and PS0013 analyses determined a 4-point reduction as a marked within-
subject clinically meaningful improvement in the weekly score each of these 3 PSD items 
that can be used to define different marked response to treatment over 16 weeks in patients 
with moderate-to-severe plaque psoriasis. Such a threshold has also been used to support 
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US label claims of other compounds approved in the same indication based on different 
PSO symptom diaries using an 11-point numeric response scale and was suggested in 
previous interactions with the FDA. Thus a 4-point threshold is proposed in the current 
study. Analyses to determine threshold for within-subject clinically meaningful 
improvement based on blinded PS0015 data are ongoing. In case the results differ from the 
4-point threshold, sensitivity analyses with the determined thresholds may be conducted. 
 
Change #12 
10.1 Extent of exposure 
The following text was updated: 
Summaries for exposure will be provided. This consists of a descriptive summary of study 
medication duration in days. In addition, total study medication duration and time at risk will be 
summarized in years by treatment group 
The cumulative study medication duration will be summarized for subjects exposed for given 
durations of time, the following categories for duration will be used: 
• >0 weeks 
• >=16 weeks 
• >=24 weeks 
• >=48 weeks 
For the final analysis (not the interim), an additional table will be created for the BKZ set with 
the above categories plus the below categories. A bimekizumab total column will be displayed 
only. 
To clarify as follows: 
Summaries for exposure will be provided for the SS, MS and BKZ set. These consist of a 
descriptive summary of study medication duration in days. In addition, total study medication 
duration and time at risk will be summarized in years by treatment group 
The cumulative study medication duration will be summarized for the SS for subjects exposed 
for given durations of time, the following categories for duration will be used: 
• >0 weeks 
• >=16 weeks 
• >=24 weeks 
• >=48 weeks 
For the final analysis (not the interim), the table will also be created for the BKZ set and will 
include the above categories plus the below categories. A bimekizumab total column will be 
displayed only. 
 
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Change #13 
The following section has been added: 
10.2.1.1 COVID-19 related data considerations 
 
Change #14 
10.2.2 AE summaries 
The following section has been added: 
For subjects who discontinue on or prior to the final scheduled visit of the Initial 
Treatment Period, any AEs that emerged more than after 112 days relative to the first dose 
but still within the 140 days SFU window will be classified as TEAE. However these AEs 
will be excluded from AE summaries based on the Initial Period but included in the AE 
summaries for Initial and Maintenance Treatment Period. See the description of time at 
risk in Section 10.1.1 for further details. 
 
Change #15 
10.2.2 AE summaries 
The following text was updated: 
• Incidence of Related TEAEs Above Reporting Threshold of 5% by SOC and PT 
To clarify as follows: 
• Incidence of Related TEAEs Above Reporting Threshold of 5% with Risk Differences by 
SOC and PT 
 
Change #16 
10.2.2 AE summaries 
The following text was updated: 
The following summary will be provided by treatment for the Initial and Maintenance Treatment 
Period (combined) for the SS (only subjects treated with BKZ): 
To clarify as follows: 
The following summary will be provided by treatment for the Initial and Maintenance Treatment 
Period (combined) for the SS (only subjects treated with BKZ, only Total BKZ will be 
summarized): 
 
Change #17 
10.2.2 AE summaries 
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The text has been added: 
• Incidence of TEAEs per 100 subject years by SOC, HLT, and PT and by Time of Onset 
Relative to COVID-19 pandemic (prior to COVID-19 pandemic, during COVID-19 
pandemic) 
 
Change #18 
The terminology in the following section has been updated: 
10.2.3.3 Major adverse Cardiac Events 
• • 
Incidence of Major Adverse Cardiac Event (MACE) TEAEs per 100 subject years by 
SOC, HLT and PT 
Adjudicated MACE will be presented in a table. The classification of an event as MACE is 
determined by an  external cardiovascular event adjudication committee. 
Extended MACE events will be presented in a separate table and listing. All events which are 
classified by the adjudication committee as any of the following events types will be considered 
an extended MACE event. 
… 
Additionally, a listing of all events identified for potential review by the cardiovascular event 
adjudication committee will be produced. This listing will indicate whether each event was 
escalated to the committee for formal review/adjudication. 
As follows: 
10.2.3.3 Cardiac events 
• Incidence of Major Adverse Cardiac Event (MACE) TEAEs per 100 subject years by SOC, 
HLT and PT 
Adjudicated MACE will be presented in a table. The classification of an event as MACE is 
determined by the external Cardiovascular Clinical Event Adjudication Committee (CV-
CAC). 
Extended MACE events will be presented in a separate table and listing. All events which are 
classified by the CV-CAC as any of the following events types will be considered an extended 
MACE event. 
… 
Additionally, a listing of all events identified for potential review by the CV-CAC will be 
produced. This listing will indicate whether each event was escalated to the committee for formal 
review/adjudication. 
 
Change #19 
10.3 Clinical laboratory evaluations 
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The following paragraph has been added: 
A figure of neutrophil values over time for subjects with at least one markedly abnormal 
neutrophil value (CTCAE Grade 3 or 4) will also be presented. 
 
Change #20 
10.3 Clinical laboratory evaluations 
The following paragraph has been added: 
Spaghetti plots of AST values over time for the subset of subjects with at least one 
markedly abnormal AST value (CTCAE Grade 3 or 4) will also be presented. A similar set 
of plots will be produced for ALT values over time for the subset of subjects with at least 
one markedly abnormal ALT value (CTCAE Grade 3 or 4). 
 
Change #21 
10.4.4.5 Patient Health Questionnaire 9 (PHQ-9) 
The following paragraph has been added: 
The number and percentage of subjects with a PHQ-9 score ≥ 15 at any point while on 
treatment and the number and percentage of subjects with a PHQ-9 score ≥ 20 at any point 
while on treatment will also be presented based on observed case data. 
 
 
 
13.3 
Amendment 3 
Rationale of the Amendment 
The main purposes of this amendment are as follows: 
• To add Section 8.4 which was accidentally omitted in Amendment 2 
• To align the SAP with protocol amendment 5 
• To include details of the Week 96 Interim analysis  
• To describe the requirements for the Open-Label Extension period 
• To update the impact due to the COVID-19 pandemic. 
General Changes 
Text has been added in several sections to indicate which variables will be produced for the 
OLE. 
 
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In addition, some texts that were accidentally omitted in previous amendment were put back (see 
Section 8.4). 
 
Change #1 
List of Abbreviations  
Maintenance Set abbreviation (MS) has been added 
 
Change #2 
Section 2.3.2.4 OLE period 
The following has been changed 
From 
At Week 96, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
subject’s dosing interval will change from 320mg Q4W to 320mg Q8W (default), unless, based 
on medical judgment, the Investigator decides differently. 
To 
From Week 64 the subjects who are receiving bimekizumab 320mg Q4W at the time of 
implementation of protocol amendment 5.0 will have their dosing interval changed to 
bimekizumab 320mg Q8W at the next clinical site assessment as described on Table 7‒2 for 
subjects who are receiving bimekizumab 320mg Q4W and have reached Week 96 prior to the 
implementation of Protocol Amendment 5.0, if PASI90 is achieved, the subject’s dosing interval 
will change from 320mg Q4W to 320mg Q8W (default), unless, based on medical judgment, the 
Investigator decides differently.  Otherwise if PASI90 is not achieved they will have their dosing 
interval changed to bimekizumab 320mg Q8W at the next clinical site assessment after 
implementation of protocol amendment 5.0 as detailed above. 
 
Change #3 
Section 3.2 Definition of Baseline value 
The following texts (in bold) have been added 
Unless specified otherwise, the process laid out above will always be followed to determine 
Baseline. An additional Baseline value for the OLE Period will be defined for anti-
bimekizumab antibodies for subjects initially randomized to secukinumab and for selected 
summaries of laboratory evaluations. This baseline for the OLE Period is the latest measurement 
on/prior to the day of first dose in the OLE Period for subjects switching from secukinumab to 
bimekizumab. 
Change #4 
Section 3.6 Open-Label Set 
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The following texts (in bold) have been added to describe the treatment groups in the Open-
Label Extension period  
 
The following treatment sequences will be used to summarize efficacy data and specific 
safety data related to laboratory, ECG, PHQ-9, eC-SSRS, and vital signs assessments: 
• Subjects receiving bimekizumab in the double-blind treatment period: 
− Initiating OLE on bimekizumab Q8W 
− Initiating OLE on bimekizumab Q4W 
• Subjects receiving secukinumab in the double-blind treatment period 
− Initiating OLE on bimekizumab Q8W 
− Initiating OLE on bimekizumab Q4W 
• All Subjects 
Adverse event data (including for a subgroup of subjects who switched from Q4W to Q8W 
during OLE period) and study compliance data will be summarized in 2 treatment groups 
based on the dose most recently received prior to the date of the event or assessment  
• Bimekizumab 320mg Q8W 
• Bimekizumab 320mg Q4W 
• Bimekizumab Total 
In addition, the following key efficacy variables: 
•  PASI90 response  
•  PASI100 response  
•  IGA Clear or Almost Clear (with at least a 2-category improvement from Baseline) 
•  IGA Clear (with at least a 2-category improvement from Baseline)  
will be summarized for the Open-Label Extension treatment period by the following 
randomized treatment sequences: 
• Bimekizumab Q4W/Q8W/Q4W for non-responder at Week 48 (<PASI90) 
• Bimekizumab Q4W/Q4W/Q4W for non-responder at Week 48 (<PASI90) 
• Secukinumab / Bimekizumab Q4W for non-responder at Week 48 (<PASI90)  
• Bimekizumab Q4W/Q8W/Q8W for responder at Week 48 (>=PASI90) 
• Bimekizumab Q4W/Q4W/Q8W for responder at Week 48 (>=PASI90) 
• Bimekizumab Q4W/Q4W/Q4W for responder at Week 48 (>=PASI90) 
• Secukinumab / Bimekizumab Q8W for responder at Week 48 (>=PASI90) 
• Secukinumab / Bimekizumab Q4W for responder at Week 48 (>=PASI90) 
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Change #5 
Section 3.10.1 Change related to COVID-19 
The following have been added due to the COVID-19 pandemic: 
The following changes have been introduced due to the COVID-19 pandemic: 
• COVID-19 protocol deviations have been defined in Section 3.4 and the presentation of 
COVID-19 protocol deviations is described in Section 5.2 
• COVID-19 impact on study visits has been assessed and are described in Section 5.1 
• COVID-19 Disposition assessments are described in Section 5.1  
Missing data methods for assessing the impact of COVID-19 are described in Section 4.2.1.7 
Data considerations for assessing the impact of COVID-19 on TEAEs are described in 
Section 10.2.1.1 and the associated analysis is described in Section 10.2.2 
 
Change #6 
Section 4.2.1.6 Missing data algorithm – MI – MCMC / Monotone Regression 
Maintenance Set: When programming multiple imputation based on the MS, PROC MI will be 
used with a separate data set for each of the 3 Maintenance Period treatment groups 
(bimekizumab 320mg Q8W, bimekizumab 320mg Q4W, secukinumab) including all scheduled 
assessment visits from Baseline to Week 56. 
Was changed to 
Maintenance Set: When programming multiple imputation based on the MS, PROC MI will be 
used with a separate data set for each of the 3 Maintenance Period treatment groups 
(bimekizumab 320mg Q8W, bimekizumab 320mg Q4W, secukinumab) including all scheduled 
assessment visits from Baseline to Week 48. 
 
Change #7   
Section 4.2.1.7 Missing data methods for assessing impact of COVID-19 
The following text in bold were added for clarifications 
If the PASI assessment at Week 48 is conducted by video call or telephone, this will be treated as 
missing since the validity and exchangeability of these assessment modalities has not been 
established. This will be determined according to collection of COVID-19 protocol deviations 
(including COVID-19 impact assessment) (see Section 3.4 for further details). 
 
Change #8   
Section 4.2.1.7.3 Approach to assess the impact of out of window assessments due to COVID-19 
The following clarification (in bold) for the approach to assess the impact of out of window 
assessments due to COVID-19 has been corrected 
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• Date of first dose of study drug + 315 days > Week 48 PASI assessment date or Week 48 
PASI assessment date > date of first dose of study drug + 357 days 
 
Change #9 
Section 4.2.2 Handling missing data for safety variables 
The following clarification (in bold) have been added to address the imputation method for 
Partial AE and concomitant medication start dates: 
Partial or missing AE and concomitant medication start dates will be imputed as follows: 
Imputation of Partial or Missing Start Dates 
• If only the month and year are specified and the month and year of first dose is not the same 
as the month and year of the start date, then use the 1st of the month 
• If only the month and year are specified and the month and year of first dose is the same as 
the month and year of the start date, then use the date of first dose 
• If only the year is specified, and the year of first dose is not the same as the year of the start 
date, then use the 1st of January of the year of the start date 
• If only the year is specified, and the year of first dose is the same as the year of the start date, 
then use the date of first dose 
• If the start date is completely unknown and the stop date is unknown or not prior to the date 
of first dose, then use the date of first dose 
• If the start date is completely unknown and the stop date is prior to the date of first 
dose of IMP, then set the start date to the 1st of January of the year of the stop date. 
Imputation of Partial Stop Dates 
• If only the month and year are specified, then use the last day of the month 
• If only the year is specified, then use December 31st of that year 
• If the stop date is completely unknown, do not impute the stop date. 
If the stop date or imputed stop date is prior to the imputed start date: 
• If the year of imputed start date is the same as the year of first dose and the stop date is 
after the date of first dose, then set the start date to the date of first dose 
• If the month and year of imputed start date is the same as the year and month of the 
first dose and the same year and month of the stop date and the stop date is prior to the 
date of first dose then set the start date to the 1st of the month  
• Otherwise, set the start date to the 1st of January of the year of the start date. 
In the event of ambiguity or incomplete data which makes it impossible to determine whether a 
medication was concomitant, or an adverse event was treatment emergent, the medication will be 
considered as concomitant or the adverse event will be considered treatment emergent. 
Change #10 
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Section 4.3 Interim analyses and data monitoring 
The following text (in bold) has been added 
An additional data cut will occur approximately after the final Week 96 visit. An interim 
analysis will be performed for the Open-Label treatment period using this Week 96 data 
cut. Selected tables, figures and listings will be produced for this interim analysis as 
detailed in Section 12.3 (Appendix C). 
A final analysis will be conducted when all data for the double-blind and OLE period 
(including SFU) will be collected. 
An independent Data Monitoring Committee (DMC) will periodically review and monitor the 
safety data from the Double-blind treatment period this study and advise UCB. 
Cardiovascular, Inflammatory bowel disease (IBD), and Neuropsychiatric Adjudication 
Committees will also periodically review and monitor safety data from this study including 
Open-label Extension treatment period and advise UCB. Details will be provided in the DMC 
Charter and in the Adjudication Committee Charters. 
Further details related to the DMC will be outlined in a separate analysis plan. 
 
Change #11 
Section 4.8 Examination of subgroups 
The following bullet points (in bold) have been added 
In addition, in order to assess whether an early response to treatment is predictive of response at 
later time points, subgroup analyses will be performed for the RS on PASI90/100 and IGA over 
time using the following early response subgroups: 
• PASI75 response (OC) at Week 4 (yes, no) to predict PASI90/100 and IGA (clear or almost 
clear) (NRI) through Week 48 
• PASI90 response (OC) at Week 16 (yes, no) to predict PASI100 (NRI) through Week 48 
• PASI90 response (OC) at Week 48 (yes, no) to predict PASI90 (NRI) during the OLE 
based on OLS 
• PASI90 response (OC) at Week 48 (yes, no) to predict PASI100 (NRI) during the OLE 
based on OLS 
• PASI90 response (OC) at Week 48 (yes, no) to predict IGA responder rates (clear) and 
IGA responder (clear or almost clear) during the OLE based on OLS. 
 
Change #12 
Section 5.1 Subject disposition 
The following texts (in bold) have been added to specify COVID-19 impact categories 
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The following listings for subject disposition will be provided: subjects who did not meet study 
eligibility criteria (all subjects screened), subject disposition (all subjects screened), study 
discontinuation (for RS), visit dates (for RS), subjects excluded from efficacy analysis (RS).  
Summaries of visits at which subjects initiated the switch from bimekizumab 320mg Q4W 
to bimekizumab 320mg Q8W dosing interval in Open-Label Extension period will be 
presented. 
In addition, the following COVID-19 impact categories will be summarized by country and 
visit for the MS and OLS  (see Section 2.3.5 for list of countries).  
• Visit not done  
• Visit performed out of window 
• Home Visit 
• Visit performed by video call 
• Visit performed by telephone 
• Investigational product shipped to study participant 
• Participant Home administration of investigational product by participant or caregiver 
• Home administration of investigational product by a healthcare professional 
• Missed study drug administration/dispensation 
• Temporary discontinuation of study drug 
• Permanent discontinuation of study drug 
• Termination of study participation 
• Other 
Note that home administration was permitted at certain visits (see Table 7-2) and only 
home administration that was not per the protocol should be captured.  
A by-subject listing of COVID-19 impact categories will be provided 
 
Change #13 
Section 6.4 Prior and concomitant medication 
The following texts (in bold) have been added 
Medication start and stop dates will be compared to the date of first dose of treatment to allow 
medications to be classified as either Prior or Concomitant. 
Details of imputation methods for missing or partial dates are described in Section 4.2.1.7. 
Prior medications include any medications that started prior to the start date of study medication. 
Concomitant medications are medications taken at least one day in common with the study 
medication dosing period (defined as from first dose of study medication [including placebo] 
up to last dose of study medication + 28 days for the double-blind treatment period, and 
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+28 days or +56 for Q4W and Q8W dosing respectively in the OLE period). Concomitant 
medications will be summarized separately for the double-blind Treatment Period (SS) and the 
OLE period (OLS). 
By-subject listings of all Prior and Concomitant medications (including COVID-19 
concomitant medications), prior and concomitant medications glossary, and psoriasis treatment 
history will be  
provided. 
A separate listing will be produced to present viral vaccines (ATC Level 3). 
 
