A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Phase: PHASE3
Conditions: Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis
Sponsor: UCB Biopharma SRL

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 1 of 216 
 
PROTOCOL PS0014 AMENDMENT 3.3 
A MULTICENTER, OPEN-LABEL STUDY TO ASSESS THE 
LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF 
BIMEKIZUMAB IN ADULT SUBJECTS WITH MODERATE TO 
SEVERE CHRONIC PLAQUE PSORIASIS 
PHASE 3 
 
EudraCT Number: 2016-003427-30 
IND Number: 128707 
Sponsor: 
UCB Biopharma SRL 
Allée de la Recherche 60 
1070 Brussels 
BELGIUM 
Protocol/Amendment number 
Date 
Type of amendment 
Final Protocol 
05 Apr 2018 
Not applicable 
Protocol Amendment 1 
16 Jan 2019 
Substantial 
Protocol Amendment 1.1 (Canada) 
26 Feb 2019 
Nonsubstantial 
Protocol Amendment 1.2 (Japan) 
09 May 2019 
Substantial 
Protocol Amendment 1.3 (Italy) 
18 Dec 2019 
Nonsubstantial 
Protocol Amendment 2 
09 Jun 2020 
Substantial 
Protocol Amendment 2.1 (Italy) 
18 Jun 2020 
Nonsubstantial 
Protocol Amendment 3 
16 Jul 2020 
Nonsubstantial 
Protocol Amendment 3.1 (Italy) 
16 Jul 2020 
Nonsubstantial 
Protocol Amendment 3.2 (Japan) 
21 Jul 2020 
Substantial 
Protocol Amendment 3.3 (US and Canada) 
12 Oct 2021 
Not applicable 
Confidential Material 
Confidential 
This document is the property of UCB and may not – in full or in part – be passed on, 
reproduced, published, or otherwise used without the express permission of UCB. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 2 of 216 
STUDY CONTACT INFORMATION 
Sponsor 
UCB Biopharma SRL 
Allée de la Recherche 60 
1070 Brussels, BELGIUM 
Sponsor Study Physician 
Name: 
 
Address: 
UCB Biosciences, 4000 Paramount Parkway, Ste 200 
Morrisville, NC 27560 
Phone: 
Fax: 
Clinical Project Manager 
Name: 
 
Address: 
UCB Biosciences GmbH, Alfred-Nobel-Str. 10, 40789 
Monheim am Rhein, Germany 
Phone: 
Fax: 
Clinical Trial Biostatistician 
Name: 
 
Address: 
UCB  
208 Bath Road, Slough, SL1 3WE, UK 
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 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 3 of 216 
SERIOUS ADVERSE EVENT REPORTING 
Serious adverse event reporting (24h) 
Fax 
Europe and Rest of the World: +32 2 386 2421 
USA and Canada: +1 800 880 6949 
or +1 866 890 3175 
Email 
Europe and Rest of the World (except Japan): DS_ICT@ucb.com 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 4 of 216 
TABLE OF CONTENTS 
LIST OF ABBREVIATIONS .................................................................................................. 10 
1 
SUMMARY ..................................................................................................................... 13 
2 
INTRODUCTION ........................................................................................................... 15 
2.1 
Psoriasis ....................................................................................................................... 15 
2.1.1 
Global epidemiology of PSO ............................................................................... 16 
2.1.2 
Current treatments for PSO ................................................................................. 16 
2.2 
Bimekizumab ............................................................................................................... 18 
2.2.1 
Clinical ................................................................................................................. 18 
2.2.1.1 
Completed studies ..................................................................................... 18 
2.2.1.2 
Ongoing studies ......................................................................................... 20 
2.2.1.3 
Feeder studies ............................................................................................ 20 
2.2.2 
Nonclinical ........................................................................................................... 20 
3 
STUDY OBJECTIVES .................................................................................................... 21 
3.1 
Primary objective ......................................................................................................... 21 
3.2 
Secondary objectives ................................................................................................... 21 
3.3 
Other objectives ........................................................................................................... 21 
4 
STUDY VARIABLES ..................................................................................................... 22 
4.1 
Primary safety variable ................................................................................................ 22 
4.2 
Secondary variables ..................................................................................................... 22 
4.2.1 
Secondary safety variables .................................................................................. 22 
4.2.2 
Secondary efficacy variables ............................................................................... 22 
4.3 
Other variables ............................................................................................................. 22 
4.3.1 
Other safety variables .......................................................................................... 22 
4.3.2 
Other efficacy variables ....................................................................................... 23 
4.3.3 
Pharmacokinetic variables ................................................................................... 24 
4.3.4 
Immunological variable ....................................................................................... 24 
5 
STUDY DESIGN ............................................................................................................. 24 
5.1 
Study description ......................................................................................................... 24 
5.2 
Study periods ............................................................................................................... 24 
5.2.1 
Treatment Period ................................................................................................. 25 
5.2.2 
OLE2 Period ........................................................................................................ 26 
5.2.3 
Safety Follow-Up Periods .................................................................................... 27 
5.2.4 
Premature End of Treatment ................................................................................ 27 
5.3 
Study duration per subject ........................................................................................... 27 
5.4 
Planned number of subjects and sites .......................................................................... 28 
5.5 
Anticipated regions and countries ................................................................................ 28 
5.6 
Schedule of study assessments..................................................................................... 28 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 5 of 216 
5.7 
Schematic diagram ....................................................................................................... 39 
5.8 
Rationale for study design and selection of dose ......................................................... 43 
6 
SELECTION AND WITHDRAWAL OF SUBJECTS ................................................... 44 
6.1 
Inclusion criteria .......................................................................................................... 44 
6.2 
Exclusion criteria ......................................................................................................... 45 
6.3 
Eligibility criteria for the OLE2 Period ....................................................................... 45 
6.3.1 
All subjects (OLE2 Groups A and B) .................................................................. 45 
6.3.2 
OLE2 Period Group A subjects ........................................................................... 45 
6.3.3 
OLE2 Period Group B subjects ........................................................................... 46 
6.4 
Withdrawal criteria ...................................................................................................... 48 
6.4.1 
Potential drug-induced liver injury IMP discontinuation criteria ........................ 50 
7 
STUDY TREATMENT ................................................................................................... 51 
7.1 
Description of IMP ...................................................................................................... 51 
7.2 
Treatments to be administered ..................................................................................... 51 
7.3 
Packaging ..................................................................................................................... 53 
7.4 
Labeling ....................................................................................................................... 53 
7.5 
Handling and storage requirements ............................................................................. 54 
7.6 
Drug accountability ...................................................................................................... 54 
7.7 
Procedures for monitoring subject compliance ............................................................ 55 
7.8 
Concomitant medications/treatments ........................................................................... 55 
7.8.1 
Permitted concomitant treatments (medications and therapies) .......................... 55 
7.8.1.1 
Topical medications .................................................................................. 55 
7.8.1.2 
Other medications ...................................................................................... 55 
7.8.2 
Prohibited concomitant treatments (medications and therapies) ......................... 55 
7.8.2.1 
Vaccines .................................................................................................... 57 
7.9 
Blinding........................................................................................................................ 57 
7.10 
Randomization and numbering of subjects .................................................................. 57 
8 
STUDY PROCEDURES BY VISIT ............................................................................... 57 
8.1 
Treatment Period .......................................................................................................... 58 
8.1.1 
Stable Dosing ....................................................................................................... 58 
8.1.1.1 
Baseline/Feeder Study Final Visit ............................................................. 58 
8.1.1.2 
Week 4 Visit (±7 days relative to Baseline) .............................................. 60 
8.1.1.3 
Week 8 Visit (±7 days relative to Baseline) .............................................. 60 
8.1.1.4 
Week 12 and Week 20 Visits (±7 days relative to Baseline) .................... 61 
8.1.1.5 
Week 16 Visit (±7 days relative to Baseline) ............................................ 61 
8.1.1.6 
Week 24 Visit (±7 days relative to Baseline) ............................................ 62 
8.1.2 
Flexible Dosing .................................................................................................... 63 
8.1.2.1 
Week 28 Visit (±7 days relative to Baseline) ............................................ 63 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 6 of 216 
8.1.2.2 
Week 32 Visit (±7 days relative to Baseline) ............................................ 63 
8.1.2.3 
Week 36 Visit (±7 days relative to Baseline) ............................................ 64 
8.1.2.4 
Week 40 Visit (±7 days relative to Baseline) ............................................ 64 
8.1.2.5 
Week 44 Visit (±7 days relative to Baseline) ............................................ 65 
8.1.2.6 
Week 48 Visit (±7 days relative to Baseline) ............................................ 65 
8.1.2.7 
Self-injection at home (Weeks 52, 56, 64, 68, 76, 80, 88, 92, 100, 104, 
112, 116, 124, 128, 136, and 140) ............................................................. 68 
8.1.2.8 
Week 60, Week 84, Week 108, and Week 132 Visit (±7 days relative to 
Baseline) .................................................................................................... 68 
8.1.2.9 
Week 72 Visit (±7 days relative to Baseline) ............................................ 69 
8.1.2.10 
Week 96 Visit (±7 days relative to Baseline) ............................................ 71 
8.1.2.11 
Week 120 Visit (±7 days relative to Baseline) .......................................... 72 
8.1.2.12 
Week 144 Visit (±7 days relative to Baseline) .......................................... 73 
8.1.3 
OLE2 Period ........................................................................................................ 75 
8.1.3.1 
OLE2 Screening (up to 4 weeks) – applicable for OLE2 Group B only ... 75 
8.1.3.2 
Dosing in the OLE2 Period ....................................................................... 76 
8.1.3.3 
OLE2 Week 48 Visit (±14 days relative to OLE2 Baseline) .................... 79 
8.2 
Premature End of Treatment Visit ............................................................................... 80 
8.3 
Safety Follow-Up Visit (20 weeks after final dose up to Week 144, ±7 days) ........... 80 
8.4 
Safety Follow-Up Visit 2 (20 weeks after final dose of the OLE2 Period, ±7 days) .. 81 
8.5 
Unscheduled Visit ........................................................................................................ 81 
9 
ASSESSMENT OF SAFETY .......................................................................................... 82 
9.1 
Adverse events ............................................................................................................. 82 
9.1.1 
Definitions ........................................................................................................... 82 
9.1.1.1 
Adverse event ............................................................................................ 82 
9.1.1.2 
Serious adverse event ................................................................................ 82 
9.1.1.3 
Adverse events of special interest ............................................................. 83 
9.1.1.4 
Other safety topics of interest .................................................................... 84 
9.1.2 
Procedures for reporting and recording AEs ....................................................... 84 
9.1.2.1 
Description of AEs .................................................................................... 84 
9.1.2.2 
Rule for repetition of an AE ...................................................................... 84 
9.1.2.3 
Additional procedures for reporting SAEs ................................................ 84 
9.1.3 
Follow up of AEs ................................................................................................. 85 
9.1.4 
Pregnancy ............................................................................................................ 85 
9.1.5 
Suspected transmission of an infectious agent via a medicinal product .............. 86 
9.1.6 
Overdose of IMP .................................................................................................. 87 
9.1.7 
Safety signal detection ......................................................................................... 87 
9.2 
Laboratory measurements ............................................................................................ 87 
9.2.1 
Evaluation of PDILI ............................................................................................ 88 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 7 of 216 
9.2.1.1 
Consultation with Medical Monitor and local hepatologist ...................... 93 
9.2.1.2 
Immediate action: determination of IMP discontinuation ......................... 93 
9.2.1.3 
Testing: identification/exclusion of alternative etiology ........................... 93 
9.2.1.4 
Follow-up evaluation ................................................................................. 95 
9.3 
Other safety measurements .......................................................................................... 95 
9.3.1 
Assessment and management of TB and TB risk factors .................................... 95 
9.3.1.1 
Tuberculosis assessment by IGRA ............................................................ 98 
9.3.1.2 
Tuberculosis questionnaire ........................................................................ 98 
9.3.1.3 
Tuberculosis management ......................................................................... 98 
9.3.2 
Pregnancy testing ................................................................................................. 99 
9.3.3 
Vital signs ............................................................................................................ 99 
9.3.4 
12-lead ECGs ....................................................................................................... 99 
9.3.5 
Physical examination ........................................................................................... 99 
9.3.6 
Body weight ......................................................................................................... 99 
9.3.7 
Assessment of suicidal ideation and behavior ..................................................... 99 
9.3.8 
Patient Health Questionnaire 9 .......................................................................... 100 
10 ASSESSMENT OF EFFICACY .................................................................................... 100 
10.1 
Psoriasis Area and Severity Index ............................................................................. 100 
10.2 
IGA ............................................................................................................................ 101 
10.3 
Dermatology Life Quality Index ................................................................................ 102 
10.4 
mNAPSI Score ........................................................................................................... 102 
10.5 
Scalp IGA................................................................................................................... 102 
10.6 
pp-IGA ....................................................................................................................... 103 
10.7 
Euro-Quality of Life 5-Dimensions, 3 levels ............................................................. 104 
10.8 
Short Form 36-Item Health Survey............................................................................ 104 
10.9 
Patient Global Assessment of PSO ............................................................................ 104 
10.10 Psoriatic Arthritis Screening and Evaluation questionnaire ...................................... 104 
10.11 Patient's Global Assessment of Disease Activity for arthritis VAS .......................... 105 
10.12 WPAI-SHP V2.0 ........................................................................................................ 105 
10.13 Treatment Satisfaction Questionnaire for Medication (TSQM-9) ............................. 105 
11 ASSESSMENT OF PHARMACOKINETIC VARIABLES ......................................... 105 
11.1 
Pharmacokinetic variables ......................................................................................... 105 
12 ASSESSMENT OF IMMUNOLOGICAL VARIABLES ............................................. 106 
13 STUDY MANAGEMENT AND ADMINISTRATION ............................................... 106 
13.1 
Adherence to protocol ................................................................................................ 106 
13.2 
Monitoring ................................................................................................................. 106 
13.2.1 
Definition of source data ................................................................................... 107 
13.2.2 
Source data verification ..................................................................................... 107 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 8 of 216 
13.3 
Data handling ............................................................................................................. 107 
13.3.1 
Case Report form completion ............................................................................ 107 
13.3.2 
Database entry and reconciliation ...................................................................... 108 
13.3.3 
Subject Baseline and Enrollment Log/Subject Identification Code list ............ 108 
13.4 
Termination of the study ............................................................................................ 108 
13.5 
Archiving and data retention ...................................................................................... 108 
13.6 
Audit and inspection .................................................................................................. 109 
13.7 
Good Clinical Practice ............................................................................................... 109 
14 STATISTICS ................................................................................................................. 109 
14.1 
Definition of analysis sets .......................................................................................... 109 
14.2 
General statistical considerations ............................................................................... 110 
14.3 
Planned safety analyses.............................................................................................. 110 
14.3.1 
Primary safety analysis ...................................................................................... 110 
14.3.2 
Other safety analysis .......................................................................................... 111 
14.4 
Planned efficacy analyses .......................................................................................... 111 
14.5 
Pharmacokinetic analyses .......................................................................................... 112 
14.6 
Immunogenicity analyses........................................................................................... 112 
14.7 
Handling of protocol deviations................................................................................. 112 
14.8 
Handling of dropouts or missing data ........................................................................ 112 
14.9 
Planned interim analysis and data monitoring ........................................................... 113 
14.10 Determination of sample size ..................................................................................... 113 
15 ETHICS AND REGULATORY REQUIREMENTS .................................................... 113 
15.1 
Informed consent ....................................................................................................... 113 
15.2 
Subject identification cards ........................................................................................ 114 
15.3 
Institutional Review Boards and Independent Ethics Committees ............................ 114 
15.4 
Subject privacy........................................................................................................... 115 
15.5 
Protocol amendments ................................................................................................. 115 
16 FINANCE, INSURANCE, AND PUBLICATION ....................................................... 115 
17 REFERENCES .............................................................................................................. 116 
18 APPENDICES ............................................................................................................... 118 
18.1 
Protocol Amendment 1 .............................................................................................. 118 
18.2 
Protocol Amendment 2 .............................................................................................. 167 
18.3 
Protocol Amendment 3 .............................................................................................. 185 
18.4 
Protocol Amendment 3.3 ........................................................................................... 187 
19 DECLARATION AND SIGNATURE OF INVESTIGATOR ..................................... 215 
20 SPONSOR DECLARATION ........................................................................................ 216 
 
LIST OF TABLES 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 9 of 216 
Table 5-1: 
Schedule of study assessments – Year 1 (Weeks 0 to 44) ............................... 29 
Table 5-2: 
Schedule of study assessments – Years 2 and 3 (Weeks 48 to 144) ................ 32 
Table 5-3: 
Schedule of study assessments – OLE2 Period (from OLE2 Screening 
Visit or from Week 144/OLE2 Visit to Week 48) ........................................... 35 
Table 7-1: 
Prohibited PSO medications ............................................................................ 56 
Table 8-1: 
Dosing scheme, Years 2 and 3 (Weeks 48 to 144) .......................................... 66 
Table 8-2: 
Dosing scheme, OLE2 Period .......................................................................... 76 
Table 9‒1: 
Anticipated SAEs for the population of subjects with moderate to severe 
chronic plaque PSO.......................................................................................... 83 
Table 9‒2: 
Laboratory measurements ................................................................................ 88 
Table 9‒3: 
Required investigations and follow up for PDILI............................................ 90 
Table 9‒4: 
PDILI laboratory measurements ...................................................................... 94 
Table 9‒5: 
PDILI information to be collected ................................................................... 95 
Table 10‒1: 
Body areas for calculation of percent BSA for PASI .................................... 101 
Table 10‒2: 
Five-point IGA ............................................................................................... 101 
Table 10‒3: 
Scalp IGA....................................................................................................... 103 
Table 10‒4: 
pp-IGA ........................................................................................................... 103 
 
