Conditions: Chronic Plaque Psoriasis Moderate to Severe Chronic Plaque Psoriasis Psoriatic Arthritis
Keywords: Bimekizumab PSO Psoriasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 567
Healthy volunteers: no

Brief summary:
This is a study to compare the efficacy of bimekizumab versus placebo and an active comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).

Detailed description:

Arms:
arm 1: Subjects will receive bimekizumab for 52 weeks. arm 2: Subjects will receive ustekinumab (dose 1 or dose 2 depending on subjects weight) for 52 weeks. Placebo will be administered at pre-specified time points to maintain the blinding. arm 3: Subjects will receive placebo up to week 16 and bimekizumab starting at week 16 through week 52.

Interventions: intervention 1: Bimekizumab intervention 2: Ustekinumab intervention 3: Placebo
Intervention descriptions: intervention 1: Bimekizumab will be provided at pre-specified time intervals. intervention 2: Ustekinumab will be provided as dose 1 for subjects weighing \<=100 kg and as dose 2 for subjects weighing \>100 kg at pre-specified time intervals. intervention 3: Subjects will receive Placebo at pre-specified time points.

Protocol document:
Prot_000.pdf: 
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PS0009 
 
 
 
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PROTOCOL PS0009 AMENDMENT 4 
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, 
PLACEBO- AND ACTIVE COMPARATOR-CONTROLLED, 
PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY 
AND SAFETY OF BIMEKIZUMAB IN ADULT SUBJECTS WITH 
MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS 
PHASE 3 
EudraCT Number: 2016-003425-42 
IND Number: 128707 
Sponsor: 
UCB Biopharma SPRL 
Allée de la Recherche 60 
1070 Brussels 
BELGIUM 
Protocol/Amendment number 
Date 
Type of 
amendment 
Final Protocol 
15 Aug 2017 
Not applicable 
Protocol Amendment 1 
19 Sep 2017 
Not applicable 
Protocol Amendment 2 
15 Oct 2017 
Not applicable 
Protocol Amendment 3 
06 Apr 2018 
Substantial 
Protocol Amendment 4 
21 May 2019 
Nonsubstantial 
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. 
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STUDY CONTACT INFORMATION 
Sponsor 
UCB Biopharma SPRL 
Allée de la Recherche 60 
1070 Brussels, BELGIUM 
Sponsor Study Physician 
Name: 
, MD, PhD 
Address: 
UCB Biosciences, 8010 Arco Corporation Drive, Raleigh, NC 27617 
Phone: 
 
Fax: 
 
Clinical Project Manager 
Name: 
 
Address: 
UCB Biosciences, 8010 Arco Corporation Drive, Raleigh, NC 27617 
Phone: 
 
Fax: 
  
Clinical Trial Biostatistician 
Name: 
 
Address: 
UCB Biosciences, 8010 Arco Corporation Drive, Raleigh, NC 27617 
Phone: 
 
Fax: 
 
Clinical Monitoring Contract Research Organization 
Name: 
PAREXEL International (IRL) Limited-Ireland 
Address: 
Ireland Limited at 70 Sir John Rogerson’s Quay, Dublin 2, Ireland 
Phone: 
+353 (1) 477 3171 
Fax: 
+353 (1) 477 3308 
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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  
 
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TABLE OF CONTENTS 
LIST OF ABBREVIATIONS .................................................................................................. 10 
1 
SUMMARY ..................................................................................................................... 14 
2 
INTRODUCTION ........................................................................................................... 15 
2.1 
Psoriasis ....................................................................................................................... 15 
2.1.1 
Global epidemiology of psoriasis ........................................................................ 15 
2.1.2 
Current treatments for psoriasis ........................................................................... 16 
2.2 
Bimekizumab ............................................................................................................... 18 
2.2.1 
Clinical ................................................................................................................. 18 
2.2.1.1 
Completed studies ..................................................................................... 18 
2.2.1.2 
Ongoing studies ......................................................................................... 20 
2.2.2 
Nonclinical ........................................................................................................... 20 
3 
STUDY OBJECTIVE(S) ................................................................................................. 21 
3.1 
Primary objective ......................................................................................................... 21 
3.2 
Secondary objectives ................................................................................................... 21 
3.3 
Other objectives ........................................................................................................... 21 
4 
STUDY VARIABLES ..................................................................................................... 22 
4.1 
Primary efficacy variables ........................................................................................... 22 
4.2 
Secondary variables ..................................................................................................... 22 
4.2.1 
Secondary efficacy variables ............................................................................... 22 
4.2.2 
Secondary safety variables .................................................................................. 22 
4.3 
Other variables ............................................................................................................. 22 
4.3.1 
Other efficacy variable(s) .................................................................................... 23 
4.3.2 
Other safety variables .......................................................................................... 24 
4.3.3 
Pharmacokinetic variable ..................................................................................... 24 
4.3.4 
Pharmacogenomic variables ................................................................................ 24 
4.3.5 
Immunological variable ....................................................................................... 24 
5 
STUDY DESIGN ............................................................................................................. 25 
5.1 
Study description ......................................................................................................... 25 
5.2 
Study periods ............................................................................................................... 25 
5.2.1 
Screening Period .................................................................................................. 25 
5.2.2 
Initial Treatment Period ....................................................................................... 25 
5.2.3 
Maintenance Treatment Period ............................................................................ 26 
5.2.4 
Safety Follow-Up ................................................................................................. 26 
5.2.5 
Premature End of Treatment ................................................................................ 26 
5.3 
Study duration per subject ........................................................................................... 26 
5.4 
Planned number of subjects and site(s) ........................................................................ 27 
5.5 
Anticipated regions and countries ................................................................................ 27 
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5.6 
Schedule of study assessments..................................................................................... 27 
5.7 
Schematic diagram ....................................................................................................... 33 
5.8 
Rationale for study design and selection of dose ......................................................... 35 
5.8.1 
Study design ......................................................................................................... 35 
5.8.2 
Dose selection ...................................................................................................... 35 
6 
SELECTION AND WITHDRAWAL OF SUBJECTS ................................................... 35 
6.1 
Inclusion criteria .......................................................................................................... 35 
6.2 
Exclusion criteria ......................................................................................................... 36 
6.3 
Withdrawal criteria ...................................................................................................... 39 
6.3.1 
Potential drug-induced liver injury IMP discontinuation criteria ........................ 41 
7 
STUDY TREATMENT(S) .............................................................................................. 42 
7.1 
Description of investigational medicinal product(s) .................................................... 42 
7.2 
Treatment(s) to be administered .................................................................................. 42 
7.3 
Packaging ..................................................................................................................... 44 
7.4 
Labeling ....................................................................................................................... 44 
7.5 
Handling and storage requirements ............................................................................. 44 
7.6 
Drug accountability ...................................................................................................... 44 
7.7 
Procedures for monitoring subject compliance ............................................................ 45 
7.8 
Concomitant medication(s)/treatment(s) ..................................................................... 45 
7.8.1 
Permitted concomitant treatments (medications and therapies) .......................... 45 
7.8.1.1 
Topical medications .................................................................................. 45 
7.8.1.2 
Other medications ...................................................................................... 45 
7.8.2 
Prohibited concomitant treatments (medications and therapies) ......................... 46 
7.8.2.1 
Vaccines .................................................................................................... 47 
7.9 
Blinding........................................................................................................................ 47 
7.9.1 
Procedures for maintaining and breaking the treatment blind ............................. 48 
7.9.1.1 
Maintenance of IMP blind ......................................................................... 48 
7.9.1.2 
Breaking the treatment blind in an emergency situation ........................... 48 
7.10 
Randomization and numbering of subjects .................................................................. 48 
8 
STUDY PROCEDURES BY VISIT ............................................................................... 48 
8.1 
Screening Visit (2 to 5 Weeks) .................................................................................... 49 
8.2 
Initial Treatment Period ............................................................................................... 50 
8.2.1 
Baseline Visit ....................................................................................................... 50 
8.2.2 
Week 1 Visit (±3 days relative to Baseline) ........................................................ 51 
8.2.3 
Week 2 Visit (±3 days relative to Baseline) ........................................................ 52 
8.2.4 
Week 4 Visit (±3 days relative to Baseline) ........................................................ 53 
8.2.5 
Week 8 Visit (±3 days relative to Baseline) ........................................................ 54 
8.2.6 
Week 12 Visit (±3 days relative to Baseline) ...................................................... 55 
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8.2.7 
Week 16 Visit (±3 days relative to Baseline) ...................................................... 56 
8.3 
Maintenance Treatment Period .................................................................................... 57 
8.3.1 
Week 20 Visit (±3 days relative to Baseline) ...................................................... 57 
8.3.2 
Week 24 Visit (±3 days relative to Baseline) ...................................................... 57 
8.3.3 
Week 28 Visit (±7 days relative to Baseline) ...................................................... 58 
8.3.4 
Week 32 Visit (±7 days relative to Baseline) ...................................................... 59 
8.3.5 
Week 36 Visit (±7 days relative to Baseline) ...................................................... 60 
8.3.6 
Week 40 Visit (±7 days relative to Baseline) ...................................................... 60 
8.3.7 
Week 44 Visit (±7 days relative to Baseline) ...................................................... 61 
8.3.8 
Week 48 Visit (±7 days relative to Baseline) ...................................................... 62 
8.3.9 
Week 52 Visit (±7 days relative to Baseline) ...................................................... 62 
8.4 
Premature End of Treatment Visit ............................................................................... 64 
8.5 
Safety Follow-Up Visit (20 weeks after last dose, ±7 days) ........................................ 64 
8.6 
Unscheduled Visit ........................................................................................................ 65 
9 
ASSESSMENT OF EFFICACY ...................................................................................... 65 
9.1 
Psoriasis Area and Severity Index ............................................................................... 65 
9.2 
Investigator’s Global Assessment ................................................................................ 66 
9.3 
Dermatology Life Quality Index .................................................................................. 66 
9.4 
Patient Health Questionnaire 9 .................................................................................... 67 
9.5 
Scalp IGA..................................................................................................................... 67 
9.6 
mNAPSI ....................................................................................................................... 67 
9.7 
pp-IGA ......................................................................................................................... 68 
9.8 
Euro Quality of Life 5-Dimensions, 3-Level ............................................................... 68 
9.9 
36-Item Short Form Health Survey.............................................................................. 68 
9.10 
Patient Global Assessment of psoriasis ....................................................................... 69 
9.11 
Patient Symptom Diary responses ............................................................................... 69 
9.12 
PASE questionnaire ..................................................................................................... 69 
9.13 
PGADA for arthritis visual analog scale ..................................................................... 70 
9.14 
HAQ-DI score .............................................................................................................. 70 
9.15 
WPAI-SHP V2.0 .......................................................................................................... 70 
9.16 
Photographs.................................................................................................................. 71 
10 ASSESSMENT OF PHARMACOKINETIC AND PHARMACOGENOMIC 
VARIABLE(S) ................................................................................................................ 71 
10.1 
Pharmacokinetic variables ........................................................................................... 71 
10.2 
Pharmacogenomic variables ........................................................................................ 71 
11 ASSESSMENT OF IMMUNOLOGICAL VARIABLE(S) ............................................ 72 
12 ASSESSMENT OF SAFETY .......................................................................................... 72 
12.1 
Adverse events ............................................................................................................. 72 
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12.1.1 
Definitions ........................................................................................................... 72 
12.1.1.1 
Adverse event ............................................................................................ 72 
12.1.1.2 
Serious adverse event ................................................................................ 73 
12.1.1.1 
Adverse events of special interest ............................................................. 74 
12.1.1.2 
Other safety topics of interest .................................................................... 74 
12.1.2 
Procedures for reporting and recording adverse events ....................................... 74 
12.1.2.1 
Description of adverse events .................................................................... 74 
12.1.2.2 
Rule for repetition of an adverse event...................................................... 75 
12.1.2.3 
Additional procedures for reporting serious adverse events ..................... 75 
12.1.3 
Follow up of adverse events ................................................................................ 76 
12.1.4 
Pregnancy ............................................................................................................ 76 
12.1.5 
Suspected transmission of an infectious agent via a medicinal product .............. 77 
12.1.6 
Overdose of investigational medicinal product ................................................... 77 
12.1.7 
Safety signal detection ......................................................................................... 77 
12.2 
Laboratory measurements ............................................................................................ 78 
12.2.1 
Evaluation of PDILI ............................................................................................ 79 
12.2.1.1 
Consultation with Medical Monitor and local hepatologist ...................... 83 
12.2.1.2 
Immediate action: determination of IMP discontinuation ......................... 83 
12.2.1.3 
Testing: identification/exclusion of alternative etiology ........................... 83 
12.2.1.4 
Follow-up evaluation ................................................................................. 85 
12.3 
Other safety measurements .......................................................................................... 86 
12.3.1 
Assessment and management of TB and TB risk factors .................................... 86 
12.3.1.1 
Tuberculosis assessment by IGRA ............................................................ 89 
12.3.1.2 
Chest x-ray for tuberculosis ...................................................................... 89 
12.3.1.3 
Tuberculosis questionnaire ........................................................................ 89 
12.3.1.4 
Tuberculosis management ......................................................................... 89 
12.3.2 
Pregnancy testing ................................................................................................. 90 
12.3.3 
Vital signs ............................................................................................................ 90 
12.3.4 
12-lead electrocardiograms .................................................................................. 90 
12.3.5 
Physical examination ........................................................................................... 90 
12.3.6 
Height and body weight ....................................................................................... 91 
12.3.7 
Assessment of suicidal ideation and behavior ..................................................... 91 
12.4 
Other study measurements ........................................................................................... 91 
12.4.1 
Demographic information .................................................................................... 91 
12.4.2 
Medical history .................................................................................................... 91 
12.4.3 
Psoriasis history ................................................................................................... 91 
12.4.4 
Data Monitoring and Adjudication Committees .................................................. 91 
13 STUDY MANAGEMENT AND ADMINISTRATION ................................................. 92 
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13.1 
Adherence to protocol .................................................................................................. 92 
13.2 
Monitoring ................................................................................................................... 92 
13.2.1 
Definition of source data ..................................................................................... 92 
13.2.2 
Source data verification ....................................................................................... 93 
13.3 
Data handling ............................................................................................................... 93 
13.3.1 
Case Report Form completion ............................................................................. 93 
13.3.2 
Database entry and reconciliation ........................................................................ 93 
13.3.3 
Subject Screening and Enrollment log/Subject Identification Code list.............. 93 
13.4 
Termination of the study .............................................................................................. 94 
13.5 
Archiving and data retention ........................................................................................ 94 
13.6 
Audit and inspection .................................................................................................... 94 
13.7 
Good Clinical Practice ................................................................................................. 95 
14 STATISTICS ................................................................................................................... 95 
14.1 
Definition of analysis sets ............................................................................................ 95 
14.2 
General statistical considerations ................................................................................. 95 
14.3 
Planned efficacy analyses ............................................................................................ 97 
14.3.1 
Analysis of the primary efficacy variable ............................................................ 97 
14.3.1.1 
Sensitivity analyses ................................................................................... 98 
14.3.2 
Other efficacy analyses ........................................................................................ 99 
14.3.2.1 
Analysis of the secondary efficacy variables ............................................ 99 
14.3.2.2 
Analysis of the other efficacy variables .................................................. 100 
14.4 
Subgroup analyses ..................................................................................................... 101 
14.5 
Planned safety and other analyses.............................................................................. 101 
14.5.1 
Safety analyses ................................................................................................... 101 
14.5.2 
Pharmacokinetic analyses .................................................................................. 101 
14.5.3 
Immunogenicity analyses .................................................................................. 101 
14.6 
Handling of protocol deviations................................................................................. 102 
14.7 
Handling of dropouts or missing data ........................................................................ 102 
14.8 
Planned interim analysis and data monitoring ........................................................... 103 
14.9 
Determination of sample size ..................................................................................... 103 
15 ETHICS AND REGULATORY REQUIREMENTS .................................................... 104 
15.1 
Informed consent ....................................................................................................... 104 
15.2 
Subject identification cards ........................................................................................ 105 
15.3 
Institutional Review Boards and Independent Ethics Committees ............................ 105 
15.4 
Subject privacy........................................................................................................... 105 
15.5 
Protocol amendments ................................................................................................. 106 
16 FINANCE, INSURANCE, AND PUBLICATION ....................................................... 106 
17 REFERENCES .............................................................................................................. 106 
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18 APPENDICES ............................................................................................................... 109 
18.1 
Protocol Amendment 1 .............................................................................................. 109 
18.2 
Protocol Amendment 2 .............................................................................................. 138 
18.3 
Protocol Amendment 3 .............................................................................................. 160 
18.4 
Protocol Amendment 4 .............................................................................................. 201 
19 DECLARATION AND SIGNATURE OF INVESTIGATOR ..................................... 205 
20 SPONSOR DECLARATION ........................................................................................ 206 
 
LIST OF TABLES 
Table 5‒1: 
Schedule of study assessments......................................................................... 28 
Table 7‒1: 
Dosing scheme ................................................................................................. 43 
Table 7‒2: 
Prohibited psoriasis medications...................................................................... 46 
Table 9‒1: 
Body areas for calculation of percent BSA for PASI ...................................... 65 
Table 9‒2: 
Five-point IGA ................................................................................................. 66 
Table 9‒3: 
Scalp IGA......................................................................................................... 67 
Table 9‒4: 
pp-IGA ............................................................................................................. 68 
Table 12‒1: 
Anticipated serious adverse events for the population of subjects with 
moderate to severe chronic plaque psoriasis .................................................... 74 
Table 12‒2: 
Laboratory measurements ................................................................................ 78 
Table 12‒3: 
Required investigations and follow up for PDILI............................................ 80 
Table 12‒4: 
PDILI laboratory measurements ...................................................................... 84 
Table 12‒5: 
PDILI information to be collected ................................................................... 85 
 
LIST OF FIGURES 
Figure 5‒1: 
Schematic diagram ........................................................................................... 34 
Figure 12-1: 
Schematic diagram of TB test results and study eligibility ............................. 88 
Figure 14-1: 
Sequence of testing .......................................................................................... 97 
 
 
 
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LIST OF ABBREVIATIONS 
AE 
adverse event 
AESI 
adverse event of special interest 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
AMS 
Active Medication Set 
ANCOVA 
analysis of covariance 
AST 
aspartate aminotransferase 
axSpA 
axial spondyloarthritis 
BA 
bioavailability 
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 
CV 
cardiovascular 
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 
Euro-Quality of Life 5-Dimensions, 3 levels 
FAS 
Full Analysis Set 
GCP 
Good Clinical Practice 
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GI 
gastrointestinal 
GMP 
Good Manufacturing Practices 
HAQ-DI 
Health Assessment Questionnaire-Disability Index 
HBcAb 
anti-hepatitis B core antibody 
HBsAg 
anti-hepatitis B surface antigen 
HCP 
healthcare practitioner 
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 
IRB 
Institutional Review Board 
IRT 
interactive response technology 
iv 
intravenous 
LOCF 
last observation carried forward 
LTB 
latent tuberculosis 
LTBI 
latent tuberculosis infection 
mAb 
monoclonal antibody 
MAR 
missing at random 
MCMC 
Markov-Chain Monte Carlo 
MCS 
Mental Component Summary 
MedDRA 
Medical Dictionary for Regulatory Activities 
MI 
multiple imputation 
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mNAPSI 
Modified Nail Psoriasis Severity Index Score 
NRI 
Nonresponder imputation 
NSAID 
non-steroidal anti-inflammatory drugs 
NTMB 
nontuberculous mycobacterium 
PASE 
Psoriatic Arthritis Screening and Evaluation 
PASI 
Psoriasis Area Severity Index 
PCS 
Physical Component Summary 
PD 
pharmacodynamics 
PDE4 
phosphodiesterase 4 
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 
PK 
pharmacokinetics 
PK-PPS 
Pharmacokinetics Per-Protocol Set 
pp-IGA 
palmoplantar Investigator’s Global Assessment 
PPS 
Per-Protocol Set 
PRO 
patient-reported outcome 
PS 
Patient Safety 
PsA 
psoriatic arthritis 
PSO 
psoriasis 
Q4W 
every 4 weeks 
QOL 
quality of life 
RS 
Randomized Set 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
sc 
subcutaneous 
scalp IGA 
scalp-specific IGA 
SD 
standard deviation 
SF-36 
Short Form 36-item Health Survey 
SFU 
Safety Follow-Up 
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SOP 
Standard Operating Procedure 
SS 
Safety Set 
TB 
tuberculosis 
TEAE 
treatment-emergent adverse event 
TNF 
tumor necrosis factor 
ULN 
upper limit of normal 
VAS 
visual analog scale 
WBC 
white blood cell 
WPAI-SHP 
Work Productivity and Activity Impairment Questionnaire-specific health 
problem 
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1 
SUMMARY 
This is a Phase 3, multicenter, randomized, double-blind, placebo- and active 
comparator-controlled, parallel-group, study to evaluate the efficacy, safety, and 
pharmacokinetics (PK) of bimekizumab compared with placebo and ustekinumab 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 and Severity Index [PASI] ≥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 ustekinumab, or for systemic PSO therapy and/or 
phototherapy. 
Approximately 750 subjects will be screened in order to have 560 subjects randomized in the 
study. For each subject, the study will last a maximum of 73 weeks and will consist of 4 periods, 
a Screening Period (2 to 5 weeks), a double-blind, placebo- and active comparator-controlled 
Initial Treatment Period (16 weeks), a double-blind, active comparator-controlled Maintenance 
Treatment Period (36 weeks), and a Safety Follow-Up (SFU) Period (20 weeks after the final 
dose of investigational medicinal product (IMP). After the 36-week Maintenance Treatment 
Period, eligible subjects will be allowed to enroll in an open-label study. 
Eligible subjects will be randomized 4:2:1 to receive the following blinded IMP regimens: 
 Bimekizumab 320mg administered subcutaneously (sc) every 4 weeks (Q4W) 
 Ustekinumab (45mg or 90mg, depending on subject weight) administered sc at Baseline and 
4 weeks later, followed by ustekinumab sc every 12 weeks 
 Placebo administered sc Q4W for 16 weeks during the Initial Treatment Period, followed by 
bimekizumab 320mg administered sc Q4W during the Maintenance Treatment Period 
Approximately 320 subjects will be randomized to bimekizumab 320mg, 160 subjects will be 
randomized to ustekinumab, and approximately 80 subjects will be randomized to placebo. 
Investigational medicinal product will be administered in the clinic at Baseline and Q4W 
thereafter, until Week 16 (Initial Treatment Period). Additional nondosing study visits will occur 
at Week 1 and Week 2. At Week 16, subjects will enter the Maintenance Treatment Period. The 
Maintenance Treatment Period will include Q4W dosing for subjects receiving bimekizumab and 
Q12W dosing for subjects receiving ustekinumab. 
At Week 52, all subjects enrolling in the open-label study will undergo the Week 52 study 
assessments before receiving their first treatment dose in the open-label study. All subjects not 
enrolling in the open-label study will have the Week 52 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. 
The primary objective of the study is to compare the efficacy of bimekizumab administered sc 
for 16 weeks versus placebo in the treatment of subjects with moderate to severe chronic plaque 
PSO. The secondary objectives of the study are listed in Section 3.2. 
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The co-primary efficacy variables are the PASI90 response (defined as a subject that achieves 
90% reduction from Baseline in the PASI score) at Week 16 and the IGA response (defined as 
Clear or Almost Clear with at least a 2-category improvement relative to Baseline) at Week 16. 
The secondary efficacy variables are listed in Section 4.2. 
Pharmacokinetic variables are listed in Section 4.3.3. Pharmacogenomic variables are listed in 
Section 4.3.4. Immunological variables are listed in Section 4.3.5. 
Pharmacokinetic, genomic, genetic, proteomic, 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), 
physical examination, 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 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). 
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 (CV) 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 in higher latitudes. Psoriasis affects approximately 2% to 4% of the population 
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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 4 (PDE4) 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: 
 Topical steroids (eg, triamcinolone, mometasone, clobetasol, betamethasone, 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. 
 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. 
 Phototherapy is a frequent option for moderate to severe patients, but the inconvenience of 
multiple treatment visits and varying efficacy limits its use in the market. 
 Methotrexate is a systemic immunosuppressant and is used in moderate to severe PSO 
patients. Toxicity concerns, particularly in older patients, are a major drawback. 
 Cyclosporine is a systemic immunosuppressant used in patients with severe, recalcitrant, 
PSO who have failed at least one systemic therapy or in whom other systemic therapies are 
contraindicated. In recommended dosages cyclosporine can cause systemic hypertension and 
nephrotoxicity, therefore, renal function must be monitored during therapy. 
 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 proinflammatory 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. 
 Biologics, including TNFα inhibitors (adalimumab, etanercept, and infliximab), 
IL-12/23 inhibitors (ustekinumab), the IL-23p19 antagonist (guselkumab), the IL-17A 
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inhibitors (secukinumab and ixekizumab), and the IL-17 receptor antagonist brodalumab are 
the treatment options of choice for patients with moderate to severe plaque PSO who are 
candidates for systemic therapy or phototherapy. These products are injected sc or delivered 
via intravenous (iv) infusion.  Different from the traditional systemic drugs that impact the 
entire immune system, biologics target specific parts of the immune system and offer reduced 
multi-organ toxicity and adverse effects associated with traditional treatments. 
 TNFα inhibitors, while effective, come with boxed warnings including the risk of serious 
infections and reports of lymphoma and malignancy in children and adolescent patients. 
The efficacy of TNFα inhibitors in treating PSO is attributed to their inhibition of 
Th17-T cells.  
 Ustekinumab has been approved in the US and the EU for the treatment of patients with 
moderate to severe plaque PSO who are candidates for phototherapy or systemic therapy. 
Ustekinumab is a human immunoglobulin (Ig) G1κ monoclonal antibody 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 monoclonal antibody that 
selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction 
with the IL-17 receptor. Ixekizumab is a humanized IgG4 monoclonal antibody that 
selectively binds with the interleukin 17A (IL-17A) cytokine and inhibits its interaction 
with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in 
normal inflammatory and immune responses. Both drugs inhibit the release of 
proinflammatory 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 
interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a 
naturally occurring cytokine that is involved in normal inflammatory and immune 
responses. Guselkumab inhibits the release of proinflammatory cytokines and 
chemokines. 
 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 proinflammatory 
cytokines and chemokines. Brodalumab has a black box warning regarding suicidal 
ideation and behavior. 
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2.2 
Bimekizumab 
Bimekizumab (UCB4940) is an engineered, humanized full length monoclonal antibody (mAb) 
of immunoglobulin (Ig) G1 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 proinflammatory 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 is an engineered, 
humanized, full-length IgG1 mAb which has been designed to inhibit the activity of IL-17A and 
IL-17F subtypes of IL-17. This property makes bimekizumab distinct 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 (Th-1) mediated immune responses, such as PSO (as opposed to 
type 2 T helper (Th-2) 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 to 
the selective IL-17A inhibition or a broader IL-17 blockade. 
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 
8 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 
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the 2 doses tested (0.656 and 0.631 for the bimekizumab 80mg and 160mg sc doses, 
respectively). The PK of bimekizumab was linear in the tested dose range and the median t1/2 
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: 
 80mg loading dose followed by 40mg at Weeks 3 and 6 
 160mg loading dose followed by 80mg at Weeks 3 and 6 
 240mg loading dose followed by 160 mg at Weeks 3 and 6 
 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 (oropharhyngitis and vulvovaginitis, respectively) that were non-serious 
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 
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 (
) were administered two 1mL injections of 80mg each 
of bimekizumab and subjects receiving Formulation B 
) were administered a 
single injection of bimekizumab 160mg given as a 1mL injection. Six subjects were randomized 
to each bimekizumab formulation. The geometric means (GeoMeans) for area under the curve  
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 
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. 
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UP0042 was a randomized double-blind, placebo-controlled, single-dose, parallel-group study to 
evaluate the safety, tolerability, and PK of bimekizumab administered as an sc injection to 
Japanese and Caucasian healthy subjects. This study demonstrated that the PK profiles following 
single administration of 80mg, 160mg, and 320mg with an 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 an sc injection was generally safe and 
well tolerated in healthy Japanese and Caucasian subjects and no major differences in safety 
findings were observed between Japanese and Caucasian subjects. 
2.2.1.2 
Ongoing studies 
Four additional studies of bimekizumab in the treatment of PSO are ongoing.  
 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. 
 PS0011 is a long-term extension study for subjects who completed PS0010 to assess the 
long-term safety, tolerability, and efficacy of bimekizumab. 
 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. 
 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 Investigator’s Brochure (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 
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 is considered the 
consequence of a change in local mucosal immunity. To date, similar findings have not been 
seen in studies in humans. 
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Additional information on the nonclinical data for bimekizumab is available in the current 
version of the IB. 
3 
STUDY OBJECTIVE(S) 
3.1 
Primary objective 
The primary objective of the study is to compare the efficacy of bimekizumab administered sc 
for 16 weeks versus placebo in the treatment of subjects with moderate to severe chronic plaque 
PSO. 
3.2 
Secondary objectives 
The secondary objectives of the study are to: 
 Evaluate the efficacy of bimekizumab compared to placebo at achieving complete clearance 
(PASI100) after 16 weeks of treatment 
 Evaluate the efficacy of bimekizumab compared to placebo after 4 weeks of treatment 
 Evaluate the efficacy of bimekizumab compared to ustekinumab after 4 weeks, 12 weeks, 16 
weeks, and 52 weeks of treatment 
 Evaluate the change in itch, pain, and scaling of bimekizumab compared to placebo after 
16 weeks of treatment as reported by subjects using the Patient Symptom Diary  
 Evaluate the change in psoriatic scalp disease of bimekizumab compared to placebo after 
16 weeks of treatment in subjects with scalp PSO at Baseline 
 Assess TEAEs, SAEs, and TEAEs leading to withdrawal adjusted by duration of subject 
exposure to study treatment 
3.3 
Other objectives 
The other objectives of the study are to demonstrate the effects of bimekizumab on aspects of the 
disease: 
 Assess the efficacy of bimekizumab over time 
 Assess the change of skin-related quality of life (QOL) 
 Assess the change of general health-related QOL 
 Assess the change in nail PSO over time in subjects with nail PSO at Baseline 
 Assess the change in scalp PSO over time in subjects with scalp PSO at Baseline 
 Assess the change in palmoplantar PSO over time in subjects with palmoplantar PSO at 
Baseline 
 Assess the change in physical function (as measured by the Health Assessment 
Questionnaire-Disability Index [HAQ-DI]) over time in subjects with PsA at Baseline 
 Assess the symptoms of PsA as measured by the Psoriatic Arthritis Screening and Evaluation 
(PASE) questionnaire 
 Assess the change of patient-reported joint symptoms in subjects with PsA at Baseline 
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 Assess the change in symptoms of PSO as reported by subjects using the Patient Symptom 
Diary (all items) through Week 16 
 Assess depression 
 Assess the PK of bimekizumab 
 Assess the immunogenicity of bimekizumab 
 Assess work productivity 
 Assess the effect of bimekizumab on gene and protein expression, and explore the 
relationship between genomic, genetic, and proteomic biomarkers and disease biology, drug 
treatment and inflammatory and immune responses (from consenting subjects who agree to 
participate in the biomarker substudy) 
 Assess the safety and tolerability of bimekizumab 
4 
STUDY VARIABLES 
4.1 
Primary efficacy variables 
The co-primary efficacy variables are the PASI90 response (defined as a subject that achieves 
90% reduction from Baseline in the PASI score) at Week 16 and the IGA response (defined as 
Clear or Almost Clear with at least a 2-category improvement relative to Baseline) at Week 16. 
4.2 
Secondary variables 
4.2.1 
Secondary efficacy variables 
The secondary efficacy variables are: 
 PASI100 response at Week 16 
 PASI75 response at Week 4 
 Patient Symptom Diary responses for itch, pain, and scaling at Week 16 
 Scalp IGA response (Clear or Almost Clear with at least a 2-category improvement from 
Baseline) at Week 16 for subjects with scalp PSO at Baseline 
 PASI90 response at Week 12 and 52 
 IGA response at Week 12 and 52 
4.2.2 
Secondary safety variables 
 TEAEs adjusted by duration of subject exposure to study treatment 
 SAEs adjusted by duration of subject exposure to study treatment 
 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). 
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4.3.1 
Other efficacy variable(s) 
The other efficacy variables are listed below and will be evaluated according to the planned 
assessments (Table 5‒1). This excludes the timepoints for the primary and secondary variables 
specified above in Section 4.1 and Section 4.2.1, respectively. 
Change from Baseline variables evaluated during the Initial Treatment Period are relative to the 
Baseline (first dose) Visit. For subjects who switch treatment at the Week 16 Visit, change from 
Baseline variables during the Maintenance Treatment Period may be evaluated relative to both 
the Baseline (first dose) Visit and the Week 16 Visit. 
For simplicity, “change from Baseline” is used below for all such variables. Greater detail on the 
definition of Baseline for different summaries will be provided in the Statistical Analysis Plan 
(SAP). Unless otherwise stated PASI responders will be calculated relative to the Baseline Visit 
(first dose). 
The other efficacy variables are: 
 PASI50, PASI75, PASI90, and PASI100 response 
 Time to PASI75, PASI90, and PASI100 response during the Initial Period 
 Absolute and percent change from Baseline in PASI score 
 IGA response (Clear with at least a 2-category improvement from Baseline)  
 IGA response (Clear or Almost Clear with at least 2 category improvement relative to 
Baseline) 
 Shift from Baseline in IGA score 
 Absolute and percent change from Baseline in the BSA affected by PSO 
 Absolute and percent change from Baseline in the product of IGA and BSA (IGAxBSA) 
 Change from Baseline in Dermatology Life Quality Index (DLQI) 
 Percent of subjects achieving a DLQI total score of 0 or 1 
 Percent of subjects achieving a minimal clinically important difference (improvement from 
Baseline of 4 or more) in the DLQI 
 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 
 Change from Baseline in Patient Global Assessment of PSO score 
 Patient Symptom Diary responses 
 Scalp-specific Investigator’s Global Assessment (scalp IGA) response (Clear or Almost 
Clear with at least a 2-category improvement from Baseline) for subjects with scalp PSO at 
Baseline 
 Change from Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) score for 
subjects with nail PSO at Baseline 
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 Palmoplantar Investigator’s Global Assessment (pp-IGA) response (Clear or Almost Clear) 
for subjects with palmoplantar PSO at Baseline 
 Change from Baseline in the HAQ-DI for subjects with PsA at Baseline 
 Change from Baseline in the PASE questionnaire scores (function score, symptom score, and 
total score) 
 Shift from Baseline in PASE score suggestive of PsA (<47 versus ≥47) 
 Change from Baseline in Short Form 36-item Health Survey (SF-36) Physical Component 
Summary (PCS) score, and Mental Component Summary (MCS) score, and individual 
domains 
 Responses to Euro-Quality of Life 5-Dimensions, 3 levels (EQ-5D-3L), absolute and changes 
from Baseline in EQ-5D-3L VAS scores 
 Change from baseline in Patient Health Questionnaire (PHQ)-9 scores  
 Change from Baseline in Work Productivity and Activity Impairment Questionnaire-specific 
health problem (WPAI-SHP) V2.0 adapted to PSO scores 
4.3.2 
Other safety variables 
Safety variables to be assessed are: 
 Severity and frequency of AEs 
 Change from Baseline in vital signs 
 ECG results 
 Change from Baseline in clinical laboratory values (chemistry, hematology, and urinalysis) 
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 
Pharmacogenomic variables 
Additional blood samples will be collected from subjects who consent to participate in the 
substudy at specific time points and stored at -80°C for up to 20 years. 
Genomic, genetic, epigenetic, proteins, and metabolite biomarkers may be measured to evaluate 
the relationship with response to treatment with bimekizumab, PSO disease biology, and 
inflammatory and immune response processes. The nature and format of these tentative substudy 
analyses will be determined when the results of the main study are made available. 
The candidate exploratory variables are the blood or blood derivative (eg, serum) concentrations 
of cytokines and chemokines of relevance to IL-17A/F signaling pathway and PSO biology. 
Additional variables may include but will not be limited to serum complement concentrations. 
4.3.5 
Immunological variable 
The immunological variable is the anti bimekizumab antibody level prior to and following IMP. 
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5 
STUDY DESIGN 
5.1 
Study description 
PS0009 is a randomized, double-blind, placebo- and active comparator-controlled study to 
evaluate the efficacy and safety of bimekizumab administered sc to subjects with 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 a 
candidate for ustekinumab, or for systemic PSO therapy and/or phototherapy. Subjects may have 
been previously exposed to a biologic therapy (see Exclusion Criterion #23). 
5.2 
Study periods 
This study will include 4 periods, a Screening Period (2 to 5 weeks), an Initial Treatment Period 
(16 weeks), a Maintenance Treatment Period (36 weeks), and a SFU Period (20 weeks after the 
final dose of IMP). After completion of the Maintenance Treatment Period, eligible subjects will 
be allowed to enroll in an open-label study. Subjects enrolling into the open-label study will not 
have the PS0009 SFU Visit. 
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, 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 
Initial Treatment Period 
During the 16-week Initial Treatment Period, approximately 560 subjects will be randomized 
4:2:1 to receive the following blinded IMP regimens: 
 Bimekizumab 320mg administered sc Q4W (320 subjects) 
 Ustekinumab (160 subjects): 
 For subjects weighing ≤100kg (220lbs) at Baseline, 45mg sc initially and 4 weeks later 
 For subjects weighing >100kg (220lbs) at Baseline, 90mg sc initially and 4 weeks later 
 Placebo administered sc Q4W (80 subjects) 
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). 
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Subjects withdrawing early from the study will undergo the PEOT Visit assessments and will 
enter the SFU Period. Subjects withdrawing early from the study will not be eligible for 
inclusion in the open-label study. 
Subjects will be followed in a double-blind fashion. Subjects may receive placebo injections at 
certain visits in order to blind the IMP. 
The assessments to be performed at each Treatment Period Visit are presented in Table 5‒1. 
5.2.3 
Maintenance Treatment Period 
After the 16-week Initial Treatment Period, subjects will enter the 36-week Maintenance 
Treatment Period. The Maintenance Treatment Period will start at Week 16 and subjects will 
return to the clinic Q4W through Week 52. 
Treatment during the Maintenance Treatment Period will be based on initial treatment, per the 
following rules: 
 Subjects in the bimekizumab 320mg treatment arm will continue to receive bimekizumab 
320mg Q4W. 
 Subjects in the ustekinumab treatment arm will continue on ustekinumab (subjects weighing 
≤100kg [220lbs] at Baseline will receive 45mg sc every 12 weeks; subjects weighing >100kg 
[220lbs] at Baseline will receive 90mg sc every 12 weeks). 
 Subjects in the placebo arm will receive bimekizumab 320mg Q4W. 
Subjects may receive placebo injections at certain visits in order to blind the IMP (see 
Section 7.2). 
At the end of the Maintenance Treatment Period, all subjects enrolling in the open-label study 
will, after signing a new ICF, undergo the Week 52 study assessments and then receive their first 
dose of bimekizumab in the open-label study. All subjects not enrolling in the open-label study 
will have the Week 52 study assessments and will enter the SFU Period. 
The assessments at each Maintenance Treatment Period Visit are presented in Table 5‒1. 
5.2.4 
Safety Follow-Up 
All subjects not continuing in the open-label study, 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. 
5.2.5 
Premature End of Treatment 
Subjects withdrawing early from the study will undergo PEOT Visit assessments (see 
Section 8.4) and will enter the SFU Period. 
5.3 
Study duration per subject 
For each subject, the study will last a maximum of up to 73 weeks, as follows: 
 Screening Period: 2 to 5 weeks 
 Double-blind, placebo- and active comparator-controlled Initial Treatment Period: 16 weeks 
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 Double-blind, active comparator-controlled Maintenance Treatment Period: 36 weeks 
 Safety Follow-Up Period: a SFU Visit is planned 20 weeks after the final dose of IMP (for 
subjects not enrolling in the open-label study) 
After the 36-week Maintenance Treatment Period, subjects will be allowed to enroll in an open-
label study, in which case subjects will undergo the Week 52 study assessments before receiving 
their first open-label IMP dose. The SFU Visit will not be required for subjects who enroll in the 
open-label study. 
The end of the study is defined as the date of the last visit of the last subject in the study. 
5.4 
Planned number of subjects and site(s) 
Approximately 750 subjects will be screened in order to have 560 subjects randomized in the 
study. There will be approximately 320 subjects in the bimekizumab 320mg treatment arm, 160 
subjects in the ustekinumab treatment arm, and 80 subjects in the placebo treatment arm. The 
planned number of study sites is approximately 100. Every eligible subject who signs an ICF will 
be randomized. 
5.5 
Anticipated regions and countries 
The regions planned for study conduct are North America, Western Europe, Central/Eastern 
Europe, and Asia/Australia, 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. At each visit, all study assessments 
should be performed prior to administration of IMP. 
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Table 5‒1: 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Period 
(weeks after first dose) 
SFUb 
Baseline 
(first dose) 
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
Informed consentc 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Xd 
 
 
Inclusion/exclusion 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine drug screen 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Demographic data 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Psoriasis history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Significant past medical history and 
concomitant diseases 
X 
Xe 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical examf, g 
X 
X 
 
 
 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
X 
Height 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Body weight 
 
X 
 
 
 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
Vital signsh 
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 
X 
X 
Urinalysis 
X 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
ECG 
X 
 
 
 
 
 
X 
 
 
  
 
X 
 
 
 
 
X 
 
Pregnancy testingi 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hepatitis B and C testingj 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV testingk 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Chest x-rayl 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 5‒1: 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Period 
(weeks after first dose) 
SFUb 
Baseline 
(first dose) 
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
IGRA Tuberculosis test 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Tuberculosis questionnaire 
X 
X 
 
 
 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
X 
Blood sample for bimekizumab 
plasma concentrationsm 
 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Blood sample for anti- 
bimekizumab antibodiesm 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Blood sample genomic, proteomic, 
metabolomics, and candidate 
biomarker analysesc,m 
 
X 
X 
 
 
X 
X 
X 
 
 
 
 
 
 
 
 
X 
 
Blood sample genetic/epigenetic 
analysisc,m 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
PASI 
X 
X 
X 
X 
X 
X 
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 
X 
X 
Percentage of BSA 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
DLQI 
 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
PHQ-9 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
eC-SSRS 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Patient Symptom Diary (daily) 
X 
X 
X 
X 
X 
X 
X 
 X 
 
 
 
 
 
 
 
 
 
 
scalp IGA 
 
X 
Xn 
Xn 
Xn 
Xn 
Xn 
Xn 
 
 
Xn 
 
 
Xn 
 
 
Xn 
 
mNAPSI 
 
X 
 
 
Xo 
Xo 
Xo 
Xo 
 
 
Xo 
 
 
Xo 
 
 
Xo 
 
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Table 5‒1: 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Period 
(weeks after first dose) 
SFUb 
Baseline 
(first dose) 
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
pp-IGA 
 
X 
 
 
Xp 
Xp 
Xp 
Xp 
 
 
Xp 
 
 
Xp 
 
 
Xp 
 
EQ-5D-3L 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
SF-36 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
Patient Global Assessment of 
psoriasisq 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
 
X 
 
PASE 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
PGADAr 
 
X 
 
 
 X 
 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
HAQ-DIr 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
WPAI-SHP V2.0 
 
X 
 
 
 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
 
Photographs of skin and nails 
(subset of sites) 
 
X 
X 
X 
X 
X 
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 
IRTs,t 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Bimekizumab, ustekinumab, or 
placebo administrations,t 
 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
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Table 5‒1: 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Period 
(weeks after first dose) 
SFUb 
Baseline 
(first dose) 
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
BSA=body surface area; CV=cardiovascular; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide 
Severity Rating Scale; eCRF=electronic Case Report Form; EQ-5D-3L=Euro-Quality of Life 5-Dimensions 3-level; GI=gastrointestinal; HAQ-DI=Health 
Assessment Questionnaire-Disability Index; HCV=hepatitis C virus; HIV=human immunodeficiency virus; ICF=Informed Consent Form; IGA=Investigator’s 
Global Assessment; IGRA=interferon-gamma release assay; IMP=investigational medicinal product; IRT=interactive response technology; 
mNAPSI=Modified Nail Psoriasis Severity Index Score; 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; SF-36=Short Form 36-item Health Survey; SFU=Safety Follow-Up; scalp 
IGA=scalp-specific Investigator’s Global Assessment; TB=tuberculosis; WPAI-SHP=Work Productivity and Activity Impairment Questionnaire-specific 
health problem 
a Visit windows of ±3 days from the first dose to the Week 24 visit. Visit windows of ±7 days from the Week 28 visit to the Week 52 visit. The SFU Visit 
window is ±7 days from last dose. 
b The SFU Visit will occur 20 weeks after the final dosefor subjects who do not enroll in the open-label study. 
c All genomic, proteomic, and metabolomics samples will be stored at -80°C at the central biorepository for up to 20 years. 
d A separate ICF is required to be completed for the open-label study. 
e Ensure no significant changes in medical history. 
f Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
g The physical examination will be performed as per Section 12.3.5. 
h Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and body temperature) are to be measured prior to blood sampling, and prior to dosing, 
where applicable. 
i Pregnancy testing will consist of serum testing at the Screening. The pregnancy test will be urine at all other visits. 
j Subjects who have evidence of or test positive for hepatitis B by any of the following criteria: 1) positive for hepatitis B surface antigen (HBsAg+); 2) positive 
for anti-hepatitis B core antibody (HBcAb+) are excluded. A positive test for HCV is defined as: 1) positive for hepatitis C antibody (anti-HCV Ab), 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. 
k The HIV test results will not be recorded in the eCRF. 
l Screening chest x-ray must occur within 3 months prior to Screening Visit. 
m All blood samples taken prior to dosing. 
n The scalp IGA will only be assessed for those subjects with scalp involvement (scalp IGA score >0) at Baseline. 
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o The mNAPSI will be assessed only in subjects with nail involvement (mNAPSI score >0) at Baseline. 
p The pp-IGA will only be assessed in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline. 
q The Patient Global Assessment of psoriasis will be performed as part of the patient symptoms diary on a weekly basis from baseline through the initial 
treatment period. During the Maintenance Treatment Period this assessment will be completed at the specified clinic visits. 
r The PGADA and HAQ-DI are assessed for all subjects at Baseline. At all subsequent visits, the PGADA and HAQ-DI are assessed only for subjects with PsA 
at Baseline (defined as a past medical history of PsA or PASE ≥47). 
s IMP administration is based on randomization. 
t The dosing window is ±3 days relative to the scheduled dosing visit through Week 24. The dosing window is ±7 days from Week 28 through the end of the 
study. 
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5.7 
Schematic diagram 
The study schematic diagram for PS0009 is presented in Figure 5‒1. 
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Figure 5‒1: Schematic diagram 
Placebo
Bimekizumab 
320mg Q4W
Ustekinumab
Screening
N=80
N=320
N=160
Initial Treatment Period
Week
16
Co-primary Endpoint: 
PASI90 Response and 
IGA Response
Bimekizumab 
extension study
to evaluate response 
to treatment and 
long-term safety
SFU Visit
20 Weeks after last 
dose for subjects not 
enrolling in extension 
study
Randomization
Ustekinumab
Maintenance Treatment Period
52
Baseline
           Bimekizumab 320mg Q4W
N=560
           Bimekizumab 320mg Q4W
 
IGA=Investigator’s Global Assessment; N=number; PASI=Psoriasis Area Severity Index; Q4W=every 4 weeks; SFU=Safety Follow-Up 
Note: At Week 24 and all following visits, subjects on continuous treatment with the same IMP 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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5.8 
Rationale for study design and selection of dose 
5.8.1 
Study design 
A randomized, double-blind, placebo- and active-controlled study design has been selected to 
demonstrate efficacy and safety of bimkeizumab for regulatory approval. 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 measures (based on PASI and IGA) 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. An initial treatment period of 16 weeks 
will be used to demonstrate the efficacy of bimekizumab over PBO and ustekinumab. The study 
duration extends beyond the initial treatment period (to 52 weeks) to collect information on 
dosing beyond initial treatment. 
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. 
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 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. Chronic plaque PSO for at least 6 months prior to the Screening Visit. 
5. PASI ≥12 and BSA affected by PSO ≥10% and IGA score ≥3 on a 5-point scale. 
6a. Subject is 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 ustekinumab per regional labeling and has no contraindications to receive 
ustekinumab 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. 
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 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: 
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 Vasectomised 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. 
9. Subject agrees not to change their usual sun exposure during the course of the study and to 
use ultraviolet A/ultraviolet B sunscreens if unavoidable exposure occurs. 
6.2 
Exclusion criteria 
Subjects are not permitted to enroll in the 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 who received at least 1 dose 
of the IMP (including placebo). 
3a. 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. 
4a. 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. 
5a. 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 ustekinumab. 
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: 
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 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 jirovicii, 
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 (HBsAg+) or 2) positive for anti-hepatitis B core antibody 
(HBcAb+). A positive test for the hepatitis C virus (HCV) is defined as: 1) positive for 
hepatitis C antibody (anti-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 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. 
13. Subject has a history of a lymphoproliferative disorder including lymphoma or current signs 
and symptoms suggestive of lymphoproliferative disease. 
14a. 
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. 
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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. 
17a. 
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 (WBC) 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 had previous exposure to ustekinumab. 
22. Criterion deleted 
23. Subject has experienced primary failure (no response within 12 weeks) to 1 or more IL-17 
biologic response modifier (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 
biologic response modifier other than an IL-17. 
24. 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). 
25. 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. 
26. 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: 
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 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 (HCP) 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. 
27a. 
Subject has presence of moderately severe major depression or severe major depression, 
indicated by a score of ≥15 using the screening PHQ-9. Medication used to treat depression 
should be stable for 8 weeks prior to baseline. 
28. 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. 
29. Subject is a UCB employee or employee of third-party organizations involved in the study. 
30. 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 
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 8.4). 
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. Criterion deleted 
4. Subject is noncompliant with the study procedures or medications in the opinion of the 
Investigator. 
5. 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. 
6. Subject has a clinical laboratory value meeting any of the following criteria: 
a. Hepatotoxicity as described in Section 6.3.1 
b. A laboratory value meeting any of the following criteria: 
◦ 
Absolute neutrophil count <1.0x103/μL 
◦ 
Absolute lymphocyte count <0.2x103/μL 
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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. 
7. 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. 
8. At Week 24 and all following visits, subjects on continuous treatment with the same IMP 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. 
9. 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). 
10. A subject considered as having either a suspected new LTB infection 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 latent TB infection (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. 
11. 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 
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. 
12. Subjects must be referred immediately to a mental health care 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. 
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 
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. 
13. Subjects must be referred immediately to a mental healthcare professional and must be 
withdrawn in case of: 
 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. 
6.3.1 
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: 
 ALT or AST ≥ 8xULN 
 ALT or AST ≥3xULN and coexisting total bilirubin ≥2xULN 
The PDILI criterion below requires immediate discontinuation of IMP for: 
 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. 
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 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 TREATMENT(S) 
7.1 
Description of investigational medicinal product(s) 
The IMPs used in this study are bimekizumab, ustekinumab, and placebo. 
 Bimekizumab will be supplied in a 
 