Change #14 
Section 7 MEASUREMENTS OF TREATMENT COMPLIANCE 
The following footnotes have been added to the table 7 -2 
a The subject’s dosing interval will change from Q4W to Q8W at Week 64 or at the next 
scheduled clinic visit after implementation of Protocol Amendment 5.2   if the subject has 
already completed the Week 64 visit. 
 b Subjects whose dosing interval is changed to Q8W should be dosed at this visit and will 
receive kits for home administration 8 weeks later. 
c Subjects whose dosing interval is changed to Q8W should NOT be dosed at this visit and 
will receive kits for home administration 4 weeks later 
 
Change #15 
Section 8.3.2 IGA response 
The following texts (in bold) have been added 
IGA response rate, Scalp IGA response rate, and Palmoplantar IGA response rate will be 
summarized for RS by treatment group and for OLS by treatment sequence and visit. 
 
Change #16 
Section 8.3.5 Dermatology Life Quality Index (DLQI) 
The following texts have been added 
The DLQI related efficacy variables will be summarized for the double-blind treatment 
visits separately for the RS and MS and for OLS by treatment sequence and visit. 
 
Change #17 
Section 8.3.6  Patient’s Global Assessment of Disease Activity (PGADA) for arthritis visual 
analog scale (VAS) 
The following texts (in bold) have been added 
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The absolute and change from baseline in PGADA will be summarized for the double-blind 
treatment visits separately for the RS and MS and OLS by treatment sequence and visit 
 
Change #18 
Section 8.3.7 Patient Global Assessment of PSO 
The following sentence (in bold) has been added 
The absolute value and shift from baseline in Patient Global Assessment (PGA) of PSO 
score will be summarized for each study period (Initial randomized, Maintenance) by 
treatment group and for OLE by treatment sequence and visit 
 
Change #19 
Section 8.3.8 Symptoms of PSO (Itch, pain, and scaling) 
The following sentence (in bold) has been added 
Absolute and percent changes from Baseline PSD item scores for each item will be summarized 
for each study period (Initial randomized, Maintenance) by treatment group  
PSD response and the proportion of subjects with score of 0 (or 0/1) will be summarized for 
OLE Treatment Period by treatment sequence and visit. 
The PS0009 and PS0013 analyses determined a 4-point reduction as a marked within-subject 
clinically meaningful improvement in the weekly score each of these 3 PSD items that can be 
used to define different marked response to treatment over 16 weeks in patients with moderate-
to-severe plaque psoriasis. Such a threshold has also been used to support US label claims of 
other compounds approved in the same indication based on different PSO symptom diaries using 
an 11-point numeric response scale and was suggested in previous interactions with the FDA. 
Analyses conducted on blinded PS0015 data support the 4-point threshold as indicative of 
marked within-subject clinically meaningful improvement that can be used for responder 
definition. 
Cumulative distribution plots will also be provided for absolute change from Baseline PSD at 
Week 16 and Week 48 for each item 
 
Change #20 
Section 8.3.9 Modified Nail Psoriasis Severity Index (mNAPSI) score 
The following sentence has been added 
An mNAPSI75 responder is defined as a subject who achieved at least a 75% improvement from 
Baseline in the mNAPSI score. mNAPSI90 and mNAPSI100 are defined accordingly. The 
proportion of mNAPSI75/90/100 responders for subjects with nail PSO at Baseline over time 
will be summarized for each study period (Initial randomized, Maintenance) by treatment 
group and OLE by treatment sequence. 
 
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Change #21 
Section8.3.10 Psoriatic Arthritis Screening and Evaluation (PASE) 
The following sentence has been added 
Change from Baseline in the PASE and Shift from Baseline in PASE will be summarized 
for each study period (Initial randomized, Maintenance) by treatment group and for OLE 
by treatment sequence and visit. 
 
Change #22 
Section 8.3.11 Euro-Quality of Life 5-Dimensions, 3 levels (EQ-5D-3L) 
The following sentence (in bold) has been added 
Responses to EQ-5D-3L will be summarized for each study period (Initial randomized, 
Maintenance) by treatment group and summarized for each study period (Initial randomized, 
Maintenance) by treatment group and for OLE by treatment sequence and visit. The 
analysis will be based on OC only as primary analysis. No imputation is applied to responses to 
EQ-5D-3L but is applied to EQ-5D-3L VAS scores. 
 
Change #23 
Section 8.3.12 Work Productivity and Activity Impairment Questionnaire – Specific Health 
Problem (WPAI-SHP) 
The following sentence has been added 
The Change from Baseline in WPAI-SHP will be summarized for each study period (Initial 
randomized, Maintenance) by treatment group and for OLE by treatment sequence at each 
visit. 
 
Change #24 
Section 8.4Additional Statistical Analysis of other Efficacy Variables 
Due to a typographical error, Section 8.4 of the SAP (Additional statistical analysis of other 
efficacy variables) was removed from the body of the SAP. However, the analyses were 
described in Section 13.1 of the SAP (Amendment 1) and were performed as described. In 
addition nominal p-values were also produced for IGA 0 response and absolute PASI score 
≤5, ≤3, ≤2, and ≤1. This change is to indicate that the Section has been put back in the SAP 
amendment 3. 
 
Change #25 
Section 9 Pharmacokinetics and Pharmacodynamics 
The following text has been added:  
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• Subjects receiving bimekizumab in the double-blind treatment period and completing 
the OLE period: 
− Bimekizumab Q4W/Q8W/Q8W 
− Bimekizumab Q4W/Q4W/Q4W (subjects in this group will switch to Q8W per 
protocol amendment 5 from Week 64 or the next scheduled clinic visit after 
implementation of Protocol Amendment #5 if the subject has already completed 
Week 64) 
− All other treatment sequences (this includes the treatment sequences 
Q4W/Q8W/Q4W, Q4W/Q4W/Q8W) 
• Subjects receiving bimekizumab in the double-blind treatment period and not 
completing the OLE period (subjects that discontinued at any visit prior to Week 144) 
• Subjects receiving secukinumab in the double-blind treatment period and completing 
the OLE period: 
− Secukinumab/Bimekizumab Q8W 
− Secukinumab/Bimekizumab Q4W  (subjects will switch to Q8W per protocol 
amendment 5 from Week 64 or the next scheduled clinic visit after implementation 
of Protocol Amendment #5 if the subject has already completed Week 64 or the next 
scheduled clinic visit after implementation of Protocol Amendment #5 if the subject 
has already completed Week 64) 
• Subjects receiving secukinumab in the double-blind treatment period and not 
completing the OLE period (subjects that discontinued at any visit prior to Week 144)  
 
Change #26 
Section 9.1 Pharmacokinetics 
The following text has been amended: 
From 
If the PK sampling date is >1 day after the dosing date data points will be excluded from the PK 
summary tables and figures, but not from the listing. 
To 
If the PK sampling date is >1 day after the dosing date, the plasma concentration at this visit will 
be excluded from the PK summary tables and figures, but not from the listing. 
 
And the following texts have been added  
If a subject misses an administration of bimekizumab, then the plasma concentration from 
all subsequent scheduled visits will be excluded from PK summary tables and graphs. 
PK and ADAb will be summarized by treatment sequence and by visit for Initial, 
Maintenance, and Open-Label Extension treatment period combined: 
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All PK concentration data will be listed. 
 
Change 27 
Section 9.3.2  Anti-bimekizumab antibodies 
The following texts (in bold) have been added 
• Spaghetti plots of ADAb titer (y-axis) by visit (x-axis), separated by treatment sequence (as 
specified above) for all anti-bimekizumab antibody positive subjects, including Baseline 
positive subjects. 
NAb data will not be summarized for the interim analysis. It may be summarized in the final 
CSR or subsequent to the final CSR, based on the team’s decision. If these data are reported, a 
table and listing will be prepared. 
These data will be summarized by the same sub-group of subjects and treatment sequence as for 
ADAb titer data 
 
Change #28 
Section 10.1.4.2  For subjects who switch from bimekizumab 320mg Q4W to Q8W during 
Open-Label Extension Period 
The following texts (in bold) have been added. 
Following Protocol Amendment 5.0, subjects should switch to Q8W during the Open-Label 
extension period. (see Section 2.3.2.4 for further details). 
 
Change #29 
Section 10.1.5.2  For subjects who switch dose 
The following texts (in bold) have been added. 
Subjects can switch bimekizumab 320mg dose schedule up to three times during the Double-
blind and Open-Label Extension Period. Switches can occur at Week 16, Week 48, and Week 96  
or at specific visit during the OLE following amendment 5.0. See Section 2.3.2 for further 
details regarding switching. 
 
Change #30 
Section 10.2 Adverse Events 
The following texts in (bold) have been added 
• Events that fulfill the anaphylaxis criteria for acute events 
• Events that fulfill the hypersensitivity criteria 
• Events with an HLT of “Administration site reactions NEC” 
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• Events with an HLT of “Injection site reactions” 
For results disclosure on public registries (eg, ClinicalTrials.gov), treatment-emergent 
adverse events and treatment-emergent serious adverse events will be published. 
 
Change #31 
Section 10.2.1.1 COVID-19 related data considerations 
The following texts (in bold) have been added 
In order to assess the impact of the COVID-19 global pandemic on TEAEs, an additional AE 
summary based on the BKZ set will be presented for the combined Initial, Maintenance and 
OLE periods. The following data considerations are introduced to support this presentation by 
the following periods: 
• Prior to COVID-19 pandemic 
• During COVID-19 pandemic 
The COVID-19 pandemic start date is defined as 11 March 2020 as it is the date the World 
Health Organization declared COVID-19 as a pandemic, see also Section 4.2.1.7.2. Note that the 
Week 48 and Week 96 interim analyses will be conducted during the pandemic therefore a post 
COVID-19 pandemic period is not defined for these analyses. If WHO declares the COVID-
19 pandemic has ended prior to the final analysis, then that date may be used to support 
presentation of a post COVID-19 pandemic period. 
Incidence of COVID-19 TEAEs will be summarized for the OLE treatment periods based 
on the OLS by treatment group. 
The following PTs will be used to classify COVID-19 adverse events: 
• Coronavirus infection 
• Coronavirus test positive  
A separate by-subject listing will be produced for COVID-19 TEAEs. 
 
Change #32 
Section 10.2.2 AE summaries 
The following sentences have been added 
The tables with risk differences will also be accompanied by figures (dot plots) which show the 
incidence of the adverse events and corresponding 95% risk difference confidence intervals. 
These will be ordered by descending order of risk difference (bimekizumab vs secukinumab). 
The following selected AEs summaries will be provided for the Open-Label Extension 
Period only and by treatment at time of AE onset and will be based on the OLS: 
• Incidence of COVID-19 TEAEs 
• Incidence of TEAEs Overview 
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• Incidence of TEAEs per 100 Subject-Years 
• Incidence of Serious TEAEs per 100 Subject-Years 
• Incidence of TEAEs Leading to Discontinuation per 100 subject-years 
• Incidence of TEAEs Leading to Death 
• Incidence of Non-Serious TEAEs Above Reporting Threshold of 5% by SOC and PT 
• Incidence of Non-Serious TEAEs Above Reporting Threshold of 5% by Relationship 
SOC and PT 
The following summaries will be provided for the BKZ Set by treatment at the time of AE onset. 
These tables will include AEs from both the double-blind and Open-Label treatment period. AEs 
that occurred while subjects received secukinumab will not be included. 
• Incidence of TEAEs Overview 
• Incidence of TEAEs per 100 Subject-Years 
• Incidence of Serious TEAEs per 100 Subject-Years 
In addition, all summaries of TEAEs based on “100 subject years” will include EAIR (with 95% 
CI) and EAER. 
The following summaries will be presented for subjects who switched from secukinumab to 
bimekizumab at Week 48. The analyses will assign AEs according to the AE onset date 
relative to last secukinumab dose and accounting for approximately 5 times half-life (Onset 
≤ 140 days from last secukinumab dose or Onset > 140 days from last secukinumab dose): 
• Incidence of TEAEs Overview 
• Incidence of TEAEs per 100 Subject-Years 
• Incidence of Serious TEAEs per 100 Subject-Years 
 
Change #33 
Section 10.2.3 Other Safety topic of interest 
The following texts (in bold) have been added 
The following summaries for AEs of other safety topics of interest will be provided by actual 
Treatment at the time of the adverse event. The following outputs will be produced for the SS for 
the initial treatment period, for the SS for the Initial and Maintenance Treatment Period, and for 
the OLS for the Open-Label Extension Period by treatment group (see section 3.6).  
Similar outputs for hypersensitivity events and hepatic events will also be produced for the 
Maintenance Treatment Period for the MS.  
Additional analyses will be presented for subjects who switched from secukinumab to 
bimekizumab at Week 48 and the AEs will be assigned according to the onset date relative 
to last secukinumab dose and accounting for approximately 5 times half-life (Onset ≤ 140 
days from last secukinumab dose or Onset > 140 days from last secukinumab dose). 
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Along with the tables described, there will be tables which displays the risk difference and 95% 
confidence intervals for each of the topics of interest during the Initial Treatment Period (SS) as 
well as for Initial and Maintenance Treatment Period combined (SS). Corresponding figures 
(with dot plots) will be prepared. 
 
Change #34 
Section 10.2.3.6 Inflammatory bowel disease 
The following has been added 
An external inflammatory bowel disease (IBD) adjudication committee will evaluate 
potential IBD events and will classify each one as follows: 
• Event Type Code 1: Possible IBD – Crohn’s Disease 
• Event Type Code 2: Probable IBD – Crohn’s Disease 
• Event Type Code 3: Definite IBD – Crohn’s Disease 
• Event Type Code 4: Possible IBD – Ulcerative Colitis 
• Event Type Code 5: Probable IBD – Ulcerative Colitis 
• Event Type Code 6: Definite IBD – Ulcerative Colitis 
• Event Type Code 7: Possible IBD – Unclassified 
• Event Type Code 8: Probable IBD – Unclassified 
• Event Type Code 9: Definite IBD – Unclassified 
• Event Type Code 10: Symptoms not consistent with IBD 
• Event Type Code 11: Possible Inflammatory Bowel Disease – Microscopic Colitis 
• Event Type Code 12: Probable Inflammatory Bowel Disease – Microscopic Colitis 
• Event Type Code 13: Definite Inflammatory Bowel Disease – Microscopic Colitis 
• Event Type Code 14: Possible Inflammatory Bowel Disease – no further differentiation 
possible 
• Event Type Code 15: Probable Inflammatory Bowel Disease – no further differentiation 
possible 
• Event Type Code 16: Definite Inflammatory Bowel Disease – no further differentiation 
possible 
• Event Type Code 99: Not enough information to adjudicate 
A table for adjudicated definite IBD events (event type codes 3, 6, 9, 13, and 16) as 
determined by the adjudication committee will be produced. This table will be produced 
overall, as well as stratified by subjects with or without a previous medical history of IBD. 
Previous medical history of IBD will be determined using the information recorded on the 
Extra-Articular Assessment at Screening CRF page. 
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A table for adjudicated probable IBD events (event type codes 2, 5, 8, 12, and 15) as 
determined by the adjudication committee will be produced. This table will be produced 
overall, as well as stratified by subjects with or without a previous medical history of IBD. 
A table for adjudicated possible IBD events (event type codes 1, 4, 7, 11, and 14) as 
determined by the adjudication committee will be produced. This table will be produced 
overall, as well as stratified by subjects with or without a previous medical history of IBD. 
A listing of all events identified for potential review by the IBD adjudication committee will 
be produced. This listing will indicate whether each event was escalated to the committee 
for formal review/adjudication.  
A separate table and listing will present the adjudicated IBD events by type. For each IBD 
event type (event type codes 1 through 16 and 99; 17 total), the individual PTs which fall 
within each event type will be summarized.  
A third listing will present the individual diagnostic criteria met for each adjudicated IBD 
event. 
 