LIST OF FIGURES 
Figure 5‒1: 
Schematic diagram, Screening through Week 48 ............................................ 40 
Figure 5-2: 
Schematic diagram, Years 2 and 3 (Week 48 through Week 144) .................. 41 
Figure 5-3: 
Schematic diagram, OLE2 Period (From OLE2 Screening through OLE2 
Week 48) .......................................................................................................... 42 
Figure 9-1: 
Schematic diagram of TB test results and study eligibility ............................. 97 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 10 of 216 
LIST OF ABBREVIATIONS 
AE 
adverse event 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
BA 
bioavailability 
BSA 
body surface area 
cAMP 
cyclic adenosine monophosphate 
CDMS 
clinical data management system 
CI 
confidence interval 
CPMP 
Committee for Proprietary Medicinal Products 
CRO 
contract research organization 
CSR 
Clinical Study Report 
DBP 
diastolic blood pressure 
DLQI 
Dermatology Life Quality Index 
EAIR 
exposure adjusted incidence rate 
EAER 
exposure adjusted event rate 
ECG 
electrocardiogram 
eCRF 
electronic Case Report Form 
eC-SSRS 
electronic Columbia Suicide Severity Rating Scale 
EQ-5D-3L 
Euro-Quality of Life 5-Dimensions, 3 levels 
FAS 
Full Analysis Set 
GCP 
Good Clinical Practice 
GMP 
Good Manufacturing Practice 
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 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 11 of 216 
IGRA 
Interferon gamma release assay 
IL 
interleukin 
IMP 
investigational medicinal product 
IRB 
Institutional Review Board 
IRT 
interactive response technology 
iv 
intravenous 
LTBI 
latent tuberculosis infection 
mAb 
monoclonal antibody 
MCS 
Mental Component Summary 
MedDRA 
Medical Dictionary for Regulatory Activities 
mNAPSI 
Modified Nail Psoriasis Severity Index Score 
NTMB 
nontuberculous mycobacterium 
OLE 
Open-label extension 
PASE 
Psoriatic Arthritis Screening and Evaluation 
PASI 
Psoriasis Area Severity Index 
PCS 
Physical Component Summary 
PD 
pharmacodynamic(s) 
PDE 
phosphodiesterase 
PDILI 
potential drug-induced liver injury 
PEOT 
Premature End of Treatment 
PGA 
Patient Global Assessment 
PGADA 
Patient's Global Assessment of Disease Activity 
PHQ-9 
Patient Health Questionnaire-9 
PK 
pharmacokinetic(s) 
PK-PPS 
Pharmacokinetics Per-Protocol Set 
pp-IGA 
palmoplantar Investigator’s Global Assessment 
PS 
Patient Safety 
PsA 
psoriatic arthritis 
PSO 
psoriasis 
PT 
preferred term 
Q4W 
every 4 weeks 
Q8W 
every 8 weeks 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 12 of 216 
QOL 
quality of life 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
SBP 
systolic blood pressure 
sc 
subcutaneous(ly) 
SD 
standard deviation 
SF-36 
Short Form 36-item Health Survey 
SFU 
Safety Follow-Up 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure(s) 
SS 
Safety Set 
TB 
tuberculosis 
TEAE 
treatment-emergent adverse event 
TNF 
tumor necrosis factor 
TSQM-9 
Treatment Satisfaction Questionnaire for Medication 
ULN 
upper limit of normal 
VAS 
visual analog scale 
WPAI-SHP 
Work Productivity and Activity Impairment Questionnaire-specific 
health problem 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 13 of 216 
1 
SUMMARY 
This is a Phase 3, multicenter, open-label study to assess the long-term safety, tolerability, and 
efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis 
(PSO) who complete 1 of the Phase 3 feeder studies. 
The study population consists of adult subjects (≥18 years of age) who have completed 1 of the 
Phase 3 feeder studies and had an initial diagnosis of moderate to severe chronic plaque PSO 
(Baseline Psoriasis Area and Severity Index [PASI] ≥12, body surface area [BSA] affected by 
PSO ≥10%, and Investigator’s Global Assessment [IGA] score ≥3 [on a 5-point scale]). Subjects 
must have achieved a PASI50 response by the designated time in the feeder study to be eligible 
for PS0014. 
Approximately 1120 subjects are expected to enroll in PS0014. For each subject, the study will 
last a maximum of 192 weeks and will consist of a Treatment Period (144 weeks) and a Safety 
Follow-Up (SFU) Period (20 weeks after the final dose of investigational medicinal product 
[IMP] depending on subject’s participation in the Open-Label Extension (OLE2) Period; see 
paragraph below). 
Subjects participating in the OLE2 (implemented as part of Protocol Amendment #3.3) will enter 
the OLE2 Period after completing the Treatment Period (at Week 144), including subjects in the 
SFU period and subjects who have completed the SFU Period. The OLE2 Period will be a 
48-week open-label treatment period with final visit at OLE2 Week 48, followed by an SFU 
Period (SFU2, 20 weeks after the final dose of IMP administered in the OLE2 Period). 
During the Treatment Period (up to Week 144), eligible subjects will receive the following IMP 
regimens as determined by the subject’s treatment regimen and PASI response in the feeder 
study. Subjects receiving: 
• Bimekizumab 320mg Q4W who do not achieve PASI90 in the feeder study will receive 
bimekizumab 320mg every 4 weeks (Q4W). 
• Bimekizumab 320mg Q4W who achieve PASI90 in the feeder study will be randomized 4:1 
to receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. 
• Bimekizumab 320mg every 8 weeks (Q8W) who do not achieve PASI90 in the feeder study 
will receive bimekizumab 320mg every 4 weeks (Q4W). 
• Bimekizumab 320mg Q8W who achieve PASI90 in the feeder study will receive 
bimekizumab 320mg Q8W. 
• Ustekinumab who do not achieve PASI90 in the feeder study will receive bimekizumab 
320mg Q4W. 
• Ustekinumab who achieve PASI90 in the feeder study will be randomized 1:1 to receive 
bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. 
• Placebo (after a Week 16 response [≥PASI90] on bimekizumab 320mg Q4W during the 
Initial Treatment Period of the feeder study) who complete the Randomized Withdrawal 
Period of the feeder study will receive bimekizumab 320mg Q4W. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 14 of 216 
At the final study visit in the feeder studies, eligible subjects continuing into PS0014 will 
complete the final study visit assessments and any additional PS0014 Baseline assessments, and 
will then receive their first dose of open-label bimekizumab in PS0014. During Year 1 of the 
Treatment Period (Weeks 0 to 44), all subjects will attend study visits at the study site Q4W for 
study assessments and IMP will be administered in the clinic by subcutaneous (sc) injection. 
During Years 2 and 3 of the Treatment Period (Weeks 48 to 144), all subjects will attend study 
visits at the study site every 12 weeks for study assessments and subjects may self-inject IMP at 
home.  
At Week 24, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
Investigator may change the subject’s dosing interval from 320mg Q4W to 320mg Q8W 
(optional).  
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 48 or at the next scheduled clinic visit after implementation 
of Protocol Amendment #2 if the subject has already completed the Week 48 visit.  
Subjects withdrawing early from the study will undergo the Premature End of Treatment (PEOT) 
Visit assessments and will enter the SFU Period. 
After the implementation of Protocol Amendment #3.3 (addition of a 48-week open-label 
treatment period, ie, OLE2 Period), subjects will be invited to continue or reinitiate bimekizumab 
treatment as per the following OLE2 Groups: 
• OLE2 Group A: Subjects in the Treatment Period at the time of Protocol Amendment #3.3 
implementation will attend the Week 144 Visit and may directly roll over to the OLE2 
Period. These subjects will continue receiving bimekizumab 320mg Q8W for 40 additional 
weeks, starting from the first treatment visit of the OLE2 Period (ie, Week 144/OLE2 
Baseline Visit; the Week 144 Visit will coincide with the Week 144/OLE2 Baseline Visit and 
data collected at this visit will be used as baseline data for subjects entering the OLE2 
Period). 
• OLE2 Group B: Eligible subjects who have completed the Treatment Week 144 Visit and 
who are in the SFU or have completed the SFU at the time of Protocol Amendment #3.3 
implementation may reinitiate bimekizumab treatment in the OLE2 Period after having 
undergone Screening assessments during a 4-week OLE2 Screening Period. The first dose 
will be administered at the Week 144/OLE2 Baseline Visit; data collected at this visit will be 
used as baseline data. Subjects with an IGA score ≥3 upon entry in the OLE2 Period will be 
treated with bimekizumab Q4W for the first 16 weeks, and will then switch to bimekizumab 
320mg Q8W. Subjects in OLE2 Group B with an IGA score <3 upon entry will be treated 
with bimekizumab Q8W from the Week 144/OLE2 Baseline Visit. 
During the OLE2 Period (Week 144/OLE2 Baseline to OLE2 Week 48), all subjects will attend 
visits at the site every 12 weeks for study assessments and subjects may self-inject IMP at home. 
Following completion or early withdrawal from the OLE2 Period, subjects will return for the 
SFU of the OLE2 Period (SFU2) Visit 20 weeks after the last dose of IMP administration. 
The primary objective of the study is to assess the long-term safety and tolerability of 
bimekizumab administered sc in the treatment of adult subjects with moderate to severe chronic 
plaque PSO. The secondary objectives of the study are listed in Section 3.2. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 15 of 216 
The primary safety variable is the incidence of treatment-emergent adverse events (TEAEs) 
adjusted by duration of subject exposure to treatment. The secondary safety variables are the 
incidence of serious adverse events (SAEs) adjusted by duration of subject exposure to treatment 
and TEAEs leading to withdrawal adjusted by duration of subject exposure to treatment (see 
Section 4.2). 
Efficacy variables are listed in Section 4.2.2 and Section 4.3.2. 
Pharmacokinetic (PK) variables are listed in Section 4.3.3 and the immunological variable is 
listed in Section 4.3.4. 
Pharmacokinetic and immunological variables will be evaluated to assess their relationship to 
treatment response. 
In addition, subjects may consent to participate in a PS0014 sub-study designed to evaluate the 
safe and effective use of self-injecting device presentations (ie, prefilled safety syringe and auto-
injector presentations) for sc self-injection of bimekizumab by subjects in select sites in Europe, 
Japan, Canada, and the US. 
2 
INTRODUCTION 
2.1 
Psoriasis 
Psoriasis is a common, chronic inflammatory disease characterized by a series of linked cellular 
changes in the skin: hyperplasia of epidermal keratinocytes, vascular hyperplasia and ectasia, and 
infiltration of T lymphocytes, neutrophils, and other types of leukocytes in affected skin. Though 
the pathophysiology of PSO is not fully understood, the importance of T-cells and inflammatory 
cytokines has been demonstrated by the clinical benefit provided by therapies directed at these 
targets (Krueger and Ellis, 2005). 
There are a variety of forms of PSO including plaque, guttate, inverse, pustular, and 
erythrodermic. Plaque PSO is the most common, comprising approximately 80% to 90% of all 
cases. Approximately 17% of those with PSO have moderate to severe disease 
(Kurd et al, 2008). 
In addition to the impact on skin, PSO has a multitude of psychosocial and emotional effects on 
patients, including increased self-consciousness, frustration, fatigue, depression, and suicidal 
ideation. As a result, patients frequently report sleeping problems, difficulties at work, problems 
interacting with family members, disrupted leisure activities, and sexual difficulties 
(Dowlatshahi et al, 2014; Gottlieb, 2005; Mukhtar et al, 2004; Ortonne, 2004; 
Krueger et al, 2001). 
A number of comorbidities have been associated with PSO, especially with more severe PSO. 
Psoriatic arthritis (PsA), cardiovascular disease, metabolic syndrome, chronic pulmonary 
disease, peptic ulcer disease, renal disease, and diabetes have all been demonstrated to have an 
increased prevalence in PSO patients (Yeung et al, 2013; Christophers et al, 2010; 
Gisondi et al, 2007; Gelfand et al, 2006). 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 16 of 216 
2.1.1 
Global epidemiology of PSO 
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 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 PSO 
Therapy for patients with PSO varies according to the severity of disease. Limited or mild 
disease is often treated with topical therapies such as corticosteroids and vitamin D analogs. 
Patients with more severe disease are often treated with phototherapy, methotrexate, 
cyclosporine, the oral phosphodiesterase (PDE) 4 inhibitor apremilast, or biologic agents, such as 
tumor necrosis factor (TNF) antagonists, interleukin (IL) 12/23 inhibitors, IL-23p19 inhibitors, 
and IL-17A inhibitors. The effectiveness of TNF inhibitors in the treatment of PSO has been 
demonstrated in many Phase 3 clinical studies and has led to the approval of multiple TNF 
inhibitors for use in patients with moderate to severe PSO. Interleukin inhibitors approved for 
this indication include the IL-12/23 antagonist ustekinumab, the IL-23p19 antagonist 
guselkumab, the IL-17A inhibitors secukinumab and ixekizumab, and the IL-17 receptor 
antagonist brodalumab. 
Standard therapies for PSO are listed below: 
• 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. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 17 of 216 
• 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 
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 
T-helper 17 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 (mAb) that 
binds with specificity to the p40 protein subunit used by both the IL-12 and IL-23 
cytokines, naturally occurring cytokines that are involved in inflammatory and immune 
responses, such as natural killer cell activation and cluster of differentiation 4+ T-cell 
differentiation and activation. 
− Secukinumab and ixekizumab have been approved in the US and the EU for the treatment 
of moderate to severe plaque PSO in adult patients who are candidates for systemic 
therapy or phototherapy. Secukinumab is a human IgG1 mAb that selectively binds to the 
IL-17A cytokine and inhibits its interaction with the IL-17 receptor. Ixekizumab is a 
humanized IgG4 mAb that selectively binds with the IL-17A cytokine and inhibits its 
interaction with the IL-17 receptor. Interleukin-17A is a naturally occurring cytokine that 
is involved in normal inflammatory and immune responses. Both drugs inhibit the release 
of 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 
IL-23 and inhibits its interaction with the IL-23 receptor. Interleukin-23 is a naturally 
occurring cytokine that is involved in normal inflammatory and immune responses. 
Guselkumab inhibits the release of proinflammatory cytokines and chemokines. 
− Brodalumab has been approved in the EU for the treatment of moderate to severe plaque 
PSO in adult patients who are candidates for systemic therapy and in the US for the 
treatment of moderate to severe plaque PSO in adult patients who are candidates for 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 18 of 216 
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 proinflammatory cytokines and 
chemokines. Brodalumab has a black box warning regarding suicidal ideation and 
behavior. 
2.2 
Bimekizumab 
Bimekizumab is an engineered, humanized, full length mAb of IgG1 subclass of approximately 
150,000 Daltons which is expressed in a genetically engineered Chinese hamster ovary cell line. 
Bimekizumab has high affinity for human IL-17A and human IL-17F and selectively and 
potently inhibits the activity of both isoforms in vitro. Interleukin-17A and IL-17F are key 
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 has been designed to inhibit 
the activity of IL-17A and IL-17F subtypes of IL-17. This property makes bimekizumab 
distinctly different from the other IL-17-targeting agents, like secukinumab and ixekizumab 
(selective anti-IL-17-A mAb) or brodalumab (anti-IL-17 receptor mAb). 
Overexpression of IL-17A, IL-17C, and IL-17F in lesion tissue suggests that broader 
IL-17 blockade may be more beneficial in the treatment of plaque PSO. However, blocking all 
IL-17 isoforms (including the IL-17E isoform, also known as IL-25) may not be the optimal 
approach. The role of IL-25 in PSO and other IL-17 mediated diseases has not been well 
established; however, it has been suggested that IL-25 may play a beneficial role in 
inflammatory conditions associated with type 1 T-helper mediated immune responses, such as 
PSO (as opposed to type 2 T-helper mediated) (Valizadeh et al, 2015).Thus, it can be 
hypothesized that inhibition of both IL-17A and IL-17F is associated with additional benefits in 
PSO compared with 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. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 19 of 216 
RA0124 was a Phase 1, open-label, parallel-group, single-dose study in healthy subjects. The 
primary objective of this study was to determine the absolute bioavailability (BA) of single sc 
doses of bimekizumab (80mg and 160mg). The secondary objectives were to evaluate the dose 
proportionality of bimekizumab 80mg and 160mg sc, and to evaluate the safety and tolerability 
of these sc doses and 160mg given by iv infusion. In RA0124, the absolute BA was similar for 
the 2 doses tested (0.656 and 0.631 for the bimekizumab 80mg and 160mg sc doses, 
respectively). The 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 Week 3 and Week 6 
• 160mg loading dose followed by 80mg at Week 3 and Week 6 
• 240mg loading dose followed by 160mg at Week 3 and Week 6 
• 560mg loading dose followed by 320mg at Week 3 and Week 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 nonserious 
and resolved with topical therapy. There was a potential reduction in mean neutrophil count in 
the active treatment group, although this drop was not clinically relevant and a clear relationship 
with dose or time was not evident. Some increases in liver function tests were reported, but none 
had a convincing relationship to exposure to IMP. The exploratory analysis showed clinically 
relevant improvement in activity of PsA and in skin involvement in those subjects with 
concomitant active psoriatic lesions. 
UP0031 was a Phase 1, open-label, parallel-group, randomized, single-dose study to evaluate the 
BA, PK, and tolerability of 2 different formulations of bimekizumab in healthy subjects. Subjects 
receiving Formulation A (histidine-based) were administered 2x1mL injections of 
 each of 
bimekizumab and subjects receiving Formulation B (acetate-based) were administered a single 
injection of bimekizumab 160mg given as a 1mL injection. Six subjects were randomized to 
each bimekizumab formulation. The geometric means for area under the curve 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 
TEAEs leading to discontinuation, and no SAEs or fatalities were reported. The only adverse 
event (AE) experienced by more than 1 subject in either treatment group was injection site pain 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 20 of 216 
(5 subjects [83.3%] and 3 subjects [50.0%] in the 2x80mg and 1x160mg groups, respectively). 
The most frequently reported TEAE considered related to the IMP was injection site pain, 
experienced by 5 subjects (83.3%) and 3 subjects (50.0%) in the 2x80mg and 1x160mg groups, 
respectively. There were no clinically significant laboratory values reported in the study. 
UP0042 was a randomized double-blind, placebo-controlled, single-dose, parallel-group study to 
evaluate the safety, tolerability, and 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 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 
healthy Japanese and Caucasian subjects and no major differences in safety findings were 
observed between Japanese and Caucasian subjects. 
Additional information on completed studies is available in the Investigator’s Brochure (IB). 
2.2.1.2 
Ongoing studies 
All ongoing studies at the time of Protocol Amendment #3.3 implementation are presented and 
described in the current version of the IB  
2.2.1.3 
Feeder studies 
Eligible subjects who complete the feeder studies are eligible for enrollment into PS0014. These 
studies include: 
• PS0008 is a Phase 3, multicenter, randomized, double-blind, parallel-group study with an 
active comparator-controlled initial treatment period followed by a dose-blind maintenance 
period to evaluate the efficacy, safety, and PK of bimekizumab administered as an sc 
injection of 320mg Q4W and 320mg Q8W compared with adalimumab in adult subjects with 
moderate to severe chronic plaque PSO. 
• PS0009 is a Phase 3, multicenter, randomized, double-blind, placebo- and active 
comparator-controlled, parallel-group study to evaluate the efficacy, safety, PK, and PD of 
bimekizumab administered as an sc injection of 320mg Q4W compared with placebo and 
ustekinumab in adult subjects with moderate to severe chronic plaque PSO. 
• PS0013 is a Phase 3, multicenter, double-blind, placebo-controlled study with an initial 
treatment period followed by a randomized withdrawal period to evaluate the efficacy, 
safety, and PK of bimekizumab administered as an sc injection of 320mg Q4W and 320mg 
Q8W compared with placebo in adult subjects with moderate to severe chronic plaque PSO. 
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 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 21 of 216 
mucosa associated lymphoid tissue via a pharmacologically-related mechanism. In a second 
repeat-dose study, none of the minor apoptosis or 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. 
Additional information on the nonclinical data for bimekizumab is available in the current 
version of the IB. 
3 
STUDY OBJECTIVES 
3.1 
Primary objective 
The primary objective of the study is to assess the long-term safety and tolerability of 
bimekizumab administered sc in adult subjects with moderate to severe chronic plaque PSO. 
3.2 
Secondary objectives 
The secondary objectives of the study are to: 
• Assess the safety of maintenance therapy bimekizumab dose regimens administered over 
144 weeks as measured by SAEs and TEAEs leading to study withdrawal 
• Assess the efficacy of maintenance therapy bimekizumab dose regimens administered over 
144 weeks as measured by PASI90 (defined as a subject who achieves 90% reduction in the 
PASI score from the feeder study Baseline) and IGA response (Clear or Almost Clear with at 
least a 2 category improvement from Baseline on a 5-point scale) 
3.3 
Other objectives 
The other objectives of the study are to: 
• Assess the safety of maintenance therapy bimekizumab dose regimens administered over 
144 weeks 
• Assess the efficacy of maintenance therapy bimekizumab dose regimens administered over 
144 weeks 
• Assess the impact of initiating bimekizumab therapy in subjects who received ustekinumab 
in PS0009 
• Assess the PK of bimekizumab 
• Assess the immunogenicity of bimekizumab 
• Assess the change in psoriatic nail disease in subjects with nail disease at Baseline in the 
feeder studies 
• Assess the change in psoriatic scalp disease over time for subjects with scalp PSO at Baseline 
in the feeder studies 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 22 of 216 
• Assess the change in palmoplantar PSO for subjects who have palmoplantar PSO at Baseline 
in the feeder studies 
• Assess the symptoms of PsA as measured by the Psoriatic Arthritis Screening and Evaluation 
(PASE) questionnaire 
• Assess general health-related quality of life (QOL), including the change in skin-related QOL 
and treatment satisfaction 
• Assess the safety of bimekizumab manufactured using Process 5 
4 
STUDY VARIABLES 
4.1 
Primary safety variable 
The primary safety variable is the incidence of TEAEs adjusted by duration of subject exposure 
to treatment. 
4.2 
Secondary variables 
4.2.1 
Secondary safety variables 
The secondary safety variables are: 
• Incidence of SAEs adjusted by duration of subject exposure to treatment 
• Incidence of TEAEs leading to withdrawal adjusted by duration of subject exposure to 
treatment 
4.2.2 
Secondary efficacy variables 
The secondary efficacy variables are: 
• PASI90 at Week 144 
• IGA 0/1 response at Week 144 
4.3 
Other variables 
The other variables are listed below and will be evaluated according to the schedule of study 
assessments in Table 5-1 and Table 5-2. Variables evaluated in the OLE2 Period are listed in 
Table 5-3. 
4.3.1 
Other safety variables 
Change from Baseline variables for safety will be defined relative to the Baseline entry 
measurement from PS0014. 
The other safety variables to be assessed are: 
• Severity and frequency of TEAEs 
• Change from Baseline in clinical laboratory variables (chemistry and hematology)  
• Change from Baseline in vital signs 
• Change from Baseline in 12-lead electrocardiogram (ECG) results 
• Change from Baseline in the Patient Health Questionnaire 9 (PHQ-9) 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 23 of 216 
Physical examination findings considered to be clinically significant changes since the physical 
examination at the Baseline Visit will be recorded as AEs. 
4.3.2 
Other efficacy variables 
Change from Baseline efficacy variables will be defined relative to the Baseline measurement 
from the feeder study. The other efficacy variables are listed below: 
• PASI75, PASI90, and PASI100 response 
• Percentage of subjects with PASI ≤1, ≤2, ≤3 and ≤5 
• IGA response (Clear or Almost Clear with at least 2 category improvement relative to 
Baseline) 
• IGA response (Clear with at least 2 category improvement relative to Baseline) 
• Absolute and percent change from Baseline in PASI 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) 
• Percentage of subjects achieving a DLQI total score of 0 or 1 
• Percentage of subjects achieving a minimal clinically important difference (improvement 
from Baseline of 4 or more) in the DLQI 
• Change from Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) score for 
subjects with nail disease at Baseline 
• mNAPSI75, mNAPSI90 and mNAPSI100 response 
• Change from Baseline in the Patient’s Global Assessment of Disease Activity (PGADA) for 
the arthritis visual analog scale (VAS) for subjects with PsA at Baseline 
• Change from Baseline in Patient Global Assessment (PGA) of PSO score 
• Scalp-specific IGA (Scalp IGA) response (Clear or Almost Clear with at least 2 category 
improvement relative to Baseline) for subjects with scalp PSO at Baseline 
• Palmoplantar Investigator’s Global Assessment (pp-IGA) response (Clear or Almost Clear 
with at least 2 category improvement relative to Baseline) for subjects with palmoplantar 
PSO at Baseline 
• 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, Mental Component Summary (MCS) score, and individual domains 
• Responses to Euro-Quality of Life 5-Dimensions, 3 levels (EQ-5D-3L) 
• Changes from Baseline in EQ-5D-3L VAS scores and all dimensions 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 24 of 216 
• Change from Baseline in Work Productivity and Activity Impairment Questionnaire-specific 
health problem (WPAI-SHP) V2.0 adapted to PSO scores 
• Treatment Satisfaction Questionnaire for Medication (TSQM-9) 
4.3.3 
Pharmacokinetic variables 
The PK variable is plasma concentrations of bimekizumab.  
4.3.4 
Immunological variable 
The immunological variable is anti-bimekizumab antibody levels prior to and following 
IMP administration.  
5 
STUDY DESIGN 
5.1 
Study description 
PS0014 is a multicenter, open-label study to assess the long-term safety, tolerability, and efficacy 
of bimekizumab in eligible adult subjects with moderate to severe chronic plaque PSO who 
complete 1 of the Phase 3 feeder studies. At the final study visit in the feeder studies, eligible 
subjects continuing into PS0014 will complete the final study visit assessments and any 
additional PS0014 Baseline assessments, and will then receive their first dose of open-label 
bimekizumab in PS0014. Subjects will receive IMP (bimekizumab 320mg Q4W or bimekizumab 
320mg Q8W) based on their treatment regimen and PASI response in the feeder study (see 
Section 5.2.1). 
An additional open-label cohort will be added in Japan to allow enrollment of subjects with PSO 
including moderate to severe chronic plaque PSO, generalized pustular PSO, and erythrodermic 
PSO. The details of this cohort are included in the country-specific protocol amendment. 
An OLE2 Period will be added in Canada and the US after the country-specific Protocol 
Amendment #3.3 implementation (addition of a 48-week open-label treatment period, ie, the 
OLE2 Period), and subjects will be invited to continue or reinitiate bimekizumab treatment for 
an additional 40 weeks. 
In addition, subjects may consent to participate in a PS0014 sub-study designed to evaluate the 
safe and effective use of self-injecting device presentations (ie, prefilled safety syringe and auto-
injector presentations) for sc self-injection of bimekizumab by subjects in select sites in Europe, 
Japan, Canada, and the US. 
5.2 
Study periods 
PS0014 will include a Treatment Period of 144 weeks (from Baseline/Feeder Study Final Visit to 
Week 144 Visit) followed by a SFU Period of 20 weeks after the last dose of IMP in the 
Treatment Period. After the implementation of Protocol Amendment #3.3 (addition of a 48-week 
open-label treatment period, ie, OLE2 Period), PS0014 will be prolonged by an OLE2 Period, 
during which eligible subjects will be invited to continue or reinitiate bimekizumab treatment for 
40 weeks (from Week 144/OLE2 Baseline to OLE2 Week 48) and will be followed in a second 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 25 of 216 
SFU Period of 20 weeks after the final dose of IMP (SFU2 Period), as appropriate. Subjects will 
be invited to continue or reinitiate bimekizumab treatment as per the following OLE2 Groups: 
• OLE2 Group A: Subjects in the Treatment Period at the time of Protocol Amendment #3.3 
implementation will attend the Week 144 Visit and may directly roll over to the OLE2 
Period. These subjects will continue receiving bimekizumab 320mg Q8W for 40 additional 
weeks, starting from the first treatment visit of the OLE2 Period (ie, Week 144/OLE2 
Baseline Visit; the Week 144 Visit will coincide with the Week 144/OLE2 Baseline Visit and 
data collected at this visit will be used as baseline data for subjects entering the OLE2 
Period). 
• OLE2 Group B: Eligible subjects who have completed the Treatment Week 144 Visit and 
who are in the SFU or have completed the SFU at the time of Protocol Amendment #3.3 
implementation may reinitiate bimekizumab treatment in the OLE2 Period after having 
undergone Screening assessments during a 4-week OLE2 Screening Period. The first dose 
will be administered at the Week 144/OLE2 Baseline Visit; data collected at this visit will be 
used as baseline data. Subjects with an IGA score ≥3 upon entry in the OLE2 Period will be 
treated with bimekizumab Q4W for the first 16 weeks, and will then switch to bimekizumab 
320mg Q8W. Subjects in OLE2 Group B with an IGA score <3 upon entry will be treated 
with bimekizumab Q8W from the Week 144/OLE2 Baseline Visit.  
5.2.1 
Treatment Period 
During the Treatment Period, eligible subjects will receive the following IMP regimens as 
determined by the subject’s treatment regimen and PASI response in the feeder study. Subjects 
receiving: 
• Bimekizumab 320mg Q4W who do not achieve PASI90 in the feeder study will receive 
bimekizumab 320mg Q4W. 
• Bimekizumab 320mg Q4W who achieve PASI90 in the feeder study will be randomized 4:1 
to receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. 
• Bimekizumab 320mg Q8W who do not achieve PASI90 in the feeder study will receive 
bimekizumab 320mg Q4W. 
• Bimekizumab 320mg Q8W who achieve PASI90 in the feeder study will receive 
bimekizumab 320mg Q8W. 
• Ustekinumab who do not achieve PASI90 in the feeder study will receive bimekizumab 
320mg Q4W. 
• Ustekinumab who achieve PASI90 in the feeder study will be randomized 1:1 to receive 
bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. 
• Placebo (after a Week 16 response [≥PASI90] on bimekizumab 320mg Q4W during the 
Initial Treatment Period of the feeder study) who complete the Randomized Withdrawal 
Period of the feeder study will receive bimekizumab 320mg Q4W. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 26 of 216 
During Year 1 of the Treatment Period (Weeks 0 to 44), all subjects will attend study visits at the 
study site Q4W for study assessments. During Years 2 and 3 of the Treatment Period (Weeks 48 
to 144), all subjects will attend study visits at the study site Q12W for study assessments.   
At Week 24, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
Investigator may change the subject’s dosing interval from 320mg Q4W to 320mg Q8W 
(optional). 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 48 or at the next scheduled clinic visit after implementation 
of Protocol Amendment #3 if the subject has already completed the Week 48 visit. The last dose 
bimekizumab 320mg Q8W in the Treatment Period will be administered at Week 136. The End 
of Treatment Visit of the Treatment Period will be the Week 144 Visit. 
The assessments to be performed at each Treatment Period Visit are presented in Table 5-1 and 
Table 5-2. 
5.2.2 
OLE2 Period 
Subjects enrolled as per Protocol Amendment #3 will be treated in the Treatment Period until 
Week 136 (last dose of bimekizumab 320mg Q8W) and will be followed in a SFU Period for 
20 weeks after their last dose of IMP. After the implementation of Protocol Amendment #3.3 
(addition of a 48-week open-label treatment period, ie, OLE2 Period), study subjects will be 
invited to continue or reinitiate bimekizumab treatment as per the following OLE2 Groups: 
• OLE2 Group A: Subjects in the Treatment Period at the time of Protocol Amendment #3.3 
implementation will attend the Week 144 Visit and may directly roll over to the OLE2 
Period. These subjects will continue receiving bimekizumab 320mg Q8W for 40 additional 
weeks, starting from the first treatment visit of the OLE2 Period (ie, Week 144/OLE2 
Baseline Visit; the Week 144 Visit will coincide with the Week 144/OLE2 Baseline Visit and 
data collected at this visit will be used as baseline data for subjects entering the OLE2 
Period). 
• OLE2 Group B: Eligible subjects who have completed the Treatment Week 144 Visit and 
who are in the SFU or have completed the SFU at the time of Protocol Amendment #3.3 
implementation may reinitiate bimekizumab treatment in the OLE2 Period after having 
undergone Screening assessments during a 4-week OLE2 Screening Period. The first dose 
will be administered at the Week 144/OLE2 Baseline Visit; data collected at this visit will be 
used as baseline data. Subjects with an IGA score ≥3 upon entry in the OLE2 Period will be 
treated with bimekizumab Q4W for the first 16 weeks, and will then switch to bimekizumab 
320mg Q8W. Subjects in OLE2 Group B with an IGA score <3 upon entry will be treated 
with bimekizumab Q8W from the Week 144/OLE2 Baseline Visit. 
During the OLE2 Period (Week 144/OLE2 Baseline to OLE2 Week 48), subjects may self-inject 
IMP at home (described in Section 7.2) at the time points specified in the schedule of 
assessments (Table 5-3).  
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 27 of 216 
5.2.3 
Safety Follow-Up Periods 
Two SFU Periods are considered since Protocol Amendment #3.3 implementation. A first SFU 
following the Treatment Period and a second SFU (SFU2) following the OLE2 Period (added as 
per Protocol Amendment #3.3). 
Following completion or early withdrawal from the Treatment Period, subjects will return for a 
SFU Visit 20 weeks after their final dose of bimekizumab.  
The assessments for the SFU are presented in Table 5-2. 
Subjects still in the Treatment Period (not having attended Week 144 yet; OLE2 Group A) will 
have the opportunity to directly roll over in the OLE2. Subjects having attended Week 144 Visit 
and who are participating in the SFU or have completed the SFU (OLE2 Group B) will be 
invited to reinitiate treatment in the OLE2 Period. 
All subjects who have completed treatment in the OLE2 Period (ie, have completed the OLE2 
Week 48 Visit), or have withdrawn from IMP during the OLE2 Period before OLE2 Week 48, 
will return for a SFU2 Visit 20 weeks after their final dose of IMP. 
The assessments for the SFU2 are presented in Table 5-3. 
5.2.4 
Premature End of Treatment 
Subjects withdrawing early from the study will undergo the PEOT Visit assessments (see 
Section 8.2) and will enter the SFU or SFU2 Period, depending on when subjects withdraw. 
5.3 
Study duration per subject 
For each subject, prior to Protocol Amendment 3.3 implementation, the study will last a 
maximum of 160 weeks and will consist of: 
• A Treatment Period during which subjects will continue to receive open-label bimekizumab 
in PS0014 for up to 144 weeks (the last dose will be administered at Week 136 and Week 
144 will be the End of Treatment Visit).  
• An SFU Period 20 weeks after the final dose of bimekizumab administered during the 
Treatment Period (subjects will enter the SFU after Week 144 Visit or after withdrawal). 
Subjects eligible for the OLE2 Period (added as part of Protocol Amendment #3.3) will enter the 
OLE2 after completing Week 144 of the Treatment Period. The OLE2 Period includes a 48-week 
open-label treatment period with a final visit at OLE2 Week 48, and an SFU Period (SFU2) of 
20 weeks after the final dose of IMP administered in the OLE2 Period.  
For subjects participating in the OLE2 Period, the maximum study duration will depend on the 
time between their participation in the Treatment Period until Week 144 and the start of the 
OLE2 Period:  
• 204 weeks for subjects still being treated in the Treatment Period and who will directly roll 
over to the OLE2 Period at Week 144. 
• 224 weeks for subjects who have attended Week 144 and who will have completed the SFU; 
these subjects will have a 4-week Screening Period before reinitiating treatment in the OLE2 
Period. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 28 of 216 
• Between 204 and 224 weeks for subjects who will have attended Week 144 and are 
participating the in the SFU. For these subjects, the maximum study duration will depend 
upon when they will stop the 20-week SFU period to enter the 4-week Screening Period of 
the OLE2 Period.  
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 sites 
Approximately 1120 subjects (including approximately 60 subjects from the Japanese-specific 
local amendment) will be enrolled in the study. The anticipated enrollment in the feeder studies 
is 1250 subjects (450 subjects from PS0008, 480 subjects from PS0009, and 320 subjects from 
PS0013) and approximately 85% are expected to roll into PS0014. 
5.5 
Anticipated regions and countries 
The regions planned for the 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 for Year 1 (Weeks 0 to 44) is presented in Table 5-1. The 
schedule of study assessments for Years 2 and 3 (Weeks 48 to 144) is presented in Table 5-2. 
The schedule of study assessments for OLE2 Period (Week 144/OLE2 Baseline to OLE2 
Week 48) is presented in Table 5-3. At each visit, all study assessments should be performed 
prior to administration of IMP. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 29 of 216 
Table 5-1: 
Schedule of study assessments – Year 1 (Weeks 0 to 44) 
Visit a/ 
Week 
Protocol activity 
Treatment Period-Year 1 
Stable Dosing 
Flexible Dosing b 
Baseline/Feeder 
Study Final  
Visit 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
X 
 
 
 
 
 
 
 
 
 
 
 
Physical exam c,d 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Body weight 
X 
 
 
 
 
 
 
 
 
 
 
 
Vital signs e 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
Hematology and chemistry 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
Urinalysis 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
Urine drug screen 
X 
 
 
 
 
 
 
 
 
 
 
 
ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy testing f 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
IGRA TB test g 
  
 
 
 
 
 
 
 
 
 
 
TB questionnaire 
X 
 
 
X 
 
 
X 
 
 
X 
 
Blood sample for bimekizumab plasma concentrations h 
X 
 
 
 
X 
 
X 
 
 
 
X 
 
Blood sample for anti-bimekizumab antibodies h 
X 
 
 
 
X 
 
X 
 
 
 
X 
 
PASI  
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 
IGA  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
DLQI 
X 
 
 
 
 
 
X 
 
 
 
 
 
PHQ-9 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
eC-SSRS 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 30 of 216 
Table 5-1: 
Schedule of study assessments – Year 1 (Weeks 0 to 44) 
Visit a/ 
Week 
Protocol activity 
Treatment Period-Year 1 
Stable Dosing 
Flexible Dosing b 
Baseline/Feeder 
Study Final  
Visit 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
mNAPSI i 
X 
 
 
 
 
 
X 
 
 
 
 
 
Scalp IGA j 
X 
 
 
 
 
 
X 
 
 
 
 
 
pp-IGAk 
X 
 
 
 
 
 
X 
 
 
 
 
 
EQ-5D-3L 
X 
 
 
 
 
 
X 
 
 
 
 
 
SF-36 
X 
 
 
 
 
 
X 
 
 
 
 
 
PGA of PSO 
X 
 
 
 
 
 
X 
 
 
 
 
 
PASE l 
X 
 
 
 
 
 
 
 
 
 
 
 
PGADAl 
X 
 
 
 
 
 
X 
 
 
 
 
 
WPAI-SHP V2.0 
X 
 
 
 
 
 
X 
 
 
 
 
 
Concomitant medication 
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 
IRT 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Bimekizumab administration Q4Wm, n 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Bimekizumab administration Q8Wm, n 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
Subject training on self-injectiono 
 
 
 
 
 
 
 
 
 
 
X 
X 
BSA=body surface area; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide Severity Rating Scale; EQ-5D-3L=Euro-
Quality of Life 5-Dimensions 3-level; IGA=Investigator’s Global Assessment; IGRA=interferon-gamma release assay; IMP=investigational medicinal product; 
IRT=interactive response technology; mNAPSI=modified Nail Psoriasis Severity Index; PASE=Psoriatic Arthritis Screening and Evaluation; PASI=Psoriasis Area Severity 
Index; PGA=Patient Global Assessment; 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; PSO=psoriasis; Q4W=every 4 weeks; Q8W=every 8 weeks; 
TB=tuberculosis; W=Week; WPAI-SHP=Work Productivity and Activity Impairment Questionnaire-specific health problem 
a Visit windows of ±7 days from the first dose at all visits. 
b At Week 24, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the Investigator may change the subject’s dosing interval from 320mg Q4W to 
320mg Q8W (optional). 
c Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 31 of 216 
Table 5-1: 
Schedule of study assessments – Year 1 (Weeks 0 to 44) 
Visit a/ 
Week 
Protocol activity 
Treatment Period-Year 1 
Stable Dosing 
Flexible Dosing b 
Baseline/Feeder 
Study Final  
Visit 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
d The physical examination will be performed as per Section 9.3.5. 
e Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable. 
f Urine pregnancy testing will be performed at all visits. Pregnancy test results must be negative prior to administering IMP. 
g Ensure that results for the latest IGRA test performed in the feeder study are negative. 
h All blood samples taken prior to dosing. 
i The mNAPSI will be assessed only in subjects with nail involvement at Baseline in the feeder studies. 
j The scalp IGA will only be assessed for those subjects with scalp involvement (scalp IGA score >0) at Baseline in the feeder studies. 
k The pp-IGA will only be assessed in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline in the feeder studies. 
l The PGADA and the PASE are assessed only for subjects with PsA at Baseline in the feeder studies. 
m The dosing window is ±7 days relative to the scheduled dosing visit.  
n Only subjects receiving IMP Q4W are dosed on Weeks 4, 12, 20, 28, 36, and 44. Subjects who are switched from IMP Q4W to IMP Q8W at Week 24 are dosed on Weeks 32 
and 40 in the Flexible Dosing Period. 
o Subject training on self-injection to be performed as described in Section 7.2. 
 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 32 of 216 
Table 5-2: 
Schedule of study assessments – Years 2 and 3 (Weeks 48 to 144) 
Visit a/ 
Week 
Protocol activity 
Treatment Period – Years 2 and 3 b 
 
 
48 C 
52 C/H 
56 C/H 
60  C 
64 C/H 
68 C/H 
72  C 
76 C/H 
80 C/H 
84  C 
88 C/H 
92 C/H 
96  C 
100 C/H 
104 C/H 
108  C 
112 C/H 
116 C/H 
120  C 
124 C/H 
128 C/H 
132  C 
136 C/H 
140 C/H 
W144 
/ 
PEOT 
SFUc 
Physical exam d,e 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Body weight 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Vital signs f 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Hematology and 
chemistry 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Urinalysis 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Urine pregnancy 
testing g 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
IGRA TB test 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
TB questionnaire 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Blood sample for 
bimekizumab plasma 
concentrations h 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
X 
X 
Blood sample for 
anti-bimekizumab 
antibodies h 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
X 
X 
PASI  
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Percentage of BSA 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
IGA  
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
DLQI 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
  
PHQ-9 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
eC-SSRS 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 33 of 216 
Table 5-2: 
Schedule of study assessments – Years 2 and 3 (Weeks 48 to 144) 
Visit a/ 
Week 
Protocol activity 
Treatment Period – Years 2 and 3 b 
 
 
48 C 
52 C/H 
56 C/H 
60  C 
64 C/H 
68 C/H 
72  C 
76 C/H 
80 C/H 
84  C 
88 C/H 
92 C/H 
96  C 
100 C/H 
104 C/H 
108  C 
112 C/H 
116 C/H 
120  C 
124 C/H 
128 C/H 
132  C 
136 C/H 
140 C/H 
W144 
/ 
PEOT 
SFUc 
mNAPSI i 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
Scalp IGA j 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
pp-IGA k 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
EQ-5D-3L 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
SF-36 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
PGA of PSO 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
PASEl 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
PGADAl 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
WPAI-SHP V2.0 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
TSQM-9 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Concomitant 
medication 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Adverse events 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
IRT 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Bimekizumab self-
injection Q4W m,n,q 
Xo 
X 
X 
Xo 
X 
X 
Xo 
X 
X 
Xo 
X 
X 
Xo 
X 
X 
Xo 
X 
X 
Xo 
X 
X 
Xo 
X 
X 
 