 for sc 
injection. 
 Placebo will be supplied as 0.9% sodium chloride aqueous solution (physiological saline, 
preservative free) of pharmacopoeia (USP/Ph.Eur) quality in a 1mL PFS for sc injection. 
 Ustekinumab is commercially available and will be supplied in a 0.5mL PFS at a 
concentration of 45mg/0.5mL. 
Further details of the IMPs and their specifications are provided in the IMP Handling Manual. 
7.2 
Treatment(s) 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. 
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An IMP Handling Manual will be provided to each site containing instructions regarding drug 
preparation and dosing. 
Double-blind Initial Treatment Period dosing 
Because of differences in the dosing schedule between bimekizumab and ustekinumab, all 
subjects will receive 2 injections sc Q4W based on the following dosing scheme: 
 Subjects randomized to receive placebo will receive 2 placebo injections sc Q4W. 
 Subjects randomized to receive bimekizumab 320mg Q4W will receive 2 bimekizumab 
160mg injections sc Q4W. 
 Subjects randomized to receive ustekinumab will receive ustekinumab sc at Baseline and 
Week 4, followed by placebo (2 placebo injections sc) at Week 8 and Week 12. Because 
ustekinumab dosing is based on weight, on ustekinumab treatment weeks subjects ≤100kg 
(220lbs) at Baseline will receive 1 ustekinumab 45mg sc injection and 1 placebo injection 
and subjects >100kg (220lbs) at Baseline will receive 2 ustekinumab 45mg sc injections. 
Maintenance Treatment Period dosing 
Investigational medicinal product treatment during the Maintenance Treatment Period will be 
based on initial treatment as described in Section 5.2.3. 
 Subjects who received bimekizumab or placebo in the Initial Treatment Period will receive 
2 bimekizumab 160mg injections sc Q4W. 
 Subjects randomized to receive ustekinumab will have received ustekinumab sc at Baseline 
and Week 4, and will continue to receive ustekinumab sc every 12 weeks (Weeks 16, 28, and 
40). Subjects will receive placebo (2 placebo injections sc) on non-ustekinumab treatment 
weeks (Weeks 20, 24, 32, 36, 44, and 48). Because ustekinumab dosing is based on weight, 
on ustekinumab treatment weeks subjects ≤100kg (220lbs) at Baseline will receive 
1 ustekinumab 45mg sc injection and 1 placebo injection and subjects >100kg (220lbs) at 
Baseline will receive 2 ustekinumab 45mg sc injections. 
The dosing scheme is depicted in Table 7‒1.  
Table 7‒1: 
Dosing scheme 
Week 
Dose Assignment 
Baseline 
(first 
dose) 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
Bimekizumab 
320mg Q4W 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
Ustekinumab 45mg 
(subjects ≤100kg) 
▲○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
Ustekinumab 90mg 
(subjects >100kg) 
▲▲ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
Placebo/ 
bimekizumab 
320mg Q4W 
○○ 
○○ 
○○ 
○○ 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
Q4W=every 4 weeks 
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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 ustekinumab 45mg injection is depicted by a black triangle (▲). 
7.3 
Packaging 
Bimekizumab, ustekinumab, and placebo 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 
Bimekizumab, ustekinumab, and placebo 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. 
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. 
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Unblinded study staff will be delegated the responsibility to receive, inventory and destroy the 
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 in order 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 Investigator (or designee) is responsible for retaining all used, unused, and partially used 
containers of IMP until returned or destroyed. 
The Investigator may 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 
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. 
7.8 
Concomitant medication(s)/treatment(s) 
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) 
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. 
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. 
7.8.1.2 
Other medications 
Subjects who are already receiving an established NSAID regimen for PsA or symptoms of 
arthritis and have been on a stable dose for at least 1 week prior to the Screening Visit may 
continue their use during the study. However, initiation of, or increase in dosage of NSAIDs 
during the study (especially in subjects with a history of gastrointestinal (GI) intolerance to 
NSAIDs or a history of GI ulceration) should not occur prior to Week 16 and should not happen 
within 2 weeks of the Week 52 Visit. 
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Subjects may take mild pain relievers (acetaminophen/paracetamol, mild opiates) as needed for 
arthritis pain but preferably not within 24 hours of the Baseline and Week 52 Visits. 
Intra-articular steroid injections of any joint and hyaluronic acid injections are allowed after 
Week 16. 
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 7‒2 presents the list of prohibited PSO medications. 
Table 7‒2: 
Prohibited psoriasis medications 
Drug 
Washout period relative to Baseline Visit 
Topicals except for those permitted (Section 7.8.1.1)  
2 weeks 
Systemic retinoids 
3 months  
Systemic treatment (non-biological): 
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: 
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 
Any exposure 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 and 
risankizumab 
briakinumab 
6 months for briakinumab 
rituximab 
12 months for rituximab 
Anti-IL-17 therapy: 
secukinumab 
ixekizumab 
brodalumab 
3 months 
(bimekizumab is excluded per exclusion 
criteria) 
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Table 7‒2: 
Prohibited psoriasis medications 
Drug 
Washout period relative to Baseline Visit 
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 
Subjects who take prohibited medications may be withdrawn from IMP but followed until the 
SFU. The decision to withdraw a subject for taking prohibited medications should be made in 
consultation with the Medical Monitor. 
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 ustekinumab, special 
precautions will be taken to ensure study blinding and study sites will have blinded and 
unblinded personnel. 
All Sponsor and Investigator site personnel involved in the study will be blinded to the 
randomized IMP assignment with the following exceptions: 
 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. 
 Bioanalytical staff analyzing blood samples for bimekizumab and anti-bimekizumab 
antibody determination. 
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. 
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. 
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7.9.1 
Procedures for maintaining and breaking the treatment blind 
7.9.1.1 
Maintenance of IMP blind 
All subject treatment details (bimekizumab, ustekinumab, or placebo) 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 (North America, Western 
Europe, Central/Eastern Europe, and Asia/Australia) and prior biologic exposure (yes/no). 
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. 
Subject numbers and kit numbers will be tracked via the IRT. 
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. 
 From the Week 1 visit to the Week 24 visit, visit windows of ±3 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 28 visit to the Week 52 visit, visit windows are 
±7 days. Changes to the dosing schedule outside of the visit window must be discussed with 
the Medical Monitor. 
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 The dosing window is ±3 days relative to the scheduled dosing visit through Week 24. The 
dosing window is ±7 days relative to the scheduled dosing visit from Week 28 through the 
end of the study. 
 For the SFU Visit (20 weeks after the last 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. 
Where local regulations permit, subjects will also be given the option to participate in the 
genomics, genetics, and proteomics substudy. Subjects agreeing to participate in the substudy 
will be required to complete a separate ICF. The ICF must be signed prior to collecting any 
samples for the substudy. The substudy will only be conducted where ethically accepted and 
authorized by the regulatory agencies. Refusal to participate in the substudy will not affect a 
subject’s ability to participate in the main PS0009 study. 
The following procedures/assessments will be performed at the Screening Visit: 
 Informed consent 
 Inclusion/exclusion 
 Urine drug screen 
 Demographic data (age, gender, race and ethnicity [according to local regulations]) 
 Psoriasis history including the date of onset and past treatments 
 Significant past medical history including clinically relevant past or coexisting medical 
conditions and surgeries 
 Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB 
 Vital signs (sitting systolic and diastolic blood pressure [BP), pulse rate, and body 
temperature) should be obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests: 
 Hematology and biochemistry 
 Urinalysis 
 Serum pregnancy test 
 Hepatitis B and Hepatitis C 
 HIV 
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 IGRA Tuberculosis test 
 Record 12-lead ECG 
 Chest x-ray (not necessary if performed within 3 months prior to Screening Visit and report 
is available) 
 Tuberculosis questionnaire 
 PASI 
 IGA 
 Percentage of BSA 
 PHQ-9 
 eC-SSRS 
 Patient Symptom Diary (daily) 
 Concomitant medication 
 AEs 
 Confirm subject eligibility and contact IRT 
8.2 
Initial Treatment Period 
8.2.1 
Baseline Visit 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
 Inclusion/exclusion 
 Significant past medical history and concomitant diseases to ensure no significant changes 
since screening 
 Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB 
 Height 
 Body weight 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and biochemistry 
 Urinalysis 
 Urine pregnancy test 
 Bimekizumab plasma concentrations 
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 Anti-bimekizumab antibodies 
 Genomic, proteomic, metabolomics, and candidate biomarker analyses (participating 
subjects only) 
 Genetic/epigenetic analysis (participating subjects only) 
 Tuberculosis questionnaire 
 PASI 
 IGA 
 Percentage of BSA 
 DLQI 
 PHQ-9 
 eC-SSRS 
 Patient Symptom Diary (daily) 
 scalp IGA 
 mNAPSI 
 pp-IGA 
 EQ-5D-3L 
 SF-36 
 PASE 
 PGADA 
 HAQ-DI 
 WPAI-SHP V2.0 
 Photographs of skin and nails (participating centers only) 
 Concomitant medication 
 AEs 
 Contact IRT 
After completion of the above-mentioned procedures, bimekizumab, ustekinumab, or placebo 
administration will occur. 
8.2.2 
Week 1 Visit (±3 days relative to Baseline) 
The following procedures/assessments will be performed/recorded: 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
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 Hematology and biochemistry 
 Bimekizumab plasma concentrations 
 Genomic, proteomic, metabolomics, and candidate biomarker analyses 
 PASI 
 IGA 
 Percentage of BSA 
 DLQI 
 eC-SSRS 
 Patient Symptom Diary (daily) 
 scalp IGA for subjects with scalp involvement at Baseline 
 Photographs of skin and nails (participating centers only) 
 Concomitant medication 
 AEs 
 Contact IRT 
8.2.3 
Week 2 Visit (±3 days relative to Baseline) 
The following procedures/assessments will be performed/recorded: 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and biochemistry 
 Bimekizumab plasma concentrations 
 PASI 
 IGA 
 Percentage of BSA 
 DLQI 
 eC-SSRS 
 Patient Symptom Diary (daily) 
 scalp IGA for subjects with scalp involvement at Baseline 
 Photographs of skin and nails (participating centers only) 
 Concomitant medication 
 AEs 
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 Contact IRT 
8.2.4 
Week 4 Visit (±3 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and biochemistry 
 Urine pregnancy test 
 Bimekizumab plasma concentrations 
 Anti-bimekizumab antibodies 
 PASI 
 IGA 
 Percentage of BSA 
 DLQI 
 PHQ-9 
 eC-SSRS 
 Patient Symptom Diary (daily) 
 scalp IGA for subjects with scalp involvement at Baseline 
 mNAPSI for subjects with nail involvement at Baseline 
 pp-IGA for subjects with palmoplantar involvement at Baseline 
 EQ-5D-3L 
 SF-36 
 PGADA (only for subjects with PsA) 
 HAQ-DI (only for subjects with PsA) 
 Photographs of skin and nails (participating centers only) 
 Concomitant medication 
 AEs 
 Contact IRT 
After completion of the above-mentioned procedures, administration of bimekizumab, 
ustekinumab, or placebo will occur. 
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8.2.5 
Week 8 Visit (±3 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and biochemistry 
 Urine pregnancy test 
 Bimekizumab plasma concentrations 
 Anti-bimekizumab antibodies 
 Genomic, proteomic, metabolomics, and candidate biomarker analyses 
 PASI 
 IGA 
 Percentage of BSA 
 DLQI 
 PHQ-9 
 eC-SSRS 
 Patient Symptom Diary (daily) 
 scalp IGA for subjects with scalp involvement at Baseline 
 mNAPSI for subjects with nail involvement at Baseline 
 pp-IGA for subjects with palmoplantar involvement at Baseline 
 EQ-5D-3L 
 SF-36 
 HAQ-DI (only for subjects with PsA) 
 Photographs of skin and nails (participating centers only) 
 Concomitant medication 
 AEs 
 Contact IRT 
After completion of the above-mentioned procedures, administration of bimekizumab or placebo 
will occur. 
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8.2.6 
Week 12 Visit (±3 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
 Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB 
 Body weight 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and biochemistry 
 Urine pregnancy test 
 Bimekizumab plasma concentrations 
 Anti-bimekizumab antibodies 
 Genomic, proteomic, metabolomics, and candidate biomarker analyses (participating 
subjects only) 
 Record 12-lead ECG 
 Tuberculosis questionnaire 
 PASI 
 IGA 
 Percentage of BSA 
 DLQI 
 PHQ-9 
 eC-SSRS 
 Patient Symptom Diary (daily) 
 scalp IGA for subjects with scalp involvement at Baseline 
 mNAPSI for subjects with nail involvement at Baseline 
 pp-IGA for subjects with palmoplantar involvement at Baseline 
 EQ-5D-3L 
 SF-36 
 PGADA (only for subjects with PsA) 
 HAQ-DI (only for subjects with PsA) 
 Photographs of skin and nails (participating centers only) 
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 Concomitant medication 
 AEs 
 Contact IRT 
After completion of the above-mentioned procedures, administration of bimekizumab or placebo 
will occur. 
8.2.7 
Week 16 Visit (±3 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and biochemistry 
 Urinalysis 
 Urine pregnancy test 
 Bimekizumab plasma concentrations 
 Anti-bimekizumab antibodies 
 Genomic, proteomic, metabolomics, and candidate biomarker analyses (participating 
subjects only) 
 PASI 
 IGA 
 Percentage of BSA 
 DLQI 
 PHQ-9 
 eC-SSRS 
 Patient Symptom Diary (daily) 
 scalp IGA for subjects with scalp involvement at Baseline 
 mNAPSI for subjects with nail involvement at Baseline 
 pp-IGA for subjects with palmoplantar involvement at Baseline 
 EQ-5D-3L 
 SF-36 
 PGADA (only for subjects with PsA) 
 HAQ-DI (only for subjects with PsA) 
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 WPAI-SHP V2.0 
 Photographs of skin and nails (participating centers only) 
 Concomitant medication 
 AEs 
 Contact IRT 
After completion of the above-mentioned procedures, the Maintenance Treatment Period will 
begin with administration of bimekizumab, ustekinumab, or placebo. 
8.3 
Maintenance Treatment Period 
8.3.1 
Week 20 Visit (±3 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and biochemistry 
 Urine pregnancy test 
 PASI 
 IGA 
 Percentage of BSA 
 PHQ-9 
 eC-SSRS 
 Concomitant medication 
 AEs 
 Contact IRT 
After completion of the above-mentioned procedures, administration of bimekizumab or placebo 
will occur. 
8.3.2 
Week 24 Visit (±3 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
 Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB 
 Body weight 
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 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and biochemistry 
 Urinalysis  
 Urine pregnancy test 
 Tuberculosis questionnaire 
 PASI 
 IGA 
 Percentage of BSA 
 PHQ-9 
 eC-SSRS 
 WPAI-SHP V2.0 
 Concomitant medication 
 AEs 
 Contact IRT 
After completion of the above-mentioned procedures, administration of bimekizumab or placebo 
will occur. 
8.3.3 
Week 28 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Urine pregnancy test 
 Bimekizumab plasma concentrations 
 Anti-bimekizumab antibodies 
 PASI 
 IGA 
 Percentage of BSA 
 DLQI 
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 PHQ-9 
 eC-SSRS 
 scalp IGA for subjects with scalp involvement at Baseline 
 mNAPSI for subjects with nail involvement at Baseline 
 pp-IGA for subjects with palmoplantar involvement at Baseline 
 EQ-5D-3L 
 SF-36 
 Patient Global Assessment of PSO 
 PGADA (only for subjects with PsA) 
 HAQ-DI (only for subjects with PsA) 
 Photographs of skin and nails (participating centers only) 
 Concomitant medication 
 AEs 
 Contact IRT 
After completion of the above-mentioned procedures, administration of bimekizumab, 
ustekinumab, or placebo will occur. 
8.3.4 
Week 32 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and biochemistry 
 Urinalysis 
 Urine pregnancy test 
 Record 12-lead ECG 
 PASI 
 IGA 
 Percentage of BSA 
 PHQ-9 
 eC-SSRS 
 Concomitant medication 
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 AEs 
 Contact IRT 
After completion of the above-mentioned procedures, administration of bimekizumab or placebo 
will occur. 
8.3.5 
Week 36 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
 Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB 
 Body weight 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Urine pregnancy test 
 Tuberculosis questionnaire 
 PASI 
 IGA 
 Percentage of BSA 
 PHQ-9 
 eC-SSRS 
 Concomitant medication 
 AEs 
 Contact IRT 
After completion of the above-mentioned procedures, administration of bimekizumab or placebo 
will occur. 
8.3.6 
Week 40 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and biochemistry 
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 Urinalysis 
 Urine pregnancy test 
 Bimekizumab plasma concentrations 
 Anti-bimekizumab antibodies 
 PASI 
 IGA 
 Percentage of BSA 
 DLQI 
 PHQ-9 
 eC-SSRS 
 scalp IGA for subjects with scalp involvement at Baseline 
 mNAPSI for subjects with nail involvement at Baseline 
 pp-IGA for subjects with palmoplantar involvement at Baseline 
 EQ-5D-3L 
 SF-36 
 Patient Global Assessment of psoriasis 
 PGADA (only for subjects with PsA) 
 HAQ-DI (only for subjects with PsA) 
 WPAI-SHP V2.0 
 Photographs of skin and nails (participating centers only) 
 Concomitant medication 
 AEs 
 Contact IRT 
After completion of the above-mentioned procedures, administration of bimekizumab, 
ustekinumab, or placebo will occur. 
8.3.7 
Week 44 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Urine pregnancy test 
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 PASI 
 IGA 
 Percentage of BSA 
 PHQ-9 
 eC-SSRS 
 Concomitant medication 
 AEs 
 Contact IRT 
After completion of the above-mentioned procedures, administration of bimekizumab or placebo 
will occur. 
8.3.8 
Week 48 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded: 
 Informed consent (to be completed for the open-label study, if applicable) 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and biochemistry 
 Urinalysis 
 Urine pregnancy test 
 IGRA Tuberculosis test 
 PASI 
 IGA 
 Percentage of BSA 
 PHQ-9 
 eC-SSRS 
 Concomitant medication 
 AEs 
 Contact IRT 
After completion of the above-mentioned procedures, administration of bimekizumab or placebo 
will occur. 
8.3.9 
Week 52 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded: 
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 Urine drug screen 
 Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB 
 Body weight 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and biochemistry 
 Urinalysis 
 Urine pregnancy test 
 Bimekizumab plasma concentrations 
 Anti-bimekizumab antibodies 
 Genomic, proteomic, metabolomics, and candidate biomarker analyses (participating 
subjects only) 
 Genetic/epigenetic analysis (participating subjects only) 
 Record 12-lead ECG 
 TB questionnaire 
 PASI 
 IGA 
 Percentage of BSA 
 DLQI 
 PHQ-9 
 eC-SSRS 
 scalp IGA for subjects with scalp involvement at Baseline 
 mNAPSI for subjects with nail involvement at Baseline 
 pp-IGA for subjects with palmoplantar involvement at Baseline 
 EQ-5D-3L 
 SF-36 
 Patient Global Assessment of PSO 
 PASE 
 PGADA (only for subjects with PsA) 
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 HAQ-DI (only for subjects with PsA) 
 WPAI-SHP V2.0 
 Photographs of skin and nails (participating centers only) 
 Concomitant medication 
 AEs 
 Contact IRT 
8.4 
Premature End of Treatment Visit 
If a subject is withdrawn from the study: 
 The subject will be withdrawn from IMP, will undergo the same assessments as the 
Week 52 visit (see Section 8.3.9), and will enter the SFU Period. 
 The subject will be encouraged to return for the SFU Visit (20 weeks after the last 
received dose; see Section 8.5). 
8.5 
Safety Follow-Up Visit (20 weeks after last dose, ±7 days) 
All subjects not continuing in the open-label study, including those withdrawn from IMP, will 
have a SFU Visit 20 weeks after their final dose of IMP. 
The following procedures/assessments will be performed/recorded: 
 Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB 
 Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and biochemistry 
 Urinalysis 
 Urine pregnancy test 
 Bimekizumab plasma concentrations 
 Anti-bimekizumab antibodies 
 Tuberculosis questionnaire 
 PASI 
 IGA 
 Percentage of BSA 
 eC-SSRS 
 Concomitant medication 
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 AEs 
 Contact IRT 
8.6 
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. 
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. 
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 and 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.  
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 
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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 PASI50, PASI75, PASI90, and PASI100 responses are based on at least 50%, 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. 
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. 
The Investigator will assess the overall severity of PSO using the following 5-point scale 
presented in Table 9‒2. 
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). 
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9.4 
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 5-9 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. 
Refer to Section 6.3 for PHQ-9-related withdrawal criteria. 
9.5 
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. 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). 
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 
9.6 
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. 
The mNAPSI will be assessed at the visits specified in Table 5‒1. 
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9.7 
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. 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). 
Table 9‒4: 
pp-IGA 
Score 
Short Descriptor 
Detailed Descriptor 
0 
Clear 
Palmoplantar areas have no signs of PSO; post-inflammatory 
hyperpigmentation may be present 
1 
Almost clear 
Palmoplantar areas have no thickening; normal to pink coloration; no to 
minimal focal scaling 
2 
Mild 
Palmoplantar areas have just detectable to mild thickening; pink to light red 
coloration; predominately fine scaling 
3 
Moderate 
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 
PSO=psoriasis; pp-IGA=palmoplantar-specific Investigator’s Global Assessment 
9.8 
Euro Quality of Life 5-Dimensions, 3-Level 
The Euro Quality of life 5-Dimensions 3-Level (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. 
9.9 
36-Item Short Form Health Survey 
The SF-36 (Version 2, standard recall) is a 36-item generic health related QOL instrument that 
uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical 
Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), 
Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 
items), and 1 item for perceived stability or change in health (Health Transition) during the last 
year. The concepts represented by these domains contribute to physical, mental, and social 
aspects of health-related QOL. In addition to domain scores, the PCS and MCS scores are 
calculated from the 8 domains (excluding the Health Transition item). Component scores 
appreciate the impact of each domain on physical and mental health status (Maruish, 2011). Each 
of the 8 domain scores and the component summary scores range from 0 to 100, with a higher 
score indicating a better health status. The domains and the 2 component summary scores are 
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standardized with a mean of 50 and a standard deviation (SD) of 10 in the general USA 
population. The minimally important differences (MIDs), in terms of T-score points at a group 
level, for SF-36 domains and component summaries are the following: PCS, 2; MCS, 3; Physical 
Functioning, 3; Role Physical, 3; Bodily Pain, 3; General Health, 2; Vitality, 2; Social 
Functioning, 3; Role Emotional, 4; and Mental Health, 3. 
The SF-36 will be completed by the subject at the visits specified in Table 5‒1. 
9.10 
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 PSO will be performed as part of the patient symptoms diary 
from Screening through the Initial Treatment Period. 
During the Maintenance Treatment Period, this assessment will be completed at the visits 
specified in Table 5‒1. 
9.11 
Patient Symptom Diary responses 
UCB developed a new patient-reported outcome (PRO) measure that will be used to assess key 
symptoms relevant to patients with moderate to severe chronic plaque PSO. PS0010 used the 
draft PRO measure in selected countries to enable psychometric validation of the PRO. Site staff 
will train the participating subjects on the use of the electronic PRO (ePRO) diary at the 
Screening Visit, following which the device will be dispensed to the subject for home use daily 
until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to 
the Week 16 Visit. 
The ePRO diary will also administer the patient global assessment of PSO as noted above 
appropriate anchor items at the end of every study week. The ePRO diary software will be 
programmed such that the subjects will be given a window of opportunity to complete the ePRO 
diary. The data collected on the ePRO diary will be uploaded to a central server database and 
will be 21 CFR Part 11 compliant. Appropriate GCP procedures (including subject/site training 
and testing) will be performed at the study sites. 
The Patient Symptom Diary responses for itch, pain, and scaling at Week 16 will be computed 
based on the responder definition as well as the absolute and percent change from Baseline. Each 
of the Patient Symptom Diary response scores included in the statistical testing procedure (itch, 
pain, and scaling) will be characterized in terms of the cumulative percent of subjects 
demonstrating a pre-specified point improvement at Week 16. The threshold for the Patient 
Symptom Diary response score of itch, pain, and scaling is 2.39, 1.98, and 2.86, respectively. 
The responder analysis will be limited to the subjects with a Baseline Patient Symptom Diary 
response score at or above the applicable threshold score (ie, at least 2.39, 1.98, and 2.86 for itch, 
pain, and scaling, respectively). 
9.12 
PASE questionnaire 
The 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 
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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 [3], 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. 
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 and HAQ-DI) as noted in 
Section 9.13 and Section 9.14. 
The PASE questionnaire will be completed at the visits specified in Table 5‒1. 
9.13 
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. 
9.14 
HAQ-DI score 
The HAQ-DI score contains 20 items divided into 8 domains that measure: dressing and 
grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Subjects 
are required to indicate the degree of difficulty they have experienced in each domain in the past 
Week on a 4-point scale that ranges from 0 (without difficulty) to 3 (unable to do). Any 
individual score of less than 2 is adjusted to 2 if the activity requires assistance from another 
individual or the use of an assistive device. The highest score in each category is then summed (0 
to 24) and divided by the number of categories scored to give a score that ranges from 0 to 3. 
All subjects will complete the HAQ-DI at Baseline. Subjects with PsA at Baseline (defined as a 
past medical history of PsA or PASE ≥47) will complete the HAQ-DI at the visits specified in 
Table 5‒1. 
9.15 
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. 
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9.16 
Photographs 
At certain clinical sites, representative photographs of the changes in skin and nail appearance 
will be captured. Subjects 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. 
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. 
10 
ASSESSMENT OF PHARMACOKINETIC AND 
PHARMACOGENOMIC VARIABLE(S) 
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). 
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 ustekinumab will not be analyzed, but stored 
for potential future PK analysis and anti-drug antibody determination. 
10.2 
Pharmacogenomic variables 
A separate ICF will be required for those subjects who agree to participate in the genomics, 
genetics, and proteomics substudy, and must be signed prior to collection of any samples for the 
substudy. The substudy will only be conducted where ethically accepted and authorized by the 
regulatory agencies. Refusal to participate in the substudy will not affect a subject’s ability to 
participate in the main study. 
These analyses will enable evaluation of biomarkers relative to disease biology and progression, 
drug treatment, and inflammatory and immune response processes. The nature and format of 
these tentative analyses will be determined at a later date. 
For individuals consenting to the genomics, genetics, and proteomics substudy, blood samples 
will be drawn for exploratory genetic/epigenetic, genomic, proteomic, metabolomics analysis, 
and for candidate biomarker analyses. Candidate biomarker evaluations may include, but are not 
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limited to, IL-17A/IL-17F pathway signaling and PSO biology (eg, IL-17A, IL-17F, IL-23, IL-6, 
tumor necrosis factor, dendritic cell-specific transmembrane protein, and circulating osteoclast 
precursors). 
Collection of these samples will occur at the time points specified in the schedule of study 
assessments (Table 5‒1). 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. The samples will be stored at -80°C at the central 
biorepository for up to 20 years. 
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. 
11 
ASSESSMENT OF IMMUNOLOGICAL VARIABLE(S) 
Blood samples for measurement of antibodies to bimekizumab will be collected at the visits 
specified in Table 5‒1. The threshold for antibody positivity will be defined prior to analysis. 
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 
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. 
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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: 
 Death 
 Life-threatening 
(Life-threatening does not include a reaction that might have caused death had it occurred in 
a more severe form.) 
 Significant or persistent disability/incapacity 
 Congenital anomaly/birth defect (including that occurring in a fetus) 
 Important medical event that, based upon appropriate medical judgment, may jeopardize the 
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 12.1.1.1], 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.) 
 Initial inpatient hospitalization or prolongation of hospitalization 
(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. 
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.
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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. 
12.1.1.1 
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. 
12.1.1.2 
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. 
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. 
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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: 
 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” 
 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 
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. 
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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: 
 The subject should return for an early discontinuation visit. 
 The subject should immediately stop the intake of the IMP. 
 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 needs 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. 
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 
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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 (e.g. 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 PS0009. If the study is available locally, the PS0009 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 PS0009. 
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. 
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. 
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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, urinalysis, and urine 
drug screen. 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. Testing 
to rule out hepatitis B, hepatitis C, and HIV (see Exclusion Criterion #9, Section 6.2) 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. 
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 
Leukocyte esterase 
Hematocrit 
Glucose 
Nitrite 
Hemoglobin 
BUN 
Urine dipstick for pregnancy testingb 
MCH 
Creatinine 
Urine drug screenc 
MCHC 
ALP 
 
MCV 
AST 
 
Platelet count 
ALT 
 
RBC count 
GGT 
 
WBC count 
Total bilirubin 
 
 
Serum pregnancy testingb 
 
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea 
nitrogen; GGT=gamma glutamyltransferase; MCH=mean corpuscular hemoglobin; MCHC=mean corpuscular 
hemoglobin concentration; MCV=mean corpuscular volume; PEOT=Premature End of Treatment; 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. 
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b Pregnancy testing will consist of serum testing at the Screening Visit. The pregnancy test will be urine at all other 
visits. 
c Urine drug screen will be performed at Screening Visit, and Week 52 or PEOT Visit. 
12.2.1 
Evaluation of PDILI 
The PDILI IMP discontinuation criteria for this study are provided in Section 6.3.1, 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 
reported as an AE of special interest (see Section 12.1.1.1), 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 6.3.1), 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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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 
Further investigation 
– immediate IMP 
discontinuation not 
required (see 
Section 12.2.1.2). 
 
IMP discontinuation 
Essential: Every 
attempt must be 
made to have repeat 
liver chemistry 
values and 
additional testing 
completed within 
48 hours at the site 
Monitoring of liver 
chemistry values at least 
twice per week for 2 
weeks.d 
 
Immediate IMP 
discontinuation 
required if liver 
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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 
up requirements).c 
required if any of the 
following occur: 
 
Subject cannot 
comply with 
monitoring 
schedule. 
 
Liver chemistry 
values continue 
to increase 
 
Liver chemistry 
values remain 
≥5xULN (and 
≥2x baseline) 
after 4 weeks of 
monitoring 
without evidence 
of resolution 
with HCP (see 
Section 12.2.1.3). 
chemistry values 
continue to increase. 
After 2 weeks of 
monitoring liver 
chemistry values: 
 
ALT or AST remains 
≥5xULN <8xULN, 
IMP should be 
temporarily withheld 
and subject should 
undergo repeat test in 
2 weeks. 
 
Continue IMP if ALT 
or AST values 
<5xULN; continue to 
monitor at least twice 
per week until values 
normalize, stabilize, 
or return to within 
baseline values. 
 
If ALT or AST 
remains ≥5xULN 
after second re-test, 
immediate, 
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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 
permanent IMP 
discontinuation 
required. 
Continue to monitor until 
values normalize, 
stabilize, or return to 
within baseline values.d 
ALP=alkaline phosphatase; ALT=alanine aminotransferase; ASAP=as soon as possible; AST=aspartate aminotransferase; HCP=healthcare practitioner; 
IMP=investigational medicinal product; NA=not applicable; PDILI=potential drug-induced liver injury; ULN=upper limit of normal 
a Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or tenderness; hypersensitivity symptoms include eosinophilia (>5%), 
rash, and fever (without clear alternative cause). 
b If the subject also has ≥2xULN ALP, the possibility of an indication of biliary obstruction should be discussed with the Medical Monitor. 
c Details provided in Section 12.2.1.1. The local hepatologist is the expert usually consulted by the treating physician for assessment and management of 
potential hepatic disease. This would usually be a hepatologist, but may be a gastroenterologist. 
d Unless an alternative monitoring schedule is agreed by the Investigator and UCB responsible physician. Determination of stabilization is at the discretion of the 
Investigator in consultation with the hepatologist (as applicable) and UCB responsible physician, as needed.
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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 6.3.1 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  
Rechallenge with IMP can occur only if ALL of the following requirements are met: 
 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).  
 The subject has shown clear therapeutic benefit from the IMP. 
 Subject’s ALT or AST elevations do not exceed ≥5xULN. 
 Subject’s total bilirubin is <2xULN. 
 Subject has no signs or symptoms of hypersensitivity or hepatitis.  
 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. 
 Subject agrees to the Investigator-recommended monitoring plan. 
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 
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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:  
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 screena 
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/INRb 
Serum pregnancy testc 
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 
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Table 12‒4: PDILI laboratory measurements 
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: 
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: 
 
History of liver disease (eg, autoimmune hepatitis, nonalcoholic steatohepatitis or other “fatty 
liver disease”) 
 
Adverse reactions to drugs 
 
Allergies 
 
Relevant family history or inheritable disorders (eg, Gilbert’s syndrome, alpha-1 antitrypsin 
deficiency) 
 
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. 
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12.3 
Other safety measurements 
12.3.1 
Assessment and management of TB and TB risk factors 
All subjects will be assessed for tuberculosis (TB) at Screening and at the timepoints specified in 
the Schedule of Assessments (Table 5‒1) 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: 
a. Known TB infection: 
 Active TB infection or clinical signs and symptoms suspicious for TB (pulmonary or 
extra-pulmonary). 
 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. 
b. 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. 
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 specialist and discussion with the Study Physician, if LTB 
infection 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 LTB infection) http://www.cdc.gov/TB/topic 
/testing/default.htm). 
d. NTMB infection is defined as a clinical infection caused by mycobacterial species other than 
those belonging to the Mycobacterium tuberculosis complex. 
e. 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 
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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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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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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 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 adverse event 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 latent or 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 subject 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 subject 
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. The 
questionnaire will assist with the identification of subjects who may require therapy for TB. A 
subject who answers “Yes” to the question 
 
 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 
LTB infection and active TB identified during study 
During the study, subjects who develop evidence of LTB infection 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 
LTB infection 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 
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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 should be withdrawn from the study and receive appropriate TB or 
prophylaxis therapy. 
If a TB specialist excludes an active TB infection the subject can proceed with the IMP no earlier 
than 4 weeks after the start of an appropriate prophylactic therapy. 
Any presumptive diagnosis or diagnosis of a TB infection is a reportable event. Confirmed active 
TB must be reported as an SAE. The Investigator is to complete and submit the TB Follow-Up 
Form provided. 
The subject should be transferred to the care of his/her physician and managed according to the 
best available standard of care. Subjects identified as having converted to active TB during the 
study must be withdrawn and scheduled to return for the PEOT Visit as soon as possible but no 
later than the next scheduled study visit and complete all PEOT Visit assessments. 
The subject should be encouraged to complete a SFU Visit (20 weeks after the final dose of 
IMP). 
If infection with NTMB is identified during the study, the same procedure as for active TB 
acquired during the study must be followed. 
12.3.2 
Pregnancy testing 
Pregnancy testing will consist of serum testing at the Screening. The pregnancy test will be urine 
at all 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 at the visits specified in Table 5‒1. Pregnancy tests should 
be administered to all female subjects of childbearing potential, regardless of their use of birth 
control. 
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. 
12.3.4 
12-lead electrocardiograms 
Twelve-lead standard ECGs will be recorded at the visits specified in Table 5‒1, 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. The physical 
examination will include general appearance; ear, nose, and throat; eyes, hair, and skin; 
respiratory; CV; GI; musculoskeletal; hepatic; neurological (including limb reflexes); and mental 
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status. All physical examinations will also include evaluation of signs and symptoms of active 
TB and risk for exposure to TB. 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. 
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). 
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 6.3 for eC-SSRS-related withdrawal criteria. 
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 Screening assessment and include all 
clinically relevant past or coexisting medical conditions and surgeries. Findings will be recorded 
in the 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 duration of membership for the committees will be inclusive of planned 
analyses for PS0009. 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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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. 
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. 
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Electronic data records, such as Holter monitor records or electroencephalogram records, must 
be saved and stored as instructed by UCB (or designee). 
Patient-reported outcome measures (eg, DLQI, EQ-5D-3L, SF-36, Patient Global Assessment of 
PSO, and PGADA) and ePRO diary data will be entered electronically by the subject. 
The ePRO diary data will be entered into an electronic diary by the subject. The data collection 
and database management system will be supplied by a vendor and will be compliant with the 
US Food and Drug Administration Part 11. The data collected on the ePRO diary 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. 
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. 
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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 
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 participants 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. 
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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 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. 
The Safety Set (SS) will consist of all subjects that received at least 1 dose of the IMP. 
The Maintenance Set will consist of all subjects who have received at least 1 dose of active IMP 
(bimekizumab or ustekinumab) in the Maintenance Treatment Period.  
The Full Analysis Set (FAS) will consist of all randomized subjects that received at least 1 dose 
of the IMP and have a valid measurement for each of the co-primary efficacy variables at 
Baseline. 
The Active Medication Set (AMS) will consist of all subjects who have received at least 1 dose 
of active IMP (bimekizumab or ustekinumab). The AMS will be used for summaries of safety 
that include all data from the Initial Treatment Period and/or Maintenance Treatment Period. 
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. 
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 
post-dose without important protocol deviations that would affect the concentration. 
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, SD, median, minimum, and maximum unless stated otherwise. 
The statistical analysis of the co-primary efficacy variables 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. 
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The hypotheses (H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15, H16, and H17) 
comparing bimekizumab vs. placebo or bimekizumab vs. ustekinumab will be tested at a 2-sided 
alpha level of 0.05. 
The first 2 hypotheses (H1 and H 2) test whether bimekizumab is superior to placebo for PASI90 
response and IGA response at Week 16. These are the hypothesis tests corresponding to the co-
primary endpoints. If both 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 secondary efficacy endpoints and are 
based on testing for non-inferiority/superiority relative to ustekinumab or for superiority relative 
to placebo. Note that while subjects randomized to ustekinumab may receive either the 45mg or 
90mg dose (according to weight at Baseline), all subjects randomized to ustekinumab will be 
analyzed as a single group (and not broken out by dose) since the proposed strategy is consistent 
with the recommended weight-based dosing for ustekinumab. See Figure 14-1 for details on this 
procedure. 
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Figure 14-1: Sequence of testing 
 
IGA=Investigator’s Global Assessment; PASI=Psoriasis Area Severity Index; PSD=Patient Symptom Diary; 
PSO=psoriasis 
14.3 
Planned efficacy analyses 
14.3.1 
Analysis of the primary efficacy variable 
The co-primary efficacy variables for this study will be PASI90 response and IGA response at 
Week 16, and the corresponding analyses will be based on the RS. A subject will be classified as 
a PASI90 responder if the PASI score at Week 16 has improved at least 90% from Baseline, and 
an IGA responder will be any subject with a score of 0 or 1 (Clear or Almost Clear) with at least 
a 2-category improvement from Baseline in the IGA score. The primary analyses will be based 
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on the stratified Cochran-Mantel-Haenszel (CMH) test 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. Pairwise treatment 
comparisons will be made based on the CMH test using the p-value for the general association. 
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 co-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, 
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 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. In addition, if the logistic 
regression model cannot converge due to lack of any placebo responders, then Fisher’s exact test 
will be used for inferential comparisons to placebo. 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 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 21 subjects will be considered acceptable for a center to be included in the model 
without pooling. Given the 4:2:1 randomization allocation scheme, this should provide a 
minimum of about 12 subjects in the bimekizumab arm, 6 subjects in the ustekinumab arm, and 
3 subjects in the placebo arm. Centers with fewer than 21 subjects will be eligible for pooling. 
The following center pooling algorithm will be used for each geographic region: 
 If a center has 21 or more subjects, then no pooling will be done for that center. 
 Centers with fewer than 21 subjects will be ordered from largest to smallest with pooling 
proceeding in the following manner: 
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 Two or more centers will be combined until the cumulative subject total is at least 21. 
 Once a pooled center has at least 21 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 21 subjects has been reached in the previous pool. 
 If this iterative process reaches the end of the ordered list of centers where the final 
pooled center has fewer than 21 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. 
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 
14.3.2.1.1 
Initial Treatment Period 
The secondary efficacy variables for time points during the initial Treatment Period will be 
analyzed for all subjects in the RS. 
For binary secondary efficacy variables, 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. For the assessment of non-inferiority, a non-inferiority margin of 
10% will be used and evaluated based on the confidence interval for the stratified Mantel-
Haenszel risk difference between bimekizumab and ustekinumab. 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. 
For continuous change from Baseline efficacy variables, an analysis of covariance (ANCOVA) 
model will be used with fixed effects of treatment, region, and prior biologic exposure and 
Baseline value as a covariate. Missing data for these variables will be imputed using multiple 
imputation (MI) and is further described in Section 14.7. 
Sensitivity analyses for the handling of missing data will be performed for the secondary efficacy 
variables during the Initial Treatment Period that are part of the fixed sequence testing 
procedure. These analyses are described in Section 14.7. 
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14.3.2.1.2 
Maintenance Treatment Period 
Because all placebo subjects will receive bimekizumab treatment starting at Week 16, statistical 
comparisons against placebo after Week 16 will not be performed. However, bimekizumab will 
be compared to ustekinumab at Week 52 for the RS. The analysis of PASI90 and IGA at 
Week 52 will be based on a stratified CMH test where region and prior biologic exposure will be 
used as stratification variables. Pairwise treatment comparisons will be made based on the p-
value for the general association. 
Missing data will be imputed using NRI. All subjects with missing data at Week 52 or who 
discontinue study treatment prior to Week 52 will also be treated as non-responders for this 
secondary efficacy analysis. 
14.3.2.2 
Analysis of the other efficacy variables 
The other efficacy variables in the Initial Treatment Period will be analyzed for all subjects in the 
RS. For the Maintenance Treatment Period, summaries will primarily be based on the RS. Full 
details will be specified in the SAP. 
Binary (responder) variables will be summarized using frequency tables by treatment group for 
each visit. 
Continuous variables will be summarized using descriptive statistics by treatment group for each 
visit. 
Time to PASI75/90/100 response during the Initial Treatment Period 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 16 Visit without 
achieving the given PASI response will be censored at the date of the Week 16 Visit. The median 
time to response, including the 2-sided 95% CI, will be calculated for each treatment. Between 
group differences (bimekizumab vs placebo and bimekizumab vs ustekinumab) will be analyzed 
with the log-rank statistic. 
All other efficacy variables during the Initial Treatment Period will be summarized based on 
imputed data (NRI and multiple imputation 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. 
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For other efficacy variables during the Maintenance Treatment Period, summaries will include 
the bimekizumab and ustekinumab treatment groups. Details of these summaries will be 
described further in the SAP, but there will be 2 key approaches for understanding the data in the 
Maintenance Treatment Period: 
1. Summary of data for the RS through Week 52 based on randomized treatment group.  
2. Summary of Maintenance Treatment Period data among responders only. 
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 14.3. 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 
therapy of any kind, Baseline disease severity, and antibody positivity. These summaries will be 
based on imputed data (NRI or MI) and will include descriptive statistics only. Note that the 
approach for deriving descriptive statistics using MI is outlined in Section 14.7. 
14.5 
Planned safety and other analyses 
14.5.1 
Safety analyses 
Safety variables will be analyzed for all subjects in the SS. The AMS will be used for summaries 
of safety that include data from the Initial Treatment Period and/or Maintenance Treatment 
Period. 
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities 
(MedDRA). Adverse events will be summarized descriptively by treatment group, primary 
system organ class, High Level Term (HLT), and preferred term. Additional tables will 
summarize AEs by intensity and relationship to IMP, AEs leading to withdrawal from the study, 
SAEs, and deaths. Specific safety topics of interest will be summarized and will be described in 
greater detail in the SAP. 
For subjects who switch treatment, AEs will be allocated to the treatment the subject was on the 
day the event occurred. If the event occurs on the day of the switch, it will be attributed to the 
initial treatment, unless the event has a HLT of “Injection Site Reactions, in which case it will be 
attributed to the new treatment. 
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. 
14.5.3 
Immunogenicity analyses 
Antibimekizumab 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. 
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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 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. 
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 co-primary efficacy variables 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 co-primary efficacy variables will be performed: 
1. Missing data will be addressed by using MI (Markov-Chain Monte Carlo [MCMC] 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/IGA 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 (MAR) pattern of 
missingness and corresponds to an estimand of the difference in outcome improvement if all 
subjects tolerated or adhered to treatment (Mallinckrodt et al, 2012). This is an estimand of 
efficacy to evaluate the de jure hypothesis. 
2. Deviations from the MAR pattern assumed above will be evaluated. A sensitivity analysis 
will be performed in which, as with the above analysis, intermittent missing data will be 
imputed using MI based on the MCMC method. However, the remaining monotone missing 
data will be assumed to follow a missing not at random pattern. These data will be imputed 
using reference-based imputation in which the imputation model is based on data from the 
placebo group, thereby assuming that monotone missing data follow a trajectory similar to 
the placebo group (Mallinckrodt et al, 2012). As specified in the previous procedure, actual 
PASI/IGA scores will be imputed and then dichotomized to get 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 estimand in this procedure is the 
difference in outcome improvement in all randomized subjects at the planned endpoint of the 
study attributable to the initially randomized medication (Mallinckrodt et al, 2012). This is an 
estimand of effectiveness to evaluate the de facto hypothesis. 
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3. A final 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 binary secondary variables during the Initial Treatment Period will be imputed 
using NRI. Missing data for continuous secondary variables will be imputed using MI. The MI 
procedure for continuous variables will be similar to sensitivity analysis #1 described above for 
the co-primary efficacy endpoints 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; and 2) the analysis model will be based on ANCOVA as opposed to the CMH test. 
For the secondary endpoints evaluated at Week 52, all subjects with missing data at Week 52 or 
who discontinue treatment prior to Week 52 will be counted as nonresponders. Sensitivity 
analyses #1 and #2 will also be performed for the Week 52 secondary endpoints. A similar 
procedure to what is described above will be followed. Further details on this analysis will be 
provided 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, min and max, 
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. This is the same 
approach that will be used when summarizing continuous secondary efficacy variables by 
subgroup. 
14.8 
Planned interim analysis and data monitoring 
After the final Week 52 visit, an interim analysis will be performed and a corresponding interim 
CSR may be written. A final analysis and updated final CSR will be prepared once all data 
(through the SFU visit) have been collected. 
14.9 
Determination of sample size 
A total of 560 subjects will be randomly assigned in a 4:2:1 ratio to the following treatment 
groups: 
 Bimekizumab 320mg (320 subjects) 
 Ustekinumab (160 subjects) 
 Placebo (80 subjects) 
The primary efficacy analysis is based on the comparison of bimekizumab to placebo for the co-
primary efficacy variables of PASI90 response and IGA response at Week 16. However, as 
described in Section 14.3, Week 16 comparisons of bimekizumab against ustekinumab for 
PASI90 response and IGA response will also be part of a fixed sequence testing procedure to 
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control for multiplicity. Therefore, this study has been powered to show statistical superiority to 
ustekinumab based on the co-primary endpoints. 
The assumed responder rates for PASI90 at Week 16 are 75%, 58%, and 2% for bimekizumab, 
ustekinumab, and placebo, respectively. Additionally, the assumed responder rates for IGA are 
85%, 68%, and 5% for bimekizumab, ustekinumab, and placebo, respectively. The assumed 
responder rates for bimekizumab are based on the Phase 2b PS0010 data. The assumptions 
related to the responder rates for ustekinumab are based on those observed in the CLEAR study 
(Thaci et al, 2015). The power to show statistical superiority of bimekizumab relative to placebo 
under these assumptions is >99% for the co-primary endpoints. 
The power to detect a statistically significant difference between bimekizumab and ustekinumab 
at a 2-sided significance level of 0.05 is 95% for PASI90 response and 98% for IGA response. 
Because both co-primary endpoints are highly powered independently, and because PASI and 
IGA response tend to be highly correlated, the overall power for achieving superiority on both 
co-primary endpoints is not calculated here. Note that the power for the non-inferiority testing 
between bimekizumab and ustekimumab for both PASI90 and IGA responses is >99% based on 
a 1-sided significance level of 0.025 and a non-inferiority margin of 10%. 
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. 
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. 
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. A 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. 
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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, 
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. 
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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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Parisi R, Symmons DP, Griffiths CE, Ashcroft DM, Identification and Management of Psoriasis 
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18 
APPENDICES 
18.1 
Protocol Amendment 1 
Rationale for the amendment 
The purpose of this amendment is the following:   
 To remove the escape arm to allow for a 1-year comparison of bimekizumab vs ustekinumab 
that is not confounded by an escape arm at Week 16. 
 To remove the mandatory withdrawal at Week 28 or later 
The other changes in this amendment are as follows: 
 Clarified the number of subjects to be screened 
 Clarified that the secondary objective of the evaluation of bimekizumab compared to 
ustekinumab to be after 4, 12, 16, and 52 weeks of treatment 
 Added assessment of the Patient Symptom Diary (daily) to the Screening and Week 16 Visits 
 Clarified that the minimum time between doses should be no less than 21 days and no more 
than 35 days 
 Removed the criterion that excluded subjects exposed to more than 3 biologic response 
modifiers (including no more than 1 IL-17) 
 Clarified that subjects who experienced primary failure (no response within 12 weeks) to 1or 
more IL-17 biologic response modifiers or more than 1 biologic response modifiers other 
than an IL-17 should be excluded from the study 
 Removed the withdrawal criterion that subjects who do not achieve a PASI50 response by 
Week 28 or later be withdrawn from the study 
 Clarified that the same assessor should evaluate the subject at each efficacy assessment. 
 Updated the assessment and management of TB and TB risk factors 
 Updated the sequence testing and the analysis of the secondary efficacy variables and other 
efficacy variables  
 Revised the List of Abbreviations 
 
Modifications and changes 
Global changes 
The following changes were made throughout the protocol: 
 The study design was changed to remove the escape arm. 
 Mandatory withdrawal at Week 28 or later was removed. 
 Minor editorial revisions were made 
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Specific changes 
Change #1  
List of abbreviations 
The following abbreviations have been deleted: 
ESS 
Escape Subject Set 
MS 
Maintenance Set 
WK12ResS 
Week 12 Responder Set 
 
Change #2  
Section 1 Summary 
Approximately 800 subjects will be screened in order to have 640 subjects randomized in the 
study. For each subject, the study will last a maximum of 72 weeks and will consist of 4 periods, 
a Screening Period (2 to 4 weeks), a double-blind, placebo- and active comparator-controlled 
Initial Treatment Period (16 weeks), a double-blind, active comparator-controlled Maintenance 
Treatment Period (36 weeks), and a Safety Follow-Up (SFU) Period (20 weeks after the last dose 
of IMP). After the 36-week Maintenance Treatment Period, eligible subjects will be allowed to 
enroll in an open-label study. 
During the Treatment Period, eligible subjects will be randomized 4:3:1 to receive the following 
blinded IMP regimens: 
 Bimekizumab 320mg administered sc Q4W 
 Ustekinumab (45mg or 90mg, depending on subject weight) administered sc at Baseline and 
4 weeks later, followed by ustekinumab sc every 12 weeks 
 Placebo administered sc Q4W  
Approximately 320 subjects will be randomized to bimekizumab 320mg, 240 subjects will be 
randomized to ustekinumab, and approximately 80 subjects will be randomized to placebo. 
Investigational medicinal product (IMP) will be administered in the clinic at Baseline and Q4W 
thereafter, until Week 16 (Initial Treatment Period). Additional nondosing study visits will occur 
at Week 1 and Week 2. At Week 16, subjects will enter the Maintenance Treatment Period and 
will be reallocated based on original treatment and response to treatment. The Maintenance 
Treatment Period will include dosing Q4W. 
Subjects who do not achieve a PASI90 response at Week 16 of the Initial Treatment will receive 
bimekizumab 320mg Q4W (ie, escape treatment). At Week 52, all subjects enrolling in the open-
label study will undergo the Week 52 study assessments before receiving their first treatment 
dose in the open-label study. All subjects not enrolling in the open-label study will have the 
Week 52 study assessments and will enter the SFU Period. 
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Has been changed to: 
 Approximately 750800 subjects will be screened in order to have 560640 subjects 
randomized in the study. For each subject, the study will last a maximum of 72 weeks and 
will consist of 4 periods, a Screening Period (2 to 4 weeks), a double-blind, placebo- and 
active comparator-controlled Initial Treatment Period (16 weeks), a double-blind, active 
comparator-controlled Maintenance Treatment Period (36 weeks), and a Safety Follow-Up 
(SFU) Period (20 weeks after the last dose of IMP). After the 36-week Maintenance 
Treatment Period, eligible subjects will be allowed to enroll in an open-label study. 
During the Treatment Period, eEligible subjects will be randomized 4:23:1 to receive the 
following blinded IMP regimens: 
 Bimekizumab 320mg administered sc Q4W 
 Ustekinumab (45mg or 90mg, depending on subject weight) administered sc at Baseline and 
4 weeks later, followed by ustekinumab sc every 12 weeks 
 Placebo administered sc Q4W for 16 weeks during the Initial Treatment Period, followed 
by bimekizumab 320mg administered sc Q4W during the Maintenance Treatment 
Period 
Approximately 320 subjects will be randomized to bimekizumab 320mg, 160240 subjects will be 
randomized to ustekinumab, and approximately 80 subjects will be randomized to placebo. 
Investigational medicinal product (IMP) will be administered in the clinic at Baseline and Q4W 
thereafter, until Week 16 (Initial Treatment Period). Additional nondosing study visits will occur 
at Week 1 and Week 2. At Week 16, subjects will enter the Maintenance Treatment Period and 
will be reallocated based on original treatment and response to treatment. The Maintenance 
Treatment Period will include Q4W dosing Q4W for subjects receiving bimekizumab and 
Q12W dosing for subjects receiving usteinumab. 
Subjects who do not achieve a PASI90 response at Week 16 of the Initial Treatment will 
receive bimekizumab 320mg Q4W (ie, escape treatment). At Week 52, all subjects enrolling 
in the open-label study will undergo the Week 52 study assessments before receiving their first 
treatment dose in the open-label study. All subjects not enrolling in the open-label study will 
have the Week 52 study assessments and will enter the SFU Period. 
 
Change #3  
Section 2.1.2 Current treatments for psoriasis 
 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. 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. 
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Has been changed to: 
 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. 
 
Change #4  
Section 2.2.1.1 
Completed studies 
Four 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, and 
UP0031 in 12 healthy volunteers. Three studies (RA0123, PS0010, and PS0016) are ongoing in 
subjects with moderate to severe rheumatoid arthritis (RA0123) and in subjects with moderate to 
severe PSO (PS0010 and PS0016). 
Has been changed to: 
Four 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, and 
UP0031 in 12 healthy volunteers. Three studies (RA0123, PS0010, and PS0016) are ongoing 
in subjects with moderate to severe rheumatoid arthritis (RA0123) and in subjects with 
moderate to severe PSO (PS0010 and PS0016). 
 
Change #5  
Section 2.2.1.2 
Ongoing studies 
Five additional studies of bimekizumab in the treatment of PSO are ongoing. 
Has been changed to: 
Four additional studies of bimekizumab in the treatment of PSO and 1 study in healthy 
volunteers are ongoing. Five additional studies of bimekizumab in the treatment of PSO are 
ongoing. 
 
Change #6  
Section 3.2 
Secondary objectives 
The secondary objectives of the study are to: 
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 Evaluate the efficacy of bimekizumab compared to placebo at achieving complete clearance 
(PASI100) after 16 weeks of treatment 
 Evaluate the efficacy of bimekizumab compared to placebo after 4 weeks of treatment 
 Evaluate the efficacy of bimekizumab compared to ustekinumab after 12 weeks, 16 weeks, 
and 52 weeks of treatment 
 Evaluate the change in itch, pain, and scaling of bimekizumab compared to placebo after 
16 weeks of treatment as reported by subjects using the Patient Symptom Diary 
 Evaluate the change in psoriatic scalp disease of bimekizumab compared to placebo after 
16 weeks of treatment in subjects with scalp PSO at Baseline 
 Assess TEAEs, SAEs, and TEAEs leading to withdrawal adjusted by duration of subject 
exposure to study treatment 
Has been changed to: 
The secondary objectives of the study are to: 
 Evaluate the efficacy of bimekizumab compared to placebo at achieving complete clearance 
(PASI100) after 16 weeks of treatment 
 Evaluate the efficacy of bimekizumab compared to placebo after 4 weeks of treatment 
 Evaluate the efficacy of bimekizumab compared to ustekinumab after 4 weeks, 12 weeks, 16 
weeks, and 52 weeks of treatment 
 Evaluate the change in itch, pain, and scaling of bimekizumab compared to placebo after 
16 weeks of treatment as reported by subjects using the Patient Symptom Diary 
 Evaluate the change in psoriatic scalp disease of bimekizumab compared to placebo after 
16 weeks of treatment in subjects with scalp PSO at Baseline 
 
Change #7  
Section 5.2.2 Initial Treatment Period 
During the 16-week Initial Treatment Period, approximately 640 subjects will be randomized 
4:3:1 to receive the following blinded IMP regimens: 
 Bimekizumab 320mg administered sc Q4W (320 subjects) 
 Ustekinumab (240 subjects): 
 For subjects weighing ≤100kg (220lbs), 45mg sc initially and 4 weeks later 
 For subjects weighing >100kg (220lbs), 90mg sc initially and 4 weeks later 
 Placebo administered sc Q4W (80 subjects) 
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). 
Has been changed to: 
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During the 16-week Initial Treatment Period, approximately 560640 subjects will be randomized 
4:23:1 to receive the following blinded IMP regimens: 
 Bimekizumab 320mg administered sc Q4W (320 subjects) 
 Ustekinumab (160240 subjects): 
 For subjects weighing ≤100kg (220lbs), 45mg sc initially and 4 weeks later 
 For subjects weighing >100kg (220lbs), 90mg sc initially and 4 weeks later 
 Placebo administered sc Q4W (80 subjects) 
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). 
 
Change #8  
Section 5.2.3 Maintenance Treatment Period 
Treatment during the Maintenance Treatment Period will be based on initial treatment and 
response to treatment at Week 16, per the following rules: 
 All subjects who do not achieve a PASI90 response at Week 16 will be allocated to the 
escape arm and be treated with bimekizumab 320mg Q4W. 
 Subjects in the bimekizumab 320mg treatment arm who achieve a PASI90 response at 
Week 16 will continue to receive bimekizumab 320mg Q4W. 
 Subjects in the ustekinumab treatment arm who achieve a PASI90 response at Week 16 will 
continue on ustekinumab (subjects weighing ≤100kg [220lbs] at Baseline will receive 45mg 
sc every 12 weeks; subjects weighing >100kg [220lbs] at Baseline will receive 90mg sc 
every 12 weeks). 
 Subjects in the placebo arm who achieve a PASI90 response at Week 16 will continue on 
placebo. 
Subjects may receive placebo injections at certain visits in order to blind the IMP (see 
Section 7.2). 
If a subject does not achieve a PASI50 response at Week 28 or later, the subject will be 
withdrawn from the study after that time point. 
At the end of the Maintenance Treatment Period, all subjects enrolling in the open-label study 
will, after signing a new ICF, undergo the Week 52 study assessments and then receive their first 
dose of bimekizumab in the open-label study. All subjects not enrolling in the open-label study 
will have the Week 52 study assessments and will enter the SFU Period. 
Has been changed to: 
Treatment during the Maintenance Treatment Period will be based on initial treatment and 
response to treatment at Week 16, per the following rules: 
 All subjects who do not achieve a PASI90 response at Week 16 will be allocated to the 
escape arm and be treated with bimekizumab 320mg Q4W. 
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 Subjects in the bimekizumab 320mg treatment arm who achieve a PASI90 response at 
Week 16 will continue to receive bimekizumab 320mg Q4W. 
 Subjects in the ustekinumab treatment arm who achieve a PASI90 response at Week 16 
will continue on ustekinumab (subjects weighing ≤100kg [220lbs] at Baseline will receive 
45mg sc every 12 weeks; subjects weighing >100kg [220lbs] at Baseline will receive 90mg 
sc every 12 weeks). 
 Subjects in the placebo arm will receive bimekizumab 320mg Q4Wwho achieve a PASI90 
response at Week 16 will continue on placebo. 
Subjects may receive placebo injections at certain visits in order to blind the IMP (see 
Section 7.2). 
If a subject does not achieve a PASI50 response at Week 28 or later, the subject will be 
withdrawn from the study after that time point. 
At the end of the Maintenance Treatment Period, all subjects enrolling in the open-label study 
will, after signing a new ICF, undergo the Week 52 study assessments and then receive their first 
dose of bimekizumab in the open-label study. All subjects not enrolling in the open-label study 
will have the Week 52 study assessments and will enter the SFU Period. 
 
Change #9  
Table 5-1 Schedule of study assessments 
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Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Period 
(weeks after first dose) 
SFUb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
eC-SSRS 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Patient Symptom Diary (daily) 
 
X 
X 
X 
X 
X 
X 
  
 
 
 
 
 
 
 
 
 
 
scalp IGA 
 
X 
Xn 
Xn 
Xn 
Xn 
Xn 
Xn 
 
 
Xn 
 
 
Xn 
 
 
Xn 
 
n For bimekizumab, the minimum time between doses should be no less than 24 days and no more than 32 days. 
Has been changed to: 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Period 
(weeks after first dose) 
SFUb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
eC-SSRS 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Patient Symptom Diary (daily) 
 
X 
X 
X 
X 
X 
X 
 X 
 
 
 
 
 
 
 
 
 
 
scalp IGA 
 
X 
Xn 
Xn 
Xn 
Xn 
Xn 
Xn 
 
 
Xn 
 
 
Xn 
 
 
Xn 
 
n For bimekizumab, the minimum time between doses should be no less than 214 days and no more than 352 days. 
 
 
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Change #10  
Figure 5-1 Schematic diagram 
 
Placebo
Bimekizumab 
320mg Q4W
Ustekinumab
Screening
N=80
N=320
N=240
Initial Treatment Period
Week
16
Co-primary Endpoint: 
PASI90 Response and 
IGA Response
Bimekizumab 
extension study
to evaluate response 
to treatment and 
long-term safety
SFU Visit
20 Weeks after last 
dose for subjects not 
enrolling in extension 
study
Randomization
 Escape arm:
             Bimekizumab 320mg Q4W
Placebo
Ustekinumab
Maintenance Period
52
28
<PASI90
<PASI90
<PASI90
≥PASI90
≥PASI90
<PASI90
Baseline
<PASI50: 
Mandatory study 
withdrawal
<PASI50
<PASI50
<PASI50
<PASI50: Mandatory 
study withdrawal at 
Week 28 or later
<PASI50
           Bimekizumab 320mg Q4W
≥PASI90
N=640
 
IGA=Investigator’s Global Assessment; PASI=Psoriasis Area Severity Index; Q4W=every 4 weeks; SFU=Safety Follow-Up 
Note: If a subject does not achieve a PASI50 response at Week 28 or later, the subject will be withdrawn from the study at the time point when the PASI50 
response is not achieved. 
Has been changed to: 
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IGA=Investigator’s Global Assessment; PASI=Psoriasis Area Severity Index; Q4W=every 4 weeks; SFU=Safety Follow-Up 
Note: If a subject does not achieve a PASI50 response at Week 28 or later, the subject will be withdrawn from the study at the time point when the 
PASI50 response is not achieved. 
 
Placebo
Bimekizumab 
320mg Q4W
Ustekinumab
Screening
N=80
N=320
N=160
Initial Treatment Period
Week
16
Co-primary Endpoint: 
PASI90 Response and 
IGA Response
Bimekizumab 
extension study
to evaluate response 
to treatment and 
long-term safety
SFU Visit
20 Weeks after last 
dose for subjects not 
enrolling in extension 
study
Randomization
Ustekinumab
Maintenance Period
52
Baseline
           Bimekizumab 320mg Q4W
N=560
           Bimekizumab 320mg Q4W
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Change #11 
Section 5.4 
Planned number of subjects and site(s) 
Approximately 860 subjects will be screened in order to have 640 subjects randomized in the 
study. There will be approximately 320 subjects in the bimekizumab 320mg treatment arm, 
240 subjects in the ustekinumab treatment arm and 80 subjects in the placebo treatment arm. The 
planned number of study sites is approximately 100. Every eligible subject who signs an ICF will 
be randomized. 
Has been changed to: 
Approximately 750860 subjects will be screened in order to have 560640 subjects randomized in 
the study. There will be approximately 320 subjects in the bimekizumab 320mg treatment arm, 
160240 subjects in the ustekinumab treatment arm and 80 subjects in the placebo treatment arm. 
The planned number of study sites is approximately 100. Every eligible subject who signs an ICF 
will be randomized. 
 
Change #12 
Section 5.8.1 Study design 
The following text has been deleted: 
The results of the Phase 2b study PS0010 indicate that approximately 80% of subjects in 
the bimekizumab 320mg Q4W treatment arm achieved a high level of response (PASI90). 
Subjects who do not achieve a PASI90 response at Week 16 are allocated to escape 
treatment with bimekizumab 320mg Q4W. Allocating subjects who do not achieve a 
PASI90 on placebo or ustekinumab to the bimekizumab 320mg Q4W escape arm provides 
them with the opportunity to potentially achieve a higher level of efficacy. Beyond just 
achieving a higher level of skin clearance, there is evidence that PASI90 is associated with 
higher levels of patient satisfaction (as measured by DLQI) compared with a lower PASI75 
threshold (Puig et al, 2017). 
If subjects are not responding to escape treatment or if they lose response over time, the 
mandatory withdrawal criterion for subjects who do not achieve a PASI50 response at 
Week 28 or later will ensure that subjects do not continue to receive prolonged exposure to 
study treatment that is providing a sub-optimal response, regardless of their initial 
randomized treatment. 
 
Change #13 
Section 6.2 
Exclusion criterion #22 
The following criterion has been deleted. 
22. Subject has been exposed to more than 3 biological response modifiers (including no 
more than 1 IL-17). 
 
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Change #14 
Section 6.2 
Exclusion criterion #23 
23. Subject has experienced one primary failure to an IL-17 biological response modifier (no 
response within 12 weeks). 
Has been changed to: 
23. Subject has experienced one primary failure to an IL-17 biological response modifier (no 
response within 12 weeks) to 1 or more  IL-17 biologic response modifier (eg, 
brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier 
other than an IL-17. 
 
Change #15 
Section 6.3 
Withdrawal criterion #3 
The following criterion has been deleted: 
3. Subject does not achieve a PASI50 response at Week 28 or later. 
 
Change #16 
Section 7.2 
Treatment(s) to be administered 
Maintenance Treatment Period dosing 
Investigational medicinal product treatment during the Maintenance Treatment Period will be 
based on initial treatment and response to treatment at Week 16 as described in Section 5.2.3. 
 Subjects who will continue to receive placebo will receive 2 placebo injections sc Q4W. 
 Subjects who are to receive bimekizumab 320mg Q4W will receive 2 bimekizumab 160mg 
injections sc Q4W. 
 Subjects randomized to receive ustekinumab will have received ustekinumab sc at Baseline 
and Week 4, and will continue to receive ustekinumab (based on Week 16 response) sc every 
12 weeks (Weeks 16, 28, and 40). Subjects will receive placebo (2 placebo injections sc) on 
non-ustekinumab treatment weeks (Weeks 20, 24, 32, 36, 44, and 48). Because ustekinumab 
dosing is based on weight, on ustekinumab treatment weeks subjects ≤100kg (220lbs) will 
receive 1 ustekinumab 45mg sc injection and 1 placebo injection and subjects >100kg 
(220lbs) will receive 2 ustekinumab 45mg sc injections. 
The dosing scheme is depicted in Table 7-1.  
Table 7-1: 
Dosing Scheme 
Week 
Dose Assignment 
Baseline 
(first 
dose) 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
Bimekizumab 
320mg Q4W 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
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Table 7-1: 
Dosing Scheme 
Ustekinumab 45mg 
(subjects ≤100kg) 
▲○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
Ustekinumab 90mg 
(subjects >100kg) 
▲▲ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
Placebo 
○○ 
○○ 
○○ 
○○ 
○○ 
○○ 
○○ 
○○ 
○○ 
○○ 
○○ 
○○ 
○○ 
NR=nonresponder; Q4W=every 4 weeks 
Notes: A bimekizumab 160mg injection is depicted by a black circle (●). A placebo injection is depicted by a white 
circle (○). A ustekinumab 45mg injection is depicted by a black triangle (▲). 
Note: Subjects who enter the bimekizumab 320mg Q4W escape arm will follow the Maintenance dosing scheme 
depicted above for the bimekizumab 320mg Q4W/Q4W group. 
Has been changed to: 
Maintenance Treatment Period dosing 
Investigational medicinal product treatment during the Maintenance Treatment Period will be 
based on initial treatment and response to treatment at Week 16 as described in Section 5.2.3. 
 Subjects who will continue to receive placebo will receive 2 placebo injections sc Q4W. 
 Subjects who are to receive bimekizumab 320mg Q4W received bimekizumab or 
placebo in the Initial Treatment Period will receive 2 bimekizumab 160mg injections sc 
Q4W. 
 Subjects randomized to receive ustekinumab will have received ustekinumab sc at Baseline 
and Week 4, and will continue to receive ustekinumab sc every 12 weeks (Weeks 16, 28, and 
40). Subjects will receive placebo (2 placebo injections sc) on non-ustekinumab treatment 
weeks (Weeks 20, 24, 32, 36, 44, and 48). Because ustekinumab dosing is based on weight, 
on ustekinumab treatment weeks subjects ≤100kg (220lbs) will receive 1 ustekinumab 45mg 
sc injection and 1 placebo injection and subjects >100kg (220lbs) will receive 2 ustekinumab 
45mg sc injections. 
The dosing scheme is depicted in Table 7-1.  
Table 7-1: 
Dosing Scheme 
Week 
Dose Assignment 
Baseline 
(first 
dose) 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
Bimekizumab 
320mg Q4W 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
Ustekinumab 45mg 
(subjects ≤100kg) 
▲○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
Ustekinumab 90mg 
(subjects >100kg) 
▲▲ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
Placebo 
○○ 
○○ 
○○ 
○○ 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
NR=nonresponder; Q4W=every 4 weeks 
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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 ustekinumab 45mg injection is depicted by a black triangle (▲). 
Note: Subjects who enter the bimekizumab 320mg Q4W escape arm will follow the Maintenance dosing 
scheme depicted above for the bimekizumab 320mg Q4W/Q4W group. 
 