Change #35 
Section 10.3 Clinical laboratory evaluations 
The following Laboratory analytes have been added in Table 10-2 
Total Cholesterol 
HDL Cholesterol 
LDL Cholesterol 
Triglycerides 
Table 13‒4: Definitions of Markedly Abnormal Biochemistry Values 
 
Parameter name 
Conventional 
Standard 
Abnormal 
Designation 
Unit 
Criteria 
Unit 
Criteria 
Creatinine 
mg/dL 
>3.0 x ULN 
mmol/L 
>3.0 x ULN 
AH 
Glucose 
mg/dL 
<40 
>250 
mmol/L 
<1.7 
>13.9 
AL 
AH 
Calcium 
mg/dL 
>12.5 
<7.0 
mmol/L 
>3.1 
<1.75 
AH 
AL 
Magnesium 
mg/dL 
>3.0 
<0.9 
mmol/L 
>1.23 
<0.4 
AH 
AL 
Potassium 
mmol/L 
>6.0 
<3.0 
mmol/L 
>6.0 
<3.0 
AH 
AL 
Sodium 
mmol/L 
>155 
<130 
mmol/L 
>155 
<130 
AH 
AL 
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Table 13‒4: Definitions of Markedly Abnormal Biochemistry Values 
 
Parameter name 
Conventional 
Standard 
Abnormal 
Designation 
Unit 
Criteria 
Unit 
Criteria 
Total Cholesterol 
mg/dL 
>400 
mmol/L 
>10.34 
AH 
HDL Cholesterol 
mg/dL 
<40 
mmol/L 
< 1.04  
AL 
LDL Cholesterol 
mg/dL 
≥190  
mmol/L 
≥ 4.90 
AH 
Triglycerides 
mg/dL 
>500 
mmol/L 
> 5.7  
AH 
 
Change #36 
Section 10.1.4.1 Vital signs 
The following texts (in bold) have been added 
The following vital signs variables should be summarized: systolic blood pressure (mmHg), 
diastolic blood pressure (mmHg), body temperature (°C) and heart rate (beats/min). The 
following summary will be provided for the Initial Treatment Period (SS) for Initial and 
Maintenance Treatment Period, and for the Open-Label Extension Period (OLS) 
 
Change #37 
Section 10.4.3 Electrocardiograms 
The following texts (in bold) have been added  
ECG data will be analyzed by treatment group and visit for the Initial Treatment Period (SS), 
the Initial and Maintenance Treatment Period (SS), and by treatment sequence for the 
Open-Label Extension Period (OLS). 
 
Change #38 
Section 10.4.4.2 Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) 
The following texts (in bold) have been added  
The incidence of subjects with suicidal ideation, suicidal behavior, suicidal ideation or behavior, 
and self-injurious behavior will be summarized by treatment group. For events that emerged 
after 112 days but still within the 140 days window, those events would be classified as 
treatment emergent, but will be excluded from the output based on the Initial Treatment Period. 
However, these events will be included in the summaries for Initial Treatment Period and 
Maintenance Treatment Period combined. Similar summaries will be presented for the Open-
Label Extension Period (OLS) by treatment sequence and visit. 
A by-subject listing of the eC-SSRS questionnaire data will be provided by treatment group. 
 
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Change #39 
Section 10.4.4.5 Patient Health Questionnaire 9 (PHQ-9) 
The following texts (in bold) has been added 
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring 
the severity of depression. The PHQ-9 scores for depression range from 0 to 27 with higher 
scores indicating worse state. A score of 5-9 is considered to be minimal symptoms of 
depression. A score of 10 to 14 is considered minor depression, dysthymia, or mild major 
depression. A score of 15 to 19 is considered to indicate moderately severe major depression, 
and a score ≥20 is considered to be severe major depression. If any of the 9 questions are 
missing, then the score is treated as missing. 
Change from Baseline in PHQ-9 is derived as post-Baseline score minus Baseline score and will 
be summarized by treatment group. 
Differently to other safety variables, PHQ-9 will be summarized using the MCMC/monotone 
regression approach described in section 8.1.3.1. A table for the SS through Week 48 will be 
produced. An additional table will be produced for the OLS by treatment sequence and 
visit. 
The number and percentage of subjects with a PHQ-9 score ≥ 15 at any point while on treatment 
and the number and percentage of subjects with a PHQ-9 score ≥ 20 at any point while on 
treatment will also be presented based on observed case data 
 
Change #40 
Section 12.2 Appendix B: Definition of CTCAE grades 
The following Laboratory analytes (in bold) have been added to Table 12-1 (see Change #34) 
Total Cholesterol has been added  
 
Change #41 
Section 12.3 has been added to describe Week 96 interim analysis 
12.3 Appendix C: Week 96 interim analysis  
An additional data cut will occur approximately after the final Week 96 visit, an interim 
analysis will be performed focused on the Open-Label extension treatment period. 
The currently anticipated date for the final Week 96 visit is 19 March 2021. The interim 
analyses will include: 
• Efficacy data through the Week 96 visit. 
• Safety data through 19 March 2021. 
Selected tables, figures and listings will be produced for this Week 96 interim analysis. 
Study population characteristics, demographics, other baseline characteristics and 
measurements of treatment compliance will be presented for the OLS. The following 
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efficacy variables will be presented for the Open-Label extension treatment period based 
on the  OLS, this will include presentations based on the subgroup of participants 
switching from secukinumab to bimekizumab: 
• PASI90 response 
• PASI100 response 
• IGA Clear or Almost Clear (with at least a 2-category improvement from Baseline) 
• IGA Clear (with at least a 2-category improvement from Baseline)  
• Scalp IGA Clear or Almost Clear (with at least 2 category improvement relative to 
Baseline)  
• Palmoplantar IGA Clear or Almost Clear (with at least a 2-category improvement from 
Baseline) 
• DLQI total score of 0 or 1  
• mNAPSI90, mNAPSI100  
• Absolute, change, and percent change from Baseline in PASI score 
• Absolute PASI scores of ≤1, ≤2, ≤3 
• Absolute and percent change from Baseline in BSA affected by PSO  
• Psoriasis BSA values of 0%, ≤1%, ≤3% 
• PSD response (itch, pain and scaling) 
• PSD 0 or 1 (itch, pain and scaling) 
• PSD 0 (itch, pain and scaling) 
The following safety variables will be presented for the Open-Label extension treatment 
period based on the OLS: 
• Extent of exposure 
• TEAEs including COVID-19 and safety topics of interest 
• Laboratory data focused on TEMA and CTCAE 
• e-CSSRS 
• PHQ-9 
• COVID-19 impact 
Selected analyses of TEAEs will be presented for the subgroup of participants switching 
from secukinumab to bimekizumab for the Open-Label extension treatment period based 
on the OLS. Selected analyses of TEAEs will also be presented for the BKZ Set by 
treatment at the time of AE onset. These tables will include AEs from both the double-blind 
and Open-Label treatment period. 
In addition, the following tables will be produced: 
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• Past psoriasis medication 
• Impact of COVID-19 and COVID-19 protocol deviations for Maintenance treatment 
period based on MS 
• Main analysis of PASI100 Responder Rates at Week 48 plus sensitivity analyses of this 
variable based on hybrid approach for assessing impact of COVID-19 
Laboratory data for lipid panel (Total Cholesterol, HDL Cholesterol, LDL Cholesterol, 
Triglycerides) for combined Initial Treatment Period and Maintenance Treatment 
period based on SS 
 
13.4 
Amendment 4 
Rationale of the Amendment 
The main purposes of this amendment are as follows: 
• To align the SAP with protocol amendment 5.4 and 5.5 
• To include details of the Week 144 analysis  
• To describe the requirements for the Open-Label Extension 2 period 
• To include the analysis related to the COVID-19 vaccine. 
 
General Changes 
Texts have been added in several sections to indicate which variables will be produced for the 
OLE2. 
 
Change #1 
List of Abbreviation 
The following abbreviations have been added: CV-CAC, pDILI, OLE2, and OLS2, SFU2 
 
Change #2 
Section 1 Introduction: the following text (in bold) have been added: 
This statistical analysis plan (SAP) defines the scope of statistical analyses and provides a 
detailed description of statistical methodology for the statistical analyses to support the final 
clinical study report. The SAP is based on the following study document: Protocol Amendment 
5.4 (US) 01 Oct 2021 and 5.5 (Canada), 08 Dec 2021 
 
Change #3  
Section 2.3.2: Study periods. The following texts in (bold) have been added: 
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This study will include 5 periods, a Screening Period (2 to 5 weeks), a double-blind Treatment 
Period (48 weeks; final dose at Week 44), an optional Open-Label extension (OLE) Period (96 
weeks, final dose at Week 136 for subjects receiving bimekizumab 320mg Q8W and at Week 
140 for subjects receiving bimekizumab 320mg Q4W), followedd by a safety follow-up (SFU) 
Period (20 weeks after the final dose of IMP). Eligible subjects from US and Canada sites 
who have completed the OLE Period (at Week 144), including subjects in the SFU period 
and subjects who have completed the SFU Period will have the option to roll over in the 48-
week Open-Label Extension 2 (OLE2) Period followed by a SFU Period (SFU2, 20 weeks 
after the final dose of IMP administered in the OLE2).  
The double-blind treatment Period will be separated into an Initial Treatment Period (16 weeks) 
and a Maintenance Treatment Period (32 weeks). The end of the study is defined as the date of 
the last visit of the last subject in the study. 
Subjects withdrawing early from the study will undergo the premature end of treatment (PEOT) 
Visit assessments and will enter the SFU Period. Following completion or early withdrawal 
from the OLE2 Period, subjects will undergo the SFU of the OLE2 Period (SFU2) and will 
return for the SFU2 Visit 20 weeks after the last dose of IMP administration. in the OLE2 
treatment period. 
The following study periods are defined for the classification by study period: 
• Screening Period: Prior to the date of first dose of study drug 
• Initial Treatment Period is defined as the time from the first study drug administration up to 
the start of the Maintenance Treatment Period 
• Maintenance Treatment Period starts with the first study drug administration at or after the 
Week 16 visit 
• Open-Label Extension Period starts with the first study drug administration at or after the 
Week 48 visit 
• SFU Period is 20 weeks after the final dose of IMP in the double-blind Treatment Period 
or Open-Label Extension Period 
• Open-Label Extension 2 Period starts with the first study drug administration at or 
after the Week 144 visit/OLE2 Baseline visit 
• SFU2 Period is 20 weeks after the final dose of IMP in the OLE2  
The Open-Label Treatment Period ends either at the Week 144 visit for subjects completing the 
Open-Label Treatment Period, or at PEOT Visit for subjects who discontinued early during the 
Open-Label Treatment Period. If a subject does not have a Week 144/PEOT visit, then the date 
of the last scheduled or unscheduled visit during the Open-Label Treatment Period will define 
the end date of the Open-Label Treatment Period. 
The OLE2 treatment Period ends either at the OLE2 Week 48 visit for subjects completing 
the OLE2 Period, or at PEOT Visit for subjects who discontinued early during the OLE2 
Period. If a subject does not have an OLE2 Week 48/PEOT visit, then the date of the last 
scheduled or unscheduled visit during the OLE2 Period will define the end date of the 
OLE2 Period. 
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Change #4 
Section 2.3.2.5 OLE2 Period has been added with the following texts 
After the implementation of Protocol Amendment #5.4 and 5.5 (with the addition of a 48-
week Open-Label treatment period, ie, OLE2 Period), subjects from US and Canada sites 
will be invited to continue or reinitiate their treatment as per the following OLE2 Groups:  
• OLE2 Group A: Subjects in the treatment phase of the OLE Period at the time of 
Protocol Amendment #5.4 and 5.5 implementation will attend the Week 144 Visit and 
directly roll over to the OLE2 Period. These subjects will continue receiving 
bimekizumab 320mg Q8W for 40 additional weeks, starting from the first treatment 
visit of the OLE2 Period (ie, Week 144/OLE2 Baseline Visit; the Week 144 Visit will 
coincide with the Week 144/OLE2 Baseline Visit and data collected at this visit will be 
used as baseline data for the OLE2 Period).  
• OLE2 Group B: Eligible subjects who have completed the Week 144 Visit and are in 
the SFU or have completed the SFU of the OLE Period at the time of Protocol 
Amendment #5.4 and 5.5 implementation, will be eligible to reinitiate their treatment in 
the OLE2 Period after having undergone additional screening assessments during a 4-
week OLE2 Screening Period.  
− The first dose of the IMP ill be administered at the OLE2 Baseline Visit and data 
collected at this visit will be used as baseline data for the OLE2 Period.  
− Subjects in OLE2 Group B with an IGA score ≥3 at the OLE2 Baseline Visit will 
receive bimekizumab Q4W for the first 16 weeks, and then will switch to 
bimekizumab 320mg Q8W.  
− Subjects in OLE2 Group B with an IGA score <3 at the OLE2 Baseline Visit will 
receive bimekizumab Q8W from the OLE2 Baseline Visit. 
Following completion or early withdrawal from the OLE2 Period, subjects will enter the 
SFU2 and will return for the SFU2 Visit 20 weeks after the last dose of IMP 
administration. 
 
Change #5 
Section 2.3.2.6: Safety Follow-Up The following texts in bold has been added:  
All subjects, including those withdrawn from IMP, will have a SFU Visit 20 weeks after their 
final dose of IMP. 
Two SFU Periods are considered following the implementation of Protocol Amendments 
#5.4 and #5.5:  
• SFU following the OLE Period that covers the initial, maintenance, and the OLE 
treatment periods 
• SFU2 following the OLE2 treatment period.  
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Change #6 
Section 2.3.2.7 Premature End of Treatment. The following texts in bold have been added 
Subjects withdrawing early from the study will undergo PEOT Visit assessments and will enter 
the SFU Period or SFU2 Period depending on when subjects withdraw from the study. 
 
Change #7 
Section 2.3.3 Study duration per subject. The following texts in bold have been added 
For each subject not entering the OLE2 treatment period, the study will last a maximum of up 
to 165 weeks, as follows: 
• Screening Period: 2 to 5 weeks 
• Double-blind Treatment Period: 48 weeks (final dose at Week 44) 
• OLE Period: 96 weeks (final dose at Week 136 for subjects receiving bimekizumab 320mg 
Q8W and at Week 140 for subjects receiving bimekizumab 320mg Q4W) 
• Safety Follow-Up Period: an SFU Visit is planned 20 weeks after the final dose of IMP 
during the OLE period (this SFU will not apply to subjects directly rolling over from 
the OLE to the OLE2 Period). 
The OLE2 Period will include a 48-week treatment period with a final visit at OLE2 Week 
48 and a SFU2 period of 20 weeks after the final dose of IMP administered in the OLE2 
Period.  
For the subjects in the OLE2 Period, maximum study duration will depend on the time 
between their participation in the OLE until Week 144 and the start of the OLE2 Period:  
• 209 weeks for subjects still being treated in the OLE Period and who will directly roll 
over to the OLE2 Period at Week 144  
• 225 weeks for subjects who have completed Week 144 and the SFU; these subjects will 
have a 4-week Screening Period before reinitiating treatment in the OLE2 Period. Note: 
for these subjects, the study duration will not be continuous 
• Between 209 and 225 weeks for subjects who have completed Week 144 and are ongoing 
in the SFU. For these subjects, the maximum study duration will depend upon when 
they stop the 20-week SFU period to enter the 4-week OLE2 Screening Period. 
 
Change #8 
Section 2.3.5 Anticipated regions and countries. The following text in bold has been added 
The regions and countries planned for study conduct are North America (Canada, USA), 
Western Europe (Belgium, France, Germany, Netherlands, Spain, United Kingdom), 
Central/Eastern Europe (Poland), Asia/Australia (Australia, Turkey). An additional OLE2 will 
be conducted in US and Canada only 
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Change #9  
Section 3.1 General presentation of summaries and analyses. The following text in bold have 
been added 
Per protocol, visit windows of ±3 days from the first dose to Week 24, ±7 days from Week 28 to 
Week 72 and ±14 days from Week 76 to Week 144 are permissible. For the SFU Visit, visit 
window is 20 weeks ±7 days from final dose.  
Per protocol, visit windows of ±14 days from the first OLE2 dose at all OLE visits except 
SFU2 are permissible, the SFU2 visit window is 20 weeks ±7 days from final dose in OLE2.  
All by-visit summaries will contain nominal (i.e. scheduled) visits only. Unscheduled visits will 
not be mapped to scheduled visits except for assessments that occur within a 3-day time window 
of a scheduled visit. In that case, the assessment will be mapped to the corresponding scheduled 
visit and will be used for the analysis. This will only occur for some vendor data. 
A complete set of data listings containing all documented data as well as calculated data 
(e.g. change from Baseline) will be generated. Separate data listings will be generated for 
the OLE2 period. 
 
Change #10 
Section 3.2 Definition of Baseline values. The following texts in (bold) have been added 
Unless specified otherwise, the process laid out above will always be followed to determine 
Baseline. An additional Baseline value for the OLE Period will be defined for anti-bimekizumab 
antibodies for subjects initially randomized to secukinumab and for selected summaries of 
laboratory evaluations. This baseline for the OLE Period is the latest measurement on/prior to the 
day of first dose in the OLE Period for subjects switching from secukinumab to bimekizumab. 
Note that for any laboratory value that occurs on the day of treatment switch, that lab value will 
be attributed and summarized for the treatment the subjects were on previously. 
For subjects enrolled in OLE2, the OLE2 first dose will be administered at the Week 
144/OLE2 Baseline Visit and data collected at this visit will be used as baseline data for 
safety data in the OLE2 Period. Efficacy data will continue to use the Week 0 Visit as 
Baseline. 
 
Change #11 
Section 3.5.7 Open-Label Set2 has been created with the following texts in bold 
The Open-label Set 2 (OLS2) will consist of all subjects that received at least 1 dose of 
bimekizumab at Week 144/OLE2 Baseline Visit or later in the OLE2 Period. 
 