 
Bimekizumab self-
injection Q8W m,n 
Xo 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 
IMP accountability 
for self-injection at 
homep 
 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
BSA=body surface area; C=clinic; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide Severity Rating Scale; 
EQ-5D-3L=Euro-Quality of Life 5-Dimensions 3-level; IGA=Investigator’s Global Assessment; H=home; IGRA=interferon-gamma release assay; IMP=investigational 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 34 of 216 
Table 5-2: 
Schedule of study assessments – Years 2 and 3 (Weeks 48 to 144) 
Visit a/ 
Week 
Protocol activity 
Treatment Period – Years 2 and 3 b 
 
 
48 C 
52 C/H 
56 C/H 
60  C 
64 C/H 
68 C/H 
72  C 
76 C/H 
80 C/H 
84  C 
88 C/H 
92 C/H 
96  C 
100 C/H 
104 C/H 
108  C 
112 C/H 
116 C/H 
120  C 
124 C/H 
128 C/H 
132  C 
136 C/H 
140 C/H 
W144 
/ 
PEOT 
SFUc 
medicinal product; IRT=interactive response technology; mNAPSI=modified Nail Psoriasis Severity Index; PASE=Psoriatic Arthritis Screening and Evaluation; 
PASI=Psoriasis Area Severity Index; PEOT=Premature End of Treatment; PGA=Patient Global Assessment; PGADA=Patient’s Global Assessment of Disease Activity; 
PHQ-9=Patient Health Questionnaire-9; pp-IGA=palmoplantar Investigator’s Global Assessment; PsA=psoriatic arthritis; PSO=psoriasis; Q4W=every 4 weeks; Q8W=every 
8 weeks; SF-36=Short Form 36-item Health Survey; SFU=Safety Follow-Up; TB=tuberculosis; TSQM-9=Treatment Satisfaction Questionnaire for Medication; W=Week; 
WPAI-SHP=Work Productivity and Activity Impairment Questionnaire-specific health problem  
Note: Starting at Week 48 of the Treatment Period, subjects may self-inject IMP at home; self-injection training will be provided to the subject/caregivers by qualified site 
personnel (see Section 7.2). 
a Visit windows of ±7 days from the first dose at all visits except SFU. The Safety Follow-Up Visit window is ±7 days from final dose. 
b Starting at Week 48 of the Treatment Period, subjects will attend site visits every 12 weeks. 
c The SFU Visit will occur 20 weeks after the final dose. 
d Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
e The physical examination will be performed as per Section 9.3.5. 
f 
Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable. 
g Urine pregnancy testing will be performed at all visits. Pregnancy test results must be negative prior to administering IMP. 
h All blood samples taken prior to dosing. 
i 
The mNAPSI will be assessed only in subjects with nail involvement at Baseline in the feeder studies. 
j 
The scalp IGA will only be assessed for those subjects with scalp involvement (scalp IGA score >0) at Baseline in the feeder studies. 
k The pp-IGA will only be assessed in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline in the feeder studies. 
l 
The PGADA and the PASE are assessed only for subjects with PsA at Baseline in the feeder studies. 
m The dosing window is ±7 days relative to the scheduled dose. 
n The last dose for subjects receiving bimekizumab 320mg Q8W will be Week 136. 
o The subject’s dosing interval will change from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W at Week 48, or at the next scheduled clinic visit (ie, Week 60, 
Week 72, Week 84, Week 96, Week 108, Week 120, or Week 132) after implementation of Protocol Amendment #3 if the subject has already completed the Week 48 visit. 
p If self-injected at home, the subject/caregiver will document the date, body location, kit number and time point of administration of study medication. All used syringes will 
be disposed of by subjects/caregivers as determined by the Investigator in an acceptable disposal (sharps) container directly after the administration. The subjects/caregivers 
return the documentation together with any used/unused containers at the next scheduled clinic visit. 
q Q4W IMP administration only applies to those subjects who have not yet changed to Q8W at Week 48, or at the next scheduled clinic visit (ie, Week 60, Week 72, Week 84, 
Week 96, Week 108, Week 120, or Week 132) after implementation of Protocol Amendment #3 if the subject has already completed the Week 48 visit. 
 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 35 of 216 
Table 5-3: 
Schedule of study assessments – OLE2 Period (from OLE2 Screening Visit or from Week 144/OLE2 
Visit to Week 48)  
 
 
Visit a/ 
Week 
 
OLE2 Periodb 
OLE2 W48/ 
PEOT 
SFU2c 
OLE2 
Screening 
W144/OLE2 
Baseline 
OLE2 W4  
OLE2 W 8 
OLE2 W 12 
OLE2 W 16 
OLE2 W 24  
OLE2 W 32  
OLE2 W 36 
OLE2 W 40 
C 
C/H 
C/H 
C 
C/H 
C 
C/H 
C 
C/H 
C 
Protocol activity 
 
 
OLE2 Groups A + B 
Informed consent 
Group B 
Group A 
 
 
 
 
 
 
 
 
 
 
Eligibility 
Group B 
Group A+B 
 
 
 
 
 
 
 
 
 
 
Urine drug screen 
Group B 
 
 
 
 
 
 
 
 
 
 
 
Significant past medical 
history and concomitant 
diseases d 
Group Bd 
 
 
 
 
 
 
 
 
 
 
 
Physical exam e 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
Body weight 
 
Group Af + B 
 
 
 
 
 
 
 
 
X 
 
Vital signs g 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
Hematology and chemistry 
Group B 
Group Af + B 
 
 
 
 
X 
 
 
 
X 
X 
Urinalysis 
Group B 
Group Af + B 
 
 
 
 
X 
 
 
 
X 
X 
Pregnancy testing (urine) h 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
Hepatitis B and C testing 
Group B 
 
 
 
 
 
 
 
 
 
 
 
HIV testing i 
Group B 
 
 
 
 
 
 
 
 
 
 
 
IGRA TB test 
 
Group Af 
 
 
 
 
 
 
 
 
X 
 
Tuberculosis questionnaire 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
 
PASI 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
 
Percentage of BSA 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 36 of 216 
Table 5-3: 
Schedule of study assessments – OLE2 Period (from OLE2 Screening Visit or from Week 144/OLE2 
Visit to Week 48)  
 
 
Visit a/ 
Week 
 
OLE2 Periodb 
OLE2 W48/ 
PEOT 
SFU2c 
OLE2 
Screening 
W144/OLE2 
Baseline 
OLE2 W4  
OLE2 W 8 
OLE2 W 12 
OLE2 W 16 
OLE2 W 24  
OLE2 W 32  
OLE2 W 36 
OLE2 W 40 
C 
C/H 
C/H 
C 
C/H 
C 
C/H 
C 
C/H 
C 
Protocol activity 
 
 
OLE2 Groups A + B 
IGA 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
 
DLQI 
 
Group Af + B 
 
 
 
 
X 
 
 
 
X 
 
PHQ-9 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
ECG 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
Blood sample for 
bimekizumab plasma 
concentrations j 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
Blood sample for 
anti‑bimekizumab antibodies j 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
scalp IGA 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
mNAPSI 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
pp-IGA 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
EQ-5D-3L 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
PASE 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
PGADA 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
WPAI-SHP V2.0 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
eC-SSRS 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
Concomitant medication 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 37 of 216 
Table 5-3: 
Schedule of study assessments – OLE2 Period (from OLE2 Screening Visit or from Week 144/OLE2 
Visit to Week 48)  
 
 
Visit a/ 
Week 
 
OLE2 Periodb 
OLE2 W48/ 
PEOT 
SFU2c 
OLE2 
Screening 
W144/OLE2 
Baseline 
OLE2 W4  
OLE2 W 8 
OLE2 W 12 
OLE2 W 16 
OLE2 W 24  
OLE2 W 32  
OLE2 W 36 
OLE2 W 40 
C 
C/H 
C/H 
C 
C/H 
C 
C/H 
C 
C/H 
C 
Protocol activity 
 
 
OLE2 Groups A + B 
Adverse events 
Group B k 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
IRT 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
Bimekizumab administration 
Q4W/Q8W l, m, n 
 
Group B l 
X 
X 
X 
X 
X 
X 
 
X 
 
 
Bimekizumab administration 
Q8W m, n 
 
Group A+B l 
 
X 
 
X 
X 
X 
 
X 
 
 
IMP accountability for self-
injection at home 
 
 
 
 
X 
 
X 
 
X 
 
X 
 
BSA=body surface area; C=clinic; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide Severity Rating Scale; 
EQ-5D-3L=Euro-Quality of Life 5-Dimensions 3-level; IGA=Investigator’s Global Assessment; H=home; HIV= human immunodeficiency virus; IGRA=interferon-gamma 
release assay; IMP=investigational medicinal product; IRT=interactive response technology; mNAPSI=modified Nail Psoriasis Severity Index; OLE=open label extension; 
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; Q4W=every 4 weeks; Q8W=every 8 weeks; SFU=Safety Follow-Up; SFU2=Safety Follow-Up #2; 
TB=tuberculosis; WPAI-SHP=Work Productivity and Activity Impairment Questionnaire-specific health problem; W=Week. 
Note: Subjects may self-inject IMP at home; self-injection training will be provided to the subject/caregivers by qualified site personnel.  
a Visit windows of ±14 days relative to the Week 144/OLE2 Baseline Visit all visits except SFU2. The SFU2 Visit window is ±7 days from final dose. 
b Assessment for the OLE2 Screening is applicable to subjects in OLE2 Group B, ie, subjects who agreed to reinitiate bimekizumab treatment after having completed the 
Week 144 Visit.  
c The SFU2 Visit will occur 20 weeks after the final dose. 
d Only applicable for subjects who completed the SFU period; only new or modified medical history since completing SFU will be entered in eCRF. 
e 
The physical examination will be performed as per Section 9.3.5. 
f 
These tests are performed as part of the Week 144 visit (the Week 144 Visit coincides with the Week 144/OLE2 Baseline Visit for subjects in Group A, ie, direct enrollers 
from Treatment Period to OLE2 Period). 
g Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable. 
h Urine pregnancy testing will be performed at all visits. Pregnancy test results must be negative prior to administering IMP.  
i 
The HIV test results will not be recorded in the eCRF. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 38 of 216 
Table 5-3: 
Schedule of study assessments – OLE2 Period (from OLE2 Screening Visit or from Week 144/OLE2 
Visit to Week 48)  
 
 
Visit a/ 
Week 
 
OLE2 Periodb 
OLE2 W48/ 
PEOT 
SFU2c 
OLE2 
Screening 
W144/OLE2 
Baseline 
OLE2 W4  
OLE2 W 8 
OLE2 W 12 
OLE2 W 16 
OLE2 W 24  
OLE2 W 32  
OLE2 W 36 
OLE2 W 40 
C 
C/H 
C/H 
C 
C/H 
C 
C/H 
C 
C/H 
C 
Protocol activity 
 
 
OLE2 Groups A + B 
j 
All blood samples taken prior to dosing. 
k Collected only from subjects in the SFU Period. 
l 
Q4W IMP administration only applies to those subjects who have entered the OLE2 Period as part of Group B and had an IGA ≥3 upon entry of OLE2 Period. These 
subjects will receive Q4W dosing for 16 weeks, then will change from Q4W to Q8W dosing. Subjects who have entered the OLE2 Period as part of Group B with an IGA 
<3 upon entry of OLE2 Period will receive Q8W dosing from the OLE2 Screening Visit onwards. 
m The dosing window is ±14 days relative to the Week 144/OLE2 Baseline Visit. 
n If self-injected at home, the subject/caregiver will document the date, body location, kit number, and time point of administration of study medication. All used syringes will 
be disposed of by subjects/caregivers as determined by the Investigator in an acceptable disposal (sharps) container directly after the administration. The subjects/caregivers 
return the documentation together with any used/unused containers at the next scheduled clinic visit. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 39 of 216 
5.7 
Schematic diagram 
The study schematic diagram for PS0014 from Screening through Week 48 is presented in 
Figure 5‒1, from Week 48 through Week 144 is presented in Figure 5-2, and from OLE2 
Screening to the OLE2 Week 48 Visit is presented in Figure 5-3. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 40 of 216 
Figure 5‒1: Schematic diagram, Screening through Week 48 
 
IMP=investigational medicinal product; PASI=Psoriasis Area Severity Index; Q4W=every 4 weeks; Q8W=every 8 weeks 
Note: Self-injection will be allowed from Week 48 onward. 
Note: At Week 28 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. 
a Subjects on placebo after a Week 16 response (≥PASI90) on bimekizumab 320mg Q4W during the Initial Treatment Period of the feeder study may enroll in PS0014.  
b Subjects on bimekizumab 320mg Q4W who achieved a PASI50 at Week 12 in the escape arm of the feeder study may enroll in PS0014. 
c Subjects on ustekinumab or bimekizumab 320mg Q4W in feeder studies who achieved PASI90 will be randomized, respectively, 1:1 or 4:1 to bimekizumab 320mg Q4W or 
320mg Q8W. 
d At Week 24, if PASI90 is achieved, Investigator may change the dosing interval from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W (optional).  
e The subject’s dosing interval will change from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W at Week 48 or at the next scheduled clinic visit (ie, Week 60, Week 72, 
Week 84, Week 96, Week 108, Week 120, or Week 132) if the subject has already completed the Week 48 visit prior to implementation of Protocol Amendment #3. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 41 of 216 
 
Figure 5-2: Schematic diagram, Years 2 and 3 (Week 48 through Week 144) 
 
Q4W=every 4 weeks; Q8W=every 8 weeks 
Note: Self-injection will be allowed from Week 48 onward. 
Note: The subject’s dosing interval will change from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W at Week 48 or at the next scheduled clinic visit (ie, Week 60, Week 
72, Week 84, Week 96, Week 108, Week 120, or Week 132) if the subject has already completed the Week 48 visit prior to implementation of Protocol Amendment #3. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 42 of 216 
Figure 5-3: Schematic diagram, OLE2 Period (From OLE2 Screening through OLE2 Week 48) 
 
IGA=Investigator’s Global Assessment; IMP=investigational medicinal product; OLE=Open Label Extension; Q4W=every 4 weeks; Q8W=every 8 weeks; 
SFU2=Safety follow-up; W=week 
Note: Q4W/Q8W IMP administration only applies to those subjects who have entered the OLE2 Period as part of Group B, and had an IGA ≥3 upon entry of 
OLE2 Period. These subjects will receive Q4W dosing for 16 weeks, then will change from Q4W to Q8W dosing. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 43 of 216 
5.8 
Rationale for study design and selection of dose 
PS0014 is an open-label study designed to assess the long-term safety, tolerability, and efficacy 
of bimekizumab over a 144-week Treatment Period. Doses used in this study are based on the 
dosing regimens (Q4W and Q8W) of the feeder studies, as well as the subjects’ PASI score upon 
entering the study. Subjects who do not achieve a PASI90 response in the feeder studies may be 
enrolled in PS0014 at the discretion of the Investigator. In the PS0011 study, a multicenter, 
48-week, double-blind, placebo-controlled, parallel-group extension study to assess the long-
term safety, tolerability, and efficacy of bimekizumab in adult subjects with moderate to severe 
chronic plaque PSO, 97% of subjects receiving 320mg Q4W were PASI90 responders at 
Week 52 (full analysis set, observed case). In addition, all subjects (100%) achieved a PASI75 
response by Week 52. 
In PS0014, doses can be adjusted at Week 24 for subjects receiving bimekizumab 320mg Q4W 
at the discretion of the Investigator (optional).  
Based on pooled data from the Phase 3 studies (PS0008, PS0009, and PS0013), during the 
maintenance period bimekizumab 320mg Q8W provided efficacy results similar to 
bimekizumab 320mg Q4W. Therefore, at Week 48, subjects receiving 
bimekizumab 320mg Q4W will switch to receive bimekizumab 320mg Q8W. Subjects who are 
receiving bimekizumab 320mg Q4W treatment who already completed the Week 48 visit at the 
time of implementation of Protocol Amendment #3 will be switched to 
bimekizumab 320mg Q8W at the next scheduled clinic visit. This change in dosing interval will 
reduce subject and site burden, while allowing collection of more long-term safety data on the 
bimekizumab 320mg Q8W dosing regimen. 
Subjects in the feeder studies who responded without biologic intervention are not eligible for 
PS0014. 
Subjects who are participating in the Treatment Period can directly roll over to the OLE2 Period 
and continue receiving bimekizumab 320mg Q8W (OLE2 Group A). Subjects who have 
attended Week 144 Visit and are participating in the SFU of the Treatment Period or have 
completed the SFU at the time of Protocol Amendment #3.3 implementation (OLE2 Group B) 
can reinitiate bimekizumab treatment in the OLE2 Period after having undergone Screening 
assessments during a 4-week OLE2 Screening Period. For eligible subjects reinitiating treatment 
with bimekizumab, treatment regimen will be based on current disease activity, as measured by 
IGA: subjects with IGA score <3 will receive bimekizumab 320mg Q8W, whereas subjects with 
IGA score ≥3 will receive 16 weeks of bimekizumab 320mg Q4W, followed by 320mg Q8W for 
the remaining dosing timepoints of the OLE2 Period.  
The OLE2 Period will 1) collect additional long-term safety data; 2) explore safety data in 
subjects who have temporarily stopped bimekizumab and could have been exposed to other 
treatments; and 3) provide an additional 48-week open-label treatment period for subjects 
continuing their current treatment or reinitiating treatment at the Week 144/OLE2 Baseline Visit. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 44 of 216 
6 
SELECTION AND WITHDRAWAL OF SUBJECTS 
6.1 
Inclusion criteria 
To be eligible to participate in this study prior to the OLE2 Period (eligibility criteria for the 
OLE2 Period are listed in Section 6.3), all of the following inclusion criteria must be confirmed 
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, and medication intake according to the judgment of the 
Investigator. 
3. Subject completes the feeder study without meeting any withdrawal criteria. 
4. Female subjects must be: 
− Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for 
which there is no other obvious pathological or physiological cause. 
− Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) 
− Or, if of childbearing potential (and engaged in sexual activity that could result in 
procreation), must be willing to use a highly effective method of contraception 
throughout the duration of the study until 20 weeks after last administration of IMP, and 
have a negative pregnancy test at the Baseline/feeder study final visit in PS0014. The 
following methods are considered highly effective when used consistently and correctly: 
o Combined (estrogen and progestogen) hormonal contraception associated with 
inhibition of ovulation (oral, intravaginal, or transdermal) 
o Progestogen-only hormonal contraception associated with inhibition of ovulation 
(oral, injectable, implantable) 
o Intrauterine device  
o Intrauterine hormone-releasing system  
o Vasectomized partner 
o Abstinence as a form of birth control is generally not allowed in the study unless 
abstinence is in accordance with a subject’s preferred and common lifestyle. Study 
personnel must confirm the continued use of abstinence is still in accordance with the 
subject’s lifestyle at regular intervals during the study. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 45 of 216 
6.2 
Exclusion criteria 
Subjects are not permitted to enroll in the study if any of the following exclusion criteria is met: 
1. Subject has previously participated in this study. 
2. Female subjects who plan to become pregnant during the study or within 20 weeks following 
final dose of study medication. 
3. Subject has any medical or psychiatric condition that, in the opinion of the Investigator, 
could jeopardize or would compromise the subject’s ability to participate in this study. 
Note: For any subject with an ongoing SAE, or a history of serious infections in the feeder 
study, the Medical Monitor must be consulted prior to the subject’s entry into PS0014, 
although the decision on whether to enroll the subject remains with the Investigator. 
4. Subject has a positive or indeterminate interferon gamma release assay (IGRA) in a feeder 
study, unless appropriately evaluated and treated as per Section 9.3.1. 
5. Subject may not participate in another study of a medicinal product or device under 
investigation other than the substudy described in Section 5.1. 
6. Subject has a history of chronic alcohol or drug abuse within 6 months prior to Baseline as 
assessed by medical history, site interview, and/or results of the specified urine drug screen. 
6.3 
Eligibility criteria for the OLE2 Period 
Prior to initiating the OLE2 Period assessments, all subjects will be asked to read and sign a 
separate Informed Consent Form (ICF).  
6.3.1 
All subjects (OLE2 Groups A and B) 
To be eligible to participate in the OLE2 Period, all of the following inclusion criteria must be 
confirmed for all subjects: 
1. Subject provided informed consent.  
2. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand 
and complete diaries), visit schedule, and medication intake according to the judgment of the 
Investigator. 
3. Subject completes the Treatment Period to Week 144 without meeting any withdrawal 
criteria defined in Section 6.4. 
6.3.2 
OLE2 Period Group A subjects 
To participate in the OLE2 Period, subjects still treated and who completed the Week 144 Visit 
by the time of Protocol Amendment #3.3 implementation will not need to fulfil other eligibility 
criteria than those listed in Section 6.3.1 and will continue treatment from the Week 144/OLE2 
Baseline Visit if they do not meet any of the withdrawal criteria defined in Section 6.4. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 46 of 216 
6.3.3 
OLE2 Period Group B subjects 
Inclusion criteria 
To be eligible to participate in the OLE2 Period, all of the additional following inclusion criteria 
must be confirmed during the OLE2 Screening Period for subjects who have attended Week 144 
and are in the SFU or have completed the SFU before Protocol Amendment #3.3 implementation 
(OLE2 Group B subjects): 
1. Female subjects must be: 
− Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for 
which there is no other obvious pathological or physiological cause. 
− Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) 
− Or, if of childbearing potential (and engaged in sexual activity that could result in 
procreation), must be willing to use a highly effective method of contraception 
throughout the duration of the study until 20 weeks after last administration of IMP, and 
have a negative pregnancy test at OLE2 Screening. The following methods are 
considered highly effective when used consistently and correctly 
o Combined (estrogen and progestogen) hormonal contraception associated with 
inhibition of ovulation (oral, intravaginal, or transdermal) 
o Progestogen-only hormonal contraception associated with inhibition of ovulation 
(oral, injectable, implantable) 
o Intrauterine device  
o Intrauterine hormone-releasing system  
o Vasectomized partner 
o Abstinence as a form of birth control is generally not allowed in the study unless 
abstinence is in accordance with a subject’s preferred and common lifestyle. Study 
personnel must confirm the continued use of abstinence is still in accordance with the 
subject’s lifestyle at regular intervals during the study. 
2. Subjects with a diagnosis of Crohn’s disease or ulcerative colitis are allowed as long as they 
have no active symptomatic disease. 
 