Change #17 
Table 7-2 
Prohibited psoriasis medications 
Anti-IL-17 therapy 
 
3 months 
(bimekizumab is excluded per exclusion 
criteria) 
Has been changed to: 
Anti-IL-17 therapy 
secukinumab 
ixekizumab 
brodalumab 
3 months 
(bimekizumab is excluded per exclusion 
criteria) 
 
Change #18 
Section 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. Efforts should be made to limit the enrollment of subjects with 
prior biologic exposure to approximately 30% of the total study population. 
Has been changed to: 
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. Efforts should be made to limit the enrollment of 
subjects with prior biologic exposure to approximately 30% of the total study population. 
 
Change #19 
Section 8.1 
Screening Visit (2 to 4 Weeks) 
The following procedures/assessments will be performed at the Screening Visit: 
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 eC-SSRS 
 Concomitant medication 
Has been changed to: 
The following procedures/assessments will be performed at the Screening Visit: 
 eC-SSRS 
 Patient Symptom Diary (daily) 
 Concomitant medication 
 
Change #20 
Section 8.2.2 Week 1 Visit (±3 days relative to Baseline) 
The bullet for PHQ-9 has been deleted. 
 
Change #21 
Section 8.2.6 Week 12 Visit (±3 days relative to Baseline) 
The bullet for WPAI-SHP V2.0 has been deleted. 
 
Change #22 
Section 8.2.7 Week 16 Visit (±3 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
 eC-SSRS 
 scalp IGA for subjects with scalp involvement at Baseline 
Has been changed to: 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
 eC-SSRS 
 Patient Symptom Diary (daily) 
 scalp IGA for subjects with scalp involvement at Baseline 
 
Change #23 
Section 9 Assessment of Efficacy 
The following text has been added: 
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The PASI, 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. 
 
Change #24 
Section 9.1 
Psoriasis Area and Severity Index 
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 as a percentage (0-100%) which will then be mapped into a grade on a scale of 0-6 
(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 PASI50, PASI75, PASI90, and PASI100 responses are based on at least 50%, 75%, 90%, 
and 100% improvement in the PASI score, respectively. 
The total BSA affected by PSO will be derived based on the regional BSA values provided when 
assessing the PASI score. 
The PASI will be completed at the visits specified in Table 5-1. 
Has been changed to: 
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 
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given region as a percentage (0-100%) which will then be mapped into a grade 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 PASI50, PASI75, PASI90, and PASI100 responses are based on at least 50%, 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 100derived based 
on the regional BSA values provided when assessing the PASI score. 
The PASI will be completed at the visits specified in Table 5-1. 
 
Change #25 
Section 9.11 Patient Symptom Diary responses 
UCB developed a new PRO measure that will be used to assess key symptoms relevant to 
patients with moderate to severe chronic plaque PSO. PS0010 used the draft PRO measure in 
selected countries to enable psychometric validation of the PRO. Site staff will train the 
participating subjects on the use of the electronic PRO (ePRO) diary at the BaselineVisit, 
following which the device will be dispensed to the subject for home use until the Week 16 Visit. 
The ePRO diary will be administered on a daily basis from Baseline to the Week 16 Visit. 
Has been changed to: 
UCB developed a new PRO measure that will be used to assess key symptoms relevant to 
patients with moderate to severe chronic plaque PSO. PS0010 used the draft PRO measure in 
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selected countries to enable psychometric validation of the PRO. Site staff will train the 
participating subjects on the use of the electronic PRO (ePRO) diary at the ScreeningBaseline 
Visit, following which the device will be dispensed to the subject for home use until the Week 16 
Visit. The ePRO diary will be administered on a daily basis from ScreeningBaseline to the 
Week 16 Visit. 
 
Change #26 
Section 12.1.1.4 Other safety topics of interest 
The following paragraph was deleted: 
The following safety topics are prespecified as being of interest for this study, based on 
findings from the IMP clinical program to date, potential risks generally associated with 
biologic immunomodulators, or findings from other medicines belonging to the same class 
of drugs. 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. 
 
Change #27 
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. Testing to rule out 
hepatitis B, hepatitis C, and HIV (see Exclusion Criterion #9, Section 6.2) 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. 
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 
Atypical lymphocytes 
Potassium 
Blood 
Monocytes 
Sodium 
Leukocyte esterase 
Neutrophils 
Glucose 
Nitrite 
Hematocrit 
BUN 
Urine dipstick for pregnancy testingb 
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Table 12-2: Laboratory measurements 
Hematology 
Chemistry 
Urinalysis dipsticka 
Hemoglobin 
Creatinine 
 
MCH 
ALP 
 
MCHC 
AST 
 
MCV 
ALT 
 
Platelet count 
GGT 
 
RBC count 
Total bilirubin 
 
WBC count 
LDH 
 
 
Serum pregnancy testingc 
 
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea 
nitrogen; ; GGT=gamma glutamyltransferase; LDH=lactate dehydrogenase; MCH=mean corpuscular hemoglobin; 
MCHC=mean corpuscular hemoglobin concentration; MCV=mean corpuscular volume; 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. The pregnancy test will be urine at all other visits. 
Has been changed to: 
Clinical laboratory assessments consist of serum chemistry, hematology, urinalysis, and urine 
drug screen. 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. Testing 
to rule out hepatitis B, hepatitis C, and HIV (see Exclusion Criterion #9, Section 6.2) 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. 
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 
Atypical lymphocytes 
Potassium 
Blood 
Monocytes 
Sodium 
Leukocyte esterase 
Neutrophils 
Glucose 
Nitrite 
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Table 12-2: Laboratory measurements 
Hematology 
Chemistry 
Urinalysis dipsticka 
Hematocrit 
BUN 
Urine dipstick for pregnancy testingb 
Hemoglobin 
Creatinine 
Urine drug screenc 
MCH 
ALP 
 
MCHC 
AST 
 
MCV 
ALT 
 
Platelet count 
GGT 
 
RBC count 
Total bilirubin 
 
WBC count 
LDH 
 
 
Serum pregnancy testingc 
 
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea 
nitrogen; ; GGT=gamma glutamyltransferase; LDH=lactate dehydrogenase; MCH=mean corpuscular hemoglobin; 
MCHC=mean corpuscular hemoglobin concentration; MCV=mean corpuscular volume; PEOT=Premature End of 
Treatment; 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 Visit. The pregnancy test will be urine at all other 
visits. 
c Urine drug screen will be performed at Screening Visit and PEOT Visit. 
 
Change #28 
Section 12.3.1 Assessment and management of TB and TB risk factors, Item d 
d. Current or history of NTMB infection despite prior or current therapy. 
Has been changed to: 
d. NTMB infection is defined as a clinical infection caused by mycobacterial species other 
than those belonging to the Mycobacterium tuberculosis complexCurrent or history of 
NTMB infection despite prior or current therapy. 
 
Change #29 
Section 12.3.1.1 Tuberculosis assessment by IGRA 
During conduct of the study, the TB assessment by IGRA (QuantiFERON TB GOLD is 
recommended) will be performed as described in Table 5-1 for all subjects. The test results will 
be reported as positive, negative, or indeterminate. Positive TB test results must be reported as an 
adverse event and appropriately updated once the final diagnosis is known (e.g. 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 latent or active TB is 
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identified, subject must undergo appropriate study-specified withdrawal procedures. The retest 
during Screening must be done during the protocol-defined Screening window. 
Has been changed to: 
During conduct of the study, the TB assessment by IGRA (QuantiFERON TB GOLD is 
recommended) will be performed as described in Table 5‒1 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 adverse event 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 latent or 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. 
 
Change #30 
Section 14.1 Definition of analysis sets 
The Enrolled Set (ES) will consist of all subjects who have given informed consent. 
The Randomized Set (RS) will consist of all randomized subjects. 
The Safety Set (SS) will consist of all subjects that received at least 1 dose of the IMP. 
The Full Analysis Set (FAS) will consist of all randomized subjects that received at least 1 dose 
of the IMP and have a valid measurement of the co-primary efficacy variables at Baseline. 
The Escape Subject Set (ESS) will consist of all subjects who receive at least 1 dose of escape 
bimekizumab treatment at Week 16 or later. 
The Week 16 Responder Set (WK16ResS) will consist of all subjects who achieve a PASI90 
response at Week 16 and receive at least 1 dose of blinded maintenance treatment at Week 16 or 
later. 
The Maintenance Set (MS) will consist of all subjects who have a PASI score at Week 16 to 
evaluate response and who receive at least 1 dose of maintenance treatment at Week 16 or later. 
Note that the MS combines the ESS and the WK16ResS. 
The Active Medication Set (AMS) will consist of all subjects who have received at least 1 dose 
of active IMP (bimekizumab or ustekinumab). The AMS will be used for summaries of safety 
that include all data from Baseline (Week 0) to Week 52. 
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. 
Has been changed to: 
The Enrolled Set (ES) will consist of all subjects who have given informed consent. 
The Randomized Set (RS) will consist of all randomized subjects. 
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The Safety Set (SS) will consist of all subjects that received at least 1 dose of the IMP. 
The Full Analysis Set (FAS) will consist of all randomized subjects that received at least 1 dose 
of the IMP and have a valid measurement of the co-primary efficacy variables at Baseline. 
The Escape Subject Set (ESS) will consist of all subjects who receive at least 1 dose of 
escape bimekizumab treatment at Week 16 or later. 
The Week 16 Responder Set (WK16ResS) will consist of all subjects who achieve a PASI90 
response at Week 16 and receive at least 1 dose of blinded maintenance treatment at 
Week 16 or later. 
The Maintenance Set (MS) will consist of all subjects who have a PASI score at Week 16 to 
evaluate response and who receive at least 1 dose of maintenance treatment at Week 16 or 
later. Note that the MS combines the ESS and the WK16ResS. 
The Active Medication Set (AMS) will consist of all subjects who have received at least 1 dose 
of active IMP (bimekizumab or ustekinumab). The AMS will be used for summaries of safety 
that include all data from Initial Treatment Period and/or Maintenance Treatment 
Periodfrom Baseline (Week 0) to Week 52. 
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. 
 
Change #31 
Section 14.2 General statistical considerations 
The hypotheses (H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15, and H16) 
comparing bimekizumab vs. placebo or bimekizumab vs. ustekinumab will be tested at a 2-sided 
alpha level of 0.05. 
Has been changed to: 
The hypotheses (H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15, and H16, and H17) 
comparing bimekizumab vs. placebo or bimekizumab vs. ustekinumab will be tested at a 2-sided 
alpha level of 0.05. 
 
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Change #32 
Figure 14-1 Sequence of testing 
 
BL=Baseline; Chg=change; DLQI=Dermatology Life Quality Index; IGA=Investigator’s Global Assessment; 
PASI=Psoriasis Area Severity Index; PSD=Patient Symptom Diary; PSO=psoriasis 
Has been changed to: 
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BL=Baseline; Chg=change; DLQI=Dermatology Life Quality Index; IGA=Investigator’s Global Assessment; 
PASI=Psoriasis Area Severity Index; PSD=Patient Symptom Diary; PSO=psoriasis 
 
Change #33 
Section 14.3.1.1 Sensitivity analyses 
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 
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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 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 24 subjects will be considered acceptable for a center to be included in the model 
without pooling. Given the 4:3:1 randomization allocation scheme, this should provide a 
minimum of about 12 subjects in the bimekizumab arm, 9 subjects in the ustekinumab arm, and 
3 subjects in the placebo arm. Centers with fewer than 24 subjects will be eligible for pooling. 
The following center pooling algorithm will be used for each geographic region: 
 If a center has 24 or more subjects, then no pooling will be done for that center. 
 Centers with fewer than 24 subjects will be ordered from largest to smallest with pooling 
proceeding in the following manner: 
 Two or more centers will be combined until the cumulative subject total is at least 24. 
 Once a pooled center has at least 24 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 24 subjects has been reached in the previous pool. 
 If this iterative process reaches the end of the ordered list of centers where the final 
pooled center has fewer than 24 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. 
Has been changed to: 
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. In addition, if the logistic 
regression model cannot converge due to lack of any placebo responders, then Fisher’s 
exact test will be used for inferential comparisons to placebo. 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 
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unable to converge due to a low number of subjects at a given center, a pooling (to be 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 2124 subjects will be considered acceptable for a center to be included in the model 
without pooling. Given the 4:23:1 randomization allocation scheme, this should provide a 
minimum of about 12 subjects in the bimekizumab arm, 69 subjects in the ustekinumab arm, and 
3 subjects in the placebo arm. Centers with fewer than 2124 subjects will be eligible for pooling. 
The following center pooling algorithm will be used for each geographic region: 
 If a center has 2124 or more subjects, then no pooling will be done for that center. 
 Centers with fewer than 2124 subjects will be ordered from largest to smallest with pooling 
proceeding in the following manner: 
 Two or more centers will be combined until the cumulative subject total is at least 2124. 
 Once a pooled center has at least 2124 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 2124 subjects has been reached in the previous pool. 
 If this iterative process reaches the end of the ordered list of centers where the final 
pooled center has fewer than 2124 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. 
 
Change #34 
Section 14.3.2.1.2 Maintenance Treatment Period 
Because it is anticipated that most placebo subjects will escape to bimekizumab treatment at 
Week 16, statistical comparisons against placebo after Week 16 will not be performed. However, 
bimekizumab will be compared to ustekinumab at Week 52 for the RS. The analysis of PASI90 
and IGA at Week 52 will be based on a stratified CMH test where region and prior biologic 
exposure will be used as stratification variables. Pairwise treatment comparisons will be made 
based on the p-value for the general association. 
Missing data will be imputed using NRI. Subjects who do not achieve a PASI90 response at 
Week 16 and are therefore eligible for escape will be treated as PASI90 and IGA nonresponders 
at Week 52. All other subjects with missing data at Week 52 or who discontinue study treatment 
prior to Week 52 will also be treated as non-responders for this secondary efficacy analysis. 
Furthermore, since subjects who do not achieve a PASI50 response at Week 28 or beyond are to 
be removed from the study, all such subjects will also be treated as non-responders at Week 52, 
whether or not they were actually removed from the study. 
Has been changed to: 
Because it is anticipated that mostall placebo subjects will escape toreceive bimekizumab 
treatment starting at Week 16, statistical comparisons against placebo after Week 16 will not be 
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performed. However, bimekizumab will be compared to ustekinumab at Week 52 for the RS. 
The analysis of PASI90 and IGA at Week 52 will be based on a stratified CMH test where region 
and prior biologic exposure will be used as stratification variables. Pairwise treatment 
comparisons will be made based on the p-value for the general association. 
Missing data will be imputed using NRI. Subjects who do not achieve a PASI90 response at 
Week 16 and are therefore eligible for escape will be treated as PASI90 and IGA 
nonresponders at Week 52. All other subjects with missing data at Week 52 or who 
discontinue study treatment prior to Week 52 will also be treated as non-responders for this 
secondary efficacy analysis. Furthermore, since subjects who do not achieve a PASI50 
response at Week 28 or beyond are to be removed from the study, all such subjects will also 
be treated as non-responders at Week 52, whether or not they were actually removed from 
the study. 
 
Change #35 
Section 14.3.2.2 Analysis of the other efficacy variables 
The other efficacy variables in the Initial Treatment Period will be analyzed for all subjects in the 
RS. For the Maintenance Period, summaries will primarily be based on the MS (or split between 
the ESS and Wk16ResS as appropriate). 
Binary (responder) variables will be summarized using frequency tables by treatment group for 
each visit. 
Continuous variables will be summarized using descriptive statistics by treatment group for each 
visit. 
… 
For other efficacy variables during the Maintenance Treatment Period, summaries will include 
the bimekizumab and ustekinumab treatment groups. Placebo will not be included in these 
summaries as few placebo subjects are expected to continue on placebo during the Maintenance 
Treatment Period. Details of these summaries will be described further in the SAP, but there will 
be 3 key approaches for understanding the data in the Maintenance Treatment Period: 
1. Summary of data for the RS through Week 52 based on randomized treatment group. 
Subjects who escape at Week 16 will be treated as non-responders during Maintenance (for 
responder variables) or have their Week 16 values carried forward (for continuous variables). 
2.  Summary of Maintenance Treatment Period data among responders only (ie, WK16ResS). 
3. Summary of Maintenance Treatment Period data for subjects who escape at Week 16 (ie, 
ESS) by treatment group at randomization. 
Has been changed to: 
The other efficacy variables in the Initial Treatment Period will be analyzed for all subjects in the 
RS. For the Maintenance Treatment Period, summaries will primarily be based on the MS (or 
split between the ESS RS and Wk16ResS as appropriate). Full details will be specified in 
the SAP. 
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Binary (responder) variables will be summarized using frequency tables by treatment group for 
each visit. 
Continuous variables will be summarized using descriptive statistics by treatment group for each 
visit. 
… 
For other efficacy variables during the Maintenance Treatment Period, summaries will include 
the bimekizumab and ustekinumab treatment groups. Placebo will not be included in these 
summaries as few placebo subjects are expected to continue on placebo during the 
Maintenance Treatment Period. Details of these summaries will be described further in the 
SAP, but there will be 32 key approaches for understanding the data in the Maintenance 
Treatment Period: 
1. Summary of data for the RS through Week 52 based on randomized treatment group. Subjects 
who escape at Week 16 will be treated as non-responders during Maintenance (for 
responder variables) or have their Week 16 values carried forward (for continuous 
variables). 
2.  Summary of Maintenance Treatment Period data among responders only (ie, WK16ResS). 
3. Summary of Maintenance Treatment Period data for subjects who escape at Week 16 
(ie, ESS) by treatment group at randomization. 
 
Change #36 
Section 14.5.1 Safety analyses 
Safety variables will be analyzed for all subjects in the SS. The AMS will be used for summaries 
of safety that include all data from Baseline (Week 0) to Week 52. 
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities 
(MedDRA). Adverse events will be summarized descriptively by treatment group, primary 
system organ class, High Level Term (HLT), and preferred term. Additional tables will 
summarize AEs by intensity and relationship to IMP, AEs leading to withdrawal from the study, 
SAEs, and deaths. Adverse Events of Special Monitoring 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. The AMS will be used for summaries 
of safety that include data from Baseline (Week 0) to Week 52the Initial Treatment Period 
and/or Maintenance Treatment Period. 
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities 
(MedDRA). Adverse events will be summarized descriptively by treatment group, primary 
system organ class, High Level Term (HLT), and preferred term. Additional tables will 
summarize AEs by intensity and relationship to IMP, AEs leading to withdrawal from the study, 
SAEs, and deaths. Adverse Events of Special MonitoringSpecific safety topics of interest will 
be summarized and will be described in greater detail in the SAP. 
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Change #37 
Section 14.7 Handling of dropouts or missing data 
For the secondary endpoints evaluated at Week 52, subjects who meet the criterion for escape at 
Week 16 (ie, do not achieve a PASI90 response) will be imputed as nonresponders for PASI90 
and IGA at Week 52. All other subjects with missing data at Week 52 or who discontinue 
randomized treatment prior to Week 52 will also be counted as nonresponders. Furthermore, 
since subjects who do not achieve a PASI50 response at Week 28 or beyond are to be removed 
from the study, all such subjects will also be treated as non-responders at Week 52, whether or 
not they were actually removed from the study. 
Sensitivity analyses #1 and #2 will also be performed for the Week 52 secondary endpoints. A 
similar procedure to what is described above will be followed with the exception that subjects 
who meet the criterion for escape at Week 16 (ie, do not achieve a PASI90 response) and those 
who meet the criterion for mandatory withdrawal (ie, do not achieve a PASI50 response at Week 
28 or later) will be considered nonresponders at Week 52 and will be handled outside of the MI 
procedure. Further details on this analysis will be provided in the SAP. 
Has been changed to: 
For the secondary endpoints evaluated at Week 52, all subjects who meet the criterion for 
escape at Week 16 (ie, do not achieve a PASI90 response) will be imputed as nonresponders 
for PASI90 and IGA at Week 52. All other subjects with missing data at Week 52 or who 
discontinue randomized treatment prior to Week 52 will also be counted as nonresponders. 
Furthermore, since subjects who do not achieve a PASI50 response at Week 28 or beyond 
are to be removed from the study, all such subjects will also be treated as non-responders 
at Week 52, whether or not they were actually removed from the study. 
Sensitivity analyses #1 and #2 will also be performed for the Week 52 secondary endpoints. A 
similar procedure to what is described above will be followed with the exception that subjects 
who meet the criterion for escape at Week 16 (ie, do not achieve a PASI90 response) and 
those who meet the criterion for mandatory withdrawal (ie, do not achieve a PASI50 
response at Week 28 or later) will be considered nonresponders at Week 52 and will be 
handled outside of the MI procedure. Further details on this analysis will be provided in the 
SAP. 
 
Change #38 
Section 14.9 Determination of sample size 
A total of 640 subjects will be randomly assigned in a 4:3:1 ratio to the following treatment 
groups: 
 Bimekizumab 320mg (320 subjects) 
 Ustekinumab (240 subjects) 
 Placebo (80 subjects) 
Has been changed to: 
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A total of 560640 subjects will be randomly assigned in a 4:23:1 ratio to the following treatment 
groups: 
 Bimekizumab 320mg (320 subjects) 
 Ustekinumab (160240 subjects) 
 Placebo (80 subjects) 
 
Change #39 
Section 14.9 Determination of sample size 
The power to detect a statistically significant difference between bimekizumab and ustekinumab 
at a 2-sided significance level of 0.05 is 98% for PASI90 response and >99% for IGA response. 
Because both co-primary endpoints are highly powered independently, and because PASI and 
IGA response tend to be highly correlated, the overall power for achieving superiority on both 
co-primary endpoints is not calculated here as it is similar to the lower of the individual tests. 
Note that the power for the non-inferiority testing between bimekizumab and ustekimumab for 
both PASI90 and IGA responses is >99% based on a 1-sided significance level of 0.025 and a 
non-inferiority margin of 10%. 
Has been changed to: 
The power to detect a statistically significant difference between bimekizumab and ustekinumab 
at a 2-sided significance level of 0.05 is 958% for PASI90 response and >989% for IGA 
response. Because both co-primary endpoints are highly powered independently, and because 
PASI and IGA response tend to be highly correlated, the overall power for achieving superiority 
on both co-primary endpoints is not calculated here as it is similar to the lower of the individual 
tests. Note that the power for the non-inferiority testing between bimekizumab and ustekimumab 
for both PASI90 and IGA responses is >99% based on a 1-sided significance level of 0.025 and a 
non-inferiority margin of 10%. 
18.2 
Protocol Amendment 2 
Rationale for the amendment 
The purpose of this amendment was the following: 
 Correct the information regarding the number of ongoing studies 
 Add a new other efficacy variable (absolute and percent change from Baseline in the product 
of IGA and BSA [IGAxBSA]) 
 Correct the Exclusion Criterion cross-reference in Section 5.1 Study description 
 Clarify the dosing window 
 Add percentage of BSA as an assessment at all visits 
 Correct all text throughout the protocol to clarify that PGADA and HAQ-DI will be 
performed on all subjects at Baseline 
 Remove the pp-IGA assessment at Week 1 and Week 2 
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Clinical Study Protocol 
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PS0009 
 
 
 
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 Add a PGADA assessment at Week 4 
 Remove the IGRA Tuberculosis test at Week 44 
 Clarify that the Maintenance Treatment Period will begin with the administration of 
bimekizumab, ustekinumab, or placebo at Week 16 
 Remove the 30% enrollment limit for subjects with prior biologic exposure  
 Delete the erroneous statements that at Week 16 subjects will be reallocated to a new 
treatment group based on the PASI response  
 Correct discrepancies between Section 8 Study procedures by visit and Table 5-1 Schedule of 
study assessments 
 Clarify in footnote c of Table 12-2 Laboratory measurements the visits in which the urine 
drug screen will be performed  
 Revised text throughout document to consistently use the term Maintenance Treatment 
Period 
 Revise the section regarding the determination of sample size 
In addition, minor spelling, editorial, and formatting changes were made, and the List of 
abbreviations was updated. 
Specific changes 
Change #1  
Section 2.2.1.2 Ongoing studies 
Four additional studies of bimekizumab in the treatment of PSO and 1 study in healthy 
volunteers are ongoing. Five additional studies of bimekizumab in the treatment of PSO are 
ongoing. 
 
Has been changed to: 
Four additional studies of bimekizumab in the treatment of PSO and 1 study in healthy 
volunteers are ongoing. Five additional studies of bimekizumab in the treatment of PSO are 
ongoing. 
 
Change #2 
Section 4.3.1 Other efficacy variable(s) 
The following was added to the bulleted list of other efficacy variables: 
 Absolute and percent change from Baseline in the product of IGA and BSA (IGAxBSA) 
 
Change #3 
Section 5.1 Study description 
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Clinical Study Protocol 
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PS0009 
 
 
 
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PS0009 is a randomized, double-blind, placebo- and active comparator-controlled study to 
evaluate the efficacy and safety of bimekizumab administered sc to subjects with 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 a 
candidate for ustekinumab, or for systemic PSO therapy and/or phototherapy and/or 
photochemotherapy. Subjects may have been previously exposed to a biologic therapy (see 
Exclusion Criteria #22 and #23). 
 
Has been changed to: 
PS0009 is a randomized, double-blind, placebo- and active comparator-controlled study to 
evaluate the efficacy and safety of bimekizumab administered sc to subjects with 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 a 
candidate for ustekinumab, or for systemic PSO therapy and/or phototherapy and/or 
photochemotherapy. Subjects may have been previously exposed to a biologic therapy (see 
Exclusion Criteriona #22 and #23). 
 
Change #4 
Table 5-1 Schedule of study assessments 
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21 May 2019 
Clinical Study Protocol 
Bimekizumab 
PS0009 
 
 
 
Confidential 
Page 141 of 206 
Table 5-1: 
Schedule of study assessments 
Visita / 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Period 
(weeks after first dose) 
SFUb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
Informed consentc 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Xd 
 
 
Inclusion/exclusion 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine drug screen 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Demographic data 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Psoriasis history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Significant past medical history and 
concomitant diseases 
X 
Xe 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical examf, g 
X 
 
 
 
 
 
 
X 
 
X 
 
 
X 
 
 
 
X 
X 
Height 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Body weight 
 
X 
 
 
 
 
 
X 
 
X 
 
 
X 
 
 
 
X 
 
Vital signsh 
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 
X 
Urinalysis 
X 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
ECG 
X 
 
 
 
 
 
 
X 
 
  
 
X 
 
 
 
 
X 
 
Pregnancy testingi 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hepatitis B and C testingk 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV testingk 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Chest x-rayl 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IGRA Tuberculosis test 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
 
 
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21 May 2019 
Clinical Study Protocol 
Bimekizumab 
PS0009 
 
 
 
Confidential 
Page 142 of 206 
Table 5-1: 
Schedule of study assessments 
Visita / 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Period 
(weeks after first dose) 
SFUb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
Tuberculosis questionnaire 
X 
X 
 
 
 
 
 
X 
 
X 
 
 
X 
 
 
X 
X 
X 
Blood sample for bimekizumab 
plasma concentrationsm 
 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Blood sample for anti- 
bimekizumab antibodiesm 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
X 
For participating centers: Blood 
sample for immunophenotypingc,m 
 
X 
X 
 
 
X 
X 
X 
 
 
 
 
 
 
 
 
X 
 
Blood sample genomic, proteomic, 
metabolomics, and candidate 
biomarker analysesc,m 
 
X 
X 
 
 
X 
X 
X 
 
 
 
 
 
 
 
 
X 
 
Blood sample genetic/epigenetic 
analysisc,m 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
PASI 
X 
X 
X 
X 
X 
X 
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 
X 
X 
DLQI 
 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
PHQ-9 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
eC-SSRS 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Patient Symptom Diary (daily) 
X 
X 
X 
X 
X 
X 
X 
 X 
 
 
 
 
 
 
 
 
 
 
scalp IGA 
 
X 
Xn 
Xn 
Xn 
Xn 
Xn 
Xn 
 
 
Xn 
 
 
Xn 
 
 
Xn 
 
mNAPSI 
 
X 
 
 
Xo 
Xo 
Xo 
Xo 
 
 
Xo 
 
 
Xo 
 
 
Xo 
 
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21 May 2019 
Clinical Study Protocol 
Bimekizumab 
PS0009 
 
 
 
Confidential 
Page 143 of 206 
Table 5-1: 
Schedule of study assessments 
Visita / 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Period 
(weeks after first dose) 
SFUb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
pp-IGA 
 
X 
Xp 
Xp 
Xp 
Xp 
Xp 
Xp 
 
 
Xp 
 
 
Xp 
 
 
Xp 
 
EQ-5D-3L 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
SF-36 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
Patient Global Assessment of 
psoriasisq 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
 
X 
 
PASE 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
PGADAr 
 
X 
 
 
  
 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
HAQ-DIr 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
WPAI-SHP V2.0 
 
X 
 
 
 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
 
Photographs of skin and nails 
(subset of sites) 
 
X 
X 
X 
X 
X 
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 
IRTs,t 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Bimekizumab, ustekinumab, or 
placebo administrations,t 
 
X 
 
 
X 
X 
X 
Xu 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
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21 May 2019 
Clinical Study Protocol 
Bimekizumab 
PS0009 
 
 
 
Confidential 
Page 144 of 206 
Table 5-1: 
Schedule of study assessments 
Visita / 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Period 
(weeks after first dose) 
SFUb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide Severity Rating Scale; eCRF=electronic Case Report 
Form; EQ-5D-3L=Euro-Quality of Life 5-Dimensions 3-level; HAQ-DI=Health Assessment Questionnaire-Disability Index; HIV=human immunodeficiency 
virus; ICF=Informed Consent Form; IGA=Investigator’s Global Assessment; IGRA=interferon-gamma release assay; IMP=investigational medicinal product; 
IRT=interactive response technology; PASE= Psoriatic Arthritis Screening and Evaluation; 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; SF-36=Short Form 36-item Health Survey; SFU=Safety Follow-Up; scalp IGA=scalp-specific Investigator’s Global Assessment; 
TB=tuberculosis; WPAI-SHP=Work Productivity and Activity Impairment Questionnaire-specific health problem 
a Visit windows of +/- 3 days from the first dose at all visits except SFU. SFU Visit window is -3 and +7 days from last dose. 
b The SFU Visit will occur 20 weeks after the last dose. 
c A separate ICF will be required for subjects who decide to participate in the genomics, genetics, and proteomics substudy. The ICF must be signed prior to 
collecting any samples for the substudy. Samples for immunophenotyping will be analyzed immediately. All PD samples and genomic, proteomic, and 
metabolomics samples will be stored at -80°C at the central biorepository for up to 20 years. 
d A separate ICF is required to be completed for the open-label study. 
e Ensure no significant changes in medical history. 
f Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
g The physical examination will include examination of the following systems: eyes, hair, and skin; respiratory; CV; and GI. 
h Vital signs (blood pressures, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable. 
i Pregnancy testing will consist of serum testing at the Screening. The pregnancy test will be urine at all other visits. 
j Subjects who have evidence of or test positive for hepatitis B by any of the following criteria: 1) positive for hepatitis B surface antigen (HBsAg+); 2) positive 
for anti-hepatitis B core antibody (HBcAb+) are excluded. A positive test for HCV is defined as: 1) positive for hepatitis C antibody (anti-HCV Ab), 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. 
k The HIV test results will not be recorded in the eCRF. 
l Screening chest x-ray must occur within 3 months prior to Screening Visit. 
m All blood samples taken prior to dosing, except at Visit 2 (at which no dose administration occurs). 
n The scalp IGA will only be assessed for those subjects with scalp involvement (scalp IGA score >0) at Baseline. 
o The mNAPSI will be assessed only in subjects with nail involvement (mNAPSI score >0) at Baseline. 
p The pp-IGA will only be assessed in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline. 
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21 May 2019 
Clinical Study Protocol 
Bimekizumab 
PS0009 
 
 
 
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Page 145 of 206 
q The Patient Global Assessment of psoriasis will be performed as part of the patient symptoms diary on a weekly basis from baseline through the initial 
treatment period with a +3 day completion window. During the maintenance period this assessment will be completed at each clinic visit specified with a 
±3 day completion window. 
r The PGADA and HAQ-DI are assessed only for subjects with PsA at Baseline (defined as a past medical history of PsA or PASE ≥47). 
s IMP administration is based on randomization. 
t For bimekizumab, the minimum time between doses should be no less than 21 days and no more than 35 days. 
u At Week 16 subjects will be re-allocated based on original treatment and response to treatment and will receive their first Maintenance Treatment Period dose. 
 
Has been changed to: 
Table 5-1: 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Period 
(weeks after first dose) 
SFUb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
Informed consentc 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Xd 
 
 
Inclusion/exclusion 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine drug screen 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Demographic data 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Psoriasis history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Significant past medical history and 
concomitant diseases 
X 
Xe 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical examf,g 
X 
 
 
 
 
 
 
X 
 
X 
 
 
X 
 
 
 
X 
X 
Height 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Body weight 
 
X 
 
 
 
 
 
X 
 
X 
 
 
X 
 
 
 
X 
 
Vital signsh 
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 
X 
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21 May 2019 
Clinical Study Protocol 
Bimekizumab 
PS0009 
 
 
 
Confidential 
Page 146 of 206 
Table 5-1: 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Period 
(weeks after first dose) 
SFUb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
Urinalysis 
X 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
ECG 
X 
 
 
 
 
 
 
X 
 
  
 
X 
 
 
 
 
X 
 
Pregnancy testingi 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hepatitis B and C testingj 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV testingk 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Chest x-rayl 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IGRA Tuberculosis test 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
 
 
Tuberculosis questionnaire 
X 
X 
 
 
 
 
 
X 
 
X 
 
 
X 
 
 
X 
X 
X 
Blood sample for bimekizumab 
plasma concentrationsm 
 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Blood sample for anti- 
bimekizumab antibodiesm 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
X 
For participating centers: Blood 
sample for immunophenotypingc,m 
 
X 
X 
 
 
X 
X 
X 
 
 
 
 
 
 
 
 
X 
 
Blood sample genomic, proteomic, 
metabolomics, and candidate 
biomarker analysesc,m 
 
X 
X 
 
 
X 
X 
X 
 
 
 
 
 
 
 
 
X 
 
Blood sample genetic/epigenetic 
analysisc,m 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
PASI 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
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21 May 2019 
Clinical Study Protocol 
Bimekizumab 
PS0009 
 
 
 
Confidential 
Page 147 of 206 
Table 5-1: 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Period 
(weeks after first dose) 
SFUb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
IGA 
X 
X 
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 
X 
X 
DLQI 
 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
PHQ-9 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
eC-SSRS 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Patient Symptom Diary (daily) 
X 
X 
X 
X 
X 
X 
X 
 X 
 
 
 
 
 
 
 
 
 
 
scalp IGA 
 
X 
Xn 
Xn 
Xn 
Xn 
Xn 
Xn 
 
 
Xn 
 
 
Xn 
 
 
Xn 
 
mNAPSI 
 
X 
 
 
Xo 
Xo 
Xo 
Xo 
 
 
Xo 
 
 
Xo 
 
 
Xo 
 
pp-IGA 
 
X 
Xp 
Xn 
Xp 
Xp 
Xp 
Xp 
 
 
Xp 
 
 
Xp 
 
 
Xp 
 
EQ-5D-3L 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
SF-36 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
Patient Global Assessment of 
psoriasisq 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
 
X 
 
PASE 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
PGADAr 
 
X 
 
 
 X 
 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
HAQ-DIr 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
WPAI-SHP V2.0 
 
X 
 
 
 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
 
Photographs of skin and nails 
(subset of sites) 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
 
X 
 
 
 
X 
 
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21 May 2019 
Clinical Study Protocol 
Bimekizumab 
PS0009 
 
 
 
Confidential 
Page 148 of 206 
Table 5-1: 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Period 
(weeks after first dose) 
SFUb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
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 
IRTs,t 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Bimekizumab, ustekinumab, or 
placebo administrations,t 
 
X 
 
 
X 
X 
X 
Xu 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
BSA=body surface area; CV=cardiovascular; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide 
Severity Rating Scale; eCRF=electronic Case Report Form; EQ-5D-3L=Euro-Quality of Life 5-Dimensions 3-level; GI=gastrointestinal; HAQ-DI=Health 
Assessment Questionnaire-Disability Index; HCV=hepatitis C virus; HIV=human immunodeficiency virus; ICF=Informed Consent Form; 
IGA=Investigator’s Global Assessment; IGRA=interferon-gamma release assay; IMP=investigational medicinal product; IRT=interactive response 
technology; mNAPSI=Modified Nail Psoriasis Severity Index Score;  PASE= Psoriatic Arthritis Screening and Evaluation; PASE=Psoriatic Arthritis 
Screening and Evaluation; PASI=Psoriasis Area Severity Index; PD=pharmacodynamics; 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; SF-36=Short Form 36-item Health Survey; SFU=Safety Follow-Up; scalp IGA=scalp-specific Investigator’s Global Assessment; TB=tuberculosis; 
WPAI-SHP=Work Productivity and Activity Impairment Questionnaire-specific health problem 
a Visit windows of +/- 3 days from the first dose at all visits except SFU. SFU Visit window is -3 and +7 days from last dose. 
b The SFU Visit will occur 20 weeks after the last dose for subjects who do not enroll in the open-label study. 
c A separate ICF will be required for subjects who decide to participate in the genomics, genetics, and proteomics substudy. The ICF must be signed prior to 
collecting any samples for the substudy. Samples for immunophenotyping will be analyzed immediately. All PD samples and genomic, proteomic, and 
metabolomics samples will be stored at -80°C at the central biorepository for up to 20 years. 
d A separate ICF is required to be completed for the open-label study. 
e Ensure no significant changes in medical history. 
f Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
g The physical examination will include examination of the following systems: eyes, hair, and skin; respiratory; CV; and GI. 
h Vital signs sitting systolic and diastolic blood pressure, pulse rate, and body temperature) are to be measured prior to blood sampling, and prior to dosing, 
where applicable. 
i Pregnancy testing will consist of serum testing at the Screening. The pregnancy test will be urine at all other visits. 
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21 May 2019 
Clinical Study Protocol 
Bimekizumab 
PS0009 
 
 
 
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Page 149 of 206 
j Subjects who have evidence of or test positive for hepatitis B by any of the following criteria: 1) positive for hepatitis B surface antigen (HBsAg+); 2) positive 
for anti-hepatitis B core antibody (HBcAb+) are excluded. A positive test for HCV is defined as: 1) positive for hepatitis C antibody (anti-HCV Ab), 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. 
k The HIV test results will not be recorded in the eCRF. 
l Screening chest x-ray must occur within 3 months prior to Screening Visit. 
m All blood samples taken prior to dosing, except at Visit 1 and Visit 2 (at which no dose administration occurs). 
n The scalp IGA will only be assessed for those subjects with scalp involvement (scalp IGA score >0) at Baseline. 
o The mNAPSI will be assessed only in subjects with nail involvement (mNAPSI score >0) at Baseline. 
p The pp-IGA will only be assessed in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline. 
q The Patient Global Assessment of psoriasis will be performed as part of the patient symptoms diary on a weekly basis from baseline through the initial 
treatment period with a +3 day completion window. During the mMaintenance Treatment  pPeriod this assessment will be completed at each clinic visit 
specified with a ±3 day completion window. 
r The PGADA and HAQ-DI are assessed for all subjects at Baseline. At all subsequent visits, the PGADA and HAQ-DI are assessed only for subjects with 
PsA at Baseline (defined as a past medical history of PsA or PASE ≥47). 
s IMP administration is based on randomization. 
t The dosing window is ±7 days relative to the scheduled dosing visitFor bimekizumab, the minimum time between doses should be no less than 21 days 
and no more than 35 days. 
u At Week 16 subjects will be re-allocated based on original treatment and response to treatment and will receive their first Maintenance Treatment 
Period dose.
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Change #5 
Figure 5-1 Schematic diagram 
 
Placebo
Bimekizumab 
320mg Q4W
Ustekinumab
Screening
N=80
N=320
N=160
Initial Treatment Period
Week
16
Co-primary Endpoint: 
PASI90 Response and 
IGA Response
Bimekizumab 
extension study
to evaluate response 
to treatment and 
long-term safety
SFU Visit
20 Weeks after last 
dose for subjects not 
enrolling in extension 
study
Randomization
Ustekinumab
Maintenance Period
52
Baseline
           Bimekizumab 320mg Q4W
N=560
           Bimekizumab 320mg Q4W
 
 
Has been changed to: 
 
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Placebo
Bimekizumab 
320mg Q4W
Ustekinumab
Screening
N=80
N=320
N=160
Initial Treatment Period
Week
16
Co-primary Endpoint: 
PASI90 Response and 
IGA Response
Bimekizumab 
extension study
to evaluate response 
to treatment and 
long-term safety
SFU Visit
20 Weeks after last 
dose for subjects not 
enrolling in extension 
study
Randomization
Ustekinumab
Maintenance Treatment Period
52
Baseline
           Bimekizumab 320mg Q4W
N=560
           Bimekizumab 320mg Q4W
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Change #6 
Section 6.2 Exclusion criterion #27 
27. Subject has presence of severe depression, indicated by a score ≥15 using the screening 
PHQ-9. Medication used to treat depression should be stable for 4 weeks prior to baseline. 
 
Has been changed to: 
27. Subject has presence of severe depression, indicated by a score ≥of 15 to 19 using the 
screening PHQ-9. Medication used to treat depression should be stable for 4 weeks prior to 
baseline. 
 
Change #7 
Section 6.3 Withdrawal criterion #2 
2. Moderately severe depression as indicated by a PHQ-9 score ≥15 if this represents an 
increase of 3 points compared to last visit. 
 
Has been changed to: 
2. Moderately severe depression as indicated by a PHQ-9 score ≥of15 to 19 if this represents an 
increase of 3 points compared to last visit. 
 
Change #8 
Section 7.8.1 Permitted concomitant treatments (medications and therapies) 
The following was deleted: 
The following concomitant medications are permitted during the study. 
 
Change #9 
Section 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). Efforts should be made to limit the enrollment of subjects with prior biologic exposure 
to approximately 30% of the total study population. 
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. 
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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 may be reallocated to a new treatment group based on their PASI response. 
Subject numbers and kit numbers will be tracked via the IRT. 
 
Has been changed to: 
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). Efforts should be made to limit the enrollment of subjects with prior biologic 
exposure to approximately 30% of the total study population. 
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 may be reallocated to a new treatment group based on their PASI 
response. 
Subject numbers and kit numbers will be tracked via the IRT. 
 
Change #10 
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. 
 Visit windows of ±3 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 window of 
±3 days is relative to Baseline and applicable for all subsequent visits. Changes to the dosing 
schedule outside of the 3-day window must be discussed with the Medical Monitor. 
 The minimum of time between doses should be no less than 21 days and no more than 35 
days. 
 For the SFU Visit (20 weeks after the last 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). 
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Has been changed to: 
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. 
 Visit windows of ±3 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 window of 
±3 days is relative to Baseline and applicable for all subsequent visits. Changes to the dosing 
schedule outside of the 3-day window must be discussed with the Medical Monitor. 
 The dosing window is ±7 days relative to the scheduled dosing visitThe minimum of 
time between doses should be no less than 21 days and no more than 35 days. 
 For the SFU Visit (20 weeks after the last 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). 
 
Change #11 
Section 8.1 Screening Visit (2 to 4 Weeks), Section 8.2.1 Baseline Visit, Section 
8.2.2 Week 1 Visit (±3 days relative to Baseline), Section 8.2.3 Week 2 Visit (±3 
days relative to Baseline), Section 8.2.4 Week 4 Visit (±3 days relative to 
Baseline), Section 8.2.5 Week 8 Visit (±3 days relative to Baseline), Section 8.2.6 
Week 12 Visit (±3 days relative to Baseline), Section 8.2.7 Week 16 Visit (±3 days 
relative to Baseline), Section 8.3.1 Week 20 Visit (±3 days relative to Baseline), 
Section 8.3.2 Week 24 Visit (±3 days relative to Baseline), Section 8.3.3 Week 28 
Visit (±3 days relative to Baseline), Section 8.3.4 Week 32 Visit (±3 days relative to 
Baseline), Section 8.3.5 Week 36 Visit (±3 days relative to Baseline), Section 8.3.6 
Week 40 Visit (±3 days relative to Baseline), Section 8.3.7 Week 44 Visit (±3 days 
relative to Baseline), Section 8.3.8 Week 48 Visit (±3 days relative to Baseline), 
Section 8.3.9 Week 52 Visit (±3 days relative to Baseline), and Section 8.5 Safety 
Follow-Up Visit (20 weeks after last dose, -3 days/+7 days) 
The following was added to the bulleted lists: 
 Percentage of BSA 
 
Change #12 
Section 8.2.1 Baseline Visit 
The following items in the bulleted list: 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Genomic, proteomic, metabolomics, and candidate biomarker analyses 
 Genetic/epigenetic analysis 
 PGADA (only for subjects with PsA) 
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 HAQ-DI (only for subjects with PsA) 
 
Have been changed to: 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Genomic, proteomic, metabolomics, and candidate biomarker analyses (participating 
subjects only) 
 Genetic/epigenetic analysis (participating subjects only) 
 PGADA (only for subjects with PsA) 
 HAQ-DI (only for subjects with PsA) 
 
Change #13 
Section 8.2.2 Week 1 Visit (±3 days relative to Baseline) 
The following was deleted from the bulleted list: 
 pp-IGA 
 
Change #14 
Section 8.2.3 Week 2 Visit (±3 days relative to Baseline) 
The following was added to the bulleted list: 
 DLQI 
 
Change #15 
Section 8.2.3 Week 2 Visit (±3 days relative to Baseline) 
The following was deleted from the bulleted list: 
 pp-IGA 
 
Change #16 
Section 8.2.4 Week 4 Visit (±3 days relative to Baseline) 
The following was added to the bulleted list: 
 PGADA (only for subjects with PsA) 
 
Change #17 
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Section 8.2.6 Week 4 Visit (±3 days relative to Baseline) and Section 8.2.7 Week 16 
Visit (±3 days relative to Baseline) 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Genomic, proteomic, metabolomics, and candidate biomarker analyses  
 
Has been changed to: 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Genomic, proteomic, metabolomics, and candidate biomarker analyses (participating 
subjects only) 
 
Change #18 
Section 8.2.7 Week 16 Visit (±3 days relative to Baseline) 
After completion of the above-mentioned procedures, administration of bimekizumab, 
ustekinumab, or placebo will occur. 
 
Has been changed to: 
After completion of the above-mentioned procedures, the Maintenance Treatment Period will 
begin with administration of bimekizumab, ustekinumab, or placebo will occur. 
 
Change #19 
Section 8.2.7 Week 16 Visit (±3 days relative to Baseline) and Section 8.3.7 Week 
44 Visit (±3 days relative to Baseline) 
The following was deleted from the bulleted lists: 
 IGRA Tuberculosis test 
 
Change #20 
Section 8.3.5 Week 36 Visit (±3 days relative to Baseline) 
The following was deleted from the bulleted list: 
 Bimekizumab plasma concentrations 
 Anti-bimekizumab antibodies 
 
Change #21 
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Section 8.3.9 Week 52 Visit (±3 days relative to Baseline) 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Genomic, proteomic, metabolomics, and candidate biomarker analyses  
 Immunophenotyping (participating centers only) 
 Genetic/epigenetic analysis  
 
Has been changed to: 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Genomic, proteomic, metabolomics, and candidate biomarker analyses (participating 
subjects only) 
 Immunophenotyping (participating centers only) 
 Genetic/epigenetic analysis (participating subjects only) 
 
Change #22 
Section 9 Assessment of efficacy 
The PASI, 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 the same assessor should evaluate the subject at each 
assessment. 
 
Change #23 
Section 9.4 Patient Health Questionnaire 9 
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. 
 
Has been changed to: 
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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. 
 
Change #24 
Section 9.10 Patient Global Assessment of psoriasis 
During the maintenance period, this assessment will be completed within a ±3-day completion 
window at the visits specified in Table 5-1. 
 
Has been changed to: 
During the mMaintenance Treatment pPeriod, this assessment will be completed within a ±3-
day completion window at the visits specified in Table 5-1. 
 
Change #25 
Section 9.14 HAQ-DI score 
Subjects with PsA at Baseline (defined as a past medical history of PsA or PASE ≥47) will 
complete the HAQ-DI at the visits specified in Table 5-1. 
 
Has been changed to: 
All subjects will complete the HAQ-DI at Baseline. Subjects with PsA at Baseline (defined as 
a past medical history of PsA or PASE ≥47) will complete the HAQ-DI at the visits specified in 
Table 5-1. 
 
Change #26 
Section 9.16 Photographs 
At certain clinical sites, representative photographs of the changes in skin and nail appearance 
will be captured. Subjects will have full body (anterior and posterior views, below neck) and nail 
photographs taken. Photographs will be anonymized. 
 
Has been changed to: 
At certain clinical sites, representative photographs of the changes in skin and nail appearance 
will be captured. Subjects will have full body (anterior and posterior views, below neck) and nail 
photographs taken. Photographs will be anonymized. 
 
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Change #27 
Table 12-2 Laboratory measurements, footnote c 
c Urine drug screen will be performed at Screening Visit and PEOT Visit 
 
Has been changed to: 
c Urine drug screen will be performed at Screening Visit, and Week 52 or PEOT Visit 
 
Change #28 
Section 14.9 Determination of sample size 
The power to detect a statistically significant difference between bimekizumab and ustekinumab 
at a 2-sided significance level of 0.05 is 95% for PASI90 response and 98% for IGA response. 
Because both co-primary endpoints are highly powered independently, and because PASI and 
IGA response tend to be highly correlated, the overall power for achieving superiority on both 
co-primary endpoints is not calculated here as it is similar to the lower of the individual tests. 
Note that the power for the non-inferiority testing between bimekizumab and ustekimumab for 
both PASI90 and IGA responses is >99% based on a 1-sided significance level of 0.025 and a 
non-inferiority margin of 10%. 
 
Has been changed to: 
The power to detect a statistically significant difference between bimekizumab and ustekinumab 
at a 2-sided significance level of 0.05 is 95% for PASI90 response and 98% for IGA response. 
Because both co-primary endpoints are highly powered independently, and because PASI and 
IGA response tend to be highly correlated, the overall power for achieving superiority on both 
co-primary endpoints is not calculated here as it is similar to the lower of the individual tests. 
Note that the power for the non-inferiority testing between bimekizumab and ustekimumab for 
both PASI90 and IGA responses is >99% based on a 1-sided significance level of 0.025 and a 
non-inferiority margin of 10%. 
 
Change #29 
Section 17 REFERENCES 
The following references were deleted from the list: 
Dauden E, Griffiths CE, Ortonne JP, Kragballe K, Molta CT, Robertson D, et al. Improvements 
in patient-reported outcomes in moderate-to-severe psoriasis patients receiving continuous or 
paused etanercept treatment over 54 weeks: the CRYSTEL study. J Eur Acad Dermatol Venereol. 
2009;23(12):1374-82. 
Langley RG, Feldman SR, Han C, Schenkel B, Szapary P, Hsu MC, et al. Ustekinumab 
significantly improves symptoms of anxiety, depression, and skin-related quality of life in 
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patients with moderate-to-severe psoriasis: Results from a randomized, doubleblind, 
placebo-controlled phase III trial. J Am Acad Dermatol. 2010;63(3):457-65. 
Puig L, Thom H, Mollon P, Tian H, Ramakrishna GS. Clear or almost clear skin improves the 
quality of life in patients with moderate-to-severe psoriasis: a systematic review and meta-
analysis. J Eur Acad Dermatol Venereol. 2017;31(2):213-220. 
Snaith RP, Zigmond AS. The hospital anxiety and depression scale, with the irritability-
depression-anxiety scale and the Leeds situational anxiety scale manual. NFER-Nelson. 1994. 
Sozu T, Sugimoto T, Hamasaki T. Sample size determination in clinical trials with multiple 
co-primary binary endpoints. Statistics in Medicine. 2010;29:2169-79. 
Sozu T, Sugimoto T, Hamasaki T. Sample size determination in clinical trials with multiple 
co-primary endpoints including mixed continuous and binary variables. Biometrical Journal. 
2012;5:716-29. 
18.3 
Protocol Amendment 3 
Rationale for the amendment 
The purpose of this amendment was the following:   
 Update name and contact information for Sponsor study physician 
 Extend the duration of the Screening Period, and therefore the overall study duration, by 
1 week 
 Update list of current treatment for PSO to reflect changes in labeling and approved countries 
 Update list of completed and ongoing bimekizumab studies to reflect completion of study 
UP0042 
 Clarify calculation of PASI responder rates 
 Remove references to PD assessments as they will not be conducted in this study 
 Update Schedule of study assessments to include a hematology and biochemistry sample at 
Week 20, to modify the visits at which the TB questionnaire, body weight, physical 
examination, and ECG are assessed, and to modify the visits at which photographs are taken 
 Clarify that all visits from first dose to Week 24 would have a ±3 day visit window, while all 
visits from Week 28 to end of study would have a ±7 day window 
 Clarify the dosing window 
 Modify exclusion criterion to clarify exclusion of subjects who have participated in other 
studies of bimekizumab, other medications (systemic or topical), or devices 
 Modify exclusion criteria pertaining to history of malignancy, systemic disease, and major 
depression 
 Add new withdrawal criteria for nonresponders and for subjects with newly diagnosed IBD 
 Clarify withdrawal criteria for subjects with depression or suicidal ideation or behavior 
 Clarify that for subjects receiving ustekinumab, dosing is based on weight at Baseline 
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 Update prohibited concomitant medications to include tildrakizumab and risankizumab 
 Corrected discrepancies between Section 8 Study procedures by visit and Table 5-1 Schedule 
of study assessments 
 Revise PASE questionnaire scoring 
 Remove immunophenotyping assessments 
 Clarify photography requirements 
 Clarify definition of abortion 
 Updated laboratory measurements to be performed 
 Provide additional details for requirements for IMP rechallenge in the event of PDILI 
 Defined a Maintenance Set as an analysis population 
 Update the definition of the FAS Set 
 Clarify regions for analyses  
 Update the sequence testing  
In addition, minor spelling, editorial, and formatting changes were made, and the List of 
abbreviations was updated. 
 
Change #1 
Study Contact Information 
Sponsor Study Physician 
Name: 
, MD 
Address: 
UCB Biosciences, 8010 Arco Corporation Drive, Raleigh, NC 27617 
Phone: 
 
Fax: 
 
Sponsor Study Physician 
Name: 
, MD, PhD 
Address: 
UCB Biosciences, 8010 Arco Corporation Drive, Raleigh, NC 27617 
Phone: 
 
Fax: 
 
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Change #2 
Section 1 Summary, second and third paragraphs 
The study population consists of adult subjects (≥18 years of age) with a diagnosis of moderate 
to severe chronic plaque PSO (Baseline Psoriasis Area and Severity Index [PASI] ≥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 ustekinumab, or for systemic PSO therapy and/or 
phototherapy and/or photochemotherapy. 
Approximately 750 subjects will be screened in order to have 560 subjects randomized in the 
study. For each subject, the study will last a maximum of 72 weeks and will consist of 4 periods, 
a Screening Period (2 to 4 weeks), a double-blind, placebo- and active comparator-controlled 
Initial Treatment Period (16 weeks), a double-blind, active comparator-controlled Maintenance 
Treatment Period (36 weeks), and a Safety Follow-Up (SFU) Period (20 weeks after the last dose 
of investigational medicinal product (IMP).  
Has been changed to:  
The study population consists of adult subjects (≥18 years of age) with a diagnosis of moderate 
to severe chronic plaque PSO (Baseline Psoriasis Area and Severity Index [PASI] ≥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 ustekinumab, or for systemic PSO therapy and/or 
phototherapy and/or photochemotherapy. 
Approximately 750 subjects will be screened in order to have 560 subjects randomized in the 
study. For each subject, the study will last a maximum of 72 73 weeks and will consist of 4 
periods, a Screening Period (2 to 4 5 weeks), a double-blind, placebo- and active comparator-
controlled Initial Treatment Period (16 weeks), a double-blind, active comparator-controlled 
Maintenance Treatment Period (36 weeks), and a Safety Follow-Up (SFU) Period (20 weeks 
after the last final dose of investigational medicinal product (IMP).  
 
Change #3 
Section 1 Summary, second to last paragraph 
Pharmacokinetic, PD, genomic, genetic, proteomic, and immunological variables will be 
evaluated to assess their relationship to treatment response. 
Has been changed to:  
Pharmacokinetic, PD, genomic, genetic, proteomic, and immunological variables will be 
evaluated to assess their relationship to treatment response. 
 
Change #4 
Section 2.1.2 Current treatments for psoriasis, first paragraph 
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 photochemotherapy, methotrexate, 
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cyclosporine, the oral phosphodiesterase 4 (PDE4) 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 (in the US only), the IL-17A inhibitors secukinumab and ixekizumab, and the 
IL-17 receptor antagonist brodalumab.  
Has been changed to:  
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 photochemotherapy phototherapy, 
methotrexate, cyclosporine, the oral phosphodiesterase 4 (PDE4) 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 (in the US only), the IL-17A inhibitors secukinumab and ixekizumab, 
and the IL-17 receptor antagonist brodalumab.  
 
Change #5 
Section 2.1.2 Current treatments for psoriasis, third bullet 
 Chemophototherapy is a frequent option for moderate to severe patients, but the 
inconvenience of multiple treatment visits and varying efficacy limits its use in the market. 
Has been changed to:  
 Chemophototherapy Phototherapy is a frequent option for moderate to severe patients, but 
the inconvenience of multiple treatment visits and varying efficacy limits its use in the 
market. 
 