Change #12 
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Section 3.6 Treatment assignment and treatment groups. The following texts in bold have 
been added 
• Secukinumab / Bimekizumab Q8W for responder at Week 48 (>=PASI90) 
• Secukinumab / Bimekizumab Q4W for responder at Week 48 (>=PASI90) 
Safety and efficacy assessments for OLE2 period will only include subjects who entered 
OLE2 period and will be based on OLS2, and will be summarized by the assigned 
treatment as follows: 
• Subjects who roll over directly from the OLE treatment period: Group A 
− Bimekizumab Q8W Group A 
• Subjects in Group B who reinitiate bimekizumab after having completed treatment in 
the OLE and have an IGA <3 upon entry to the OLE2): Group B. 
− Bimekizumab Q8W Group B 
• Subjects in Group B who reinitiate bimekizumab after having completed treatment in 
the OLE and have an IGA ≥3 upon entry to the OLE2: Group B. 
− Bimekizumab Q4W/Q8W Group B 
• For safety summaries only 
− BKZ Total. 
 
Change #13 
Section 3.8 Coding dictionaries. The following change in bold has be made: 
All medications other than study drug will be classified by WHO Anatomical Therapeutic 
Chemical (ATC) Classification, presenting Anatomical Main Group (ATC Level 1), 
Pharmacological Subgroup (ATC level 3), and preferred term, using World Health 
Organization Drug Dictionary (WHO-DD) version SEP 2015 for Week 48 and Week 96 
analysis, and MAR 2021 for Week 144 and Final analysis, according to UCB standard 
operating procedures (SOP). 
 
Change #14 
Section 3.9 Relative Day. The following texts in bold have been added 
Relative day will only be computed for fully completed dates and will be missing for partial 
dates.  Two relative days will be used: 
• Compared to the first dose of study drug in the Initial Treatment Period for all 
subjects 
• Compared to the first dose of study drug in the Open-Label Extension 2 Period for 
subjects in OLS2 only 
 
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Change #15 
Section 3.10.1 Changes related to COVID-19. The following texts have been added  
The following changes have been introduced due to the COVID-19 pandemic: 
• COVID-19 protocol deviations have been defined in Section 3.4 and the presentation of 
COVID-19 protocol deviations is described in Section 5.2 
• COVID-19 impact on study visits has been assessed and are described in Section 5.1 
• COVID-19 Disposition assessments are described in Section 5.1  
• Missing data methods for assessing the impact of COVID-19 are described in Section 4.2.1.7  
Data considerations for assessing the impact of COVID-19 on TEAEs including COVID-19 
vaccine AEs are described in Section 10.2.1.1 and the associated analysis is described in 
Section 10.2.2 
 
Change #16 
Section 4.2.1.6 Missing data algorithm – MI – MCMC / Monotone Regression. The 
following texts in bold have been added: 
Table 4-2 Allowable ranges for imputation by variable. At ypo in bold has been corrected  
Variable 
Minimum value 
Maximum value 
Integer values only 
PASI 
0 
72 
No 
IGA 
0 
4 
Yes 
PSD items (itch, pain, 
scaling) 
0 
10 
No 
Scalp IGA 
0 
4 
Yes 
mNAPSI 
0 
130 
No 
BSA 
0 
100 
No 
IGAxBSA 
0 
400 
No 
DLQI 
0 
30 
Yes 
PGADA 
0 
100 
No 
EQ-5D-3L VAS 
0 
100 
Yes 
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Variable 
Minimum value 
Maximum value 
Integer values only 
WPAI dimension 
scores 
0 
100 
No for variables: 
“Percent work time 
missed due to problem” 
and “Percent overall 
work impairment due to 
problem”. 
Yes for variables: 
“Percent impairment 
while working due to 
problem” and “Percent 
activity impairment due 
to problem”. These two 
variables can only take 
values that are 
multiples of 10. 
PHQ-9 
0 
27 
Yes 
Maintenance Set: When programming multiple imputation based on the MS, PROC MI will be 
used with a separate data set for each of the 3 Maintenance Period treatment groups 
(bimekizumab 320mg Q8W, bimekizumab 320mg Q4W, secukinumab) including all scheduled 
assessment visits from Baseline to Week 48. 
Open-Label Set: When programming multiple imputations based on the OLS, PROC MI will be 
used with a separate data set for each of the 6 treatment sequences based on the combination of 
randomized treatment at Baseline, Maintenance Period treatment and OLE period treatment at 
Week 48 including all scheduled assessment visits from Baseline to Week 144. However, the 
summary values for the 4 treatment sequences based on the combination of randomized 
treatment at Baseline and OLE period treatment at Week 48 will be computed after the 
imputation steps 
The Open-label Set2: The analyses will be based on OC. Multiple imputation methods 
described above will not be applied.  
 
Change #17 
Section 4.3 Interim analyses and data monitoring. The following texts in bold have been 
added 
The following data cuts will occur and corresponding interim analyses will be performed:  
• After the final Week 48 visit, an interim analysis will be performed and a corresponding 
interim clinical study report (CSR) will be written, For subjects that participate in the OLE 
period, data will be cut at the day of their Week 48 study drug administration. Data from the 
OLE will not be included in this interim analysis.  
• An additional Week 96 data cut will occur approximately after the last Week 96 visit. A 
Week 96 analysis will be performed for the Open-Label treatment period using this Week 96 
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data cut. Selected tables, figures, and listings based on Week 96 data cut will be produced 
for these analyses as detailed in Section 12.3 (Appendix C). No corresponding CSR for 
these analyses was planned. 
• In addition, a Week 144 data cut will occur after Week 144 visit and SFU. A Week 144 
analysis will be performed using Week 144 and SFU data cut and a corresponding 
Week 144 interim CSR will be written.  
• A final analysis will be conducted when all data for the double-blind, OLE (including 
SFU), and OLE2 (including SFU2) treatment periods have been collected and final CSR 
will be written. 
An independent Data Monitoring Committee (DMC) will periodically review and monitor the 
safety data from the Double-blind treatment period of this study and advise UCB.  
Cardiovascular, Inflammatory bowel disease (IBD), and Neuropsychiatric Adjudication 
Committees will also periodically review and monitor safety data from this study including two 
Open-label Extension (OLE and OLE2) treatment periods and advise UCB. Details will be 
provided in the DMC Charter and in the Adjudication Committee Charters. 
Further details related to the DMC will be outlined in a separate analysis plan. 
 
Change #18 
Section 4.5: Multiple comparisons/multiplicity. The following texts in bold have been added. 
Note: Tests for H1, H2, H3, and H4 are based on all subjects initially randomized to bimekizumab 
compared to secukinumab. For H5 and H6, testing is based on the subjects re-randomized at 
Week 16 to bimekizumab 320mg Q4W, and bimekizumab 320mg Q8W, respectively, compared 
to secukinumab. 
A table will be produced containing the results for all hypotheses. P-values or confidence 
intervals only will be shown as appropriate. 
Other tables will include p-values of primary and secondary endpoints. These p-values should 
not be considered to evaluate hypotheses as they are not controlled for multiplicity. 
 
Change #19 
Section 4.8 Examination of subgroups. The following texts in bold have been added 
Subgroup analyses will be conducted based on Week 48 data cut only. These analyses will be 
performed on the PASI75/90/100 response rates, using by visit summaries only. The following 
subgroups for analysis will be determined for the RS using baseline data: 
Age (<40 years, 40 to <65 years, ≥65 years) 
 
In addition, in order to assess whether an early response to treatment is predictive of response at 
later time points, subgroup analyses will be performed for PASI90/100 and IGA over time using 
the following early response subgroups: 
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• PASI75 response (OC) at Week 4 (yes, no) to predict PASI90/100 and IGA (clear or 
almost clear) (NRI) through Week 48 Based on RS 
• PASI90 response (OC) at Week 16 (yes, no) to predict PASI100 (NRI) through Week 48 
based on RS 
• PASI90 response (OC) at Week 48 (yes, no) to predict PASI90 (NRI) during the OLE 
based on OLS 
• PASI90 response (OC) at Week 48 (yes, no) to predict PASI100 (NRI) during the OLE 
based on OLS 
• PASI90 response (OC) at Week 48 (yes, no) to predict IGA responder rates (clear) and 
IGA responder (clear or almost clear) during the OLE based on OLS. 
All summaries will be based on imputed data as appropriate and will include descriptive statistics 
only. 
Additional subgroup analyses are described in Section 4.2.1.7.2 to assess the impact of the 
COVID-19 pandemic on planned statistical analysis of PASI100 response at Week 48. 
 
Change #20 
Section 5.1 Subject disposition. The following texts in bold have been added 
Summaries of reasons for screen failures (for all subjects screened), disposition of subjects (for 
all subjects screened), disposition of analysis sets (for RS, MS and OLS), disposition and 
discontinuation reasons (for RS, MS, OLS, and OLS2), as well as for the subjects who 
discontinued due to AEs (for RS, MS, OLS, and OLS2) will be produced. The disposition of 
subjects for all subjects screened will include the number of subjects included in each analysis 
set (RS, SS, FAS, MS, OLS, OLS2, BKZ Set, PPS and PK-PPS) overall and by site. 
The following listings for subject disposition will be provided: subjects who did not meet study 
eligibility criteria (all subjects screened), subject disposition (all subjects screened), study 
discontinuation (for RS), visit dates (for RS), subjects excluded from efficacy analysis (RS). 
Summaries of visits at which subjects initiated the switch from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W dosing interval in Open-Label Extension period will be presented. 
Similar listings will be provided separately for the OLE and the OLE2 treatment periods. 
In addition, the following COVID-19 impact categories will be summarized by country and visit 
for the MS OLS, and OLS2 (see Section 2.3.5 for list of countries). Separate listings of 
COVID-19 impact will be provided for the OLE and OLS2 treatment periods. 
A by-subject listing of COVID-19 impact categories will be provided separately for the OLE 
and the OLE2 treatment periods. 
 
Change #21 
Section 5.2 Protocol deviations. The following texts in bold have been added 
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A summary of number and percentage of subjects with an important protocol deviation 
(including a summary of subjects excluded from any analysis set due to important protocol 
deviations) by treatment group will be provided for the RS, MS, OLS, and OLS2. 
A by-subject listing of important protocol deviations will be provided separately for Initial and 
Maintenance treatment periods for RS. Similar listings will be provided separately for the 
OLE and the OLE2 treatment periods. 
A summary of number and percentage of subjects with COVID-19 protocol deviations by 
treatment group and visit will be provided for the MS and OLS.  
A by-site, subject and visit listing of COVID-19 protocol deviations will be provided.  
Separate listings of subjects with COVID-19 protocol deviations will also be provided for 
the OLE and the OLE2 treatment periods. 
 
Change #22  
Section 6 DEMOGRAPHICS AND OTHER BASELINE CHARACTERISTICS 
All summaries detailed in this section will be performed on the RS by treatment group. 
Summaries for demographics and other Baseline characteristics will also be repeated on SS, MS, 
OLS, and OLS2. All these summaries (including the OLS and the OLS2 summaries) will use 
the Baseline value from Week 0 of the double-blind treatment period. If the RS and SS 
analysis sets are identical the summaries will not be repeated. 
 
Change #23 
Section 6.3 Medical history and concomitant diseases. The following texts in bold have been 
added 
Previous and ongoing medical history will be summarized by treatment group(s), SOC and PT 
using MedDRA® version. Medical procedures are not coded. 
The following listings for medical history and concomitant diseases will be provided: medical 
history, psoriasis history, concomitant medical procedures, previous and ongoing medical history 
glossary, previous and ongoing medical history conditions, and procedure history. 
For subjects enrolling in OLE2 Group B, any additional medical history collected during 
OLE2 screening will be flagged in the medical history listing. 
 
Change #24 
Section 6.4 Prior and concomitant medications. The following texts in bold have been added 
Concomitant medications are medications taken at least one day in common with the study 
medication dosing period (defined as from first dose of study medication [including placebo] up 
to last dose of study medication + 28 days for the double-blind treatment period, and +28 days or 
+56 for Q4W and Q8W dosing respectively in the OLE period). Concomitant medications will 
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be summarized separately for the double-blind Treatment Period (SS), the OLE treatment 
period (OLS). 
 
Past psoriasis medications will be captured separately and will also be summarized by treatment 
group. These medications are not subject to dictionary coding. In addition, subjects who failed 
past psoriasis biologic treatment will be summarized by reason of failure as captured on the 
Psoriasis Treatment History CRF module. 
The number and percentage of subjects with concomitant vaccines for COVID-19 will be 
summarized by treatment group, overall and by World Health Organization Drug 
Dictionary Standardised Drug Grouping (SDG), presenting SDG subgroup, and preferred 
term. The SDG subgroup Vaccines for COVID-19 will be used to identify vaccines for 
COVID-19 using the narrow scope; this subgroup is divided further into separate 
subgroups which is the level that will be presented. The number of individual occurrences 
of the vaccine for COVID-19 will also be summarized. 
By-subject listings of all Prior and Concomitant medications (including COVID-19 concomitant 
medications), prior and concomitant medications glossary, and psoriasis treatment history will be 
provided separately for OLE and OLE2 treatment periods. Ongoing concomitant 
medications from OLE to OLE2 treatment period will be flagged. 
An additional listing of concomitant vaccines for COVID-19 will be provided separately for 
OLE and OLE2 treatment periods.  
. 
 
Change #25 
Section 7 MEASUREMENTS OF TREATMENT COMPLIANCE. The following texts in 
bold and 7-3 have been added 
A summary of percent treatment compliance categorized as <75% and ≥75% will be provided by 
treatment group and study periods (Initial Treatment Period for the SS, Maintenance Treatment 
Period for the SS, Initial and Maintenance Treatment Period for the SS, Open-Label Extension 
Period for the OLS and Open-Label 2 Extension Period for the OLS2). 
A by-subject listing of treatment compliance will be provided. Separate listings of treatment 
compliance will be provided for the OLE and the OLE2 treatment periods. 
 
Table 13‒5: 
Dosing scheme, OLE2 Period 
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Visit/Week 
 
Dose Assignment 
OLE2 Period 
Week 144/OLE2 
Baseline 
OLE2 Week 4 
OLE2 Week 8 
OLE2 Week 12 a 
OLE2 Week 16 
OLE2 Week 24 b 
OLE2 Week 32 
OLE2 Week 36 c 
OLE2 Week 40 
OLE2 Week 48 
 
C 
H 
H 
C 
H 
C 
H 
C 
H 
C 
Bimekizumab 320mg 
Q4W/Q8Wd 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
 
●● 
 
Bimekizumab 320mg Q8W 
●● 
 
●● 
 
●● 
●● 
●● 
 
●● 
 
C=Clinic; H=home; IGA=Investigator's Global Assessment; IMP=investigational medication product; 
OLE=Open Label Extension; Q4W/Q8W=every 4 weeks for 16 weeks, followed by every 8 weeks; 
Q8W=every 8 week; W=week 
Notes: A bimekizumab 160mg injection is depicted by black circle (●).  
a Subjects will receive kits for home administration 4 weeks later. 
b Subjects will receive kits for home administration 8 weeks later.  
c Subjects should NOT be dosed at this visit and will receive kits for home administration 4 weeks later.  
d Q4W/Q8W IMP administration only applies to those subjects who have entered the OLE2 Period as part of 
Group B and had an IGA ≥3 upon entry of OLE2 Period. These subjects will receive Q4W dosing for 16 
weeks until OLE2 Week 16, then will change from Q4W to Q8W and will receive their next dose at the 
scheduled clinic visit OLE2 Week 24. 
 
Change # 26 
Section 8.1.1 Derivations of primary efficacy variable. The following texts in bold have been 
added 
Unless otherwise specified, the Baseline value to be used in the analysis of efficacy 
endpoints will be the assessments from Week 0 of the double-blind treatment period of the 
study. A table of efficacy variables analyzed at each treatment period is provided in Section 
12.4 Appendix D 
 
Change #27 
Section 8.1.2 Primary analysis of the primary efficacy variable  
A line plot of the percentage improvement from Baseline in PASI score over time by treatment 
group will be produced by randomized treatment group for the RS and repeated for the MS. An 
additional plot will be produced for the OLS by OLE treatment groups. 
By-subject listings of PASI and PASI responder variables will be provided. for the Initial and 
the Maintenance periods combined based on RS. This listing will also be provided 
separately for the OLE and the OLE2 treatment periods. 
 
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Change #28 
Section 8.3: Analysis of other efficacy variables. The following texts have been added:  
For variables that are part of the sequence testing procedure, summaries based on observed case 
data will also be provided. There may be cases where the multiple imputation model fails to 
converge. In such situations, the LOCF approach will instead be used to impute the missing data. 
Selected efficacy variables will also be summarized by visit through Week 144 for the OLE 
Period for the OLS. Subjects will be summarized by treatment sequence comprising randomized 
treatment at Baseline and OLE period treatment at Week 48.  
The OC approaches will be used to summarize the following efficacy variables for subjects 
in the OLE2 treatment period: PASI90. PASI100, IGA (0/1), IGA (0), DLQI(0/1), and PSD 
responder. 
 
Change #29 
Section 8.3.1.1 PASI75, PASI90 and PASI100 response rates. The following texts in bold 
have been added. 
A line plot of the PASI responder (PASI75, PASI90, and PASI100) rate over time, by treatment 
group will be produced for the RS and by randomized treatment groups. Additional plots will be 
produced separately for the MS by maintenance treatment groups, for the OLS and for the 
OLS2 (excluding PASI75) by OLE and OLE2 treatment sequences respectively. 
 
Change #30 
Section 8.3.1.2 Time to PASI75, PASI90 and PASI100 response. The following texts in 
boldnhave been added. 
Kaplan-Meier plots of time to PASI responses will also be presented by initially randomized 
treatment group. In these Kaplan-Meier plots, the line will start at 0 (since there are no 
responders at Week 0) and will increase over time, representing time to achieving the response. 
Time to PASI75. PASI90, and PASI100 response analyses will not be conducted for the 
OLE and the OLE2 treatment periods. 
 