Exclusion criteria 
Subjects in the OLE2 Group B are not permitted to enroll in the OLE2 Period if any of the 
following exclusion criteria are met: 
1. Female subjects who plan to become pregnant during the OLE2 Period or within 20 weeks 
following final dose of study medication. 
2. Subject has developed any medical or psychiatric condition that, in the opinion of the 
Investigator, could jeopardize or would compromise the subject’s ability to participate in the 
OLE2 Period. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 47 of 216 
3. Any subjects with an ongoing SAE, or a history of serious infections, the Medical Monitor 
must be consulted prior to the subject’s entry in the OLE2 Period, although the decision on 
whether to enroll the subject remains with the Investigator. 
4. Subject had a positive or indeterminate IGRA in the Treatment Period to Week 144, unless 
appropriately evaluated and treated as per Section 12.3.1. 
5. Subject may not participate in another study of a medicinal product or device under 
investigation  
6. Subject has a history of chronic alcohol or drug abuse within 6 months prior to reentry as 
assessed by medical history, site interview, and/or results of the urine drug screen. 
7. Subjects who have used systemic treatments for PSO after Week 144 must have stopped this 
treatment 1 month prior to receiving the first bimekizumab injection in the OLE2 Period (See 
Section 7.8.2 regarding prohibited medications). 
8. Subject has erythrodermic, guttate, or pustular form of PSO. 
9. Subject is noncompliant with the study procedures or medications in the opinion of the 
Investigator. 
10. Subject has a clinical laboratory value meeting any of the following criteria: 
a. ≥3.0x ULN of any of the following: ALT, AST, alkaline phosphatase (ALP); or >ULN 
total bilirubin (≥1.5xULN total bilirubin if known Gilbert’s syndrome) 
b. A laboratory value meeting any of the following criteria: 
◦ 
Absolute neutrophil count <1.0x103/μL 
◦ 
Absolute lymphocyte count <0.2x103/μL 
Subjects may enter the OLE2 Period if the result is transient. If a retest is required, it must be 
done within 1 to 2 weeks. 
11. Subject has concurrent acute or chronic viral hepatitis B or C or HIV infection. Subjects who 
have evidence of, or tested positive for hepatitis B or hepatitis C are excluded. A positive test 
for the hepatitis B virus is defined as: (1) positive for hepatitis B surface antigen, or (2) 
positive for anti-hepatitis B core antibody. A positive test for the hepatitis C virus is defined 
as: (1) positive for hepatitis C antibody, and (2) positive via a confirmatory test for hepatitis 
C virus (for example, hepatitis C virus polymerase chain reaction). 
12. There is confirmation of a pregnancy, as evidenced by a positive pregnancy test (see 
Section 9.1.4 for more information regarding pregnancies). 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 48 of 216 
13. Subjects showing: 
• Suicidal ideation in the past month prior to the OLE2 Screening Visit as indicated by a 
positive response ("Yes") to either Question 4 or Question 5 of the electronic Columbia 
Suicide Severity Rating Scale (eC SSRS). 
• Any suicidal behavior since last visit. 
14. Subject has presence of moderately severe or severe major depression, indicated by a score 
≥15 on the PHQ-9. Medication used to treat depression should be stable for 4 weeks prior to 
Week 144/OLE2 Baseline. 
15. Subject has developed any active malignancy or history of malignancy prior to the OLE2 
Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell 
carcinoma, or in situ cervical cancer. 
16.  Subject has received any live (includes attenuated) vaccination within the 8 weeks prior to 
the Week 144/OLE2 Baseline Visit. 
6.4 
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 8.2). 
Subjects should be withdrawn from the study and will be encouraged to come back for the 
SFU and/or SFU2 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 must be withdrawn from IMP and will be asked to come back for the SFU and/or 
SFU2 Visit 20 weeks after final dose of IMP if any of the following events occur: 
1. Subject develops an illness that in the opinion of the Investigator would interfere with his/her 
continued participation if the risk of continuing IMP outweighs the potential benefit. 
2. Subject develops erythrodermic, guttate, or pustular form of PSO. 
3. Subject is noncompliant with the study procedures or medications in the opinion of the 
Investigator. 
4. Subject uses prohibited concomitant medications, with the exception of topicals, as defined 
in this protocol (Section 7.8.2), that may present a risk to the safety of the subject or the 
integrity of the study data, in the opinion of the Investigator and/or the Medical Monitor. 
5. Subject has a clinical laboratory value meeting any of the following criteria: 
c. Hepatotoxicity as described in Section 6.4.1. 
d. A laboratory value meeting any of the following criteria: 
◦ 
Absolute neutrophil count <1.0x103/μL 
◦ 
Absolute lymphocyte count <0.2x103/μL 
Subjects may remain in the study if the result is transient. A retest is required within 1 to 
2 weeks at a scheduled or unscheduled visit. If the repeat absolute neutrophil count or 
absolute lymphocyte count is still below the allowable values, the subject must be 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 49 of 216 
withdrawn. If the repeat absolute neutrophil count or absolute lymphocyte count is above 
the allowable values, the subject may continue in the study. 
6. The subject experiences a severe AE, an SAE, or a clinically significant change in a 
laboratory value occurs that, in the opinion of the Investigator, merits the discontinuation of 
the IMP. 
7. There is confirmation of a pregnancy during the study, as evidenced by a positive pregnancy 
test (see Section 9.1.4 for more information regarding pregnancies). 
8. At Week 28 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. A subject considered as having either a suspected new latent tuberculosis infection (LTBI) or 
who develops active tuberculosis (TB) or nontuberculosis mycobacterium (NTMB) infection 
during the study (including but not limited to, conversion demonstrated by IGRA or other 
diagnostic means) must be immediately discontinued from IMP, a PEOT Visit must be 
scheduled as soon as possible, but not later than the next regular visit. 
The subject must be permanently withdrawn if further examinations result in a diagnosis of 
active TB, or if the subject is diagnosed with LTBI with no initiation of prophylactic 
treatment, prematurely discontinues prophylactic treatment, or, in the opinion of the 
Investigator or Sponsor, is noncompliant with prophylactic TB therapy. 
Confirmed active TB is an SAE and must be captured on an SAE Report Form and provided 
to the Sponsor in accordance with SAE reporting requirements. As with all SAEs, periodic 
follow-up reports should be completed as per protocol requirements until such time as the 
TB infection resolves. 
Additional information on TB policies is provided in Section 9.3.1. 
10. Subjects with newly diagnosed inflammatory bowel disease (IBD) or with IBD flares during 
the study must: 
• Be referred, as appropriate, to a health care professional treating IBD, such as a 
gastroenterologist. 
• Discontinue IMP and be followed-up until resolution of active IBD symptoms. 
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. 
11. Subjects must be referred immediately to a mental health care professional (ie, locally 
licensed psychiatrist, psychologist, or master’s level therapist) and may be withdrawn from 
the study based upon the Investigator’s judgment of benefit/risk for: 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 50 of 216 
• Active suicidal ideation as indicated by a positive response (“Yes”) to Question 4 of the 
“Since Last Visit” version of the eC-SSRS. 
• Moderately severe major depression as indicated by a PHQ-9 score of 15 to 19 if this 
represents an increase of 3 points compared to last visit. 
12. Subjects must be referred immediately to a mental healthcare professional (ie, locally 
licensed psychiatrist, psychologist, or master’s level therapist) and must be withdrawn for: 
• Active suicidal ideation as indicated by a positive response (“Yes”) to Question 5 of the 
“Since Last Visit” version of the eC-SSRS. 
• Any suicidal behavior since last visit. 
• Severe major depression as indicated by a PHQ-9 score ≥20. 
The mental health consultation must be recorded in source documentation. 
Investigators should attempt to obtain information on subjects in the case of withdrawal or 
discontinuation. For subjects considered as lost to follow-up, the Investigator should make an 
effort (at least 1 phone call and 1 written message to the subject), and document his/her effort 
(date and summary of the phone call and copy of the written message in the source documents), 
to complete the final evaluation. All results of these evaluations and observations, together with a 
narrative description of the reason(s) for removing the subject, must be recorded in the source 
documents. The electronic Case Report Form (eCRF) must document the primary reason for 
withdrawal or discontinuation. 
Investigators should contact the Medical Monitor, whenever possible, to discuss the withdrawal 
of a subject in advance. 
6.4.1 
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: 
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥8x upper limit of 
normal (ULN). 
• Alanine aminotransferase 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 9.2.1.2.1 are followed. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 51 of 216 
The PDILI criterion below allows for subjects to continue on IMP at the discretion of the 
Investigator. 
• 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 9.2.1 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 <8xULN 
after re-test, IMP should be temporarily withheld and subject should undergo a repeat test in 
2 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 
PDILI. 
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 
7.1 
Description of IMP 
The IMP used in this study is bimekizumab. Bimekizumab will be manufactured using 2 
manufacturing processes: Process 4 (Phase 3 clinical supply manufacturing process) and 
Process 5 (planned commercial manufacturing process). Bimekizumab will be supplied in a 1mL 
prefilled syringe or a 1ml prefilled auto-injector (only in some countries) at a concentration of 
160mg/mL (55mM sodium acetate, 220mM glycine, 0.04% polysorbate 80 at pH 5.0) for sc 
injection. 
Further details of the IMP and its specifications are provided in the IMP Handling Manual. 
7.2 
Treatments to be administered 
Study staff will be responsible for preparation of the clinical study material, including recording 
the administration information on source documents, and administration of the IMP as sc 
injections. 
Suitable areas for sc injections are the lateral abdominal wall, upper outer thigh, or upper arm. 
During each dosing visit, each of the injections should be administered at a separate injection 
site. Injection sites should be rotated at each visit and injections should not be given into a 
PSO plaque or areas where the skin is tender, bruised, erythematous, or indurated. The injection 
should last approximately 10 to 15 seconds. 
An IMP Handling Manual will be provided to each site containing instructions regarding drug 
preparation and dosing. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 52 of 216 
Treatment Period dosing 
The initial dose of bimekizumab administered in PS0014 will be based on the subject’s 
PASI response and previous dose regimen in the feeder study. Subjects receiving: 
• Bimekizumab 320mg Q4W who do not achieve PASI90 in the feeder study will receive 
bimekizumab 320mg Q4W. 
• Bimekizumab 320mg Q4W who achieve PASI90 in the feeder study will be randomized 4:1 
to receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. 
• Bimekizumab 320mg Q8W who do not achieve PASI90 in the feeder study will receive 
bimekizumab 320mg Q4W. 
• Bimekizumab 320mg Q8W who achieve PASI90 in the feeder study will receive 
bimekizumab 320mg Q8W. 
• Ustekinumab who do not achieve PASI90 in the feeder study will receive bimekizumab 
320mg Q4W. 
• Ustekinumab who achieve PASI90 in the feeder study will be randomized 1:1 to receive 
bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. 
• Placebo (after a Week 16 response [≥PASI90] on bimekizumab 320mg Q4W during the 
Initial Treatment Period of the feeder study) who complete the Randomized Withdrawal 
Period of the feeder study will receive bimekizumab 320mg Q4W. 
At Week 24, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
Investigator may change the subject’s dosing interval from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W (optional). 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 48 or at the next scheduled clinic visit after implementation 
of Protocol Amendment #3 if the subject has already completed the Week 48 visit.  
After Week 48 and in between the scheduled study visits at the site, subjects will have the option 
to perform self-injection at home. All other injections will be administered preferably by self-
injection during scheduled visits. Self-injection training will be provided to the 
subject/caregivers by qualified site personnel at Week 40 and Week 44. After Week 48, the 
subject/caregiver will perform administration under the supervision of the site staff to ensure that 
study medication is being properly and safely injected. 
OLE2 Period dosing  
After the implementation of Protocol Amendment #3.3 (addition of a 48-week open-label 
treatment period, ie, OLE2 Period), subjects will be invited to continue or reinitiate treatment as 
per the following OLE2 Groups: 
• OLE2 Group A: Subjects in the Treatment Period at the time of Protocol Amendment #3.3 
implementation will attend the Week 144 Visit and may directly roll over to the OLE2 
Period. These subjects will continue receiving bimekizumab 320mg Q8W for 40 additional 
weeks, starting from the first treatment visit of the OLE2 Period (ie, Week 144/OLE2 
Baseline Visit; the Week 144 Visit will coincide with the Week 144/OLE2 Baseline Visit and 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 53 of 216 
data collected at this visit will be used as baseline data for subjects entering the OLE2 
Period). 
• OLE2 Group B: Eligible subjects who have completed the Treatment Week 144 Visit and 
who are in the SFU or have completed the SFU at the time of Protocol Amendment #3.3 
implementation may reinitiate bimekizumab treatment in the OLE2 Period after having 
undergone Screening assessments during a 4-week OLE2 Screening Period. The first dose 
will be administered at the Week 144/OLE2 Baseline Visit; data collected at this visit will be 
used as baseline data. Subjects with an IGA score ≥3 upon entry in the OLE2 Period will be 
treated with bimekizumab Q4W for the first 16 weeks, and will then switch to bimekizumab 
320mg Q8W. Subjects in OLE2 Group B with an IGA score <3 upon entry will be treated 
with bimekizumab Q8W from the Week 144/OLE2 Baseline Visit. 
During the OLE2 Period (Week 144/OLE2 Baseline to OLE2 Week 48), all subjects will attend 
study visits at the study site every 12 weeks for study assessments and subjects may self-inject 
IMP at home. 
Once subjects/caregivers as determined by the Investigator (or designee) have been trained, the 
study medication may be administered at home. The subject will receive the required number of 
syringes for injections at each visit needed to perform the Q4W or Q8W administrations at home. 
Subjects who are unable to or decide not to self-inject IMP or those without a family 
member/friend/caregiver who can help, will not be discontinued, but may continue to visit the 
site for unscheduled visits for IMP administration only. 
If administered at home, the subject/caregiver will document the date, body location, kit number 
and time point of administration of study medication. 
All used syringes will be disposed of by subjects/caregivers as determined by the Investigator in 
an acceptable disposal (sharps) container directly after the administration. The 
subjects/caregivers return the documentation together with any used/unused containers at the 
next scheduled clinic visit. 
7.3 
Packaging 
Bimekizumab will be packaged and labeled according to Good Manufacturing Practice (GMP) 
guidelines and applicable laws or regulations. It 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 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. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 54 of 216 
7.5 
Handling and storage requirements 
Refer to the IMP Handling Manual for the storage conditions of the IMP. 
The Investigator (or designee) is responsible for the safe and proper storage of IMP at the site. 
Investigational medicinal product stored by the Investigator is to be kept in a secured area with 
limited access according to the storage conditions mentioned on the label. 
Appropriate storage conditions must be ensured either by controlling the temperature (eg, room, 
refrigeration unit) or by completion of a temperature log in accordance with local requirements 
on a regular basis (eg, once a week), showing actual and minimum/maximum temperatures 
reached over the time interval. 
In case an out-of-range temperature is noted, it must be immediately reported as per instructions 
contained in the IMP Handling Manual. 
The IMP will be shipped to the study sites in temperature-controlled containers. Out-of-range 
shipping or storage conditions must be brought to the attention of the Sponsor or designee, 
immediately. Authorization to use any out-of-range IMP must be documented and received prior 
to dispensing or administering the IMP at the study site. 
In addition, the Investigator (or designee) will instruct the subject on how to handle the IMP 
during the transport and how to store the IMP following the instruction guide. Cooler bags with 
freezer packs will be provided to the subjects. Specific attention will be put on the transport from 
site to home using cold bags, and the subject will be instructed to put the IMP as quickly as 
possible into his/her refrigerator. In case of broken refrigerator, or broken or lost syringes, the 
subject will inform the site immediately and new IMP will be prepared. All efforts should be 
made to follow the treatment scheme as per protocol. 
7.6 
Drug accountability 
A Drug Accountability form will be used to record IMP dispensing and return information on a 
by-subject basis and will serve as source documentation during the course of the study. Details of 
any IMP lost, damaged (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. 
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. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 55 of 216 
7.7 
Procedures for monitoring subject compliance 
During Year 1 of the Treatment Period of this study, the IMP will be administered in the clinic 
and compliance will be determined at the visit by study personnel. Drug accountability must be 
recorded on the Drug Accountability Form. 
After Week 48, self-injection at home will be possible at the following weeks: Weeks 52, 56, 64, 
68, 76, 80, 88, 92, 100, 104, 112, 116, 124, 128, 136, 140, and at the OLE2 Weeks 4, 8, 16, 32, 
and 40. Dates, locations, kit numbers and time of self-injection will be captured using a home 
administration form. All used syringes will be disposed of by subjects/caregivers as determined 
by the Investigator in an acceptable disposal (sharps) container directly after the administration. 
The subjects/caregivers return the documentation together with any used/unused containers at the 
next scheduled clinic visit. Completed home administration forms should be reviewed by the 
Investigator.  
If a subject is noncompliant with the study procedures or medications that may present a risk to 
the safety of the subject in the opinion of the Investigator, then the subject should be withdrawn 
as described in Section 6.4. 
7.8 
Concomitant medications/treatments 
Any treatment administered from the time of informed consent to the final study visit will be 
considered concomitant medication. This includes medications that were started before the study 
and are ongoing during the study. 
7.8.1 
Permitted concomitant treatments (medications and therapies) 
The following concomitant medications are permitted during the study. 
7.8.1.1 
Topical medications 
Subjects may continue to use topical moisturizers or emollients, bath oils, or oatmeal bath 
preparations for skin conditions during the study, as needed. Over-the-counter shampoos for the 
treatment of PSO of the scalp are also permitted. 
Topical steroids and vitamin D analogue ointment will be permitted for use, as needed. 
7.8.1.2 
Other medications 
Subjects may take pain relievers (acetaminophen/paracetamol, non-steroidal anti-inflammatory 
drugs, opiates) as needed for pain but not within 24 hours of the Baseline and Week 144 Visits. 
Intra-articular injections (eg, steroids, hyaluronic acid) are permitted and must be carefully 
recorded in the eCRF. 
Subjects who are receiving an established regimen for depression during the feeder study should 
continue treatment. 
7.8.2 
Prohibited concomitant treatments (medications and therapies) 
Table 7-1 presents the list of prohibited PSO medications. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 56 of 216 
Table 7-1: 
Prohibited PSO medications  
Drug 
Systemic retinoids 
Systemic treatment (nonbiological): 
systemic immunosuppressant agents (eg, methotrexate, cyclosporine, azathioprine, thioguanine) 
fumaric acid esters specifically used for the treatment of PSO 
systemic corticosteroids 
phototherapy  
Anti-TNFs: 
infliximab (including biosimilar), golimumab 
etanercept (including biosimilar) 
certolizumab pegol 
adalimumab (including biosimilar) 
Other biologics and other systemic therapies, eg: 
alefacept 
efalizumab 
apremilast 
rituximab 
ustekinumab 
briakinumab 
tofacitinib 
guselkumab 
tildrakizumab 
risankizumab 
Anti-IL-17 therapy 
secukinumab 
ixekizumab 
brodalumab 
Any other antipsoriatic agent (systemic or topical) under investigation (or approved after the protocol is 
approved) 
IL-17=interleukin 17; PSO=psoriasis; TNF=tumor necrosis factor 
Up to Week 144 
Subjects who take prohibited medications may be withdrawn from IMP but followed until the 
SFU Visit. The decision to withdraw a subject for taking prohibited medications should be made 
in consultation with the Medical Monitor. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 57 of 216 
Post Week 144 (OLE2 Period) 
Subjects who have used systemic treatments for PSO after Week 144 must have stopped this 
treatment 1 month prior to receiving the first bimekizumab injection in the OLE2 Period. 
Subjects receiving systemic immunomodulatory medications for an indication other than PSO 
must have their eligibility confirmed by the Medical Monitor prior to enrollment in the OLE2 
Period. 
Subjects who take prohibited medications during the OLE2 Period may be withdrawn from IMP 
but followed until the SFU2 Visit. 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. Administration of inactivated vaccines is 
allowed during the study at the discretion of the Investigator. 
7.9 
Blinding 
PS0014 is an open-label study; thus, there will be no blinding. 
7.10 
Randomization and numbering of subjects 
Subjects who received ustekinumab and achieved PASI90 in the feeder study will be randomized 
1:1 to a treatment regimen using an interactive response technology (IRT). Subjects who 
received bimekizumab 320mg Q4W and who achieved PASI90 in the feeder study will be 
randomized 4:1 to receive bimekizumab 320mg Q4W or bimekizumab 320mg Q8W. All other 
subjects will be assigned to a treatment regimen based on the PASI90 status and dosing regimen 
from their feeder study. The same unique 5-digit identification number used in the feeder study 
will be used in PS0014. This subject number will be used to identify the subject throughout the 
study and to maintain subject confidentiality. At study visits, an IRT will assign the applicable 
subject kits of IMP. Further instructions will be provided in the IRT manual.  
Subjects who roll over directly from the Treatment Period into the OLE2 Period will continue 
receiving bimekizumab 320mg Q8W and will keep their unique 5-digit identification number. 
Subjects who reinitiate bimekizumab after having completed treatment (subjects in the SFU of 
the Treatment Period or who have completed the SFU of the Treatment Period) will receive 
either bimekizumab 320mg Q4W/Q8W or bimekizumab 320mg Q8W depending on their disease 
activity at time of reentry (bimekizumab 320mg Q4W/Q8W for subjects with IGA score ≥3 or 
bimekizumab 320mg Q8W for subjects with IGA score <3). For these subjects, the same unique 
5-digit identification number used in the study will be reused. 
8 
STUDY PROCEDURES BY VISIT 
Table 5-1 (Schedule of study assessments) provides a general overview of study assessments in 
Year 1 (Weeks 0 to 44). Table 5-2 (Schedule of study assessments) provides a general overview 
of study assessments in Years 2 and 3 (Weeks 48 to 144). Table 5-3 (Schedule of study 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 58 of 216 
assessments) provides a general overview of study assessments in OLE2 Period (from OLE2 
Screening or Week 144/OLE2 Baseline to OLE2 Week 48).  
A list of procedures to be completed at each visit up to Week 144 is described below. 
• Visit windows of ±7 days on either side of the scheduled dosing are permitted; however, the 
Investigator should try to keep the subjects on the original dosing schedule. The window of 
±7 days is relative to Baseline and applicable for all subsequent visits. Changes to the dosing 
schedule outside of the visit 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 final dose), the visit window is ±7 days relative to the 
scheduled visit date. 
A list of procedures to be completed at each visit of the OLE2 Period is described below. 
• Visit windows of ±14 days on either side of the scheduled dosing are permitted; however, the 
Investigator should try to keep the subjects on the original dosing schedule. The window of 
±14 days is relative to Week 144/OLE2 Baseline and applicable for all subsequent visits. 
Changes to the dosing schedule outside of the visit window must be discussed with the 
Medical Monitor. 
• The dosing window is ±14 days relative to the scheduled dosing visit. 
• For the SFU2 Visit (20 weeks after the final dose), the visit window is ±7 days relative to the 
scheduled visit date. 
8.1 
Treatment Period 
8.1.1 
Stable Dosing 
8.1.1.1 
Baseline/Feeder Study Final Visit 
The following procedures/assessments will be performed/recorded on the last visit of the feeder 
study and prior to administration of IMP in PS0014: 
• Informed consent 
• Inclusion/exclusion 
• Physical exam 
• Body weight 
• Vital signs (sitting systolic blood pressure [SBP], sitting diastolic blood pressure [DBP], 
pulse rate, and body temperature) should be obtained prior to blood sampling 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 59 of 216 
• Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
− Hematology and chemistry 
− Urinalysis 
− Urine drug screen 
− Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies 
• ECG 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• DLQI 
• PHQ-9 
• eC-SSRS 
• mNAPSI for subjects with nail involvement at Baseline in the feeder study 
• Scalp IGA for subjects with scalp involvement at Baseline in the feeder study 
• pp-IGA for subjects with palmoplantar involvement at Baseline in the feeder study 
• EQ-5D-3L 
• SF-36 
• PGA of PSO 
• PASE 
• PGADA (only for subjects with PsA) 
• WPAI-SHP V2.0 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration will occur. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 60 of 216 
8.1.1.2 
Week 4 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
• Vital signs 
• Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
• PASI 
• Percentage of BSA 
• IGA 
• PHQ-9 
• eC-SSRS 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W dosing will occur. 
8.1.1.3 
Week 8 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
• Vital signs 
• Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
• PASI 
• Percentage of BSA 
• IGA 
• PHQ-9 
• eC-SSRS 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 61 of 216 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration will occur. 
8.1.1.4 
Week 12 and Week 20 Visits (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
• Physical exam (Week 12 only) 
• Urine pregnancy test 
• PASI 
• Percentage of BSA 
• IGA 
• TB questionnaire (Week 12 only) 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W dosing will occur. 
8.1.1.5 
Week 16 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
• Vital signs 
• Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies 
• PASI 
• Percentage of BSA 
• IGA 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 62 of 216 
• PHQ-9 
• eC-SSRS 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration will occur. 
8.1.1.6 
Week 24 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
• Physical exam 
• Vital signs 
• Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• DLQI 
• PHQ-9 
• eC-SSRS 
• mNAPSI for subjects with nail involvement at Baseline 
• Scalp IGA for subjects with scalp involvement at Baseline 
• pp-IGA for subjects with palmoplantar involvement at Baseline 
• EQ-5D-3L 
• SF-36 
• PGA of PSO 
• PGADA 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 63 of 216 
• WPAI-SHP V2.0 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration will occur. 
At Week 24, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
Investigator may change the subject’s dosing interval from 320mg Q4W to 320mg Q8W 
(optional). 
8.1.2 
Flexible Dosing 
8.1.2.1 
Week 28 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
• PASI 
• Percentage of BSA 
• IGA 
• Urine pregnancy test 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W dosing will occur. 
8.1.2.2 
Week 32 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
• Vital signs 
• Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
• PASI 
• Percentage of BSA 
• IGA 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 64 of 216 
• PHQ-9 
• eC-SSRS 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration will occur. 
8.1.2.3 
Week 36 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
• Physical exam 
• Urine pregnancy test 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W dosing will occur. 
8.1.2.4 
Week 40 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
• Vital signs 
• Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test  
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies 
• PASI 
• Percentage of BSA 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 65 of 216 
• IGA 
• PHQ-9 
• eC-SSRS 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration will occur. 
Self-injection training will be provided to the subject/caregivers by qualified site personnel to 
allow self-injection to be performed at home after Week 48 (see Section 7.2). 
8.1.2.5 
Week 44 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
• PASI 
• Percentage of BSA 
• IGA 
• Urine pregnancy test 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W dosing will occur. 
Self-injection training will be provided to the subject/caregivers by qualified site personnel to 
allow self-injection to be performed at home after Week 48 (see Section 7.2). 
8.1.2.6 
Week 48 Visit (±7 days relative to Baseline) 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 48, or at the next scheduled clinic visit if the subject has 
already completed the Week 48 visit prior to implementation of Protocol Amendment #3.  
Subjects whose dosing interval is being changed to bimekizumab 320mg Q8W at Week 48 
should be dosed at this visit and should receive kits for home administration 8 weeks later 
(Table 8-1). 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 66 of 216 
Table 8-1: 
Dosing scheme, Years 2 and 3 (Weeks 48 to 144) 
Week 
 
Dose 
Assignment 
48 a,b 
Year 2 
Year 3 
52 
56 
60a,c 
64 
68 
72a,b 
76 
80 
84a,c 
88 
92 
96a,b 
100 
104 
108a,c 
112 
116 
120a,b 
124 
128 
132a,c 
136 
140 
C 
C/
H 
C/
H 
C 
C/
H 
C/
H 
C 
C/
H 
C/
H 
C 
C/
H 
C/
H 
C 
C/
H 
C/
H 
C 
C/
H 
C/
H 
C 
C/
H 
C/
H 
C 
C/
H 
C/
H 
Bimekizumab 
320mg Q4W 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
Bimekizumab 
320mg Q8W 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
C=Clinic; H=home; Q4W=every 4 weeks; Q8W=every 8 weeks 
Notes: A bimekizumab 160mg injection is depicted by a black circle (●). 
a The subject’s dosing interval will change from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W at Week 48 or at the next scheduled clinic visit if 
the subject has already completed the Week 48 visit prior to implementation of Protocol Amendment #3. 
b Subjects whose dosing interval is changed to bimekizumab 320mg Q8W should be dosed at this visit and should receive kits for home administration 
8 weeks later. 
c Subjects whose dosing interval is changed to bimekizumab 320mg Q8W should NOT be dosed at this visit and should receive kits for home administration 
4 weeks later. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 67 of 216 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
• Physical exam 
• Body weight 
• Vital signs (sitting SBP and DBP, 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 chemistry 
− Urinalysis 
− Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies 
− IGRA TB test 
• ECG 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• DLQI 
• PHQ-9 
• eC-SSRS 
• mNAPSI for subjects with nail involvement at Baseline 
• Scalp IGA for subjects with scalp involvement at Baseline 
• pp-IGA for subjects with palmoplantar involvement at Baseline 
• EQ-5D-3L 
• SF-36 
• PGA of PSO 
• PASE 
• PGADA (only for subjects with PsA) 
• WPAI-SHP V2.0 
• TSQM-9 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 68 of 216 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, subjects will be given the opportunity for 
self-injection of bimekizumab (see Section 7.2). 
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. 
8.1.2.7 
Self-injection at home (Weeks 52, 56, 64, 68, 76, 80, 88, 92, 100, 104, 
112, 116, 124, 128, 136, and 140) 
Subjects receiving bimekizumab 320mg Q4W will be given the opportunity for self-injection of 
bimekizumab at home (described in Section 7.2) on the following weeks: Weeks 52, 56, 64, 68, 
76, 80, 88, 92, 100, 104, 112, 116, 124, 128, 136, and 140. This only applies to those subjects 
who have not yet changed to bimekizumab 320mg Q8W. 
Subjects receiving bimekizumab 320mg Q8W will be given the opportunity for self-injection of 
bimekizumab at home (described in Section 7.2) on the following weeks: Weeks 56, 64, 80, 88, 
104, 112, 128, and 136.   
• Adverse events will be captured spontaneously if the subject decides to visit the site to 
receive the bimekizumab administration.  
• All used syringes will be disposed of by subjects/caregivers as determined by the Investigator 
in an acceptable disposal (sharps) container directly after the administration. The 
subjects/caregivers return the documentation together with any used/unused containers at the 
next scheduled clinic visit (Section 7.2). 
8.1.2.8 
Week 60, Week 84, Week 108, and Week 132 Visit (±7 days relative to 
Baseline) 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W as follows: 
• At Week 60 if the subject has already completed the Week 48 visit prior to implementation 
of Protocol Amendment #3.  
• At Week 84 if the subject has already completed the Week 72 visit prior to implementation 
of Protocol Amendment #3.  
• At Week 108 if the subject has already completed the Week 96 visit prior to implementation 
of Protocol Amendment #3.  
• At Week 132 if the subject has already completed the Week 120 visit prior to implementation 
of Protocol Amendment #3.  
As depicted in Table 8-1, subjects whose dosing interval is being changed to 
bimekizumab 320mg Q8W at one of these visits should NOT be dosed at that visit, and should 
receive kits for home administration 4 weeks later. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 69 of 216 
The following procedures/assessments will be performed/recorded at this visit. If IMP is 
administered at this visit, they should be performed/recorded prior to administration of IMP: 
• Physical exam 
• Vital signs 
• Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• PHQ-9 
• WPAI-SHP V2.0 (Week 132 only) 
• eC-SSRS 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W dosing will occur, preferably by self-injection. This only applies to those subjects 
who have not yet changed to Q8W after implementation of Protocol Amendment #3. 
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. 
8.1.2.9 
Week 72 Visit (±7 days relative to Baseline) 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 72 if the subject has already completed the Week 48 and 
Week 60 visits prior to implementation of Protocol Amendment #3. As depicted in Table 8-1, 
subjects whose dosing interval is being changed to bimekizumab 320mg Q8W at Week 72 
should be dosed at this visit and should receive kits for home administration 8 weeks later. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 70 of 216 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
• Physical exam 
• Vital signs 
• Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• DLQI 
• PHQ-9 
• eC-SSRS 
• mNAPSI for subjects with nail involvement at Baseline 
• Scalp IGA for subjects with scalp involvement at Baseline 
• pp-IGA for subjects with palmoplantar involvement at Baseline 
• EQ-5D-3L 
• SF-36 
• PGA of PSO 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W or Q8W dosing will occur, preferably by self-injection. The Q4W dosing only 
applies to those subjects who have not yet changed to Q8W after implementation of Protocol 
Amendment #3. 
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7.  
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 71 of 216 
8.1.2.10 
Week 96 Visit (±7 days relative to Baseline) 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 96 if the subject had already completed the Week 84 visit 
prior to implementation of Protocol Amendment #3. As depicted in Table 8-1, subjects whose 
dosing interval is being changed to bimekizumab 320mg Q8W at Week 96 should be dosed at 
this visit, and should receive kits for home administration 8 weeks later. 
The following procedures/assessments will be performed/recorded: 
• Physical exam 
• Body weight 
• Vital signs (sitting SBP and DBP, 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 chemistry 
− Urinalysis 
− Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies  
− IGRA TB test 
• ECG 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• DLQI 
• PHQ-9 
• eC-SSRS 
• mNAPSI for subjects with nail involvement at Baseline 
• Scalp IGA for subjects with scalp involvement at Baseline 
• pp-IGA for subjects with palmoplantar involvement at Baseline 
• EQ-5D-3L 
• SF-36 
• PGA of PSO 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 72 of 216 
• PASE 
• PGADA (only for subjects with PsA) 
• WPAI-SHP V2.0 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W or Q8W dosing will occur, preferably by self-injection. The Q4W dosing only 
applies to those subjects who have not yet changed to Q8W after implementation of Protocol 
Amendment #3. 
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. 
8.1.2.11 
Week 120 Visit (±7 days relative to Baseline) 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 120 if the subject had already completed the Week 108 visit 
prior to implementation of Protocol Amendment #3. As depicted in Table 8-1, subjects whose 
dosing interval is being changed to bimekizumab 320mg Q8W at Week 120 should be dosed at 
this visit, and should receive kits for home administration 8 weeks later. 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
• Physical exam 
• Vital signs 
• Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• DLQI  
• PHQ-9 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 73 of 216 
• eC-SSRS 
• mNAPSI for subjects with nail involvement at Baseline 
• Scalp IGA for subjects with scalp involvement at Baseline 
• pp-IGA for subjects with palmoplantar involvement at Baseline 
• EQ-5D-3L 
• SF-36 
• PGA of PSO 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W or Q8W dosing will occur, preferably by self-injection. The Q4W dosing only 
applies to those subjects who have not yet changed to Q8W after implementation of Protocol 
Amendment #3. 
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. 
8.1.2.12 
Week 144 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded: 
• Physical exam 
• Body weight 
• Vital signs (sitting SBP and DBP, 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 chemistry 
− Urinalysis 
− Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies  
− IGRA TB test 
• ECG 
• TB questionnaire 
• PASI 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 74 of 216 
• Percentage of BSA 
• IGA 
• DLQI 
• PHQ-9 
• eC-SSRS 
• mNAPSI for subjects with nail involvement at Baseline 
• Scalp IGA for subjects with scalp involvement at Baseline 
• pp-IGA for subjects with palmoplantar involvement at Baseline 
• EQ-5D-3L 
• SF-36 
• PGA of PSO 
• PASE 
• PGADA (only for subjects with PsA) 
• WPAI-SHP V2.0 
• Concomitant medication 
• AEs 
• Contact IRT 
Return of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. 
If Protocol Amendment #3.3 is implemented at the time study subjects are treated in the 
Treatment Period (ie, up to Week 144; OLE2 Group A subjects), these subjects will be invited to 
participate in the OLE2 Period and may directly roll over and continue bimekizumab treatment 
from the Week 144/OLE2 Baseline Visit as long as they do not meet any of the withdrawal 
criteria and have provided informed consent. 
If Protocol Amendment #3.3 is implemented at the time subjects have completed the Week 144 
Visit and are in the SFU Period of the Treatment Period or have completed the SFU of the 
Treatment Period (Group B subjects), these subjects will be invited to enter the OLE2 Period to 
reinitiate bimekizumab treatment in the OLE2 Period. However, before receiving the first dose at 
the Week 144/OLE2 Baseline Visit, they will first undergo screening during the 4-week OLE2 
Screening Period (see Section 8.1.3.1 for the procedures that will apply for the Screening of the 
OLE2 Period). 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 75 of 216 
8.1.3 
OLE2 Period  
8.1.3.1 
OLE2 Screening (up to 4 weeks) – applicable for OLE2 Group B only 
Prior to any study specific activities of the OLE2 Period, subjects who completed the Week 144 
Visit and are in the SFU or have completed the SFU of the Treatment Period (OLE2 Group B) 
will undergo screening. Subjects who have used systemic treatments for PSO after Week 144 
must have stopped this treatment 1 month prior to receiving the first bimekizumab injection in 
the OLE2 Period. Screening procedures may be performed during this time. Subjects receiving 
systemic immunomodulatory medications for an indication other than PSO must have their 
eligibility confirmed by the Medical Monitor prior to enrollment in the OLE2 Period. 
At the Screening Visit of the OLE2 Period (OLE2 Screening Visit), subjects will be asked to 
read, sign, and date an ICF that has been approved by the Sponsor and an IRB/IEC and that 
complies with regulatory requirements. Subjects will be given adequate time to consider any 
information concerning the study given to them by the Investigator or designee. As part of the 
informed consent procedure, subjects will be given the opportunity to ask the Investigator any 
questions regarding potential risks and benefits of continued participation in the study. 
The following procedures/assessments will be performed at the OLE2 Screening Visit for 
subjects in the OLE2 Group B: 
• Informed consent 
• Inclusion/exclusion 
• Urine drug screen 
• Significant past medical history including clinically relevant past or coexisting medical 
conditions and surgeries (only applicable for subjects who completed the SFU; only new or 
modified medical history since completing the SFU should be entered in eCRF) 
• Physical exam 
• 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: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
− Hepatitis B and Hepatitis C 
− HIV 
• Tuberculosis questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 76 of 216 
• PHQ-9 
• eC-SSRS 
• Prior and concomitant medication (including new or modified medications initiated after 
SFU) 
• AE (only for subjects in the SFU) 
• Contact IRT 
8.1.3.2 
Dosing in the OLE2 Period 
Subjects will be dosed in the OLE2 Period according to the dosing schedule presented in 
Table 8-2. 
Table 8-2: 
Dosing scheme, OLE2 Period  
 
OLE2 Period 
Visits/Week 
 
 
 
 
Dose Assignment 
Week 144/OLE2 
Baseline 
OLE2 W4 
OLE2 W8 
OLE2 W12 a 
OLE2 W16 
OLE2 W24 b 
OLE2 W32 
OLE2 W36 c 
OLE2 W40 
C 
H 
H 
C 
H 
C 
H 
C 
H 
Bimekizumab 320mg 
Q4W/Q8W d 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
 
●● 
Bimekizumab 320mg Q8W 
●● 
 
●● 
 
●● 
●● 
●● 
 
●● 
C=Clinic; H=home; IGA= Investigator’s Global Assessment; IMP=investigational medicinal product; OLE=open 
label extension; Q4W/Q8W=every 4 weeks for 16 weeks, followed by every 8 weeks; Q8W=every 8 weeks 
Notes: A bimekizumab 160mg injection is depicted by a black circle (●). 
a Subjects will receive kits for home administration 4 weeks later. 
b Subjects will receive kits for home administration 8 weeks later. 
c Subjects should NOT be dosed at this visit and will receive kits for home administration 4 weeks later. 
d Q4W/Q8W IMP administration only applies to those subjects who have entered the OLE2 Period as part of 
Group B and had an IGA ≥3 upon entry of the OLE2 Period. These subjects will receive Q4W dosing for 
16 weeks until OLE2 Week 16, then will change from Q4W to Q8W and will receive their next dose at the 
scheduled clinic visit OLE2 Week 24. 
 
