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: PHASE3
Conditions: Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis
Sponsor: UCB Biopharma SRL

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 
C
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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
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 6 of 263
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
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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
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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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Clinical Study Protocol
Bimekizumab
PS0015
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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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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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Bimekizumab
PS0015
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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
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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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01 Oct 2021
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Bimekizumab
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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
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
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Page 20 of 263
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
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multiple treatment visits and varying efficacy limits its use in the market.
x
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patients. Toxicity concerns, particularly in older patients, are a major drawback.
x
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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.
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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
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 21 of 263
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.

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. 
Guselkumab inhibits the release of pro-inflammatory cytokines and chemokines.
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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
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 22 of 263
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
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 23 of 263
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
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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
PASI75, PASI90, and PASI100 response
x
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Absolute and percent change from Baseline in PASI 
x
Percentage of subjects with PASI ≤1, ≤2, ≤3, and ≤5
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 26 of 263
x
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Baseline)
x
Shift from Baseline in IGA score
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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)
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Change from Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) score for 
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nail PSO at Baseline
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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)
x
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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application and any extensions or variations thereof. 

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
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
32
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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
X
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32
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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.
PUBLIC
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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
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)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
X
mNAPSIj
X
X
X
X
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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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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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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.
=90% im
90% im
change fr
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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)

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
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(oral, injectable, implantable)
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 53 of 263
o
Intrauterine hormone-releasing system 
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Vasectomized partner
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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
C
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H
C
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
H
C
H
H
Bimekizumab 
320mg Q4W
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
Bimekizumab 
320mg Q8W
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
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
OLE2 W4
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OLE2 W12 a
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OLE2 W32
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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 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
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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
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Hepatitis B and Hepatitis C
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x
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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
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AEs
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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
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Anti-bimekizumab antibodies
x
Tuberculosis questionnaire
x
PASI
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 72 of 263
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
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Anti-bimekizumab antibodies
x
PASI
x
Percentage of BSA
x
IGA
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 73 of 263
x
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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:

Hematology and biochemistry
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Urine pregnancy test
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Bimekizumab/secukinumab plasma concentrations

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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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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Bimekizumab/secukinumab plasma concentrations

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x
Tuberculosis questionnaire (Week 12 only)
x
PASI
x
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DLQI
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x
Patient Global Assessment of psoriasis
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
Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling
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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 76 of 263
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AEs
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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
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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
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obtained prior to blood sampling
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 77 of 263
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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Bimekizumab/secukinumab plasma concentrations
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Anti-bimekizumab antibodies
x
Tuberculosis questionnaire
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.
8.2.9
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

Urinalysis

Urine pregnancy test
x
Record 12-lead ECG
x
PASI
x
Percentage of BSA
x
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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x
scalp IGA for subjects with scalp involvement at Baseline
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x
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x
WPAI-SHP V2.0
x
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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
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PHQ-9
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 79 of 263
x
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AEs
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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
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PASE
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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
EQ-5D-3L
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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
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
PASE
x
PGADA (only for subjects with PsA)
x
WPAI-SHP V2.0
x
EQ-5D-3L
x
eC-SSRS
x
Concomitant medication
x
AEs
x
Contact IRT
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

IGRA tuberculosis test

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
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
x
pp-IGA for subjects with palmoplantar involvement at Baseline
x
PASE
x
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x
WPAI-SHP V2.0
x
EQ-5D-3L
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.
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
x
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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:

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
Blood sample for bimekizumab plasma concentrations
x
Blood sample for anti‑bimekizumab antibodies
x
IGRA TB test
x
scalp IGA
x
mNAPSI
x
pp-IGA
x
EQ-5D-3L
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
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 97 of 263
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
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
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
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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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01 Oct 2021
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Bimekizumab
PS0015
Confidential
Page 101 of 263
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
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 102 of 263
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
The outcome date of the first AE that is not related to the natural course of the disease being 
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
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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
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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
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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
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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
Urine drug screen
MCHC
ALP
MCV
AST
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ALT
RBC count
GGT
WBC count
Total bilirubin
LDH
CRPb
Lipid panelb
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
Confidential
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.
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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
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hypersensitivity
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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
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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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UCB
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Bimekizumab
PS0015
Confidential
Page 118 of 263
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
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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.
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than 4 weeks after the start of an appropriate prophylactic therapy.
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TB must be reported as an SAE. The Investigator is to complete and submit the TB Follow-Up
Form provided.
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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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UCB
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Bimekizumab
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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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UCB
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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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UCB
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Bimekizumab
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Page 123 of 263
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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UCB
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Bimekizumab
PS0015
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Page 124 of 263
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
Clinical Study Protocol
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
Confidential
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
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x
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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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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.
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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
Clinical Study Protocol
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
Clinical Study Protocol
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
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Bimekizumab
PS0015
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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
Bimekizumab 320mg (350 subjects)
x
Secukinumab (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%.
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
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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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Confidential
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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
Inclusion/exclusion
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 142 of 263
Physical examd, e
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
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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:

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“Since Last Visit” version of the eC-SSRS
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Severe major depression as indicated by a PHQ-9 score ≥20
COPY 
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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
●●
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●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
Secukinumab 
300mg 
▲▲
▲▲
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▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
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 
▲▲
▲▲
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▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
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
01 Oct 2021
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Bimekizumab
PS0015
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
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
01 Oct 2021
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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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01 Oct 2021
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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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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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Page 161 of 263
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
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.
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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
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Informed consent
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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
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HIV testingi
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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
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28
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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 
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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
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32
32
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of
th

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
C
LIC
X
BL
UBL
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PU
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COPY 
X
Y
X
PY
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This document 
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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
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ECG=e
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32
32
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of
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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
PUBLIC 
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thereo

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
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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
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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
●●
○○
○○
○○
●●
●●
●●
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●●
●●
●●
●●
●●
●●
●●
●●
Q8W
●●
○○
●●
○○
●●
○○
●●
○○
Secukinumab 
300mg 
▲▲
▲▲
▲▲
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▲▲
▲▲
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▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
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
Upon confirmation of subject’s eligibility, randomization will occur
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
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.
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
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
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

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
x
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DLQI
x
Patient symptoms (itch, pain, and scaling)
x
PHQ-9
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EQ-5D-3L
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Concomitant medication
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AEs
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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
x
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:

Hematology and biochemistry
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Urinalysis
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Urine pregnancy test

IGRA tuberculosis test

Bimekizumab plasma concentrations

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
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PASI
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IGA
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DLQI
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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.
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

Anti-bimekizumab antibodies
x
Record 12-lead ECG
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PASI
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DLQI
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Patient symptoms (itch, pain, and scaling)
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PHQ-9
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pp-IGA for subjects with palmoplantar involvement at Baseline
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WPAI-SHP V2.0
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EQ-5D-3L
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eC-SSRS
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Concomitant medication
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AEs
x
Contact IRT
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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
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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
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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.
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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
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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 
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Essential: Must have 
repeat liver chemistry 
values and additional 
testing completed 
ASAP (see 
Section 12.2.1.3); 
recommended to 
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HCP.
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twice per week until values 
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values. d
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up requirements). c
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required (see 
Section 12.2.1.2).
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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
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Immediate IMP 
discontinuation 
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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 
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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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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, 
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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:
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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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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
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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
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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
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C
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H
C
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C
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H
C
H
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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
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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
300mg Q4W
Bimekizumab 
320mg Q4W
Bimekizumab 
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Q4W
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 
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●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
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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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
C
C
H
C
H
C
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H
C
H
H
C
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H
C
H
H
C
H
H
C
H
H
Bimekizumab 
320mg Q4W
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
Bimekizumab 
320mg Q8W
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
●●
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 
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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
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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
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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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Group A f
scalp IGA
Group A f
mNAPSI
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Group A f
PASE
Group A f
PGADA
Group A f
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X
X
X
X
X
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Group B
Group Af + B
X
X
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UCB
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
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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
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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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
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OLE2 W40
C
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●●
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Bimekizumab 320mg Q8W
●●
●●
●●
●●
●●
●●
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
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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:

Hematology and biochemistry

Urinalysis

Urine pregnancy test
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
Blood sample for bimekizumab plasma concentrations
x
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x
IGRA TB test
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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
Patient symptoms (itch, pain, and scaling)
x
PHQ-9
x
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 256 of 263
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:

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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
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should be obtained prior to blood sampling
x
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be obtained prior to dosing:
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x
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x
PASI
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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
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.
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
AEs
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UCB
01 Oct 2021
Clinical Study Protocol
Bimekizumab
PS0015
Confidential
Page 258 of 263
x
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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
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application and any extensions or 
ature
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va
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ea
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by 
s were m
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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.