Change #31 
Section 8.3.1.3 PASI score. The following texts have been added. 
Absolute and percent change from Baseline in PASI score is defined in Section 8.1.1.1. 
The percentage of subjects with absolute PASI score ≤1, ≤2, ≤3 and ≤5 will be presented over 
time using NRI for the RS, the MS, and the OLS. 
Absolute PASI score categories will not be summarized for the OLE2 treatment period. 
 
Change #32 
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Section 8.3.2 IGA response. Table 8.3 footnote has been updated and following texts in bold 
have been added 
Palmoplantar disease will be assessed in terms of clinical signs of redness, thickness, and 
scaliness using a 5-point scale as outlined in Table 8‒3 below. 
Table 13‒6: Palmoplantar IGA 
Score 
Short Descriptor 
Detailed Descriptor 
0 
Clear 
Palmoplantar has no signs of PSO; post-inflammatory 
hyperpigmentation may be present 
1 
Almost clear 
Palmoplantar has no thickening; normal to pink coloration; no to 
minimal focal scaling 
2 
Mild 
Palmoplantar has just detectable to mild thickening; pink to light red 
coloration; predominately fine scaling 
3 
Moderate 
Palmoplantar has clearly distinguishable to moderate thickening; dull to 
bright red and clearly distinguishable coloration; moderate scaling 
4 
Severe 
Palmoplantar has severe thickening with hard edges; bright to deep dark 
red coloration; severe/coarse scaling covering almost all or all lesions; 
numerous fissures 
PSO=psoriasis. 
A line plot of the IGA responder rates (both clear or almost clear and clear) over time, by 
treatment group will be produced for the RS and by randomized treatment groups. This plot will 
include assessments from the Initial and Maintenance Treatment Period. An additional plot will 
be produced by re-randomized maintenance treatment groups only for the Maintenance 
Treatment Period for the MS. Additional plots will be produced based on the OLS and the 
OLS2 for (IGA clear [0] and for IGA (clear [0] or almost clear [1]) only) by treatment 
sequence 
 
Change #33 
Section 8.3.3 Body Surface Area (BSA). The following texts in bold have been added. 
The percent of subjects with absolute BSA=0%, ≤1%, ≤3% and ≤5% will be presented over time 
using NRI. 
BSA results will be listed but will not be summarized for the OLE2 treatment period. 
 
Change #34 
Section 8.3.4 Body Surface Area (BSA). The following texts in bold have been added 
The absolute and percentage change from baseline will be summarized for each study period 
(Initial randomized, Maintenance) by treatment group and visit. 
The product of IGA and BSA will not be summarized for the OLE2 treatment period. 
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Change #35 
Section 8.3.5 Dermatology Life Quality Index (DLQI). The following texts in bold have been 
added 
The DLQI related efficacy variables will be summarized for the double-blind treatment visits 
separately for the RS and MS, and separately for OLS and OLS2 [DLQI(0/1) only] by 
treatment sequence respectively and visit 
 
Change #36 
Section 8.3.8 Symptoms of PSO (Itch, pain, and scaling). The following texts in bold have 
been added 
Cumulative distribution plots will also be provided for absolute change from Baseline PSD at 
Week 16 and Week 48 for each item 
Listings of response to individual question of the patient diary will be provided separately 
for the Initial., Maintenance, OLE, and the OLE2 treatment periods. 
Summaries of PSD responder to Itch, Pain, and scaling symptoms will be produced for the 
OLE2 by treatment sequence as described in Section 3.6. 
 
Change #37 
Section 9: PHARMACOKINETICS AND PHARMACODYNAMICS The following 
treatment sequences and texts (in bold) have been added: 
For the Week 48 Interim the following treatment groups were summarized for the Initial 
and Maintenance Treatment Period. 
Bimekizumab 320mg Q4W/Q8W with switch from Q4W to Q8W occurring at Week 16  
Bimekizumab 320mg Q4W.  
PK and ADAb will also be summarized through to Week 144 by the following treatment 
sequence and by visit for Initial, Maintenance, and Open-Label Extension treatment period 
combined. No PK or ADAb samples will be collected in the OLE2 treatment period. 
• Subjects receiving bimekizumab in the double-blind treatment period until treatment 
discontinuation: 
− Bimekizumab 320mg Q4W/Q8W with switch from Q4W to Q8W occurring at Week 
16  
− Bimekizumab 320mg Q4W/Q8W with switch from Q4W to Q8W occurring at Week 
48  
− Bimekizumab 320mg Q4W/Q8W with switch from Q4W to Q8W occurring at Week 
72 or 84  
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− Bimekizumab 320mg Q4W/Q8W with switch from Q4W to Q8W occurring at Week 
96 or later  
− Bimekizumab Total (only for immunogenicity analyses). 
Subjects with any other treatment sequence groups (eg, Bimekizumab 320mg 
Q4W/Q8W/Q4W or Q4W/Q8W/Q4W/Q8W) will be allocated the "Bimekizumab Total" 
treatment sequence group for immunogenicity analysis only. All data will be included in 
the listings. 
• Subjects receiving secukinumab in the double-blind treatment period: 
− Bimekizumab 320mg Q8W from Week 48 
− Bimekizumab 320mg Q4W/Q8W with switch from Q4W to Q8W occurring at Week 
72 or 84 
− Bimekizumab 320mg Q4W/Q8W with switch from Q4W to Q8W occurring at Week 
96 or later 
− Bimekizumab Total (only for immunogenicity analyses) 
Note that subjects who received Bimekizumab 320mg Q4W only, ie, those who 
discontinued before switching to Q8W, will be allocated to the corresponding Q4W/Q8W 
treatment sequence group depending on when the subject discontinued. For example, if a 
subject discontinued at week 68, they will be allocated to group Bimekizumab 320mg 
Q4W/Q8W, switch occurring at Week 72 for PK summary table and figure purposes. 
 
Change #38 
Section 9.3 Immunogenicity. The following texts in bold have been added. 
The analysis of immunogenicity for the Week 48 Interim will be based on the SS All other 
analyses will be based on the BKZ Set. 
 
Change #39 
Section 9.3.2: Anti-bimekizumab antibodies 
The following texts (in bold) have been added:  
Anti-bimekizumab antibodies will be measured using a three tiered assay approach: screening 
assay, confirmatory assay and titration assay. Samples confirmed as positive within the 
confirmatory assay, will be further evaluated in a neutralizing assay to evaluate the potential of 
the ADAb to neutralize the activity of Bimekizumab (IL17A or IL17F, or both) in-vitro. Samples 
were taken at baseline, week 1, week 2, week 4, week 8, week 12, week 16, week 20, week 24, 
week 36, week 48, Week 72, Week 96, Week 120, Week144 (or PEOT) and at SFU which is 20 
weeks after the last dose. Due to the planned entry of some subjects to the OLE2 period, not 
all subjects will have an SFU period immediately following Week 144 with PK and 
immunogenicity samples.  
 
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If the titer for an ADAb level that is positive screen and positive immunodepletion is 
missing, then a conservative approach will be used and ADAb status will be considered as 
positive. No imputation rules apply for the missing titer. If the ADAb level is positive 
screen but no confirmatory result could be determined, then a conservative approach will 
be used and ADAb status will be considered as positive. 
Anomalous values will be not included in summaries/analysis and will be reviewed and 
flagged by pharmacokinetic expert. 
For each subject an overall ADAb status in the treatment period (Baseline to Week 144) 
will be derived: 
• Overall Positive is defined as having at least one value that is confirmed positive during 
the treatment period. 
• Overall Negative is defined as having no values that are confirmed positive at any time 
up to Week 144 and at least 2/3 of the protocol scheduled post-baseline assessments up 
to Week 144 are evaluable (i.e. neither missing as per schedule nor inconclusive) 
• Overall Missing is defined as having no values that are confirmed positive at any visit in 
the treatment period, but the subject has 1/3 or more protocol scheduled post-baseline 
assessments missing (or inconclusive) up to Week 144.  
This differs from the Week 48 interim analysis where all subjects were defined as either 
overall positive or overall negative only (a missing category was not considered). As the 
time on treatment is protracted in this open label extension study (up to 144 Weeks), 
missing data or subject discontinuation may be more prevalent and is therefore considered 
for the final analysis 
The double-blind and OLE treatment periods do not include Baseline/pre-treatment 
samples or SFU. 
Furthermore, the following subcategories for each subject will be derived: 
1. Pre anti-bimekizumab antibody negative – treatment emergent anti-bimekizumab 
antibody negative: Includes subjects who are negative at Baseline and antibody 
negative at all sampling points post treatment (excluding SFU) 
2. Pre anti-bimekizumab antibody negative – treatment emergent anti-bimekizumab 
antibody positive: Includes subjects who are negative at Baseline and antibody 
positive at any sampling point post treatment (excluding SFU). This group also 
includes subjects who have a missing pre-treatment sample (either missing or 
insufficient volume) at Baseline with one or more anti-bimekizumab antibody 
positive post-treatment samples. 
3. Pre anti-bimekizumab antibody positive – treatment emergent reduced anti-
bimekizumab antibody: Includes subjects who are positive at Baseline, and 
antibody negative at all sampling points post treatment (excluding SFU). 
4. Pre anti-bimekizumab antibody positive – treatment emergent unaffected anti-
bimekizumab antibody positive: Includes subjects who are positive at Baseline and 
are positive at any sampling point post treatment (excluding SFU) with titer values 
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of the same magnitude as Baseline (ie, less than a 2.07 fold difference from the 
Baseline value). 
5. Pre anti-bimekizumab antibody positive – treatment emergent anti-bimekizumab 
antibody boosted positive: Includes subjects who are positive at Baseline and are 
positive at any sampling point post treatment (excluding SFU) with increased titer 
values compared to baseline (greater than a 2.07 fold difference increase from 
Baseline value which will be defined within the validation of the assay). 
6. Inconclusive: Includes subjects who have a positive pre-treatment sample and 
some post-treatment samples are missing, while other post-treatment samples are 
anti-bimekizumab antibody negative. 
7. Total treatment-emergent ADAb positivity (Category 7 [Categories 2 and 5 
combined]): Includes study participants who are pre ADAb negative – treatment-
emergent ADAb positive (Category 2) and pre ADAb positive – treatment boosted 
ADAb positive (Category 5).  
8. Total prevalence of pre- ADAb positivity (Category 8 [Categories 3, 4 and 5 
combined]): Study participants that are tested ADAb positive at Baseline. 
9. Missing: Includes subjects who are antibody negative at baseline, are not positive 
at any post-baseline visit, and have at least one missing post-treatment scheduled 
assessment. Note this is also applicable to subjects who have missing baseline. 
For the Week 144 analysis, when all OLE and SFU data will be available, data from the 
OLE and SFU visits will be considered. That is, each instance of “excluding SFU” in the 
categories above, should be changed to “including SFU.” 
In the case that a sample is collected one or more days following the scheduled visit date in 
which the drug was administered, the anti-bimekizumab antibody results for that sample 
will be associated with the scheduled visit and summarized accordingly. Such samples will 
also be considered when anti-bimekizumab antibody results are summarized over a given 
study period. 
Analysis 
• Immunogenicity will be assessed through summary tables, figures, and listing of individual 
results by subject. The analysis of immunogenicity will be summarized by treatment 
sequence as described in Section 9 and visit. All analyses will be run on the safety 
population, unless specified otherwise. Summary of anti-bimekizumab antibody status 
overall and by each visit separated by treatment sequence 
• Summary of the time-point of the first occurrence of anti-bimekizumab antibody positivity 
during the treatment period by treatment sequence. A plot of the titer by time to first anti-
bimekizumab antibody positivity will be prepared. 
• All individual subject-level anti-bimekizumab antibody results will be listed. 
• The number and percentage of subject in each of the 8 anti-bimekizumab antibody categories 
during the treatment period by treatment sequence, with an additional category combining 
subjects in categories 2 and 5, summarized as total treatment emergent. In addition, the count 
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and percentage of subjects who are pre anti-bimekizumab positive will be calculated (this is 
the sum of categories 3, 4, and 5). 
• The prevalence of immunogenicity, separated by treatment sequence, and defined 
subcategory, will be reported by visit, defined as (cumulative) proportion of subjects having 
confirmed positive anti-bimekizumab antibody samples at any visit up to and including that 
visit. Missing samples will not be included in the denominator. 
• The time to achieving treatment-emergent anti-bimekizumab antibody positivity, separated 
by treatment sequence and defined sub-category, will be analyzed based on Kaplan-Meier 
methods. Subjects will be considered to have an event at the time point at which treatment 
emergent anti-bimekizumab antibody positive is first achieved. Subjects classified as 
treatment-emergent anti-bimekizumab antibody negative will be censored at the time of the 
last available anti-bimekizumab antibody result. 
• A summary of PASI 100 responders, separated by treatment sequence and defined sub-
category, at weeks 16 and 48 as a function of ADAb titer will be presented graphically. This 
will be repeated for PASI 75 and 90 responders. 
• Individual plots of Bimekizumab Concentrations/ anti-bimekizumab antibody titer and PASI 
score all plotted on the Y-axes by visit (x-axis) for the full treatment period (excluding SFU 
and OLE period for interim analyses and including SFU and OLE period for final analyses), 
where a patient has not progressed into the OLE. Plots should be labeled and grouped into 
the 7 sub-categories. 
• Spaghetti plots of ADAb titer (y-axis) by visit (x-axis), separated by treatment sequence (as 
specified above) for all anti-bimekizumab antibody positive subjects, including Baseline 
positive subjects. 
• Box plots Plot of ADAb titer (logscale) by time to first ADAb positivity by treatment 
sequence. 
For purposes of efficacy subgroup analyses based on anti-bimekizumab antibody status, two 
categories will be used: 
• Anti-bimekizumab antibody positive – This is defined as subjects who have anti-
bimekizumab antibody levels above the specified cut point on at least 2 time points while on 
treatment (ie, excluding Baseline, excluding SFU). 
• Anti-bimekizumab antibody negative – Subjects who are not defined as anti-bimekizumab 
positive (as described above) will be defined as anti-bimekizumab antibody negative. 
The groups for defining anti-bimekizumab antibody status for safety subgroup analyses are as 
follows: 
− AEs starting before first anti-bimekizumab antibody positive result 
− AEs starting on or after first anti-bimekizumab antibody positive result 
− AEs for subjects who were always anti-bimekizumab antibody negative 
In addition to the anti-bimekizumab antibody classifications, subjects may also receive an overall 
neutralizing (NAb) classification for each NAb assay separately (IL-17AA and IL-17FF), 
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inclusive of Baseline and post-Baseline results, on the NAb assay results. The classifications 
are as follows: 
− NAb negative: No NAb positive samples at Baseline or post-Baseline and did not 
discontinue prior to Week 144. Subjects can have up to 1 missing sample. 
− NAb positive: One or more positive samples (IL-17AA positive, IL-17FF positive, or 
both) at Baseline or post-Baseline (regardless of missing samples). Subjects who are 
NAb positive will be further classified as follows: 
◦ 
Positive for IL-17AA only: one or more positive samples for IL-17AA at Baseline 
or post Baseline. No positive samples for IL-17FF 
◦ 
Positive for IL-17FF only: one or more positive samples for IL-17 FF at Baseline 
or post Baseline. No positive samples for IL-17AA 
◦ 
Positive for both IL-17AA and IL-17FF: one or more positive samples for both 
IL-17AA and IL-17FF at Baseline or post Baseline 
− NAb Missing: >1 relevant NAb samples are missing, eg, if subject had samples 
selected for NAb testing based on their anti-bimekizumab antibody levels, but there 
was insufficient sample left for NAb testing, or the subject discontinued prior Week 
144 visit. 
A summary table covering the initial, maintenance and OLE periods combined by 
treatment sequence will be produced, in addition, to summarize the NAb status overall. 
A listing will be produced to summarize the NAb status by visit. The listing should be 
sorted by treatment sequence, subject identifier, and visit and would provide the following 
information for each subject: 
− Visit 
◦ 
Study week since first BKZ dose 
◦ 
Sample date and time 
◦ 
Time since previous dose (weeks) 
− NAb status and the corresponding bimekizumab plasma concentration (ug/mL) and 
the anti-bimekizumab antibody level titer at this visit 
− IL-17AA NAb status and corresponding IL-17AA signal/negative control result 
IL-17FF NAb status and corresponding IL-17FF signal/negative control result 
The tables will provide the following overall summary statistics by treatment group: 
− Total number and percentage of anti-bimekizumab antibody positive, anti-
bimekizumab antibody negative and missing subjects at each visit 
− Number and percentage of subjects who are NAb positive, NAb negative and 
missing at each visit  
− The number and percentage of subjects who are IL-17AA NAb positive, IL-17FF 
NAb positive, or both 
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Change #40 
Section 10.1 Extent of exposure: The following texts in bold have been added: 
For the Week 144 analysis and for the final analysis, the table will also be created for the BKZ 
set and will include the above categories plus the below categories. A bimekizumab total column 
will be displayed. 
• >=72 weeks 
• >=96 weeks 
• >=120 weeks 
• >=144 weeks 
In addition, the OLE2 exposure will be displayed as follow: 
• >0 weeks 
• >=16 weeks 
• >=24 weeks 
• >=48 weeks 
Throughout this section, date of last clinical contact for each subject is defined as the maximum 
of (last visit date including SFU or SFU2 visit, last imputed AE start date, date of study 
 