Change #6 
Section 2.1.2 Current treatments for psoriasis, last bullet, second and fourth sub-bullets 
 Ustekinumab has been approved in the US and the EU for the treatment of adult patients 
with moderate to severe plaque PSO who are candidates for phototherapy or systemic 
therapy. Ustekinumab is a human immunoglobulin (Ig) G1κ monoclonal antibody 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.  
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 Guselkumab has been approved in the US 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 
interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a 
naturally occurring cytokine that is involved in normal inflammatory and immune 
responses. Guselkumab inhibits the release of proinflammatory cytokines and 
chemokines. 
Has been changed to:  
 Ustekinumab has been approved in the US and the EU for the treatment of adult patients 
with moderate to severe plaque PSO who are candidates for phototherapy or systemic 
therapy. Ustekinumab is a human immunoglobulin (Ig) G1κ monoclonal antibody 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.  
 Guselkumab has been approved in the US and the 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 interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor. 
IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and 
immune responses. Guselkumab inhibits the release of proinflammatory cytokines and 
chemokines. 
 
Change #7 
Section 2.2.1.1 Completed studies 
Four 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, and 
UP0031 in 12 healthy volunteers.  
Hs been changed to: 
Four 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, and UP0031 in 12 healthy volunteers, and UP0042 in 48 healthy volunteers.  
And the following paragraph has been added: 
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 safe and well tolerated in 
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healthy Japanese and Caucasian subjects and no major differences in safety findings were 
observed between Japanese and Caucasian subjects. 
 
Change #8 
Section 2.2.1.1 Ongoing studies 
Four additional studies of bimekizumab in the treatment of PSO and 1 study in healthy 
volunteers are ongoing.  
 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. 
 PS0011 is a long-term extension study for subjects who completed PS0010 to assess the 
long-term safety, tolerability, and efficacy of bimekizumab. 
 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. 
 PS0018 is a long-term extension study for eligible subjects from PS0016 to assess the safety, 
tolerability, and efficacy of bimekizumab. 
 UP0042 is a Phase 1 study designed to evaluate the safety, tolerability, and PK of 
bimekizumab administered as an sc injection of 80mg, 160mg, or 320mg to Japanese and 
Caucasian healthy subjects. 
Has been changed to:  
Four additional studies of bimekizumab in the treatment of PSO and 1 study in healthy 
volunteers are ongoing.  
 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. 
 PS0011 is a long-term extension study for subjects who completed PS0010 to assess the 
long-term safety, tolerability, and efficacy of bimekizumab. 
 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. 
 PS0018 is a long-term extension study for eligible subjects from PS0016 to assess the safety, 
tolerability, and efficacy of bimekizumab. 
 UP0042 is a Phase 1 study designed to evaluate the safety, tolerability, and PK of 
bimekizumab administered as an sc injection of 80mg, 160mg, or 320mg to Japanese 
and Caucasian healthy subjects. 
 
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Change #9 
Section 3.3 
Other objectives, 12th bullet 
 Assess the PK and PD of bimekizumab 
Has been changed to:  
 Assess the PK and PD of bimekizumab 
 
Change #10 
Section 4.3 Other variables 
The following text has been added: 
The other variables are listed below and will be evaluated according to the planned 
assessments Table 5-1. 
 
 
Change #11 
Section 4.3.1 Other efficacy variables, last sentence in third paragraph 
Note that PASI responder rates will always be calculated relative to the Baseline (first dose) 
Visit. 
Has been changed to:  
Note that Unless otherwise stated PASI responder rates will always be calculated relative to the 
Baseline Visit (first dose). 
 
Change #12 
Section 4.4 Pharmacokinetic and pharmacodynamic variable(s) 
Section 4.4.1.1 Pharmacokinetic and pharmacodynamic variables 
The PK variable is the plasma concentration of bimekizumab. 
For subjects enrolled in participating centers, immunophenotyping by flow cytometry on whole 
blood will be performed. 
Has been changed to:  
Section 4.3.3 Pharmacokinetic and pharmacodynamic variable(s) 
Section 4.4.1.1 Pharmacokinetic and pharmacodynamic variables 
The PK variable is the plasma concentration of bimekizumab. 
For subjects enrolled in participating centers, immunophenotyping by flow cytometry on 
whole blood will be performed. 
 
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Change #13 
Section 4.5 Pharmacogenomic variables 
Section 4.6 Immunological variable 
Have been changed to:  
Section 4.3.4 Pharmacogenomic variables 
Section 4.3.5 Immunological variable 
 
Change #14 
Section 5.1 Study description 
PS0009 is a randomized, double-blind, placebo- and active comparator-controlled study to 
evaluate the efficacy and safety of bimekizumab administered sc to subjects with 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 a 
candidate for ustekinumab, or for systemic PSO therapy and/or phototherapy and/or 
photochemotherapy. Subjects may have been previously exposed to a biologic therapy (see 
Exclusion Criterion #23). 
Has been changed to:  
PS0009 is a randomized, double-blind, placebo- and active comparator-controlled study to 
evaluate the efficacy and safety of bimekizumab administered sc to subjects with 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 a 
candidate for ustekinumab, or for systemic PSO therapy and/or phototherapy and/or 
photochemotherapy. Subjects may have been previously exposed to a biologic therapy (see 
Exclusion Criterion #23). 
 
Change #15 
Section 5.2 
Study periods 
This study will include 4 periods, a Screening Period (2 to 4 weeks), an Initial Treatment Period 
(16 weeks), a Maintenance Treatment Period (36 weeks), and a SFU Period (20 weeks after the 
last dose of IMP). After completion of the Maintenance Treatment Period, eligible subjects will 
be allowed to enroll in an open-label study. Subjects enrolling into the open-label study will not 
have the PS0009 SFU Visit. 
Has been changed to:  
This study will include 4 periods, a Screening Period (2 to 4 5 weeks), an Initial Treatment 
Period (16 weeks), a Maintenance Treatment Period (36 weeks), and a SFU Period (20 weeks 
after the last final dose of IMP). After completion of the Maintenance Treatment Period, eligible 
subjects will be allowed to enroll in an open-label study. Subjects enrolling into the open-label 
study will not have the PS0009 SFU Visit. 
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Change #16 
Section 5.2.1 Screening Period 
The Screening Period will last 2 weeks, but can be extended up to a total of 4 weeks. 
Has been changed to:  
The Screening Period will last 2 weeks, but can be extended up to a total of 4 5 weeks in cases 
where a laboratory assessment needs to be repeated or to allow washout of prohibited 
medications. 
 
Change #17 
Section 5.2.2 Initial Treatment Period 
 Ustekinumab (160 subjects): 
 For subjects weighing ≤100kg (220lbs), 45mg sc initially and 4 weeks later 
 For subjects weighing >100kg (220lbs), 90mg sc initially and 4 weeks later 
Has been changed to:  
 Ustekinumab (160 subjects): 
 For subjects weighing ≤100kg (220lbs) at Baseline, 45mg sc initially and 4 weeks later 
 For subjects weighing >100kg (220lbs) at Baseline, 90mg sc initially and 4 weeks later 
 
Change #18 
Section 5.3 Study duration per subject 
For each subject, the study will last a maximum of up to 72 weeks, as follows: 
 Screening Period: 2 to 4 weeks 
Has been changed to:  
For each subject, the study will last a maximum of up to 72 73 weeks, as follows: 
 Screening Period: 2 to 4 5 weeks 
 
Change #19 
Section 5.5 Anticipated regions and countries 
 The regions planned for study conduct are Europe, Canada, and the US, with possible 
extension to other regions and countries.   
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Has been changed to:  
The regions planned for study conduct are North America, Western Europe, Canada, and the 
US Central/Eastern Europe, and Asia/Australia, with possible extension to other regions and 
countries. 
 
Change #20 
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. 
 
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PS0009 
 
 
 
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Table 5--1 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Peri 
(weeks after first dose) 
SFUbb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
Informed consentc 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Xd 
 
 
Inclusion/exclusion 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine drug screen 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Demographic data 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Psoriasis history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Significant past medical history and 
concomitant diseases 
X 
Xe 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical examf, g 
X 
 
 
 
 
 
 
X 
 
X 
 
 
X 
 
 
 
X 
X 
Height 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Body weight 
 
X 
 
 
 
 
 
X 
 
X 
 
 
X 
 
 
 
X 
 
Vital signsh 
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 
X 
Urinalysis 
X 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
ECG 
X 
 
 
 
 
 
 
X 
 
  
 
X 
 
 
 
 
X 
 
Pregnancy testingi 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hepatitis B and C testingj 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV testingk 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Chest x-rayl 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IGRA Tuberculosis test 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
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Table 5--1 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Peri 
(weeks after first dose) 
SFUbb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
Tuberculosis questionnaire 
X 
X 
 
 
 
 
 
X 
 
X 
 
 
X 
 
 
X 
X 
X 
Blood sample for bimekizumab 
plasma concentrationsm 
 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Blood sample for anti- 
bimekizumab antibodiesm 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
X 
For participating centers: Blood 
sample for immunophenotypingc,m 
 
X 
X 
 
 
X 
X 
X 
 
 
 
 
 
 
 
 
X 
 
Blood sample genomic, proteomic, 
metabolomics, and candidate 
biomarker analysesc,m 
 
X 
X 
 
 
X 
X 
X 
 
 
 
 
 
 
 
 
X 
 
Blood sample genetic/epigenetic 
analysisc,m 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
PASI 
X 
X 
X 
X 
X 
X 
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 
X 
X 
Percentage of BSA 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
DLQI 
 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
PHQ-9 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
eC-SSRS 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Patient Symptom Diary (daily) 
X 
X 
X 
X 
X 
X 
X 
 X 
 
 
 
 
 
 
 
 
 
 
scalp IGA 
 
X 
Xn 
Xn 
Xn 
Xn 
Xn 
Xn 
 
 
Xn 
 
 
Xn 
 
 
Xn 
 
mNAPSI 
 
X 
 
 
Xo 
Xo 
Xo 
Xo 
 
 
Xo 
 
 
Xo 
 
 
Xo 
 
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Clinical Study Protocol 
Bimekizumab 
PS0009 
 
 
 
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Table 5--1 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Peri 
(weeks after first dose) 
SFUbb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
pp-IGA 
 
X 
 
 
Xp 
Xp 
Xp 
Xp 
 
 
Xp 
 
 
Xp 
 
 
Xp 
 
EQ-5D-3L 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
SF-36 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
Patient Global Assessment of 
psoriasisq 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
 
X 
 
PASE 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
PGADAr 
 
X 
 
 
 X 
 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
HAQ-DIr 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
WPAI-SHP V2.0 
 
X 
 
 
 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
 
Photographs of skin and nails 
(subset of sites) 
 
X 
X 
X 
X 
X 
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 
IRTs,t 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Bimekizumab, ustekinumab, or 
placebo administrations,t 
 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
BSA=body surface area; CV=cardiovascular; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide 
Severity Rating Scale; eCRF=electronic Case Report Form; EQ-5D-3L=Euro-Quality of Life 5-Dimensions 3-level; GI=gastrointestinal; HAQ-DI=Health 
Assessment Questionnaire-Disability Index; HCV=hepatitis C virus; HIV=human immunodeficiency virus; ICF=Informed Consent Form; IGA=Investigator’s 
Global Assessment; IGRA=interferon-gamma release assay; IMP=investigational medicinal product; IRT=interactive response technology; 
mNAPSI=Modified Nail Psoriasis Severity Index Score; PASE=Psoriatic Arthritis Screening and Evaluation; PASI=Psoriasis Area Severity Index; 
PD=pharmacodynamics; PEOT=Premature End of Treatment; PGADA=Patient’s Global Assessment of Disease Activity; PHQ-9=Patient Health 
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Table 5--1 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Peri 
(weeks after first dose) 
SFUbb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
Questionnaire 9; pp-IGA=palmoplantar Investigator’s Global Assessment; PsA=psoriatic arthritis; SF-36=Short Form 36-item Health Survey; SFU=Safety 
Follow-Up; scalp IGA=scalp-specific Investigator’s Global Assessment; TB=tuberculosis; WPAI-SHP=Work Productivity and Activity Impairment 
Questionnaire-specific health problem 
a Visit windows of +/- 3 days from the first dose at all visits except SFU. SFU Visit window is -3 and +7 days from last dose. 
b The SFU Visit will occur 20 weeks after the last dose for subjects who do not enroll in the open-label study. 
c A separate ICF will be required for subjects who decide to participate in the genomics, genetics, and proteomics substudy. The ICF must be signed prior to 
collecting any samples for the substudy. Samples for immunophenotyping will be analyzed immediately. All PD samples and genomic, proteomic, and 
metabolomics samples will be stored at -80°C at the central biorepository for up to 20 years. 
d A separate ICF is required to be completed for the open-label study. 
e Ensure no significant changes in medical history. 
f Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
g The physical examination will include examination of the following systems: eyes, hair, and skin; respiratory; CV; and GI. 
h Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and body temperature) are to be measured prior to blood sampling, and prior to dosing, 
where applicable. 
i Pregnancy testing will consist of serum testing at the Screening. The pregnancy test will be urine at all other visits. 
j Subjects who have evidence of or test positive for hepatitis B by any of the following criteria: 1) positive for hepatitis B surface antigen (HBsAg+); 2) positive 
for anti-hepatitis B core antibody (HBcAb+) are excluded. A positive test for HCV is defined as: 1) positive for hepatitis C antibody (anti-HCV Ab), 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. 
k The HIV test results will not be recorded in the eCRF. 
l Screening chest x-ray must occur within 3 months prior to Screening Visit. 
m All blood samples taken prior to dosing. 
n The scalp IGA will only be assessed for those subjects with scalp involvement (scalp IGA score >0) at Baseline. 
o The mNAPSI will be assessed only in subjects with nail involvement (mNAPSI score >0) at Baseline. 
p The pp-IGA will only be assessed in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline. 
q The Patient Global Assessment of psoriasis will be performed as part of the patient symptoms diary on a weekly basis from baseline through the initial 
treatment period with a +3 day completion window. During the Maintenance Treatment Period this assessment will be completed at each clinic visit specified 
with a ±3 day completion window. 
r The PGADA and HAQ-DI are assessed for all subjects at Baseline. At all subsequent visits, the PGADA and HAQ-DI are assessed only for subjects with PsA 
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Table 5--1 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Peri 
(weeks after first dose) 
SFUbb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
at Baseline (defined as a past medical history of PsA or PASE ≥47). 
s IMP administration is based on randomization. 
t The dosing window is ±7 days relative to the scheduled dosing visit. 
 
 
Has been changed to:  
Table 5-1: 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Peri 
(weeks after first dose) 
SFUcb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
Informed consentc 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Xd 
 
 
Inclusion/exclusion 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine drug screen 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Demographic data 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Psoriasis history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Significant past medical history and 
concomitant diseases 
X 
Xe 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical examf, g 
X 
X 
 
 
 
 
X 
X 
 
X 
 
 
X 
 
 
 
X 
X 
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Table 5-1: 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Peri 
(weeks after first dose) 
SFUcb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
Height 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Body weight 
 
X 
 
 
 
 
X 
X 
 
X 
 
 
X 
 
 
 
X 
 
Vital signsh 
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 
X 
X 
Urinalysis 
X 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
ECG 
X 
 
 
 
 
 
X 
X 
 
  
 
X 
 
 
 
 
X 
 
Pregnancy testingi 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hepatitis B and C testingj 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV testingk 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Chest x-rayl 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IGRA Tuberculosis test 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Tuberculosis questionnaire 
X 
X 
 
 
 
 
X 
X 
 
X 
 
 
X 
 
 
X 
X 
X 
Blood sample for bimekizumab 
plasma concentrationsm 
 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Blood sample for anti- 
bimekizumab antibodiesm 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
X 
For participating centers: Blood 
sample for 
immunophenotypingc,m 
 
X 
X 
 
 
X 
X 
X 
 
 
 
 
 
 
 
 
X 
 
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Table 5-1: 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Peri 
(weeks after first dose) 
SFUcb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
Blood sample genomic, proteomic, 
metabolomics, and candidate 
biomarker analysesc,m 
 
X 
X 
 
 
X 
X 
X 
 
 
 
 
 
 
 
 
X 
 
Blood sample genetic/epigenetic 
analysisc,m 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
PASI 
X 
X 
X 
X 
X 
X 
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 
X 
X 
Percentage of BSA 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
DLQI 
 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
PHQ-9 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
eC-SSRS 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Patient Symptom Diary (daily) 
X 
X 
X 
X 
X 
X 
X 
 X 
 
 
 
 
 
 
 
 
 
 
scalp IGA 
 
X 
Xn 
Xn 
Xn 
Xn 
Xn 
Xn 
 
 
Xn 
 
 
Xn 
 
 
Xn 
 
mNAPSI 
 
X 
 
 
Xo 
Xo 
Xo 
Xo 
 
 
Xo 
 
 
Xo 
 
 
Xo 
 
pp-IGA 
 
X 
 
 
Xp 
Xp 
Xp 
Xp 
 
 
Xp 
 
 
Xp 
 
 
Xp 
 
EQ-5D-3L 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
SF-36 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
Patient Global Assessment of 
psoriasisq 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
 
X 
 
PASE 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
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Table 5-1: 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Peri 
(weeks after first dose) 
SFUcb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
PGADAr 
 
X 
 
 
 X 
 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
HAQ-DIr 
 
X 
 
 
X 
X 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
WPAI-SHP V2.0 
 
X 
 
 
 
 
 
X 
 
X 
 
 
 
X 
 
 
X 
 
Photographs of skin and nails 
(subset of sites) 
 
X 
X 
X 
X 
X 
X 
X 
 
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 
IRTs,t 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Bimekizumab, ustekinumab, or 
placebo administrations,t 
 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
BSA=body surface area; CV=cardiovascular; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide 
Severity Rating Scale; eCRF=electronic Case Report Form; EQ-5D-3L=Euro-Quality of Life 5-Dimensions 3-level; GI=gastrointestinal; HAQ-DI=Health 
Assessment Questionnaire-Disability Index; HCV=hepatitis C virus; HIV=human immunodeficiency virus; ICF=Informed Consent Form; IGA=Investigator’s 
Global Assessment; IGRA=interferon-gamma release assay; IMP=investigational medicinal product; IRT=interactive response technology; 
mNAPSI=Modified Nail Psoriasis Severity Index Score; PASE=Psoriatic Arthritis Screening and Evaluation; PASI=Psoriasis Area Severity Index; 
PD=pharmacodynamics; 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; SF-36=Short Form 36-item Health Survey; SFU=Safety 
Follow-Up; scalp IGA=scalp-specific Investigator’s Global Assessment; TB=tuberculosis; WPAI-SHP=Work Productivity and Activity Impairment 
Questionnaire-specific health problem 
a Visit windows of +/- 3 ±3 days from the first dose to the Week 24 visit. Visit windows of ±7 days from the Week 28 visit to the Week 52 visit. The SFU 
Visit window is ±7 days -3 and +7 days from last final dose. 
b The SFU Visit will occur 20 weeks after the last final dose for subjects who do not enroll in the open-label study. 
c A separate ICF will be required for subjects who decide to participate in the genomics, genetics, and proteomics substudy. The ICF must be signed 
prior to collecting any samples for the substudy. Samples for immunophenotyping will be analyzed immediately. All PD samples and genomic, 
proteomic, and metabolomics samples will be stored at -80°C at the central biorepository for up to 20 years. 
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Table 5-1: 
Schedule of study assessments 
Visita/ 
Week 
 
Protocol activity 
Screening 
Initial Treatment Period 
(weeks after first dose) 
Maintenance Treatment Peri 
(weeks after first dose) 
SFUcb 
Baseline 
(first 
dose)
1 
2 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52/ 
PEOT 
d A separate ICF is required to be completed for the open-label study. 
e Ensure no significant changes in medical history. 
f Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
g The physical examination will include examination of the following systems: eyes, hair, and skin; respiratory; CV; and GI be performed as per 
Section 12.3.5. 
h Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and body temperature) are to be measured prior to blood sampling, and prior to dosing, 
where applicable. 
i Pregnancy testing will consist of serum testing at the Screening. The pregnancy test will be urine at all other visits. 
j Subjects who have evidence of or test positive for hepatitis B by any of the following criteria: 1) positive for hepatitis B surface antigen (HBsAg+); 2) positive 
for anti-hepatitis B core antibody (HBcAb+) are excluded. A positive test for HCV is defined as: 1) positive for hepatitis C antibody (anti-HCV Ab), 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. 
k The HIV test results will not be recorded in the eCRF. 
l Screening chest x-ray must occur within 3 months prior to Screening Visit. 
m All blood samples taken prior to dosing except at Visit 1 and Visit 2 (at which no dose administration occurs). 
n The scalp IGA will only be assessed for those subjects with scalp involvement (scalp IGA score >0) at Baseline. 
o The mNAPSI will be assessed only in subjects with nail involvement (mNAPSI score >0) at Baseline. 
p The pp-IGA will only be assessed in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline. 
q The Patient Global Assessment of psoriasis will be performed as part of the patient symptoms diary on a weekly basis from baseline through the initial 
treatment period with a +3 day completion window. During the Maintenance Treatment Period this assessment will be completed at each clinic visit 
specified with a ±3 day completion window the specified clinic visits. 
r The PGADA and HAQ-DI are assessed for all subjects at Baseline. At all subsequent visits, the PGADA and HAQ-DI are assessed only for subjects with PsA 
at Baseline (defined as a past medical history of PsA or PASE ≥47). 
s IMP administration is based on randomization. 
t The dosing window is ±7 ±3 days relative to the scheduled dosing visit through Week 24. The dosing window is ±7 days from Week 28 through the end of 
the study. 
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Change #21 
Section 5.7 Schematic diagram 
The following footnote was added after Figure 5-1 Schematic diagram:  
Note: At Week 24 and all following visits, subjects on continuous treatment with the same 
IMP 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 #22 
Section 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: 
6. Subject is a candidate for systemic PSO therapy and/or phototherapy and/or 
photochemotherapy. 
Have been changed to: 
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: 
6. Subject is a candidate for systemic PSO therapy and/or phototherapy and/or 
photochemotherapy. 
 
Change #23 
Section 6.2 
Exclusion criteria 
3. Subject previously participated in another study of a medication (systemic) under 
investigation within the 12 weeks or at least 5 half-lives prior to the Screening Visit, 
whichever is greater, or is currently participating in another study of a medication (systemic) 
under investigation. 
4. Subject previously participated in another study of a topical medication under investigation 
within the 4 weeks prior to the Screening Visit, or is currently participating in another study 
of a topical medication under investigation. 
5. Subject previously participated in another study of a medical device under investigation 
within the 4 weeks prior to the Screening Visit, or is currently participating in another study 
of a medical device under investigation. 
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, or ductal carcinoma in situ of the breast. 
17. Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, 
diabetes) considered by the Investigator to be uncontrolled, unstable, or likely to progress to 
a clinically significant degree during the course of the study. 
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27. Subject has presence of severe depression, indicated by a score of 15 to 19 using the 
screening PHQ-9. Medication used to treat depression should be stable for 4 weeks prior to 
Baseline. 
Have been changed to: 
3a. Subject previously participated in another study of a medication (systemic) under 
investigation within the 12 weeks or at least 5 half-lives prior to the Screening Visit, 
whichever is greater, or 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. 
4a. Subject previously participated in another study of a topical medication under 
investigation within the 4 weeks prior to the Screening Visit, or 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. 
5a. Subject previously participated in another study of a medical device under investigation 
within the 4 weeks prior to the Screening Visit, or is currently, or was within the 4 weeks 
prior to the Baseline Visit, participating in another study of a medical device under 
investigation. 
14a. 
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, or ductal carcinoma in situ of the breast. 
17a. 
Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver 
disease, diabetes 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. 
27a. 
Subject has presence of moderately severe major depression or severe major 
depression, indicated by a score of 15 to 19 ≥15 using the screening PHQ-9. Medication used 
to treat depression should be stable for 4-8 weeks prior to Baseline. 
 
Change #24 
Section 6.2 
Exclusion criteria 
The following text has been added: 
30. Subject is taking or has taken prohibited psoriasis medications without meeting the 
mandatory washout period relative to the Baseline Visit (Table 7-2). 
 
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Change #25 
Section 6.3 Withdrawal criteria  
The following withdrawal criteria have been added, modified, and/or renumbered: 
8. At Week 24 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 study product. 
9. 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). 
10. A subject considered as having either a suspected new LTB infection 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 latent TB infection (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. 
11. 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 
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. 
12. Subjects must be referred immediately to a mental health care professional and may be 
withdrawn from the study based upon the Investigator’s judgment of benefit/risk for either 
of the following: 
 Active suicidal ideation as indicated by a positive response (“Yes”) to Questions 4 or 5 or to 
the suicidal behavior questions 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. 
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13. Subjects must be referred immediately to a mental healthcare professional and must be 
withdrawn in case of: 
 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 will be documented must be recorded in source 
documentation. 
 
Change #26 
Section 7.2 Treatment(s) to be administered 
Double-blind Initial Treatment Period dosing 
 Subjects randomized to receive ustekinumab will receive ustekinumab sc at Baseline and 
Week 4, followed by placebo (2 placebo injections sc) at Week 8 and Week 12. Because 
ustekinumab dosing is based on weight, on ustekinumab treatment weeks subjects ≤100kg 
(220lbs) will receive 1 ustekinumab 45mg sc injection and 1 placebo injection and subjects 
>100kg (220lbs) will receive 2 ustekinumab 45mg sc injections. 
Maintenance Treatment Period dosing 
 Subjects randomized to receive ustekinumab will have received ustekinumab sc at Baseline 
and Week 4, and will continue to receive ustekinumab sc every 12 weeks (Weeks 16, 28, and 
40). Subjects will receive placebo (2 placebo injections sc) on non-ustekinumab treatment 
weeks (Weeks 20, 24, 32, 36, 44, and 48). Because ustekinumab dosing is based on weight, 
on ustekinumab treatment weeks subjects ≤100kg (220lbs) will receive 1 ustekinumab 45mg 
sc injection and 1 placebo injection and subjects >100kg (220lbs) will receive 2 ustekinumab 
45mg sc injections. 
Has been changed to: 
Double-blind Initial Treatment Period dosing 
 Subjects randomized to receive ustekinumab will receive ustekinumab sc at Baseline and 
Week 4, followed by placebo (2 placebo injections sc) at Week 8 and Week 12. Because 
ustekinumab dosing is based on weight, on ustekinumab treatment weeks subjects ≤100kg 
(220lbs) at Baseline will receive 1 ustekinumab 45mg sc injection and 1 placebo injection 
and subjects >100kg (220lbs) at Baseline will receive 2 ustekinumab 45mg sc injections. 
Maintenance Treatment Period dosing 
 Subjects randomized to receive ustekinumab will have received ustekinumab sc at Baseline 
and Week 4, and will continue to receive ustekinumab sc every 12 weeks (Weeks 16, 28, and 
40). Subjects will receive placebo (2 placebo injections sc) on non-ustekinumab treatment 
weeks (Weeks 20, 24, 32, 36, 44, and 48). Because ustekinumab dosing is based on weight, 
on ustekinumab treatment weeks subjects ≤100kg (220lbs) at Baseline will receive 
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1 ustekinumab 45mg sc injection and 1 placebo injection and subjects >100kg (220lbs) at 
Baseline will receive 2 ustekinumab 45mg sc injections. 
 
Change #27 
Section 7.2 Treatment(s) to be administered 
Table 7-1: 
Dosing scheme 
Week 
Dose Assignment 
Baseline 
(first 
dose) 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
Bimekizumab 
320mg Q4W 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
Ustekinumab 45mg 
(subjects ≤100kg) 
▲○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
Ustekinumab 90mg 
(subjects >100kg) 
▲▲ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
Placebo 
○○ 
○○ 
○○ 
○○ 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
Q4W=every 4 weeks 
Has been changed to: 
Table 7-1: 
Dosing scheme 
Week 
Dose Assignment 
Baseline 
(first 
dose) 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
Bimekizumab 
320mg Q4W 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
Ustekinumab 45mg 
(subjects ≤100kg) 
▲○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
Ustekinumab 90mg 
(subjects >100kg) 
▲▲ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
Placebo/ 
bimekizumab 
320mg Q4W 
○○ 
○○ 
○○ 
○○ 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
Q4W=every 4 weeks 
Change #28 
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 study 
material, including recording the administration information on source documents. 
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Has been changed to:  
Unblinded study staff will be delegated the responsibility to receive, inventory and destroy 
the 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 in 
order to maintain the blind. 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 study material, including recording the administration information on source documents. 
 
Change #29 
Section 7.8.2 Prohibited concomitant treatments (medications and therapies) 
Table 7-2: 
Prohibited psoriasis medications 
Drug 
Washout period relative to Baseline Visit 
Topicals except for those permitted (Section 7.8.1.1) 
2 weeks 
Systemic retinoids 
3 months  
Systemic treatment (nonbiological): 
systemic immunosuppressant agents (eg, 
methotrexate, cyclosporine, azathioprine, thioguanine) 
fumaric acid esters specifically used for the treatment 
of PSO 
systemic corticosteroids 
phototherapy or photochemotherapy 
1 month 
Anti-TNFs: 
adalimumab (including biosimilar) 
etanercept (including biosimilar) 
infliximab (including biosimilar), golimumab, 
certolizumab pegol 
 
Any exposure to adalimumab 
1 month for etanercept 
3 months for infliximab (including biosimilar), 
golimumab, certolizumab pegol 
Other biologics and other systemic therapies, eg: 
 
apremilast, tofacitinib 
2 weeks for apremilast and tofacitinib 
alefacept, efalizumab, guselkumab 
3 months for alefacept, efalizumab, and guselkumab 
ustekinumab, briakinumab 
6 months for ustekinumab and briakinumab 
rituximab 
12 months for rituximab 
Anti-IL-17 therapy: 
brodalumab 
ixekizumab 
secukinumab 
3 months 
(bimekizumab is excluded per exclusion criteria) 
Any other antipsoriatic agent (systemic) under 
investigation (or approved after the protocol is approved) 
3 months or 5 half-lives, whichever is greater 
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Table 7-2: 
Prohibited psoriasis medications 
Drug 
Washout period relative to Baseline Visit 
Any other antipsoriatic agent (topical) under investigation 
1 month 
IL-17=interleukin 17; PSO=psoriasis; TNF=tumor necrosis factor 
Has been changed to:  
Table 7-2: 
Prohibited psoriasis medications 
Drug 
Washout period relative to Baseline Visit 
Topicals except for those permitted (Section 7.8.1.1) 
2 weeks 
Systemic retinoids 
3 months  
Systemic treatment (nonbiological): 
systemic immunosuppressant agents (eg, 
methotrexate, cyclosporine, azathioprine, thioguanine) 
fumaric acid esters specifically used for the treatment 
of PSO 
systemic corticosteroids 
phototherapy or photochemotherapy 
1 month 
Anti-TNFs: 
adalimumab (including biosimilar) 
etanercept (including biosimilar) 
infliximab (including biosimilar), golimumab, 
certolizumab pegol 
 
Any exposure to adalimumab 
1 month for etanercept 
3 months for infliximab (including biosimilar), 
golimumab, certolizumab pegol 
Other biologics and other systemic therapies, eg: 
 
apremilast, tofacitinib 
2 weeks for apremilast and tofacitinib 
alefacept, efalizumab, guselkumab 
3 months for alefacept, efalizumab, and guselkumab 
tildrakizumab, risankizumab 
5 months for tildrakizumab and risankizumab 
ustekinumab, briakinumab 
6 months for ustekinumab and briakinumab 
rituximab 
12 months for rituximab 
Anti-IL-17 therapy: 
brodalumab 
ixekizumab 
secukinumab 
3 months 
(bimekizumab is excluded per exclusion criteria) 
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 
Change #30 
Section 7.10 Randomization and numbering of subjects, first paragraph 
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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. 
Has been changed to:  
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 (North America, Western 
Europe, Central/Eastern Europe, and Asia/Australia) and prior biologic exposure (yes/no). 
The IRT will generate individual assignments for subject kits of IMP, as appropriate, according 
to the visit schedule. 
 
Change #31 
Section 8 STUDY PROCEDURES BY VISIT, first bullet 
 Visit windows of ±3 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 window of 
±3 days is relative to Baseline and applicable for all subsequent visits. Changes to the dosing 
schedule outside of the 3-day window must be discussed with the Medical Monitor. 
 The dosing window is ±7 days relative to the scheduled dosing visit. 
 For the SFU Visit (20 weeks after the last dose), the visit window 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: 
 From the Week1 visit to the Week 24 visit, Visit visit windows of ±3 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 window of ±3 days is relative to Baseline and 
applicable for all subsequent visits. From the Week 28 visit to the Week 52 visit, visit 
windows are ±7 days. Changes to the dosing schedule outside of the visit window must be 
discussed with the Medical Monitor. 
 The dosing window is ±3 days relative to the scheduled dosing visit through Week 24. 
The dosing window is ±7 days relative to the scheduled dosing visit from Week 28 through 
the end of the study. 
 For the SFU Visit (20 weeks after the last final dose), the visit window should occur no 
more than 3 days prior to the scheduled visit date and within 7 days after is ±7 days 
relative to the scheduled visit date (-3 days/+7 days). 
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Change #32 
Section 8.1 Screening Visit (2 to 4 weeks) 
Has been changed to:  
Section 8.1 Screening Visit (2 to 4 5 weeks) 
 
Change #33 
Sections 8.2.1 Baseline Visit 
The following has been added from the bulleted list: 
 Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB 
 
Change #34 
Sections 8.2.1 Baseline Visit, 8.2.2 Week 1 Visit (±3 days relative to Baseline), 8.2.5 Week 8 
Visit (±3 days relative to Baseline), 8.2.6 Week 12 Visit (±3 days relative to Baseline), 8.3.9 
Week 52 (±3 ±7 days), 
The following has been deleted from the bulleted list: 
 Immunophenotyping (participating centers only) 
 
Change #35 
Section 8.2.6 Week 12 Visit (±3 days relative to Baseline) 
The following have been added to the bulleted list: 
 Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB 
 Body weight 
 TB questionnaire 
 Record 12-lead ECG 
 
Change #36 
Section 8.2.7 Week 16 Visit (±3 days relative to Baseline) 
The following have been deleted from the bulleted list: 
 Physical exam including evaluation of signs and symptoms of active TB and risk for 
exposure to TB 
 Body weight 
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 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Immunophenotyping (participating centers only) 
 Record 12-lead ECG 
 TB questionnaire 
 
Change #37 
Section 8.3.1 Week 20 Visit (±3 days relative to Baseline) 
The following have been added to the bulleted list: 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and biochemistry 
 
Change #38 
Section 8.3.2 Week 24 Visit (±3 days relative to Baseline) 
The following have been deleted from the bulleted list: 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Urinalysis and electrolytes 
 Photographs of skin and nails (participating centers only) 
 
Change #39 
Sections 8.3.3 Week 28 Visit (±3 days relative to Baseline) and 8.3.6 Week 40 Visit (±3 days 
relative to Baseline) 
The following has been added to the bulleted list: 
 Photographs of skin and nails (participating centers only) 
 
Change #40 
Sections 8.3.3 Week 28 (±3 days), 8.3.4 Week 32 (±3 days), 8.3.5 Week 36 (±3 days), 8.3.6 
Week 40 (±3 days), 8.3.7 Week 44 (±3 days), 8.3.8 Week 48 (±3 days), and 8.3.9 Week 52 (±3 
days) 
Has been changed to:  
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Sections 8.3.3 Week 28 (±3 ±7 days), 8.3.4 Week 32 (±3 ±7 days), 8.3.5 Week 36 (±3 ±7 
days), 8.3.6 Week 40 (±3±7 days), 8.3.7 Week 44 (±3 ±7 days), 8.3.8 Week 48 (±3 ±7 days), 
and 8.3.9 Week 52 (±3 ±7 days)  
 
Change #41 
Section 8.3.5 Week 36 Visit (±3 days relative to Baseline) 
The following has been deleted from the bulleted list: 
 Photographs of skin and nails (participating centers only) 
 
Change #42 
Section 8.3.8 Week 48 Visit (±7 days relative to Baseline) 
The following has been deleted from the bulleted list: 
 TB questionnaire 
 
Change #43 
Section 8.5 Safety Follow-Up Visit (20 weeks after last dose, -3 days/+7 days) 
Has been changed to:  
Section 8.5 Safety Follow-Up Visit (20 weeks after last final dose, -3 days/+7 days ±7 days) 
 
Change #44 
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, the The same assessor should evaluate the subject at each 
assessment. 
 
Change #45 
Section 9.10 Patient Global Assessment of psoriasis, second and third paragraphs 
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The Patient Global Assessment of PSO will be performed as part of the patient symptoms diary 
from baseline through the Initial Treatment Period; the assessment is to completed within a +3 
day completion window at each of the visits specified in Table 5-1. 
During the double-blind Maintenance Treatment Period, this assessment will be completed 
within a +3 day completion window at the visits specified in Table 5-1. 
Has been changed to:  
The Patient Global Assessment of PSO will be performed as part of the patient symptoms diary 
from baseline Screening through the Initial Treatment Period; the assessment is to completed 
within a +3 day completion window at each of the visits specified in Table 5-1. 
During the double-blind Maintenance Treatment Period, this assessment will be completed 
within a +3 day completion window at the visits specified in Table 5-1. 
 
Change #46 
Section 9.11 Patient Symptom Diary responses, second paragraph 
The ePRO diary will also administer the patient global assessment of PSO as noted above 
appropriate anchor items at the end of every study week. The ePRO diary software will be 
programmed such that the subjects will be given a window of opportunity to complete the ePRO 
diaryeach evening. The data collected on the ePRO diary will be uploaded to a central server 
database and will be 21 CFR Part 11 compliant. Appropriate GCP procedures (including 
subject/site training and testing) will be performed at the study sites. 
Has been changed to:  
The ePRO diary will also administer the patient global assessment of PSO as noted above 
appropriate anchor items at the end of every study week. The ePRO diary software will be 
programmed such that the subjects will be given a window of opportunity to complete the ePRO 
diaryeach evening. The data collected on the ePRO diary will be uploaded to a central server 
database and will be 21 CFR Part 11 compliant. Appropriate GCP procedures (including 
subject/site training and testing) will be performed at the study sites. 
 
Change #47 
Section 9.12 PASE questionnaire 
The 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 [1], agree [2], no idea [3], disagree [4], and 
strongly disagree [5]).  
Has been changed to:  
The 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 
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categories relating to agreement (strongly agree [15], agree [24], no idea [3], disagree [42], 
and strongly disagree [51]).  
 
Change #48 
Section 9.16 Photographs 
At certain clinical sites, representative photographs of the changes in skin and nail appearance 
will be captured. Subjects will have full body (anterior and posterior views) and nail photographs 
taken. Photographs will be anonymized. 
Has been changed to:  
At certain clinical sites, representative photographs of the changes in skin and nail appearance 
will be captured. Subjects will have full body (anterior and posterior views) and nail 
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 scalp disease at 
Baseline will have scalp photographs taken. Photographs will be anonymized. 
 
Change #49 
Section 10 Assessment Of Pharmacokinetic/ Pharmacodynamic/ And Pharmacogenomic 
Variable(s) 
Section 10.1 Pharmacokinetic and pharmacodynamic variables 
Blood samples for measurement of PK assessments (Section 4.4) will be collected at the time 
points specified in the schedule of study assessments (Table 5‒1). 
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 ustekinumab will not be analyzed, but stored 
for potential future PK analysis and anti-drug antibody determination. 
At participating centers, immunophenotyping will be assessed by flow cytometry using 
fluorescent-activated cell sorting on whole blood of T-cells, B-cells, natural killer cells, and T-
helper subsets. 
Has been changed to:  
Section 10 Assessment Of Pharmacokinetic And Pharmacogenomic Variable(s) 
Section 10.1 Pharmacokinetic variables 
Blood samples for measurement of PK assessments (Section 4.4) will be collected at the time 
points specified in the schedule of study assessments (Table 5‒1). 
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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 ustekinumab will not be analyzed, but stored 
for potential future PK analysis and anti-drug antibody determination. 
At participating centers, immunophenotyping will be assessed by flow cytometry using 
fluorescent-activated cell sorting on whole blood of T-cells, B-cells, natural killer cells, and 
T-helper subsets. 
 
Change #50 
Section 12.1.4 Pregnancy 
 The subject should immediately stop the intake of the IMP or be down-titrated as instructed 
at the PEOT visit. 
A pregnancy becomes an SAE in the following circumstances: miscarriage, abortion (elective or 
spontaneous), 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. 
Have been changed to:  
 The subject should immediately stop the intake of the IMP or be down-titrated as 
instructed at the PEOT visit. 
A pregnancy becomes an SAE in the following circumstances: miscarriage, elective abortion 
(elective or spontaneousabortion when medically indicated (e.g. 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. 
 
Change #51 
Section 12.2 Laboratory measurements 
Table 12-2: Laboratory measurements 
Hematology 
Chemistry 
Urinalysis dipsticka 
Basophils 
Calcium 
pH 
Eosinophils 
Chloride 
Albumin (protein) 
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Table 12-2: Laboratory measurements 
Hematology 
Chemistry 
Urinalysis dipsticka 
Lymphocytes 
Magnesium 
Glucose 
Atypical lymphocytes 
Potassium 
Blood 
Monocytes 
Sodium 
Leukocyte esterase 
Neutrophils 
Glucose 
Nitrite 
Hematocrit 
BUN 
Urine dipstick for pregnancy testingb 
Hemoglobin 
Creatinine 
Urine drug screend 
MCH 
ALP 
 
MCHC 
AST 
 
MCV 
ALT 
 
Platelet count 
GGT 
 
RBC count 
Total bilirubin 
 
WBC count 
LDH 
 
 
Serum pregnancy testingb 
 
Has been changed to:  
Table 12-2: Laboratory measurements 
Hematology 
Chemistry 
Urinalysis dipsticka 
Basophils 
Calcium 
pH 
Eosinophils 
Chloride 
Albumin (protein) 
Lymphocytes 
Magnesium 
Glucose 
Atypical lymphocytes 
Potassium 
Blood 
Monocytes 
Sodium 
Leukocyte esterase 
Neutrophils 
Glucose 
Nitrite 
Hematocrit 
BUN 
Urine dipstick for pregnancy testingb 
Hemoglobin 
Creatinine 
Urine drug screend 
MCH 
ALP 
 
MCHC 
AST 
 
MCV 
ALT 
 
Platelet count 
GGT 
 
RBC count 
Total bilirubin 
 
WBC count 
LDH 
 
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Table 12-2: Laboratory measurements 
Hematology 
Chemistry 
Urinalysis dipsticka 
 
Serum pregnancy testingb 
 
 
Change #52 
Section 12.2.1 Evaluation of PDILI 
Rechallenge with a substance potentially causing drug-induced liver injury is dangerous, may be 
fatal, and must not occur. 
Has been changed to:  
Rechallenge with a substance potentially causing drug-induced liver injury is dangerous, 
may be fatal, and must not occur. 
 
Change #53 
Section 12.2.1.2.1 IMP restart/rechallenge (if applicable) 
Rechallenge with a substance potentially causing drug-induced liver injury is dangerous, may be 
fatal, and must not occur. 
Has been changed to:  
Section 12.2.1.2.1 IMP restart/rechallenge (if applicable) 
Rechallenge with a substance potentially causing drug-induced liver injury is dangerous, 
may be fatal, and must not occur. Rechallenge with IMP can occur only if ALL of the 
following requirements are met: 
 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).  
 The subject has shown clear therapeutic benefit from the IMP. 
 Subject’s ALT or AST elevations do not exceed ≥5xULN. 
 Subject’s total bilirubin is <2xULN. 
 Subject has no signs or symptoms of hypersensitivity or hepatitis.  
 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. 
 Subject agrees to the Investigator-recommended monitoring plan. 
Change #54 
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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. 
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. 
 
Change #55 
Section 12.3.1.1 Tuberculosis assessment by IGRA 
During conduct of the study, the TB assessment by IGRA (QuantiFERON TB GOLD is 
recommended) will be performed as described in Table 5-1 for all subjects.  
Has been changed to:  
During conduct of the study, the TB assessment by IGRA (QuantiFERON TB GOLD test is 
recommended) will be performed as described in Table 5-1 for all subjects. 
 
Change #56 
Section 12.3.1.3 Tuberculosis questionnaire, last paragraph 
Subjects with a latent or active TB infection must be withdrawn from the study. 
Has been deleted: 
Subjects with a latent or active TB infection must be withdrawn from the study. 
 
Change #57 
Section 12.3.1.4 Tuberculosis management, second paragraph 
During the study, subjects who develop evidence of LTB infection 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 
LTB infection 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 LTB infection should be withdrawn from the study and receive 
appropriate TB or prophylaxis therapy. 
Has been changed to: 
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During the study, subjects who develop evidence of LTB infection 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 
LTB infection 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 LTB infection should be withdrawn from the study and receive 
appropriate TB or prophylaxis therapy. 
 
Change #58 
Section 12.3.2 Pregnancy testing 
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 and at all subsequent post-dosing visits. Pregnancy tests 
should be administered to all female subjects of childbearing potential, regardless of their use of 
birth control. 
Has been changed to: 
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 and at all subsequent post-dosing visits at the visits 
specified in Table 5-1. Pregnancy tests should be administered to all female subjects of 
childbearing potential, regardless of their use of birth control. 
 
Change #59 
Section 13.3.1.1 Electronic Health Record extraction pilot 
It is anticipated that a selection of data points (Demography, Medical History, Concomitant 
Medications, and potentially Vital Signs) will be collected via the subjects’ Electronic 
Healthcare Record (EHR) at specific sites as part of a small EHR Pilot. Retrieve Form for Data 
Capture (RFD) will be used to extract the selected data points from the EHR and imported into 
the EDC system. An archive of selected data points, at the time of extraction, will be stored at 
the sites. 
Has been deleted: 
Section 13.3.1.1 Electronic Health Record extraction pilot 
It is anticipated that a selection of data points (Demography, Medical History, Concomitant 
Medications, and potentially Vital Signs) will be collected via the subjects’ Electronic 
Healthcare Record (EHR) at specific sites as part of a small EHR Pilot. Retrieve Form for 
Data Capture (RFD) will be used to extract the selected data points from the EHR and 
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imported into the EDC system. An archive of selected data points, at the time of extraction, 
will be stored at the sites. 
 
Change #60 
Section 14.1 Definition of analysis sets 
The Full Analysis Set (FAS) will consist of all randomized subjects that received at least 1 dose 
of the IMP and have a valid measurement of the co-primary efficacy variables at Baseline. 
Has been changed to:  
The Maintenance Set will consist of all subjects who have received at least 1 dose of active 
IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.  
The Full Analysis Set (FAS) will consist of all randomized subjects that received at least 1 dose 
of the IMP and have a valid measurement for each of the co-primary efficacy variables at 
Baseline. 
The Pharmacodynamics Per-protocol Set (PD-PPS) will consist of all randomized subjects 
who received at least 1dose of the IMP and provided at least 1 PD measurement post-dose 
without important protocol deviations affecting the measurement. 
 
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Change #61 
Section 14.2 General statistical considerations 
Figure 14-1: Sequence of testing 
 
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.Has been changed to:  
Figure 14-1: Sequence of testing 
 
 
Change #62 
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 14.3. The following variables 
for subgroup analyses will be defined: age, gender, disease duration, region, weight, body mass 
index (BMI), prior systemic chemotherapy or photochemotherapy, prior biologic exposure, prior 
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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. 
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 14.3. The following variables 
for subgroup analyses will be defined: age, gender, disease duration, region, weight, body mass 
index (BMI), prior systemic chemotherapy or photochemotherapy phototherapy, prior 
biologic exposure, 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 #63 
Section 14.5.2 Pharmacokinetic/pharmacodynamic analyses 
The relationship between efficacy response (PASI/IGA) and bimekizumab plasma concentration 
will be explored via graphical and a model based (PK-PD) approach quantify the time course of 
dose/exposure response. In addition, the relationship between safety and exposure will also be 
explored. The data will be combined with that from other bimekizumab trials in psoriasis for a 
pooled, cross trial analysis. The details of this analysis will be described in a data analysis plan, 
and the analysis itself will be reported separately from the Clinical Study Report (CSR). 
Candidate biomarkers may include, but are not limited to: IL-17A/IL-17F pathway signaling and 
PSO biology (eg, IL-17A, IL-17F, IL-23, IL-6, TNF, DC-STAMP, and circulating osteoclast 
precursors). The details of the model and the approach will be specified in a data analysis plan. 
Pharmacodynamic variables will be analyzed for all subjects in the PD-PPS. 
Has been changed to:  
Section 14.5.2 Pharmacokinetic/pharmacodynamic analyses 
The relationship between efficacy response (PASI/IGA) and bimekizumab plasma 
concentration will be explored via graphical and a model-based (PK-PD) approach to 
quantify the time course of dose/exposure response. In addition, the relationship between 
safety and exposure will also be explored. The data will be combined with that from other 
bimekizumab trials in psoriasis for a pooled, cross trial analysis. The details of this analysis 
will be described in a data analysis plan, and the analysis itself will be reported separately 
from the Clinical Study Report (CSR). Candidate biomarkers may include, but are not 
limited to: IL-17A/IL-17F pathway signaling and PSO biology (eg, IL-17A, IL-17F, IL-23, 
IL-6, TNF, DC-STAMP, and circulating osteoclast precursors) (not applicable in Japan). 
The details of the model and the approach will be specified in a data analysis plan. 
Pharmacodynamic variables will be analyzed for all subjects in the PD-PPS. 
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Change #64 
Section 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. 
Has been changed to:  
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. 
 
Change #65 
Section 17 References 
The following reference has been deleted: 
Bretz F, Maurer W, Brannath W, Posch M. A graphical approach to sequentially rejective 
multiple test procedure. Statistics in Medicine. 2009;28:586-604. 
 
18.4 
Protocol Amendment 4 
Rationale for the amendment 
The purpose of this amendment was to update the secondary and “other” efficacy variables to be 
consistent with the wording in the statistical analysis plan (SAP). The secondary and “other” 
efficacy variables for the scalp IGA response, and the “other” efficacy variable for the IGA 
response were updated to clarify that the response required “at least a 2-category improvement 
from Baseline,” as it is described in the SAP. 
For the Patient Symptom Diary, the secondary and “other” efficacy variables were updated from 
“change from Baseline” to “response” on the items of itch, pain, and scaling in order to align the 
protocol with the planned responder analyses described in the SAP which define clinically 
meaningful thresholds of change for defining treatment response, rather than change from 
Baseline. The hierarchy figure (Figure 14.1) was also updated to reflect this change. There is no 
change to the frequency of diary assessments or how the diary assessments are performed.  
The name and contact information of the Clinical Project Manager was also changed. 
Change #1  
Clinical Project Manager 
Name: 
 
Address: 
UCB Biosciences, 8010 Arco Corporation Drive, Raleigh, NC 27617 
Phone: 
 
Fax: 
 
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Has been changed to:  
Name: 
 
Address: 
UCB Biosciences, 8010 Arco Corporation Drive, Raleigh, NC 27617 
Phone: 
 
Fax: 
 
Change #2 
Section 4.2.1  Secondary efficacy variables 
The following bullets: 
 Change from Baseline in the Patient Symptom Diary responses for itch, pain, and scaling at 
Week 16 
 Scalp IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp PSO at 
Baseline 
Have been changed to:  
 Change from Baseline in the Patient Symptom Diary responses for itch, pain, and scaling at 
Week 16 
 Scalp IGA response (Clear or Almost Clear with at least a 2-category improvement from 
Baseline) at Week 16 for subjects with scalp PSO at Baseline 
Change #3 
Section 4.3.1 Other efficacy variable(s) 
The following bullets: 
 IGA response (Clear)  
 Change from Baseline in the Patient Symptom Diary responses 
 Scalp-specific Investigator’s Global Assessment (scalp IGA) response (Clear or Almost 
Clear) for subjects with scalp PSO at Baseline 
Has been changed to:  
 IGA response (Clear with at least a 2-category improvement from Baseline)  
 Change from Baseline in the Patient Symptom Diary responses 
 Scalp-specific Investigator’s Global Assessment (scalp IGA) response (Clear or Almost 
Clear with at least a 2-category improvement from Baseline) for subjects with scalp PSO 
at Baseline 
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Change #4 
Section 9.11 Patient Symptom Diary responses 
A third paragraph has been added: 
The Patient Symptom Diary responses for itch, pain, and scaling at Week 16 will be 
computed based on the responder definition as well as the absolute and percent change 
from Baseline. Each of the Patient Symptom Diary response scores included in the 
statistical testing procedure (itch, pain, and scaling) will be characterized in terms of the 
cumulative percent of subjects demonstrating a pre-specified point improvement at 
Week16. The threshold for the Patient Symptom Diary response score of itch, pain, and 
scaling is 2.39, 1.98, and 2.86, respectively. The responder analysis will be limited to the 
subjects with a Baseline Patient Symptom Diary response score at or above the applicable 
threshold score (ie, at least 2.39, 1.98, and 2.86 for itch, pain, and scaling, respectively). 
Change #5 
Figure 14 1: Sequence of testing 
  
BL=Baseline; IGA=Investigator’s Global Assessment; PASI=Psoriasis Area Severity Index; PSD=Patient Symptom 
Diary; PSO=psoriasis 
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Has been changed to:  
 
BL=Baseline; IGA=Investigator’s Global Assessment; PASI=Psoriasis Area Severity Index; PSD=Patient Symptom 
Diary; PSO=psoriasis 
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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 Good Clinical Practice 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 
 
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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 Good Clinical Practice. 
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Approval Signatures
Name:
ps0009-protocol-amend-4
Version:
1. 0
Document Number:
CLIN-000134866
Title:
PS0009 Protocol Amendment 4
Approved Date:
23 May 2019
Document Approvals
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 22-May-2019 19:51:04 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 22-May-2019 19:54:05 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 23-May-2019 05:35:09 GMT+0000
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SAP_001.pdf: 
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STATISTICAL ANALYSIS PLAN  
Study: PS0009 
Product: Bimekizumab  
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-
Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult 
Subjects with Moderate to Severe Chronic Plaque Psoriasis 
 