8.1.3.2.1 
Week 144/OLE2 Baseline Visit 
Subjects who will still be treated in the Treatment Period at the time of implementing Protocol 
Amendment #3.3 (OLE2 Group A subjects) will attend Week 144 Visit and directly roll over to 
the OLE2 Period to continue treatment (bimekizumab 320mg Q8W). They will undergo all study 
assessments of the Week 144 Visit and will receive bimekizumab 320mg Q8W at this visit, 
which will also coincide with the first visit of the OLE2 Period, ie, the Week 144/OLE2 Baseline 
Visit. 
Subjects who have completed Week 144 Visit and are in the SFU of the Treatment Period or 
have completed the SFU Period at the time of Protocol Amendment #3.3 implementation (OLE2 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 77 of 216 
Group B subjects) will reinitiate bimekizumab treatment at the Week 144/OLE2 Baseline Visit, 
and will be assigned a treatment regimen based on disease severity at the Week 144/OLE2 
Baseline Visit (bimekizumab 320mg Q4W/Q8W for subjects with IGA score ≥3 or bimekizumab 
320mg Q8W for subjects with IGA score <3). 
Applicable for OLE2 Groups A and B: 
• Confirmation of eligibility  
• Physical exam 
• 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: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
• eC-SSRS 
• Tuberculosis questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• PHQ-9 
• DLQI 
• Concomitant medication 
• AEs 
• Contact IRT 
 
Additional Procedures/assessments applicable for OLE2 Group A  
• Informed Consent  
• ECG 
• Blood sample for bimekizumab plasma concentrations 
• Blood sample for anti‑bimekizumab antibodies 
• IGRA TB test 
• scalp IGA 
• mNAPSI 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 78 of 216 
• pp-IGA 
• EQ-5D-3L 
• PASE 
• PGADA 
• WPAI-SHP V2.0 
 
At the Week 144/OLE2 Baseline Visit, after completion of the above-mentioned procedures, 
administration of IMP will occur, preferably by self-injection under supervision of the site 
personnel. 
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. 
8.1.3.2.2 
Self-injection at home (OLE2 Weeks 4, 8, 16, 32, and 40) 
Subjects receiving bimekizumab 320mg Q8W will be given the opportunity for self-injection of 
bimekizumab at home on the following weeks: OLE2 Weeks 8, 16, 32, and 40. 
Subjects receiving bimekizumab 320mg Q4W/Q8W will be given the opportunity for self-
injection of bimekizumab at home on the following weeks: OLE2 Weeks 4, 8, and 16. At OLE2 
Week 16, subjects receiving bimekizumab 320mg Q4W/Q8W will switch to bimekizumab 
320mg Q8W regimen and will be given the opportunity for self-injection of bimekizumab at 
home at OLE2 Weeks 32 and 40. 
Adverse events will be captured spontaneously if the subject decides to visit the site to receive 
the bimekizumab administration.  
All used syringes will be disposed of by subjects/caregivers as determined by the Investigator in 
an acceptable disposal (sharps) container directly after the administration. The 
subjects/caregivers return the documentation together with any used/unused containers at the 
next scheduled clinic visit. 
8.1.3.2.3 
OLE2 Week 12, Week 24, and Week 36 Visits (±14 days relative to 
OLE2 Baseline) 
As depicted in Table 8-2, subjects receiving bimekizumab 320mg  Q4W/Q8W should receive 
IMP at the OLE2 Week 12 Visit, and all subjects will receive kits for home administration 
4 weeks later at OLE2 Week 16. All subjects will receive IMP administration at the OLE2 
Week 24 Visit, and will receive kits for home administration 8 weeks later. At the OLE2 Week 
36 Visit, subjects will not be dosed and will receive kits for home administration 4 weeks later at 
OLE2 Week 40. 
The following procedures/assessments will be performed/recorded at every clinic visit prior to 
administration of IMP: 
• Physical exam 
• Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 79 of 216 
• Urine pregnancy test, for applicable subjects 
• Tuberculosis questionnaire  
• PASI 
• Percentage of BSA  
• IGA 
• PHQ-9  
• eC-SSRS  
• Concomitant medication  
• AEs  
• Contact IRT  
 
The following additional assessments will be performed / recorded every 24 weeks (ie, at OLE2 
Week 24 Visit) prior to administration of IMP: 
• Collection of blood and urine samples for the following tests should be obtained prior to 
dosing: 
− Hematology and chemistry 
− Urinalysis 
• DLQI  
 
At the OLE2 Week 12 (OLE2 Group B subjects on Q4W/Q8W dosing only) and Week 24 Visit, 
after completion of the above-mentioned procedures, administration of IMP will occur, 
preferably by self-injection under supervision of the site personnel. 
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. 
8.1.3.3 
OLE2 Week 48 Visit (±14 days relative to OLE2 Baseline) 
The following procedures/assessments will be performed/recorded: 
• Physical exam 
• Body weight 
• Vital signs (sitting systolic BP 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: 
− Hematology and chemistry 
− Urinalysis 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 80 of 216 
− Urine pregnancy test 
− IGRA TB test 
• Tuberculosis questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• DLQI 
• PHQ-9 
• eC-SSRS 
• Concomitant medication 
• AEs 
• Contact IRT 
Return of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. 
8.2 
Premature End of Treatment Visit 
If a subject is withdrawn from the study during the Treatment Period (up to Week 144): 
• The subject will be withdrawn from IMP, will undergo the same assessments as the 
Week 144 visit (see Section 8.1.2.12), 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 8.3). 
If a subject is withdrawn from the study during the OLE2 Period: 
• The subject will be withdrawn from IMP, will undergo the same assessments as the OLE2 
Week 48 visit (see Section 8.1.3.3), and will enter the SFU2 Period. 
• The subject will be encouraged to return for the SFU2 Visit (20 weeks after the last received 
dose; see Section 8.4). 
8.3 
Safety Follow-Up Visit (20 weeks after final dose up to Week 
144, ±7 days) 
All subjects, 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 
• Body weight 
• Vital signs (sitting SBP and DBP, pulse rate, and body temperature) should be obtained prior 
to blood sampling 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 81 of 216 
• Collection of blood and urine samples for the following clinical laboratory tests: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies 
• PHQ-9 
• eC-SSRS 
• Concomitant medication 
• AEs 
• Contact IRT 
8.4 
Safety Follow-Up Visit 2 (20 weeks after final dose of the OLE2 
Period, ±7 days) 
The following procedures/assessments will be performed/recorded: 
• Physical exam  
• 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 tests should be obtained at this visit: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
• PHQ-9 
• eC-SSRS 
• Concomitant medication 
• AEs 
• Contact IRT 
8.5 
Unscheduled Visit 
At the Investigator’s discretion, an Unscheduled Visit may be completed at any time during the 
study, but prior to the SFU Visit or SFU2 Visit (depending on which period [Treatment Period or 
OLE2 Period] the subject is in), if deemed necessary for the subject’s safety and well-being. 
If an Unscheduled Visit is conducted due to safety or efficacy reasons, an eC-SSRS assessment 
will be performed with the subject during the visit. If an Unscheduled Visit is conducted for 
reasons other than safety or efficacy concerns (eg, repeated collection of a laboratory specimen 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 82 of 216 
due to collection or analysis issues, injection for subjects not making use of home self-
injections), an eC-SSRS will not be required at these visits. 
At this visit, any assessment may be performed, as needed, depending on the reason for the visit. 
9 
ASSESSMENT OF SAFETY 
9.1 
Adverse events 
9.1.1 
Definitions 
9.1.1.1 
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 Informed Consent Form), 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. 
9.1.1.2 
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 9.1.1.3], allergic bronchospasm requiring intensive treatment in an emergency room 
or at home, blood dyscrasias that do not result in inpatient hospitalization, or the 
development of drug dependency or drug abuse.) 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 83 of 216 
• 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.) 
9.1.1.2.1 
Anticipated SAEs 
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 9.1.2.3. 
Table 9‒1: 
Anticipated SAEs for the population of subjects with moderate to 
severe chronic plaque PSO 
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; PSO=psoriasis; 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. 
9.1.1.3 
Adverse events of special interest 
An AE of special interest 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 AE of special interest (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. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 84 of 216 
 
9.1.1.4 
Other safety topics of interest 
Pre-specified safety topics of interest for the study are: infections (serious, opportunistic, fungal, 
and TB), neutropenia, hypersensitivity, suicidal ideation and behavior, depression, major 
cardiovascular events, liver function test changes/enzyme elevations, malignancies, and IBDs 
(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. 
9.1.2 
Procedures for reporting and recording AEs 
The subject will be given the opportunity to report AEs spontaneously. A general prompt will 
also be given at each study assessment 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. 
9.1.2.1 
Description of AEs 
When recording an AE, the Investigator should use the overall diagnosis or syndrome using 
standard medical terminology, rather than recording individual symptoms or signs. The eCRF 
and source documents should be consistent. Any discrepancies between the subject’s own words 
on his/her own records (eg, diary card) and the corresponding medical terminology should be 
clarified in the source documentation. 
When recording the severity of an AE in the eCRF (ie, mild, moderate, or severe), the 
Investigator may refer to the Common Terminology Criteria for Adverse Events 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. 
9.1.2.2 
Rule for repetition of an AE 
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 
9.1.2.3 
Additional procedures for reporting SAEs 
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 SAE 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 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 85 of 216 
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. 
9.1.3 
Follow up of AEs 
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 AEs of special interest; further details 
regarding follow up of PDILI events is provided in Section 9.2.1.4. 
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. 
9.1.4 
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 SAE 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 a PEOT Visit. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 86 of 216 
• 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 Institutional Review 
Board (IRB)/Independent Ethics Committee (IEC) and should be available in the Investigator 
site file. In case of questions about the consent process, the Investigator may contact the UCB or 
the 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 SAE reporting information at the beginning of this protocol) only after the 
partner has agreed that additional information can be captured and has provided the signed 
Partner Pregnancy Consent form. UCB’s PS department is also the primary contact for any 
questions related to the data collection for the partner pregnancy, eventual birth, and follow up. 
A pregnancy becomes an SAE in the following circumstances: miscarriage, elective abortion 
when medically indicated (eg, when pregnancy is endangering life or health of woman or when 
fetus will be born with severe abnormalities), unintended pregnancy after hormonal 
contraceptive failure (if the hormonal contraceptive was correctly used), ectopic pregnancy, fetal 
demise, or any congenital anomaly/birth defect of the baby. Those SAEs must be additionally 
reported using the Investigator SAE Report form. 
Should a subject become pregnant while participating in the study, the subject may be offered the 
option to enroll in a separate observational pregnancy follow-up study sponsored by UCB and 
conducted independently from study PS0014. If the study is available locally, the PS0014 
Investigator 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 PS0014. 
9.1.5 
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 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 87 of 216 
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. 
9.1.6 
Overdose of IMP 
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). 
9.1.7 
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. 
The Study Physician or medically qualified designee/equivalent will conduct an ongoing review 
of SAEs and perform ongoing SAE reconciliations in collaboration with the PS representative. 
As appropriate for the stage of development and accumulated experience with the IMP, 
medically qualified personnel at UCB may identify additional safety measures (eg, AEs, vital 
signs, laboratory or ECG results) for which data will be periodically reviewed during the course 
of the study. 
9.2 
Laboratory measurements 
Clinical laboratory assessments consist of serum chemistry, hematology, and urinalysis at visits 
specified in Table 5-1, Table 5-2, and Table 5-3. A centralized laboratory will be used to supply 
all laboratory test supplies and analyze all blood and urine samples for hematology, chemistry, 
and urinalysis measurements. Any unscheduled laboratory testing should also be collected using 
the central laboratory. If tests are done locally, a concurrent sample should also be sent to the 
central laboratory whenever possible. 
Specific details regarding the handling and processing of serum chemistry, hematology, and 
urinalysis samples are provided in the study laboratory manuals. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 88 of 216 
The following laboratory parameters will be measured: 
Table 9‒2: 
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 
Drug screenb 
MCH 
Creatinine 
Urine dipstick for pregnancy 
testingc 
MCHC 
ALP 
 
MCV 
AST 
 
Platelet count 
ALT 
 
RBC count 
GGT 
 
WBC count 
Total bilirubin 
 
 
HIV d 
 
 
Hepatitis B and C d 
 
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; 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 Only at Baseline/Feeder Study Final Visit and OLE2 Screening Visit.  
c Urine pregnancy testing will be performed at all visits.  
d Only for Group B; only at the OLE2 Screening Visit. 
 
9.2.1 
Evaluation of PDILI 
The PDILI IMP discontinuation criteria for this study are provided in Section 6.4.1, 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 9.1.1.3), and, if applicable, also reported as an 
SAE (see Section 9.1.1.2). 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 89 of 216 
Evaluation of PDILI consists of the diagnostic testing and continued monitoring included in 
Table 9‒3 (specific tests dependent on laboratory results and corresponding symptoms) and 
consultation with a local hepatologist (if applicable; discussed in Section 9.2.1.1). 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 9.2.1.4). 
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 6.4.1), 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 9.2.1.2.1 are met, rechallenge with IMP may be appropriate.  
Table 9‒3 summarizes the approach to investigate PDILI. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 90 of 216 
Table 9‒3: 
Required investigations and follow up for PDILI 
Laboratory value 
 
Immediate 
Follow up 
ALT or 
AST 
Total 
bilirubin 
Symptomsa of 
hepatitis of 
hypersensitivity 
Consultation 
requirements 
Actions 
Testing 
Evaluation 
≥3xULN 
≥2xULNb 
NA 
Hepatology consultc. 
Medical Monitor must 
be notified within 
24 hours (eg, by 
laboratory alert) and 
subject discussed with 
Medical Monitor 
ASAP. 
Immediate, 
permanent IMP 
discontinuation e 
Essential: Must have 
repeat liver 
chemistry values 
and additional 
testing completed 
ASAP (see 
Section 9.2.1.2.1); 
recommended to 
occur at the site with 
HCP. 
Monitoring of liver 
chemistry values at least 
twice per week until 
values normalize, 
stabilize, or return to 
within baseline values.d 
≥3xULN 
NA 
Yes 
≥8xULN 
NA 
NA 
Hepatology consult.  
Medical Monitor must 
be notified within 
24 hours (eg, by 
laboratory alert) and 
subject discussed with 
Medical Monitor 
ASAP. 
Immediate, 
permanent IMP 
discontinuation 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 91 of 216 
≥5xULN 
and 
<8xULN  
<2xULN 
No 
Discussion with 
Medical Monitor 
required. 
Consider need for 
hepatology consult if 
there is no evidence of 
resolution (see Follow 
up requirements). c 
Further investigation 
– immediate IMP 
discontinuation not 
required (see 
Section 9.2.1.2) 
 
IMP discontinuation 
required if any of the 
following occur: 
• 
Subject cannot 
comply with 
monitoring 
schedule. 
• 
Liver chemistry 
values continue 
to increase 
• 
Liver chemistry 
values remain 
≥5xULN after 
4 weeks of 
monitoring 
without evidence 
of resolution 
Essential: Every 
attempt must be 
made to have repeat 
liver chemistry 
values and 
additional testing 
completed within 
48 hours at the site 
with HCP (see 
Section 9.2.1.2.1). 
Monitoring of liver 
chemistry values at least 
twice per week for 
2 weeks.d 
• 
Immediate IMP 
discontinuation 
required if liver 
chemistry values 
continue to increase. 
After 2 weeks of 
monitoring liver 
chemistry values: 
• 
ALT or AST remains 
≥5xULN <8xULN, 
IMP should be 
temporarily withheld 
and subject should 
undergo repeat test in 
2 weeks. 
 
Continue IMP if ALT 
or AST values 
<5xULN; continue to 
monitor at least twice 
per week until values 
normalize, stabilize, 
or return to within 
Baseline values. 
If ALT or AST 
remains ≥5xULN 
after second re-test, 
immediate, 
permanent IMP 
discontinuation 
required. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 92 of 216 
Table 9‒3: 
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 
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 9.2.1.1. The local hepatologist is the expert usually consulted by the treating physician for assessment and management of potential 
hepatic disease. This would usually be a hepatologist, but may be a gastroenterologist. 
d Unless an alternative monitoring schedule is agreed by the Investigator and UCB responsible physician. Determination of stabilization is at the discretion of the 
Investigator in consultation with the hepatologist (as applicable) and UCB responsible physician, as needed.  
e  Details provided in Section 9.2.1.2.1. 
 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 93 of 216 
9.2.1.1 
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 9.2.1.3) and SAE report (if applicable). 
9.2.1.2 
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 6.4.1 and Table 9‒3 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. 
9.2.1.2.1 
Investigational medicinal product restart/rechallenge 
Subjects who are immediately discontinued from IMP due to having met certain criteria for 
PDILI (as described in Section 6.4.1 and Table 9‒3), but for whom an alternative diagnosis is 
confirmed, ie, drug-induced liver injury is excluded, can rarely restart IMP. 
Rechallenge with IMP can occur only if ALL of the following requirements are met at the time 
of the rechallenge: 
• The results of additional testing and monitoring described Section 9.2.1.3 and Section 9.2.1.4 
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. 
• Subject agrees to the Investigator-recommended monitoring plan. 
9.2.1.3 
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 9‒4 (laboratory measurements) and Table 9‒5 (additional information). Results of the 
laboratory measurements and information collected are to be submitted to the Sponsor on the 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 94 of 216 
corresponding eCRF. If the medical history of the subject indicates a requirement for other 
assessments not included below, these additional assessments should be completed and 
submitted, as applicable. 
All blood samples should be stored, if possible. If tests are done locally for more rapid results, a 
concurrent sample must also be sent to the central laboratory. 
The following measurements are to be assessed: 
Table 9‒4: 
PDILI laboratory measurements 
Virology-
related 
Hepatitis A IgM antibody 
HBsAg 
Hepatitis E IgM antibody 
HBcAb-IgM 
Hepatitis C RNA 
Cytomegalovirus IgM antibody 
Epstein-Barr viral capsid antigen IgM antibody (if unavailable, obtain heterophile 
antibody or monospot testing) 
Immunology 
Anti-nuclear antibody (qualitative and quantitative) 
Anti-smooth muscle antibody (qualitative and quantitative) 
Type 1 anti-liver kidney microsomal antibodies (qualitative and quantitative) 
Hematology 
Eosinophil count 
Urinalysis 
Urine drug screen a 
Chemistry 
Amylase 
Sodium, potassium, chloride, glucose, BUN, creatinine 
Total bilirubin, ALP, AST, ALT, GGT, total cholesterol, albumin 
If total bilirubin ≥1.5xULN, obtain fractionated bilirubin to obtain % direct bilirubin 
Serum CPK and LDH to evaluate possible muscle injury causing transaminase elevation 
Additional 
Prothrombin time/INR b 
Serum pregnancy test c 
PK sample 
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea 
nitrogen; CPK=creatine phosphokinase; GGT=gamma glutamyltransferase; HBcAb-IgM=hepatitis B core 
antibody-IgM; HBsAg=hepatitis B surface antigen; IgM=immunoglobulin M; INR=international normalized ratio; 
LDH=lactate dehydrogenase; PDILI=potential drug-induced liver injury; PK=pharmacokinetic; RNA=ribonucleic 
acid; ULN=upper limit of normal 
 a Tests in addition to the specified analytes may be performed based on the Investigator’s medical judgment and 
subject history. 
 b Measured only for subjects with ALT >8xULN, elevations in total bilirubin, and symptoms of hepatitis or 
hypersensitivity. Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 95 of 216 
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 9‒5: 
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 
9.2.1.4 
Follow-up evaluation 
Potential drug-induced liver injury events require follow-up monitoring as described in Table 9‒
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. 
9.3 
Other safety measurements 
9.3.1 
Assessment and management of TB and TB risk factors 
All subjects will be assessed for TB at the time points specified in the Schedule of study 
assessments Table 5-1, Table 5-2, and Table 5-3 through physical examination for signs and 
symptoms of TB, laboratory testing (Section 9.3.1.1), and subject questionnaire (Section 9.3.1.2). 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 96 of 216 
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 Baseline. 
− 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 LTBI is 
identified. The retest must be done during the protocol-defined Baseline window. 
Note: If available, respiratory or other specimens must also be smear and culture negative for TB 
(Centers for Disease Control diagnosis of LTBI) http://www.cdc.gov/TB/topic 
/testing/default.htm). 
d. A 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 
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 9-1. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 97 of 216 
Figure 9-1: 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.
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 98 of 216 
9.3.1.1 
Tuberculosis assessment by IGRA 
During conduct of the study, the TB assessment by IGRA (QuantiFERON TB test) will be 
performed as described in Table 5-1, Table 5-2, and Table 5-3 for all subjects. The test results 
will be reported as positive, negative, or indeterminate. Positive and indeterminate TB test results 
must be reported as an AE and appropriately updated once the final diagnosis is known (eg, 
active TB, LTBI, 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. 
9.3.1.2 
Tuberculosis questionnaire 
The questionnaire “Evaluation of signs and symptoms of tuberculosis” should be used as a 
source document. The questionnaire will be completed as described in Table 5-1, Table 5-2, and 
Table 5-3. The questionnaire will assist with the identification of subjects who may require 
therapy for TB. 
9.3.1.3 
Tuberculosis management 
LTBI and active TB identified during study 
During the study, subjects who develop evidence of LTBI or active TB must immediately stop 
further administration of IMP and will be referred to an appropriate TB specialist (pulmonologist 
or infectious disease specialist) for further evaluation. Evidence of LTBI is defined as subject’s 
IGRA test converts to positive or indeterminate (and confirmed indeterminate on repeat), or the 
subject’s questionnaire or history and physical indicates that TB infection or exposure may have 
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 (Section 8.2). 
The subject should be encouraged to complete a SFU Visit (20 weeks after the final dose of IMP, 
Section 8.3). 
If infection with NTMB is identified during the study, the same procedure as for active TB 
acquired during the study must be followed. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 99 of 216 
9.3.2 
Pregnancy testing 
Urine pregnancy testing will be performed at all visits as specified in Table 5-1, Table 5-2, and 
Table 5-3. The Baseline Visit pregnancy testing results must be negative, and received and 
reviewed prior to administration of IMP. A negative urine pregnancy test result must be obtained 
immediately prior to each administration of IMP at the visits specified in Table 5-1, Table 5-2, 
and Table 5-3. Pregnancy tests should be administered to all female subjects of childbearing 
potential, regardless of their use of birth control. 
9.3.3 
Vital signs 
Vital signs will be collected the time points specified in Table 5-1, Table 5-2, and Table 5-3 and 
will include SBP, DBP, 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. 
9.3.4 
12-lead ECGs 
Twelve-lead standard ECGs will be recorded at the visits specified in Table 5-1 and Table 5-2, 
and read by a central ECG reader.  
Full details of ECG recording will be provided in the ECG Manual. 
9.3.5 
Physical examination 
A physical examination will be performed at visits specified in Table 5-1, Table 5-2, and 
Table 5-3. The physical examination will include general appearance; ear, nose, and throat; eyes, 
hair, and skin; respiratory; cardiovascular; gastrointestinal; musculoskeletal; hepatic; 
neurological (including limb reflexes); and mental 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 Baseline will be 
recorded as AEs. 
9.3.6 
Body weight 
Body weight will be measured at visits specified in Table 5-1, Table 5-2, and Table 5-3. 
9.3.7 
Assessment of suicidal ideation and behavior 
Suicidal ideation and behavior will be assessed by using the eC-SSRS; the questionnaire will be 
self-administered by the subject and assessed by trained study personnel. This scale will be used 
to assess suicidal ideation and behavior that may occur during the study. The visits at which the 
eC-SSRS assessments will be performed are specified in the schedule of study assessments 
(Table 5-1, Table 5-2, and Table 5-3). 
The eC-SSRS is a standardized and validated instrument developed for the assessment of the 
severity and frequency of suicidal ideation and behavior (Posner et al, 2011; Mundt et al, 2010). 
Subjects respond to standardized clinical questions that are presented in a uniform fashion. The 
eC-SSRS defines 5 subtypes of suicidal ideation and behavior in addition to self-injurious 
behavior with no suicidal intent. The eC-SSRS takes approximately 3 to 10 minutes to complete. 
Refer to Section 6.4 for eC-SSRS-related withdrawal criteria. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 100 of 216 
9.3.8 
Patient Health Questionnaire 9 
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring 
the severity of depression. The PHQ-9 scores for depression range from 0 to 27, with higher 
scores indicating worse state. A score of 5 to 9 is considered to be minimal symptoms of 
depression. A score of 10 to 14 is considered minor depression, dysthymia, or mild major 
depression. A score of 15 to 19 is considered to indicate moderately severe major depression, 
and a score ≥20 is considered to be severe major depression. 
The PHQ-9 will be assessed at the visits specified in Table 5-1, Table 5-2, and Table 5-3. 
Refer to Section 6.4 for PHQ-9-related withdrawal criteria. 
10 
ASSESSMENT OF EFFICACY 
The PASI, BSA, IGA, scalp IGA, pp-IGA, and mNAPSI 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. 
10.1 
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 10‒1). 
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. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 101 of 216 
Table 10‒1: Body areas for calculation of percent BSA for PASI 
Body area 
Details of area 
BSA 
Degree of 
involvement of 
body area a 
Head 
Face, back of head 
10% 
0 to 6 
Upper extremities 
Left, right, upper lower, flexor 
surface, extensor surface 
20% 
0 to 6 
Trunk 
Front, back, groin 
30% 
0 to 6 
Lower extremities 
Left, right, upper lower, flexor 
surface, extensor surface, including 
buttocks 
40% 
0 to 6 
Total 
 