Change #41 
Section 10.1.4.1: For subjects who do not switch study treatments 
The number of days in (bold) added to the time at risk has been changed from 140 to 141 
Time at risk (days) 
Study medication duration (days) 
• For subjects who receive Q4W in the Open-Label Extension Period (subjects who 
discontinue prior to switching to Q8W): 
− Date of last bimekizumab dose in the Open-Label Extension Period – date of first dose in 
the Open-Label Extension Period + 28 days (for subjects on Q4W dosing) 
• For subjects who receive Q8W in the Open-Label Extension Period use the minimum 
of: 
− Date of last bimekizumab dose in the Open-Label Extension Period – date of first dose in 
the Open-Label Extension Period + 56 days  
− First dose date in Open-Label Extension 2 Period – date of first dose in the Open-
Label Extension Period + 1 
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Note: If date of last bimekizumab dose in the Open-Label Extension Period + 28 days (or 56 
days for subjects on Q8W dosing) extends to a date beyond the final visit date (including 
PEOT, but not including SFU), then this calculation reverts to: 
− Final visit date (including PEOT, but not including SFU) – date of first dose in the Open-
Label Extension Period+ 1. 
Note: For subjects who die, if date of last bimekizumab dose in the Open-Label Extension 
Period + 28 days (or 56 days for subjects on Q8W dosing) extends to a date beyond the date 
of death, then this calculation reverts to: 
− Date of death – date of first dose in the Open-Label Extension Period+ 1. 
Time at risk (days) 
• For all subjects, use the minimum of the following: 
− Date of last dose in the Open-Label Extension Period – date of first dose in the Open-
Label Extension Period + 140 days, 
− Date of first dose in OLE2 - date of first dose in the Open-Label Extension Period + 1 
day 
− Date of last clinical contact in OLE and SFU – date of first dose in the Open-Label 
Extension Period + 1. 
− Date of death – date of OLE first dose +1 
 
Change #42 
Section 10.1.4.2: For subjects who switch from BKZ 320mg Q4W to Q8W during Open-Label 
Extension Period 
Following Protocol Amendment 5.0, subjects receiving Q4W should switch to Q8W during the 
Open-Label extension period. (see Section 2.3.2.4 for further details). 
Study medication duration (days) 
• Attributed to BKZ 320mg Q4W: 
− Date of last BKZ 320mg Q4W dose in the OLE Period – date of first BKZ 320mg Q4W 
dose in the OLE Period + 28 days 
Note: If date of last BKZ 320mg Q4W dose in the OLE Period + 28 days extends to a date 
beyond the date of first BKZ 320mg Q8W dose in the OLE Period, then this calculation 
reverts to: 
− Date of first BKZ 320mg Q8W dose in the OLE Period – date of first BKZ 320mg Q4W 
dose in the OLE Period + 1. 
• Attributed to BKZ 320mg Q8W use the minimum of: 
− Date of last BKZ 320mg Q8W dose in the OLE Period – date of first BKZ 320mg Q8W 
dose in the OLE Period + 56 days. 
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− First dose date in Open-Label Extension 2 Period – date of first BKZ 320mg Q8W 
dose in the Open-Label Extension Period+ 1. 
Note: If date of last bimekizumab dose in the Open-Label Extension Period + 56 days 
extends to a date beyond the final visit date (including PEOT, but not including SFU), then 
this calculation reverts to: 
− Final visit date (including PEOT, but not including SFU) – date of first BKZ 320mg 
Q8W dose in the OLE Period + 1. 
Note: For subjects who die, if date of last bimekizumab dose in the Open-Label Extension 
Period + 56 days extends to a date beyond the date of death, then this calculation reverts to: 
− Date of death – date of first BKZ 320mg Q8W dose in the OLE Period + 1. 
• Attributed to Total BKZ 
− Sum of study medication duration in OLE period attributed to BKZ 320mg Q4W and 
study medication duration in OLE period attributed to BKZ 320mg Q8W - 1. 
Time at risk (days) 
• Attributed to BKZ 320mg Q4W: 
− Date of first BKZ 320mg Q8W dose in the OLE Period – date of last BKZ 320mg Q4W 
dose in the OLE Period + 1 day 
• Attributed to BKZ 320mg Q8W: 
− For all subjects, use the minimum of the following: 
◦ 
Date of last BKZ 320mg Q8W dose in the OLE Period – date of first BKZ 320mg 
Q8W dose in the OLE Period + 140 days. 
◦ 
Date of first BKZ 320mg Q8W dose in OLE2 - date of first BKZ 320mg Q8W dose 
in the Open-Label Extension Period + 1 day 
◦ 
Date of last clinical contact – date of first BKZ 320mg Q8W dose in the OLE Period 
+ 1.  
◦ 
Date of death – date of first BKZ 320mg Q8W dose in the OLE Period + 1. 
• Attributed to Total BKZ: 
− Use the time at risk algorithm specified for subjects who do not switch study treatments 
in Section 10.1.4.1 
 
Change # 43 
Section 10.1.5.1 For subjects who do not switch dose 
Time at risk (days) 
• For all subjects, use the minimum of the following: 
− Date of last dose – date of first + 140 days. 
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• Date of last clinical contact – date of first dose + 1. 
• Date of death – date of first dose + 1. 
For subjects randomized to secukinumab at Baseline who initiate bimekizumab at Week 48 and 
continue on the same dose schedule in the OLE without switching, use the study medication 
duration and time at risk algorithms specified for subjects who do not switch study treatments in 
Section 10.1.4.1 
 
Change #44 
Section 10.1.5.2: For subjects who do not switch dose 
The following texts (in bold) have been added: 
Study medication duration (days) 
Total study medication duration attributed to each dose will be obtained by summing the study 
medication duration(s) at each specific dose in each individual study period. Total study 
medication duration attributed to BKZ Total will be obtained by summing the study medication 
durations in each individual study period and deducting n-1, where n is the number of periods 
covered that are being summed.  
 
• Attributed to BKZ 320mg Q8W 
− Date of last consecutive BKZ 320mg Q8W dose in current study period– date of first 
consecutive BKZ 320mg Q8W dose in current study period + 56 days 
Note: If date of last consecutive BKZ 320mg Q8W dose in current study period+ 56 days 
extends to a date beyond the date of first BKZ 320mg Q4W dose in the next study period, 
then this calculation reverts to: 
− Date of first BKZ 320mg Q4W dose in the next study period – date of first BKZ 320mg 
Q4W dose in the current study period. 
Note: If BKZ 320mg Q8W is the last dosing schedule received in the last study period the 
subject receives bimekizumab in and date of last consecutive BKZ 320mg Q8W dose in 
current study period+ 56 days extends to a date beyond the final visit date (including PEOT, 
but not including SFU), then this calculation reverts to: 
− Final visit date (including PEOT, but not including SFU) – date of first BKZ 320mg 
Q8W dose in the current study period + 1. 
Note: For subjects who progress into the OLE2, if date of last bimekizumab dose in the 
Open-Label Extension Period + 56 days extends to a date beyond the date of first dose 
in the Open-Label Extension 2 Period then this calculation reverts to: 
− First dose date in Open-Label Extension 2 Period – date of first BKZ 320mg Q8W 
dose in the current study period + 1. 
Note: For subjects who die, where BKZ 320mg Q8W is the last dosing schedule received in 
the last study period the subject receives bimekizumab in and date of last consecutive BKZ 
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320mg Q8W dose in current study period+ 56 days extends to a date beyond the date of 
death, then this calculation reverts to: 
− Date of death – date of first BKZ 320mg Q8W dose in the current study period + 1. 
 
Time at risk (days) 
Total time at risk attributed to each dose will be obtained by summing the time(s) at risk at each 
specific dose in each individual study period and deducting n-1, where n is the number of 
non-consecutive periods covered that are being summed. Total time at risk attributed to BKZ 
Total will be obtained by using the time at risk algorithms specified for subjects who do not 
switch study treatments in Section 10.1.5.1. 
• Time at risk at each specific dose in each individual study period is calculated separately as 
follows: 
− Attributed to BKZ 320mg Q4W: 
◦ 
Date of first BKZ 320mg Q8W dose in the next study period – date of first BKZ 
320mg Q4W dose in the current study period. 
Note: If BKZ 320mg Q4W is the last dosing schedule received in the last study period, 
then this calculation reverts to: 
− For all subjects, use the minimum of the following: 
◦ 
Date of last BKZ 320mg Q4W dose in the current study period – date of first BKZ 
320mg Q4W dose in the current study period + 140 days. 
◦ 
Date of first BKZ 320mg Q8W dose in OLE2 - date of first BKZ 320mg Q4W dose 
in the Open-Label Extension Period + 1 day. The OLE and The OLE2 treatment 
periods should not overlap by more than 1 day 
◦ 
Date of last clinical contact – date of first BKZ 320mg Q4W dose in the OLE Period 
+ 1. 
◦ 
Date of death – date of first BKZ 320mg Q4W dose in the current study period + 
1 
− Attributed to BKZ 320mg Q8W: 
◦ 
Date of first BKZ 320mg Q4W dose in the next study period – date of first BKZ 
320mg Q8W dose in the current study period. 
Note: If BKZ 320mg Q8W is the last dosing schedule received in the last study period, 
then this calculation reverts to: 
− For all other subjects, use the minimum of the following: 
◦ 
Date of last BKZ 320mg Q8W dose in the current study period – date of first BKZ 
320mg Q8W dose in the current study period + 140 days. 
◦ 
Date of first dose in OLE2 - date of first BKZ 320mg Q8W dose in the Open-Label 
Extension Period + 1 day.  
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◦ 
Date of last clinical contact – date of first BKZ 320mg Q8W dose in the OLE Period 
+ 1. 
 
Chane #45 
Section 10.1.6 Exposure during the OLE2 Period based on BKZ set  
Eligible subjects from sites in the US or Canada who have completed the Week 144 Visit, 
or are in the SFU, or have completed the SFU of the OLE Period, can roll over to an 
additional OLE2 period. 
Definitions for study medication duration (days) and time at risk (days) during the OLE2 
Period will be provided for the following subjects: 
• Group A: Subjects who roll over directly from OLE to OLE2 
• 
Group B: Subjects who reinitiate bimekizumab and who were in the SFU or had completed the SFU 
of the OLE Period 
Section 10.1.6.1 Group A: Subjects who roll over directly from OLE to OLE2  
Study medication duration (days) 
• Date of last bimekizumab dose in the OLE2 Period – date of first dose in the OLE2 Period + 
56 days 
Note: If date of last bimekizumab dose in the OLE2 Period + 56 days extends to a date 
beyond the final visit date (including PEOT, but not including SFU2), then this calculation 
reverts to: 
− Final visit date (including PEOT, but not including SFU2) – date of first dose in the 
OLE2 Period+ 1. 
Note: For subjects who die, if date of last bimekizumab dose in the OLE2 Period + 56 days 
extends to a date beyond the date of death, then this calculation reverts to: 
− Date of death – date of first dose in the OLE2 Period+ 1. 
Time at risk (days) 
• Use the minimum of the following: 
− Date of last dose in the OLE2 Period – date of first dose in the OLE2 Period + 140 days. 
− Date of last clinical contact – date of first dose in the Open-Label Extension Period + 1. 
− Date of death – date of first dose in the OLE2 Period+1. 
Section 10.1.6.2 Group B: Subjects who reinitiate bimekizumab 
Section 10.1.6.2.1 Subjects reinitiated to receive BKZ Q8W at OLE2 start 
• Study medication duration (days) 
− Date of last bimekizumab dose in the OLE2 period– date of first bimekizumab dose in 
the OLE2 + 56 days 
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Note: If date of last bimekizumab dose in the OLE2 + 56 days extends to a date beyond the 
final visit date (including PEOT, but not including SFU2), then this calculation reverts to: 
− Final visit date (including PEOT, but not including SFU2) – date of first dose in the 
OLE2 Period + 1. 
Note: For subjects who die, if date of last bimekizumab 320mg Q8W dose + 56 days extends 
to a date beyond the date of death, then this calculation reverts to: 
− Date of death – date of first dose in the OLE2 Period + 1. 
• Time at risk (days) 
− Use the minimum of the following: 
◦ 
Date of last dose – date of first dose in OLE2 + 140 days. 
◦ 
Date of last clinical contact – date of first dose in OLE2 + 1.Date of death – date of 
first dose + 1. 
Section 10.1.6.2.2 Subjects reinitiated to receive BKZ Q4W/Q8W at OLE2 start 
• Attributed to BKZ Q4W/Q8W 
− Date of last BKZ 320mg Q8W dose in the OLE2 Period – date of first BKZ 320mg 
Q4W dose in the OLE2 Period + 56 days. 
Note: If date of last bimekizumab dose in the OLE2 Period + 56 days extends to a date 
beyond the final visit date (including PEOT, but not including SFU2), then this calculation 
reverts to: 
− Final visit date (including PEOT, but not including SFU2) – date of first BKZ 
320mg Q4W dose in the OLE2 Period + 1. 
Note: For subjects who die, if date of last bimekizumab dose in the OLE2 Period + 56 days 
extends to a date beyond the date of death, then this calculation reverts to: 
− Date of death – date of first dose in the OLE2 Period + 1 
• If the subject discontinued prior to the switch to Q8W then:  
− Date of last BKZ 320mg Q4W dose in the OLE2 Period – date of first BKZ 320mg 
Q4W dose in the OLE2 Period + 28 days. 
If date of last bimekizumab dose in the OLE2 Period + 28 days extends to a date beyond 
the final visit date (including PEOT, but not including SFU2), then this calculation reverts 
to: 
− Final visit date (including PEOT, but not including SFU2) – date of first BKZ 
320mg Q4W dose in the OLE2 Period + 1. 
Note: For subjects who die prior to switch to Q8W, if date of last bimekizumab dose in the 
OLE2 Period + 28 days extends to a date beyond the date of death, then this calculation 
reverts to: 
Date of death – date of first dose in the OLE2 Period + 1. 
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Time at risk (days) 
• Attributed to BKZ Q4W/Q8W : 
− Use the time at risk algorithm specified for subjects who do not switch study 
treatments in Section 10.1.6.1.   
   
Change #46 
Section 10.2: Adverse events 
The following text (in bold) have been added. 
Adverse events will be coded according to the MedDRA. AEs will be allocated to the respective 
randomized treatment arm. For subjects who switch treatment at Week 16, Week 48 or (on or 
after Week 64), any adverse events that occur after initiation of the new treatment are 
attributable to the new treatment. If an adverse event occurs on the date of a treatment switch, the 
event is attributed to the original treatment. The only exception to this is if the AE fulfills any of 
the criteria specified below: 
 
Change #47 
Section 10.2.1 Data considerations. The PBO subscript in the following formula has been 
changed to SEC 
𝑆𝐸𝑅𝐷= √(𝐼𝑃𝐵𝐾𝑍× (1 −𝐼𝑃𝐵𝐾𝑍
𝑛𝐵𝐾𝑍
)) + (𝑰𝑷𝑺𝑬𝑪× (1 −𝐼𝑃𝑆𝐸𝐶
𝑛𝑆𝐸𝐶
)) 
A separate by-subject listings of all TEAEs for the OLE and the OLE2 treatment periods 
will be provided. 
 
Change #48 
Section 10.2.1.1 COVID-19 related data considerations. The following texts have been added 
The COVID-19 pandemic start date is defined as 11 March 2020 as it is the date the World 
Health Organization declared COVID-19 as a pandemic, see also Section 4.2.1.7.2. Note that the 
Week 48 and Week 96 interim analyses will be conducted during the pandemic therefore a post 
COVID-19 pandemic period is not defined for these analyses. If WHO declares the COVID-19 
pandemic has ended prior to Week 144, then that date may be used to support presentation of a 
post COVID-19 pandemic period. 
 
Incidence of COVID-19 TEAEs will be summarized for the OLE treatment periods based on the 
OLS by treatment group. 
The following PTs will be used to identify COVID-19 adverse events: 
• Corona virus infection 
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• Coronavirus test positive  
By-subject listings of COVID-19 TEAEs will be produced separately for OLE and OLE2 
treatment periods  
To assess the impact of COVID-19 mass vaccination on TEAEs, a sensitivity analysis will 
present all TEAEs excluding TEAEs assessed as exclusively related to COVID-19 vaccine 
by the investigator. TEAEs recorded as related to both study medication and COVID-19 
vaccination should not be excluded. A complementary table of TEAEs related to COVID-
19 vaccine will be presented.  
Another sensitivity analysis will present all TEAEs excluding TEAEs with start date on or 
up to 5 days after date of COVID-19 vaccine. Note that subjects may receive more than one 
administration of COVID-19 vaccine. A complementary table and listing of TEAEs with 
start date on or up to 5 days after date of COVID-19 vaccine will also be presented.  
Complementary listings of TEAEs related to COVID-19 vaccine will be presented for the 
OLE and the OLE2 treatment periods separately. 
 
Change #49  
Section 10.2.2 AE summaries. The following texts in bold have been added 
AE summaries will be provided by actual treatment at the time of the adverse event. Separate 
AE summaries for OLE2 treatment period will be provided by treatment sequence as 
specified in Section 3.6 and will be based on OLS2. 
For subjects who discontinue on or prior to the final scheduled visit of the Initial Treatment 
Period, any AEs that emerged more than after 112 days relative to the first dose but still within 
the 140 days SFU window will be classified as TEAE. However, these AEs will be excluded 
from AE summaries based on the Initial Period but included in the AE summaries for Initial and 
Maintenance Treatment Period. See the description of time at risk in Section 10.1.1 for further 
details. 
 