SAP/Amendment Number Date 
Final SAP 
24 Jan 2018 
Amendment 1 
16 Aug 2018 
Amendment 2 
13 Sep 2019 
Confidentiality Statement 
Confidential 
This document is the property of UCB and may not – in full or in part – be passed on, reproduced, 
published, or otherwise used without the express permission of UCB. 
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TABLE OF CONTENTS 
LIST OF ABBREVIATIONS .................................................................................................... 7 
1 
INTRODUCTION ........................................................................................................... 10 
2 
PROTOCOL SUMMARY ............................................................................................... 10 
2.1 Study objectives ............................................................................................................... 10 
2.1.1 
Primary objective ................................................................................................. 10 
2.1.2 
Secondary objectives ........................................................................................... 10 
2.1.3 
Other objectives ................................................................................................... 10 
2.2 Study variables ................................................................................................................. 11 
2.2.1 
Efficacy variables ................................................................................................ 11 
2.2.1.1 
Primary efficacy variables ......................................................................... 11 
2.2.1.2 
Secondary efficacy variables ..................................................................... 11 
2.2.1.3 
Other efficacy variables ............................................................................. 12 
2.2.2 
Pharmacokinetic variable ..................................................................................... 13 
2.2.3 
Safety variables .................................................................................................... 13 
2.2.3.1 
Secondary safety variables ........................................................................ 13 
2.2.3.2 
Other safety variables ................................................................................ 13 
2.2.4 
Pharmacogenomic variables ................................................................................ 14 
2.2.5 
Immunological variable ....................................................................................... 14 
2.3 Study design and conduct ................................................................................................ 14 
2.3.1 
Study description ................................................................................................. 14 
2.3.2 
Study periods ....................................................................................................... 14 
2.3.2.1 
Screening Period ........................................................................................ 14 
2.3.2.2 
Initial Treatment Period ............................................................................. 15 
2.3.2.3 
Maintenance Treatment Period.................................................................. 15 
2.3.2.4 
Safety Follow-Up Period ........................................................................... 16 
2.3.2.5 
Premature End of Treatment ..................................................................... 16 
2.3.3 
Study duration per subject ................................................................................... 16 
2.3.4 
Planned number of subjects and sites .................................................................. 16 
2.3.5 
Anticipated regions and countries ....................................................................... 16 
2.4 Determination of sample size ........................................................................................... 17 
3 
DATA ANALYSIS CONSIDERATIONS ...................................................................... 17 
3.1 General presentation of summaries and analyses ............................................................ 17 
3.2 Definition of Baseline values ........................................................................................... 19 
3.3 Mapping of data from early withdrawal visits ................................................................. 19 
3.4 Protocol deviations ........................................................................................................... 20 
3.5 Analysis sets ..................................................................................................................... 20 
3.5.1 
Enrolled Set ......................................................................................................... 20 
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3.5.2 
Randomized Set ................................................................................................... 20 
3.5.3 
Safety Set ............................................................................................................. 20 
3.5.4 
Full Analysis Set .................................................................................................. 20 
3.5.5 
Active Medication Set ......................................................................................... 20 
3.5.6 
Maintenance Set ................................................................................................... 20 
3.5.7 
Per Protocol Set ................................................................................................... 20 
3.5.8 
Pharmacokinetics Per-Protocol Set ...................................................................... 21 
3.6 Treatment assignment and treatment groups ................................................................... 21 
3.7 Center pooling strategy .................................................................................................... 21 
3.8 Coding dictionaries .......................................................................................................... 22 
3.9 Relative day ..................................................................................................................... 22 
3.10 Changes to protocol-defined analyses.............................................................................. 22 
4 
STATISTICAL/ANALYTICAL ISSUES ....................................................................... 23 
4.1 Adjustments for covariates............................................................................................... 23 
4.2 Handling of dropouts or missing data .............................................................................. 23 
4.2.1 
Handling missing data for efficacy variables ...................................................... 23 
4.2.1.1 
Handling missing data for the primary efficacy variable .......................... 24 
4.2.1.2 
Handling missing data for the secondary efficacy variables ..................... 24 
4.2.1.3 
Handling missing data for the other efficacy variables ............................. 24 
4.2.1.4 
Handling missing data for subgroup analyses ........................................... 24 
4.2.1.5 
Missing data overview and summary ........................................................ 24 
4.2.1.6 
Missing data algorithms ............................................................................ 25 
4.2.2 
Handling missing data for safety variables .......................................................... 30 
4.3 Interim analyses and data monitoring .............................................................................. 30 
4.4 Multicenter studies ........................................................................................................... 31 
4.5 Multiple comparisons/multiplicity ................................................................................... 31 
4.6 Use of an efficacy subset of subjects ............................................................................... 33 
4.7 Active-control studies intended to show equivalence ...................................................... 33 
4.8 Examination of subgroups ............................................................................................... 33 
5 
STUDY POPULATION CHARACTERISTICS ............................................................. 34 
5.1 Subject disposition ........................................................................................................... 34 
5.2 Protocol deviations ........................................................................................................... 34 
6 
DEMOGRAPHICS AND OTHER BASELINE CHARACTERISTICS ........................ 34 
6.1 Demographics .................................................................................................................. 34 
6.2 Other Baseline characteristics .......................................................................................... 35 
6.3 Medical history and concomitant diseases ....................................................................... 36 
6.4 Prior and concomitant medications .................................................................................. 36 
7 
MEASUREMENTS OF TREATMENT COMPLIANCE ............................................... 37 
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8 
EFFICACY ANALYSES ................................................................................................ 39 
8.1 Statistical analysis of the co-primary efficacy variables .................................................. 39 
8.1.1 
Derivations of co-primary efficacy variables ...................................................... 39 
8.1.1.1 
Psoriasis Area and Severity Index (PASI) ................................................ 39 
8.1.1.2 
PASI90 response at Week 16 .................................................................... 40 
8.1.1.3 
Investigator’s Global Assessment (IGA) Response at Week 16 ............... 40 
8.1.2 
Primary analysis of the co-primary efficacy variables ........................................ 40 
8.1.3 
Sensitivity analyses of the co-primary efficacy variables ................................... 42 
8.1.3.1 
Sensitivity Analysis #1 .............................................................................. 42 
8.1.3.2 
Sensitivity Analysis #2 .............................................................................. 42 
8.1.3.3 
Sensitivity Analysis #3 .............................................................................. 43 
8.1.3.4 
Sensitivity Analysis #4 .............................................................................. 43 
8.1.3.5 
Sensitivity Analysis #5 .............................................................................. 43 
8.1.3.6 
Sensitivity Analysis #6 .............................................................................. 43 
8.1.3.7 
Sensitivity Analysis #7 .............................................................................. 43 
8.2 Statistical analysis of the secondary efficacy variables ................................................... 44 
8.2.1 
Derivations of secondary efficacy variables ........................................................ 44 
8.2.1.1 
PASI100 response at Week 16 .................................................................. 44 
8.2.1.2 
IGA Response at Week 16 ........................................................................ 44 
8.2.1.3 
PASI75 response at Week 4 ...................................................................... 44 
8.2.1.4 
Patient Symptom Diary (PSD) .................................................................. 44 
8.2.1.5 
Scalp IGA response at Week 16 ................................................................ 45 
8.2.1.6 
PASI90 response at Week 12 and 52 ........................................................ 46 
8.2.1.7 
IGA response at Week 12 and Week 52 .................................................... 46 
8.2.2 
Primary analysis of the secondary efficacy variables .......................................... 46 
8.2.2.1 
PASI and IGA responses ........................................................................... 46 
8.2.2.2 
Scalp IGA response ................................................................................... 47 
8.2.2.3 
Patient Symptom Diary (PSD) .................................................................. 47 
8.2.3 
Sensitivity analyses of the secondary efficacy variables ..................................... 48 
8.3 Statistical analysis of the other efficacy variables ........................................................... 48 
8.3.1 
PASI ..................................................................................................................... 49 
8.3.1.1 
PASI50, PASI75, PASI90, and PASI100 response ................................... 49 
8.3.1.2 
Time to PASI50, PASI75, PASI90, and PASI100 response during the 
Initial Treatment Period ............................................................................. 49 
8.3.1.3 
PASI score ................................................................................................. 50 
8.3.2 
Modified Nail Psoriasis Severity Index (mNAPSI) score ................................... 50 
8.3.3 
IGA response ....................................................................................................... 50 
8.3.4 
Body Surface Area (BSA) ................................................................................... 51 
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8.3.5 
Product of IGA and BSA (IGAxBSA) ................................................................ 52 
8.3.6 
Dermatology Life Quality Index (DLQI) ............................................................ 52 
8.3.7 
Patient's Global Assessment of Disease Activity (PGADA) for arthritis visual 
analog scale (VAS) .............................................................................................. 53 
8.3.8 
Patient Global Assessment of PSO score ............................................................ 54 
8.3.9 
Patient Symptom Diary (PSD) ............................................................................. 54 
8.3.10 
Health Assessment Questionnaire-Disability Index (HAQ-DI) score ................. 54 
8.3.11 
Psoriatic Arthritis Screening and Evaluation (PASE) ......................................... 55 
8.3.12 
Short Form – 36 Items Health Survey (SF-36) .................................................... 55 
8.3.13 
Euro-Quality of Life 5-Dimensions, 3 levels (EQ-5D-3L) ................................. 56 
8.3.14 
Work Productivity and Activity Impairment Questionnaire – Specific Health 
Problem (WPAI-SHP) ......................................................................................... 56 
8.4 Statistical analysis of PsA related efficacy variables ....................................................... 57 
8.4.1 
ACR20, ACR50, and ACR70 responses ............................................................. 57 
8.4.2 
Swollen and tender joint counts (66/68 joints evaluations) ................................. 58 
8.4.3 
PGADA ................................................................................................................ 58 
8.4.4 
Physician’s Global Assessment of Disease Activity (PhGADA) ........................ 58 
8.4.5 
Patient’s Assessment of Arthritis Pain VAS ....................................................... 58 
8.4.6 
HAQ-DI ............................................................................................................... 58 
8.5 Additional statistical analysis of other efficacy variables ................................................ 59 
9 
PHARMACOKINETICS AND PHARMACODYNAMICS .......................................... 61 
9.1 Pharmacokinetics ............................................................................................................. 61 
9.2 Pharmacodynamics .......................................................................................................... 61 
9.3 Immunogenicity ............................................................................................................... 62 
9.3.1 
Auto-antibodies .................................................................................................... 62 
9.3.2 
Anti-bimekizumab antibodies .............................................................................. 62 
10 SAFETY ANALYSES ..................................................................................................... 64 
10.1 Extent of exposure ........................................................................................................... 65 
10.1.1 
Exposure during the Initial Treatment Period ..................................................... 65 
10.1.2 
Exposure during the Maintenance Treatment Period .......................................... 66 
10.1.3 
Exposure during the Initial and Maintenance Treatment Period ......................... 67 
10.2 Adverse events ................................................................................................................. 68 
10.2.1 
Data considerations .............................................................................................. 68 
10.2.2 
AE Summaries ..................................................................................................... 70 
10.2.3 
Other Safety topics of interest ............................................................................. 71 
10.2.3.1 
Infections (serious, opportunistic, fungal and TB) .................................... 72 
10.2.3.2 
Malignancies ............................................................................................. 74 
10.2.3.3 
Major adverse cardiac event ...................................................................... 74 
10.2.3.4 
Neutropenia ............................................................................................... 75 
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10.2.3.5 
Suicidal Ideation and Behavior (SIB) ....................................................... 75 
10.2.3.6 
Inflammatory bowel disease ...................................................................... 75 
10.2.3.7 
Anaphylactic reaction ................................................................................ 76 
10.2.3.8 
Hepatic events and drug-induced liver injuries ......................................... 76 
10.3 Clinical laboratory evaluations ........................................................................................ 76 
10.4 Vital signs, physical findings, and other observations related to safety .......................... 79 
10.4.1 
Vital signs ............................................................................................................ 79 
10.4.2 
Physical examination ........................................................................................... 80 
10.4.3 
Electrocardiograms .............................................................................................. 80 
10.4.4 
Other safety variables .......................................................................................... 80 
10.4.4.1 
Assessment and management of TB and TB risk factors .......................... 80 
10.4.4.2 
Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) .............. 80 
10.4.4.3 
Pregnancy testing ...................................................................................... 81 
10.4.4.4 
Childbearing potential and Lifestyle ......................................................... 81 
10.4.4.5 
Patient Health Questionnaire 9 (PHQ-9) scores ........................................ 81 
11 REFERENCES ................................................................................................................ 83 
12 APPENDIX ...................................................................................................................... 84 
12.1 Appendix A: MedDRA algorithmic approach to anaphyalaxis ....................................... 84 
12.2 Appendix B: Definition of CTCAE grades ...................................................................... 86 
13 AMENDMENT(S) TO THE STATISTICAL ANALYSIS PLAN ................................. 87 
13.1 Amendment 1 ................................................................................................................... 87 
13.2 Amendment 2 ................................................................................................................. 107 
STATISTICAL ANALYSIS PLAN SIGNATURE PAGE ................................................... 121 
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LIST OF ABBREVIATIONS 
ADAb 
anti-bimekizumab antibodies 
AE 
adverse event 
AH 
Abnormal high 
AL 
Abnormal low 
ALT 
Alanine aminotransferase 
AMS 
Active Medication Set 
ANA 
Anti-nuclear antibodies 
ANCOVA 
Analysis of covariance 
AST 
Aspartate aminotransferase 
ATC 
Anatomical Therapeutic Chemical 
BKZ 
bimekizumab 
BLQ 
below level of quantification 
BMI 
body mass index 
BSA 
body surface area 
CDF 
cumulative distribution function  
CI 
confidence interval 
CMH 
Cochran-Mantel-Haenszel 
CSR 
clinical study report 
CTCAE 
Common Terminology Criteria for Adverse Events 
CV 
coefficient of variation 
DLQI 
Dermatology Life Quality Index 
DMC 
Data Monitoring Committee 
EAER 
exposure adjusted event rate 
EAIR 
exposure adjusted incidence rate 
ECG 
electrocardiogram 
eCRF 
Electronic Case Report Form 
EQ-5D-3L 
Euro-Quality of Life 5-Dimensions, 3 levels 
ES 
Enrolled Set 
eC-SSRS 
electronic Columbia Suicide Severity Rating Scale 
FAS 
Full Analysis Set 
GGT 
Gamma-glutamyltransferase 
HAQ-DI 
Health Assessment Questionnaire-Disability Index 
HLT 
High Level Term 
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ICF 
Informed consent form 
IGA 
Investigator’s Global Assessment 
IGRA 
Interferon-gamma release assay 
IMP 
investigational medicinal product 
LFT 
liver function test 
LLOQ 
lower level of quantification 
LOCF 
last observation carried forward 
MACE 
Major adverse cardiovascular events 
MAR 
missing at random 
MCID 
minimal clinically important difference 
MCMC 
Markov Chain Monte Carlo 
MCS 
Mental Component Summary 
MedDRA 
Medical Dictionary for Regulatory Activities 
MI 
multiple imputation 
mNAPSI 
modified Nail Psoriasis Severity Index 
MNAR 
missing not at random 
MS 
Maintenance Set 
nADAb 
neutralizing anti-bimekizumab antibodies 
NRI 
non-responder imputation 
OC 
Observed case 
PASE 
Psoriatic Arthritis Screening and Evaluation 
PASI  
Psoriasis Area and Severity Index 
PCS 
Physical Component Summary 
PD 
pharmacodynamics 
PEOT 
Premature end of treatment 
PF 
Physical function 
PGA 
Patient’s Global Assessment 
PGADA 
Patient's Global Assessment of Disease Activity 
PHQ-9 
Patient Health Questionnaire 
PK 
pharmacokinetics 
PK-PPS 
Pharmacokinetics Per-Protocol Set 
pp-IGA 
palmoplantar Investigator’s Global Assessment 
PPS 
Per Protocol Set 
PRO 
patient-reported outcome 
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PsA 
psoriatic arthritis 
PSD 
Patient symptom diary 
PSO 
Psoriasis 
PT 
preferred term 
Q4W 
every four weeks 
QOL 
quality of life 
RS 
Randomized Set 
SAE 
serious adverse event 
SIB 
suicidal ideation and behavior 
sc 
subcutaneously 
scalp IGA 
scalp-specific IGA 
SD 
standard deviation 
SAP 
statistical analysis plan 
SF-36 
Short Form 36 item Health Survey 
SFU 
Safety Follow-Up 
SMQ 
Standard MedDRA query 
SOC 
system organ class 
SS 
Safety Set 
TB 
tuberculosis 
TEAE 
treatment-emergent adverse event 
TNF 
Tumor necrosis factor 
ULN 
Upper limit of normal 
VAS 
visual analog scale 
WBC 
white blood cell 
WHO 
World Health Organization 
WHO-DD 
World Health Organization Drug Dictionary 
WPAI-SHP 
Work productivity and activity impairment questionnaire 
 
 
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1 
INTRODUCTION 
This statistical analysis plan (SAP) defines the scope of statistical analyses and provides a 
detailed description of statistical methodology for the statistical analyses to support the final 
clinical study report (CSR). The SAP is based on the following study document: Protocol 
Amendment 4, 21 May 2019. 
2 
PROTOCOL SUMMARY 
2.1 
Study objectives 
2.1.1 
Primary objective 
The primary objective of the study is to compare the efficacy of bimekizumab (BKZ) 
administered subcutaneously (sc) for 16 weeks versus placebo in the treatment of the subjects 
with moderate to severe chronic plaque psoriasis (PSO). 
2.1.2 
Secondary objectives 
The secondary objectives of the study are to: 
 Evaluate the efficacy of bimekizumab compared to placebo at achieving complete clearance 
Psoriasis Area and Severity Index 100 [PASI100] after 16 weeks of treatment 
 Evaluate the efficacy of bimekizumab compared to placebo after 4 weeks of treatment 
 Evaluate the efficacy of bimekizumab compared to ustekinumab after 4 weeks, 12 weeks, 16 
weeks, and 52 weeks of treatment 
 Evaluate the change in itch, pain, and scaling of bimekizumab compared to placebo after 16 
weeks of treatment as reported by subjects using the Patient Symptom Diary 
 Evaluate the change in psoriatic scalp disease of bimekizumab compared to placebo after 16 
weeks of treatment in subjects with scalp PSO at Baseline 
 Assess TEAEs, SAEs, and TEAEs leading to withdrawal adjusted by duration of subject 
exposure to study treatment  
2.1.3 
Other objectives 
The other objectives of the study are to demonstrate the effects of bimekizumab on aspects of the 
disease: 
 Assess the efficacy of bimekizumab over time 
 Assess the change of skin-related quality of life (QOL) 
 Assess the change of general health-related QOL 
 Assess the change in nail PSO over time in subjects with nail PSO at Baseline 
 Assess the change in scalp PSO over time in subjects with scalp PSO at Baseline 
 Assess the change in palmoplantar PSO over time in subjects with palmoplantar PSO at 
Baseline 
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 Assess the change in physical function (as measured by the Health Assessment 
Questionnaire-Disability Index [HAQ-DI] over time in subjects with psoriatic arthritis (PsA) 
at Baseline  
 Assess the symptoms of PsA as measured by the Psoriatic Arthritis Screening and Evaluation 
(PASE) questionnaire 
 Assess the change of patient-reported joint symptoms in subjects with PsA at Baseline 
 Assess the change in symptoms of PSO as reported by subjects using the Patient Symptom 
Diary (all items) through Week 16 
 Assess depression 
 Assess the PK of bimekizumab 
 Assess the immunogenicity of bimekizumab 
 Assess work productivity 
 Assess the effect of bimekizumab on gene and protein expression, and explore the 
relationship between genomic, genetic, and proteomic biomarkers and disease biology, drug 
treatment and inflammatory and immune responses (from consenting subjects who agree to 
participate in the biomarker substudy) 
 Assess the safety and tolerability of bimekizumab  
2.2 
Study variables 
2.2.1 
Efficacy variables 
2.2.1.1 
Primary efficacy variables 
The co-primary efficacy variables are the PASI90 response (defined as a subject that achieves 
90% reduction from Baseline in the PASI score) at Week 16 and the Investigator’s Global 
Assessment (IGA) response (defined as Clear or Almost Clear with at least a 2-category 
improvement relative to Baseline) at Week 16. 
2.2.1.2 
Secondary efficacy variables 
The secondary efficacy variables are: 
 PASI100 response at Week 16 
 IGA response (defined as Clear with at least a 2-category improvement relative to Baseline) 
at Week 16 
 PASI75 response at Week 4 
 Patient Symptom Diary responses for itch, pain, and scaling at Week 16 
 Scalp IGA response (Clear or Almost Clear with at least a two-category improvement from 
Baseline) at Week 16 for subjects with scalp PSO at Baseline 
 PASI90 response at Week 12 and 52 
 IGA response (Clear or Almost Clear with at least a two-category improvement from 
Baseline) at Week 12 and 52 
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2.2.1.3 
Other efficacy variables 
Change from Baseline variables evaluated during the Initial Treatment Period are relative to the 
Baseline (first dose) Visit. For subjects who switch treatment at the Week 16 Visit, change from 
Baseline variables during the Maintenance Treatment Period may be evaluated relative to both 
the Baseline (first dose) Visit and the Week 16 Visit. 
For simplicity, “change from Baseline” is used below for all such variables. Greater detail will 
be provided below in the Section 3.2 .  Note that PASI responder rates will always be calculated 
relative to the Baseline (first dose) Visit. 
The other efficacy variables are listed below and will be summarized for all time points specified 
in the protocol schedule of assessments, with the exception of the previously defined primary 
and secondary efficacy variables (which will be summarized separately): 
 PASI50, PASI75, PASI90, and PASI100 response 
 Time to PASI75, PASI90, and PASI100 response during the Initial Period 
 Absolute and percent change from Baseline in PASI score 
 Percent of subjects with absolute PASI score ≤1, ≤2, ≤3, and ≤5 
 IGA response (Clear with at least 2 category improvement relative to Baseline) 
 IGA response (Clear or Almost Clear with at least 2 category improvement relative to 
Baseline) 
 Shift from Baseline in IGA score 
 Absolute and percent change from Baseline in the body surface area (BSA) affected by PSO 
 Percent of subjects with absolute BSA=0%, ≤1%, ≤3%, and ≤5% 
 Absolute and percent change from Baseline in the product of IGA and BSA (IGAxBSA) 
 Change from Baseline in Dermatology Life Quality Index (DLQI) 
 Percent of subjects achieving a DLQI total score of 0 and 1 
 Percent of subjects achieving a minimal clinically important difference (improvement from 
Baseline of 4 or more) in the DLQI 
 American College of Rheumatology (ACR) 20, 50, 70% response (ACR20, 50, 70) in the 
subpopulation of subjects with PsA at Baseline 
 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 
 Change from Baseline in Patient Global Assessment of PSO score 
 Change from Baseline in the Patient Symptom Diary responses 
 Scalp-specific Investigator’s Global Assessment (scalp IGA) response (Clear or Almost 
Clear with at least a two-category improvement from Baseline) for subjects with scalp PSO 
at Baseline 
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 Change from Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) score for 
subjects with nail PSO at Baseline 
 mNAPSI75 response (defined as a subject that achieves at least a 75% reduction from 
Baseline in the mNAPSI score) 
 mNAPSI90 response (defined as a subject that achieves at least a 90% reduction from 
Baseline in the mNAPSI score) 
 mNAPSI100 response (defined as a subject that achieves a 100% reduction from Baseline in 
the mNAPSI score) 
 Palmoplantar Investigator’s Global Assessment (pp-IGA) response (Clear or Almost Clear 
with at least a two-category improvement from Baseline) for subjects with palmoplantar PSO 
at Baseline 
 Change from Baseline in the HAQ-DI for subjects with PsA at Baseline 
 Change from Baseline in the PASE questionnaire scores (function score, symptom score, and 
total score)   
 Shift from Baseline in PASE score suggestive of PsA (<47 versus ≥47) 
 Change from Baseline in Short Form 36-item Health Survey (SF-36) Physical Component 
Summary (PCS) score, and Mental Component Summary (MCS) score, and individual 
domains 
 Responses to Euro-Quality of Life 5-Dimensions, 3 levels (EQ-5D-3L), absolute and changes 
from Baseline in EQ-5D-3L VAS scores 
 Change from Baseline in Work Productivity and Activity Impairment Questionnaire-specific 
health problem (WPAI-SHP) V2.0 adapted to PSO scores  
2.2.2 
Pharmacokinetic variable 
The pharmacokinetic (PK) variable is the plasma concentration of bimekizumab.  
2.2.3 
Safety variables 
2.2.3.1 
Secondary safety variables 
The secondary safety variables include the following treatment emergent adverse events 
(TEAEs) and serious adverse events (SAEs). 
 TEAEs adjusted by duration of subject exposure to study treatment 
 SAEs adjusted by duration of subject exposure to study treatment  
 TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment 
2.2.3.2 
Other safety variables 
Safety variables to be assessed are: 
 Severity and frequency of AEs (including serious AEs) 
 Change from Baseline in vital signs 
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 Electrocardiogram (ECG) results 
 Change from Baseline in clinical laboratory values (chemistry and hematology) 
 Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) scores 
Physical examination findings considered clinically significant changes since the physical 
examination at the Screening Visit will be recorded as adverse events (AEs). 
2.2.4 
Pharmacogenomic variables 
Additional blood samples will be collected from subjects who consent to participate in the 
substudy at specific time points and stored at -80°C for up to 20 years. 
Genomic, genetic, epigenetic, proteins, and metabolite biomarkers may be measured to evaluate 
the relationship with response to treatment with bimekizumab, PSO disease biology, and 
inflammatory and immune response processes. The nature and format of these tentative substudy 
analyses will be determined when the results of the main study made available. 
The candidate exploratory variables are the blood or blood derivative (eg, serum) concentrations 
of cytokines and chemokines of relevance to interleukin-17 A/F (IL-17A/F) signaling pathway 
and PSO biology. 
Additional variables may include but will not be limited to serum complement concentrations. 
2.2.5 
Immunological variable 
The immunological variable is the anti bimekizumab antibody level prior to and following 
investigational medicinal product (IMP).  
2.3 
Study design and conduct 
2.3.1 
Study description 
PS0009 is a phase 3, multicenter, randomized, double-blind, placebo- and active comparator-
controlled study to evaluate efficacy and safety, pharmacokinetics (PK) of bimekizumab 
administered sc to subjects with 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 a candidate for ustekinumab, or for systemic PSO therapy 
and/or phototherapy. Subjects may have been previously exposed to a biologic therapy. 
2.3.2 
Study periods 
 This study will include 4 periods, a Screening Period (2 to 5 weeks), an Initial Treatment Period 
(16 weeks), a Maintenance Treatment Period (36 weeks), and a safety follow-up (SFU) Period 
(20 weeks after the final dose of IMP). The Maintenance Treatment Period starts with the first 
study drug administration on or after the Week 16 visit. After completion of the Maintenance 
Treatment Period, eligible subjects will be allowed to enroll in an open-label study. Subjects 
enrolling into the open-label study will not have the PS0009 SFU Visit. 
The assessments for each period are specified in protocol Table 5-1. 
2.3.2.1 
Screening Period 
The Screening Period will last 2 weeks, but can be extended up to a total of 5 weeks in cases 
where a laboratory assessment needs to be repeated or to allow washout of prohibited 
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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, will be verified as stable. The 
Screening Period will also enable washout of any medications not permitted for use during the 
study. Subjects who require prophylaxis for latent tuberculosis infection must be on treatment for 
at least 8 weeks prior to their first dose of IMP. These subjects may be rescreened once they have 
completed the first 8 weeks of prophylaxis treatment. 
One rescreening may be allowed after consultation with the Medical Monitor. 
2.3.2.2 
Initial Treatment Period 
During the 16-week Initial Treatment Period, approximately 560 subjects will be randomized 
4:2:1 to receive the following blinded IMP regimens: 
 Bimekizumab 320mg administered sc every four weeks (Q4W) (320 subjects) 
 Ustekinumab (160 subjects) 
 For subjects weighing ≤100kg (220lbs) at Baseline, 45mg sc initially and 4 weeks later 
 For subjects weighing >100kg (220lbs) at Baseline, 90mg sc initially and 4 weeks later 
 Placebo administered sc Q4W (80 subjects) 
Investigational medicinal product will be administered in the clinic by sc injection at the time 
points specified in the protocol Table 5-1. Subjects withdrawing early from the study will 
undergo the premature end of treatment (PEOT) Visit assessments and will enter the SFU Period. 
Subjects withdrawing early from the study will not be eligible for inclusion in the open-label 
study. 
Subjects will be followed in the double-blinded fashion. Subjects may receive placebo injections 
at certain visits in order to blind the IMP. 
Subjects will be classified as completing the initial treatment period if they complete the Week 
16 Visit without early withdrawal from the study or if they start treatment in the maintenance 
treatment period. The start of the maintenance treatment period marks the end of the initial 
treatment period.  . 
2.3.2.3 
Maintenance Treatment Period 
After the 16-week Initial Treatment Period, subjects will enter the 36-week Maintenance 
Treatment Period. The Maintenance Treatment Period will start with the first study drug 
administration on or after Week 16 and subjects will return to the clinic Q4W through Week 52. 
Treatment during the Maintenance Treatment Period will be based on initial treatment, per 
following rules: 
 Subjects in the bimekizumab 320mg treatment arm will continue to receive bimekizumab 
320mg Q4W. 
 Subjects in the ustekinumab treatment arm will continue on ustekinumab (subjects weighing 
≤100kg [220lbs] at Baseline will receive 45mg sc every 12 weeks; subjects weighing >100kg 
[220lbs] at Baseline will receive 90mg sc every 12 weeks). 
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 Subjects in the placebo arm will receive bimekizumab 320mg Q4W. 
Subjects may receive placebo injections at certain visits in order to blind the IMP. 
At the end of the Maintenance Treatment Period, all subjects enrolling in the open-label study 
will, after signing a new ICF, undergo the Week 52 study assessments and then receive their first 
dose of bimekizumab in the open-label study. All subjects not enrolling in the open-label study 
will have the Week 52 study assessments and will enter the SFU Period. 
2.3.2.4 
Safety Follow-Up Period 
All subjects not continuing in the open-label study, including those withdrawn from IMP, will 
have SFU Visit 20 weeks after their final dose of IMP. 
2.3.2.5 
Premature End of Treatment 
Subjects withdrawing early from the study will undergo PEOT Visit assessments and will enter 
the SFU Period. 
2.3.3 
Study duration per subject 
For each subject, the study will last a maximum of up to 73 weeks, as follows: 
 Screening Period: 2 to 5 weeks 
 Double-blind, placebo- and active comparator-controlled Initial Treatment Period: 16 weeks 
 Double-blind, active comparator-controlled Maintenance Treatment Period: 36 weeks 
 Safety Follow-Up Period: a SFU Visit is planned 20 weeks after the final dose of IMP (for 
subjects not enrolling in the open-label study) 
After the 36-week Maintenance Treatment Period, subjects will be allowed to enroll in an open-
label study, in which case subjects will undergo the Week 52 study assessments before receiving 
their first open-label IMP dose. The SFU Visit will not be required for subjects who enroll in the 
open-label study. 
The end of study is defined as the date of the last visit of the last subject in the study.  
2.3.4 
Planned number of subjects and sites 
Approximately 750 subjects will be screened in order to have 560 subjects randomized in the 
study. There will be approximately 320 subjects in the bimekizumab 320mg treatment arm, 160 
subjects in the ustekinumab treatment arm, and 80 subjects in the placebo treatment arm. The 
planned number of study sites is approximately 100. Every eligible subject who signs an ICF will 
be randomized. 
2.3.5 
Anticipated regions and countries 
The regions planned for study conduct are North America, Western Europe, Central/Eastern 
Europe, and Asia/Australia. 
A subset of tables, listings, and figures will be repeated for the subgroup of subjects randomized 
in Japan. A list of these outputs will be added to the TLF shells. 
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2.4 
Determination of sample size 
A total of 560 subjects will be randomly assigned in a 4:2:1 ratio to the following treatment 
groups: 
 Bimekizumab 320mg (320 subjects) 
 Ustekinumab (160 subjects) 
 Placebo (80 subjects) 
The primary efficacy analysis is based on the comparison of bimekizumab to placebo for the co-
primary efficacy variables of PASI90 response and IGA response at Week 16. However, Week 
16 comparisons of bimekizumab against ustekinumab for PASI90 response and IGA response 
will also be part of a fixed sequence testing procedure to control for multiplicity. Therefore, this 
study has been powered to show statistical superiority to ustekinumab based on the co-primary 
endpoints. 
The assumed responder rates for PASI90 at Week 16 are 75%, 58%, and 2% for bimekizumab, 
ustekinumab, and placebo, respectively. Additionally, the assumed responder rates for IGA are 
85%, 68%, and 5% for bimekizumab, ustekinumab, and placebo, respectively. The assumed 
responder rates for bimekizumab are based on the Phase 2b PS0010 data. The assumptions 
related to the responder rates for ustekinumab are based on those observed in the CLEAR study 
(Thaci et al, 2015). The power to show statistical superiority of bimekizumab relative to placebo 
under these assumptions is >99% for the co-primary endpoints. 
The power to detect a statistically significant difference between bimekizumab and ustekinumab 
at a 2-sided significance level of 0.05 is 95% for PASI90 response and 98% for IGA response. 
Because both co-primary endpoints are highly powered independently, and because PASI and 
IGA response tend to be highly correlated, the overall power for achieving superiority on both 
co-primary endpoints is not calculated here. Note that the power for the non-inferiority testing 
between bimekizumab and ustekinumab for both PASI90 and IGA responses is >99% based on a 
1-sided significance level of 0.025 and a non-inferiority margin of 10%. 
3 
DATA ANALYSIS CONSIDERATIONS 
3.1 
General presentation of summaries and analyses 
Statistical analysis and generation of tables, figures, subject data listings, and statistical output 
will be performed using SAS Version 9.3 or higher. All tables and listings will use Courier New 
font size 9.  
Descriptive statistics will be displayed to provide an overview of the study results. For 
continuous variables, descriptive statistics will include number of subjects with available 
measurements (n), mean, standard deviation (SD), median, minimum, and maximum.  
For categorical variables, the number and percentage of subjects in each category will be 
presented. Unless otherwise noted, the denominator for percentages should be based on the 
number of subjects included in the respective analysis set. Subjects with missing data will be 
accounted for using the following approaches: 
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 For summaries of demographics and Baseline characteristics: summarize percentages based 
on all subjects in the analysis set and include a “Missing” category (corresponding to subjects 
with missing data for the variable being summarized) as the last row in the list of categories 
being summarized.  
 For summaries of efficacy and safety endpoints, unless otherwise specified: summarize 
percentages based only on those subjects with observed data for the variable being 
summarized. As the denominator may be different from the number of subjects in the 
analysis set being considered, the denominator should be displayed in the table. The general 
format for displaying this will be “n/Nsub (%).” 
Percentages will be presented to 1 decimal place.  If the percentage is 100%, do not present a 
decimal. If the percentage is 0, do not present the percentage. Typically, the % sign should be 
presented in the column header, but not with each individual value. 
For bimekizumab PK concentrations, summary statistics will include geometric mean, geometric 
coefficient of variation (CV), 95% confidence intervals for geometric mean, arithmetic mean, 
SD, median, minimum, and maximum.  All summaries of PK variables will be based on the 
observed values. No imputation will be used. 
Decimal places for descriptive statistics will always apply the following rules: 
 “n” will be an integer 
 Mean, SD, and median will use one additional decimal place compared to the original data 
 CV[%] will be presented with one decimal place 
 Minimum and maximum will have the same number of decimal places as the original value. 
Derived variables in general will display the mean, SD and median to 1 more decimal place than 
the variables used in the derivation. If the number of decimal places reported in the raw data is 
varied then use either the maximum raw number of reported decimal places or 3, whichever is 
the lowest, as a guide for the descriptive statistics. 
Statistical tests of efficacy variables will be presented as two-sided p-values rounded to three 
decimal places. P-values less than 0.001 will be presented as “<0.001” and p-values greater than 
0.999 will be presented as “>0.999.” Statistical comparisons will be two-sided and will be 
performed at the 0.05 level of significance. 
A complete set of data listings containing all documented data as well as calculated data (eg, 
change from Baseline) will be generated. 
Per protocol, visit windows of ±3 days from the first dose to Week 24 and ±7 days from Week 
28 to Week 52 are permissible. For the SFU Visit, visit window is ±7 days from final dose. All 
by-visit summaries will contain nominal (i.e. scheduled) visits only. Unscheduled visits will not 
be mapped to scheduled visits except for assessments that occur within a 3-day time window of a 
scheduled visit. In that case, the assessment will be mapped to the corresponding scheduled visit 
and will be used for the analysis. This will only occur for some vendor data. 
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3.2 
Definition of Baseline values 
A Baseline value for a subject is defined as the latest measurement for that subject up to and 
including the day of administration of first study medication, unless otherwise stated. If a 
Baseline assessment is taken on the same day as first administration of study medication, it is 
eligible to be used as the Baseline value, even in the case that the time of the assessment is 
recorded as taking place after the time of first study medication administration. This is 
considered acceptable as this measurement is still the best representation of the Baseline value of 
the given assessment since it is highly unlikely that the study medication could have an impact 
on any measurement in such a short period of time. However, such cases should be rare as study 
center personnel are instructed to do all assessments at the Baseline visit prior to administering 
study medication. One exception to this rule is plasma concentration. If Baseline plasma 
concentration is measured at a time after the first administration of study medication, then it 
should not be eligible to be considered as a Baseline plasma concentration. Such cases should be 
discussed with the quantitative clinical pharmacologist. If a Baseline measurement is missing or 
not collected, and a Screening value is available, the Screening value will be utilized as Baseline 
instead.  
For subjects who switch treatment from placebo to bimekizumab at the Week 16 Visit, the 
variables listed below, will have an additional Baseline defined as the Baseline for Maintenance 
Treatment Period. Baseline for Maintenance Treatment Period is the latest measurement on/prior 
to the day of first dose in the maintenance period. 
 PASI score 
 DLQI 
 Laboratory data (only in shift tables) 
Note that for any laboratory value that occurs on the day of treatment switch, that lab value will 
be attributed and summarized for the treatment they were on previously. For subjects that switch 
treatment, the Baseline value is the laboratory value of the day of treatment switch. 
Baseline values for component scores should be computed using components from the same visit 
where the relevant measurements were recorded prior to dosing. For example, if the Screening 
visit has all of the components, but the Baseline visit is missing one or more components, the 
Baseline value for the component score should be calculated using the Screening visit values.  
 
3.3 
Mapping of data from early withdrawal visits 
If the early withdrawal visit occurs at a scheduled visit as outlined in the schedule of 
assessments, then no mapping is necessary, and any early withdrawal assessments should 
correspond to that scheduled visit. Premature study withdrawal visit assessments that occur on a 
date after a scheduled visit will be assigned to the next scheduled site visit per the protocol 
following the last visit where assessments were available. This approach means that there is a 
chance that data will be mapped to a visit where a given assessment was not actually collected 
per the protocol schedule of assessments. Such data will not be summarized in by-visit tables 
(though it will be available in the listings).  
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The only exception to the above rule is for anti-bimekizumab antibody assessments, in which all 
early withdrawal visit assessments will be assigned to the next scheduled visit at which anti-
bimekizumab antibody are assessed. All by-visit summaries will contain nominal visits only. 
Unscheduled visits will not be mapped to scheduled visits. Note that based on the early 
withdrawal mapping conventions described above, a mapped early withdrawal visit is considered 
as observed at that visit and should be summarized as such in the tables.   
3.4 
Protocol deviations 
Important protocol deviations are deviations from the protocol which potentially could have a 
meaningful impact on study conduct or on the primary efficacy, key safety, or PK outcomes for 
an individual subject. The criteria for identifying important protocol deviations will be defined 
within the appropriate protocol-specific document at study start. Important protocol deviations 
will be reviewed as part of the ongoing data cleaning process. Important protocol deviations 
including those that lead to exclusion from the analysis sets will be identified and documented 
prior to unblinding. 
3.5 
Analysis sets 
For all analysis sets, each unique subject will only be included once, even if the same subject has 
more than one unique subject identification. 
3.5.1 
Enrolled Set 
The Enrolled Set (ES) will consist of all subjects who have given informed consent. 
3.5.2 
Randomized Set 
The Randomized Set (RS) will consist of all randomized subjects. 
3.5.3 
Safety Set 
The Safety Set (SS) will consist of all subjects that received at least 1 dose of IMP. 
3.5.4 
Full Analysis Set 
The Full Analysis Set (FAS) will consist of all randomized subjects that received at least 1 dose 
of the IMP and have a valid measurement for each of the co-primary efficacy variables at 
Baseline. 
3.5.5 
Active Medication Set 
The Active Medication Set (AMS) will consist of all subjects who have received at least 1 dose 
of active IMP (bimekizumab or ustekinumab). The AMS will be used for summaries of safety 
that include all data from the initial Treatment Period and/or Maintenance Treatment Period. 
3.5.6 
Maintenance Set 
The Maintenance Set (MS) will consist of all subjects who have received at least 1 dose of active 
IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period. 
3.5.7 
Per Protocol Set 
The Per-Protocol Set (PPS) will consist of all subjects in the RS who had no important protocol 
deviations affecting the co- primary efficacy variables. Important protocol deviations will be 
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predefined and subjects with important protocol deviations will be evaluated during ongoing data 
cleaning meetings prior to unblinding of the data. 
3.5.8 
Pharmacokinetics Per-Protocol Set 
The Pharmacokinetics Per-Protocol Set (PK-PPS) will consist of randomized subjects who 
received at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration 
post-dose without important protocol deviations that would affect the concentration. 
3.6 
Treatment assignment and treatment groups 
It is expected that subjects receive treatment as randomized and hence safety analyses will be 
based on the SS, as randomized. However, if after unblinding it is determined that subjects 
randomized to placebo or ustekinumab received bimekizumab at any time, then for safety 
analyses these subjects will be reallocated to the appropriate bimekizumab treatment group, 
unless otherwise specified.  Subjects randomized to bimekizumab will only be reallocated to the 
placebo or ustekinumab treatment group if they never received bimekizumab. Subjects 
randomized to ustekinumab will only be reallocated to the placebo if they never received 
ustekinumab or bimekizumab.  
Efficacy analyses should be performed according to randomized treatment and not actual 
treatment received. 
3.7 
Center pooling strategy 
The subject treatment assignment is stratified by prior biologic exposure and region. Geographic 
regions have been categorized as North America, Western Europe, Central/Eastern Europe, and 
Asia/Australia. Below is a table of geographic regions with corresponding countries.  
Table 3‒1: 
Geographic regions and corresponding countries 
Region 
Countries 
North America 
Canada, United States 
Western Europe 
Belgium, Germany, Italy, United Kingdom 
Central/Eastern Europe 
Hungary, Poland, Russian Federation 
Asia/Australia 
Australia, Japan 
The following center pooling algorithm will be used for each geographic region: 
 If a center has 21 or more subjects, then no pooling will be done for that center. 
 Centers with fewer than 21 subjects will be ordered from largest to smallest with pooling 
proceeding in the following manner: 
 Two or more centers will be combined until the cumulative subject total is at least 21. 
 Once a pooled center has at least 21 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 21 subjects has been reached in the previous pool. 
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 If this iterative process reaches the end of the ordered list of centers where the final 
pooled center has fewer than 21 subjects, then the subjects from the centers in that pool 
will be combined with the pooled center formed in the previous iteration. 
This procedure is only to be performed within a geographic region – there will be no pooling of 
centers across regions. 
In the event that the percentage of randomized subjects is less than 10% in either of the 
Asia/Australia or Western Europe regions, the two regions will be combined as a geographic 
region stratum for efficacy modeling, so that there are no modeling convergence issues across 
efficacy variables. 
3.8 
Coding dictionaries 
All medications other than study drug will be classified by WHO Anatomical Therapeutic 
Chemical (ATC) Classification, presenting Anatomical Main Group (ATC Level 1), 
Pharmacological Subgroup (ATC level 3), and preferred term, using version SEP/2015 of the 
World Health Organization Drug Dictionary (WHO-DD), according to UCB standard operating 
procedures. 
All AEs will be classified by primary system organ class (SOC), high level term (HLT) and 
preferred term (PT) using version 19.0 of MedDRA® according to UCB Standard Operating 
Procedures.  
Previous and ongoing medical history will be classified by version 19.0 of MedDRA® SOC and 
PT. 
3.9 
Relative day 
The relative day will be included in different listings and will be calculated as follows: 
 If the start (stop) date occurred on or after the first dose, but prior to the double-blind drug 
stop date, relative day is calculated as start (stop) date minus first dose date + 1 
 If the start (stop) date occurred after the last dose of double-blind drug, the relative day to the 
most recent dose is calculated as start (stop) date minus most recent dose date. The relative 
day in this situation should be preceded by a ‘+’ 
 If the start (stop) date occurred before the first dose, the relative day is calculated as start 
(stop) date minus first dose date. The relative day in this situation should be preceded by a 
‘-‘. 
For AEs, relative days for start and stop dates will be calculated as the number of days since the 
first injection of the medication. For non-treatment emergent AEs, relative day of onset will be 
negative if the event started and stopped before the first dose. Relative day will only be 
computed for fully completed dates and will be missing for partial dates. 
3.10 
Changes to protocol-defined analyses 
The following variable was added as a secondary efficacy variable and added to the sequential 
testing procedure: 
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 IGA response (defined as Clear with at least a 2-category improvement relative to Baseline) 
at Week 16. 
For the following endpoints, the definition of response has been clarified: 
 Scalp IGA response (clear or almost clear with at least a two-category improvement from 
Baseline) for subjects with scalp PSO at Baseline 
 Palmoplantar Investigator’s Global Assessment (pp-IGA) response (clear or almost clear 
with at least a two-category improvement from Baseline) for subjects with palmoplantar PSO 
at Baseline 
The following endpoints are not listed in the protocol, but have been added to the SAP in order 
to achieve consistency with other studies from the program: 
 mNAPSI75/90/100 response (defined as a subject that achieves at least a 75%, 90% and 
100% reduction from Baseline in the mNAPSI score) 
 Percent of subjects with absolute PASI score ≤1, ≤2, ≤3, and ≤5 
 Percent of subjects with absolute BSA=0%, ≤1%, ≤3%, and ≤5% 
The following additional changes were made: 
 The calculation of nominal p-values has been added for selected other efficacy variables 
 Modifications have been made to the text regarding the multiple imputation algorithm for 
clarity 
 Change from Baseline in PHQ-9 score is listed an efficacy variable in the protocol. 
However, it is considered as a safety variable in this SAP.    
 Selected TEAE tables were added to include calculation of risk differences. 
4 
STATISTICAL/ANALYTICAL ISSUES 
4.1 
Adjustments for covariates 
The primary efficacy analyses and selected secondary analyses will be adjusted for the following 
covariates: 
 Prior biologic exposure 
 Region 
4.2 
Handling of dropouts or missing data 
4.2.1 
Handling missing data for efficacy variables 
Based on previous studies of biologics in subjects with moderate to severe chronic plaque 
psoriasis, it is expected that the number of subjects who discontinue prior to Week 16 will be 
low. For the small percentage of subjects for whom primary endpoint data are unavailable at 
Week 16, this lack of data is suggestive of an ineffective study treatment, thereby supporting the 
imputation of nonresponse. Achieving the clinical response and making it through 16 weeks of 
study treatment are both critical components of the primary outcome. Therefore, nonresponder 
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imputation (NRI) will be used as the method for handling missing data in the primary analysis 
for binary efficacy variables.  
If a subject discontinues study treatment without terminating from the study and still continues 
with scheduled assessments, all efficacy data after discontinuation of study treatment will be 
treated as missing and subject to imputation as applicable. 
4.2.1.1 
Handling missing data for the primary efficacy variable 
Missing data for co-primary efficacy variables will be imputed using NRI as primary method. 
That is, subjects with missing data at Week 16 or who discontinue treatment prior to Week 16 
will be counted as non-responders for the analysis. 
In addition, sensitivity analyses using MI-MCMC/monotone regression, MI-MCMC/reference 
based methods, last observation carried forward (LOCF), and observed case (OC) method will be 
performed which will assess the impact of different methods of handling missing data. These 
methods are described in Section 8.1.3.1 - Section 8.1.3.3. 
4.2.1.2 
Handling missing data for the secondary efficacy variables 
For secondary binary efficacy variables, missing data will be imputed using NRI as primary 
method. MI-MCMC/monotone regression and OC methods will be performed as sensitivity 
analysis. 
For secondary continuous efficacy variables, MI-MCMC/monotone regression is the primary 
method for imputing missing data. If the imputation model cannot converge, last observation 
carried forward (LOCF) will be used. OC method will be performed as sensitivity analysis. 
4.2.1.3 
Handling missing data for the other efficacy variables 
For other binary efficacy variables, missing data will be imputed using NRI as primary method. 
For other continuous efficacy variables, MI-MCMC/monotone regression method will be used to 
impute missing data as primary method. If the imputation model cannot converge, last 
observation carried forward (LOCF) will be used.  
For other ordinal variables (EQ-5D-3L, shift in IGA score, and Patient Global Assessment of 
PSO), OC method will be applied as the primary analysis method. No imputation is applied. 
For those other efficacy variables that were included in the sequence testing procedure, OC 
method will also be applied as sensitivity analysis. 
4.2.1.4 
Handling missing data for subgroup analyses 
For subgroup analyses specified in Section 4.8, NRI will be used for responder variables. Only 
descriptive statistics will be provided. 
4.2.1.5 
Missing data overview and summary 
In summary, the approaches listed below will be used in this study for handling missing data for 
efficacy variables as appropriate: 
 Non-responder imputation (NRI): Subjects who have missing data at the time point of 
interest are treated as though they did not respond to the treatment. 
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 Multiple Imputation (MI) – Markov Chain Monte Carlo (MCMC) / Monotone Regression: 
Using multiple imputation methodology, intermittent missing data are imputed based on the 
MCMC method, and monotone missing data are imputed using monotone regression. 
 MI – MCMC / Reference-based imputation: Using multiple imputation methodology, 
intermittent missing data are imputed based on the MCMC method, and monotone missing 
data are imputed using an imputation model based on placebo (reference) data. 
 Last observation carried forward (LOCF): Post-Baseline missing data are imputed by 
carrying forward the last available observation (including Baseline). 
 Observed case (OC): Missing data are not imputed. Only subjects with available data who 
have not discontinued study treatment at the given time point are considered. 
The following table depicts which missing data handling approaches should be used based on 
variable priority (primary, secondary, other) and variable type (responder, continuous, ordinal).  
Table 4‒1: 
Missing data handling approach by variable priority and type 
Variable 
Priority 
Variable Type 
NRI 
MI 
(MCMC/ 
Monotone 
Regression) 
MI 
(MCMC/ 
Reference-
based) 
LOCF 
OC 
Primary 
Responder 
P 
Sa 
Sa 
S 
S 
Secondary 
Responder 
P 
Sa 
 
 
S 
Continuous 
 
P 
 
B 
S 
Other 
Responder 
P 
 
 
 
Sb, c 
Continuouse 
 
P 
 
B 
Sb 
Ordinal 
 
 
 
 
Pd 
P=Primary method, S=Sensitivity method, B=Backup method, NRI=Nonresponder imputation, MI=Multiple 
imputation, MCMC=Markov Chain Monte Carlo, LOCF=Last observation carried forward, OC=Observed Case 
Note: Backup method is only applicable when the primary method is unable to converge due to challenges with the 
imputation model. 
a Imputation method is applied on continuous data, and responder variable is derived from the continuous variable 
based on complete data set. 
b Only applies to by-visit summaries of variables that are in the multiplicity-controlled testing procedure. 
c Includes PASI75, PASI90, PASI100, Scalp IGA, IGA responses, and PSD responder variables 
d Includes Patient Global Assessment of PSO, IGA score, and EQ-5D-3L responses 
e For PASE, OC is the primary analysis method. 
4.2.1.6 
Missing data algorithms 
MI – MCMC / Monotone Regression 
Investigators will be given discretion to discontinue study treatment for subjects not responding 
in order to provide them with alternative therapy to treat the condition. Therefore, in many cases, 
missing efficacy data due to study treatment discontinuation should be dependent on the 
observed efficacy scores, but independent of unobserved data. This would be consistent with a 
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missing at random (MAR) pattern of missingness. To investigate the efficacy results under the 
assumption of data being MAR, a multiple imputation method will be applied as follows: 
1. Create a data set, one for each treatment group (note that a separate imputation procedure 
must be invoked in SAS for each treatment group as the seed cannot be set for by groups 
beyond the first when using a by statement), of subjects with observed values and those 
needing estimation by multiple imputation. The intermittent missing PASI/IGA values in 
each data set (ie, missing values for a given subject that has available data before and after 
the missing time point) will be filled in using the MCMC method, with a total of 100 sets of 
imputations being performed. The seed used for these imputations will be 852 (note that all 
other multiple imputation procedures described in this SAP related to MCMC/Monotone 
Regression analyses will use this same seed as well). For monotone missing data (ie, where 
all subject data is missing after a given time point), monotone regression will be used to 
impute missing data. Again, this will be based on the 100 sets of imputations already created 
using the MCMC method such that there will be 100 imputation in total. In both cases, 
biologic exposure, geographic region and PASI/IGA values at Baseline and at each post-
Baseline visit (in chronological order, see additional notes below about visits to include for 
different analysis sets) will be included in the imputation model. Note that PASI scores at 
earlier visits will also be used as predictors for the model of PASI at later visits. The resulting 
data sets for each treatment arm will be combined into one complete data set based on each 
of the 100 imputations. 
Note: The imputation model will only allow continuous variables. Therefore, prior biologic 
exposure and region will be re-coded as indicator variables. For prior biologic exposure, this 
will simply be 0 for biologic-naïve subjects and 1 for biologic-exposed subjects. For region, 
which has 4 levels, one indicator variable will be defined as 0 for regions other than North 
America and 1 for North America. Two more indicator variables will be defined similarly 
replacing North America with Central/Eastern Europe, and Western Europe respectively. An 
indicator variable for Asia/Australia is not needed as the fourth region will be adequately 
represented by the other region indicator variables all being 0. In the event that the 
percentage of randomized subjects is less than 10% in either of the Asia/Australia or Western 
Europe regions, the two regions will be combined as a geographic region stratum for efficacy 
modeling, so that there are no modeling convergence issues across efficacy variables. In 
order to achieve model convergence, prior biologic exposure may be dropped from the 
model. If convergence is still not obtained, then region may also be dropped from the model.  
2. For each complete imputed data set, the dichotomous responder variable (PASI90/IGA 0 or 
1) based on the PASI/IGA scores will be computed. Each complete imputed data set will then 
be analyzed based on the stratified CMH test. 
Note: For derivation of PASI90 response, the PASI value at Week 16 in the imputed data sets 
will be compared directly to the observed Baseline PASI value to determine whether or not a 
reduction of at least 90% was achieved. If values outside of the pre-defined range of values 
for PASI (0-72) are imputed, they will be cut off as appropriate after the multiple imputation 
procedure but before deriving the responder variable. For example, an imputed PASI value of 
-0.5 would be changed to 0 before deriving the PASI90 responder variable. 
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Note: Standard rounding rules will be applied to the imputed IGA values in order to derive 
the binary IGA 0/1 responder variable. In addition, if values outside of the pre-defined range 
of values for IGA (0-4) are imputed, they will be cut off as appropriate after the multiple 
imputation procedure but before deriving the responder variable. For example, if a subject 
has an IGA score imputed as 1.4 (and assuming a Baseline IGA score of 3), this imputed 
value would be rounded down to 1, and the minimum change from Baseline of 2 would have 
been met. Therefore, this subject would be considered an IGA 0/1 responder.  
Additional ranges of values for other variables are defined in Table 4-2. 
Table 4‒2: Allowable ranges for imputation by variable  
Variable 
Minimum value 
Maximum value 
Integer values only 
PASI 
0 
72 
No 
IGA 
0 
4 
Yes 
PSD item 
0 
10 
No 
Scalp IGA 
0 
4 
Yes 
mNAPSI 
0 
130 
No 
BSA 
0 
100 
Yes 
IGAxBSA 
0 
400 
Yes 
DLQI 
0 
30 
Yes 
PGADA 
0 
100 
Yes 
HAQ-DI 
0 
3 
No 
SF-36 
0 
100 
No 
EQ-5D-3L VAS 
0 
100 
Yes 
WPAI 
dimension 
scores 
0 
100 
No for variables: “Percent work time missed 
due to problem” and “Percent overall work 
impairment due to problem”. 
Yes for variables: “Percent impairment 
while working due to problem” and “Percent 
activity impairment due to problem”. These 
two variables can only take values that are 
multiples of 10. 
PHQ-9 
0 
27 
Yes 
 
 
3. The Week 16 results from the specified statistical analysis (e.g. stratified CMH, logistic 
regression) of each of the 100 imputed data sets will be combined for overall inference using 
Rubin’s rules, which account for the uncertainty associated with the imputed values (Rubin, 
1987). This will be done using SAS PROC MIANALYZE. 
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Some key points to consider relative to the calculation of the odds ratios and corresponding 
confidence intervals are noted below: 
If stratified CMH or logistic regression are used, the estimates of the odds ratios from the logistic 
regression model in step 3 follow a log-normal distribution, and a log transformation is needed to 
normalize these estimates since the procedures for combining results from multiple imputed 
datasets are based on the assumption that the statistics estimated from each imputed dataset are 
normally distributed. Therefore, the log of the odds ratio estimates from the logistic regression 
model are used when combining into a single inference (the use of PROC MIANALYZE in step 
3). Appropriate transformations to the standard errors and p-values should also be made in order 
to get the correct confidence intervals, for the CMH test using the p-value for the general 
association the Wilson-Hilferty transformation should be used (Ratitch, 2013).  
Missing data for continuous primary or secondary efficacy variables will be imputed using MI as 
appropriate (see Table 4‒1). The MI procedure for continuous variables will be similar to that 
described above with the following differences: 1). No dichotomization will be necessary; and 2) 
the analysis model will be based on an analysis of covariance (ANCOVA) model. 
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 also be 
similar to that described above with the following differences: 1) No dichotomization will be 
necessary; 2) instead of using the stratified CMH test or logistic regression, 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, min and max, 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. This is the same approach that will be used when summarizing continuous secondary 
efficacy variables by subgroup.  
Further details about imputation for different analysis sets are provided below: 
 Randomized Set – When programming multiple imputation based on the RS, PROC MI will 
be used with a separate data set for each of the 3 randomized treatment groups (Placebo, 
Bimekizumab 320mg Q4W, Ustekinumab). For Bimekizumab 320mg Q4W and 
Ustekinumab, include all scheduled assessment visits from Baseline to Week 52. For 
Placebo, include all scheduled assessment visits from Baseline to Week 16.  
 Maintenance Set – When programming multiple imputation based on the MS, PROC MI will 
be used with a separate data set for each of the 3 randomized treatment groups (Placebo, 
Bimekizumab 320mg Q4W, Ustekinumab) including all scheduled assessment visits from 
Baseline to Week 52.  
 
MI – MCMC / Reference-based imputation 
In this case, placebo will be described as the reference arm.  
This procedure will use an imputation model developed based on data from the placebo group 
only (Mallinckrodt, 2013). Reference-based multiple imputation assumes that the statistical 
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behavior of the bimekizumab and placebo-treated subjects after discontinuing study medication 
becomes that of the placebo-treated subjects. All time points after discontinuation of the double-
blind study treatment for both the bimekizumab and placebo groups will be considered missing. 
Multiple imputations are used to replace missing outcomes for bimekizumab- and placebo-
treated subjects who discontinued using multiple draws from the posterior predictive distribution 
estimated from the placebo arm. For binary efficacy variables (eg, PASI90 at Week 16), 
imputation will be done on the raw PASI before assessing the imputed results for PASI90 
response. 
The steps for the procedure are as follows: 
1. For non-monotone (intermittent) missing data, MCMC will be used to impute PASI, with 
biologic exposure, geographic region, and PASI values at Baseline and at each post-
Baseline visit (in chronological order, as described in the MCMC step in the previous 
missing data algorithm) being included in the imputation model. This will be done only 
once for each subject in order to provide a dataset with monotone missing data. 
2. Data will be processed sequentially by repeatedly calling SAS® PROC MI to impute 
missing outcome data at visits t=1,…. T, where T is Week 16 for PASI90 or IGA (as the 
reference arm (placebo) dataset created in Step 1 only includes assessments from 
Baseline to Week 16, data cannot be imputed beyond Week 16 in Step 2).. 
a. Initialization. Set t=1 (Baseline visit) 
b. Iteration. Set t=t+1. Create a data set combining records from bimekizumab- and 
placebo-treated subjects with columns for covariates (prior biologic exposure and 
geographic region) and outcomes at visits 1 to t. Outcomes for all bimekizumab-
treated subjects are set to missing at visit t and set to observed or previously 
imputed values at visits 1 to t-1. Outcomes for placebo-treated subjects are set to 
observed at visit t or observed or previously imputed values at visits 1 to t-1. 
c. Imputation. Run MCMC to impute missing values for visit t using previous 
outcomes for visits 1 to t-1, prior biologic exposure, and geographic region. Note 
that only placebo data will be used to estimate the imputation model since no 
outcome is available for bimekizumab-treated subjects at visit t. 
d. Repeat steps 2a-2c, 100 times with different seed values (seeds ranging from 853 
to 952) to create 100 imputed complete data sets. 
e. Analysis. For each completed data set, the outcome (response or change from 
Baseline) will be calculated using the complete datasets (with no missing data). 
3. Each complete imputed data set will then be analyzed based on the statistical model 
specified in this study (stratified CMH test). The Week 16 results from stratified CMH 
test of each of the 100 imputed data sets will be combined for overall inference using 
Rubin’s rules, which account for the uncertainty associated with the imputed values 
(Rubin, 1987). This will be done using SAS PROC MIANALYZE 
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4.2.2 
Handling missing data for safety variables 
For analyses of AEs and concomitant medication usage, a complete date must be established in 
order to correctly identify the AE or medication as occurring during treatment or not. For 
purposes of imputing missing components of partially-reported start and stop dates for AEs and 
for medication use, the algorithms listed below will be followed. Start and stop dates of AEs or 
concomitant medication will be displayed as reported in the subject data listings (i.e., no imputed 
values will be displayed in data listings). 
Partial AE and concomitant medication start dates will be imputed as follows: 
Imputation of Partial Start Dates 
 If only the month and year are specified and the month and year of first dose is not the same 
as the month and year of the start date, then use the 1st of the month 
 If only the month and year are specified and the month and year of first dose is the same as 
the month and year of the start, then use the date of first dose 
 If only the year is specified, and the year of first dose is not the same as the year of the start 
date, then use the 1st of January of the year of the start date 
 If only the year is specified, and the year of first dose is the same as the year of the start date, 
then use the date of first dose 
 If the start date is completely unknown and the stop date is unknown or not prior to the date 
of first dose, then use the date of first dose. 
Imputation of Partial Stop Dates 
 If only the month and year are specified, then use the last day of the month 
 If only the year is specified, then use December 31st of that year 
 If the stop date is completely unknown, do not impute the stop date. 
In the event of ambiguity or incomplete data which makes it impossible to determine whether a 
medication was concomitant or an adverse event was treatment emergent, the medication will be 
considered as concomitant or the adverse event will be considered treatment emergent. 
4.3 
Interim analyses and data monitoring 
After the final Week 52 visit, an interim analysis will be performed and a corresponding interim 
clinical study report (CSR) may be written. A final analysis and updated final CSR will be 
prepared once all data (through the safety follow-up (SFU) visit) have been collected.  
In addition, an independent Data Monitoring Committee (DMC) will periodically review and 
monitor the safety data from this study and advise UCB. 
Cardiovascular and Neuropsychiatric Adjudication Committees will also periodically review and 
monitor relevant safety data from this study and advise UCB. Details will be provided in the 
DMC Charter and in the Adjudication Committee Charters. 
Further details related to the DMC will be outlined in a separate analysis plan. 
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4.4 
Multicenter studies 
The center-by-treatment interaction will be tested by replacing region with center in the logistic 
regression model used for the sensitivity analysis (Section 8.1.3.6) and adding a center-by-
treatment interaction term (Section 8.1.3.7). In the model, center will be based on the original 
centers prior to pooling (Section 3.7). However, if the model is unable to converge due to a low 
number of subjects at a given center, a pooling by center will be applied in order to allow the 
model to converge. If convergence is still not achieved a pooling by region will be applied. If 
convergence still cannot be achieved, this analysis will not be performed. Detailed strategy in the 
Section 3.7 will be applied in order to allow the model to converge. 
4.5 
Multiple comparisons/multiplicity 
The statistical analysis of the co-primary efficacy variables 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, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15, H16, H17 and H18) 
comparing bimekizumab vs. placebo or bimekizumab vs. ustekinumab will be tested at a 2-sided 
alpha level of 0.05. The pairwise comparisons will follow the sequential testing sequence in 
Figure 4‒1  and the formal evaluation of statistical significance of each comparison is dependent 
upon the previous comparison achieving statistical significance at the 5% 2-sided level. 
The first 2 hypotheses (H1 and H2) test whether bimekizumab is superior to placebo for PASI90 
response and IGA response at Week 16. These are the hypothesis tests corresponding to the co-
primary endpoints. If both 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 secondary efficacy endpoints and are 
based on testing for non-inferiority/superiority relative to ustekinumab or for superiority relative 
to placebo. Note that while subjects randomized to ustekinumab may receive either the 45mg or 
90mg dose (according to weight at Baseline), all subjects randomized to ustekinumab will be 
analyzed as a single group (and not broken out by dose) since the proposed strategy is consistent 
with the recommended weight-based dosing for ustekinumab. See Figure 4‒1 for details on this 
procedure. 
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Figure 4‒1: Sequence of testing 
 
 
BL=Baseline; IGA=Investigator’s Global Assessment; PASI=Psoriasis Area Severity Index, PSD=patient symptom 
diary; PSO=psoriasis; Q4W=every 4 weeks; Q8W=every 8 weeks. 
 