100% 
 
BSA=body surface area; PASI=Psoriasis Area and Severity Index 
 a Where 0=none; 1=1% to <10% affected; 2=10% to <30% affected; 3=30% to <50% affected; 4=50% to <70% 
affected; 5=70% to <90% affected; 6=90% to 100% affected. 
The PASI75, PASI90, and PASI100 responses are based on at least 75%, 90%, and 100% 
improvement in the PASI score, respectively. 
The total BSA affected by PSO will be entered as a percentage from 0 to 100. 
The PASI will be completed at the visits specified in Table 5-1, Table 5-2, and Table 5-3. 
10.2 
IGA 
A static IGA for PSO will be used to assess disease severity in all subjects during the study. The 
IGA will be completed at the visits specified in Table 5-1, Table 5-2, and Table 5-3. 
The Investigator will assess the overall severity of PSO using the following 5-point scale 
presented in Table 10‒2. 
Table 10‒2: 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 
coloration; 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 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 102 of 216 
10.3 
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 quality of life (QOL). This instrument asks subjects about symptoms and 
feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has 
been shown to be valid and reproducible in subjects with PSO. The DLQI score ranges from 0 to 
30 with higher scores indicating lower health related QOL. A 4-point change in the DLQI score 
(DLQI response) has been reported to be meaningful for the subject (within-subject minimal 
important difference); while a DLQI absolute score of 0 or 1 indicates no or small impact of the 
disease on health related QOL. Subjects will be asked to complete the DLQI as outlined in the 
Schedule of study assessments (Table 5-1, Table 5-2, and Table 5-3). 
10.4 
mNAPSI Score 
Psoriatic nail disease 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 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. Subjects with nail disease at Baseline are defined as those with an mNAPSI 
score >0 at Baseline.  
The mNAPSI will be assessed at the visits specified in Table 5-1 and Table 5-2. 
10.5 
Scalp IGA 
A static IGA for 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 in the feeder study will complete the scalp IGA at the visits specified in Table 5-1 and 
Table 5-2. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA 
score >0 at Baseline. 
Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using 
a 5-point scale (Table 10‒3). 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 103 of 216 
Table 10‒3: 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 coloration; 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 
IGA=Investigator’s Global Assessment; PSO=psoriasis 
10.6 
pp-IGA 
A static IGA for palmoplantar PSO will be used to assess palmoplantar disease severity. 
All subjects will complete the pp-IGA at Baseline. Only subjects with palmoplantar involvement 
at Baseline in the feeder study will complete the pp-IGA at the other visits specified in Table 5-1 
and Table 5-2. Subjects with palmoplantar involvement at Baseline are defined as those with a 
pp-IGA score >0 at Baseline. 
Palmoplantar disease will be assessed in terms of clinical signs of redness, thickness, and 
scaliness using a 5-point scale (Table 10‒4). 
Table 10‒4: 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 
pp-IGA=palmoplantar Investigator’s Global Assessment; PSO=psoriasis 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 104 of 216 
10.7 
Euro-Quality of Life 5-Dimensions, 3 levels 
The EQ-5D-3L health questionnaire provides a descriptive profile and a single index value for 
health status. The instrument is comprised of a 5-item health status measure and a VAS. The 
EQ-5D-3L VAS records the respondent’s self-rated health status on a vertical 20cm scale, 
graduated from 0 to 100 (0=worst imaginable health status, 100=best imaginable health status). 
The EQ-5D-3L will be assessed at the visits specified in Table 5-1 and Table 5-2. 
10.8 
Short Form 36-Item 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 
standardized with a mean of 50 and a standard deviation (SD) of 10 in the general US 
population. The minimally important differences, 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 and Table 5-2. 
10.9 
Patient Global Assessment of PSO 
The PGA 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 PGA of PSO will be completed at the visits specified in Table 5-1 and Table 5-2. 
10.10 
Psoriatic Arthritis Screening and Evaluation 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 [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. 
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 assessment (PGADA) as noted in Section 10.11. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 105 of 216 
The PASE questionnaire will be completed at the visits specified in Table 5-1 and Table 5-2. 
10.11 
Patient's Global Assessment of Disease Activity for arthritis 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. 
Only subjects with PsA will complete the PGADA at the visits specified in Table 5-1 and 
Table 5-2. 
10.12 
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 (Reilly et al, 1993). It has been 
used in several clinical studies of biologic therapy in subjects with plaque PSO 
(Kimball et al, 2012; Vender et al, 2012). 
Five out of 6 items of the WPAI-SHP are regrouped into the 4 dimensions, with scores expressed 
as percentage, where higher numbers indicate greater impairment and less productivity, ie, worse 
outcomes, as described in the WPAI-SHP scoring rules. 
The WPAI-SHP V2.0 will be assessed at the visits specified in Table 5-1 and Table 5-2. 
10.13 
Treatment Satisfaction Questionnaire for Medication (TSQM-9) 
The TSQM-9 (Bharmal et al, 2009) is a 9-item measure developed to provide a suitable measure 
of treatment satisfaction with medication. It has 5 to 7 Likert response options per item and 
consists of 3 subscales: effectiveness (3 items), convenience (3 items), and a global satisfaction 
scale (3 items). The TSQM-9 was developed from the TSQM 1.4 (Atkinson et al, 2004) which 
has an additional subscale which measures side effects (3 items). The estimated completion time 
for this measure is less than 5 minutes. Scores range from 0 (worst) to 100 (best).  
The TSQM will be performed at Week 48. 
11 
ASSESSMENT OF PHARMACOKINETIC VARIABLES 
11.1 
Pharmacokinetic variables 
Blood samples for measurement of PK assessments (Section 4.3.3) will be collected at the time 
points specified in the Schedule of study assessments (Table 5-1 and Table 5-2). Blood samples 
for the measurement of PK assessments will not be collected in the OLE2 Period.  
At dosing visits, blood samples will be drawn prior to dosing, and will be drawn at the same time 
of the sampling for clinical laboratory tests. The time and date of collection will be recorded in 
the eCRF. 
Instructions pertaining to sample collection, processing, storage, labeling, and shipping are 
provided in the Laboratory Manual for this study. Detailed information on sample analysis will 
be provided in a bioanalytical report. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 106 of 216 
12 
ASSESSMENT OF IMMUNOLOGICAL VARIABLES 
Blood samples for measurement of antibodies to bimekizumab will be collected at the visits 
specified in Table 5-1 and Table 5-2. The threshold for antibody positivity will be defined prior 
to analysis. Blood samples for the measurement of antibodies to bimekizumab will not be 
collected in the OLE2 Period. 
At dosing visits, blood samples will be drawn prior to dosing, and will be drawn at the same time 
of the sampling for clinical laboratory tests. The time and date of collection will be recorded in 
the eCRF. 
Instructions pertaining to sample collection, processing, storage, labeling, and shipping are 
provided in the Laboratory Manual for this study. The presence of antibodies to bimekizumab 
will be determined using a validated bioanalytical method. Detailed information on sample 
analysis will be provided in a bioanalytical report. 
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 Clinical Project Manager 
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. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 107 of 216 
13.2.1 
Definition of source data  
All source documents must be accurate, clear, unambiguous, permanent, and capable of being 
audited. They should be made using some permanent form of recording (ink, typing, printing, 
optical disc). They should not be obscured by correction fluid or have temporary attachments 
(such as removable self-stick notes). Photocopies and/or printouts of eCRFs are not considered 
acceptable source documents. 
Source documents are original records in which raw data are first recorded. These may include 
hospital/clinic/general practitioner records, charts, diaries, x-rays, laboratory results, printouts, 
pharmacy records, care records, ECG or other printouts, completed scales, or QOL 
questionnaires, for example. Source documents should be kept in a secure, limited access area. 
Source documents that are computer generated and stored electronically must be printed for 
review by the monitor (eg, ECG reports). Once printed, these copies should be signed and dated 
by the Investigator and become a permanent part of the subject’s source documents. The 
Investigator will facilitate the process for enabling the monitor to compare the content of the 
printout and the data stored in the computer to ensure all data are consistent. 
Electronic data records, such as Holter monitor records or electroencephalogram records, must 
be saved and stored as instructed by UCB (or designee). 
Patient-Reported Outcome measures (eg, DLQI, EQ-5D-3L, SF-36, PGA of PSO, and PGADA) 
will be entered electronically by the subject. 
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 
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. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 108 of 216 
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. Case Report form data are entered into the clinical database using independent, 
double-data entry, with the exception of comment fields, which are verified by a second person. 
The data are entered into the eCRFs once and are subsequently verified if the study is performed 
using electronic data capture. 
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 Baseline and Enrollment Log/Subject Identification Code list 
The subject’s Baseline and enrollment will be recorded in the Subject Baseline and Enrollment 
Log. 
The Investigator will keep a Subject Identification Code list. This list remains with the 
Investigator and is used for unambiguous identification of each subject. 
The subject’s consent and enrollment in the study must be recorded in the subject’s medical 
record. These data should identify the study and document the dates of the subject’s 
participation. 
13.4 
Termination of the study 
UCB reserves the right to temporarily suspend or prematurely discontinue this study either at a 
single site, multiple sites, or at all sites at any time for reasons including, but not limited to, 
safety or ethical issues, inaccurate or incomplete data recording, noncompliance, or 
unsatisfactory enrollment with respect to quality or quantity. 
If the study is prematurely terminated or suspended, UCB (or its representative) will inform the 
Investigators/institutions and the regulatory authority(ies) of the termination or suspension and 
the reason(s) for the termination or suspension, in accordance with applicable regulatory 
requirement(s). The IRB/IEC should also be informed and provided with reason(s) for the 
termination or suspension by the Sponsor or by the Investigator/institution, as specified by the 
applicable regulatory requirement(s). In addition, arrangements will be made for the return of all 
unused IMP and other material in accordance with UCB procedures for the study. 
13.5 
Archiving and data retention 
The Investigator will maintain adequate records for the study, including eCRFs, medical records, 
laboratory results, Informed Consent documents, drug dispensing and disposition records, safety 
reports, information regarding subjects who discontinued, and other pertinent data. 
All essential documents are to be retained by the Investigator until at least 2 years after the last 
approval of a marketing application in an ICH region and until there are no pending or 
contemplated marketing applications in an ICH region, or at least 2 years have elapsed since the 
formal discontinuation of clinical development of the IMP. These documents should be retained 
for a longer period; however, if required by the applicable regulatory requirement(s) or by an 
agreement with UCB (Committee for Proprietary Medicinal Products [CPMP]/ICH/135/95, 2002 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 109 of 216 
[Section 4.9.5]). The Investigator will contact UCB for authorization prior to the destruction of 
any study records or in the event of accidental loss or destruction of any study records. The 
Investigator will also notify UCB should he/she relocate or move the study-related files to a 
location other than that specified in the Sponsor’s Trial Master File. 
13.6 
Audit and inspection 
The Investigator will permit study-related audits mandated by UCB, after reasonable notice, and 
inspections by domestic or foreign regulatory authorities. 
The main purposes of an audit or inspection are to confirm that the rights and well-being of the 
subjects enrolled have been protected, that enrolled subjects (ie, signing consent and undergoing 
study procedures) are appropriate for the study, and that all data relevant for the evaluation of the 
IMP have been processed and reported in compliance with the planned arrangements, the 
protocol, investigational site, and IRB/IEC SOPs, ICH-GCP, and applicable regulatory 
requirements. 
The Investigator will provide direct access to all study documents, source records, and source 
data. If an inspection by a regulatory authority is announced, the Investigator will immediately 
inform UCB (or designee). 
13.7 
Good Clinical Practice 
Noncompliance with the protocol, ICH-GCP, or local regulatory requirements by the 
Investigator, institution, institution staff, or designees of the Sponsor will lead to prompt action 
by UCB to secure compliance. Continued noncompliance may result in the termination of the 
site’s involvement in the study. 
14 
STATISTICS 
A description of statistical methods follows and will be described in more detail in the Statistical 
Analysis Plan (SAP). 
14.1 
Definition of analysis sets 
The Enrolled Set (ES) will consist of all subjects who have given informed consent for PS0014. 
The Safety Set (SS) will consist of all subjects who receive at least 1 dose of the IMP in PS0014. 
The Full Analysis Set (FAS) will consist of all enrolled subjects who receive at least 1 dose of 
the IMP and have a valid efficacy measurement for PASI at Baseline of the Feeder Study and 
Baseline of PS0014. 
The OLE2 Period Set (OL2S) will consist of all subjects that receive at least 1 dose of IMP at 
Week 144/OLE2 or later in the OLE2 Period (including the Week 144/OLE2 Baseline dose). 
The Pharmacokinetics Per-Protocol Set (PK-PPS) will consist of all enrolled subjects who 
receive at least 1 dose of the IMP and provide at least 1 quantifiable plasma concentration 
postdose without protocol deviations that would affect the concentration in PS0014. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 110 of 216 
14.2 
General statistical considerations 
Descriptive statistics will be used to provide an overview of the safety and efficacy results. For 
categorical parameters, the number and percentage of subjects in each category will be 
presented. The denominator for percentages will be based on the number of subjects appropriate 
for the purpose of analysis. For continuous parameters, descriptive statistics will include n, 
mean, SD, median, minimum, and maximum. No statistical hypothesis testing will be performed. 
Baseline values for safety and efficacy variables will be determined from Baseline values of the 
primary study. 
Further methods pertaining to the summary and analysis of the efficacy and safety data are 
presented in the following sections, and will be described in more detail in the SAP. 
14.3 
Planned safety analyses 
Safety variables will be analyzed for all subjects in the SS and selected summaries will be 
provided for subjects in the OLE2 period (OL2S). 
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities 
(MedDRA®). Treatment-emergent AEs will be defined as events that have a start date on or 
following the first administration of study treatment in PS0014 through the final administration 
of study treatment + 140 days (covering the 20-week SFU Period). Treatment-emergent AEs will 
be categorized to treatment group based on the dose being received at the time of onset of the 
event. Tables will include columns for bimekizumab 320mg Q4W, bimekizumab 320mg Q8W, 
and All bimekizumab (any dose of bimekizumab). 
For all safety analyses, change from Baseline variables will be defined relative to the Baseline 
entry measurement in PS0014. 
14.3.1 
Primary safety analysis 
All TEAEs will be summarized descriptively by treatment group, primary System Organ Class 
(SOC), high level term (HLT), and preferred term (PT). This summary will include the exposure 
adjusted incidence rate (EAIR) with associated 95% CI and the exposure adjusted event rate 
(EAER). 
For EAIR, the numerator will be the total number of subjects experiencing the AE. The 
denominator will be 100 subject-years; that is, the total summation of individual subject-years at 
risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at 
risk for those subjects not experiencing that AE, divided by 100. Exposure adjusted incidence 
rates will be presented with a 95% exact CI based upon the Chi-Square distribution (Ulm, 1990). 
For EAERs, the numerator will be the number of AEs including repeat occurrences in individual 
subjects; the denominator will be 100 subject-years. That is, the total summation of individual 
subject-years at risk divided by 100. No CI will be computed for EAER. 
Patient exposure at risk in days will be defined as date of last administration of study medication 
– date of first administration of study medication + 140 days (ie, the duration of the SFU Period). 
If a subject dies, patient exposure at risk is censored at the date of death. The sum of these 
exposure days at risk across subjects is converted to years for the EAIR and EAER calculations 
described above. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 111 of 216 
14.3.2 
Other safety analysis 
Additional tables will summarize TEAEs by intensity and relationship to study medication, 
TEAEs leading to withdrawal from the study, treatment-emergent SAEs, and deaths. In addition 
to summaries that characterize events that occur during PS0014, for TEAEs and SAEs, 
additional summaries will be produced summarizing feeder study and PS0014 combined, where 
treatment emergence and exposure at risk are relative to the first dose of study drug in the feeder 
study. In the case of a subject that switches study treatment when starting PS0014, exposure at 
risk to feeder study treatment will end the day prior to the first PS0014 dose.  
In order to evaluate if there is any difference in the TEAE profile of subjects who have dose 
adjustments, additional summaries will be generated. With respect to dose adjustments, for the 
Week 48 interim analysis, subjects will be classified into 1 of 2 groups: 
• Nonadjusters – This group consists of subjects who do not experience a dose adjustment 
prior to Week 48. 
• Adjusters – This group consists of subjects who experience a dose regimen adjustment at 
Week 24. This means that the subjects in this group had a dose adjustment from 320mg Q4W 
to 320mg Q8W at Week 24. 
For the full analysis, subjects will be categorized into those who did not experience a dose 
regimen adjustment during the study and those that experienced a dose regimen adjustment at 
any time. 
Summaries based on these groups will be done for the TEAE overview, incidence of TEAEs (by 
SOC, HLT, and PT), and incidence of treatment-emergent SAEs. 
Extent of exposure to study medication in PS0014 will be summarized using descriptive 
statistics. As with the primary summaries of TEAEs, extent of exposure will be presented with 
columns for bimekizumab 320mg Q4W, bimekizumab 320 Q8W, and All bimekizumab. 
Change from Baseline in laboratory values, ECGs, and vital signs will be presented using 
descriptive statistics by the treatment received in PS0014 and overall. 
Additional summaries to assess the safety of bimekizumab manufactured using Process 5 will be 
described further in the SAP. 
14.4 
Planned efficacy analyses 
Efficacy analyses will be summarized based on the FAS during the Treatment Period. The 
summaries described in this section will provide data on maintenance of effect of open-label 
bimekizumab over 144 weeks and beyond. Additionally, it will allow an assessment of the 
impact of dose adjustments on efficacy results. As these variables are summarized over time and 
the initial values can be impacted by the treatment in the feeder study, the presentation using a 
combination of feeder/extension study treatment groups is intended to provide perspective on the 
change in these values from the feeder study through the Treatment Period of PS0014. The table 
presentations will display descriptive statistics for the Baseline of the feeder study and the 
observed and change from Baseline study results by scheduled visit for PS0014. Selected 
efficacy summaries during the OLE2 Period may also be provided for selected efficacy variables. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 112 of 216 
Responder efficacy variables (PASI75, PASI90, PASI100, IGA, DLQI score of 0 or 1, 
mNAPSI75, mNAPSI90, mNAPSI100, pp-IGA and scalp IGA) will be summarized 
descriptively. The PASI responder variables are derived relative to the Baseline in the feeder 
study. 
Continuous efficacy variables based on the change from Baseline (PASI, DLQI, BSA affected by 
PSO, PGADA, SF-36, the EQ-5D-3L PCS, MCS and domain scores, WPAI-SHP, PGA of PSO, 
and PASE) will be summarized using descriptive statistics by scheduled visit. The table 
presentations will display descriptive statistics for the Baseline of the feeder study and the 
observed and change from Baseline results by scheduled visit for PS0014. Figures for selected 
variables will also be generated in order to demonstrate the kinetics of response over time. 
In addition to the summaries described above, the impact of dose regimen adjustment on efficacy 
will be considered. This will be done primarily by summarizing efficacy variables by the adjuster 
groups described above, for the Week 48 interim analysis and for the full analysis.  
14.5 
Pharmacokinetic analyses 
Pharmacokinetic variables will be analyzed for all subjects in the PK-PPS. 
Bimekizumab plasma concentrations will be summarized for each treatment group at each visit 
specified in Table 5-1 and Table 5-2. Treatment groups presented will be relative to the treatment 
received in PS0014. 
14.6 
Immunogenicity analyses 
Anti-bimekizumab antibodies (including positivity) will be summarized by treatment at each 
scheduled visit at which samples are collected. Treatment groups presented will be relative to 
both the treatment received in the feeder study, as well PS0014 treatment. 
14.7 
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 key 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. 
14.8 
Handling of dropouts or missing data 
For responder efficacy variables (PASI75, PASI90, PASI100, IGA, DLQI score of 0 or 1, 
mNAPSI75, mNAPSI90, mNAPSI100, pp-IGA and scalp IGA), missing data will be handled by 
nonresponder imputation, meaning that subjects that discontinue early or who have missing data 
at a given time point are imputed as though they did not achieve the given response. Supportive 
summaries will be based on observed case data. 
For continuous efficacy variables based on the change from Baseline (PASI, DLQI, BSA 
affected by PSO, PGADA, SF-36, the EQ-5D-3L PCS, MCS and domain scores, WPAI-SHP, 
PGA of PSO, and PASE), missing data will be handled by using multiple imputation via the 
Markov-Chain Monte Carlo method. Supportive summaries will be based on observed case data. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 113 of 216 
Additional methods of missing data imputation may be explored, and will be outlined in the 
SAP. 
14.9 
Planned interim analysis and data monitoring 
An interim analysis is planned at Week 48 and Week 144, details of which will be documented 
in the SAP. Additional interim analyses may be performed (details of which will be documented 
in the SAP). Corresponding interim Clinical Study Reports (CSRs) may be written. A final 
analysis and updated final CSR will be prepared once all data through the OLE2 Period and 
SFU2 Visit have been collected. 
14.10 
Determination of sample size 
As the primary objective of this study is to assess the long-term safety and tolerability of 
bimekizumab, the number of subjects anticipated is based on the number of subjects recruited 
into and completing the feeder studies and meeting the eligibility requirements for PS0014. 
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 Informed Consent form should be signed and personally 
dated by the subject, or his/her legal representative, and by the person who conducted the 
informed consent discussion (Investigator or designee). The subject or his/her legal 
representative must receive a copy of the signed and dated Informed Consent form. As part of 
the consent process, each subject must consent to direct access to his/her medical records for 
study-related monitoring, auditing, IRB/IEC review, and regulatory inspection. 
All subjects enrolling in the OLE2 Period will sign a new ICF.  
If the Informed Consent form 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 Informed Consent form 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 Informed Consent form. An eCRF 
must not be started, nor may any study specific procedure be performed for a given subject, 
without having obtained his/her written consent to participate in the study. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 114 of 216 
15.2 
Subject identification cards 
Upon signing the Informed Consent and Assent form (as applicable), the subject or legal 
representative 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, Informed 
Consent form, 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. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 115 of 216 
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 Baseline. 
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. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 116 of 216 
17 
REFERENCES 
Atkinson MJ, Sinha A, Hass SL, Colman SS, Kumar RN, Brod M, Rowland CR. Validation of a 
general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for 
Medication (TSQM), using a national panel study of chronic disease. Health Qual Life 
Outcomes. 2004;26;2:12. 
Augustin M, Glaeske G, Radtke MA, Christophers E, Reich K, Schäfer I. Epidemiology and 
comorbidity of psoriasis in children. Br J Dermatol. 2010;162:633-6. 
Bharmal M, Payne K, Atkinson MJ, Desrosiers MP, Morisky DE, Gemmen E. Validation of an 
abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among patients on 
antihypertensive medications. Health Qual Life Outcomes. 2009; 7:36. 
Christophers E, Barker JN, Griffiths CE, Daudén E, Milligan G, Molta C, et al. The risk of 
psoriatic arthritis remains constant following initial diagnosis of psoriasis among patients seen in 
European dermatology clinics. J Eur Acad Dermatol Venereol. 2010;24:548-54. 
CPMP/ICH/135/95 Note for guidance on Good Clinical Practice (EMEA) Jul 2002. 
Dowlatshahi EA, Wakkee M, Arends LR, Nijsten T. The prevalence and odds of depressive 
symptoms and clinical depression in psoriasis patients: a systematic review and meta-analysis. 
J Invest Dermatol. 2014;134:1542-51. 
Feldman SR. A quantitative definition of severe psoriasis for use in clinical trials. J Dermatolog 
Treat. 2004;15(1):27-9. 
Gelfand JM, Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB. Risk of myocardial 
infarction in patients with psoriasis. JAMA. 2006;296:1735-41. 
Gisondi P, Tessari G, Conti A, Piaserico S, Schianchi S, Peserico A, et al. Prevalence of 
metabolic syndrome in patients with psoriasis: a hospital-based case-control study. 
Br J Dermatol. 2007;157:68-73. 
Gottlieb AB. Psoriasis: Emerging therapeutic strategies. Nat Rev Drug Discov. 2005;4:19-34. 
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. 
Icen M, Crowson CS, McEvoy MT, Dann FJ, Gabriel SE, Maradit Kremers H. Trends in 
incidence of adult-onset psoriasis over three decades: a population-based study. 
J Am Acad Dermatol. 2009;60:394-401. 
Kimball AB, Yu AP, Signorovitch J, Xie J, Tsaneva M, Gupta SR, et al. The effects of 
adalimumab treatment and psoriasis severity on self-reported work productivity and activity 
impairment for patients with moderate to severe psoriasis. J Am Acad Dermatol. 
2012;66(2):e67-e75. 
Krueger G, Ellis CN. Psoriasis–recent advances in understanding its pathogenesis and treatment. 
J Am Acad Dermatol. 2005;53(1 Suppl 1):S94-100. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 117 of 216 
Krueger G, Koo J, Lebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on 
quality of Life. Results of a 1998 National Psoriasis Foundation patient-membership survey. 
Arch Dermatol. 2001;137:280-4. 
Kurd SK, Smith N, VanVoorhees A, Troxel AB, Badmaev V, Seykora JT, et al. Oral curcumin 
in the treatment of moderate to severe psoriasis vulgaris: a prospective clinical trial. 
J Am Acad Dermatol. 2008;58:625-31. 
Kurd SK, Gelfand JM. The prevalence of previously diagnosed and undiagnosed psoriasis in US 
adults: results from NHANES 2003-2004. J Am Acad Dermatol. 2009;60:218-24. 
Langley RG, Krueger GG, Griffiths CEM. Psoriasis: epidemiology, clinical features, and quality 
of life. Ann Rheum Dis. 2005;64(Suppl II):ii18–ii23. 
Maruish, ME (Ed.). User’s manual for the SF-36v2 Health Survey (3rd ed.). Lincoln, RI: 
QualityMetric Incorporated. 2011. 
Mukhtar R, Choi J, Koo JY. Quality of life issues in psoriasis. Dermatol Clin. 2004;22:389-95. 
Mundt JC, Greist JH, Gelenberg AJ, Katzelnick DJ, Jefferson JW, Modell JG. Feasibility and 
Validation of a Computer-Automated Columbia-Suicide severity Rating Scale Using Interactive 
Voice Response Technology. J Psychiatr Res. 2010;44(16):1224-8. 
Ortonne JP. Redefining clinical response in psoriasis: targeting the pathological basis of disease. 
J Drugs Dermatol. 2004;3:13-20. 
Parisi R, Symmons DP, Griffiths CE, Ashcroft DM, Identification and Management of Psoriasis 
and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: A 
systematic review of incidence and prevalence. J Invest Dermatol. 2013;133:377-385. 
Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, et al. The 
Columbia-Suicide Severity Rating Scale: Initial validity and internal consistency findings from 
three multisite studies with adolescents and adults. Am J Psychiatry. 2011;168(12):1266-77. 
Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United 
States. J Am Acad Dermatol. 2014;70:512-6. 
Raychaudhuri SP, Gross J. A comparative study of pediatric onset psoriasis with adult onset 
psoriasis. Pediatric Dermatology. 2000;17(3):174-78. 
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and 
activity impairment instrument. PharmacoEconomics. 1993;4(5):353-65. 
Ulm K. A simple method to calculate the confidence interval of a standardized mortality ratio. 
Am J Epidemiol. 1990;131(2):373-375. 
Valizadeh A, Khosravi A, Zadeh LJ, Parizad EG. Role of IL-25 in Immunity. J Clin Diagn Res. 
2015;9(4):OE01–OE04. 
Vender R, Lynde C, Ho V, Chau D, Poulin-Costello M. Work productivity and healthcare 
resource utilization outcomes for patients on etanercept for moderate-to-severe plaque psoriasis: 
Results from a 1-year, multicentre, open-label, single-arm study in a clinical setting. Appl Health 
Econ Health Policy. 2012:10(5):343-53. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 118 of 216 
Yeung H, Takeshita J, Mehta NN, Kimmel SE, Ogdie A, Margolis DJ, et al. Psoriasis severity 
and the prevalence of major medical comorbidity: a population-based study. JAMA Dermatol. 
2013;149:1173-9. 
 
18 
APPENDICES 
18.1 
Protocol Amendment 1 
Rationale for the amendment 
The protocol has been amended for the following reasons: 
• Extended the study duration for an additional 2 years. Changes include addition of a new 
schedule of assessments for years 2 and 3, and updates to Section 8, Study procedures by 
visit. 
• Modified the text in Section 7 to include guidance for allowing subjects the option to 
self-inject study drug at home after Week 48. 
• Modified guidance to the Investigator regarding changing a subject’s dosing interval from 
320mg Q4W to 320mg Q8W if PASI90 is achieved at Week 24, to clarify this is optional. 
Added a requirement that a subject’s dosing interval will change from 320mg Q4W to 320mg 
Q8W (default) if PASI90 is achieved at Week 48 unless, based on medical judgement, the 
Investigator decides differently. 
• Provided rationale (Section 5.8) why subjects who received bimekizumab 320mg Q4W, but 
did not achieve PASI90 in the feeder study, should continue receiving bimekizumab 320mg 
Q4W in PS0014 requested by the Medicines and Healthcare products Regulatory Agency).    
• Amended Inclusion Criterion #4 to add contraceptive measures according to the feeder 
studies PS0009 and PS0013 (requested by the Medicines and Healthcare products Regulatory 
Agency). 
• Amended Exclusion Criterion #3 to clarify that the Investigator will have the ultimate 
decision regarding whether a subject with an ongoing SAE, or a history of serious infections 
in the feeder study, can continue receiving bimekizumab in PS0014 (requested by the 
Medicines and Healthcare products Regulatory Agency). 
• Amended Exclusion Criterion #4 to clarify that subjects who have a positive or indeterminate 
IGRA test result in a feeder study are excluded from PS0014 unless they are appropriately 
evaluated and treated.  
• Updated the lists of efficacy, safety, and PK variables; added the Treatment Satisfaction 
Questionnaire for Medication (TSQM-9) to the study as an “other” efficacy variable; and 
updated the corresponding description of statistical methods in Section 14). 
• Changed the pregnancy testing assessment to urine pregnancy testing at all study visits. 
• Updated Section 9.2.1 (Evaluation of PDILI) for improved clarity. 
• Added plans for interim analyses at Week 24 and Week 48 (Section 14.9).  
• Updated study contact details for the clinical trial biostatistician. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 119 of 216 
Modifications and changes 
Global changes: 
The following changes were made throughout the protocol: 
• The duration of the open-label Treatment Period has been changed from 48 weeks to 
144 weeks throughout the document. 
• The maximum duration of the study has been changed from 64 weeks to 160 weeks 
throughout the document. 
• Cross references to the new schedule of assessments (Table 5-2) for the 2-year extension 
have been made throughout the document.  
• The list of abbreviations was updated accordingly. 
• Minor spelling, editorial, and formatting changes were made throughout the document. 
Specific changes: 
Change #1  
Clinical Trial Biostatistician 
Name: 
 
Address: 
UCB Biosciences, 8010 Arco Corporation Drive, Raleigh, NC 
27617 
Phone: 
Fax: 
Has been changed to: 
Clinical Trial Biostatistician 
Name: 
 
Address: 
UCB Biosciences, 8010 Arco Corporation Drive, Raleigh, NC 
27617 
Phone: 
Fax: 
Change #2 
Section 1 Summary, paragraph 3 
Approximately 1120 subjects are expected to enroll in PS0014. For each subject, the study will 
last a maximum of 64 weeks and will consist of a Treatment Period (48 weeks) and a Safety 
Follow-Up (SFU) Period (20 weeks after the final dose of investigational medicinal product 
[IMP]). 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 120 of 216 
Has been changed to: 
Approximately 1120 subjects are expected to enroll in PS0014. For each subject, the study will 
last a maximum of 64160 weeks and will consist of a Treatment Period (48144 weeks) and a 
Safety Follow-Up (SFU) Period (20 weeks after the final dose of investigational medicinal 
product [IMP]). 
And paragraph 5 
At the final study visit in the feeder studies, eligible subjects continuing into PS0014 will 
complete the final study visit assessments and any additional PS0014 Baseline assessments, and 
will then receive their first dose of open-label bimekizumab in PS0014. During the Treatment 
Period, all subjects will attend study visits at the study site Q4W for study assessments. 
Following completion or early withdrawal from the Treatment Period, subjects will return for a 
SFU Visit 20 weeks after their final dose of bimekizumab. 
Has been changed to: 
At the final study visit in the feeder studies, eligible subjects continuing into PS0014 will 
complete the final study visit assessments and any additional PS0014 Baseline assessments, and 
will then receive their first dose of open-label bimekizumab in PS0014. During Year 1 of the 
Treatment Period (Weeks 0 to 44), all subjects will attend study visits at the study site Q4W for 
study assessments and IMP will be administered in the clinic by subcutaneous (sc) injection. 
During Years 2 and 3 of the Treatment Period (Weeks 48 to 144), all subjects will attend 
study visits at the study site Q12W for study assessments and subjects may self-inject IMP 
at home.  
At Week 24, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
Investigator may change the subject’s dosing interval from 320mg Q4W to 320mg Q8W 
(optional). At Week 48, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is 
achieved, the subject’s dosing interval will change from 320mg Q4W to 320mg Q8W 
(default) unless, based on medical judgement, the investigator decides differently. 
Following completion or early withdrawal from the Treatment Period, subjects will return for a 
SFU Visit 20 weeks after their final dose of bimekizumab. 
Change #3 
Section 2.2.1.2 
Ongoing studies 
Four additional studies of bimekizumab for 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. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 121 of 216 
• PS0018 is a long-term extension study for eligible subjects from PS0016 to assess the safety, 
tolerability, and efficacy of bimekizumab. 
Has been changed to: 
Four Five additional studies of bimekizumab for 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. 
• PS0015 is a Phase 3b, double-blind, active comparator controlled, parallel group study 
to evaluate the efficacy and safety of bimekizumab compared with secukinumab in 
adult subjects with moderate to severe chronic PSO. 
Change #4 
Section 3.2 
Secondary objectives 
The secondary objectives of the study are to: 
• Assess the safety of maintenance therapy bimekizumab dose regimens administered over 
48 weeks as measured by SAEs and TEAEs leading to study withdrawal 
• Assess the efficacy of maintenance therapy bimekizumab dose regimens administered over 
48 weeks as measured by PASI90 (defined as a subject who achieves 90% reduction in the 
PASI score from the feeder study Baseline) and IGA response (Clear or Almost Clear with at 
least a 2 category improvement from Baseline on a 5-point scale) 
Has been changed to: 
The secondary objectives of the study are to: 
• Assess the safety of maintenance therapy bimekizumab dose regimens administered over 
48144 weeks as measured by SAEs and TEAEs leading to study withdrawal 
• Assess the efficacy of maintenance therapy bimekizumab dose regimens administered over 
48144 weeks as measured by PASI90 (defined as a subject who achieves 90% reduction in 
the PASI score from the feeder study Baseline) and IGA response (Clear or Almost Clear 
with at least a 2 category improvement from Baseline on a 5-point scale) 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 122 of 216 
Change #5 
Section 3.3 
 