The following selected outputs will be produced for the SS for the Initial Treatment Period, for 
the MS for the Maintenance Treatment Period, for the SS for the Initial and Maintenance 
Treatment Period, for the OLS for the Open-Label Extension Period:  
• Incidence of TEAEs – Overview 
• Incidence of TEAEs per 100 subject years by SOC, HLT, and PT 
• Incidence of Serious TEAEs per 100 subject years by SOC, HLT, and PT  
• Incidence of TEAEs Leading to Discontinuation per 100 subject-years by SOC, HLT and PT 
• Incidence of TEAEs by decreasing frequency of PT 
 
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The following selected AEs summaries will be provided separately for the Open-Label 
Extension Period, Separate AEs summaries will be provided for the OLE2 treatment period 
by treatment sequence as described in Section 3.6  and will be based on the OLS2: 
• Incidence of COVID-19 TEAEs 
• Incidence of TEAEs Overview 
• Incidence of TEAEs per 100 Subject-Years 
• Incidence of Serious TEAEs per 100 Subject-Years 
• Incidence of Serious TEAEs by Relationship  
• Incidence of TEAEs Leading to Discontinuation per 100 subject-years 
• Incidence of TEAEs Leading to Death 
• Incidence of Non-Serious TEAEs Above Reporting Threshold of 5% by SOC and PT 
• Incidence of Non-Serious TEAEs Above Reporting Threshold of 5% by Relationship SOC 
and PT 
In addition, the following AEs summaries will be provided for the Open-Label Extension 
Period only by treatment at the time of AE onset and will be based on the OLS (excluding 
OLE2 treatment period). 
• Incidence of TEAEs Excluding TEAEs Exclusively Related to COVID-19 Vaccine by 
SOC, HLT, and PT  
• Incidence of TEAEs Exclusively Related to COVID-19 Vaccine by SOC, HLT, and PT  
• Listing of TEAEs Related to COVID-19 Vaccine  
• Incidence of COVID-19 Vaccine Interval Censored TEAEs by SOC, HLT, and PT  
• Incidence of COVID-19 Vaccine Interval TEAEs by SOC, HLT, and PT  
• Listing of COVID-19 Vaccine Interval TEAEs  
 
The following summaries will be provided for the BKZ Set by treatment at the time of AE onset. 
These tables will include AEs from both the double-blind and Open-Label treatment period 
(excluding OLE2 treatment period). AEs that occurred while subjects received secukinumab 
will not be included. 
• Incidence of TEAEs Overview 
• Incidence of TEAEs per 100 Subject-Years 
• Incidence of Serious TEAEs per 100 Subject-Years 
• Incidence of TEAEs by decreasing frequency of PT  
• Incidence of TEAEs per 100 subject years by SOC, HLT, and PT and by Time of Onset 
Relative to COVID-19 pandemic (prior to COVID-19 pandemic, during COVID-19 
pandemic). 
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Change #50 
Section 10.2.3 Other Safety topics of interest. The following texts in bold have been added 
The following summaries for AEs of other safety topics of interest will be provided by actual 
Treatment at the time of the adverse event. The following outputs will be produced separately 
for the SS for the initial treatment period, for the SS for the Initial and Maintenance Treatment 
Period, and for the OLS for the Open-Label Extension Period by treatment group (see 
Section 3.6).  
Along with the tables described, there will be tables which displays the risk difference and 95% 
confidence intervals for each of the topics of interest during the Initial Treatment Period (SS) as 
well as for Initial and Maintenance Treatment Period combined (SS). Corresponding figures 
(with dot plots) will be prepared. No safety topics of interest AE summaries will be produced 
for the Open-Label Extension 2 treatment period (OLS2). 
Listings of all treatment emergent adverse events of other safety topics of interest will be 
provided separately for the OLE and the OLE2 treatment periods. 
 
Change #51 
Section 10.2.3.1 Infections (serious, opportunistic, fungal and Tuberculosis [TB]). The 
following texts in bold were added. 
• Incidence of Opportunistic Infection TEAEs per 100 subject years by SOC, HLT and 
PT 
Opportunistic infections (including tuberculosis) will be summarized in a stand-alone table. 
The table will include all opportunistic infection TEAEs identified using UCB-defined 
search criteria which were adjudicated as opportunistic infections  
 
Change #52 
Section 10.2.3.2 Malignancies. The following paragraphs in bold have been replaced with the 
updated Bimekizumab standard convention. 
These events will be presented in the following tables: 
− One table will be based on the criteria (SMQ) = “Malignant or unspecified tumours 
(SMQ)” 
− One table will be based on the criteria SMQ = ”Malignant tumours (SMQ)”. 
SMQ search should include all TEAEs which code to a PT included in the Scope=Narrow 
group within each SMQ. 
Note that the events included in the “Malignant tumours” table will be a subset of the 
events included in the “Malignant or unspecified tumours” table. While the “Malignant 
tumours (SMQ)” is most relevant, “Malignant or unspecified tumours (SMQ)” must be 
reviewed for potential malignancies. 
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The output table will include 2 different overall incidence rows: 
− The first overall incidence row will summarize “Any malignancies”  and this row 
will summarize the incidence of all AEs flagged for inclusion in the table (using the 
appropriate SMQ depending on the table), regardless of the High Level Term 
(HLT) it codes to 
− The second overall incidence row will summarize “Any malignancy excluding non-
melanomic skin cancers HLT” and this row will summarize the incidence of AEs 
flagged for inclusion in the table (using the appropriate SMQ depending on the 
table), excluding those which code to an HLT of “skin neoplasms malignant and 
unspecified (excl melanoma)”. 
 
Change #53 
Section 10.2.3.3 Cardiac events. The following paragraphs in bold have been replaced with 
the updated Bimekizumab standard convention. 
Potential cardiovascular events are adjudicated by the independent Cardiovascular Event 
Adjudication Committee (CV-CAC) according to the CV-CAC Charter (version 6.0).  
Adjudicated events are classified by the CV-CAC to one of the event types as defined in the 
table below. The classification of an event as a Major Adverse Cardiac Event (MACE) is 
also determined by the CV-CAC. Events which are classified by the CV-CAC as any of the 
events types identified in the third column of the table will be considered an extended 
MACE. Note that extended MACE is determined programmatically and includes a broader 
scope definition of MACE.  
MACE as determined by the CV-CAC will be presented in a table and listing. Extended 
MACE will be presented separately in a table and listing. Additional listings of all MACE 
as determined by the CV-CAC will be presented separately for the OLE and the OLE2 
treatment periods. 
Another table and listing will present the adjudicated cardiovascular events by type. For 
each cardiovascular event type, the individual PTs which fall within each event type will be 
summarized. This listing will indicate whether each event was determined to be a MACE 
and/or an extended MACE. Similar listings of the adjudicated cardiovascular events by 
type will be presented separately for the OLE and the OLE2 treatment periods. 
Additionally, a listing of all events identified for potential review by the CV-CAC will be 
produced. This listing will indicate whether each event was identified by the CV-CAC 
Chair for full committee review. Similar listings of all events identified for potential review 
by the CV-CAC will be produced separately for the OLE and the OLE2 treatment periods. 
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Cardiovascular event classifications 
Event 
Type 
Code 
Event Type 
Extended 
MACE 
1 
Non-Fatal Myocardial Infarction (MI) 
Yes 
2 
Non-Fatal Stroke: hemorrhagic 
Yes 
3 
Non-Fatal Stroke: ischemic 
Yes 
4 
Non-Fatal Stroke: embolic 
Yes 
5 
Non-Fatal Stroke: undeterminable 
Yes 
6 
Hospitalization or ER for Unstable Angina with urgent 
revascularization 
Yes 
7 
Hospitalization or ER for Unstable Angina without urgent 
revascularization 
No 
8 
Hospitalization for Heart Failure 
Yes 
9 
Transient Ischemic Attack (TIA) 
No 
10 
Coronary Revascularization Procedures (e.g. percutaneous coronary 
intervention, coronary artery bypass grafting) 
Yes 
11 
Urgent Revascularization Procedures (i.e. due to symptoms of brain 
ischemia or pending infarction) 
Yes 
12 
Arrhythmia (not associated with ischemia) 
No 
13 
Peripheral Arterial Event 
No 
14 
Venous Thromboembolic Event: pulmonary embolism (PE) 
No 
15 
Venous Thromboembolic Event: deep vein thrombosis (DVT) 
No 
16 
Venous Thromboembolic Event: PE and DVT 
No 
17 
Other CV Event 
No 
18 
Death due to Myocardial Infarction (MI) 
Yes 
19 
Death due to Stroke 
Yes 
20 
Sudden Cardiac Death 
Yes 
21 
Other CV Death (e.g. heart failure, pulmonary embolism, 
cardiovascular procedure-related) 
Yes 
22 
Cardiovascular: Undetermined Cause of Death (i.e. cause of death 
unknown) 
Yes 
23 
Non-Cardiovascular Death 
No 
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Cardiovascular event classifications 
Event 
Type 
Code 
Event Type 
Extended 
MACE 
24 
Non-Cardiovascular Event 
No 
99 
Inadequate information to adjudicate 
No 
 
Change #54 
Section 10.2.3.5 Suicidal Ideation and Behavior (SIB) The following paragraphs in bold 
have been replaced with the updated Bimekizumab standard convention. 
Potential neuropsychiatric events are adjudicated by the independent Neuropsychiatric 
Adjudication Committee according to the Neuropsychiatric Adjudication Committee 
(version 8.0).  Adjudicated events are classified by the Committee as Suicidal or Non-
suicidal. Adjudicated events are also further classified by the Committee to one of the event 
types as defined in the neuropsychiatric Table below. Suicidal Ideation and Behavior (SIB) 
is defined as events classified by the Committee as Suicidal. 
A table and listing will present SIB events. This listing will also be provided separately for 
OLE and OLE2 treatment periods. 
Another table and listing will present the adjudicated neuropsychiatric events by type. For 
each neuropsychiatric event type, the individual PTs which fall within each event type will 
be summarized. This listing will indicate whether each event was determined to be Suicidal 
or Non-Suicidal. For event type suicidal ideation, the listing will also indicate if intent was 
present and if the suicidal ideation was clinically significant. A similar listing of the 
adjudicated neuropsychiatric events by type will be presented. 
Additionally, a listing of all events identified for potential review by the Committee will be 
produced. This listing will indicate whether each event was identified by the 
Neuropsychiatric Event Adjudication Committee Chair for full committee review. Similar 
listings will be provided separately for the OLE and the OLE2 treatment periods. 
 
Neuropsychiatric event classifications 
Event 
Type 
Code 
Event 
Classification 
Event Type 
1 
Suicidal 
Suicidal events/completed suicide 
2 
Suicidal 
Suicide attempt 
3 
Suicidal 
Preparatory acts toward imminent suicidal behavior 
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Neuropsychiatric event classifications 
Event 
Type 
Code 
Event 
Classification 
Event Type 
4 
Suicidal/Non-
suicidalc 
Suicidal ideation 
7 
Non-suicidal 
Nonsuicidal Self-injurious behavior 
8 
Non-suicidal 
Nonsuicidal Other 
99 
Not applicable 
Inadequate information to adjudicate 
Suicidal ideation event types can be classified by the Neuropsychiatric Adjudication Committee as Suicidal or  
Non-suicidal depending on whether intent to die was present 
 
Change #55 
10.2.3.6 
Inflammatory bowel disease. The following paragraphs in bold have been replaced 
with the updated Bimekizumab standard convention. 
• 
Incidence of Inflammatory Bowel Disease TEAEs per 100 subject years by SOC, HLT 
and PT 
Selected gastrointestinal events are adjudicated by the independent Inflammatory Bowel 
Disease (IBD) Adjudication Committee (IBD-CAC) according to the IBD-CAC Charter 
(version 3.0).  Adjudicated events are classified by the IBD-CAC into one of the diagnostic 
types as defined in the IBD event classifications Table below. The events will further be 
classified as definite, probable or possible IBD. 
An overview of adjudicated IBD events will be stratified by subjects with or without a 
previous medical history of IBD. Previous medical history of IBD will be determined using 
the information recorded on the Extra-Articular Assessment at Screening CRF page 
("Does subject have a history of IBD?”). This overview table will present events 
adjudicated by the IBD-CAC as either possible, probable or definite IBD. Definite and 
probable IBD will also be aggregated and summarized in this table. In addition, this table 
will summarize each IBD event classification (possible, probable or definite) separately. 
Another table and listing will present the adjudicated IBD events by type. For each IBD 
event type, the individual PTs which fall within each event type will be summarized. 
Similar listings of the adjudicated IBD events by type will be presented separately for OLE 
and OLE2 treatment periods. 
Additionally, a listing of all events identified for potential review by the IBD-CAC will be 
produced. This listing will indicate whether each event was identified by the IBD-CAC 
Chair for full committee review. Similar listings of all events identified for potential review 
by the IBD-CAC Chair for full committee review will be produced separately for the OLE 
and the OLE2 treatment periods. 
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A further supportive listing will present the individual diagnostic criteria met for each 
adjudicated IBD event. This listing will also be presented separately for the OLE and the 
OLE2 treatment periods combined  
IBD event classifications 
Event 
Type 
Code 
Event Type (Classification and diagnosis) 
Classification 
1 
Possible Inflammatory Bowel Disease – Crohn’s Disease 
Possible 
2 
Probable Inflammatory Bowel Disease – Crohn’s Disease 
Probable 
3 
Definite Inflammatory Bowel Disease – Crohn’s Disease 
Definite 
4 
Possible Inflammatory Bowel Disease – Ulcerative Colitis 
Possible 
5 
Probable Inflammatory Bowel Disease – Ulcerative Colitis 
Probable 
6 
Definite Inflammatory Bowel Disease – Ulcerative Colitis 
Definite 
7 
Possible Inflammatory Bowel Disease – type unclassified 
Possible 
8 
Probable Inflammatory Bowel Disease – type unclassified 
Probable 
9 
Definite Inflammatory Bowel Disease – type unclassified 
Definite 
10 
Symptoms not consistent with Inflammatory Bowel Disease 
Not applicable 
11 
Possible Inflammatory Bowel Disease – Microscopic Colitis 
Possible 
12 
Probable Inflammatory Bowel Disease – Microscopic Colitis 
Probable 
13 
Definite Inflammatory Bowel Disease – Microscopic Colitis 
Definite 
14 
Possible Inflammatory Bowel Disease – no further 
differentiation possible 
Possible 
15 
Probable Inflammatory Bowel Disease – no further 
differentiation possible 
Probable 
16 
Definite Inflammatory Bowel Disease – no further 
differentiation possible 
Definite 
99 
Not enough information to adjudicate 
Not applicable 
IBD=inflammatory bowel disease. 
Note: IBD diagnoses of “microscopic colitis” and “no further differentiation possible” were added in an adjudication 
charter amendment, accounting for the event type numbering. 
 
Change #56 
10.2.3.7 
Hypersensitivity (including anaphylaxis). The following paragraphs in bold have 
been replaced with the updated Bimekizumab standard convention. 
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• 
Incidence of Anaphylactic Reaction TEAEs per 100 subject years by SOC, HLT and PT 
A separate table will be prepared based on the MedDRA anaphylaxis Algorithm (see 
Appendix 1) for acute anaphylactic events (reported on the same day as when an injection 
was administered or one day after). An AE glossary table will also be produced to 
summarize the MedDRA coding for these events. The glossary table will include the 
following fields: reported term, PT, LLT, HLT, and SOC. 
A separate table will be prepared to summarize hypersensitivity events, identified using the 
SMQ “Hypersensitivity (SMQ)”. All TEAEs which code to a PT included in the 
Scope=Narrow search will be included in this table. In addition, a separate table will be 
prepared to summarize serious hypersensitivity events, identified using the SMQ 
“Hypersensitivity (SMQ)”. All serious TEAEs which code to a PT included in the 
Scope=Narrow search will be included in this table. An AE glossary table will also be 
produced to summarize the MedDRA coding for these events. The glossary table will 
include the following fields: reported term, PT, LLT, HLT, and SOC. 
Furthermore, a separate table will be prepared to summarize injection site reactions, 
identified using the HLTs: “Administration site reactions NEC” and “Injection site 
reactions”. 
 
Change #57 
Section 10.2.3.8 Hepatic events. The following paragraphs in bold have been replaced with 
the updated Bimekizumab standard convention. 
• 
Incidence of hepatic events TEAEs per 100 subject years by SOC, HLT and PT 
A table for hepatic events will be created based on the SMQ of “Drug related hepatic 
disorders - comprehensive search (SMQ)”. However, these 2 sub-SMQs are to be excluded: 
“Liver neoplasms, benign (incl cysts and polyps) (SMQ)” and “Liver neoplasms, malignant 
and unspecified (SMQ)”. For each of the above SMQs, include all TEAEs which code to a 
PT included in the Scope=Broad and/or Scope=Narrow. 
Note that all AEs meeting the above criteria are to be included. It should not be limited to 
events that the investigator determined to be related to study drug. 
Cases of Hy’s Law will be reported separately in a liver function test table. Section 10.3 
A by-subject listing of all AEs of safety topics of interest by type of safety topics of interest 
will be provided. 
 