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4.6 
Use of an efficacy subset of subjects 
The primary efficacy analysis (described in Section 8.1.2 ) will be repeated based on the FAS 
and PPS as a sensitivity analysis.  
4.7 
Active-control studies intended to show equivalence 
A non-inferiority margin of 10% has been selected as this is considered to be a clinically relevant 
difference that could influence the choice of interventions used to treat chronic plaque PSO. 
4.8 
Examination of subgroups 
Subgroup analyses will be performed on the PASI75/90/100 and IGA. The following subgroups 
for analysis will be determined using Baseline data:  
 Age (<40 years, 40 to <65 years, ≥65 years) 
 Gender (male, female) 
 Disease duration (<median, ≥median) 
 Region (North America [Canada, USA], Western Europe [Belgium, Germany, Italy, United 
Kingdom], Central/Eastern Europe [Hungary, Poland, Russian Federation], Asia/Australia 
[Australia, Japan]) 
 Weight (≤100 kg, >100 kg) 
 BMI (<25 kg/m2, 25 to <30 kg/m2, ≥30 kg/m2) 
 Prior systemic chemotherapy or phototherapy (yes, no) 
 Prior biologic exposure (yes, no) 
 Prior systemic therapy of any kind (yes, no) 
 Baseline disease severity (PASI<20, PASI≥20)  
 Antibody positivity (confirmatory assay: negative or positive) 
Antibody positivity is the only subgroup that is not determined by Baseline data. It will be 
presented in a separate table. 
The definition of prior systemic therapy of any kind is if a subject received previous biologic 
therapy, previous systemic therapy (non-biologic), or previous systemic chemotherapy or 
phototherapy. Subjects who never received previous biologic therapy, previous systemic therapy 
(non-biologic), or previous systemic chemotherapy or phototherapy will be classified as not 
receiving prior systemic treatment for psoriasis.  
In addition, in order to assess whether an early response to treatment is predictive of response at 
later time points, subgroup analyses will be performed for the RS on PASI90/100 and IGA over 
time using the following early response subgroups: 
 PASI75 response (OC) at Week 4 (yes, no) to predict PASI90/100 and IGA (NRI) through 
Week 52 
 PASI90 response (OC) at Week 16 (yes, no) to predict PASI100 (NRI) through Week 52 
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All summaries will be based on imputed data as appropriate and will include descriptive statistics 
only.  
5 
STUDY POPULATION CHARACTERISTICS 
5.1 
Subject disposition 
Summaries of reasons for screen failures (for all subjects screened), disposition of subjects (for 
all subjects screened), disposition of analysis sets (for RS), disposition and discontinuation 
reasons in Initial Treatment Period (for RS) and in Maintenance Treatment Period (for MS), as 
well as the subjects who discontinued due to AEs in Initial Treatment Period (for RS) and in 
Maintenance Treatment Period (for MS) will be produced. The disposition of subjects for all 
subjects screened will include the number of subjects included in each analysis set (RS, SS, FAS, 
AMS, MS, PPS, and PK-PPS) overall and by site. 
The following listings for subject disposition will be provided: subjects who did not meet study 
eligibility criteria (all subjects screened), subject disposition (all subjects screened), study 
discontinuation (RS), visit dates (RS), subjects excluded from efficacy analysis (RS).  
5.2 
Protocol deviations 
A summary, using the RS, displaying the number and percentage of subjects with an important 
protocol deviation (including a summary of subjects excluded from the PPS or PK-PPS due to 
important protocol deviations) by treatment group and in Initial Treatment Period and in 
Maintenance Treatment Period will be provided. 
A by-subject listing of important protocol deviations will be provided. 
6 
DEMOGRAPHICS AND OTHER BASELINE 
CHARACTERISTICS 
All summaries detailed in this section will be performed on the RS by treatment group. 
Summaries for demographics and other Baseline characteristics will also be repeated in SS and 
MS. If the RS and SS analysis sets are identical the summaries will not be repeated. 
6.1 
Demographics 
Demographic variables will be summarized by treatment group and overall. 
The following continuous variables will be summarized using descriptive statistics (number of 
subjects, mean, SD, minimum, median and maximum). 
 Age at the time of study entry (years) 
 Height (cm) 
 Weight (kg) 
 BMI (kg/m2)  
BMI (kg/m2) will be calculated as: 
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BMI = Weight (kg)
(Height (m))2 
 
The following categorical variables will be summarized using frequency counts and percentages. 
 Age group (18-<65, 65-<85, ≥85 years) 
 Age group (≤18, 19-<65, ≥65 years)  
 Age group (<40, 40-<65, ≥65 years) 
 Body weight (≤100 kg, >100 kg) 
 Gender 
 Race 
 Ethnicity  
 BMI (<25 kg/m2, 25 to <30 kg/m2, ≥30 kg/m2) 
By-subject listings of demographics for all subjects screened will be provided. 
6.2 
Other Baseline characteristics 
Baseline characteristics (including Baseline clinical measures) will be summarized by treatment 
group and overall. 
Generally, the following continuous variables will be summarized using descriptive statistics 
(number of subjects, mean, SD, minimum, median and maximum). 
 Psoriasis Body Surface Area (BSA; %) 
 Psoriasis Area and Severity Index (PASI) score 
 Modified Nail Psoriasis Severity Index (mNAPSI) total score 
 Modified Nail Psoriasis Severity Index (mNAPSI) total score for subjects with nail 
involvement (i.e. mNAPSI>0) 
 Patient Global Assessment of Disease Activity (PGADA) for arthritis visual analogue scale 
(VAS) score 
 Dermatology Life Quality Index (DLQI) total score 
 Duration of disease (years) 
Duration of disease (years) will be calculated as: 
 
Disease Duration = (Date of randomization −Date of onset of Plaque Psoriasis1)
365.25
 
 
1If the date of onset of plaque psoriasis is partial, it should be imputed to the most recent feasible 
date (ie, last day of the month if only day is missing, or the last day of the year if day and month 
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are missing). Note that if the date of randomization is missing then the duration of disease will be 
derived using the date of screening.  
The following categorical variables will be summarized using frequency counts and percentages. 
 Region (North America [Canada, USA], Western Europe [Belgium, Germany, Italy, United 
Kingdom], Central/Eastern Europe [Hungary, Poland, Russian Federation], Asia/Australia 
[Australia, Japan]) 
 Country 
 Duration of disease (<median, ≥median) 
 Investigator’s Global Assessment (IGA) score 
 Baseline disease severity (PASI<20, PASI≥20)   
 Nail involvement (yes, no) 
 Scalp involvement (yes, no) 
 Palmoplantar involvement (yes, no) 
 Prior biologic therapy (yes, no) 
 Prior primary failure to biologic (yes/no) 
 Prior anti-TNF therapy (yes, no) 
 Prior phototherapy or chemotherapy (yes, no) 
 Any prior systemic therapy (yes, no) 
 PSD item scores: Pain, Itch, Scaling 
Baseline nail, scalp, and palmoplantar involvement are based on the number of subjects 
achieving mNAPSI>0, Scalp IGA>0, and pp-IGA>0, respectively. The categorization of whether 
or not subjects received prior biologic therapy will be based on the Psoriasis Treatment History 
CRF module. Prior anti-TNFs include etanercept, adalimumab, infliximab, certolizumab pegol, 
and golimumab. 
By-subject listings of Baseline characteristics will be provided. 
6.3 
Medical history and concomitant diseases 
Previous and ongoing medical history will be summarized by treatment groups, system organ 
class (SOC) and preferred term (PT) using MedDRA®. Medical procedures are not coded.  
The following listings for medical history and concomitant diseases will be provided: medical 
history, psoriasis history, concomitant medical procedures, previous and ongoing medical history 
glossary, previous and ongoing medical history conditions, and procedure history.  
6.4 
Prior and concomitant medications 
Medication start and stop dates will be compared to the date of first dose of treatment to allow 
medications to be classified as either Prior or Concomitant. 
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Details of imputation methods for missing or partial dates are described in Section 4.2.2. 
Prior medications include any medications that started prior to the start date of study medication.  
Concomitant medications are medications taken at least one day in common with the study 
medication dosing period.  
The number and percentage of subjects taking prior medications (excluding past psoriasis 
medications) will be summarized by treatment group, overall and by Anatomical Therapeutic 
Chemical classification (ATC) class, presenting Anatomical Main Group (ATC Level 1), 
Pharmacological Subgroup (ATC level 3), and preferred term. The number and percentage 
taking concomitant medications will be summarized similarly.  
Past psoriasis medications will be captured separately and will also be summarized by treatment 
group. These medications are not subject to dictionary coding. In addition, subjects who failed 
past psoriasis biologic treatment will be summarized by reason of failure as captured on the 
Psoriasis Treatment History CRF module.  
By-subject listings of all Prior and Concomitant medications, prior and concomitant medications 
glossary, and psoriasis treatment history will be provided.    
7 
MEASUREMENTS OF TREATMENT COMPLIANCE 
Due to the method of administration of the treatments, compliance will be examined in terms of 
completed injections. 
Treatment compliance will be calculated as: 
 
total number of completed injections
total number of expected injections  ×  100% 
 
where the total number of expected injections is derived relative to when the subject finishes 
treatment.  In this study, Baseline visit and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 are 
dosing visits. Two injections are administered at each given visit either with active dosing or 
placebo injection. It is expected that a subject should complete total 26 injections by the end of 
study. If a subject discontinues early, then the number of expected injections is based on the time 
of early discontinuation relative to the dosing visits. For example, if a subject discontinues after 
Week 8 visit and prior to Week 12 visit, the total number of expected injections will be 6. 
A summary of percent treatment compliance categorized as <75% and >≥75% will be provided 
by treatment group and study periods (Initial Treatment Period for the SS, Maintenance 
Treatment Period for the MS, and the Initial and Maintenance Treatment Period for the AMS). 
A by-subject listing of treatment compliance will be provided. 
 
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Table 7‒1: 
Dosing scheme 
Week 
Dose Assignment 
Baseline 
(first dose) 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
Bimekizumab 320mg Q4W 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
Ustekinumab 45mg 
(subjects ≤100kg) 
▲○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
Ustekinumab 90mg 
(subjects >100kg) 
▲▲ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
Placebo/ bimekizumab 
320mg Q4W 
○○ 
○○ 
○○ 
○○ 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
Q4W=every 4 weeks 
Notes: A bimekizumab 160mg injection is depicted by a black circle (●). A placebo injection is depicted by a white circle (○). A ustekinumab 45mg injection is 
depicted by a black triangle (▲). 
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8 
EFFICACY ANALYSES 
All efficacy analyses will be performed on the RS unless otherwise specified. All efficacy 
summary tables will be displayed by treatment group unless otherwise specified. 
8.1 
Statistical analysis of the co-primary efficacy variables 
8.1.1 
Derivations of co-primary efficacy variables 
8.1.1.1 
Psoriasis Area and Severity Index (PASI) 
PASI90 is defined to be equal to 1 if the percentage improvement from Baseline in the PASI 
scores is 90% or greater and 0 if the percentage improvement from Baseline is less than 90%. 
This definition is introduced for the purpose of identifying subjects who respond to the treatment 
(1 = responder, 0 = non-responder). 
PASI scoring of psoriatic plaques is based on three criteria: redness (R), thickness (T), and 
scaliness (S). Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 
4 for very marked involvement). The body is divided into four areas comprising the head (h), 
upper extremities (u), trunk (t), and lower extremities (l). In each of these areas, the fraction of 
total surface area affected is graded on a 0-6 scale (0 for no involvement; up to 6 for 90% - 100% 
involvement). 
The various body regions are weighted to reflect their respective proportion of BSA. The 
composite PASI score is then calculated by multiplying the sum of the individual-severity scores 
for each area by the weighted area-of-involvement score for that respective area, and then 
summing the four resulting quantities as follows (note for R, T, and S scores are as follows: 0 = 
none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked):  
PASI = (0.1 × (Rh + Th + Sh) × Ah) + (0.2 × (Ru + Tu + Su) × Au)
+ (0.3 × (Rt + Tt + St) × At) + (0.4 × (Rl + Tl + Sl) × Al) 
where  
Rh, Ru, Rt, Rl = redness score of plaques on the head, upper extremities, trunk, and lower 
extremities, scored 0-4 respectively;  
Th, Tu, Tt, Tl = thickness score of plaques on the head, upper extremities, trunk, and lower 
extremities, scored 0-4 respectively;  
Sh, Su, St, Sl = scaliness score of plaques on the head, upper extremities, trunk, and lower 
extremities, scored 0-4 respectively;  
Ah, Au, At, Al = numerical value translation of % area of psoriatic involvement score for the 
head, upper extremities, trunk, and lower extremities, respectively (where 0 = 0% [clear], 1 = 
>0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to <90%, and 6 
= 90% to 100%). 
The highest potential PASI score is 72 for severe disease; the lowest is 0 for no psoriasis lesions. 
PASI scores are treated as continuous. The percent improvement in PASI scores from Baseline 
will be computed as:  
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Percent improvement from Baseline = 100 × Baseline PASI −Post Baseline PASI
Baseline PASI
 
If a subject has experienced an improvement, this measure will be positive. If a subject has 
experienced a worsening in their condition, this measure will be negative.  
If a subject is missing 1 or 2 severity measurements for a certain region, the average of the 
remaining severity measurement(s) within that region will be utilized to substitute for the 
missing severity measurement(s) in that region. If the area of affected skin and/or all severity 
measurements for up to 2 regions are missing, then the missing (R+T+S) x A for a region will be 
substituted by the average of the available (R+T+S) x A. Otherwise, the PASI will be set to 
missing. 
8.1.1.2 
PASI90 response at Week 16  
A categorical response variable, PASI90 at Week 16 is defined to be equal to 1 if the percentage 
improvement from Baseline to Week 16 in the PASI scores is 90% or greater and 0 if the 
percentage improvement from Baseline to Week 16 is less than 90%. This definition is 
introduced for the purpose of identifying subjects who respond to the treatment (1 = responder, 0 
= non-responder).  
8.1.1.3 
Investigator’s Global Assessment (IGA) Response at Week 16 
A static IGA for psoriasis will be used to assess disease severity in all subjects during the study. 
The Investigator will assess the overall severity of psoriasis using the following five-point scale: 
Table 8‒1: 
Investigator’s Global Assessment 
Score 
Short Descriptor 
Definition 
0 
Clear 
No signs of psoriasis; post-inflammatory hyperpigmentation may be 
present 
1 
Almost clear 
No thickening; normal to pink coloration; no to minimal focal 
scaling 
2 
Mild 
Just detectable to mild thickening; pink to light red coloration; 
predominately fine scaling 
3 
Moderate 
Clearly distinguishable to moderate thickening; dull to bright red, 
clearly distinguishable to moderate thickening; moderate scaling 
4 
Severe 
Severe thickening with hard edges; bright to deep dark red 
coloration; severe/coarse scaling covering almost all or all lesions 
IGA response is defined as clear [0] or almost clear [1] with at least a two-category improvement 
from Baseline at Week 16.  
8.1.2 
Primary analysis of the co-primary efficacy variables 
The co-primary efficacy variables for this study are PASI90 response and IGA response at Week 
16, and the corresponding analyses are based on the RS. A subject will be classified as a PASI90 
responder if the PASI score at Week 16 has improved at least 90% from Baseline, and IGA 
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responder is any subject with a score of 0 or 1 (Clear or Almost Clear) with at least a 2-category 
improvement from Baseline to Week 16 in IGA score.   
The primary analysis will be based on the stratified Cochran-Mantel-Haenszel (CMH) test where 
region and prior biologic exposure (yes/no) will be used as stratification variables. For the 
assessment of noninferiority, a noninferiority margin of 10% will be used and evaluated based on 
the confidence interval for the stratified Cochran Mantel-Haenszel risk difference between 
bimekizumab and ustekinumab. 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. The evaluation of superiority 
to placebo will use pairwise treatment comparisons based on the CMH test using the p-value for 
the general association. The odds ratio and associated confidence interval (CI) based on the Wald 
test will be presented. If one of the treatment groups has 0 or very low response where CMH can 
no longer be used, the logit method will be applied instead. 
To calculate the stratified Mantel-Haenszel risk difference, the method of Greenland and Robins 
(1985) is used. For each combination of strata, a 2x2 table of treatment group and response is 
created. A theoretical 2x2 table for a given stratum is shown below, where n = a+b+c+d. 
Treatment Group 
Response 
Yes 
No 
Bimekizumab 
a 
c 
Ustekinumab 
b 
d 
 
Given that structure, the stratified Mantel-Haenszel risk difference, standard error, and two-sided 
(1-α)*100% confidence interval may be written as follows: 
𝑅𝐷𝑀𝐻=
∑((𝑎𝑖∗(𝑏𝑖+ 𝑑𝑖)/𝑛𝑖) −(𝑏𝑖∗(𝑎𝑖+ 𝑐𝑖)/𝑛𝑖)
𝑖
∑((𝑎𝑖+ 𝑐𝑖) ∗(𝑏𝑖
𝑖
+ 𝑑𝑖))/𝑛𝑖
 
 
𝑆𝐸𝑀𝐻= √
∑{[𝑎𝑖∗𝑐𝑖∗(𝑏𝑖+ 𝑑𝑖)3] + [𝑏𝑖∗𝑑𝑖∗(𝑎𝑖+ 𝑐𝑖)3]
(𝑎𝑖+ 𝑐𝑖) ∗(𝑏𝑖+ 𝑑𝑖) ∗𝑛𝑖
2
}
𝑖
{∑[(𝑎𝑖+ 𝑐𝑖) ∗(𝑏𝑖+ 𝑑𝑖)
𝑛𝑖
]
𝑖
}
2
 
 
𝐶𝐼𝑀𝐻= 𝑅𝐷𝑀𝐻± probit(1 −(𝛼2
⁄ )) ∗𝑆𝐸𝑀𝐻 
 
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For the assessment of non-inferiority of bimekizumab to ustekinumab, the lower 97.5% confidence limit 
for the stratified Mantel-Haenszel risk difference will be considered. If that value is greater than -10%, 
then non-inferiority will have been established. 
 
Non-responder imputation 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 co-primary efficacy variables at the Week 16 time point will be considered as a non-
responder. 
The number and percentage of subjects who are PASI90 responders at Week 16 will be 
summarized. IGA response will be summarized in the same manner as PASI90 responder 
variable.  
A line plot of the percentage improvement from Baseline in PASI score over time by treatment 
group will be produced.  
By-subject listings of PASI and IGA responder variables, PASI and IGA data will be provided. 
8.1.3 
Sensitivity analyses of the co-primary efficacy variables 
The following sensitivity analyses for the co-primary efficacy variables will be performed to 
evaluate the assumptions related to the handling of missing data: 
8.1.3.1 
Sensitivity Analysis #1 
Missing data will be addressed by using MI (Markov-Chain Monte Carlo [MCMC] method for 
intermittent missing data, followed by monotone regression for monotone missing data, see 
Section 4.2.1.6 ) to evaluate the effect of the method for handling missing data on the analysis. 
The actual PASI/IGA 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 (MAR) pattern of 
missingness and corresponds to an estimand of the difference in outcome improvement if all 
subjects tolerated or adhered to treatment (Mallinckrodt et al, 2012). This is an estimand of 
efficacy to evaluate the de jure hypothesis. 
8.1.3.2 
Sensitivity Analysis #2  
Deviations from the MAR pattern assumed above will be evaluated. A sensitivity analysis will 
be performed in which, as with the above analysis, intermittent missing data will be imputed 
using MI based on the MCMC method. However, the remaining monotone missing data will be 
assumed to follow a missing not at random (MNAR) pattern. These data will be imputed using 
reference-based imputation in which the imputation model is based on data from placebo group 
(see Section 4.2.1.6 ), thereby assuming that monotone missing data follow a trajectory similar to 
the placebo group (Mallinckrodt et al, 2012). As specified in the previous procedure, actual 
PASI/IGA scores will be imputed and then dichotomized to get the response status. The 
treatment differences for each imputed data set will subsequently be evaluated using the 
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stratified CMH test as used in the primary analysis. The estimand in this procedure is the 
difference in outcome improvement in all randomized subjects at the planned endpoint of the 
study attributable to the initially randomized medication (Mallinckrodt et al, 2012). This is an 
estimand of effectiveness to evaluate the de facto hypothesis. 
8.1.3.3 
Sensitivity Analysis #3  
This sensitivity analysis will be based on observed data at Week 16. Subjects with missing data 
or who have prematurely discontinued IMP will be treated as missing (see Section 4.2.1.6 ). The 
same stratified CMH test as in the primary efficacy analysis will be used.        
8.1.3.4 
Sensitivity Analysis #4  
The primary efficacy analyses from Section 8.1.2 will be repeated using LOCF as the imputation 
method (see Section 4.2.1.5). 
8.1.3.5 
Sensitivity Analysis #5  
The primary efficacy analyses from Section 8.1.2 will be repeated based on the FAS and the 
PPS.  
8.1.3.6 
Sensitivity Analysis #6  
As a sensitivity analysis to the primary analysis method, logistic regression based on the RS will 
be used. The odds ratio of the responder rates at Week 16 will be estimated and tested between 
treatment groups using a logistic regression model with factors of treatment group, region, and 
prior biologic exposure (yes/no). The odds ratio, associated confidence interval (CI), and p-value 
based on the Wald test will be presented. If the logistic regression model is unable to converge, 
then prior biologic exposure may be dropped from the model to facilitate convergence. If the 
model is still unable to converge, then region may be removed from the model as well. In 
addition, if the logistic regression model cannot converge, then Fisher’s exact test will be used 
for inferential comparisons. As with the primary analysis, missing data will be handled using 
NRI. 
8.1.3.7 
Sensitivity Analysis #7 
The center-by-treatment interaction will be tested by replacing region with center in the logistic 
regression model described in Section 8.1.3.6  and adding a center-by-treatment interaction term. 
In the model, center will be based on the original centers prior to pooling. However, if the model 
is unable to converge due to a low number of subjects at a given center, a pooling (see 
Section 3.7) will be described in order to allow the model to converge. In order to obtain 
reasonable estimates of variability for a treatment arm at a given center, a minimum of 21 
subjects will be considered acceptable for a center to be included in the model without pooling. 
Given the 4:2:1 randomization allocation scheme, this should provide a minimum of about 12 
subjects in the bimekizumab arm, 6 subjects in the ustekinumab arm, and 3 subjects in the 
placebo arm. Centers with fewer than 21 subjects will be eligible for pooling. The pooling 
algorithm used is described in Section 3.7. 
In order to achieve model convergence, other explanatory variables e.g. other prior biologic 
exposure may be dropped from the model as for the logistic regression with region. 
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If the center-by-treatment interaction is not found to be significant (α=0.10), then no further 
analyses will be performed. On the other hand, if the interaction is significant, further analyses 
will be conducted to determine which center or centers may be the source of interaction. This 
will be done by running the logistic regression model (including the interaction term) where each 
center will be systematically removed from the model. This impact of a given center will be 
based on the change in the interaction p-value when that center is removed. The center or centers 
that appear to be driving the significant interaction effect will then be removed from the model to 
verify that conclusions remain the same with or without the influential center(s). This sensitivity 
analysis will be based on RS with NRI for missing data.  
8.2 
Statistical analysis of the secondary efficacy variables 
8.2.1 
Derivations of secondary efficacy variables 
8.2.1.1 
PASI100 response at Week 16  
A categorical response variable, PASI100 at Week 16 is defined to be equal to 1 if the 
percentage improvement from Baseline to Week 16 in the PASI scores is 100% and 0 if the 
percentage improvement from Baseline to Week 16 is less than 100%. This definition is 
introduced for the purpose of identifying subjects who respond to the treatment (1 = responder, 0 
= non-responder). The definition of percentage improvement from Baseline is given in 
Section 8.1.1.1. 
8.2.1.2 
IGA Response at Week 16  
A categorical response variable, IGA response (Clear with at least 2-category improvement from 
Baseline) is defined as an IGA score of zero (Table 8-1) with at least 2-category improvement 
from Baseline. 
8.2.1.3 
PASI75 response at Week 4  
A categorical response variable, PASI75 at Week 4 is defined to be equal to 1 if the percentage 
improvement from Baseline to Week 4 in the PASI scores is 75% or greater and 0 if the 
percentage improvement from Baseline to Week 4 is less than 75%. This definition is introduced 
for the purpose of identifying subjects who respond to the treatment (1 = responder, 0 = non-
responder). The definition of percentage improvement from Baseline is given in Section 8.1.1.1. 
8.2.1.4 
Patient Symptom Diary (PSD) 
A patient reported outcome (PRO) measure, the Patient Symptom Diary (PSD), will be used to 
assess key symptoms relevant to subjects with moderate to severe chronic plaque PSO. The 
electronic (ePRO) diary will be administered on a daily basis from Screening to the end of the 
Week 16 Visit. 
The PSD consists of 14 different items, each measuring an aspect of the disease and its impact on 
the subject’s quality of life. Each item will be scored separately on a 0-10 scale with 0 for no 
symptom and 10 for very severe or worst symptom. Weekly averages will be derived for each of 
the 14 items of the Psoriasis Diary up to Week 16. A weekly average is the sum of the scored 
item over the course of the study week (up to the actual visit date) divided by the number of days 
on which the item was completed and will be set to missing if four or more daily assessments 
(irrespective of whether these are consecutive or not) were missing of the corresponding 
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question. The Baseline value is also based on a weekly average (up to and including the Baseline 
visit) and will be computed in the same manner. 
 Change from Baseline in PSD responses for itch, pain, and scaling at Week 16 is defined as 
Week 16 PSD response minus Baseline PSD response.  
Each of three PSD response scores -itch, pain, and scaling, will be characterized in terms of the 
cumulative percent of subjects demonstrating a pre-specified point improvement at Week 16. 
The thresholds for the PSD response score of itch, pain, and scaling are 2.39, 1.98, and 2.86, 
respectively. For this responder analysis, it will be limited to the subjects with a Baseline PSD 
response score at or above the applicable threshold score (ie, at least 2.39, 1.98, and 2.86 for itch, 
pain and scaling respectively). 
8.2.1.5 
Scalp IGA response at Week 16  
A static IGA for PSO will be used to assess disease severity on the scalp in all subjects during 
the study. 
All subjects will complete the scalp IGA at Baseline. Only subjects with scalp involvement at 
Baseline will complete the scalp IGA at the other visits specified in the schedule of assessments. 
Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at 
Baseline. 
Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using 
a 5-point scale as outlined in the Table 8‒2 below. This is the same scale with corresponding 
descriptors used for the overall IGA, but this will be specific to the scalp. 
Table 8‒2: 
Scalp IGA 
Score 
Short Descriptor 
Detailed Descriptor 
0 
Clear 
Scalp has no signs of PSO; post-inflammatory hyperpigmentation may be 
present 
1 
Almost clear 
Scalp has no thickening; normal to pink coloration; no to minimal focal 
scaling 
2 
Mild 
Scalp has just detectable to mild thickening; pink to light red coloration; 
predominately fine scaling 
3 
Moderate 
Scalp has clearly distinguishable to moderate thickening; dull to bright 
red, moderate scaling 
4 
Severe 
Scalp has severe thickening with hard edges; bright to deep dark red 
coloration; severe/coarse scaling covering almost all or all lesions 
Scalp IGA response at Week 16 is defined as clear [0] or almost clear [1] with at least a two-
category improvement from Baseline to Week 16. For analysis purposes, the evaluation of scalp 
IGA will be limited to subjects with a Baseline scalp IGA of at least 2. Therefore, if a subject has 
a score of 2 at Baseline, they can only be considered a responder if their IGA is 0 (thereby 
meeting the criterion for a two-category improvement from Baseline). Subjects with a Baseline 
scalp IGA of 1 will be assessed per the protocol but will not be part of the scalp IGA analysis.    
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8.2.1.6 
PASI90 response at Week 12 and 52 
PASI90 response definition and derivation are outlined in Section 8.1.1.1 and Section 8.1.1.2, 
use the data for weeks 12 and 52 respectively. 
8.2.1.7 
IGA response at Week 12 and Week 52 
IGA response and IGA 5-point scale are outlined in the Section 8.1.1.3, define at Weeks 12 and 
52 respectively.   
8.2.2 
Primary analysis of the secondary efficacy variables 
Binary (responder) variables will be summarized using frequency tables by treatment group for 
each visit. Continuous variables will be summarized using descriptive statistics by treatment 
group for each visit. Primary analysis for secondary efficacy variables will be summarized based 
on imputed data (NRI), unless otherwise specified. 
8.2.2.1 
PASI and IGA responses 
For PASI100 response at Week 16, IGA response (clear) at Week 16, PASI75 response at Week 
4, PASI90 and IGA response (clear or almost clear) at Week 12, the stratified CMH test similar 
to the primary analysis will be implemented to test for non-inferiority/superiority.   
For the assessment of non-inferiority, a non-inferiority margin of 10% will be used and evaluated 
based on the confidence interval for the stratified Mantel-Haenszel risk difference between 
bimekizumab and ustekinumab. 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. 
To calculate the stratified Mantel-Haenszel risk difference, the method of Greenland and Robins (1985) is 
used. For each combination of strata, a 2x2 table of treatment group and response is created. A theoretical 
2x2 table for a given stratum is shown below, where n = a+b+c+d. 
Treatment Group 
Response 
Yes 
No 
Bimekizumab 
a 
c 
Ustekinumab 
b 
d 
 
Given that structure, the stratified Mantel-Haenszel risk difference, standard error, and two-sided (1-
α)*100% confidence interval may be written as follows: 
𝑅𝐷𝑀𝐻=
∑((𝑎𝑖∗(𝑏𝑖+ 𝑑𝑖)/𝑛𝑖) −(𝑏𝑖∗(𝑎𝑖+ 𝑐𝑖)/𝑛𝑖)
𝑖
∑((𝑎𝑖+ 𝑐𝑖) ∗(𝑏𝑖
𝑖
+ 𝑑𝑖))/𝑛𝑖
 
 
𝑆𝐸𝑀𝐻= √
∑{[𝑎𝑖∗𝑐𝑖∗(𝑏𝑖+ 𝑑𝑖)3] + [𝑏𝑖∗𝑑𝑖∗(𝑎𝑖+ 𝑐𝑖)3]
(𝑎𝑖+ 𝑐𝑖) ∗(𝑏𝑖+ 𝑑𝑖) ∗𝑛𝑖
2
}
𝑖
{∑[(𝑎𝑖+ 𝑐𝑖) ∗(𝑏𝑖+ 𝑑𝑖)
𝑛𝑖
]
𝑖
}
2
 
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𝐶𝐼𝑀𝐻= 𝑅𝐷𝑀𝐻± probit(1 −(𝛼2
⁄ )) ∗𝑆𝐸𝑀𝐻 
 
For the assessment of non-inferiority of bimekizumab to ustekinumab, the lower 97.5% confidence limit 
for the stratified Mantel-Haenszel risk difference will be considered. If that value is greater than -10%, 
then non-inferiority will have been established. 
Because all placebo subjects will receive bimekizumab treatment starting at Week 16, statistical 
comparisons against placebo after Week 16 will not be performed. 
8.2.2.2 
Scalp IGA response 
For scalp IGA (Clear or Almost Clear) at Week 16, the stratified CMH test similar to the primary 
analysis will be applied.  
8.2.2.3 
Patient Symptom Diary (PSD) 
For each of the three PSD response scores of itch, pain, and scaling, the following analyses will 
be performed for the purpose of supporting each item as individual key secondary variables.  
 
Each of three PSD response scores itch, pain, and scaling, will be characterized in terms of the 
cumulative percent of subjects demonstrating a pre-specified point improvement at Week 16. 
The thresholds for the PSD response scores of itch, pain, and scaling are 2.39, 1.98, and 2.86, 
respectively. For this responder analysis, it will be limited to the subjects with a Baseline PSD 
response score at or above the applicable threshold score (ie, at least 2.39, 1.98, and 2.86 for itch, 
pain and scaling respectively). Stratified CMH test, similar to the primary efficacy analysis will 
be applied within each of these responder analyses.  
Lastly, the entire distribution of responses for each of PSD response scores of itch, pain and 
scaling will be evaluated via continuous plots showing the absolute and percent change from 
Baseline on the X-axis and the percent of subjects experiencing that change on the Y-axis. This 
distribution curve will reveal the extent to which overall results are driven by outliers who 
improve or worsen more than others. The cumulative distribution function (CDF) is the 
probability that the variable takes a value less than or equal to x. That is: 
 
where the right-hand side represents the probability that the random variable X takes on a value 
less than or equal to x. The probability that X lies in the interval [a, b] is therefore: 
FX(b) − FX(a) if a < b 
Note that cumulative distribution plots will be provided for absolute and percent change from 
Baseline PSD at Week 16 for itch, pain, and scaling.  
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8.2.3 
Sensitivity analyses of the secondary efficacy variables 
Sensitivity analyses for the handling of missing data will be performed for the binary and 
continuous secondary efficacy variables that are part of the fixed sequence testing procedures in 
Figure 4‒1. 
For binary response variables (PASI100 at Week 16, IGA Response (clear) at Week 16, PASI75 
at Week 4, Patient Symptom Diary responses for Pain, Itch, Scaling, and Scalp IGA at Week 16, 
PASI90 at Weeks 12 and 52, and IGA at Weeks 12 and 52), sensitivity analyses #1 and #3 
(Sections 8.1.3.1, 8.1.3.3 ) will be performed.  
Missing data for binary secondary efficacy variables will be imputed using NRI. Specifically, if a 
subject has missing data at the respective visit or has discontinued from study treatment, they 
will be treated as a non-responder at the respective visit for this analysis. 
Missing data for these PSD responder variables will use the MI procedure similar to the 
sensitivity analysis #1 (Section 8.1.3.1) for the co-primary efficacy variables with the following 
differences:  
1. The data included in the imputation model will be limited only to those subjects with 
sufficiently high Baseline values to achieve the response for a given item (based on observed 
cases). 
2. The PSD item value will be imputed. Once imputation has been performed across the 100 
iterations specified, any values below 0 and above 10 will be truncated to 0 and 10, 
respectively. 
3. The change from Baseline values will be computed based on the complete data sets. 
4. The analysis model will be based on  the CMH test. 
8.3 
Statistical analysis of the other efficacy variables 
The other efficacy variables are listed below and will be evaluated according to the planned 
assessments in the protocol, this excludes the timepoints for the primary and secondary variables 
specified above in Section 8.1.1 and Section 8.2.1 .  
Binary (responder) variables will be summarized using frequency tables by treatment group for 
each visit. Continuous variables will be summarized using descriptive statistics by treatment 
group for each visit. All variables will be summarized based on imputed data (NRI and 
MCMC/Monotone Regression for binary and continuous variables, respectively), unless 
otherwise specified. 
Missing data for continuous secondary efficacy variables will be imputed using MI. The MI 
procedure for continuous variables will be similar to sensitivity analysis #1 described in Section 
8.1.3.1 for the co-primary efficacy endpoints with the following difference – no dichotomization 
will be necessary. Also, no requirement of meeting minimum threshold at baseline is needed to 
be included in imputation for a continuous variable. 
For variables that are part of the sequence testing procedure, summaries based on observed case 
data will also be provided. There may be cases where the multiple imputation model fails to 
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converge. In such situations, the last observation carried forward (LOCF) approach will instead 
be used to impute the missing data.  
Note that in addition, for subjects who change to bimekizumab from placebo at Week 16, change 
from two Baselines (i.e. Baseline at Week 0 visit and Baseline at Week 16) will be summarized 
in MS. 
Lastly, by visit summaries will include the bimekizumab and ustekinumab treatment groups. 
There will be 2 key approaches for understanding the data in the Maintenance Treatment Period: 
1. Summary of data for the RS through Week 52 based on randomized treatment group.  
2.  Summary of Maintenance Treatment Period data among Week 16 responders only for 
PASI90, PASI100, IGA (0/1), and DLQI respectively. 
Selected summaries for subjects switching from Placebo to Bimekizumab will be provided 
separately for the MS. 
8.3.1 
PASI 
8.3.1.1 
PASI50, PASI75, PASI90, and PASI100 response  
Categorical response variables, PASI50, PASI75, PASI90 and PASI100 over time are defined to 
be equal to 1 if the percentage improvement from Baseline to visit timepoint in the PASI scores 
is 50%, 75%, 90% and 100% respectively or greater and 0 if the percentage improvement from 
Baseline to visit timepoint is less than 50%, 75%, 90% and 100% respectively. This definition is 
introduced for the purpose of identifying subjects who respond to the treatment (1 = responder, 0 
= non-responder). The definition of PASI score percentage improvement from Baseline is given 
in Section 8.1.1.1. 
A line plot of the PASI responder (PASI50, PASI75, PASI90, and PASI100) rate over time, by 
treatment group will be produced. 
8.3.1.2 
Time to PASI50, PASI75, PASI90, and PASI100 response during the 
Initial Treatment Period 
Time to PASI50, PASI75, PASI90, and PASI100 response (in days) during the Initial Treatment 
Period will each be calculated as: 
𝑀𝑖𝑛 (𝐷𝑎𝑡𝑒 𝑜𝑓 𝑓𝑖𝑟𝑠𝑡 𝑃𝐴𝑆𝐼𝑥𝑥 𝑟𝑒𝑠𝑝𝑜𝑛𝑠𝑒, 𝐷𝑎𝑡𝑒 𝑜𝑓 𝑊𝑒𝑒𝑘 16 𝑣𝑖𝑠𝑖𝑡) –  𝐷𝑎𝑡𝑒 𝑜𝑓 𝐵𝑎𝑠𝑒𝑙𝑖𝑛𝑒 𝑣𝑖𝑠𝑖𝑡 +  1, 
with  xx representing 50, 75, 90, 100 respectively. All visits including unscheduled visits are 
considered. 
Subjects who discontinue study treatment without achieving a given PASI response prior to 
Week 16 visit will be censored at the date of the last observed PASI assessment on or prior to the 
date of treatment discontinuation. Subjects who reach the Week 16 Visit without achieving the 
given response will be censored at the date of the last observed PASI assessment on or prior to 
the Week 16 Visit. Subjects will be censored at Baseline if there is no Baseline PASI assessment 
or no Post Baseline PASI assessment. 
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Time to PASI50, PASI75, PASI90, and PASI100 response during Initial Treatment Period will 
each be estimated and presented using the Kaplan-Meier product-limit method for each treatment 
group.  
Kaplan-Meier plots of time to PASI responses will also be presented by treatment group. In these 
Kaplan-Meier plots, the line will start at 0 (since there are no responders at Week 0) and will 
increase over time, representing time to achieving the response. 
The median time to response, including the two-sided 95% confidence interval, will be 
calculated for each treatment. Comparisons of bimekizumab vs placebo or ustekinumab will be 
analyzed using a log-rank test stratified by region and prior biologic exposure.  
8.3.1.3 
PASI score 
Absolute and percent change from Baseline in PASI score is defined in Section 8.1.1.1. 
The percent of subjects with absolute PASI score ≤1, ≤2, ≤3 and ≤5 will be presented over time 
using NRI. 
8.3.2 
Modified Nail Psoriasis Severity Index (mNAPSI) score  
Psoriatic nail disease will be evaluated at the Baseline visit using the mNAPSI. All affected nails 
will be scored (0 to 3) for onycholysis/oil drop dyschromia, nail plate crumbling, and pitting and 
will be scored (0 for “no” or 1 for “yes”) for leukonychia, nail bed hyperkeratosis, splinter 
haemorrhages and red spots in the lunula. The score for an individual nail ranges from 0 to 13 
with higher scores indicative of more severe nail disease. The total mNAPSI score is the sum of 
the scores for each individual nail. If a nail is unaffected, it will be recorded as such and will not 
contribute to the total mNAPSI score. 
If any of the 7 response items that contribute to mNAPSI is present, while other items are 
missing (ie, partial mNAPSI data), then the missing items are assumed to be 0 for the mNAPSI 
calculation. In some cases, the data may be captured in such a way that only non-zero component 
scores are present in the database. Again, those components that are not present are simply 
assumed to be 0 for the mNAPSI calculation. 
Change from Baseline in Modified Nail Psoriasis Index (mNAPSI) score for subjects with nail 
PSO at Baseline is defined as Post-Baseline mNAPSI score minus Baseline mNAPSI. 
An mNAPSI75 responder is defined as a subject who achieved at least a 75% improvement from 
Baseline in the mNAPSI score. mNAPSI90 and mNAPSI100 are defined accordingly. The 
proportion of mNAPSI75/90/100 responders over time will be summarized for each treatment 
group. 
8.3.3 
IGA response  
 IGA response (Clear) is defined as IGA score of zero (Table 8‒1) with at least a two-
category improvement from Baseline at visit timepoint. 
 IGA response (Clear or Almost Clear with at least 2 category improvement relative to 
Baseline) is defined as IGA score of clear [0] or almost clear [1] with at least a two-category 
improvement from Baseline at visit timepoint.  
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 Shift from Baseline in IGA score is defined at each Post-Baseline visit timepoint relative to 
Baseline. 
 Scalp-specific IGA response definition and derivation are outlined in Section 8.2.1.5. 
 Palmoplantar Investigator’s Global Assessment (pp-IGA) response  
A static IGA for palmoplantar PSO will be used to assess palmoplantar disease severity. 
Only subjects with palmoplantar involvement at Baseline will complete the pp-IGA at the other 
visits specified in the protocol. Subjects with palmoplantar involvement at Baseline are defined 
as those with a pp-IGA score >0 at Baseline. 
Palmoplantar disease will be assessed in terms of clinical signs of redness, thickness, and 
scaliness using a 5-point scale as outlined in the table below. 
Table 8‒3: 
Palmoplantar IGA 
Score 
Short Descriptor 
Detailed Descriptor 
0 
Clear 
Palmoplantar has no signs of PSO; post-inflammatory hyperpigmentation 
may be present 
1 
Almost clear 
Palmoplantar has no thickening; normal to pink coloration; no to minimal 
focal scaling 
2 
Mild 
Palmoplantar has just detectable to mild thickening; pink to light red 
coloration; predominately fine scaling 
3 
Moderate 
Palmoplantar has clearly distinguishable to moderate thickening; dull to 
bright red and clearly distinguishable coloration; moderate scaling 
4 
Severe 
Palmoplantar has severe thickening with hard edges; bright to deep dark 
red coloration; severe/coarse scaling covering almost all or all lesions; 
numerous fissures 
PSO=psoriasis; pp-IGA=palmoplantar-specific Investigator’s Global Assessment 
Palmoplantar IGA response is defined as clear [0] or almost clear [1] with at least a two-category 
improvement from Baseline. For analysis purposes, the evaluation of pp-IGA will be limited to 
subjects with a Baseline pp-IGA of at least 2. Therefore, if a subject has a score of 2 at Baseline, 
they can only be considered a responder if their IGA is 0 (thereby meeting the criterion for a 
two-category improvement from Baseline). Subjects with a Baseline pp-IGA of 1 will be 
assessed per the protocol but will not be part of the palmoplantar IGA analysis.   
A line plot of the IGA responder rates (both clear or almost clear and clear) over time, by 
treatment group will be produced. 
8.3.4 
Body Surface Area (BSA) 
 Absolute change from Baseline in the BSA affected by PSO is defined as Post Baseline BSA 
minus Baseline BSA affected by PSO.  
 Percent change from Baseline in BSA affected by PSO is defined as 
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Percent change from Baseline = 100 × Post Baseline BSA −Baseline BSA
Baseline BSA
 
The percent of subjects with absolute BSA=0%, ≤1%, ≤3% and ≤5% will be presented over time. 
8.3.5 
Product of IGA and BSA (IGAxBSA) 
 Absolute change from Baseline in the product IGAxBSA is defined as Post Baseline 
IGAxBSA minus product of Baseline IGAxBSA.  
 Percent change from Baseline in the product of IGAxBSA is defined as 
Percent change from Baseline = 100 × Post Baseline IGAxBSA −Baseline IGAxBSA
Baseline IGAxBSA
 
8.3.6 
Dermatology Life Quality Index (DLQI)  
The DLQI questionnaire is used for patients with psoriasis and consists of 10-questions. This is 
validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, 
daily activities, leisure, work and school, personal relationships, and treatment, as assessed over 
the past week.   
The scoring of each answer for the DLQI is as follows: 
Table 8‒4: 
Dermatology Life Quality Index  
DLQI Scoring 
Response 
Score 
Very much 
3 
A lot 
2 
A little 
1 
Not at all 
0 
Not relevant 
0 
Question unanswered 
0 
Q7: ‘prevented work or studying’ = yes 
3 
The DLQI total score is calculated by adding the score of each question. The maximum score is 
30, and the minimum score is 0. The higher the score, the more quality of life is impaired. 
Meaning of DLQI Scores 
0-1 = no effect at all on patient’s life 
2-5 = small effect on patient’s life 
6-10 = moderate effect on patient’s life 
11-20 = very large effect on patient’s life 
21-30 = extremely large effect on patient’s life 
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This categorization will not be utilized in the analysis. 
Because Q7 has a sub-question (referred to as Q7a here) after the leading yes/no question, some 
clarifying rules for scoring are provided: 
 If Q7 is marked as “yes”, a score of 3 is given regardless of the responses to Q7a. 
 If Q7 is marked as “no”, “not relevant”, or is missing and Q7a is “A lot”, a score of 2 is 
given. 
 If Q7 is marked as “no”, “not relevant”, or is missing and Q7a is “A little”, a score of 1 is 
given. 
 If Q7 is marked as “no”, “not relevant”, or is missing and Q7a is “Not at all”, a score of 0 
is given. 
 If Q7 is marked as “no” or “not relevant” and Q7a is missing, a score of 0 is given. 
 If Q7 is missing and Q7a is missing, Q7 is considered unanswered (see below for details 
on how this impacts the overall DLQI score). 
If 1 question is left unanswered, this is scored 0 and the scores are summed and expressed as 
usual out of a maximum of 30. If 2 or more questions are left unanswered, the questionnaire is 
not scored. 
A subject is considered to have achieved the minimally clinical important difference (MCID) if 
their individual improvement from Baseline score is > 4.  A 4-point improvement in the DLQI 
score (DLQI response) has been reported to be meaningful for the subject (within-subject 
MCID).   
A DLQI absolute score of 0 or 1 indicates no or small impact of the disease on health-related 
quality of life. 
The DLQI related efficacy variables are defined as follows: 
 Change from Baseline in DLQI is defined as Post-Baseline DLQI minus Baseline DLQI. 
 Percent of subjects achieving a DLQI total score of 0 or 1 is defined as the number of 
subjects with DLQI absolute score of 0 or 1 divided by the number of subjects in RS. 
 Percent of subjects achieving a MCID in DLQI is defined as the number of subjects with 
improvement from Baseline score of 4 or more divided by the number of subjects in RS. 
Only subjects with a Baseline DLQI of 4 or greater will be considered for this analysis. 
8.3.7 
Patient's Global Assessment of Disease Activity (PGADA) for 
arthritis visual analog scale (VAS) 
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.” 
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All subjects will complete the PGADA at Baseline. Subjects with PsA at Baseline (defined as a 
past medical history of PsA or PASE ≥47) will complete the PGADA at the visits specified in 
the protocol.  
Change from Baseline in PGADA is defined as Post-Baseline PGADA minus Baseline PGADA. 
8.3.8 
Patient Global Assessment of PSO score 
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 response to the question are “no symptoms”, “mild symptoms”, “moderate symptoms”, 
“severe symptoms”, or “very severe symptoms”. 
The Patient Global Assessment of psoriasis will be summarized based on OC as the primary 
analysis. No imputation is applied. 
Shift from Baseline in PGA (Patient Global Assessment) of PSO score is defined to each Post-
Baseline visit timepoint relative to Baseline. 
8.3.9 
Patient Symptom Diary (PSD) 
Absolute and percent changes from Baseline PSD for each item will be summarized by visit for 
each treatment group.  
For PSD responder analysis, the threshold criteria in term of changes from Baseline are set to 
3.05, 1.99, 2.01, 3.04, 2.82, 2.60, 2.69, 2.68, 1.51, 2.43, and 2.14 respectively for the redness, 
burning, cracking, dryness, irritation, sensitivity, lesions, thickening, fatigue, embarrassment, 
choice of clothing. Number and percentage of subjects who are responders will be summarized 
based on each of these items.  
In addition, cumulative distribution plots (see details in Section 8.2.2.3) will be provided for 
absolute and percent change from Baseline PSD at Week 16 for each item. 
8.3.10 
Health Assessment Questionnaire-Disability Index (HAQ-DI) score 
The HAQ-DI assesses the degree of difficulty a subject has experienced during the past week in 
8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, 
reach, grip, and other activities.  Each activity category or domain consists of 2 or 3 items.  For 
each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 
representing “without any difficulty,” 1 as “with some difficulty,” 2 as “with much difficulty,” 
and 3 as “unable to do”.  The domain score for each domain is the maximum (ie, worst) of the 
scores from the items/questions within the domain.  If this domain score is ≥ 2, no further 
adjustment is needed.  If it is < 2 (ie, 0 or 1) but no aids, devices or help from another person is 
indicated, then also no adjustment is needed.  However, if it is < 2 and any aid, device or help 
from another person is indicated, then it is further adjusted upward to 2. 
For each domain, the domain score will be determined by non missing scores from the questions.  
A domain score will only be missing if all scores within the domain are missing.  The HAQ-DI 
total score is the average of all the 8 domain scores.  If > 2 domain scores are not complete or 
missing, HAQ-DI score is considered missing, else the HAQ DI score is computed as the 
average of the non missing domain scores. 
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Change from Baseline in HAQ-DI is defined as Post-Baseline HAQ-DI minus Baseline HAQ-
DI. 
8.3.11 
Psoriatic Arthritis Screening and Evaluation (PASE) 
The 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.  
PASE will be collected at Baseline and Week 52/PEOT visit. PASE will be summarized based 
on OC only. No imputation is applied. 
Change from Baseline in the PASE questionnaire scores (function score, symptom score, and 
total score) is defined as Post-Baseline PASE questionnaire score (function, symptom, and total) 
minus Baseline PASE questionnaire score (function, symptom, and total). 
Shift from Baseline in PASE score suggestive of PsA (<47 versus ≥47) is defined to Week 
52/PEOT visit timepoint relative to Baseline. 
8.3.12 
Short Form – 36 Items Health Survey (SF-36)  
The SF-36v2, standard recall, measures the following 8 health domains as rated by the subjects 
over the past four weeks: Physical Functioning, Role Physical, Bodily Pain, General Health, 
Vitality, Social Functioning, Role Emotional, and Mental Health (Maruish, 2011).  
The SF-36 Physical and Mental Component Summary scores (PCS and MCS, respectively) are 
used to measure the two broad components, or aspects, of health-physical and mental. PCS and 
MCS are based on the aggregate of 8 health concepts described above and all of the 8 health 
domain scales are used to score both components summary measures. 
One additional item asks respondents about health change over the past year. 
The SF-36 will be used using QualityMetric’s Health Outcomes™ Scoring Software version 5.1 
or later. The software uses updates 2009 U.S. population norms and applies a Full Missing Score 
Estimation (Full MSE) method as follows: 
 A health domain score (except the physical functioning (PF) domain) will be estimated 
provided that at least one non-missing response is available within that domain. 
 For the PF domain item response theory will be used to develop a model for estimates of 
the missing score (Thomas and Cyr, 2002). 
 Regression methods are then applied to estimate the PCS and the MCS on the basis of the 
available domains. 
 Change from Baseline in Short Form 36-item Health Survey PCS score, and MCS score, and 
individual domains is defined as respective score at Post-Baseline timepoint minus the 
Baseline score.  
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8.3.13 
Euro-Quality of Life 5-Dimensions, 3 levels (EQ-5D-3L) 
The EQ-5D-3L health questionnaire provides a descriptive profile and a single index value for 
health status. The instrument is comprised of a 5-item health status measure and a visual analog 
scale (VAS).  
Responses to EQ-5D-3L are scored as 1 for “no problem”, 2 for “some or moderate problems”, 
and 3 for “extreme problems” 
Absolute EQ-5D-3L VAS score records the respondent’s self-rated health status on a vertical 
20cm scale, 0 to 100 graduated (0=worst imaginable health status, 100=best imaginable health 
status) 
Change from Baseline in EQ-5D-3L VAS scores is defined as Post-Baseline EQ-5D-3L VAS 
score minus Baseline EQ-5D-3L VAS score. 
Responses to EQ-5D-3L will be summarized based on OC only as primary analysis. No 
imputation is applied to responses to EQ-5D-3L but is applied to EQ-5D-3L VAS scores. 
8.3.14 
Work Productivity and Activity Impairment Questionnaire – Specific 
Health Problem (WPAI-SHP)  
The WPAI-SHP is a subject-reported questionnaire that assesses subject’s employment status, 
work absenteeism, work impairment while working, overall work, and daily activity impairment 
attributable to a specific health problem. Five out of 6 items of the WPAI-SHP are regrouped 
into the 4 dimensions, with scores expressed as percentage, where higher numbers indicate 
greater impairment and less productivity, ie, worse outcomes, as described in the WPAI-SHP 
scoring rules. 
The scoring rules for the WPAI-SHP are as follows: 
Questions: 
1 = 
 