Other objectives 
The first 2 bullets have been revised:  
• Assess the safety of maintenance therapy bimekizumab dose regimens administered over 
48144 weeks 
• Assess the efficacy of maintenance therapy bimekizumab dose regimens administered over 
48144 weeks 
And a new bullet has been added to the list: 
• Assess general health-related quality of life (QOL), including the change of skin-related 
QOL and treatment satisfaction 
Change #6 
Section 4.2.2 Secondary efficacy variables 
The secondary efficacy variables are: 
• PASI90 at Week 48 
• IGA response at Week 48 
Has been changed to: 
The secondary efficacy variables are: 
• PASI90 at Week 48144 
• IGA response at Week 48144 
Change #7 
Section 4.3.1 Other safety variables 
The following bullet has been added: 
• Change from Baseline in the Patient Health Questionnaire 9 (PHQ-9) 
Change #8 
Section 4.3.2 Other efficacy variables 
Change from Baseline efficacy variables will be defined relative to the Baseline measurement 
from the feeder study. The other efficacy variables are listed below: 
• PASI75, PASI90, and PASI100 response 
• IGA response 
• Absolute and percent change from Baseline in PASI score 
• Change from Baseline in IGA score 
• Absolute and percent change from Baseline in the product of IGA and BSA (IGAxBSA) 
• Change from Baseline in Dermatology Life Quality Index (DLQI) 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 123 of 216 
• Percentage of subjects achieving a DLQI total score of 0 or 1 
• Percentage of subjects achieving a minimal clinically important difference (improvement 
from Baseline of 4 or more) in the DLQI 
• Change from Baseline in the Patient Health Questionnaire 9 (PHQ-9) 
• Change from Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) score for 
subjects with nail disease at Baseline 
• Change from Baseline in the Patient’s Global Assessment of Disease Activity (PGADA) for 
the arthritis visual analog scale (VAS) for subjects with PsA at Baseline 
• Change from Baseline in Patient Global Assessment (PGA) of PSO score 
• Change from Baseline in the scalp IGA for subjects with scalp PSO at Baseline 
• Palmoplantar Investigator’s Global Assessment (pp-IGA) response (Clear or Almost Clear) 
for subjects with palmoplantar PSO 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, Mental Component Summary (MCS) score, and individual domains 
• Responses to Euro-Quality of Life 5-Dimensions, 3 levels (EQ-5D-3L) 
• Changes from Baseline in EQ-5D-3L VAS scores and all dimensions 
• Change from Baseline in Work Productivity and Activity Impairment Questionnaire-specific 
health problem (WPAI-SHP) V2.0 adapted to PSO scores 
Has been changed to: 
Change from Baseline efficacy variables will be defined relative to the Baseline measurement 
from the feeder study. The other efficacy variables are listed below: 
• PASI75, PASI90, and PASI100 response 
• Percentage of subjects with PASI ≤1, ≤2, ≤3 and ≤5 
• IGA response 
• Absolute and percent change from Baseline in PASI score 
• Change from Baseline in IGA score 
• Absolute and percent change from Baseline in the body surface area (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) 
• Percentage of subjects achieving a DLQI total score of 0 or 1 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 124 of 216 
• Percentage of subjects achieving a minimal clinically important difference (improvement 
from Baseline of 4 or more) in the DLQI 
• Change from Baseline in the Patient Health Questionnaire 9 (PHQ-9) 
• Change from Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) score for 
subjects with nail disease at Baseline 
• mNAPSI75, mNAPSI90 and mNAPSI100 response 
• Change from Baseline in the Patient’s Global Assessment of Disease Activity (PGADA) for 
the arthritis visual analog scale (VAS) for subjects with PsA at Baseline 
• Change from Baseline in Patient Global Assessment (PGA) of PSO score 
• Change from Baseline in the scalp IGA for subjects with scalp PSO at Baseline 
• Scalp-specific IGA (Scalp IGA) response (Clear or Almost Clear with at least 
2 category improvement relative to Baseline) for subjects with scalp PSO at Baseline 
• Palmoplantar Investigator’s Global Assessment (pp-IGA) response (Clear or Almost Clear 
with at least 2 category improvement relative to Baseline) for subjects with palmoplantar 
PSO at Baseline 
• 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, Mental Component Summary (MCS) score, and individual domains 
• Responses to Euro-Quality of Life 5-Dimensions, 3 levels (EQ-5D-3L) 
• Changes from Baseline in EQ-5D-3L VAS scores and all dimensions 
• Change from Baseline in Work Productivity and Activity Impairment Questionnaire-specific 
health problem (WPAI-SHP) V2.0 adapted to PSO scores 
• Treatment Satisfaction Questionnaire for Medication (TSQM-9) 
Change #9 
Section 4.3.3 Pharmacokinetic variables 
The PK variables are plasma concentrations of bimekizumab and population PK including: 
• Total body clearance (CL/F) 
• Apparent volume of distribution (V/F) 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 125 of 216 
Has been changed to: 
The PK variables are is plasma concentrations of bimekizumab. and population PK including: 
• Total body clearance (CL/F) 
• Apparent volume of distribution (V/F) 
Change #10 
Section 5.2 
Study periods 
PS0014 will include 2 periods, a Treatment Period (48 weeks) and a SFU Period (20 weeks after 
the final dose of IMP). 
Has been changed to: 
PS0014 will include 2 periods, a Treatment Period (48144 weeks) and a SFU Period (20 weeks 
after the final dose of IMP). 
Change #11 
Section 5.2.1 Treatment Period; paragraphs 2, 3, 4, and 5 
During the Treatment Period, all subjects will attend study visits at the study site Q4W for study 
assessments.  
At Week 24 only, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
Investigator may change the subject’s dosing interval from 320mg Q4W to 320mg Q8W. 
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). 
The assessments to be performed at each Treatment Period Visit are presented in Table 5-1. 
Has been changed to: 
During Year 1 of the Treatment Period (Weeks 0 to 44), all subjects will attend study visits at 
the study site Q4W for study assessments. During Years 2 and 3 of the Treatment Period 
(Weeks 48 to 144), all subjects will attend study visits at the study site Q12W for study 
assessments.   
At Week 24 only, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
Investigator may change the subject’s dosing interval from 320mg Q4W to 320mg Q8W 
(optional). At Week 48, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is 
achieved, the subject’s dosing interval will change from 320mg Q4W to 320mg Q8W 
(default) unless, based on medical judgement, the investigator decides differently. 
During Year 1 of the Treatment Period (Weeks 0 to 44), IMP 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). During Years 2 and 3 of the Treatment Period 
(Weeks 48 to 144), subjects may self-administer IMP at home (described in Section 7.2) at 
the time points specified in the schedule of assessments (Table 5-2).  
The assessments to be performed at each Treatment Period Visit are presented in Table 5-1 and 
Table 5-2. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 126 of 216 
Change #12 
Section 5.2.2 Safety Follow-Up; second sentence 
The assessments for the SFU are presented in Table 5-1. 
Has been changed to: 
The assessments for the SFU are presented in Table 5-1 Table 5-2. 
Change #13 
Section 5.3 
Study duration per subject; first sentence 
Eligible subjects will continue to receive open-label bimekizumab in PS0014 for up to 48 weeks 
or until the Sponsor decides to discontinue the study 
Has been changed to: 
Eligible subjects will continue to receive open-label bimekizumab in PS0014 for up to 
48144 weeks or until the Sponsor decides to discontinue the study.  
Change #14 
Section 5.6 
Schedule of study assessments 
The schedule of study assessments is presented in Table 5-1. At each visit, all study assessments 
should be performed prior to administration of IMP. 
Has been changed to: 
The schedule of study assessments for Year 1 (Weeks 0 to 44) is presented in Table 5-1. The 
schedule of study assessments for Years 2 and 3 (Weeks 48 to 144) is presented in 
Table 5-2. At each visit, all study assessments should be performed prior to administration of 
IMP. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 127 of 216 
Change #15 
Table 5 1: 
Schedule of study assessments 
Visit a/ 
Week 
Protocol activity 
Treatment Period 
 
 
Stable Dosing 
Flexible Dosing b 
W48/ 
PEOT 
SFU c 
Baseline/Feede
r Study Final 
Visit 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical exam d,e 
X 
 
 
X 
 
 
X 
 
 
 
 
 
X 
X 
Body weight 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Vital signs f 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
Hematology and chemistry 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
Urinalysis 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
Urine drug screen 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Pregnancy testing g 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
IGRA TB test h 
 
 
 
 
 
 
 
 
 
 
 
X 
 
TB questionnaire 
X 
 
 
X 
 
 
X 
 
 
X 
 
X 
X 
Blood sample for bimekizumab plasma concentrations i 
X 
 
 
 
X 
 
X 
 
 
 
X 
 
X 
X 
Blood sample for anti-bimekizumab antibodies i 
X 
 
 
 
X 
 
X 
 
 
 
X 
 
X 
X 
PASI  
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 
IGA  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
DLQI 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
PHQ-9 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 128 of 216 
Table 5 1: 
Schedule of study assessments 
Visit a/ 
Week 
Protocol activity 
Treatment Period 
 
 
Stable Dosing 
Flexible Dosing b 
W48/ 
PEOT 
SFU c 
Baseline/Feede
r Study Final 
Visit 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
 
 
eC-SSRS 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
mNAPSI j 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
Scalp IGA k 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
pp-IGA l 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
EQ-5D-3L 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
SF-36 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
PGA of PSO 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
PASEm 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
PGADAm 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
WPAI-SHP V2.0 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
Concomitant medication 
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 
IRT 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Bimekizumab administration n 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 129 of 216 
Table 5 1: 
Schedule of study assessments 
Visit a/ 
Week 
Protocol activity 
Treatment Period 
 
 
Stable Dosing 
Flexible Dosing b 
W48/ 
PEOT 
SFU c 
Baseline/Feede
r Study Final 
Visit 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
 
 
BSA=body surface area; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide Severity Rating Scale; EQ-5D-3L=Euro-
Quality of Life 5-Dimensions 3-level; IGA=Investigator’s Global Assessment; IGRA=interferon-gamma release assay; IMP=investigational medicinal product; 
IRT=interactive response technology; mNAPSI=modified Nail Psoriasis Severity Index; PASE=Psoriatic Arthritis Screening and Evaluation; PASI=Psoriasis Area Severity 
Index; PEOT=Premature End of Treatment; PGA=Patient Global Assessment; 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; PSO=psoriasis; Q4W=every 4 
weeks; Q8W=every 8 weeks; SFU=Safety Follow-Up; TB=tuberculosis; W=Week; WPAI-SHP=Work Productivity and Activity Impairment Questionnaire-specific health 
problem 
a Visit windows of ±7 days from the first dose at all visits except SFU. The Safety Follow-Up Visit window is ±7 days from final dose. 
b At Week 24 only, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the Investigator may change the subject’s dosing interval from 320mg Q4W to 
320mg Q8W. 
c The SFU Visit will occur 20 weeks after the final dose. 
d Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
e The physical examination will be performed as per Section 9.3.5. 
f Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable. 
g Pregnancy testing will consist of serum testing at Baseline and Week 48/PEOT. Urine pregnancy tests will be performed at all other visits. Pregnancy test results must be 
negative prior to administering IMP. 
h Ensure that an IGRA test was performed during the last dosing visit of the feeder study and the result was negative. 
i All blood samples taken prior to dosing. 
j The mNAPSI will be assessed only in subjects with nail involvement at Baseline in the feeder studies. 
k The scalp IGA will only be assessed for those subjects with scalp involvement (scalp IGA score >0) at Baseline in the feeder studies. 
l The pp-IGA will only be assessed in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline in the feeder studies. 
m The PGADA is assessed only for subjects with PsA at Baseline in the feeder studies. 
n The dosing window is ±7 days relative to the scheduled dosing visit. 
 
 
 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 130 of 216 
Has been changed to: 
Table 5 1: 
Schedule of study assessments – Year 1 (Weeks 0 to 44) 
Visit a/ 
Week 
Protocol activity 
Treatment Period-Year 1 
 
 
Stable Dosing 
Flexible Dosing b 
W48/ 
PEOT 
SFU c 
Baseline/Feede
r Study Final 
Visit 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical exam c,d 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Body weight 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Vital signs e 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
Hematology and chemistry 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
Urinalysis 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
Urine drug screen 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Pregnancy testing f 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
IGRA TB test g 
  
 
 
 
 
 
 
 
 
 
 
 
X 
 
TB questionnaire 
X 
 
 
X 
 
 
X 
 
 
X 
 
X 
X 
Blood sample for bimekizumab plasma concentrations h 
X 
 
 
 
X 
 
X 
 
 
 
X 
 
X 
X 
Blood sample for anti-bimekizumab antibodies h 
X 
 
 
 
X 
 
X 
 
 
 
X 
 
X 
X 
PASI  
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 
IGA  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
DLQI 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
PHQ-9 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 131 of 216 
Table 5 1: 
Schedule of study assessments – Year 1 (Weeks 0 to 44) 
Visit a/ 
Week 
Protocol activity 
Treatment Period-Year 1 
 
 
Stable Dosing 
Flexible Dosing b 
W48/ 
PEOT 
SFU c 
Baseline/Feede
r Study Final 
Visit 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
 
 
eC-SSRS 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
mNAPSI i 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
Scalp IGA j 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
pp-IGAk 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
EQ-5D-3L 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
SF-36 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
PGA of PSO 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
PASE l 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
PGADAl 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
WPAI-SHP V2.0 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
Concomitant medication 
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 
IRT 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Bimekizumab administrationm, n 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Subject training on self-injectiono 
 
 
 
 
 
 
 
 
 
 
X 
X 
 
 
BSA=body surface area; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide Severity Rating Scale; EQ-5D-3L=Euro-
Quality of Life 5-Dimensions 3-level; IGA=Investigator’s Global Assessment; IGRA=interferon-gamma release assay; IMP=investigational medicinal product; 
IRT=interactive response technology; mNAPSI=modified Nail Psoriasis Severity Index; PASE=Psoriatic Arthritis Screening and Evaluation; PASI=Psoriasis Area Severity 
Index; PEOT=Premature End of Treatment; PGA=Patient Global Assessment; 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; PSO=psoriasis; Q4W=every 4 
weeks; Q8W=every 8 weeks; SFU=Safety Follow-Up; TB=tuberculosis; W=Week; WPAI-SHP=Work Productivity and Activity Impairment Questionnaire-specific health 
problem 
a Visit windows of ±7 days from the first dose at all visits except SFU. The Safety Follow-Up Visit window is ±7 days from final dose. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 132 of 216 
Table 5 1: 
Schedule of study assessments – Year 1 (Weeks 0 to 44) 
Visit a/ 
Week 
Protocol activity 
Treatment Period-Year 1 
 
 
Stable Dosing 
Flexible Dosing b 
W48/ 
PEOT 
SFU c 
Baseline/Feede
r Study Final 
Visit 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
 
 
b At Week 24 only, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the Investigator may change the subject’s dosing interval from 320mg Q4W to 
320mg Q8W (optional). 
c The SFU Visit will occur 20 weeks after the final dose. 
c Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
d The physical examination will be performed as per Section 9.3.5. 
e Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable. 
f Urine pregnancy testing will be performed at all visits Pregnancy testing will consist of serum testing at Baseline and Week 48/PEOT. Urine pregnancy tests will be 
performed at all other visits. Pregnancy test results must be negative prior to administering IMP. 
g Ensure that results for the latest IGRA test performed in the feeder study are negative an IGRA test was performed during the last dosing visit of the feeder study and the 
result was negative. 
h All blood samples taken prior to dosing. 
i The mNAPSI will be assessed only in subjects with nail involvement at Baseline in the feeder studies. 
j The scalp IGA will only be assessed for those subjects with scalp involvement (scalp IGA score >0) at Baseline in the feeder studies. 
k The pp-IGA will only be assessed in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline in the feeder studies. 
l The PGADA and the PASE are assessed only for subjects with PsA at Baseline in the feeder studies. 
m The dosing window is ±7 days relative to the scheduled dosing visit.  
n Only subjects receiving IMP Q4W are dosed on Week s 4, 12, 20, 28, 36, and 44. 
o Subject training on self-injection to be performed as described in Section 7.2. 
 
 
 
 
 
 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 133 of 216 
Change #16 
A new schedule of assessments (Table 5-2) has been added for years 2 and 3. 
Table 5-2: 
Schedule of study assessments – Years 2 and 3 (Weeks 48 to 144) 
Visit a/ 
Week 
Protocol activity 
Treatment Period – Years 2 and 3 b 
 
 
48 
5
2 
H 
5
6 
H 
60 
6
4 
H 
6
8 
H 
72 
7
6 
H 
8
0 
H 
84 
8
8 
H 
9
2 
H 
96 
1
0
0 
H 
1
0
4 
H 
108 
1
1
2 
H 
1
1
6 
H 
120 
1
2
4 
H 
1
2
8 
H 
132 
1
3
6 
H 
1
4
0 
H 
W144 
/ 
PEOT 
SFUc 
Physical exam d,e 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Body weight 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Vital signs f 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Hematology and 
chemistry 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Urinalysis 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Urine pregnancy 
testing g 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
IGRA TB test 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
TB questionnaire 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Blood sample for 
bimekizumab plasma 
concentrations h 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
X 
X 
Blood sample for 
anti-bimekizumab 
antibodies h 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
X 
X 
PASI  
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Percentage of BSA 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
IGA  
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
DLQI 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
X 
 
 
X 
  
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 134 of 216 
Table 5-2: 
Schedule of study assessments – Years 2 and 3 (Weeks 48 to 144) 
Visit a/ 
Week 
Protocol activity 
Treatment Period – Years 2 and 3 b 
 
 
48 
5
2 
H 
5
6 
H 
60 
6
4 
H 
6
8 
H 
72 
7
6 
H 
8
0 
H 
84 
8
8 
H 
9
2 
H 
96 
1
0
0 
H 
1
0
4 
H 
108 
1
1
2 
H 
1
1
6 
H 
120 
1
2
4 
H 
1
2
8 
H 
132 
1
3
6 
H 
1
4
0 
H 
W144 
/ 
PEOT 
SFUc 
PHQ-9 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
eC-SSRS 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
mNAPSI i 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
Scalp IGA j 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
pp-IGA k 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
EQ-5D-3L 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
SF-36 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
PGA of PSO 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
PASEl 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
PGADAl 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
WPAI-SHP V2.0 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
TSQM-9 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Concomitant 
medication 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Adverse events 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
IRT 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Bimekizumab self-
injection m,n 
Xo 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
IMP accountability 
for self-injection at 
homep 
 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
BSA=body surface area; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide Severity Rating Scale; EQ-5D-3L=Euro-
Quality of Life 5-Dimensions 3-level; IGA=Investigator’s Global Assessment; H=home; IGRA=interferon-gamma release assay; IMP=investigational medicinal product; 
IRT=interactive response technology; mNAPSI=modified Nail Psoriasis Severity Index; PASE=Psoriatic Arthritis Screening and Evaluation; PASI=Psoriasis Area Severity 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 135 of 216 
Table 5-2: 
Schedule of study assessments – Years 2 and 3 (Weeks 48 to 144) 
Visit a/ 
Week 
Protocol activity 
Treatment Period – Years 2 and 3 b 
 
 
48 
5
2 
H 
5
6 
H 
60 
6
4 
H 
6
8 
H 
72 
7
6 
H 
8
0 
H 
84 
8
8 
H 
9
2 
H 
96 
1
0
0 
H 
1
0
4 
H 
108 
1
1
2 
H 
1
1
6 
H 
120 
1
2
4 
H 
1
2
8 
H 
132 
1
3
6 
H 
1
4
0 
H 
W144 
/ 
PEOT 
SFUc 
Index; PEOT=Premature End of Treatment; PGA=Patient Global Assessment; PGADA=Patient’s Global Assessment of Disease Activity; PHQ-9=Patient Health 
Questionnaire-9; pp-IGA=palmoplantar Investigator’s Global Assessment; PsA=psoriatic arthritis; PSO=psoriasis; Q4W=every 4 weeks; Q8W=every 8 weeks; SF-36=Short 
Form 36-item Health Survey; SFU=Safety Follow-Up; TB=tuberculosis; TSQM-9=Treatment Satisfaction Questionnaire for Medication; W=Week; WPAI-SHP=Work 
Productivity and Activity Impairment Questionnaire-specific health problem  
Note: Starting at Week 48 of the Treatment Period, subjects may self-inject IMP at home; self-injection training will be provided to the subject/caregivers by qualified site 
personnel (see Section 7.2). 
a Visit windows of ±7 days from the first dose at all visits except SFU. The Safety Follow-Up Visit window is ±7 days from final dose. 
b Starting at Week 48 of the Treatment Period, subjects will attend site visits every 12 weeks. 
c The SFU Visit will occur 20 weeks after the final dose. 
d Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
e The physical examination will be performed as per Section 9.3.5. 
f Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable. 
g Urine pregnancy testing will be performed at all visits. Pregnancy test results must be negative prior to administering IMP. 
h All blood samples taken prior to dosing. 
i The mNAPSI will be assessed only in subjects with nail involvement at Baseline in the feeder studies. 
j The scalp IGA will only be assessed for those subjects with scalp involvement (scalp IGA score >0) at Baseline in the feeder studies. 
k The pp-IGA will only be assessed in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline in the feeder studies. 
l The PGADA and the PASE are assessed only for subjects with PsA at Baseline in the feeder studies. 
m The dosing window is ±7 days relative to the scheduled dose. 
n The last dose for subjects receiving bimekizumab 320mg Q4W will be Week 140 and the last dose for subjects receiving bimekizumab 320mg Q8W will be Week 136. 
o At Week 48, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the subject’s dosing interval will change from 320mg Q4W to 320mg Q8W (default) 
unless, based on medical judgement, the investigator decides differently. 
p If self-injected at home, the subject/caregiver will document the date, body location, kit number and time point of administration of study medication. All used syringes will be 
disposed of by subjects/caregivers as determined by the Investigator in an acceptable disposal (sharps) container directly after the administration. The subjects/caregivers return 
the documentation together with any used/unused containers at the next scheduled clinic visit. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 136 of 216 
Change #17 
Figure 5‒1: Schematic diagram 
 
PASI= Psoriasis Area Severity Index; Q4W=every 4 weeks; Q8W=every 8 weeks  
Note: At Week 28 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. 
a Subjects on placebo after a Week 16 response (≥PASI90) on bimekizumab 320mg Q4W during the Initial Treatment Period of the feeder study may enroll in PS0014.  
b Subjects on bimekizumab 320mg Q4W who achieved a PASI50 at Week 12 in the escape arm of the feeder study may enroll in PS0014. 
c Subjects on ustekinumab or bimekizumab 320mg Q4W in feeder studies who achieved PASI90 will be randomized, respectively, 1:1 or 4:1 to bimekizumab 320mg Q4W or 
320mg Q8W. 
d At Week 24 only, if PASI90 is achieved, Investigator may change the dosing interval from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W.  
Dosing 
(All)
Dosing 
(Q4W)
Dosing 
(All)
Dosing 
(Q4W)
Dosing 
(Q4W)
Dosing 
(Q4W)
Dosing 
(Q4W)
Dosing 
(Q4W)
Dosing 
(All)
Dosing 
(All)
Dosing 
(All)
Dosing 
(All)
Bimekizumab 320mg Q8W 
<PASI90 
Bimekizuma
b 
b
Feeder Study Dose
Treatment Period (open-label)
Safety 
Follow up 
Visit 20 
weeks after
Bimekizumab 320mg Q4W 
<PASI90 
Placebo
a 
(Bimekizumab 
320mg Q4W Week 
16 → Placebo) 
Ustekinumab 
Bimekizuma
b
≥PASI90 
≥PASI90 
1:1 or  
4:1
c 
Baseline 
16 
Week 
4 
8 
12 
20 
24
d 
28 
32 
36 
40 
44 
48 
20 weeks  
after last  
dose
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 137 of 216 
Has been changed to: 
Figure 5‒1: Schematic diagram 
 
IMP=investigational medicinal product; PASI=Psoriasis Area Severity Index; Q4W=every 4 weeks; Q8W=every 8 weeks 
Note: Self-injection will be allowed from Week 48 onward. 
Note: At Week 28 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. 
a Subjects on placebo after a Week 16 response (≥PASI90) on bimekizumab 320mg Q4W during the Initial Treatment Period of the feeder study may enroll in PS0014.  
b Subjects on bimekizumab 320mg Q4W who achieved a PASI50 at Week 12 in the escape arm of the feeder study may enroll in PS0014. 
c Subjects on ustekinumab or bimekizumab 320mg Q4W in feeder studies who achieved PASI90 will be randomized, respectively, 1:1 or 4:1 to bimekizumab 320mg Q4W or 
320mg Q8W. 
d At Week 24 only, if PASI90 is achieved, Investigator may change the dosing interval from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W (optional).  
e At Week 48, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the subject’s dosing interval will change from 320mg Q4W to 320mg Q8W (default) 
unless, based on medical judgement, the investigator decides differently. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 138 of 216 
Change #18 
Section 5.8 
Rationale for study design and selection of dose 
PS0014 is an open-label study designed to assess the long-term safety, tolerability, and efficacy 
of bimekizumab over a 48-week Treatment Period. Doses used in this study are based on the 
dosing regimens (Q4W and Q8W) of the feeder studies, as well as the subjects’ PASI score upon 
entering the study, and can be adjusted at Week 24 only for subjects receiving bimekizumab 
320mg Q4W at the discretion of the Investigator. Subjects in the feeder studies who responded 
without biologic intervention are not eligible for PS0014. 
Has been changed to: 
PS0014 is an open-label study designed to assess the long-term safety, tolerability, and efficacy 
of bimekizumab over a 144 48-week Treatment Period. Doses used in this study are based on the 
dosing regimens (Q4W and Q8W) of the feeder studies, as well as the subjects’ PASI score upon 
entering the study. Subjects who do not achieve a PASI90 response in the feeder studies may 
be enrolled in PS0014 at the discretion of the Investigator. In the PS0011 study, a 
multicenter, 48-week, double-blind, placebo-controlled, parallel-group extension study to 
assess the long-term safety, tolerability, and efficacy of bimekizumab in adult subjects with 
moderate to severe chronic plaque PSO, 97% of subjects receiving 320mg Q4W were 
PASI90 responders at Week 52 (full analysis set, observed case). In addition, all subjects 
(100%) achieved a PASI75 response by Week 52. , and  
In PS0014, doses can be adjusted at Week 24 only for subjects receiving bimekizumab 320mg 
Q4W at the discretion of the Investigator (optional). At Week 48, for subjects receiving 
bimekizumab 320mg Q4W, if PASI90 is achieved, the subject’s dosing interval will change 
from 320mg Q4W to 320mg Q8W (default) unless, based on medical judgement, the 
investigator decides differently. 
Subjects in the feeder studies who responded without biologic intervention are not eligible for 
PS0014. 
Change #19 
Section 6.1 
Inclusion criteria 
4.  Female subjects of childbearing potential must continue to use an acceptable method of 
contraception (as detailed in the feeder study) for up to 20 weeks after the final dose of 
bimekizumab in PS0014. 
Has been changed to: 
4.  Female subjects must be:Female subjects of childbearing potential must continue to use 
an acceptable method of contraception (as detailed in the feeder study) for up to 
20 weeks after the final dose of bimekizumab in PS0014. 
− Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, 
for which there is no other obvious pathological or physiological cause. 
− Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 139 of 216 
− 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 the Baseline/Feeder study final visit in 
PS0014. The following methods are considered highly effective when used 
consistently and correctly:  
o Combined (estrogen and progestogen) hormonal contraception associated with 
inhibition of ovulation (oral, intravaginal, or transdermal) 
o Progestogen-only hormonal contraception associated with inhibition of ovulation 
(oral, injectable, implantable) 
o Intrauterine device  
o Intrauterine hormone-releasing system  
o Vasectomized partner 
o Abstinence as a form of birth control is generally not allowed in the study unless 
abstinence is in accordance with a subject’s preferred and common lifestyle. 
Study personnel must confirm the continued use of abstinence is still in 
accordance with the subject’s lifestyle at regular intervals during the study. 
Change #20 
Section 6.2 
Exclusion criteria; criterion 3  
3. Subject has any medical or psychiatric condition that, in the opinion of the Investigator, 
could jeopardize or would compromise the subject’s ability to participate in this study. 
Note: For any subject with an ongoing SAE, or a history of serious infections in the feeder 
study, the Medical Monitor must be consulted prior to the subject’s entry into PS0014. 
Has been changed to: 
3. Subject has any medical or psychiatric condition that, in the opinion of the Investigator, 
could jeopardize or would compromise the subject’s ability to participate in this study. 
Note: For any subject with an ongoing SAE, or a history of serious infections in the feeder 
study, the Medical Monitor must be consulted prior to the subject’s entry into PS0014, 
although the decision on whether to enroll the subject remains with the Investigator. 
And criterion 4: 
4.  Subject must have a negative interferon gamma release assay (IGRA) as measured at the 
final dosing visit of the feeder study.  
Has been changed to: 
4.  Subject must have a negative interferon gamma release assay (IGRA) as measured at the 
final dosing visit of the feeder study. Subject has a positive or indeterminate interferon 
gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and 
treated as per Section 9.3.1. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 140 of 216 
Change #21 
Section 6.3 
 
Withdrawal criteria; criterion 11, first sentence  
11. 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: 
Has been changed to: 
11. Subjects must be referred immediately to a mental health care professional (ie, locally 
licensed psychiatrist, psychologist, or master’s level therapist) and may be withdrawn 
from the study based upon the Investigator’s judgment of benefit/risk for: 
And criterion 12, first sentence 
12. Subjects must be referred immediately to a mental healthcare professional and must be 
withdrawn for: 
Has been changed to: 
12. Subjects must be referred immediately to a mental healthcare professional (ie, locally 
licensed psychiatrist, psychologist, or master’s level therapist) and must be withdrawn 
for: 
Change #22 
Section 6.3.1 Potential drug-induced liver injury IMP discontinuation criteria; 
paragraph 3, fist bullet: 
• 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%). 
Has been changed to: 
• 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 could include fever (without 
clear alternative cause), rash, or eosinophilia (ie, >5%) (without clear alternative cause). 
Change #23 
Section 7.1 
 