Change #58  
Section 10.3 Clinical laboratory evaluations. The following texts in bold have been added 
• A shift table of the number and percentage of subjects experiencing CTCAE grade 0, 1, 2, 3, 
or 4 values (as applicable) at Baseline to minimum/maximum post-Baseline CTCAE grade, 
by laboratory variable and treatment group. Two separate tables will show results for the 
initial treatment period (for the SS) and the Initial and Maintenance Treatment Period (for the 
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MS). An additional table for the OLE period will be provided for the OLS by treatment the 
subjects were receiving at the time of the assessment of the value with the given CTCAE 
grade. A lipid profile table of treatment emergent markedly abnormal laboratory data 
will be provided for Initial and Maintenance Treatment Period (SS) and Open-label 
Extension treatment period (OLS) separately. 
In addition, a shift table of number and percentage of subjects experiencing post-
Baseline HDL Low risk (≥ 1.55 mmol/L), Intermediate risk ( ≥ 1.04 - < 1.55 mmol/L) 
and High risk (< 1.04 mmol/L) compared to baseline will be provided for then Initial 
and Maintenance Treatment Period (SS) and the  Open-Label Extension Treatment 
Period  (OLS). 
A figure of neutrophil values over time for subjects with at least one markedly abnormal 
neutrophil value (CTCAE Grade 3 or 4) will also be presented. 
A by-subject listing of all laboratory data (including urinalysis) will be provided. Separate 
by-subject listings for the OLE and the OLE2 treatment periods will be provided. These 
listings will be presented by treatment group and will include: center, subject identifier, age, sex, 
race, weight, visit, laboratory variable, result (with abnormal values flagged as “L” or “H” 
accordingly) and unit. 
. 
In addition, a table will be produced to summarize potential Hy’s Law cases. The following two 
definitions will be used in that table: 
•  [AST ≥3xULN or ALT ≥3xULN] and  
• Total Bilirubin ≥2xULN in the absence of ALP ≥2xULN 
 
In order to meet the above criteria, a subject must experience the elevation in bilirubin and 
ALT or AST (and the absence of ALP elevation, if applicable) at the same visit. For 
example, a subject who experiences a ≥2 x ULN elevation of bilirubin at one visit and a 
≥3xULN elevation in ALT (or AST) at a subsequent visit has not fulfilled the Hy’s law 
criteria. 
Potential hepatotoxicity (meeting one of the pDILI or Hy’s law laboratory criteria at least 
once) will be considered with and without symptoms potentially associated with hepatitis or 
hypersensitivity according to the investigator (reported on the Symptoms of Hepatitis and 
Hypersensitivity CRF page).” 
A table for potential drug induced liver injuries (pDILI) will be presented by treatment 
group for subjects with at least one post-Baseline liver laboratory assessment. Number and 
percentage of subjects meeting laboratory criteria for pDILI for at least 1 visit and 
reporting at least 1 symptom potentially associated with hepatitis or hypersensitivity 
according to the Investigator on the pDILI CRF will be presented. All criteria must be met 
at the same visit for subjects who potentially meet Hy’s law criteria at least 1 time during 
exposure to be counted as potential Hy’s Law. 
 
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Change #59 
Section 10.4.1 Vital signs. The following texts in bold have been added 
The following vital signs variables should be summarized: systolic blood pressure (mmHg), 
diastolic blood pressure (mmHg), body temperature (°C) and heart rate (beats/min). The 
following summary will be provided for the Initial Treatment Period (SS) for Initial and 
Maintenance Treatment Period, and for the Open-Label Extension Period (OLS). Vital signs will 
not be summarized for the OLE2. 
• A summary of the absolute and change from Baseline value for each vital sign variable by 
treatment group and visit. 
• A shift from Baseline to Post-Baseline systolic and diastolic blood pressure values based 
on the following categorization will be provided for the Initial and Maintenance 
Treatment Period (SS), and the Open-label Extension Period (OLS): 
− Hypotension: systolic blood pressure <90 mmHg or diastolic blood pressure <60 
− Normal: systolic blood pressure ≥90 and <120 mmHg and diastolic blood pressure 
≥60 and <80 mmHg 
− Elevated: systolic blood pressure between 120-129 mmHg and diastolic blood 
pressure <80 
− Stage 1: systolic blood pressure between 130-139 mmHg or diastolic blood pressure 
between 80-89 
− Stage 2: systolic blood pressure ≥140 and ≤180 mmHg or diastolic blood pressure 
≥90 and ≤120 mmHg 
− Hypertensive crisis: systolic blood pressure >180 mmHg and/or diastolic blood 
pressure >120 mmHg.  
A by-subject listing of all vital signs data will be provided. This listing will be presented by 
treatment group and will include: center, subject identifier, age, sex, race, weight, visit, vital sign 
variable and result (with abnormal values flagged as “L” or “H” accordingly). This listing will 
also be provided separately for the OLE and the OLE2 treatment periods. 
 
Change #60 
Section 10.4.2 Physical examination. The following texts in bold have been added. 
Abnormal results of the physical examination together with details of abnormalities: abnormality 
clinically significant or not, will be listed by subject and visit separately for the Initial and 
Maintenance (SS), Open-Label Extension (OLS) and Open-Label Extension 2 (OLS2) 
treatment periods. 
 
Change 61  
Section 10.4.3 Electrocardiograms. The following texts in bold have been added 
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Two separate by-subject listing of all 12-lead ECG data will be provided based on interpretation 
from central reader and from site.  
 
Change #62 
Section 10.4.4.2 Assessment and management of TB and TB risk factors. The following texts 
in bold have been added 
A by-subject listing of the “Evaluation of signs and symptoms of tuberculosis” questionnaire 
data and IGRA results will be provided. This listing will also be provided separately for the 
OLE and the OLE2 treatment periods. 
A by-subject listing of the result of chest x-ray for tuberculosis will be provided by treatment. 
 
Change #63 
Section 10.4.4.2 Electronic Columbia Suicide Severity Rating Scale (eC-SSRS. The 
following texts in bold have been added 
A by-subject listing of the eC-SSRS questionnaire data will be provided by treatment group. 
This listing will also be provided separately for the OLE and OLE2 treatment periods. 
 
Change #64 
Section 10.4.4.3 Pregnancy testing. The following texts in bold have been added. 
A by-subject listing of the pregnancy test data will be provided by treatment group.  
 
Change #65 
Section 10.4.4.5 Patient Health Questionnaire 9 (PHQ-9) . The following texts in bold have 
been added 
The number and percentage of subjects with a PHQ-9 score ≥ 15 at any point while on treatment 
and the number and percentage of subjects with a PHQ-9 score ≥ 20 at any point while on 
treatment will also be presented based on observed case data. 
A by-subject listing of PHQ-9 data will be provided separately for the OLE and the OLE2 
treatment periods. This listing will include site, subject number, visit, total score observed 
result, and total score change from Baseline value. 
Change #66 
Section 12.2 Apendix B  
Table 13‒1: Definitions of CTCAE grades by biochemistry parameter 
The CTCAE grades (1-4) for the following Lab parameters in bold have been added to Table 
12.1: 
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Parameter (unit) 
Definition 
Unit 
Grade 
1 
Grade 
2 
Grade 3 
Grade 4 
Alanine 
Aminotransferase               
High 
UL 
>ULN 
- 3.0 x 
ULN 
>3.0 - 
5.0 x 
ULN 
>5.0 - 20.0 x 
ULN 
>20.0 x ULN 
Alkaline 
Phosphatase                                   
High 
UL 
>ULN 
- 2.5 x 
ULN 
>2.5 - 
5.0 x 
ULN 
>5.0 - 20.0 x 
ULN 
>20.0 x ULN 
Aspartate 
Aminotransferase                       
High 
U/L 
>ULN 
- 3.0 x 
ULN 
>3.0 - 
5.0 x 
ULN 
>5.0 - 20.0 x 
ULN 
>20.0 x ULN 
Bilirubin 
High 
umol/L 
>ULN 
- 1.5 x 
ULN 
>1.5 - 
3.0 x 
ULN 
>3.0 - 10.0 x 
ULN 
>10.0 x ULN 
Gamma Glutamyl  
Transferase 
High 
U/L 
>ULN 
- 2.5 x 
ULN 
>2.5 - 
5.0 x 
ULN 
>5.0 - 20.0 x 
ULN 
>20.0 x ULN 
Glucose                    
High 
mg/dL 
Fasting 
glucose 
value 
>ULN 
- 
160 
mg/dL;  
Fasting 
glucose 
value 
>160 - 
250 
mg/dL; 
>250 - 500 
mg/dL 
hospitalization 
indicated 
>500 mg/dL 
lifethreatening 
consequences 
Creatinine 
High 
mmol/L 
>ULN-
1.5 x 
ULN 
(>1.5 – 
3.0) x 
ULN 
(>3.0 – 6.0) x 
ULN 
6.0 x ULN 
Sodium 
Low 
mmol/L 
130-
<LLN 
N/A 
120-<130 
<120 
Sodium 
High 
mmol/L 
>ULN-
150 
>150-
155 
>155-160 
>160 
Potassium 
Low 
mmol/L 
3.0-
<LLN 
3.0-
<LLN 
2.5-<3.0 
<2.5 
Potassium 
High 
mmol/L 
>ULN-
5.5 
>5.5-
6.0 
>6.0-7.0 
>7.0 
Calcium 
Low 
mmol/L 
2.0-
<LLN 
1.75-
<2.0 
1.5-<1.75 
<1.5 
Calcium 
High 
mmol/L 
>ULN-
2.9 
>2.9-
3.1 
>3.1-3.4 
>3.4 
Magnesium 
Low 
mmol/L 
0.5-
<LLN 
0.4-
<0.5 
0.3-<0.4 
<0.3 
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Magnesium 
High 
mmol/L 
>ULN-
1.23 
N/A 
>1.23-3.30 
>3.30 
Total cholesterol 
High 
mmol/L 
>ULN-
7.75 
>7.75-
10.34 
>10.34-12.92 
>12.92 
Triglyceride 
High 
mmol/L 
1.71 - 
3.42 
>3.42 - 
5.7 
>5.7 - 11.4 
>11.4 
 
Change #67 
12.1 
Appendix A: MedDRA algorithmic approach to anaphylaxis. The Table has been 
replaced with the following texts  
Appendix A: MedDRA algorithmic approach to anaphylaxis 
The SMQ Anaphylactic reaction consists of three parts: 
1. A narrow search containing PTs that represent core anaphylactic reaction terms  
• Category A – core anaphylactic reaction terms 
− Anaphylactic reaction 
− Anaphylactic shock 
− Anaphylactic transfusion reaction 
− Anaphylactoid reaction 
− Anaphylactoid shock 
− Circulatory collapse 
− Dialysis membrane reaction 
− Kounis syndrome 
− Procedural shock 
− Shock 
− Shock symptom 
− Type I hypersensitivity 
2. A broad search that contains additional terms that are added to those included in the narrow 
search. These additional terms are signs and symptoms possibly indicative of anaphylactic 
reaction and categorized in B, C, or D. 
• Category B (Upper Airway/Respiratory terms) 
− Acute respiratory failure 
− Asthma 
− Bronchial oedema 
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− Bronchospasm 
− Cardio-respiratory distress 
− Chest discomfort 
− Choking 
− Choking sensation 
− Circumoral oedema 
− Cough 
− Cough variant asthma 
− Cyanosis 
− Dyspnoea 
− Hyperventilation 
− Irregular breathing 
− Laryngeal dyspnoea 
− Laryngeal oedema 
− Laryngospasm 
− Laryngotracheal oedema 
− Mouth swelling 
− Nasal obstruction 
− Oedema mouth 
− Oropharyngeal oedema 
− Oropharyngeal spasm 
− Oropharyngeal swelling 
− Pharyngeal oedema 
− Pharyngeal swelling 
− Respiratory arrest 
− Respiratory distress 
− Respiratory failure 
− Reversible airways obstruction 
− Sensation of foreign body 
− Sneezing 
− Stridor 
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− Swollen tongue 
− Tachypnoea 
− Throat tightness 
− Tongue oedema 
− Tracheal obstruction 
− Tracheal oedema 
− Upper airway obstruction 
− Wheezing 
• Category C (Angioedema/Urticaria/Pruritus/Flush terms) 
− Acquired C1 inhibitor deficiency 
− Allergic oedema 
− Angioedema 
− Circumoral swelling 
− Erythema 
− Eye oedema 
− Eye pruritus 
− Eye swelling 
− Eyelid oedema 
− Face oedema 
− Flushing 
− Hereditary angioedema with C1 esterase inhibitor deficiency 
− Injection site urticaria 
− Lip oedema 
− Lip swelling 
− Nodular rash 
− Ocular hyperaemia 
− Oedema 
− Oedema blister 
− Periorbital oedema 
− Periorbital swelling 
− Pruritus 
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− Pruritus allergic 
− Rash 
− Rash erythematous 
− Rash pruritic 
− Skin swelling 
− Swelling 
− Swelling face 
− Swelling of eyelid 
− Urticaria 
− Urticaria papular 
• Category D (Cardiovascular/Hypotension terms) 
− Blood pressure decreased 
− Blood pressure diastolic decreased 
− Blood pressure systolic decreased 
− Cardiac arrest 
− Cardio-respiratory arrest 
− Cardiovascular insufficiency 
− Diastolic hypotension 
− Hypotension 
− Hypotensive crisis 
− Post procedural hypotension 
3. An algorithmic approach which combines a number of anaphylactic reaction symptoms in 
order to increase specificity. A case must include one of the following where both occur on 
either the same day as when an injection was administered or one day after, and for scenarios 
where two must have been reported, both events must have occurred within one day of each 
other: 
• A narrow term or a term from Category A 
• A term from Category B – (Upper Airway/Respiratory) AND a term from Category C – 
(Angioedema/Urticaria/Pruritus/Flush) 
• A term from Category D – (Cardiovascular/Hypotension) AND [a term from Category B – 
(Upper Airway/Respiratory) OR a term from Category C – 
(Angioedema/Urticaria/Pruritus/Flush) 
• Hypersensitivity events will be identified using the “Hypersensitivity (SMQ)”. All TEAEs 
which code to a PT included in the Scope=Narrow search will be included. 
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Change #68 
The following Section 12.4 Appendix D has been added: 
Appendix D: Efficacy analyses by data cut visit 
Table 13‒2: Efficacy analyses reporting 
Parameter 
Week 48 
Week 96 
Week 
144/OLEa 
Final/OL
E2b 
PASI100 
X 
X 
X 
X 
PAS90 
X 
X 
X 
X 
PASI75 
X 
 
X 
 
Absolute change and percent change from Baseline 
in PASI score 
X 
X 
X 
 
Absolute PASI scores of ≤1, ≤2, ≤3, ≤5, 
X 
X 
X 
 
Time to PASI100 response 
X 
 
 
 
Time to PASI90 response 
X 
 
 
 
Time to PASI75 response 
X 
 
 
 
IGA Clear 
X 
X 
X 
X 
IGA Clear or Almost Clear 
X 
X 
X 
X 
IGA Change from Baseline 
X 
 
 
 
Scalp IGA Clear or Almost Clear 
X 
X 
X 
 
Palmoplantar IGA Clear or Almost Clear 
X 
X 
X 
 
Change from Baseline in DLQI Total Score 
X 
X 
X 
 
DLQI Total Score of 0 or 1 
X 
X 
X 
X 
MCID ≥4 more in DLQI 
X 
X 
X 
 
mNAPSI100 
X 
X 
X 
 
mNAPSI90 
X 
X 
X 
 
mNAPSI75  
X 
X 
X 
 
Change from Baseline in mNAPSI score 
X 
X 
X 
 
Change from Baseline in Psoriasis BSA 
X 
X 
X 
 
Patient Global Assessment of PSO 
X 
 
 
 
Absolute and percent change from Baseline in BSA 
affected by PSO  
X 
X 
X 
 
Psoriasis BSA values of 0%, ≤1%, ≤3%, ≤5%, 
X 
X 
X 
 
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Parameter 
Week 48 
Week 96 
Week 
144/OLEa 
Final/OL
E2b 
Absolute and percent change from Baseline in the 
product of IGA and BSA 
X 
 
X 
 
PSD response (itch, pain and scaling) 
X 
X 
X 
X 
PSD 0 or 1 (itch, pain and scaling) 
X 
X 
X 
 
PSD 0 (itch, pain and scaling) 
X 
X 
X 
 
PGADA for arthritis analog scale 
X 
 
X 
 
PASE 
X 
 
X 
 
PASE (<47 versus ≥47) 
X 
 
 
 
EQ-5D-3L 
X 
 
X 
 
WPAI-SHP 
X 
 
X 
 
a All Week 48 analyses will also be re-run at Week 144/OLE. 
b  All Week 48 and Week 144 analyses will also be rerun at Final/OLE2 
 
 
 
 
 
 
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STATISTICAL ANALYSIS PLAN SIGNATURE PAGE 
This document has been reviewed and approved per the Review and Approval of Clinical 
Documents Standard Operating Procedures. Signatures indicate that the final version of the 
Statistical Analysis Plan (SAP) or amended SAP is released for execution. 
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Approval Signatures
Name:
ps0015-sap-amendment-4 v1.0
Version:
1. 0
Document Number:
CLIN-000185626
Title:
PS0015 SAP amendment 4 v1.0
Approved Date:
15 Mar 2022
Document Approvals
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 15-Mar-2022 09:13:08 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 15-Mar-2022 15:50:27 GMT+0000
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