2 = 
 
3 = 
 
4 = 
 
5 = 
 
6 = 
 
Scores:  
 Percent work time missed due to problem: [Q2 hours/(Q2 hours +Q4 hours)]  *100 
 Percent impairment while working due to problem: [Q5 score/10] *100 
 Percent overall work impairment due to problem: 
[Q2 hours/(Q2 hours +Q4 hours)+[(1-(Q2 hours/(Q2 hours +Q4 hours))x(Q5 score/10)] ] *100 
 Percent activity impairment due to problem: [Q6 score/10] *100 
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 Change from Baseline score is derived as post Baseline score minus Baseline score.  A 
negative change score indicates a reduction in the score/improvement for the subject. 
8.4 
Statistical analysis of PsA related efficacy variables 
The following PsA related efficacy variables will only be assessed for subjects enrolled in Japan: 
 Swollen and tender joint count 
 Physician’s Global Assessment of Disease Activity (PhGADA) 
 Patient’s Assessment of Arthritis Pain VAS 
 C-Reactive Protein (CRP) 
Subsequently, also ACR20/50/70 are only calculated for subjects enrolled in Japan. 
The Patient’s Assessment of Arthritis Pain VAS, PGADA, and HAQ-DI will be assessed for all 
subjects at Baseline. At all subsequent visits, the Patient’s Assessment of Arthritis Pain VAS, 
PGADA, and HAQ-DI will be assessed only for subjects with PsA at Baseline (defined as a past 
medical history of PsA or PASE ≥47). Only subjects with PsA at Baseline will be assessed with 
swollen and tender joint count, and PhGADA at Baseline and subsequent visits. 
The number and percentage of subjects with ACR20, ACR50, ACR70 will be summarized by 
treatment group and visit in subjects with PsA at Baseline.  
By-subject listings of ACR responder variables and percent change in ACR components 
(swelling joints count, tender joints count, PGADA and PhGADA VAS, Patient’s Assessment of 
Arthritis Pain VAS, HAQ-DI, and CRP) from Baseline data will be provided. 
8.4.1 
ACR20, ACR50, and ACR70 responses 
American College of Rheumatology (ACR) ACR20/50/70 represents at least 20%, 50%, or 70% 
respective improvement from Baseline for each of the following: 
 Tender joint counts (TJC) 
 Swelling joint counts (SJC) 
 At least 3 of the 5 remaining core set measures: 
 Disease activity as assessed by PGADA 
 Disease activity as assessed by PhGADA 
 Pain as assessed by Patient’s Assessment of Arthritis Pain VAS 
 Physical function as assessed by the HAQ-DI 
 Acute phase response as assessed by the C-reactive protein (CRP) 
For all non-missed visits, if any of the component scores are missing, then those scores will be 
considered as not having met the criteria for improvement for the respective component. For 
component scores with a Baseline value of 0, the percentage improvement is not calculable and 
is treated as missing. For component scores with a Baseline value >0 and a post-Baseline value 
of 0, percentage improvement will be calculated as for any other non-missing data. 
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8.4.2 
Swollen and tender joint counts (66/68 joints evaluations) 
The following 68 joints are to be examined for tenderness by an Investigator who has 
documented training performing the assessment. The Investigator can also delegate the 
assessment to a rheumatologist. Preferably the same assessor should evaluate the subject at each 
arthritis assessment (see Table 8‒5). 
 Upper body (6): bilateral temporomandibular, sternoclavicular, and acromioclavicular joints 
 Upper extremity (34): bilateral shoulders, elbows, wrists (includes radiocarpal, and carpal 
and carpometacarpal bones considered as a single unit), MCP I, II, III, IV, and V, thumb 
interphalangeals, PIP II, III, IV, and V and distal interphalangeals (DIP, II, III, IV, and V) 
 Lower extremity (28): bilateral hips, knees, ankles, tarsi (includes subtalar, transverse tarsal, 
and tarsometatarsal considered as a single unit), metatarsophalangeals (MTP I, II, III, IV, and 
V), great toe interphalangeals, and proximal interphalangeals (PIP II, III, IV, and V) 
 The assessment for swelling is made on 66 joints from the above list. The hip joints are 
excluded.  
Artificial and ankylosed joints are excluded from both tenderness and swelling assessments.  
8.4.3 
PGADA 
The definition and analysis of PGADA VAS score is given in Section 8.3.7. 
8.4.4 
Physician’s Global Assessment of Disease Activity (PhGADA) 
The Investigator will assess the overall status of the subject with respect to their PsA signs and 
symptoms and functional capacity (considering both joint and skin components) using a VAS 
where 0 is “very good, asymptomatic and no limitation of normal activities” and 100 is “very 
poor, very severe symptoms which are intolerable and inability to carry out all normal activities.” 
8.4.5 
Patient’s Assessment of Arthritis Pain VAS 
The Patient’s Assessment of Arthritis Pain VAS or “Pain VAS” is part of the ACR core set of 
measures in arthritis (Felson et al, 1993). 
The Pain VAS consists of a horizontal line 100mm in length on which subjects are asked to 
indicate the level of their arthritis pain at the day of the visit between 0 (“no pain”) and 100 
(“most severe pain”) in response to the question: “Please mark a vertical line on the scale below 
to show how much pain you have from your arthritis today” (Dworkin et al, 2008).  
8.4.6 
HAQ-DI 
The definition, derivation, and analysis of HAQ-DI score is given in Section 8.3.10. 
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8.5 
Additional statistical analysis of other efficacy variables 
For selected other efficacy variables, it is of interest to perform statistical tests and to calculate 
inferential statistics. As these tests are not part of the multiplicity-controlled procedure, the 
associated p-values are considered nominal and are not controlled for multiplicity. 
For responder variables, the analysis will follow what was specified for the primary analysis. 
Specifically, a stratified Cochran-Mantel-Haenszel (CMH) test will be used, where region and 
prior biologic exposure (yes/no) will be stratification variables. The p-value will be based on the 
CMH test for a general association. Missing values will be imputed using NRI. 
For continuous variables, the MI – MCMC / Monotone Regression approach used for other 
continuous variables will be applied for the imputation model. The analysis model will be based 
on analysis of covariance (ANCOVA) with fixed effects of treatment, region, and prior biologic 
exposure and Baseline value as a covariate.  
Below is a list of variables for which these nominal p-values will be calculated (with the time 
points in parentheses). The results of these inferential tests will all be presented in a single table 
summarizing the testing performed outside of the multiplicity-controlled testing procedure. 
 PASI90 
 Bimekizumab vs Placebo (Weeks 1, 2, 4, 8, and 12) 
 Bimekizumab vs Ustekinumab (Weeks 1, 2, 4, and 8) 
 IGA Clear or Almost Clear 
 Bimekizumab vs Placebo (Weeks 1, 2, 4, 8, and 12) 
 Bimekizumab vs Ustekinumab (Weeks 1, 2, 4, and 8) 
 PASI100 
 Bimekizumab vs Placebo (Weeks 4, 8, and 12) 
 Bimekizumab vs Ustekinumab (Weeks 4, 8, 12, 16, and 52) 
 IGA Clear 
 Bimekizumab vs Placebo (Weeks 4, 8, and 12) 
 Bimekizumab vs Ustekinumab (Weeks 4, 8, 12, 16, and 52) 
 PASI75 
 Bimekizumab vs Placebo (Weeks 1, 2, and 16) 
 Bimekizumab vs Ustekinumab (Weeks 1, 2, 4, and 16) 
 PSD Response – Pain 
 Bimekizumab vs Placebo (Weeks 1, 2, and 4) 
 Bimekizumab vs Ustekinumab (Week 16) 
 PSD Response – Itch 
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 Bimekizumab vs Placebo (Weeks 1, 2, and 4) 
 Bimekizumab vs Ustekinumab (Week 16) 
 PSD Response – Scaling 
 Bimekizumab vs Placebo (Weeks 1, 2, and 4) 
 Bimekizumab vs Ustekinumab (Week 16) 
 Scalp IGA Clear or Almost Clear (subjects with Baseline Scalp IGA ≥2) 
 Bimekizumab vs Placebo (Weeks 1, 2, and 4) 
 Bimekizumab vs Ustekinumab (Weeks 16 and 52) 
 pp-IGA Clear or Almost Clear (subjects with Baseline pp-IGA ≥2) 
 Bimekizumab vs Placebo (Week 16) 
 Bimekizumab vs Ustekinumab (Weeks 16 and 52) 
 mNAPSI change from Baseline (subjects with Baseline mNAPSI>0) 
 Bimekizumab vs Placebo (Week 16) 
 mNAPSI75 response (subjects with Baseline mNAPSI>0) 
 Bimekizumab vs Placebo (Week 16) 
 Bimekizumab vs Ustekinumab (Weeks 16 and 52) 
 mNAPSI90 response (subjects with Baseline mNAPSI>0) 
 Bimekizumab vs Placebo (Week 16) 
 Bimekizumab vs Ustekinumab (Weeks 16 and 52) 
 mNAPSI100 response (subjects with Baseline mNAPSI>0) 
 Bimekizumab vs Placebo (Week 16) 
 Bimekizumab vs Ustekinumab (Weeks 16 and 52) 
 DLQI change from Baseline 
 Bimekizumab vs Placebo (Week 16) 
 DLQI 0/1 response 
 Bimekizumab vs Placebo (Week 16) 
 Bimekizumab vs Ustekinumab (Weeks 16 and 52) 
 SF-36 PCS change from Baseline 
 Bimekizumab vs Placebo (Week 16) 
 SF-36 MCS change from Baseline 
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 Bimekizumab vs Placebo (Week 16) 
 WPAI-SHP change from Baseline (percent impairment while working, percent overall work 
impairment, percent activity impairment) 
 Bimekizumab vs Placebo (Week 16) 
 PASI percentage change from Baseline 
 Bimekizumab vs Placebo (Weeks 1, 2, 4, 8, 12, and 16) 
 PASI ≤2 response 
 Bimekizumab vs Placebo (Weeks 1, 2, 4, 8, 12, and 16) 
 PASI ≤5 response 
 Bimekizumab vs Placebo (Weeks 1, 2, 4, 8, 12, and 16) 
9 
PHARMACOKINETICS AND PHARMACODYNAMICS  
9.1 
Pharmacokinetics 
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. 
PK summaries will be based on observed values. No imputation will be used. However, if 
plasma concentration measurements are below the level of quantification (BLQ), then for 
calculation of the derived statistics the result will be set to 0.125 µg/ml, which is ½ of the lower 
level of quantification (LLOQ). Descriptive statistics including geometric mean, geometric 
coefficient of variation, and geometric mean 95% CI if applicable will be calculated if at least 
2/3 of the values of interest are above the LLOQ. If this is not the case, only median, minimum, 
and maximum will be presented.  
In addition, geometric mean plasma concentration will be plotted by treatment group, and by 
cumulative antibody status for subjects randomized to bimekizumab on linear and log linear 
scale.  
If the dosing for a visit is +/- 21 days out of window, then the plasma concentration from that 
visit and all subsequent visits will be excluded from the PK summary. 
If the PK sampling date is >1 day after the dosing date data points will be excluded from the PK 
summary tables and figures, but not from the listing. 
However, all PK concentrations will be listed.  
The PK will be subject to a population PK and PK/PD analysis and will be described in a 
separate analysis plan and reported independently. 
9.2 
Pharmacodynamics 
Not applicable 
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9.3 
Immunogenicity 
The analysis of immunogenicity will be based on the SS. 
9.3.1 
Auto-antibodies 
Not applicable. 
9.3.2 
Anti-bimekizumab antibodies 
Anti-bimekizumab antibodies will be measured using a three tiered assay approach: screening 
assay, confirmatory assay and titration assay. Samples confirmed as positive within the 
confirmatory assay, will be further evaluated in a neutralizing assay to evaluate the potential of 
the ADAb to neutralize the activity of Bimekizumab (IL17A or IL17F, or both) in-vitro. Samples 
were taken at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 40, and 
Week 52 and in subjects who do not enter into the OLE (PS0014) a sample at SFU which is 20 
weeks after the last dose. 
Anti-bimekizumab antibody samples are not analyzed when subjects are on a treatment other 
than bimekizumab. For subjects who switch from placebo to bimekizumab, samples are analyzed 
starting at the visit when the switch to bimekizumab occurs. The sample at the visit when the 
switch occurs will act as the Baseline for that treatment group. For subjects randomized to 
Ustekinumab, no ADAb samples will be analysed. 
In subjects randomized to placebo for the first 16 weeks, no samples will be analysed until Week 
16 which will act as the Baseline for this treatment group. 
Screening, confirmatory and titer cut points of the respective assays will be determined by the 
bioanalytical laboratory based either on using commercially available drug-naïve samples or on 
the pre-dose samples of the study itself. In case cut point is being set on commercially available 
samples, the representative for the study population is being checked. The screening cut point 
will be used to determine the status of ADA in test sample as above the cut point or below the 
cut point. Samples presenting ADA levels above the cut point, will be further evaluated in the 
confirmatory assay, the result of which will be reported as either “confirmed positive” or “not 
confirmed positive”. 
 Values ≤ screening cut point (BCP) or above the screening cut point and confirmed 
negative (NCP) are defined as anti-bimekizumab antibody negative 
 Values > predefined screening cut point (ACP) and confirmed positive (CP) are defined 
as anti-bimekizumab antibody positive 
Confirmed positive samples will be titrated, and the titer (reciprocal dilution factor including 
MRD) reported. The samples (or a subset) will also be subject to a neutralizing assay to evaluate 
whether the anti-bimekizumab antibody neutralizes the activity of bimekizumab (IL17 A or 
IL17F or both) in- vitro. This will be reported subsequent to the main DBL and CSR.  
Subject Classification:  
 Pre anti-bimekizumab antibody negative – treatment emergent anti-bimekizumab 
antibody negative: Includes subjects who are negative at Baseline and antibody negative at 
all sampling points post treatment (excluding SFU)  
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 Pre anti-bimekizumab antibody negative – treatment emergent anti-bimekizumab 
antibody positive: Includes subjects who are negative at Baseline and antibody positive at 
any sampling point post treatment (excluding SFU). This group also includes subjects who 
have a missing pre-treatment sample (either missing or insufficient volume) at Baseline with 
one or more anti-bimekizumab antibody positive post-treatment samples.  
 Pre anti-bimekizumab antibody positive – treatment emergent reduced anti-
bimekizumab antibody: Includes subjects who are positive at Baseline, and antibody 
negative at all sampling points post treatment (excluding SFU).  
 Pre anti-bimekizumab antibody positive – treatment emergent unaffected anti-
bimekizumab antibody positive: Includes subjects who are positive at Baseline and are 
positive at any sampling point post treatment (excluding SFU) with titer values of the same 
magnitude as Baseline (ie, less than a 2.07 fold difference from the Baseline value).  
 Pre anti-bimekizumab antibody positive – treatment emergent anti-bimekizumab 
antibody boosted positive: Includes subjects who are positive at Baseline and are positive at 
any sampling point post treatment (excluding SFU) with increased titer values compared to 
baseline (greater than a 2.07 fold difference increase from Baseline value which will be 
defined within the validation of the assay).  
 Inconclusive: Includes subjects who have a positive pre-treatment sample and some post-
treatment samples are missing, while other post-treatment samples are anti-bimekizumab 
antibody negative.  
Derivation for above classification will be different for the interim analysis and the final 
analysis. For the interim analysis no SFU data will be considered. Only for the final analysis, 
when all SFU data will be available, data from the SFU visits will be considered. That is, each 
instance of “excluding SFU” in the categories above, should be changed to “including SFU.”  
In the case that a sample is collected one or more days following the scheduled visit date in 
which the drug was administered, the anti-bimekizumab antibody results for that sample will be 
associated with the scheduled visit and summarized accordingly. Such samples will also be 
considered when anti-bimekizumab antibody results are summarized over a given study period.   
Analysis: 
Immunogenicity will be assessed through summary tables and figures, and listing of individual 
results by subject. All analyses will be run on the safety population, unless specified otherwise. 
 Number and percentage of subjects with anti-bimekizumab antibody level above the 
specified cut point at the time of each visit, separated by treatment group 
 Number and percentage of subjects with anti-bimekizumab antibody level above the 
specified cut point at any visit during the treatment period, separated by treatment group. 
 The time-point of the first occurrence of anti-bimekizumab anti-body positivity during 
the treatment period) will be summarized for each treatment group . A plot of the Titre 
versus elapsed time will be plotted 
 All individual subject-level anti-bimekizumab antibody results will be listed. 
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 The number and percentage of subject in each of the 6 categories will be tabulated and 
separated by treatment group with an additional category combining subjects in 
categories 2 and 5, summarized as total treatment emergent. In addition, the counts and 
percentage of subjects who are pre-anti-bimekizumab positive will be calculated (this is 
the sum of categories 3,4, and 5). 
 The prevalence of immunogenicity, separated by treatment group, and defined sub-
category, will be reported per time point, defined as (cumulative) proportion of subjects 
having confirmed positive ADAb samples at any point up to and including that time 
point. Missing samples will not be included in the denominator.  
 The time to achieving treatment-emergent ADAb positivity, separated by treatment group 
and defined sub-category, will be analyzed based on Kaplan-Meier approach, subjects 
will be considered to have an event at time where treatment emergent ADAb positive is 
first achieved. Subjects classified as treatment-emergent ADAb negative will be censored 
at time of last available ADAb result. 
 A summary of PASI 90 responder, separated by treatment group and defined sub-
category, at Weeks 16 and 52 as a function of ADAb titer will be presented graphically. 
This will be repeated for PASI 100 and 75 responders. 
 Individual plots of Bimekizumab Concentrations/ADAb titer and % Change from 
Baseline (all Y-axes) versus time (x-axis) for the full treatment period, including SFU 
where a patient has not progressed into the OLE. Plots should be labeled and grouped 
into the 6 sub-categories. 
 Spaghetti plots of ADAb titer (Y-axis) against time (X-axis), separated by treatment 
group for all ADAb positive subjects, including Baseline positive subjects. 
 Box plots of all Bimekizumab concentrations where ADAb titers exists versus ADAb 
titer classification (group 1 >; group 2 >; group 3 >) presented on a linear scale. Cut 
points will be determined on availability of the titre data. 
For purposes of efficacy subgroup analyses based on anti-bimekizumab antibody status, two 
categories will be used:  
 Anti-bimekizumab antibody positive – This is defined as subjects who have anti-
bimekizumab antibody levels above the specified cut point on at least 2 time points while on 
treatment (ie, excluding Baseline, excluding SFU).  
 Anti-bimekizumab antibody negative – Subjects who are not defined as anti-bimekizumab 
positive (as described above) will be defined as anti-bimekizumab antibody negative.   
 
10 
SAFETY ANALYSES 
If not specified otherwise, all safety summaries and listings will be created using all subjects in 
the SS. 
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The AMS will be used for summaries of safety that include data from the Initial Treatment 
Period and/or Maintenance Treatment Period. 
10.1 
Extent of exposure 
Summaries for exposure will be provided. This consists of a descriptive summary of study 
medication duration in days. In addition, total study medication duration and time at risk will be 
summarized in years by treatment group and treatment period (i.e., the Initial Treatment Period, 
the Maintenance Treatment Period, and the Initial and Maintenance Treatment Period). Summary 
of exposure in Maintenance Treatment Period will be on MS. The cumulative study medication 
duration will be summarized for subjects exposed for given durations of time, with four weekly 
categories through Week 16 and 24.  For the cumulative duration through Week 52 the following 
categories for duration will be used: 
 >0 weeks 
 >=16 weeks 
 >=24 weeks 
 >=52 weeks 
Definitions for study medication duration and time at risk in days are provided in this section. 
Time at risk will be summarized in years. Time at risk in years is calculated by dividing the time 
at risk in days by 365.25.  
Throughout this section, date of last clinical contact for each subject is defined as the maximum 
of [last visit date including SFU visit, last imputed AE start date, date of study termination or 
completion, last date of study drug administration]. 
10.1.1 
Exposure during the Initial Treatment Period 
Definitions for study medication duration (days) and time at risk (days) during the Initial Period 
are provided as follows: 
Study medication duration (days) 
 
Date of last dose in the Initial Period – date of first dose in the Initial Period + 28 days.  
Note: If date of last dose in the Initial Period + 28 days extends to a date beyond the date of first 
dose in the Maintenance Treatment Period, then this calculation reverts to:  
o Date of first dose in the Maintenance Treatment Period – date of first dose in the Initial 
Period + 1.  
Note: For subjects who die during the Initial Period, if date of last dose in the Initial Period + 28 
days extends to a date beyond the date of death, then this calculation reverts to:  
o Date of death – date of first dose in the Initial Period + 1. 
Time at risk (days) 
 For subjects who complete the final visit of the Initial Period and continue to the 
Maintenance Treatment Period: Date of first dose in the Maintenance Treatment Period – 
date of first dose in the Initial Period + 1. 
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 For subjects who die prior to the final visit of the Initial Period: Date of death – date of first 
dose in the Initial Period +1. 
 For subjects who discontinue on or prior to the final visit of the Initial Period, use the 
minimum of the following:  
 Date of last dose in the Initial Period – date of first dose in the Initial Period + 140 days. 
 The total number of days in the Initial Period. 
 Date of last clinical contact – date of first dose in the Initial Period + 1.  
10.1.2 
Exposure during the Maintenance Treatment Period 
Definitions for study medication duration (days) and time at risk (days) during the Maintenance 
Period are provided as follows: 
Study medication duration (days) 
 
Date of last dose in the Maintenance Treatment Period – date of first dose in the Maintenance 
Treatment Period + 28 days.  
Note: If date of last dose in the Maintenance Treatment Period + 28 days extends to a date 
beyond the final visit date of the Maintenance Treatment Period (including PEOT, but not 
including SFU), then this calculation reverts to:  
o Final visit date of the Maintenance Treatment Period (including PEOT, but not including 
SFU) – date of first dose in the Maintenance Treatment Period + 1.  
Note: For subjects who die during the Maintenance Treatment Period, if date of last dose in the 
Maintenance Treatment Period + 28 days extends to a date beyond the date of death, then this 
calculation reverts to:  
o Date of death – date of first dose in the Maintenance Treatment Period + 1. 
Time at risk (days) 
 
For subjects who complete the Maintenance Treatment Period as planned and continue into an open-
label study (and, therefore, do not have the SFU visit in the feeder study): Final visit date of the 
Maintenance Treatment Period – date of first dose in the Maintenance Treatment Period + 1. 
 
For subjects who die prior to the final visit of the Maintenance Treatment Period: Date of death – date 
of first dose in the Maintenance Treatment Period + 1. 
 
For all other subjects, use the minimum of the following:  
 
Date of last dose in the Maintenance Treatment Period – date of first dose in the Maintenance 
Treatment Period + 140 days. 
 
Date of last clinical contact – date of first dose in the Maintenance Treatment Period + 1.  
Note: This group could include subjects who discontinue the Maintenance Treatment Period 
early, subjects who complete the Maintenance Treatment Period as scheduled but choose not to 
continue into an open-label study, or subjects who are ongoing in the SFU period at the time of 
the data snapshot. 
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10.1.3 
Exposure during the Initial and Maintenance Treatment Period 
Definitions for study medication duration (days) and time at risk (days) during the entire study 
treatment period (the Initial and Maintenance Treatment Period combined) are provided as 
follows: 
Study medication duration (days) 
For subjects who do not switch study treatments: 
 
Date of last dose – date of first dose + 28 days.  
Note: If date of last dose + 28 days extends to a date beyond the final visit date (including PEOT, 
but  not including SFU), then this calculation reverts to:  
o Final visit date (including PEOT, but  not including SFU) – date of first dose + 1.  
Note: For subjects who die, if date of last dose + 28 days extends to a date beyond the date of 
death, then this calculation reverts to:  
o Date of death – date of first dose + 1. 
For subjects who switch study treatments (between Initial and Maintenance Treatment Periods): 
 
Initial Period (attributed to initially randomized treatment): 
o Date of last dose in the Initial Period – date of first dose in the Initial Period + 28 days.  
Note: If date of last dose in the Initial Period + 28 days extends to a date beyond the date 
of first dose in the Maintenance Treatment Period, then this calculation reverts to:  
o Date of first dose in the Maintenance Treatment Period – date of first dose in the Initial 
Period + 1.  
 
Maintenance Treatment Period (attributed to the treatment initiated in the Maintenance Treatment 
Period): 
o Use the study medication duration algorithm specified for the Maintenance Treatment 
Period. 
Time at risk (days):  
For subjects who do not switch study treatments: 
 
For subjects who complete the Maintenance Treatment Period as planned and continue into an open-
label study (and, therefore, do not have the SFU visit in the feeder study): Final visit date – date of 
first dose + 1. 
 
For subjects who die prior to the final visit: Date of death – date of first dose in the + 1. 
 
For all other subjects, use the minimum of the following:  
 
Date of last dose – date of first dose + 140 days. 
 
Date of last clinical contact – date of first dose + 1.  
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Note: This group could include subjects who discontinue early, subjects who complete the 
Maintenance Treatment Period as scheduled but choose not to continue into an open-label study, 
or subjects who are ongoing in the SFU period at the time of the data snapshot. 
For subjects who switch study treatments (between Initial and Maintenance Treatment Periods): 
 
Initial Period (attributed to initially randomized treatment): 
o Date of first dose in the Maintenance Treatment Period – date of first dose in the Initial 
Period + 1. (Note: This assumes that anyone in this category has completed the Initial 
Period and doses [with a new study treatment] in the Maintenance Treatment Period.) 
 
Maintenance Treatment Period (attributed to the treatment initiated in the Maintenance Treatment 
Period): 
o Use the time at risk algorithm specified for the Maintenance Treatment Period. 
A by-subject listing of exposure to study medications will be provided by treatment group. 
10.2 
Adverse events 
An AE is any untoward medical occurrence in a subject or clinical investigation subject 
administered a pharmaceutical product that does not necessarily have a causal relationship with 
this treatment. An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease temporally associated with the use of a 
medicinal (investigational) product, whether or not related to the medicinal (investigational) 
product.  
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities 
(MedDRA version 19.0). For subjects who switch from placebo to bimekizumab at Week 16, 
any adverse events that occur after initiation of the new treatment are attributable to the new 
treatment. If an adverse event occurs on the date of a treatment switch, the event is attributed to 
the original treatment. The only exception to this is if the AE fulfills any of the criteria specified 
below: 
 Events that fulfill the anaphylaxis criteria for acute events (refer to Appendix A in Section 
12.1) 
 Hypersensitivity events identified by the SMQ “Hypersensitivity (SMQ)” (see Section 12.1 
Appendix A) 
 Events with an HLT of “Administration site reactions NEC” 
 Events with an HLT of “Injection site reactions” 
10.2.1 
Data considerations 
Treatment-emergent AEs (TEAEs) are defined as those AEs that have a start date on or 
following the first dose of study treatment through the final dose of study treatment + 140 days 
(covering the 20-week SFU period). If it is not possible (due to partial dates) to determine 
whether or not an AE is treatment-emergent then it will be assumed to be a TEAE.  
The rules for imputing partial start or stop dates are outlined in Section 4.2.2 . 
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If the intensity of an adverse event is unknown, it is considered as severe. If the relationship to 
study drug is missing, it is considered as related. 
AEs will be presented as “number of subjects (percentage of subjects) [number of events]”.  In 
this style of output, “[number of events]” will include all cases of an AE including repeat 
occurrences in individual subjects, while “number of subjects” will count each subject only once. 
Subject time at risk represents the time a subject is at risk for having an AE. The definitions for 
subject time at risk (in days) are outlined in Section 10.1. These definitions will be used for 
exposure-adjusted AE summaries. 
Selected AE summaries will include the exposure adjusted incidence rate (EAIR) with associated 
95% confidence interval and the exposure adjusted event rate (EAER). 
The EAIR is defined as the number of subjects (n) with a specific AE adjusted for the exposure 
and will be scaled to 100 patient-years: 
 
𝐸𝐴𝐼𝑅= 100 × 𝑛/ ∑(𝑇𝐸𝑥𝑝(𝑖))
𝑁
𝑖=1
 
 
If a subject has multiple events, the time of exposure is calculated to the first occurrence of the 
AE being considered. If a subject has no events, the total time at risk is used. 
Exact Poisson 95% confidence intervals for incidence rates are calculated using the relationship 
between the Poisson and the Chi-square distribution (Ulm, 1990; Fay and Feuer, 1997): 
 
 
where n is the number of subjects with a specific AE for the incidence rate of interest and is the 
basis for the number of the degrees of freedom for the chi-square quantile for the upper tail 
probability χ2. 
The EAER will be the number of AEs including repeat occurrences in individual subjects 
divided by the total time at risk scaled to 100 patient-years and calculated using: 
 
𝐸𝐴𝐸𝑅= 100 × 𝑁𝐴𝐸/ ∑(𝑇𝑅𝑖𝑠𝑘(𝑖))
𝑁
𝑖=1
 
 
where NAE is the total number of AEs. 
No confidence interval will be computed for EAER. 
Selected summaries, as specified in Section 10.2.2, will include the risk difference between 
bimekizumab and ustekinumab. The risk difference is calculated as: 
𝑅𝐷= 𝐼𝑃𝐵𝐾𝑍−𝐼𝑃𝐴𝐷𝐴 
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where 𝐼𝑃𝐵𝐾𝑍 is the incidence proportion for the bimekizumab-treated group and 𝐼𝑃𝑃𝐵𝑂 is the 
incidence proportion for the placebo group. Note that incidence proportion simply refers to the 
percentage of subjects within the specified treatment group that experienced a given adverse 
event. 
The standard error for the risk difference is calculated as follows: 
𝑆𝐸𝑅𝐷= √(𝐼𝑃𝐵𝐾𝑍× (1 −𝐼𝑃𝐵𝐾𝑍
𝑛𝐵𝐾𝑍
)) + (𝐼𝑃𝑃𝐵𝑂× (1 −𝐼𝑃𝑃𝐵𝑂
𝑛𝑃𝐵𝑂
)) 
where 𝑛𝐵𝐾𝑍 is the number of subjects in the bimekizumab-treated group and 𝑛𝑃𝐵𝑂 is the number 
of subjects in the placebo group.  
The corresponding confidence interval for the risk difference is as follows: 
𝐶𝐼𝑅𝐷= 𝑅𝐷 ± 𝑍1−𝛼2
⁄ × (𝑆𝐸𝑅𝐷)  
where 𝑍1−𝛼2
⁄  is the 𝑍 statistic for the corresponding level of alpha. For the risk difference 
confidence intervals calculated in this SAP, 1.96 will be used (corresponding to a two-sided 
alpha of 0.05 and 95% confidence interval).  
 
10.2.2 
AE Summaries 
The following summaries will be provided in three different ways: by treatment in the Initial 
Treatment Period for the SS, by treatment during the Maintenance Treatment Period for the MS, 
and by treatment during the Initial and Maintenance Treatment Period (combined) for the AMS: 
 Incidence of TEAEs – Overview 
 Incidence of TEAEs per 100 subject years by SOC, HLT, and PT  
 Incidence of Serious TEAEs per 100 subject years by SOC, HLT, and PT  
 Incidence of TEAEs Leading to Discontinuation per 100 subject years by SOC, HLT, and PT  
The following summaries will be provided in two different ways: by treatment in the Initial 
Treatment Period for the SS, and by treatment in the Initial and Maintenance Treatment Period 
(combined) for the AMS: 
 Incidence of TEAEs Leading to Death by SOC, HLT, and PT  
 Incidence of TEAEs by Maximum Relationship by SOC, HLT, and PT  
 Incidence of Serious TEAEs by Relationship SOC, HLT, and PT  – Note: For EudraCT 
reporting purposes 
 Incidence of Related Serious TEAEs by SOC, HLT, and PT 
 Incidence of TEAEs Leading to Death by Relationship by SOC, HLT, and PT  – Note: For 
EudraCT reporting purposes  
 Incidence of TEAEs by Maximum Severity, SOC, HLT, and PT 
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 Incidence of TEAEs by decreasing frequency of PT 
 Incidence of Non-Serious TEAEs Above Reporting Threshold of 5% by SOC and PT 
 Incidence of Non-Serious TEAEs by SOC, HLT, and PT 
 Incidence of Non-Serious TEAEs by Maximum Relationship SOC, HLT, and PT 
 Incidence of Non-Serious TEAEs Above Reporting Threshold of 5% by SOC and PT 
 Incidence of Non-Serious TEAEs Above Reporting Threshold of 5% by Relationship SOC 
and PT 
 Incidence of Related TEAEs by SOC, HLT, and PT 
 Incidence of Related TEAEs Above Reporting Threshold of 5% by SOC and PT 
The following summary will be provided by treatment for the Initial Treatment Period for the 
SS: 
 Incidence of TEAEs Above Reporting Threshold of 5% with Risk Differences by SOC and 
PT 
 Incidence of Serious TEAEs and Risk Differences by SOC and PT  
 
The following summary will be provided by treatment for the Initial and Maintenance Treatment 
Period (combined) for the SS (only subjects treated with BKZ): 
 Incidence of TEAEs per 100 subject years by SOC, HLT, and PT and by Time of Onset 
Relative to Anti-bimekizumab Antibody Status  
In addition, all summaries of TEAEs based on “100 subject years” will include EAIR (with 95% 
confidence interval) and EAER. 
The tables with risk differences will also be accompanied by figures (dot plots) which show the 
incidence of the adverse events and corresponding 95% risk difference confidence intervals. 
These will be ordered by descending order of risk difference (bimekizumab vs ustekinumab). 
For AEs that emerged after 112 days but still within the 140 days window, those AEs would be 
classified as TEAE. These AEs will be excluded from the outputs based on the Initial Period but 
included in the AE summaries for Initial and Maintenance Treatment Period. 
10.2.3 
Other Safety topics of interest 
The following are AEs of other safety topics of interest that require special statistical analyses 
and will be provided in two different ways: by treatment in the Initial Treatment Period for the 
SS, and by treatment in the Initial and Maintenance Treatment Period (combined) for the AMS. 
Along with the tables described, there will be a table which displays the risk difference and 95% 
confidence intervals for each of the topics of interest. A corresponding figure (with dot plots) 
will be prepared. 
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10.2.3.1 
Infections (serious, opportunistic, fungal and TB) 
 Incidence of Serious Infection TEAEs per 100 subject years by SOC, HLT and PT  
Serious infections will be identified based on MedDRA classification (SOC “Infections and 
infestations”) using the “Any SAE” table. A separate table does not need to be produced to 
summarize these events. 
 Incidence of Fungal Infection TEAEs per 100 subject years by SOC, HLT and PT 
Fungal infections will be summarized in a stand-alone table. The table will include all 
TEAEs (serious and non-serious) which code into the High Level Group Term “Fungal 
infectious disorders” 
 Incidence of Opportunistic Infection TEAEs per 100 subject years by SOC, HLT and 
PT  
Opportunistic infections (including tuberculosis) will be summarized in a stand-alone table. 
The table will include all TEAEs identified using UCB-defined search criteria (refer to Excel 
spreadsheet on “OI - MedDRA v19.0.xlsx” in “Bimekizumab-Safety-Topics-of-
Interest.docx”).  
The following steps are followed for identifying and reviewing opportunistic infections: 
Identification Process 
The two steps below outline two ways in which opportunistic infections (or potential opportunistic 
infections) can be identified: 
Step 1: Refer to column B of the spreadsheet which identifies the Preferred Terms (PTs) to be 
classified as opportunistic infections using either a single ‘x’ or a double ‘xx’. 
 
TEAEs which code to a PT flagged with a single ‘x’ need to also be serious to be considered 
an opportunistic infection. 
 
All TEAEs which code to a PT flagged with a double ‘xx’ are considered to be an 
opportunistic infection, regardless of seriousness.  
Step 2: Refer to column C of the spreadsheet which identifies the PTs that need to be evaluated on a 
case-by-case basis by the study physician to determine whether or not it is an opportunistic infection. 
If Column C has a single ‘x’, then the corresponding preferred term should be flagged for case-by-
case review by the study physician.  
Review Process 
Opportunistic infections for a given study will be reviewed on the following occasions: 
 
At quarterly Infectious Disease Committee (IDC) Meetings, listings will be produced for each 
study (see details below) and reviewed by the corresponding study physician ahead of the 
IDC Meeting. These listings will be posted as part of the broader SSD deliverable to a folder 
named for the given quarter (eg, 2018Q4) on the SharePoint. They should be based on the 
same data cut as the one used for SSD and should be delivered at the same time as the SSD 
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outputs. The IDC will then agree on the final adjudication for each potential opportunistic 
infection. 
 
For each study, a final listing for opportunistic infections (in the format described below) will 
be produced and agreed upon between the study physician and the IDC prior to finalizing the 
database. 
In each of the circumstances described above, the study programming team will produce an Excel 
listing that will be provided to the project lead statistician, project lead programmer, and to the 
study physician (who will subsequently provide it to the IDC). The Excel listing will contain the 
following columns (using the descriptions below as the column headings in the Excel listing): 
 
Study ID 
 
Unique Subject ID 
 
AE Term (Verbatim) 
 
AE Preferred Term 
 
AE System Organ Class 
 
AE High Level Term 
 
AE Low Level Term 
 
Date of Onset 
 
Outcome of Adverse Event 
 
Date of Outcome 
 
TEAE Flag 
 
Serious Adverse Event? 
 
Relationship to Study Medication  
 
Intensity 
 
Action Taken with IMP 
 
Opportunistic Infection – Automatic 
 
Opportunistic Infection – Manual Review 
 
Flag 
 
Data Cut Date 
 
Opportunistic Infection – Final Adjudication 
Note the following about the final 5 variables in this listing: 
 
Opportunistic Infection – Automatic: This is flagged as “Y” if the criteria for automatic 
selection as described in “Step 1” of the identification process are met. 
 
Opportunistic Infection – Manual Review: This is flagged as “Y” if the criteria for case-
by-case selection as described in “Step 2” of the identification process are met. 
 
Flag – This has a value of either “NEW” or “OLD”. It is marked as “NEW” if the event 
is appearing for the first time in that run of the listing. Otherwise, if it has appeared 
previously, it is marked as “OLD”. Unique records are determined by USUBJID AESPID 
for purposes of identifying whether an event has been modified from a previous run. 
 
Date – Only for cases where Flag is “NEW”, this field will be populated with the data cut 
date for that particular run of the listing. 
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 
Opportunistic Infection – Final Adjudication – For new events, this is always left blank 
by the programmers. It should be completed by the study physician/IDC for every event 
that appears in the listing. For events adjudicated as opportunistic, the field should be 
populated with a “Y”.  
Following each review by the study physician and IDC, the Opportunistic Infection – Final 
Adjudication column will be completed (as described above), and the spreadsheets for each study 
will be returned to the study programming team via e-mail (coordinated by the IDC secretary). 
Then, for subsequent runs of the listing, the study programming teams will incorporate 
adjudications from previous runs. 
10.2.3.2 
Malignancies 
 Incidence of Malignant or Unspecified Tumours TEAEs per 100 subject years by SOC, 
HLT and PT 
These events will be presented in the following tables: 
 One table will be based on the criteria Standardized MedDRA Query (SMQ) = 
“Malignant or unspecified tumours (SMQ)”  
 One table will be based on the criteria SMQ = ”Malignant tumours (SMQ)”. 
SMQ search should include all TEAEs which code to a PT included in the Scope=Narrow group 
within each SMQ. 
Note that the events included in the “Malignancies” table will be a subset of the events included 
in the “Malignancies (including unspecified)” table. While the “Malignant tumours (SMQ)” is 
most relevant, “Malignant or unspecified tumours (SMQ)” must be reviewed for potential 
malignancies. 
The output tables will include 2 different overall incidence rows: 
 The first overall incidence row will summarize “Any malignancy”  and this row will 
summarize the incidence of all AEs flagged for inclusion in the table, (using the 
appropriate SMQ depending on the table) regardless of the High Level Term (HLT) it 
codes to.  
 The second overall incidence row will summarize “Any malignancy” and this row will 
summarize the incidence of AEs flagged for inclusion in the table (using the appropriate 
SMQ depending on the table), excluding those which code to an HLT of “skin neoplasms 
malignant and unspecified (excl melanoma)”. 
10.2.3.3 
Major adverse cardiac event  
 Incidence of Adjudicated Major Cardiac Event (MACE) TEAEs per 100 subject years 
by SOC, HLT and PT 
Major adverse cardiac events (MACE) will be presented in a table. The classification of an event 
as MACE is determined by an external cardiovascular event adjudication committee. 
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A separate table and listing will present the adjudicated cardiovascular events by type. For each 
cardiovascular event type (24 total), the individual PTs which fall within each event type will be 
summarized.  
Additionally, a listing of all events identified for potential review by the cardiovascular event 
adjudication committee will be produced. This listing will indicate whether each event was 
escalated to the committee for formal review/adjudication. 
10.2.3.4 
Neutropenia  
 Incidence of Neutropenia TEAEs per 100 subject years by SOC, HLT and PT 
This table will be based on the following PTs (regardless of seriousness): 
 Autoimmune neutropenia 
 Band neutrophil count decreased 
 Cyclic neutropenia 
 Febrile neutropenia 
 Idiopathic neutropenia 
 Neutropenia 
 Neutropenic infection 
 Neutropenic sepsis 
 Neutrophil count decreased 
10.2.3.5 
Suicidal Ideation and Behavior (SIB) 
 Incidence of SIB-Adjudicated Neuropsychiatric TEAEs per 100 subject years by SOC, 
HLT and PT 
An external neuropsychiatric adjudication committee will evaluate potential neuropsychiatric 
events and determine whether any of those events were associated with suicidal ideation and 
behavior (SIB). If an event is adjudicated as SIB, further information will be provided. A table 
and a separate listing for SIB events as determined by the adjudication committee will be 
included. 
Additionally, a listing of all events identified for potential review by the neuropsychiatric 
adjudication committee will be produced. This listing will indicate whether each event was 
escalated to the committee for formal review/adjudication. 
10.2.3.6 
Inflammatory bowel disease 
 Incidence of Inflammatory Bowel Disease TEAEs per 100 subject years by SOC, HLT 
and PT 
These events will be presented in a stand-alone table which will include all TEAEs which code 
into the HLT of “Colitis excl infective”. 
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Inflammatory bowel disease events will be summarized stratified by subjects with or without a 
previous medical history of inflammatory bowel disease. Previous medical history of 
inflammatory bowel disease will be determined using the information recorded on the Extra-
Articular Assessment at Screening CRF page (“Does subject have a history of IBD?”). 
10.2.3.7 
Anaphylactic reaction 
 Incidence of Anaphylactic Reaction TEAEs per 100 subject years by SOC, HLT and PT 
 A separate table will be prepared based on the MedDRA anaphylaxis Algorithm (see 
Appendix A) for acute anaphylactic events (reported on the same day as when an injection 
was administered or one day after). 
 A separate table will be prepared to summarize hypersensitivity events, identified using the 
SMQ “Hypersensitivity (SMQ)”. All TEAEs which code to a PT included in the 
Scope=Narrow search will be included in this table. 
Furthermore, injection site reactions will be evaluated based on the any TEAE table (no separate 
table needed) by looking under the following HLTs: “Administration site reactions NEC” and 
“Injection site reactions”. 
10.2.3.8 
Hepatic events and drug-induced liver injuries 
 Incidence of hepatic events TEAEs per 100 subject years by SOC, HLT and PT 
A table for hepatic events will be created based on the SMQ of “Drug related hepatic disorders - 
comprehensive search (SMQ)”. However, these 2 sub-SMQs are to be excluded: “Liver 
neoplasms, benign (incl cysts and polyps) (SMQ)” and “Liver neoplasms, malignant and 
unspecified (SMQ)”. For each of the above SMQs, include all TEAEs which code to a PT 
included in the Scope=Broad and/or Scope=Narrow. 
Note that all AEs meeting the above criteria are to be included. It should not be limited to events 
that the investigator determined to be related to study drug. 
Cases of Hy’s Law will be reported separately in a liver function test table. 
A by-subject listing of all AEs of safety topics of interest will be presented by type of safety 
topics of interest. 
10.3 
Clinical laboratory evaluations 
Laboratory values, including markedly abnormal laboratory values will be presented 
descriptively by treatment group for SS.  
Tables presenting markedly abnormal values and those based on CTCAE grade only include 
selected laboratory variables. 
For tables where data are summarized by visit, unscheduled and repeat visits will not be 
summarized, but these data will be included in listings. For tables where multiple measurements 
over a period of time are considered (as in shift tables), unscheduled and repeat visits will be 
considered as long as they were collected in the period being summarized. All summaries will be 
presented in SI units and will be based on observed case values. In the case where laboratory 
values are below the lower limit of quantification, then these will be set to the midpoint between 
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0 and the lower limit of quantification for the purpose of summarizing the data. The following 
summaries are required: 
 A summary of observed results and change from Baseline values in each laboratory variable 
by treatment group and visit for the SS 
 A summary of the number and percentage of subjects experiencing markedly abnormal 
values at any time while on treatment (assessment on or following the first dose of study 
treatment through the final dose of study treatment + 140 days) by laboratory variable and 
treatment group. Two separate tables will show results for the initial treatment period (for the 
SS) and the initial and maintenance treatment period (for the AMS). 
 A summary of the number and percentage of subjects with a given CTCAE grade (0, 1, 2, 3, 
or 4) based on minimum/maximum post-baseline value by laboratory variable and treatment 
group. Two separate tables will show results for the initial treatment period (for the SS) and 
the initial and maintenance treatment period (for the AMS). 
 A shift table of the number and percentage of subjects experiencing CTCAE grade 0, 1, 2, 3, 
or 4 values (as applicable) at Baseline to minimum/maximum post-Baseline CTCAE grade, 
by laboratory variable and treatment group. Two separate tables will show results for the 
initial treatment period (for the SS) and the initial and maintenance treatment period (for the 
AMS). 
Shift laboratory summaries will use the Baseline for Maintenance Treatment Period where 
applicable as described in Section 3.2. 
A by-subject listing of all laboratory data will be provided. This listing will be presented by 
treatment group and will include: center, subject identifier, age, sex, race, weight, visit, 
laboratory variable, result (with abnormal values flagged as “L” or “H” accordingly) and unit. 
Markedly abnormal values are defined as those with a severity of Grade 3 and above based on 
the common terminology criteria for adverse events (CTCAE) criteria (U.S. Department of 
Health and Human Services 2010). Definitions of markedly abnormal values using the Grade 3 
cut points are given in the tables below for age ranges of ≥17 years (Table 10-1 for markedly 
abnormal liver function test values, Table 10-2 for markedly abnormal biochemistry values, and 
Table 10-3 for markedly abnormal hematology values). Tables summarizing markedly abnormal 
values should include a summary (counts and percentages) of markedly abnormal labs observed 
at any time while on treatment (ie, treatment-emergent markedly abnormal [TEMA]). For this 
summary, Baseline values and values observed more than 140 days after the last administration 
of study medication are not considered. The laboratory results classified as Grade 3 or Grade 4 
will be summarized and listed separately. 
Table 10‒1: Definitions of Markedly Abnormal Liver Function Values 
 
Parameter name 
Conventional 
Standard 
Abnormal 
Designation 
Unit 
Criteria 
Unit 
Criteria 
Alkaline Phosphatase 
 
>5.0 x ULN 
 
>5.0 x ULN 
AH 
ALT 
U/L 
>5.0 x ULN 
U/L 
>5.0 x ULN 
AH 
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Conventional 
Standard 
Abnormal 
D
i
i
AST 
U/L 
>5.0 x ULN 
U/L 
>5.0 x ULN 
AH 
Total Bilirubin 
mg/dL 
>3.0 x ULN 
umol/L 
>3.0 x ULN 
AH 
GGT 
U/L 
>5.0 x ULN 
U/L 
>5.0 x ULN 
AH 
 
Table 10‒2: Definitions of Markedly Abnormal Biochemistry Values 
 
Parameter name 
Conventional 
Standard 
Abnormal 
Designation 
Unit 
Criteria 
Unit 
Criteria 
Creatinine 
mg/dL 
>3.0 x ULN 
mmol/L 
>3.0 x ULN 
AH 
Glucose 
mg/dL 
<40 
>250 
mmol/L 
<1.7 
>13.9 
AL 
AH 
Calcium 
mg/dL 
>12.5 
<7.0 
mmol/L 
>3.1 
<1.75 
AH 
AL 
Magnesium 
mg/dL 
>3.0 
<0.9 
mmol/L 
>1.23 
<0.4 
AH 
AL 
Potassium 
mmol/L 
>6.0 
<3.0 
mmol/L 
>6.0 
<3.0 
AH 
AL 
Sodium 
mmol/L 
>155 
<130 
mmol/L 
>155 
<130 
AH 
AL 
 
Table 10‒3: Definitions of Markedly Abnormal Hematology Values 
 
Parameter name 
Conventional 
Standard 
Abnormal 
Designation 
Unit 
Criteria 
Unit 
Criteria 
Hemoglobin 
g/dL 
<8.0 
>4.0 above ULN 
g/L 
<80 
>40 above ULN 
AL 
AH 
Lymphocytes Absolute 
109/L 
<0.5 
>20.0 
109/L 
<0.5 
>20.0 
AL 
AH 
Neutrophils Absolute 
109/L 
<1.0 
109/L 
<1.0 
AL 
Platelets 
109/L 
<50 
109/L 
<50 
AL 
WBC/Leukocytes 
109/L 
<2.0 
>100 
109/L 
<2.0 
>100 
AL 
AH 
Abbreviations: AH=abnormal high; AL=abnormal low; ALT= alanine aminotransferase; AST = aspartate 
aminotransferase; dL = deciliter; GGT: gamma-glutamyltransferase; L = liter; mg = milligram; mmol = 
millimoles; μg = microgram; ULN = upper limit of normal. 
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The table for markedly abnormal liver function tests (LFTs) will contain data beyond the 
CTCAE Grade 3 thresholds outlined in Table 10‒1: Definitions of Markedly Abnormal Liver 
Function Values above in order to allow for a more thorough review of elevated LFTs. There 
will be one table which will list the count and percentage of subjects meeting the below criteria 
at any time during the study: 
 AST: >3xULN, >5xULN, >8xULN, >10xULN, >20xULN 
 ALT: >3xULN, >5xULN, >8xULN, >10xULN, >20xULN 
 AST or ALT: >3xULN, >5xULN, >8xULN, >10xULN, >20xULN 
 Bilirubin: >1.5xULN, >2xULN 
In addition, a table will be produced to summarize potential Hy’s Law cases. The following two 
definitions will be used in that table: 
  [AST ≥3xULN or ALT ≥3xULN] and Total Bilirubin ≥2xULN in the absence of ALP 
≥2xULN  
In order to meet the above criteria, a subject must experience the elevation in bilirubin and ALT 
or AST (and the absence of ALP elevation, if applicable) at the same visit. For example, a 
subject who experiences a ≥2 x ULN elevation of bilirubin at one visit and a ≥3xULN elevation 
in ALT (or AST) at a subsequent visit has not fulfilled the Hy’s law criteria.   
 
10.4 
Vital signs, physical findings, and other observations related to 
safety 
10.4.1 
Vital signs 
The following vital signs variables should be summarized: systolic blood pressure (mmHg), 
diastolic blood pressure (mmHg), body temperature (°C) and heart rate (beats/min). The 
following summaries will be provided for SS: 
 A summary of the absolute and change from Baseline value for each vital sign variable by 
treatment group and visit 
 A summary of the number and percentage of subjects experiencing at least one markedly 
abnormal value for a vital sign variable as defined in Table 10‒4 , by treatment group. 
Table 10‒4: Definitions of Markedly Abnormal Blood Pressure Values 
Parameter (unit) 
Markedly Abnormal Low 
Markedly Abnormal High 
Systolic blood pressure (mmHg) 
<90 and a decrease from 
Baseline of ≥20 
>180 and an increase from 
Baseline of ≥20 
Diastolic blood pressure (mmHg) 
<50 and a decrease from 
Baseline of ≥15 
>105 and an increase from 
Baseline of ≥15 
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A by-subject listing of all vital signs data will be provided. This listing should be presented by 
treatment group and will include: center, subject identifier, age, sex, race, weight, visit, vital sign 
variable and result (with abnormal values flagged as “L” or “H” accordingly). 
10.4.2 
Physical examination 
Abnormal results of the physical examination together with details of abnormalities: abnormality 
clinically significant or not, will be listed by subject and visit for SS. 
10.4.3 
Electrocardiograms  
Electrocardiogram data will be analyzed by treatment group and visit for SS.  
A summary of the number and percentage of subjects with normal, abnormal ECG results, as 
determined by the central reader will be presented for all applicable visits.  
The following ECG variables will be summarized (absolute values and change from Baseline) by 
visit: QTcF, RR, PR, QRS and QT. 
QTc outliers are defined as QTcF values following dosing that are greater than 450 ms or are 
increases from Baseline greater than 30 ms.  QTcF outliers will be highlighted in the data listing 
and summarized using the following categories: 
 Values >450 ms, >480 ms, >500 ms 
 Increase from Baseline of >30 ms, increase from Baseline of >60 ms, increase from Baseline 
of >90 ms 
 Values >450 ms and increases of >30 ms.  Values >500 ms and increases of >60 ms 
The number and percentage of subjects who meet the ECG outlier criteria at any assessment post 
first dose will be summarized. 
Two separate by-subject listings of all 12-lead ECG data will be provided based on interpretation 
from central reader and from site. 
10.4.4 
Other safety variables 
10.4.4.1 
Assessment and management of TB and TB risk factors 
A summary of the number and percentage of subjects with negative, positive, and indeterminate   
IGRA (Interferon-Gamma Release Assay) results at all applicable visits will be presented for the 
Initial and Maintenance Treatment Period (combined). 
A by-subject listing of the “Evaluation of signs and symptoms of tuberculosis” questionnaire 
data and IGRA results will be provided by treatment group. 
A by-subject listing of the result of chest x-ray for tuberculosis will be provided by treatment 
group. 
10.4.4.2 
Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) 
eC-SSRS questionnaire will be self-administered by the subject and assessed by trained study 
personnel. This scale will be used to assess suicidal ideation and behavior that may occur during 
the study. Results of the eC-SSRS will be summarized using the number of subject and 
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percentage with (i) suicidal ideation, (iii) suicidal behavior, (iii) suicidal ideation or behavior, 
and (iv) self-injurious behavior without suicidal intent. 
Suicidal ideation is defined as an event in any of the following 5 categories: 
 
 
 
 
 
Suicidal behavior is defined as an event in any of the following 4 categories: 
 
 
 
 
 
 
 
 
Suicidal behavior or ideation is defined as an event in any of the above 9 categories. 
Self-injurious behavior without suicidal intent is defined as an event in the category non-suicidal 
self-injurious injuries. 
The incidence of subjects with suicidal ideation, suicidal behavior, suicidal ideation or behavior, 
and self-injurious behavior will be summarized by treatment group.   
A by-subject listing of the eC-SSRS questionnaire data will be provided by treatment group. 
10.4.4.3 
Pregnancy testing 
Pregnancy testing will consist of serum testing at the Screening. The pregnancy test will be urine 
at all other visits. 
A by-subject listing of the pregnancy test data will be provided by treatment group. 
10.4.4.4 
Childbearing potential and Lifestyle 
Childbearing potential and lifestyle will be collected at Screening. A by-subject listing will be 
provided for all the subjects screened. 
10.4.4.5 
Patient Health Questionnaire 9 (PHQ-9) scores 
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring 
the severity of depression. The PHQ-9 scores for depression range from 0 to 27 with higher 
scores indicating worse state. A score of 5-9 is considered to be minimal symptoms of 
depression. A score of 10 to 14 is considered minor depression, dysthymia, or mild major 
depression. A score of 15 to 19 is considered to indicate moderately severe major depression, 
and a score ≥20 is considered to be severe major depression. Change from Baseline in PHQ-9 is 
derived as post-Baseline score minus Baseline score and will be summarized by treatment group.  
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Different to other safety variables, PHQ-9 will be summarized using the MCMC/monotone 
regression approach described for continuous variable. A table for the SS through Week 52 will 
be produced as well as a table for subjects switching from Placebo to bimekizumab for the MS. 
 
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11 
REFERENCES 
Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. Interpreting the 
clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT 
recommendations. J Pain. 2008;9(2):105-21.  
Fay MP, Feuer EJ. Confidence intervals for directly standardized rates: A method based on the 
gamma distribution. Statistics in Medicine 1997; 16(7):791-801 
Felson DT, Anderson JJ, Boers M, Bombardier C, Chernoff M, Fried B, et al. The American 
College of Rheumatology preliminary core set of disease activity measures for rheumatoid 
arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical 
Trials. Arthritis Rheum. 1993;36(6):729-40.  
Food and Drug Administration. Guidance for Industry. Drug-induced liver injury: premarketing 
clinical evaluation. US Dept of Health and Human Services, Center for Drug Evaluation and 
Research, Center for Biologics Evaluation and Research, 07/2009. 
Greenland S, Robins JM. Estimation of common effect parameter from sparse follow up data. 
Biometrics 1985;41:55-68. 
Husni ME, Qureshi AA, Keonig AS, Pedersen R, Robertson D. Utility of the PASE 
questionnaire, psoriatic arthritis (PsA) prevalenece and PsA improvement with anti-TNF 
therapy: results from the PRISTINE trial. J Dermatolog Treat. 2014;25(1):90-5. 
Mallinckrodt CH, Watkin JG, Molenberghs G, Carroll RJ. Choice of the primary analysis in 
longitudinal clinical trials. Pharmaceutical Statistics 2004; 3:161-69 
Mallinckrodt CH, Lin Q, Lipkovich I, and Molenberghs G. A structured approach to choosing 
estimands and estimators in longitudinal clinical trials. Pharmaceutical Statistics 2012; 11:456-
61. 
Mallinckrodt CH. Preventing and Treating Missing Data in Longitudinal Clinical Trials: A 
Practical Guide. New York, NY: Cambridge University Press; 2013. 
Maruish, M. E., User’s manual for the SF-36v2 Health Survey (3rd ed.). Lincoln, RI: Quality 
Metric Incorporated, 2011. 
Ratitch, B., Lipkovich, I., O’Kelly, M. Combining Analysis Results from Mutiply Imputed 
Categorical Data, PharmaSUG, 2013, SP03 
Rubin D.B. 1987. Multiple Imputation for Nonresponse in Surveys. New York: John Wiley and 
Sons. 
Thomas, D. Roland and Cyr, Andre. Applying Item Response Theory Methods to Complex 
Survey Data. SSC Annual Meeting, May 2002. 
Ulm, K., A simple method to calculate the confidence interval of a standardized mortality ratio. 
American Journal of Epidemiology, 1990; 131(12), 373-375 
U.S. Department of Health and Human Services, Common Terminology Criteria for Adverse 
Events (CTCAE), Version 4.0, June 2010. 
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12 
APPENDIX 
12.1 
Appendix A: MedDRA algorithmic approach to anaphyalaxis 
The SMQ Anaphylactic reaction consists of three parts:  
 
 A narrow search containing PTs that represent core anaphylactic reaction terms  
 
 A broad search that contains additional terms that are added to those included in the narrow 
search. These additional terms are signs and symptoms possibly indicative of anaphylactic 
reaction and categorized in B, C or D  
 Cat B   
 
 
 
 
 
 
 
 
 
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 Cat C 
 
 
 
 
 
 Cat D 
 
 An algorithmic approach which combines a number of anaphylactic reaction symptoms in 
order to increase specificity. A case must include either (on either the same day as when an 
injection was administered or one day after):  
 A narrow term or a term from Category A;  
 A term from Category B - (Upper Airway/Respiratory) AND a term from Category C - 
(Angioedema/Urticaria/Pruritus/Flush);  
 A term from Category D - (Cardiovascular/Hypotension) AND [a term from Category B - 
(Upper Airway/Respiratory) OR a term from Category C - (Angioedema/Urticaria/ 
Pruritus/Flush)]  
 Hypersensitivity events will be identified using the “Hypersensitivity (SMQ)”. All TEAEs 
which code to a PT included in the Scope=Narrow search will be included.   
 
 
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12.2 
Appendix B: Definition of CTCAE grades 
Table 12‒1:  Definitions of CTCAE grades by biochemistry parameter 
Parameter (unit) 
Definition 
Unit 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Creatinine 
High 
mmol/L 
>ULN-1.5 x 
ULN 
(>1.5 – 3.0) 
x ULN 
(>3.0 – 6.0) 
x ULN 
6.0 x ULN 
Sodium 
Low 
mmol/L 
130-<LLN 
N/A 
120-<130 
<120 
Sodium 
High 
mmol/L 
>ULN-150 
>150-155 
>155-160 
>160 
Potassium 
Low 
mmol/L 
3.0-<LLN 
3.0-<LLN 
2.5-<3.0 
<2.5 
Potassium 
High 
mmol/L 
>ULN-5.5 
>5.5-6.0 
>6.0-7.0 
>7.0 
Calcium 
Low 
mmol/L 
2.0-<LLN 
1.75-<2.0 
1.5-<1.75 
<1.5 
Calcium 
High 
mmol/L 
>ULN-2.9 
>2.9-3.1 
>3.1-3.4 
>3.4 
Magnesium 
Low 
mmol/L 
0.5-<LLN 
0.4-<0.5 
0.3-<0.4 
<0.3 
Magnesium 
High 
mmol/L 
>ULN-1.23 
N/A 
>1.23-3.30 
>3.30 
Table 12‒2:  Definitions of CTCAE grades by hematology parameter 
Parameter (unit) 
Definition 
Unit 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Hemoglobin 
Low 
g/L 
100-<LLN 
80-<100 
<80 
N/A 
Hemoglobin 
High 
g/L 
>0-20 above 
BL 
>20-40 
above BL 
>40 above 
BL 
N/A 
Platelets 
Low 
109/L 
75-<LLN 
50-<75 
25-<50 
<25 
WBC 
Low 
109/L 
3-<LLN 
2-<3 
1-<2 
<1 
WBC 
High 
109/L 
N/A 
N/A 
>100 
N/A 
Lymphocytes 
Low 
109/L 
0.8-<LLN 
0.5-<0.8 
0.2-<0.5 
<0.2 
Lymphocytes 
High 
109/L 
N/A 
>4-20 
>20 
N/A 
Neutrophils 
Low 
109/L 
1.5-<LLN 
1.0-<1.5 
0.5-<1.0 
<0.5 
Note that subjects who meet the decreased potassium criterion of 3.0< LLN, which is specified 
as the decreased potassium lab criterion for both CTCAE Grade 1 and Grade 2, will be counted 
as Grade 2.  
 
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13 
AMENDMENT(S) TO THE STATISTICAL ANALYSIS PLAN  
13.1 
Amendment 1 
Rationale of the Amendment 
The main purpose of this amendment is to align the SAP with protocol amendment 3 and to 
achieve consistency with other SAPs of the program. 
Modification and changes 
Global Changes 
The following changes were made throughout the SAP 
- 
As no PD analysis will be performed (see specific change #4) references to PD or the PD-
PPS have been removed from the SAP 
- 
For the following endpoints, the definition of response has been clarified by adding the 
requirement of an improvement of at least two categories: 
o Scalp IGA response (clear or almost clear with at least a two-category 
improvement from Baseline) for subjects with scalp PSO at Baseline 
o Palmoplantar Investigator’s Global Assessment (pp-IGA) response (clear or 
almost clear with at least a two-category improvement from Baseline) for 
subjects with palmoplantar PSO at Baseline 
- 
The following changes have been done for the list of participating countries throughout 
the SAP: 
o Region (North America [Canada, USA], Western Europe [Belgium, France, 
Germany, Italy, Norway, Spain, Sweden, Switzerland, United Kingdom], 
Central/Eastern Europe [Czech Republic, Hungary, Poland, Russian Federation], 
Asia/Australia [Australia, Japan, Korea, Taiwan]) 
- 
Throughout section 8.1 the term ‘responder’ has been replaced by ‘response’ (e.g. 
PASI100 response at Week 16 instead of PASI100 responder at Week 16) 
 
Specific Changes 
Change #1 
List of abbreviation 
The following abbreviations have been added: 
ADAb 
anti-bimekizumab antibodies 
LFT 
liver function test 
MedDRA 
Medical Dictionary for Regulatory Activities 
nADAb 
neutralizing anti-bimekizumab antibodies 
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ADAb 
anti-bimekizumab antibodies 
The following abbreviations have been removed: 
DAP 
Data Analysis Plan 
DILI 
Drug-induced liver injury 
HLGT 
Higher level group term 
LTB 
Latent tuberculosis 
PD-PPS 
Pharmacodynamics Per-Protocol Set 
SOP 
Standard operating procedure 
 
Change #2 
1 Introduction 
Protocol Amendment 2.1, 15 Nov 2017  
Has been changed to to  
Protocol Amendment 3, 06 Apr 2018. 
 
Change #3 
Section 2.2.1.3 Other efficacy variables 
The following variables have been added: 
 Percent of subjects with absolute PASI score ≤1, ≤2, ≤3, and ≤5 
 Percent of subjects with absolute BSA=0%, ≤1%, ≤3%, and ≤5% 
 mNAPSI75 response (defined as a subject that achieves at least a 75% reduction from 
Baseline in the mNAPSI score) 
 mNAPSI90 response (defined as a subject that achieves at least a 90% reduction from 
Baseline in the mNAPSI score) 
 mNAPSI100 response (defined as a subject that achieves a 100% reduction from 
Baseline in the mNAPSI score) 
 
Change #4 
2.2.2 Pharmacokinetic/pharmacodynamic variables 
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The pharmacokinetic (PK) variable is the plasma concentration of bimekizumab.  
For subjects enrolled in participating centers, immunophenotyping by flow cytometry on whole 
blood will be performed. 
Has been changed to  
2.2.2 Pharmacokinetic variable 
The pharmacokinetic (PK) variable is the plasma concentration of bimekizumab.  
 
Change #5 
2.3.1 Study Description 
This study will include 4 periods, a Screening Period (2 to 4 weeks), an Initial Treatment Period 
(16 weeks), a Maintenance Treatment Period (36 weeks), and a safety follow-up (SFU) Period 
(20 weeks after the last dose of IMP). 
Has been changed to 
This study will include 4 periods, a Screening Period (2 to 4 weeks), an Initial Treatment Period 
(16 weeks), a Maintenance Treatment Period (36 weeks), and a safety follow-up (SFU) Period 
(20 weeks after the final dose of IMP). The Maintenance Treatment Period starts with the 
first study drug administration on or after the Week 16 visit. 
 
Change #6 
2.3.2.1 Screening Period 
The Screening Period will last 2 weeks, but can be extended up to a total of 4 weeks. 
Has been changed to 
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. 
 
Change #7 
2.3.2.2 Initial Treatment Period 
For subjects weighing ≤100kg (220lbs)… 
Has been changed to 
For subjects weighing ≤100kg (220lbs) at Baseline… 
 
Change #8 
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3.2 Definition of Baseline Value 
The following variables have been removed from the list of variables that will have an additional 
Week 16 Baseline defined: 
 PASI75 
 PASI90 
 PASI100 
 Percentage of BSA 
 Product of IGA and BSA (IGAxBSA) 
 Patient Global Assessment of PSO 
 mNAPSI 
 HAQ-DI 
 SF-36 
 EQ-5D-3L VAS 
 WPAI-SHP V2.0 
Only the following variables remained in the list: 
 PASI score 
 DLQI 
 
Change #9 
3.7 Center pooling strategy and 4.2.1.6 Missing data algorithms 
The following pooling strategy has been added to sections 3.7 and 4.2.1.6: 
In the event that the percentage of randomized subjects is less than 10% in either of the 
Asia/Australia or Western Europe regions, the two regions will be combined as a 
geographic region stratum for efficacy modeling, so that there are no modeling 
convergence issues across efficacy variables. 
 
Change #10 
3.10 Changes to protocol-defined analyses 
The following text has been added to section 3.10: 
For the following endpoints, the definition of response has been clarified: 
 Scalp IGA response (clear or almost clear with at least a two-category improvement 
from Baseline) for subjects with scalp PSO at Baseline 
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 Palmoplantar Investigator’s Global Assessment (pp-IGA) response (clear or almost 
clear with at least a two-category improvement from Baseline) for subjects with 
palmoplantar PSO at Baseline 
The following endpoints are not listed in the protocol, but have been added to the SAP in 
order to achieve consistency with other studies from the program: 
 mNAPSI75/90/100 response (defined as a subject that achieves at least a 75%, 90% and 
100% reduction from Baseline in the mNAPSI score) 
 Percent of subjects with absolute PASI score ≤1, ≤2, ≤3, and ≤5 
 Percent of subjects with absolute BSA=0%, ≤1%, ≤3%, and ≤5% 
 
Change #11 
4.2.1.1 Handling missing data for the primary efficacy variable 
In addition, sensitivity analyses using MI-MCMC/monotone regression, MI-MCMC/reference 
based methods, and observed case (OC) method will be performed which will assess the impact 
of different methods of handling missing data. 
Has been changed to 
In addition, sensitivity analyses using MI-MCMC/monotone regression, MI-MCMC/reference 
based methods, last observation carried forward (LOCF), and observed case (OC) method 
will be performed which will assess the impact of different methods of handling missing data. 
 
Change #12 
4.2.1.4 Handling missing data for other efficacy variables 
For other ordinal variables (EQ-5D-3L and Patient Global Assessment of PSO), OC method will 
be applied as the primary analysis method. 
Has been changed to 
For other ordinal variables (EQ-5D-3L, shift in IGA score, and Patient Global Assessment of 
PSO), OC method will be applied as the primary analysis method. 
 
Change #13 
4.2.1.5 Missing data overview and summary 
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Table 13‒1: Missing data handling approach by variable priority and type 
Variable 
Priority 
Variable Type 
NRI 
MI 
(MCMC/ 
Monotone 
Regression) 
MI 
(MCMC/ 
Reference-
based) 
LOCF 
OC 
Primary 
Responder 
P 
Sa 
Sa 
 
S 
Secondary 
Responder 
P 
Sa 
 
 
S 
Continuous 
 
P 
 
B 
S 
Other 
Responder 
P 
 
 
 
Sb, c 
Continuousf 
 
P 
 
B 
Sb, d 
Ordinal 
 
 
 
 
Pe 
P=Primary method, S=Sensitivity method, B=Backup method 
Note: Backup method is only applicable when the primary method is unable to converge due to challenges with the 
imputation model. 
a Imputation method is applied on continuous data, and responder variable is derived from the continuous variable 
based on complete data set. 
b Only applies to by-visit summaries of variables that are in the multiplicity-controlled testing procedure. 
c Includes PASI75, PASI90, Scalp IGA, IGA 
d Includes PSD of PSO for pain, itch, and scaling 
e includes Patient Global Assessment of PSO and EQ-5D-3L  
f For PASE, OC is the primary analysis method. 
Has been changed to 
Table 13‒1: Missing data handling approach by variable priority and type 
Variable 
Priority 
Variable Type 
NRI 
MI 
(MCMC/ 
Monotone 
Regression) 
MI 
(MCMC/ 
Reference-
based) 
LOCF 
OC 
Primary 
Responder 
P 
Sa 
Sa 
S 
S 
Secondary 
Responder 
P 
Sa 
 
 
S 
Continuous 
 
P 
 
B 
S 
Other 
Responder 
P 
 
 
 
Sb, c 
Continuousf 
 
P 
 
B 
Sb, d 
Ordinal 
 
 
 
 
Pe 
P=Primary method, S=Sensitivity method, B=Backup method, NRI=Nonresponder imputation, MI=Multiple 
imputation, MCMC=Markov Chain Monte Carlo, LOCF=Last observation carried forward, OC=Observed 
Case 
Note: Backup method is only applicable when the primary method is unable to converge due to challenges with the 
imputation model. 
a Imputation method is applied on continuous data, and responder variable is derived from the continuous variable 
based on complete data set. 
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b Only applies to by-visit summaries of variables that are in the multiplicity-controlled testing procedure. 
c Includes PASI75, PASI90, PASI100, Scalp IGA, IGA response 
d Includes PSD of PSO for pain, itch, and scaling 
e includes Patient Global Assessment of PSO, IGA score, and EQ-5D-3L  
f For PASE, OC is the primary analysis method. 
 
Change #14 
4.2.1.6 Missing data algorithms 
In bullet point 1 the following sentences have been added: 
The seed used for these imputations will be 852 (note that all other multiple imputation 
procedures described in this SAP related to analyses will use this same seed as well). 
The following sentence has been added (as already mentioned in Change #9): 
In the event that the percentage of randomized subjects is less than 10% in either of the 
Asia/Australia or Western Europe regions, the two regions will be combined as a 
geographic region stratum for efficacy modeling, so that there are no modeling 
convergence issues across efficacy variables. 
In bullet point 2d the seed range has been specified: 
Repeat steps 2a-2d, 100 times with different seed values (seeds ranging from 853 to 952) to 
create 100 imputed complete data sets. 
 
Change #15 
4.8 Examination of subgroups 
Subgroup analyses will be performed on the PASI75/90/100 and IGA. The following subgroup 
analyses will be used:  
 Age (<40 years, 40 to <65 years, ≥65 years) 
 Gender (male, female) 
 Disease duration (<median, ≥median) 
 Region (North America [Canada, USA], Western Europe [Belgium, France, Germany, Italy, 
Norway, Spain, Sweden, Switzerland, United Kingdom], Central/Eastern Europe [Czech 
Republic, Hungary, Poland, Russian Federation], Asia/Australia [Australia, Japan, Korea, 
Taiwan]) 
 Weight (≤100 kg, >100 kg) 
 BMI (<25 kg/m2, 25 to <30 kg/m2, ≥30 kg/m2) 
 Prior systemic chemotherapy or photochemotherapy (yes, no) 
 Prior biologic exposure (yes, no) 
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 Prior systemic therapy of any kind (yes, no) 
 Baseline disease severity (PASI<20, PASI≥20)  
 Antibody positivity (negative, positive) 
The definition of prior systemic therapy of any kind is if a subject received previous biologic 
therapy, previous systemic therapy (non-biologic), or previous systemic photochemotherapy or 
phototherapy. Subjects who never received previous biologic therapy, previous systemic therapy 
(non-biologic), or previous systemic photochemotherapy or phototherapy will be classified as not 
receiving prior systemic treatment for psoriasis.  
Has been changed to 
4.8 Examination of subgroups 
Subgroup analyses will be performed on the PASI75/90/100 and IGA. The following subgroups 
for analysis will be determined using Baseline data:  
 Age (<40 years, 40 to <65 years, ≥65 years) 
 Gender (male, female) 
 Disease duration (<median, ≥median) 
 Region (North America [Canada, USA], Western Europe [Belgium, Germany, Italy, 
United Kingdom], Central/Eastern Europe [Hungary, Poland, Russian Federation], 
Asia/Australia [Australia, Japan]) 
 Weight (≤100 kg, >100 kg) 
 BMI (<25 kg/m2, 25 to <30 kg/m2, ≥30 kg/m2) 
 Prior systemic chemotherapy or phototherapy (yes, no) 
 Prior biologic exposure (yes, no) 
 Prior systemic therapy of any kind (yes, no) 
 Baseline disease severity (PASI<20, PASI≥20)  
 Antibody positivity (confirmatory assay: negative or positive) 
The definition of prior systemic therapy of any kind is if a subject received previous biologic 
therapy, previous systemic therapy (non-biologic), or previous systemic chemotherapy or 
phototherapy. Subjects who never received previous biologic therapy, previous systemic therapy 
(non-biologic), or previous systemic chemotherapy or phototherapy will be classified as not 
receiving prior systemic treatment for psoriasis.  
In addition, in order to assess whether an early response to treatment is predictive of 
response at later time points, subgroup analyses will be performed on PASI90/100 and IGA 
over time using the following early response subgroups: 
 PASI75 response at Week 4 (yes, no) to predict PASI90/100 and IGA through Week 16 
 PASI90 response at Week 16 (yes, no) to predict PASI100 through Week 52 
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Change #16 
6 DEMOGRAPHICS AND OTHER BASELINE CHARACTERISTICS 
All summaries detailed in this section will be performed on the SS by treatment group. 
Summaries for demographics and other Baseline characteristics will also be repeated in FAS and 
MS. If the SS and FAS analysis sets are identical the summaries will not be repeated. 
Has been changed to 
All summaries detailed in this section will be performed on the RS by treatment group. 
Summaries for demographics and other Baseline characteristics will also be repeated in SS and 
MS. If the RS and SS analysis sets are identical the summaries will not be repeated. 
 
Change #17 
6.2 Other Baseline Characteristics 
 Prior phototherapy or chemophototherapy (yes, no) 
Has been changed to 
 Prior phototherapy or chemotherapy (yes, no) 
 
Change #18 
7 MEASUREMENTS OF TREATMENT COMPLIANCE 
Table 7-1 has been added: 
Table 13‒1: Dosing scheme 
Week 
Dose 
Assignment 
Baselin
e (first 
dose) 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
Bimekizumab 
320mg Q4W 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
Ustekinumab 
45mg (subjects 
≤100kg) 
▲○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
▲○ 
○○ 
○○ 
Ustekinumab 
90mg (subjects 
>100kg) 
▲▲ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
▲▲ 
○○ 
○○ 
Placebo/ 
bimekizumab 
320mg Q4W 
○○ 
○○ 
○○ 
○○ 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
Q4W=every 4 weeks 
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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 ustekinumab 45mg injection is depicted by a black triangle (▲). 
 
Change #19 
8.1.1.1 
Psoriasis Area and Severity Index (PASI) 
The following clarification has been added: 
PASI90 is defined to be equal to 1 if the percentage improvement from Baseline in the 
PASI scores is 90% or greater and 0 if the percentage improvement from Baseline is less 
than 90%. This definition is introduced for the purpose of identifying subjects who respond 
to the treatment (1 = responder, 0 = non-responder). 
 
Change #20 
8.1.3 Sensitivity analyses of the co-primary efficacy variables 
Sensitivity Analysis #4  
The primary efficacy analyses from Section 8.1.2 will be repeated based on the FAS and the 
PPS.  
Has been changed to 
The primary efficacy analyses from Section 8.1.2 will be repeated using LOCF as the 
imputation method (see Section 4.2.1.5). 
Sensitivity Analysis 5 has been added: 
Sensitivity Analysis #5 
The primary efficacy analyses from Section 8.1.2 will be repeated based on the FAS and the 
PPS.  
Sensitivity Analysis #6 (previously Sensitivity Analysis #5) 
In addition, if the logistic regression model cannot converge due to lack of any placebo 
responders, then Fisher’s exact test will be used for inferential comparisons to placebo. As with 
the primary analysis, missing data will be handled using NRI. 
Has been changed to 
In addition, if the logistic regression model cannot converge, then Fisher’s exact test will be used 
for inferential comparisons. As with the primary analysis, missing data will be handled using 
NRI. 
And 
Sensitivity Analysis #7 from SAP version 1.0 has been removed from SAP amendment 1. 
 
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Change #21 
8.2.3 Sensitivity analyses of the secondary efficacy variables 
For binary response variables (PASI100 at Week 16, PASI75 at Week 4, Scalp IGA at Week 16, 
PASI90 at Weeks 12 and 52, and IGA at Weeks 12 and 52), sensitivity analyses #1 and #3 
(Sections 8.1.3.1, 8.1.3.3 ) will be performed.  
In addition, for PASI90 and IGA response at Week 52, sensitivity analysis #7 will be performed. 
For change from Baseline in PSD response for itch, pain, and scaling, sensitivity analyses #3 
(Section 8.1.3.3 ) will be performed.  
Details regarding Missing data algorithm can be found in Section 4.2.1.6. 
Has been changed to 
Sensitivity analyses for the handling of missing data will be performed for the binary and 
continuous secondary efficacy variables that are part of the fixed sequence testing 
procedures in Figure 4‒1. 
For binary response variables (PASI100 at Week 16, PASI75 at Week 4, Scalp IGA at Week 16, 
PASI90 at Weeks 12 and 52, and IGA at Weeks 12 and 52), sensitivity analyses #1 and #3 
(Sections 8.1.3.1, 8.1.3.3 ) will be performed.  
For change from Baseline in PSD response for itch, pain, and scaling, sensitivity analyses #3 
(observed cases, Section 8.1.3.3 ) will be performed.  
Missing data for binary secondary efficacy variables will be imputed using NRI. 
Missing data for continuous secondary efficacy variables will be imputed using MI. The MI 
procedure for continuous variables will be similar to sensitivity analysis #1 described in 
Section 8.1.3.1 for the co-primary efficacy endpoints 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; and 2) the analysis model will be based on ANCOVA 
as opposed to the stratified CMH test. 
 
Change #22 
8.3.2 Modified Nail Psoriasis Severity Index (mNAPSI) score  
The following sentence has been added 
An mNAPSI75 responder is defined as a subject who achieved at least a 75% improvement 
from Baseline in the mNAPSI score. mNAPSI90 and mNAPSI100 are defined accordingly. 
The proportion of mNAPSI75/90/100 responders over time will be summarized for each 
treatment group. 
 
Change #23 
8.3.3 IGA response 
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A line plot of the IGA, scalp IGA responder rate over time, by treatment group will be produced. 
Has been changed to 
A line plot of the IGA responder rate over time, by treatment group will be produced. 
 
Change #24 
8.3.6 Dermatology Life Quality Index (DLQI) 
Percent of subjects achieving a minimal clinically important difference (MICD) in DLQI is 
defined as the number of subjects with improvement from Baseline score of 4 or more divided by 
the number of subjects in RS. 
Has been changed to 
Percent of subjects achieving a MCID in DLQI is defined as the number of subjects with 
improvement from Baseline score of 4 or more divided by the number of subjects in RS. Only 
subjects with a Baseline DLQI of 4 or greater will be considered for this analysis. 
 
Change #25 
8.3.7 Patient's Global Assessment of Disease Activity (PGADA) 
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.” 
Change from Baseline in PGADA is defined as Post-Baseline PGADA minus Baseline PGADA. 
Has been changed to 
8.3.7 Patient's Global Assessment of Disease Activity (PGADA) for arthritis visual analog 
scale (VAS) 
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 the protocol.  
Change from Baseline in PGADA is defined as Post-Baseline PGADA minus Baseline PGADA. 
 
Change #26 
8.3.8 Patient Global Assessment of PSO score 
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The following sentences have been removed: 
The Patient Global Assessment of psoriasis will be performed as part of the patient symptoms 
diary on a weekly basis from Screening to Week 16 Visit with a +3 day completion window. 
During the Maintenance Treatment Period this assessment will be completed at each clinic visit 
specified in the protocol with a ±3 day completion window. 
 
Change #27 
8.3.9 Patient Symptom Diary (PSD) 
In addition, cumulative distribution plots (see details in Section 8.2.2.3) will be provided for 
absolute and percent change from Baseline PSD at Week 16 for each item 
Has been changed to 
In addition, cumulative distribution plots (see details in Section 8.2.2.3) will be provided for 
absolute change from Baseline PSD at Week 16 for each item 
 
Change #28 
8.4 Statistical analysis of PsA related efficacy variables 
The following clarification has been added: 
The following PsA related efficacy variables will only be assessed for subjects enrolled in 
Japan: 
 Swollen and tender joint count 
 Physician’s Global Assessment of Disease Activity (PhGADA) 
 Patient’s Assessment of Arthritis Pain VAS 
 C-Reactive Protein (CRP) 
Subsequently, also ACR20/50/70 are only calculated for subjects enrolled in Japan. 
 
Change #29 
9.1 Pharmacokinetics 
In addition, geometric mean plasma concentration will be plotted by treatment group, and by 
cumulative antibody status for subjects randomized to bimekizumab.  
PK concentrations will also be listed.  
Has been changed to 
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In addition, geometric mean plasma concentration will be plotted by treatment group, and by 
cumulative antibody status for subjects randomized to bimekizumab on linear and log linear 
scale.  
If the dosing for a visit is +/- 21 days out of window, then the plasma concentration from 
that visit and all subsequent visits will be excluded from the PK summary. 
However, all PK concentrations will be listed.  
 
Change #30 
Sections 9.2 Pharmacodynamics and 9.3.1 Auto-antibodies have been set to not applicable. 
 
 
Change #31 
9.3.2 Anti-bimekizumab antibodies 
Anti-bimekizumab antibody status will be determined for each visit where samples were taken 
for drug concentration measures. At each visit: 
 Values ≤ predefined cut point are defined as anti-bimekizumab antibody - 
 Values > predefined cut point are defined as anti-bimekizumab antibody + 
In addition, overall anti-bimekizumab antibody  status should be determined:  
 Subject overall anti-bimekizumab antibody + is defined as having a value > predefined cut 
point at any time in the treatment period. This does not include Baseline/pre-treatment.   
 Subject anti-bimekizumab antibody positivity at Baseline is defined as having a value > 
predefined cut point at Baseline. 
 Subject overall anti-bimekizumab antibody - is defined as having no values > predefined cut 
point during the treatment period. 
Note that the predefined cut point value is lab-specific and specific for different indications.  
Cut-off values must be provided by the lab performing the analysis prior to database lock.  
The number and percentage of subjects with anti-bimekizumab antibody levels above the 
specified cut point will be reported as: 
 Number and percentage of subjects with anti-bimekizumab antibody level above the 
specified cut point at the time of each visit 
 Number and percentage of subjects with anti-bimekizumab antibody level above the 
specified cut point at any visit during the treatment period. 
In addition, the timepoint of the first occurrence of anti-bimekizumab antibody positivity during 
the treatment period (excluding Baseline and pre-treatment) will be summarized for each 
treatment group. 
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All individual subject-level anti-bimekizumab antibody results will be listed. 
Has been changed to 
Anti-bimekizumab antibodies will be measured using a three tiered assay approach: 
screening assay, confirmatory assay and titration assay. Samples confirmed as positive 
within the confirmatory assay, will be further evaluated in a neutralizing assay to evaluate 
the potential of the ADAb to neutralize the activity of Bimekizumab (IL17A or IL17F, or 
both) in-vitro. Samples were taken at Baseline, Week 4, Week 8, Week 12, Week 16, Week 
20, Week 24, Week 40, and Week 52 and in subjects who do not enter into the OLE 
(PS0014) a sample at SFU which is 20 weeks after the last dose. 
In subjects randomized to Ustekinumab, no ADAb samples will be analysed. 
In subjects randomized to placebo for the first 16 weeks, no samples will be analysed until 
Week 16 which will act as the Baseline for this treatment group 
Screening, confirmatory and titer cut points of the respective assays will be determined by 
the bioanalytical laboratory based either on using commercially available drug-naïve 
samples or on the pre-dose samples of the study itself. In case cut point is being set on 
commercially available samples, the representative for the study population is being 
checked. The screening cut point will be used to determine the status of ADA in test sample 
as above the cut point or below the cut point. Samples presenting ADA levels above the cut 
point, will be further evaluated in the confirmatory assay, the result of which will be 
reported as either “confirmed positive” or “not confirmed positive”. 
 Values ≤ screening cut point (BCP) or above the screening cut point and confirmed 
negative (NCP) are defined as anti-bimekizumab antibody negative 
 Values > predefined screening cut point (ACP) and confirmed positive (CP) are 
defined as anti-bimekizumab antibody positive 
 Confirmed positive samples will be titrated, and the titer (reciprocal dilution factor 
including MRD) reported. The samples (or a subset) will also be subject to a 
neutralizing assay to evaluate whether the anti-bimekizumab antibody neutralizes 
the activity of bimekizumab (IL17 A or IL17F or both) in- vitro. This will be 
reported subsequent to the main DBL and CSR.  
Subject Classification:  
 For subjects who are negative at Baseline, and antibody negative at all sampling 
points post treatment (including SFU) - pre ADAb negative - treatment emergent 
ADAb negative 
 For subjects who are negative at Baseline, and antibody positive at any sampling 
point post treatment (including SFU) - pre ADAb negative - treatment emergent 
ADAb positive.  If a subject has a missing pre-treatment sample (either missing or 
insufficient volume) at Baseline with one or more ADAb positive post-treatment 
samples will be also classified as pre ADAb negative - treatment emergent ADAb 
positive  
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 For subjects who are positive at Baseline, and antibody negative at all sampling 
points post treatment (including SFU) - pre ADAb positive - treatment emergent 
reduced ADAb 
 For subjects who are positive at Baseline, and are positive at any sampling point 
post treatment (including SFU) with titer values of the same magnitude as Baseline 
(i.e. ≤ then a predefined fold difference from the Baseline value) - pre ADAb positive 
- treatment emergent unaffected ADAb positive 
 For subjects who are positive at Baseline, and are positive at any sampling point 
post treatment (including SFU) with increased titer values compared to Baseline 
(above a predefined fold difference increase from Baseline value which will be 
defined within the validation of the assay and will be included in the TFLs and/or 
SAP when available) - pre ADAb positive - treatment emergent ADAb boosted 
positive. 
 For Subjects who have a positive pre-treatment sample and some post-treatment 
samples are missing, while other post-treatment samples are ADAb negative, the 
subject will be classed as inconclusive. 
 
In addition to the ADAb classifications, subjects will also receive an overall neutralizing 
(nADAb) classification for each nADAb assay separately, inclusive of Baseline and post-
Baseline results, on the nADAb assay results: 
 nADAb negative: no nADAb positive samples at Baseline or post-Baseline 
 nADAb positive: one or more positive samples at Baseline or post-Baseline 
 Missing: relevant nADAb samples are missing, e.g. if subject had samples selected 
for nADAb testing based on their ADAb levels, but there was insufficient sample left 
for nADAb testing. 
Analysis 
Immunogenicity will be assessed through summary tables and figures, and listing of 
individual results by subject. All analyses will be run on the safety population, unless 
specified otherwise. 
 Number and percentage of subjects with anti-bimekizumab antibody level above the 
specified cut point at the time of each visit, separated by treatment group 
 Number and percentage of subjects with anti-bimekizumab antibody level above the 
specified cut point at any visit during the treatment period, separated by treatment 
group. 
 The time-point of the first occurrence of anti-bimekizumab anti-body positivity 
during the treatment period) will be summarized for each treatment group . A plot 
of the Titre versus elapsed time will be plotted 
 All individual subject-level anti-bimekizumab antibody results will be listed. 
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 The number and percentage of subject in each of the 6 categories will be tabulated 
and separated by treatment group with an additional category combining subjects 
who are pre ADAb negative - treatment emergent ADAb positive and - pre ADAb 
positive - treatment emergent ADAb boosted positive, summarized as Total 
treatment emergent. 
 The prevalence of immunogenicity, separated by treatment group, and defined sub-
category, will be reported per time point, defined as (cumulative) proportion of 
subjects having confirmed positive ADAb samples at any point up to and including 
that time point. Missing samples will not be included in the denominator.  
 The time to achieving treatment-emergent ADAb positivity, separated by treatment 
group and defined sub-category, will be analyzed based on Kaplan-Meier approach, 
subjects will be considered to have an event at time where treatment emergent 
ADAb positive is first achieved. Subjects classified as treatment-emergent ADAb 
negative will be censored at time of last available ADAb result. 
 A summary of PASI 90 responder, separated by treatment group and defined sub-
category, at Weeks 16 and 52 as a function of ADAb titer will be presented 
graphically. This will be repeated for PASI 100 and 75 responders. 
 Individual plots of Bimekizumab Concentrations/ADAb titer and % Change from 
Baseline (all Y-axes) versus time (x-axis) for the full treatment period, including 
SFU where a patient has not progressed into the OLE. Plots should be labeled and 
grouped into the 6 sub-categories. 
 Spaghetti plots of ADAb titer (Y-axis) against time (X-axis), separated by treatment 
group for all ADAb positive subjects, including Baseline positive subjects. 
 Box plots of all Bimekizumab concentrations where ADAb titers exists versus ADAb 
titer classification (group 1 >; group 2 >; group 3 >) presented on a linear scale. Cut 
points will be determined on availability of the titre data. 
 A summary table to present the incidence (%) of subjects classified as treatment 
emergent ADAb positive with incidence of IL17-A and IL17F neturalizing ADAb, 
respectively over the 52 weeks. 
 
Change #31 
10.1 Extent of Exposure 
The cumulative study medication duration will be summarized for subjects exposed for given 
durations of time, the following categories for duration will be used: 
 >0 weeks 
 >=16 weeks 
 >=24 weeks 
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 >=48 weeks 
 >=52 weeks 
Has been changed to 
The cumulative study medication duration will be summarized for subjects exposed for given 
durations of time, with four weekly categories through Week 16 and 24.  For the cumulative 
duration through Week 52 the following categories for duration will be used: 
 >0 weeks 
 >=16 weeks 
 >=24 weeks 
 >=52 weeks 
 
Change #32 
10.2 Averse events 
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities 
(MedDRA). For subjects who switch from placebo to bimekizumab at Week 16, AEs will be 
allocated to the treatment the subject was on the day the event occurred. If the event occurs on 
the day of the switch, it will be attributed to placebo, unless the event has a HLT of “Injection 
Site Reactions, in which case it will be attributed to bimekizumab. 
Has been changed to 
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities 
(MedDRA version 19.0). For subjects who switch from placebo to bimekizumab at Week 16, 
any adverse events that occur after initiation of the new treatment are attributable to the 
new treatment. If an adverse event occurs on the date of a treatment switch, the event is 
attributed to the original treatment. The only exception to this is if the AE fulfills any of the 
criteria specified below: 
 Events that fulfill the anaphylaxis criteria for acute events (refer to Appendix A in 
Section 12.1) 
 Events with a reported term containing the term “hypersensitivity” 
 Events with an HLT of “Administration site reactions NEC” 
 Events with an HLT of “Injection site reactions” 
Change #30 
10.2.3.1 Infections (serious, opportunistic, fungal and TB) 
The embedded OI - MedDRA v19.0.xlsx file has been removed from the document. 
And 
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1. Study programming team creates a spreadsheet which lists all of the subjects with a 
TEAE present in the database which codes to a PT identified as case-by-case. 
Information from the AE dataset to be included in the spreadsheet: Subject ID, AE 
verbatim term, SOC, High Level Term (HLT), Lower Level Term (LLT), PT, AE start 
date, AE end date, seriousness, severity, relationship to study medication, action taken. 
Additionally, a column will be included where the study physician can document their 
decision on the case. 
2. Study physician reviews the cases in the spreadsheet and indicates in the additional 
column which AEs are confirmed to be opportunistic infections via a single ‘x’. 
3. Study programming team incorporates these decisions into the AE dataset by merging the 
study physician decisions for individual subjects / PTs and flagging the confirmed 
opportunistic infections as such in the dataset. 
Has been changed to 
1. Study programming team creates a spreadsheet which lists all of the subjects with a 
TEAE present in the database which codes to a PT identified as case-by-case. 
Information from the AE dataset to be included in the spreadsheet: Subject ID, AE 
verbatim term, SOC, High Level Term (HLT), Lower Level Term (LLT), PT, AE start 
date, AE end date, seriousness, severity, relationship to study medication, action taken. 
Additionally, a column will be included where the study physician can document their 
decision on the case. 
2. Study physician reviews the cases in the spreadsheet and indicates in the additional 
column which AEs are confirmed to be opportunistic infections via a single ‘x’. 
3. At quarterly Infectious Disease Committee (IDC) Meetings, outputs will be 
produced and reviewed by the study physician ahead of the IDC Meeting. The IDC 
will then agree on the final adjudication for each potential opportunistic infection. A 
final output for opportunistic infections will be produced and agreed upon between 
the study physician and the IDC prior to finalizing the database. 
4. Study programming team incorporates these decisions into the AE dataset by merging the 
final decisions for individual subjects / PTs and flagging the confirmed opportunistic 
infections as such in the dataset. 
 
Change #33 
10.2.3.1 Clinical laboratory evaluations 
Laboratory values (including markedly abnormal laboratory values), urinary values will be 
presented descriptively by treatment group for SS.  
Has been changed to  
Laboratory values and urinary values will be presented descriptively by treatment group for SS.  
Markedly abnormal values and shifts from Baseline (Week 0) will be presented for the SS. 
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And 
A summary table highlighting the potential cases of Hy’s Law, within each treatment group will 
be presented. Hy’s Law is defined as:  
 AST >3xULN or ALT >3xULN and 
 Total Bilirubin >2xULN 
In order to meet the above criteria, a subject must experience the elevation in bilirubin and ALT 
or AST at the same visit. For example, a subject who experiences a >=2 x ULN elevation of 
bilirubin at one visit and a 3 x ULN elevation in ALT (or AST) at a subsequent visit has not 
fulfilled the Hy’s law criteria. 
Has been changed to 
The table for markedly abnormal liver function tests (LFTs) will contain data beyond the 
CTCAE Grade 3 thresholds outlined in Table 10‒1: Definitions of Markedly Abnormal Liver 
Function Values above in order to allow for a more thorough review of elevated LFTs. 
There will be one table which will list the count and percentage of subjects meeting the 
below criteria at any time during the study: 
 AST: >2xULN, >3xULN, >5xULN, >10xULN, >20xULN 
 ALT: >2xULN, >3xULN, >5xULN, >10xULN, >20xULN 
 AST or ALT: >2xULN, >3xULN, >5xULN, >10xULN, >20xULN 
 Bilirubin: >1xULN, >1.5xULN 
 ALP: >2xULN 
In addition, a table will be produced to summarize potential Hy’s Law cases. The following 
two definitions will be used in that table: 
 [AST ≥3xULN or ALT ≥3xULN] and Total Bilirubin ≥2xULN 
 [AST ≥3xULN or ALT ≥3xULN] and Total Bilirubin ≥2xULN in the absence of ALP 
≥2xULN  
In order to meet either of the above criteria, a subject must experience the elevation in 
bilirubin and ALT or AST (and the absence of ALP elevation, if applicable) at the same 
visit. For example, a subject who experiences a ≥2 x ULN elevation of bilirubin at one visit 
and a ≥3xULN elevation in ALT (or AST) at a subsequent visit has not fulfilled the Hy’s 
law criteria.   
 
Change #33 
13 Appendix  
Appendix A: MedDRA algorithmic approach to anaphyalaxis has been added 
 
 
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13.2 
Amendment 2 
Rationale of the Amendment 
The main purpose of this amendment is to align the SAP with protocol amendment 4 and to 
achieve consistency with other SAPs of the program. 
 
Modification and changes 
Global Changes 
The following changes were made throughout the SAP 
 “IGA response (defined as Clear with at least a 2-category improvement relative to Baseline) 
at Week 16” has been added as a secondary endpoint 
 The secondary endpoint “Change from baseline in the Patient Symptom Diary responses for 
itch, pain, and scaling at Week 16” has been altered to “Patient Symptom Diary responses for 
itch, pain, and scaling at Week 16” 
 “Change from Baseline in Patient Health Questionnaire (PHQ) 9 scores” is no longer seen as 
an efficacy endpoint and got moved from the efficacy section to the safety section 
 
Specific Changes 
Change #1 
List of abbreviation 
The following abbreviation have been added: 
SIB 
suicidal ideation and behavior 
 
Change #2 
2.3.2.2 Initial Treatment Period 
Subjects will be classified as completing the initial treatment period if they complete the Week 
16 Visit without early withdrawal from the study or if they start treatment in the maintenance 
treatment period. The start of the maintenance treatment period marks the end of the initial 
treatment period. 
Has been changed to: 
Subjects will be classified as completing the initial treatment period if they complete the Week 
16 Visit without early withdrawal from the study or if they start treatment in the maintenance 
treatment period. The start of the maintenance treatment period marks the end of the 
initial treatment period.   
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Change #3 
2.3.5 
Anticipated regions and countries 
The following got added: 
A subset of tables, listings, and figures will be repeated for the subgroup of subjects 
randomized in Japan. A list of these outputs will be added to the TLF shells. 
 
Change #4 
3.2 
Definition of Baseline values 
A Baseline value for a subject is defined as the latest measurement for that subject up to and 
including the day of administration of first study medication, unless otherwise stated. If a 
Baseline assessment is taken on the same day as first administration of study medication, it is 
eligible to be used as the Baseline value, even in the case that the time of the assessment is 
recorded as taking place after the time of first study medication administration. This is 
considered acceptable as this measurement is still the best representation of the Baseline value of 
the given assessment since it is highly unlikely that the study medication could have an impact 
on any measurement in such a short period of time. However, such cases should be rare as study 
center personnel are instructed to do all assessments at the Baseline visit prior to administering 
study medication. One exception to this rule is plasma concentration. If Baseline plasma 
concentration is measured at a time after the first administration of study medication, then it 
should not be eligible to be considered as a Baseline plasma concentration. Such cases should be 
discussed with the quantitative clinical pharmacologist. If a Baseline measurement is missing or 
not collected, and a Screening value is available, the Screening value will be utilized as Baseline 
instead.  
For subjects who switch treatment from placebo to bimekizumab at the Week 16 Visit, the 
variables listed below, will have an additional Baseline defined as the Baseline for Maintenance 
Treatment Period. Baseline for Maintenance Treatment Period is the latest measurement on/prior 
to the day of first dose in the maintenance period. 
 PASI score 
Has been changed to 
A Baseline value for a subject is defined as the latest measurement for that subject up to 
and including the day of administration of first study medication, unless otherwise stated. 
If a Baseline assessment is taken on the same day as first administration of study 
medication, it is eligible to be used as the Baseline value, even in the case that the time of 
the assessment is recorded as taking place after the time of first study medication 
administration. This is considered acceptable as this measurement is still the best 
representation of the Baseline value of the given assessment since it is highly unlikely that 
the study medication could have an impact on any measurement in such a short period of 
time. However, such cases should be rare as study center personnel are instructed to do all 
assessments at the Baseline visit prior to administering study medication. One exception to 
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this rule is plasma concentration. If Baseline plasma concentration is measured at a time 
after the first administration of study medication, then it should not be eligible to be 
considered as a Baseline plasma concentration. Such cases should be discussed with the 
quantitative clinical pharmacologist. If a Baseline measurement is missing or not collected, 
and a Screening value is available, the Screening value will be utilized as Baseline instead.  
For subjects who switch treatment from placebo to bimekizumab at the Week 16 Visit, the 
variables listed below, will have an additional Baseline defined as the Baseline for 
Maintenance Treatment Period. Baseline for Maintenance Treatment Period is the latest 
measurement on/prior to the day of first dose in the maintenance period. 
 PASI score 
 DLQI 
 Laboratory data (only in shift tables) 
Note that for any laboratory value that occurs on the day of treatment switch, that lab 
value will be attributed and summarized for the treatment they were on previously. For 
subjects that switch treatment, the Baseline value is the laboratory value of the day of 
treatment switch. 
Baseline values for component scores should be computed using components from the same 
visit where the relevant measurements were recorded prior to dosing. For example, if the 
Screening visit has all of the components, but the Baseline visit is missing one or more 
components, the Baseline value for the component score should be calculated using the 
Screening visit values.  
 
Change #5 
4.2.1.6 
Missing data algorithms 
Modifications have been made to the text regarding the multiple imputation algorithm for clarity. 
Change #6 
4.4 
Multicenter studies 
The following has been added: 
If convergence still cannot be achieved, this analysis will not be performed. 
 
Change #7 
4.8 
Examination of subgroups 
The following has been added: 
Antibody positivity is the only subgroup that is not determined by Baseline data. It will be 
presented in a separate table. 
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In the following text analysis sets and imputation methods have been added for clarity: 
In addition, in order to assess whether an early response to treatment is predictive of response at 
later time points, subgroup analyses will be performed for the RS on PASI90/100 and IGA over 
time using the following early response subgroups: 
 PASI75 response (OC) at Week 4 (yes, no) to predict PASI90/100 and IGA (NRI) through 
Week 52 
 PASI90 response (OC) at Week 16 (yes, no) to predict PASI100 (NRI) through Week 52 
 
Change #8 
6.2 
Other Baseline characteristics 
The following variables have been added to the list of other baseline characteristics: 
 Nail involvement (yes, no) 
 Scalp involvement (yes, no) 
 Palmoplantar involvement (yes, no) 
 Prior primary failure to biologic (yes/no) 
 PSD items: Pain, Itch, Scaling 
Baseline nail, scalp, and palmoplantar involvement are based on the number of subjects 
achieving mNAPSI>0, Scalp IGA>0, and pp-IGA>0, respectively. 
 
Change #9 
7 
MEASUREMENTS OF TREATMENT COMPLIANCE 
The following has been removed: 
All summaries detailed in this section will be performed on the SS 
Percentages and analysis sets have been updated in the following: 
A summary of percent treatment compliance categorized as <75% and >≥75% will be provided 
by treatment group and study periods (Initial Treatment Period for the SS, Maintenance 
Treatment Period for the MS, and the Initial and Maintenance Treatment Period for the AMS). 
 
Change #10 
8.1.2 
Primary analysis of the co-primary efficacy variables 
The primary analysis will be based on the stratified Cochran-Mantel-Haenszel (CMH) test where 
region and prior biologic exposure (yes/no) will be used as stratification variables. For the 
assessment of noninferiority, a noninferiority margin of 10% will be used and evaluated based on 
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the confidence interval for the stratified Cochran Mantel-Haenszel risk difference between 
bimekizumab and ustekinumab. 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. The evaluation of superiority 
will use pairwise treatment comparisons based on the CMH test using the p-value for the general 
association. The odds ratio and associated confidence interval (CI) based on the Wald test will be 
presented. If one of the treatment groups has 0 or very low response where CMH can no longer 
be used, the logit method will be applied instead. 
Has been changed to: 
The primary analysis will be based on the stratified Cochran-Mantel-Haenszel (CMH) test 
where region and prior biologic exposure (yes/no) will be used as stratification variables. 
For the assessment of noninferiority, a noninferiority margin of 10% will be used and 
evaluated based on the confidence interval for the stratified Cochran Mantel-Haenszel risk 
difference between bimekizumab and ustekinumab. 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. The evaluation of superiority will use pairwise treatment comparisons based on 
the CMH test using the p-value for the general association. The odds ratio and associated 
confidence interval (CI) based on the Wald test will be presented. If one of the treatment 
groups has 0 or very low response where CMH can no longer be used, the logit method will 
be applied instead. 
And 
The number and percentage of subjects who are PASI90 responders and those who are non-
responder at Week 16 will be summarized. IGA response will be summarized in the same 
manner as PASI90 responder variable.  
Has been changed to 
The number and percentage of subjects who are PASI90 responders at Week 16 will be 
summarized. IGA response will be summarized in the same manner as PASI90 responder 
variable.  
And 
Details about the calculation of the stratified Mantel-Haenszel risk difference, using the method 
of Greenland and Robins (1985), have been added. 
Change #11 
8.1.3.7 
Sensitivity Analysis #7 
The following has been added: 
In order to achieve model convergence, other explanatory variables e.g. other prior biologic 
exposure may be dropped from the model as for the logistic regression with region. 
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Change #12 
8.2.1.4 
Patient Symptom Diary (PSD) 
 
The PSD consists of 14 different items, each measuring an aspect of the disease and its impact on 
the subject’s quality of life. Each item will be scored separately on a 0-10 scale with 0 for no 
symptom and 10 for very severe or worst symptom. Weekly averages will be derived for each of 
the 14 items of the Psoriasis Diary up to Week 16. A weekly average is the sum of the scored 
item over the course of the study week divided by the number of days on which the item was 
completed and will be set to missing if four or more daily assessments (irrespective of whether 
these are consecutive or not) were missing of the corresponding question. only if there are no 
data available from any of the daily assessments during the previous week for the corresponding 
question.  
Has been changed to: 
The PSD consists of 14 different items, each measuring an aspect of the disease and its impact on 
the subject’s quality of life. Each item will be scored separately on a 0-10 scale with 0 for no 
symptom and 10 for very severe or worst symptom. Weekly averages will be derived for each of 
the 14 items of the Psoriasis Diary up to Week 16. A weekly average is the sum of the scored 
item over the course of the study week (up to the actual visit date) divided by the number of 
days on which the item was completed and will be set to missing if four or more daily 
assessments (irrespective of whether these are consecutive or not) were missing of the 
corresponding question. The Baseline value is also based on a weekly average (up to and 
including the Baseline visit) and will be computed in the same manner. 
 
Change #13 
8.2.2 
Primary analysis of the secondary efficacy variables 
The following has been updated: 
Primary analysis for secondary efficacy variables will be summarized based on imputed data 
(NRI and MCMC/Monotone Regression for binary and continuous variables, respectively), 
unless otherwise specified. 
 
Change #14 
8.2.2.3 Patient Symptom Diary (PSD) 
The following has been removed 
The percentage change as well as the absolute change from Baseline to the Week 16 for the 
weekly average will be analyzed in separate analyses of covariance (ANCOVA) with fixed 
effects of treatment, region and prior biologic exposure and Baseline value as a covariate. The 
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analysis based on the absolute change from Baseline will be the primary analysis. Differences 
between treatment groups will be determined using least square means and t-tests using the 
pooled error term from the linear model. 95% confidence intervals for the treatment difference 
will be calculated based on differences in least-square means estimates. All continuous variables 
in the model will be centered with respect to their mean values. Missing data for these PSD 
variables will use the MI procedure similar to the sensitivity analysis #1 (Section 8.1.3.1 ) used 
in the co-primary analysis with the following differences:  
1) The imputation model will use change from Baseline (instead of actual) valued by visit and no 
dichotomization will be necessary;  
2) The analyses model will be based on analysis of covariance (ANCOVA) as opposed to the 
Cochran-Mantel-Haenszel (CMH) test.  
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. Note that for LOCF imputation, any missing data or data 
collected following discontinuation of IMP will be imputed with the most recent previous value. 
 
Change #15 
8.2.3  
 
Sensitivity analyses of the secondary efficacy variables 
The following has been added: 
Missing data for these PSD responder variables will use the MI procedure similar to the 
sensitivity analysis #1 (Section 8.1.3.1) for the co-primary efficacy variables with the 
following differences:  
5. The data included in the imputation model will be limited only to those subjects with 
sufficiently high Baseline values to achieve the response for a given item (based on 
observed cases). 
6. The PSD item value will be imputed. Once imputation has been performed across the 
100 iterations specified, any values below 0 and above 10 will be truncated to 0 and 10, 
respectively. 
7. The change from Baseline values will be computed based on the complete data sets. 
8. The analysis model will be based on  the CMH test. 
 
Change #16 
8.3 
Statistical analysis of the other efficacy variables 
The following has been added: 
Summaries for subjects switching from Placebo to Bimekizumab will be provided separately for 
the MS. 
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Change #17 
8.3.1.2 
Time to PASI50, PASI75, PASI90, and PASI100 response during the 
Initial Treatment Period 
Time to PASI50, PASI75, PASI90, and PASI100 response (in days) during the Initial Treatment 
Period will each be calculated as: 
𝑀𝑖𝑛 (𝐷𝑎𝑡𝑒 𝑜𝑓 𝑓𝑖𝑟𝑠𝑡 𝑃𝐴𝑆𝐼𝑥𝑥 𝑟𝑒𝑠𝑝𝑜𝑛𝑠𝑒, 𝐷𝑎𝑡𝑒 𝑜𝑓 𝑊𝑒𝑒𝑘 16 𝑣𝑖𝑠𝑖𝑡) –  𝐷𝑎𝑡𝑒 𝑜𝑓 𝐵𝑎𝑠𝑒𝑙𝑖𝑛𝑒 𝑣𝑖𝑠𝑖𝑡 +  1, 
with  xx representing 50, 75, 90, 100 respectively. 
Subjects who discontinue study treatment without achieving a given PASI response prior to 
Week 16 visit will be censored at the date of study treatment discontinuation. Subjects who reach 
the Week 16 Visit without achieving the given response will be censored at the date of the 
Week 16 Visit. 
Has been changed to: 
Time to PASI50, PASI75, PASI90, and PASI100 response (in days) during the Initial Treatment 
Period will each be calculated as: 
𝑀𝑖𝑛 (𝐷𝑎𝑡𝑒 𝑜𝑓 𝑓𝑖𝑟𝑠𝑡 𝑃𝐴𝑆𝐼𝑥𝑥 𝑟𝑒𝑠𝑝𝑜𝑛𝑠𝑒, 𝐷𝑎𝑡𝑒 𝑜𝑓 𝑊𝑒𝑒𝑘 16 𝑣𝑖𝑠𝑖𝑡) –  𝐷𝑎𝑡𝑒 𝑜𝑓 𝐵𝑎𝑠𝑒𝑙𝑖𝑛𝑒 𝑣𝑖𝑠𝑖𝑡 +  1, 
with xx representing 50, 75, 90, 100 respectively. All visits including unscheduled visits are 
considered. 
Subjects who discontinue study treatment without achieving a given PASI response prior to 
Week 16 visit will be censored at the date of the last observed PASI assessment on or prior to 
the date of treatment discontinuation. Subjects who reach the Week 16 Visit without 
achieving the given response will be censored at the date of the last observed PASI assessment 
on or prior to the Week 16 Visit. Subjects will be censored at Baseline if there is no 
Baseline PASI assessment or no Post Baseline PASI assessment. 
Change #18 
8.3.2 
Modified Nail Psoriasis Severity Index (mNAPSI) score 
If 1 or 2 response items scored on the 0 to 1 scale are missing, the missing response(s) will be 
imputed by the average of the available responses. Otherwise, the total mNAPSI score will be set 
to missing. 
Has been replaced by: 
If any of the 7 response items that contribute to mNAPSI is present, while other items are 
missing (ie, partial mNAPSI data), then the missing items are assumed to be 0 for the 
mNAPSI calculation. In some cases, the data may be captured in such a way that only non-
zero component scores are present in the database. Again, those components that are not 
present are simply assumed to be 0 for the mNAPSI calculation. 
 
Change #19 
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8.5 
Additional statistical analysis of other efficacy variables 
Added new Section 8.5 for additional statistical testing for other efficacy variables with nominal 
p-values 
 
Change #20 
9.1 
Pharmacokinetics 
Value of LLOG has been added: 
…then for calculation of the derived statistics the result will be set to 0.125 µg/ml, which is ½ of 
the lower level of quantification (LLOQ). 
The following has been added: 
If the PK sampling date is >1 day after the dosing date data points will be excluded from 
the PK summary tables and figures, but not from the listing. 
 
Change #21 
9.3 
Immunogenicity 
The analysis of immunogenicity will be based on the PK-PPS. 
Has been changed to: 
The analysis of immunogenicity will be based on the SS. 
 
Change #22 
9.3.2 
Anti-bimekizumab antibodies 
The following two bullet points for subject classification have been updated: 
 For subjects who are positive at Baseline, and are positive at any sampling point post 
treatment (including SFU) with titer values of the same magnitude as Baseline (i.e. ≤ than a 
2.07 fold difference from the Baseline value) - pre ADAb positive - treatment emergent 
unaffected ADAb positive 
 For subjects who are positive at Baseline, and are positive at any sampling point post 
treatment (including SFU) with increased titer values compared to Baseline (i.e. > than a 2.07 
fold difference from the Baseline value) - pre ADAb positive - treatment emergent ADAb 
boosted positive. 
The following has been added: 
Derivation for above classification will be different for the interim analysis and the final 
analysis. For the interim analysis no SFU data will be considered. Only for the final analysis, 
when all SFU data will be available, data from the SFU visits will be considered. 
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Change #23 
10.2.1 
Data considerations 
The following has been added: 
Selected summaries, as specified in Section 10.2.2, will include the risk difference between 
bimekizumab and ustekinumab. The risk difference is calculated as: 
𝑅𝐷= 𝐼𝑃𝐵𝐾𝑍−𝐼𝑃𝐴𝐷𝐴 
where 𝐼𝑃𝐵𝐾𝑍 is the incidence proportion for the bimekizumab-treated group and 𝐼𝑃𝑃𝐵𝑂 is the 
incidence proportion for the placebo group. Note that incidence proportion simply refers to the 
percentage of subjects within the specified treatment group that experienced a given adverse 
event. 
The standard error for the risk difference is calculated as follows: 
𝑆𝐸𝑅𝐷= √(𝐼𝑃𝐵𝐾𝑍× (1 −𝐼𝑃𝐵𝐾𝑍
𝑛𝐵𝐾𝑍
)) + (𝐼𝑃𝑃𝐵𝑂× (1 −𝐼𝑃𝑃𝐵𝑂
𝑛𝑃𝐵𝑂
)) 
where 𝑛𝐵𝐾𝑍 is the number of subjects in the bimekizumab-treated group and 𝑛𝑃𝐵𝑂 is the number 
of subjects in the placebo group.  
The corresponding confidence interval for the risk difference is as follows: 
𝐶𝐼𝑅𝐷= 𝑅𝐷 ± 𝑍1−𝛼2
⁄ × (𝑆𝐸𝑅𝐷)  
where 𝑍1−𝛼2
⁄  is the 𝑍 statistic for the corresponding level of alpha. For the risk difference 
confidence intervals calculated in this SAP, 1.96 will be used (corresponding to a two-sided 
alpha of 0.05 and 95% confidence interval).  
 
Change #24 
10.2.2 
AE Summaries 
Section has been updated to: 
The following summaries will be provided in three different ways: by treatment in the Initial 
Treatment Period for the SS, by treatment during the Maintenance Treatment Period for the 
MS, and by treatment during the Initial and Maintenance Treatment Period (combined) for the 
AMS: 
 Incidence of TEAEs – Overview 
 Incidence of TEAEs per 100 subject years by SOC, HLT, and PT  
 Incidence of Serious TEAEs per 100 subject years by SOC, HLT, and PT  
 Incidence of TEAEs Leading to Discontinuation per 100 subject years by SOC, HLT, and PT  
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The following summaries will be provided in two different ways: by treatment in the Initial 
Treatment Period for the SS, and by treatment in the Initial and Maintenance Treatment 
Period (combined) for the AMS: 
 Incidence of TEAEs Leading to Death by SOC, HLT, and PT  
 Incidence of TEAEs by Maximum Relationship by SOC, HLT, and PT  
 Incidence of Serious TEAEs by Relationship SOC, HLT, and PT  – Note: For EudraCT 
reporting purposes 
 Incidence of Related Serious TEAEs by SOC, HLT, and PT 
 Incidence of TEAEs Leading to Death by Relationship by SOC, HLT, and PT  – Note: For 
EudraCT reporting purposes  
 Incidence of TEAEs by Maximum Severity, SOC, HLT, and PT 
 Incidence of TEAEs by decreasing frequency of PT 
 Incidence of TEAEs Above Reporting Threshold of 5% by SOC and PT 
 Incidence of Non-Serious TEAEs by SOC, HLT, and PT 
 Incidence of Non-Serious TEAEs by Relationship SOC, HLT, and PT 
 Incidence of Non-Serious TEAEs Above Reporting Threshold of 5% by SOC and PT 
 Incidence of Non-Serious TEAEs Above Reporting Threshold of 5% by Relationship SOC 
and PT 
 Incidence of Related TEAEs by SOC, HLT, and PT 
 Incidence of Related TEAEs Above Reporting Threshold of 5% by SOC and PT 
The following summary will be provided by treatment for the Initial Treatment Period for 
the SS: 
 Incidence of TEAEs Above Reporting Threshold of 5% with Risk Differences by SOC 
and PT 
 Incidence of Serious TEAEs and Risk Differences by SOC and PT  
 
The following summary will be provided by treatment for the Initial and Maintenance 
Treatment Period (combined) for the SS (only subjects treated with BKZ): 
 Incidence of TEAEs per 100 subject years by SOC, HLT, and PT and by Time of Onset 
Relative to Anti-bimekizumab Antibody Status  
In addition, all summaries of TEAEs based on “100 subject years” will include EAIR (with 
95% confidence interval) and EAER. 
The tables with risk differences will also be accompanied by figures (dot plots) which show 
the incidence of the adverse events and corresponding 95% risk difference confidence 
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intervals. These will be ordered by descending order of risk difference (bimekizumab vs 
ustekinumab). 
 
Change #25 
10.2.3 
Other Safety topics of interest 
The section has been updated to: 
The following are AEs of other safety topics of interest that require special statistical analyses 
and will be provided in two different ways: by treatment in the Initial Treatment Period 
for the SS, and by treatment in the Initial and Maintenance Treatment Period (combined) 
for the AMS. 
Along with the tables described, there will be a table which displays the risk difference and 
95% confidence intervals for each of the topics of interest. A corresponding figure (with 
dot plots) will be prepared. 
 
Change #26 
10.2.3.1 Infections (serious, opportunistic, fungal and TB) 
The whole section about identification and review of opportunistic infections has been 
updated. 
 
Change #27 
10.2.3.3 
Major adverse cardiac event 
The following has been added: 
A separate table and listing will present the adjudicated cardiovascular events by type. For 
each cardiovascular event type (24 total), the individual PTs which fall within each event 
type will be summarized.  
Additionally, a listing of all events identified for potential review by the cardiovascular 
event adjudication committee will be produced. This listing will indicate whether each 
event was escalated to the committee for formal review/adjudication. 
 
Change #28 
10.2.3.5 
Suicidal Ideation and Behavior (SIB) 
Section title has been updated and the following has been removed: 
This table is based on the SMQ of “Depression and suicide/self-injury” (all TEAEs which code 
to a PT included in the Scope=Broad and/or Scope=Narrow). 
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Change #29 
10.2.3.6 
Inflammatory bowel disease 
The following has been added: 
Inflammatory bowel disease events will be summarized stratified by subjects with or 
without a previous medical history of inflammatory bowel disease. Previous medical 
history of inflammatory bowel disease will be determined using the information recorded 
on the Extra-Articular Assessment at Screening CRF page (“Does subject have a history of 
IBD?”). 
 
Change #30 
10.2.3.7 
Anaphylactic reaction 
This table will be prepared based on the MedDRA anaphylaxis algorithm (refer to Appendix 1 in 
Section 12.1”) for acute events (reported on the same day) and for treatment-emergent PTs 
including the term “hypersensitivity” reported at any time. 
Has been replaced by the following: 
 A separate table will be prepared based on the MedDRA anaphylaxis Algorithm (see 
Appendix A) for acute anaphylactic events (reported on the same day as when an 
injection was administered or one day after). 
 A separate table will be prepared to summarize hypersensitivity events, identified using 
the SMQ “Hypersensitivity (SMQ)”. All TEAEs which code to a PT included in the 
Scope=Narrow search will be included in this table. 
 
Change #31 
10.3 
Clinical laboratory evaluations 
Section has been updated to: 
Laboratory values, including markedly abnormal laboratory values and urinary values will be 
presented descriptively by treatment group for SS.  
Tables presenting markedly abnormal values and those based on CTCAE grade only 
include selected laboratory variables. 
For tables where data are summarized by visit, unscheduled and repeat visits will not be 
summarized, but these data will be included in listings. For tables where multiple measurements 
over a period of time are considered (as in shift tables), unscheduled and repeat visits will be 
considered as long as they were collected in the period being summarized. All summaries will be 
presented in SI units and will be based on observed case values. In the case where laboratory 
values are below the lower limit of quantification, then these will be set to the midpoint between 
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0 and the lower limit of quantification for the purpose of summarizing the data. The following 
summaries are required: 
 A summary of observed results and change from Baseline values in each laboratory variable 
by treatment group and visit for the SS 
 A summary of the number and percentage of subjects experiencing markedly abnormal 
values at any time while on treatment (assessment on or following the first dose of study 
treatment through the final dose of study treatment + 140 days) by laboratory variable 
and treatment group. Two separate tables will show results for the initial treatment 
period (for the SS) and the initial and maintenance treatment period (for the AMS). 
 A summary of the number and percentage of subjects with a given CTCAE grade (0, 1, 
2, 3, or 4) based on minimum/maximum post-baseline value by laboratory variable and 
treatment group. Two separate tables will show results for the initial treatment period 
(for the SS) and the initial and maintenance treatment period (for the AMS). 
 A shift table of the number and percentage of subjects experiencing CTCAE grade 0, 1, 
2, 3, or 4 values (as applicable) at Baseline to minimum/maximum post-Baseline 
CTCAE grade, by laboratory variable and treatment group. Two separate tables will 
show results for the initial treatment period (for the SS) and the initial and maintenance 
treatment period (for the AMS). 
Shift laboratory summaries will use the Baseline for Maintenance Treatment Period where 
applicable as described in Section 3.2 
A by-subject listing of all laboratory data will be provided. This listing will be presented by 
treatment group and will include: center, subject identifier, age, sex, race, weight, visit, 
laboratory variable, result (with abnormal values flagged as “L” or “H” accordingly) and unit. 
Markedly abnormal values are defined as those with a severity of Grade 3 and above based on 
the common terminology criteria for adverse events (CTCAE) criteria (U.S. Department of 
Health and Human Services 2010). Definitions of markedly abnormal values using the Grade 3 
cut points are given in the tables below for age ranges of ≥17 years (Table 10-1 for markedly 
abnormal liver function test values, Table 10-2 for markedly abnormal biochemistry values, and 
Table 10-3 for markedly abnormal hematology values). Tables summarizing markedly 
abnormal values should include a summary (counts and percentages) of markedly 
abnormal labs observed at any time while on treatment (ie, treatment-emergent markedly 
abnormal [TEMA]). For this summary, Baseline values and values observed more than 140 
days after the last administration of study medication are not considered. The laboratory 
results classified as Grade 3 or Grade 4 will be summarized and listed separately. 
 
 
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UCB 
 
13 Sep 2019 
Statistical Analysis Plan 
Bimekizumab 
PS0009 
 
 
 
 
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Page 121 of 121 
STATISTICAL ANALYSIS PLAN SIGNATURE PAGE 
This document has been reviewed and approved per the Review and Approval of Clinical 
Documents Standard Operating Procedures. Signatures indicate that the final version of the 
Statistical Analysis Plan (SAP) or amended SAP is released for execution. 
 
 
 
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Approval Signatures
Name:
PS0009-sap-amend-2
Version:
1. 0
Document Number:
CLIN-000141074
Title:
PS0009 Statistical Analysis Plan
Approved Date:
13 Sep 2019
Document Approvals
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 13-Sep-2019 12:55:45 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 13-Sep-2019 13:07:53 GMT+0000
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