Description of IMP, paragraph 1 
The IMP used in this study is bimekizumab. Bimekizumab will be manufactured using 2 
manufacturing processes: Process 4 (Phase 3 clinical supply manufacturing process) and 
Process 5 (planned commercial manufacturing process). Bimekizumab will be supplied in a 1mL 
prefilled syringe at a concentration of 160mg/mL (55mM sodium acetate, 220mM glycine, 
0.04% polysorbate 80 at pH 5.0) for sc injection. 
Has been changed to: 
The IMP used in this study is bimekizumab. Bimekizumab will be manufactured using 2 
manufacturing processes: Process 4 (Phase 3 clinical supply manufacturing process) and 
Process 5 (planned commercial manufacturing process). Bimekizumab will be supplied in a 1mL 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 141 of 216 
prefilled syringe or a 1ml prefilled auto-injector (only in some countries) at a concentration of 
160mg/mL (55mM sodium acetate, 220mM glycine, 0.04% polysorbate 80 at pH 5.0) for sc 
injection. 
Change #24 
Section 7.2 
 
Treatments to be administered, paragraphs 5, 6, 7, 8, 9 
At Week 24 only, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
Investigator may change the subject’s dosing interval from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W. 
Has been changed to: 
At Week 24 only, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
Investigator may change the subject’s dosing interval from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W (optional).At Week 48, for subjects receiving bimekizumab 
320mg Q4W, if PASI90 is achieved, the subject’s dosing interval will change from 320mg 
Q4W to 320mg Q8W (default) unless, based on medical judgement, the investigator decides 
differently. 
After Week 48 and in between the scheduled study visits at the site, subjects will have the 
option to perform self-injection at home. All other injections will be administered 
preferably by self-injection during scheduled visits. Self-injection training will be provided 
to the subject/caregivers by qualified site personnel at Week 40 and Week 44. After Week 
48, the subject/caregiver will perform administration under the supervision of the site staff 
to ensure that study medication is being properly and safely injected.  
Once subjects/caregivers as determined by the Investigator (or designee) have been trained, 
the study medication may be administered at home. The subject will receive the required 
number of syringes for injections at each visit needed to perform the Q4W or Q8W 
administrations at home. Subjects who are unable to or decide not to self-inject IMP or 
those without a family member/friend/caregiver who can help, will not be discontinued, but 
may continue to visit the site for unscheduled visits for IMP administration only.  
If administered at home, the subject/caregiver will document the date, body location, kit 
number and time point of administration of study medication.  
All used syringes will be disposed of by subjects/caregivers as determined by the 
Investigator in an acceptable disposal (sharps) container directly after the administration. 
The subjects/caregivers return the documentation together with any used/unused 
containers at the next scheduled clinic visit.  
Change #25 
Section 7.5 
Handling and storage requirements 
The following paragraph has been added: 
In addition, the Investigator (or designee) will instruct the subject on how to handle the 
IMP during the transport and how to store the IMP following the instruction guide. Cooler 
bags with freezer packs will be provided to the subjects. Specific attention will be put on 
the transport from site to home using cold bags, and the subject will be instructed to put 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 142 of 216 
the IMP as quickly as possible into his/her refrigerator. In case of broken refrigerator, or 
broken or lost syringes, the subject will inform the site immediately and new IMP will be 
prepared. All efforts should be made to follow the treatment scheme as per protocol. 
Change #26 
Section 7.7 
Procedures for monitoring subject compliance 
During the Treatment Period of this study, the IMP will be administered in the clinic and 
compliance will be determined at the visit by study personnel. Drug accountability must be 
recorded on the Drug Accountability Form. 
Has been changed to: 
During Year 1 of the Treatment Period of this study, the IMP will be administered in the clinic 
and compliance will be determined at the visit by study personnel. Drug accountability must be 
recorded on the Drug Accountability Form. 
After Week 48, self-injection at home will be possible at the following weeks: Weeks 52,56, 
64, 68, 76, 80, 88, 92, 100, 104, 112, 116, 124, 128, 136, and 140. Dates, locations, kit 
numbers and time of self-injection will be captured using a home administration form. All 
used syringes will be disposed of by subjects/caregivers as determined by the Investigator 
in an acceptable disposal (sharps) container directly after the administration. The 
subjects/caregivers return the documentation together with any used/unused containers at 
the next scheduled clinic visit. Completed home administration forms should be reviewed 
by the Investigator.  
If a subject is noncompliant with the study procedures or medications that may present a 
risk to the safety of the subject in the opinion of the Investigator, then the subject should be 
withdrawn as described in Section 6.3. 
Change #27 
Section 7.8.1.2 
Other medications, paragraph 1 
Subjects may take pain relievers (acetaminophen/paracetamol, non-steroidal anti-inflammatory 
drugs, opiates) as needed for pain but not within 24 hours of the Baseline and Week 48 Visits. 
Intra-articular injections (eg, steroids, hyaluronic acid) are permitted and must be carefully 
recorded in the eCRF. 
Has been changed to: 
Subjects may take pain relievers (acetaminophen/paracetamol, non-steroidal anti-inflammatory 
drugs, opiates) as needed for pain but not within 24 hours of the Baseline and Week 48144 
Visits. Intra-articular injections (eg, steroids, hyaluronic acid) are permitted and must be 
carefully recorded in the eCRF. 
Change #28 
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. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 143 of 216 
Has been changed to: 
Table 5-1 (Schedule of study assessments) provides a general overview of study assessments in 
Year 1 (Weeks 0 to 44). Table 5-2 (Schedule of study assessments) provides a general 
overview of study assessments in Years 2 and 3 (Weeks 48 to 144). A list of procedures to be 
completed at each visit is described below. 
Change #29 
Section 8.1.1.1 
Baseline/Feeder Study Final Visit 
The following bullet: 
− Serum pregnancy test 
Has been changed to: 
− Serum Urine pregnancy test 
Change #30 
Section 8.1.1.2 
Week 4 Visit (±7 days relative to Baseline) 
The first bullet has been deleted from the list: 
• Physical exam 
Change #31 
Section 8.1.1.6 
Week 24 Visit (±7 days relative to Baseline); last paragraph 
At Week 24 only, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
Investigator may change the subject’s dosing interval from 320mg Q4W to 320mg Q8W. 
Has been changed to: 
At Week 24 only, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
Investigator may change the subject’s dosing interval from 320mg Q4W to 320mg Q8W 
(optional).  
Change #32 
Section 8.1.2.1 
Week 28 and Week 44 Visits (±7 days relative to Baseline) 
Has been changed to: 
Section 8.1.2.1 
Week 28 Visit and Week 44 Visits (±7 days relative to Baseline) 
Change #33 
Section 8.1.2.3 
 
Week 36 Visit (±7 days relative to Baseline) 
A new bullet has been added to the list: 
• Physical exam 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 144 of 216 
Change #34 
Section 8.1.2.4 
Week 40 Visit (±7 days relative to Baseline) 
A new paragraph has been added: 
Self-injection training will be provided to the subject/caregivers by qualified site personnel 
to allow self-injection to be performed at home after Week 48 (see Section 7-2). 
Change #35 
A new subsection has been added and subsequent subsections were renumbered 
accordingly: 
Section 8.1.2.5 
Week 44 Visit (±7 days relative to Baseline)   
The following procedures/assessments will be performed/recorded prior to administration 
of IMP: 
• PASI 
• Percentage of BSA 
• IGA 
• Urine pregnancy test 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration for 
subjects receiving Q4W dosing will occur. 
Self-injection training will be provided to the subject/caregivers by qualified site personnel 
to allow self-injection to be performed at home after Week 48 (see Section 7.2). 
Change #36 
Section 8.1.2.6 
Week 48 Visit (±7 days relative to Baseline)   
The following procedures/assessments will be performed/recorded: 
• Physical exam 
• Body weight 
• Vital signs (sitting SBP and DBP, 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 chemistry 
− Urinalysis 
− Serum pregnancy test 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 145 of 216 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies 
• ECG 
• IGRA TB test 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• DLQI 
• PHQ-9 
• eC-SSRS 
• mNAPSI for subjects with nail involvement at Baseline 
• Scalp IGA for subjects with scalp involvement at Baseline 
• pp-IGA for subjects with palmoplantar involvement at Baseline 
• EQ-5D-3L 
• SF-36 
• PGA of PSO 
• PASE 
• PGADA (only for subjects with PsA) 
• WPAI-SHP V2.0 
• Concomitant medication 
• AEs 
• Contact IRT 
Has been changed to: 
Section 8.1.2.6 
Week 48 Visit (±7 days relative to Baseline)   
At Week 48, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
subject’s dosing interval will change from 320mg Q4W to 320mg Q8W (default) unless, 
based on medical judgement, the investigator decides differently. 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
• Physical exam 
• Body weight 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 146 of 216 
• Vital signs (sitting SBP and DBP, 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 chemistry 
− Urinalysis 
− Serum Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies 
− IGRA TB test 
• ECG 
• IGRA TB test 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• DLQI 
• PHQ-9 
• eC-SSRS 
• mNAPSI for subjects with nail involvement at Baseline 
• Scalp IGA for subjects with scalp involvement at Baseline 
• pp-IGA for subjects with palmoplantar involvement at Baseline 
• EQ-5D-3L 
• SF-36 
• PGA of PSO 
• PASE 
• PGADA (only for subjects with PsA) 
• WPAI-SHP V2.0 
• TSQM-9 
• Concomitant medication 
• AEs 
• Contact IRT 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 147 of 216 
After completion of the above-mentioned procedures, subjects will be given the opportunity 
for self-injection of bimekizumab (see Section 7.2). 
Distribution of IMP and accountability activities for home administration to be performed 
as described in Section 7.2, Section 7.5, and Section 7.7. 
Change #37 
The following new subsections have been added: 
Section 8.1.2.7 
Self-injection at home injection (Weeks 52, 56, 64, 68, 76, 80, 88, 92, 100, 
104, 112, 116, 124, 128, 136 and 140) 
Subjects receiving bimekizumab 320mg Q4W will be given the opportunity for self-
injection of bimekizumab at home (described in Section 7.2) on the following weeks: Weeks 
52, 56, 64, 68, 76, 80, 88, 92, 100, 104, 112, 116, 124, 128, 136 and 140.   
Subjects receiving bimekizumab 320mg Q8W will be given the opportunity for self-
injection of bimekizumab at home (described in Section 7.2) on the following weeks: Weeks 
56, 64, 80, 88, 104, 112, 128, and 136.   
• Adverse events will be captured spontaneously if the subject decides to visit the site to 
receive the bimekizumab administration.  
• All used syringes will be disposed of by subjects/caregivers as determined by the 
Investigator in an acceptable disposal (sharps) container directly after the 
administration. The subjects/caregivers return the documentation together with any 
used/unused containers at the next scheduled clinic visit (Section 7.2). 
Section 8.1.2.8 
Week 60, Week 84, Week 108, and Week 132 Visit (±7 days relative to 
Baseline) 
The following procedures/assessments will be performed/recorded prior to administration 
of IMP: 
• Physical exam 
• Vital signs 
• Collection of blood and urine samples for the following clinical laboratory tests should 
be obtained prior to dosing: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• DLQI (Week 132 only) 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 148 of 216 
• PHQ-9 
• WPAI-SHP V2.0 (Week 132 only) 
• eC-SSRS 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration for 
subjects receiving Q4W dosing will occur, preferably by self-injection. 
Distribution of IMP and accountability activities for home administration to be performed 
as described in Section 7.2, Section 7.5, and Section 7.7. 
Section 8.1.2.9 
Week 72 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration 
of IMP: 
• Physical exam 
• Vital signs 
• Collection of blood and urine samples for the following clinical laboratory tests should 
be obtained prior to dosing: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• DLQI 
• PHQ-9 
• eC-SSRS 
• mNAPSI for subjects with nail involvement at Baseline 
• Scalp IGA for subjects with scalp involvement at Baseline 
• pp-IGA for subjects with palmoplantar involvement at Baseline 
• EQ-5D-3L 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 149 of 216 
• SF-36 
• PGA of PSO 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration for 
subjects receiving Q4Wor Q8W dosing will occur, preferably by self-injection. 
Distribution of IMP and accountability activities for home administration to be performed 
as described in Section 7.2, Section 7.5, and Section 7.7. 
Section 8.1.2.10 Week 96 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded: 
• Physical exam 
• Body weight 
• Vital signs (sitting SBP and DBP, 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 chemistry 
− Urinalysis 
− Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies  
− IGRA TB test 
• ECG 
• IGRA TB test 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• DLQI 
• PHQ-9 
• eC-SSRS 
• mNAPSI for subjects with nail involvement at Baseline 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 150 of 216 
• Scalp IGA for subjects with scalp involvement at Baseline 
• pp-IGA for subjects with palmoplantar involvement at Baseline 
• EQ-5D-3L 
• SF-36 
• PGA of PSO 
• PASE 
• PGADA (only for subjects with PsA) 
• WPAI-SHP V2.0 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration for 
subjects receiving Q4W dosing will occur, preferably by self-injection. 
Distribution of IMP and accountability activities for home administration to be performed 
as described in Section 7.2, Section 7.5, and Section 7.7. 
Section 8.1.2.11 Week 120 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded prior to administration 
of IMP: 
• Physical exam 
• Vital signs 
• Collection of blood and urine samples for the following clinical laboratory tests should 
be obtained prior to dosing: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• PHQ-9 
• eC-SSRS 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 151 of 216 
• mNAPSI for subjects with nail involvement at Baseline 
• Scalp IGA for subjects with scalp involvement at Baseline 
• pp-IGA for subjects with palmoplantar involvement at Baseline 
• EQ-5D-3L 
• SF-36 
• PGA of PSO 
• Concomitant medication 
• AEs 
• Contact IRT 
After completion of the above-mentioned procedures, bimekizumab administration for 
subjects receiving Q4W or Q8W dosing will occur, preferably by self-injection. 
Distribution of IMP and accountability activities for home administration to be performed 
as described in Section 7.2, Section 7.5, and Section 7.7. 
Section 8.1.2.12 Week 144 Visit (±7 days relative to Baseline) 
The following procedures/assessments will be performed/recorded: 
• Physical exam 
• Body weight 
• Vital signs (sitting SBP and DBP, 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 chemistry 
− Urinalysis 
− Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies  
− IGRA TB test 
• ECG 
• IGRA TB test 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 152 of 216 
• DLQI 
• PHQ-9 
• eC-SSRS 
• mNAPSI for subjects with nail involvement at Baseline 
• Scalp IGA for subjects with scalp involvement at Baseline 
• pp-IGA for subjects with palmoplantar involvement at Baseline 
• EQ-5D-3L 
• SF-36 
• PGA of PSO 
• PASE 
• PGADA (only for subjects with PsA) 
• WPAI-SHP V2.0 
• Concomitant medication 
• AEs 
• Contact IRT 
Return of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. 
Change #38 
Section 8.2 
 
Premature End of Treatment Visit; first bullet 
• The subject will be withdrawn from IMP, will undergo the same assessments as the Week 48 
visit (see Section 8.1.2.5), and will enter the SFU Period. 
Has been changed to: 
• The subject will be withdrawn from IMP, will undergo the same assessments as the 
Week 144 visit (see Section 8.1.2.5Section 8.1.2.12), and will enter the SFU Period. 
Change #39 
Section 8.3 
 
Safety Follow-Up Visit (20 weeks after final dose, ±7 days) 
All subjects, 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 
• Vital signs (sitting SBP and DBP, pulse rate, and body temperature) should be obtained prior 
to blood sampling 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 153 of 216 
• Collection of blood and urine samples for the following clinical laboratory tests: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies 
• TB questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• PHQ-9 
• eC-SSRS 
• Concomitant medication 
• AEs 
• Contact IRT 
Has been changed to: 
All subjects, 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 
• Body weight 
• Vital signs (sitting SBP and DBP, 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 chemistry 
− Urinalysis 
− Urine pregnancy test 
− Bimekizumab plasma concentrations 
− Anti-bimekizumab antibodies 
• TB questionnaire 
• PASI 
• Percentage of BSA 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 154 of 216 
• IGA 
• PHQ-9 
• eC-SSRS 
• Concomitant medication 
• AEs 
• Contact IRT 
Change #40 
Section 8.4 
 
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. 
Has been changed to: 
At the Investigator’s discretion, an Unscheduled Visit may be completed at any time during the 
study, but prior to the SFU Visit, if deemed necessary for the subject’s safety and well-being. 
If an Unscheduled Visit is conducted due to safety or efficacy reasons, an eC-SSRS assessment 
will be performed with the subject during the visit. If an Unscheduled Visit is conducted for 
reasons other than safety or efficacy concerns (eg, repeated collection of a laboratory specimen 
due to collection or analysis issues, injection for subjects not making use of home self-
injections), an eC-SSRS will not be required at these visits. 
At this visit, any assessment may be performed, as needed, depending on the reason for the visit. 
Change #41 
Table 9-2; the following has been removed from the table: 
Serum pregnancy testing 
And footnote c: 
 
Urine pregnancy testing will be performed at all visits consist of serum testing at Baseline 
and Week 48/PEOT Visit. Urine pregnancy tests will be performed at all other visits. 
Has been changed to: 
 
Urine pregnancy testing will be performed at all visits consist of serum testing at Baseline 
and Week 48/PEOT Visit. Urine pregnancy tests will be performed at all other visits. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 155 of 216 
Change #42 
Table 9 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 
9.2.1.2.1); 
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 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 156 of 216 
≥5xULN 
(and ≥2x 
baseline) 
and 
<8xULN  
<2xULN 
No 
Discussion with 
Medical Monitor 
required. 
Consider need for 
hepatology consult if 
there is no evidence of 
resolution (see Follow 
up requirements). c 
Further investigation 
– immediate IMP 
discontinuation not 
required (see Section 
9.2.1.2). 
 
IMP discontinuation 
required if any of the 
following occur: 
• 
Subject cannot 
comply with 
monitoring 
schedule. 
• 
Liver chemistry 
values continue 
to increase 
• 
Liver chemistry 
values remain 
≥5xULN (and 
≥2x Baseline) 
after 4 weeks of 
monitoring 
without evidence 
of resolution 
Essential: Every 
attempt must be 
made to have repeat 
liver chemistry 
values and 
additional testing 
completed within 
48 hours at the site 
with HCP (see 
Section 9.2.1.2.1). 
Monitoring of liver 
chemistry values at least 
twice per week for 
2 weeks.d 
• 
Immediate IMP 
discontinuation 
required if liver 
chemistry values 
continue to increase. 
After 2 weeks of 
monitoring liver 
chemistry values: 
• 
ALT or AST remains 
≥5xULN <8xULN, 
IMP should be 
temporarily withheld 
and subject should 
undergo repeat test in 
2 weeks. 
 
Continue IMP if ALT 
or AST values 
<5xULN; continue to 
monitor at least twice 
per week until values 
normalize, stabilize, 
or return to within 
Baseline values. 
If ALT or AST 
remains ≥5xULN 
after second re-test, 
immediate, 
permanent IMP 
discontinuation 
required. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 157 of 216 
Table 9 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 
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 9.2.1.1. 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. 
Has been changed to: 
Table 9-5:  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 
Immediate, 
permanent IMP 
discontinuation.e 
Essential: Must have 
repeat liver 
chemistry values 
and additional 
testing completed 
ASAP (see Section 
Monitoring of liver 
chemistry values at least 
twice per week until 
values normalize, 
≥3xULN 
NA 
Yes 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 158 of 216 
Table 9-5:  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 
Medical Monitor 
ASAP. 
9.2.1.2.1); 
recommended to 
occur at the site with 
HCP. 
stabilize, or return to 
within baseline values.d 
≥8xULN 
NA 
NA 
Hepatology consult. 
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 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 159 of 216 
≥5xULN 
(and ≥2x 
baseline) 
and 
<8xULN  
<2xULN 
No 
Discussion with 
Medical Monitor 
required. 
Consider need for 
hepatology consult if 
there is no evidence of 
resolution (see Follow 
up requirements). c 
Further investigation 
– immediate IMP 
discontinuation not 
required (see Section 
9.2.1.2). 
 
IMP discontinuation 
required if any of the 
following occur: 
• 
Subject cannot 
comply with 
monitoring 
schedule. 
• 
Liver chemistry 
values continue 
to increase 
• 
Liver chemistry 
values remain 
≥5xULN (and 
≥2x Baseline) 
after 4 weeks of 
monitoring 
without evidence 
of resolution 
Essential: Every 
attempt must be 
made to have repeat 
liver chemistry 
values and 
additional testing 
completed within 
48 hours at the site 
with HCP (see 
Section 9.2.1.2.1). 
Monitoring of liver 
chemistry values at least 
twice per week for 
2 weeks.d 
• 
Immediate IMP 
discontinuation 
required if liver 
chemistry values 
continue to increase. 
After 2 weeks of 
monitoring liver 
chemistry values: 
• 
ALT or AST remains 
≥5xULN <8xULN, 
IMP should be 
temporarily withheld 
and subject should 
undergo repeat test in 
2 weeks. 
 
Continue IMP if ALT 
or AST values 
<5xULN; continue to 
monitor at least twice 
per week until values 
normalize, stabilize, 
or return to within 
Baseline values. 
If ALT or AST 
remains ≥5xULN 
after second re-test, 
immediate, 
permanent IMP 
discontinuation 
required. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 160 of 216 
Table 9-5:  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 
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 9.2.1.1. The local hepatologist is the expert usually consulted by the treating physician for assessment and management of potential 
hepatic disease. This would usually be a hepatologist, but may be a gastroenterologist. 
d Unless an alternative monitoring schedule is agreed by the Investigator and UCB responsible physician. Determination of stabilization is at the discretion of the 
Investigator in consultation with the hepatologist (as applicable) and UCB responsible physician, as needed.  
e  Details provided in Section 9.2.1.2.1. 
 
 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 161 of 216 
Change #43 
Section 9.2.1.2.1 Investigational medicinal product restart/rechallenge 
Rechallenge with IMP can occur only if ALL of the following requirements are met: 
• The results of additional testing and monitoring described Section 9.2.1.3 and Section 9.2.1.4 
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, Data Monitoring Committee 
(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. 
Has been changed to: 
Subjects who are immediately discontinued from IMP due to having met certain criteria 
for PDILI (as described in Section 6.3.1 and Table 9-3), but for whom an alternative 
diagnosis is confirmed, ie, drug-induced liver injury is excluded, can rarely restart IMP. 
Rechallenge with IMP can occur only if ALL of the following requirements are met at the time 
of the rechallenge: 
• The results of additional testing and monitoring described Section 9.2.1.3and Section 
9.2.1.4confirm 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, Data Monitoring Committee 
(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. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 162 of 216 
Change #44 
Section 9.3.1.2 
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 “Has the subject been in close contact with an 
individual with active TB, or an individual who has recently been treated for TB?” at Baseline is 
excluded (see Exclusion Criterion #4, Section 6.2). A “Yes” response to any of the other 
questions within the questionnaire at Baseline should trigger further careful assessment to 
determine if subject has LTBI or active TB. A “Yes” response to any of the questions during the 
study should trigger further assessments to determine if the subject has either LTBI or active 
TB infection. 
Has been changed to: 
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 and Table 5-2. 
The questionnaire will assist with the identification of subjects who may require therapy for TB. 
A subject who answers “Yes” to the question “Has the subject been in close contact with an 
individual with active TB, or an individual who has recently been treated for TB?” at Baseline is 
excluded (see Criterion #4, Section 6.2). A “Yes” response to any of the other questions within 
the questionnaire at Baseline should trigger further careful assessment to determine if subject has 
LTBI or active TB. A “Yes” response to any of the questions during the study should trigger 
further assessments to determine if the subject has either LTBI or active TB infection. 
Change #45 
Section 9.3.2 Pregnancy testing 
Pregnancy testing will consist of serum testing at Baseline and Week 48/PEOT, and urine 
pregnancy testing at all other visits as specified in Table 5-1. 
The Baseline Visit serum pregnancy testing results must be negative, and received and reviewed 
prior to administration of IMP. A negative urine pregnancy test result must 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. 
Has been changed to: 
Urine pregnancy testing will be performed at all visits Pregnancy testing will consist of serum 
testing at Baseline and Week 48/PEOT, and urine pregnancy testing at all other visits as 
specified in Table 5-1 and Table 5-2. 
The Baseline Visit serum pregnancy testing results must be negative, and received and reviewed 
prior to administration of IMP. A negative urine pregnancy test result must be obtained 
immediately prior to each administration of IMP at the visits specified in Table 5-1 and 
Table 5-2. Pregnancy tests should be administered to all female subjects of childbearing 
potential, regardless of their use of birth control. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 163 of 216 
Change #46 
Section 9.3.6 Body weight 
Body weight will be measured at Baseline and at the Week 48/PEOT Visit. 
Has been changed to: 
Body weight will be measured at Baseline and at the Week 48/PEOT Visit at the visits specified 
in Table 5-1 and Table 5-2. 
Change #47 
Section 9.3.8 Patient Health Questionnaire 9 
A new subsection has been added (moved from Section 10.4): 
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 to 9 is considered to be minimal 
symptoms of depression. A score of 10 to 14 is considered minor depression, dysthymia, or 
mild major depression. A score of 15 to 19 is considered to indicate moderately severe 
major depression, and a score ≥20 is considered to be severe major depression. 
The PHQ-9 will be assessed at the visits specified in Table 5-1 and Table 5-2. 
Refer to Section 6.3 for PHQ-9-related withdrawal criteria. 
Change #48 
Section 10.4 Patient Health Questionnaire 9 
This subsection has been moved to Section 9.3.8 
Change #49 
Section 10.11 Psoriatic Arthritis Screening and Evaluation questionnaire 
The last sentence of the first paragraph has been deleted: 
Subjects with scores ≥47 should be referred to a rheumatologist for evaluation. 
Change #50 
Section 10.14 Treatment Satisfaction Questionnaire for Medication (TSQM-9) 
A new subsection has been added: 
The TSQM-9 (Bharmal et al, 2009) is a 9-item measure developed to provide a suitable measure 
of treatment satisfaction with medication. It has 5 to 7 Likert response options per item and 
consists of 3 subscales: effectiveness (3 items), convenience (3 items), and a global satisfaction 
scale (3 items). The TSQM-9 was developed from the TSQM 1.4 (Atkinson et al, 2004) which 
has an additional subscale which measures side effects (3 items). The estimated completion time 
for this measure is less than 5 minutes. Scores range from 0 (worst) to 100 (best).  
The TSQM will be performed at Week 48. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 164 of 216 
Change #51 
Section 
14.1 
Definition of analysis sets, paragraph 4 
The Pharmacokinetics Per-Protocol Set (PK-PPS) will consist of all enrolled subjects who 
receive at least 1 dose of the IMP and provide at least 1 quantifiable plasma concentration 
postdose in PS0014. 
Has been changed to: 
The Pharmacokinetics Per-Protocol Set (PK-PPS) will consist of all enrolled subjects who 
receive at least 1 dose of the IMP and provide at least 1 quantifiable plasma concentration 
postdose without protocol deviations that would affect the concentration in PS0014. 
Change #52 
Section 
14.3.2 Other safety analyses; paragraph 2, second bullet: 
• Adjusters – This group consists of subjects who experience a dose regimen adjustment at 
Week 24 only during the study. This means that the subjects in this group had a dose 
adjustment from 320mg Q4W to 320mg Q8W at Week 24. 
Has been changed to: 
• Adjusters – This group consists of subjects who experience a dose regimen adjustment at 
Week 24 or Week 48 only during the study. This means that the subjects in this group had a 
dose adjustment from 320mg Q4W to 320mg Q8W at Week 24 or Week 48. 
Change #53 
Section 14.4 Planned efficacy analyses 
Efficacy analyses will be summarized based on the FAS. The summaries described in this 
section will provide data on maintenance of effect of open-label bimekizumab over 48 weeks and 
beyond. Additionally, it will allow an assessment of the impact of dose adjustments on efficacy 
results. As these variables are summarized over time and the initial values can be impacted by 
the treatment in the feeder study, the presentation by the randomized treatment group (feeder 
study) is intended to provide perspective on the change in these values starting with the initial 
study randomization (feeder study) through the Treatment Period of PS0014. The table 
presentations will display descriptive statistics for the Baseline of the feeder study and the 
observed and change from Baseline study results by scheduled visit for PS0014.  
Responder efficacy variables (PASI75, PASI90, PASI100, IGA, DLQI score of 0 or 1, mNAPSI, 
and scalp IGA) will be summarized descriptively in the feeder study and overall. The PASI 
responder variables are derived relative to the Baseline in the feeder study. 
Continuous efficacy variables based on the change from Baseline (PASI, DLQI, PHQ-9, 
PGADA, SF-36, the EQ-5D-3L PCS, MCS and domain scores, WPAI-SHP, PGA of PSO, and 
PASE) will be summarized using descriptive statistics by scheduled visit and the randomized 
treatment group in the feeder study and overall. The table presentations will display descriptive 
statistics for the Baseline of the feeder study and the observed and change from Baseline results 
by scheduled visit for PS0014. Figures for selected variables will also be generated in order to 
demonstrate the kinetics of response over time. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 165 of 216 
In addition to the summaries described above, the impact of dose regimen adjustment on efficacy 
will be considered. This will be done primarily by summarizing efficacy variables by the 
2 adjuster groups described above. Furthermore, a supportive analysis specifically for dose 
adjusters will be performed in which PASI score will be summarized by visit, where Baseline is 
recalibrated for each individual subject and defined as the visit where the bimekizumab 320mg 
Q8W is initiated. The visits summarized will be in weeks relative to when the dosing regimen is 
decreased to Q8W, as opposed to the scheduled week of the PS0014 assessment. These 
summaries will be based on observed case only. 
Has been changed to: 
Efficacy analyses will be summarized based on the FAS. The summaries described in this 
section will provide data on maintenance of effect of open-label bimekizumab over 48144 weeks 
and beyond. Additionally, it will allow an assessment of the impact of dose adjustments on 
efficacy results. As these variables are summarized over time and the initial values can be 
impacted by the treatment in the feeder study, the presentation using a combination of 
feeder/extension study treatment groups by the randomized treatment group (feeder study) is 
intended to provide perspective on the change in these values from the feeder study starting 
with the initial study randomization (feeder study) through the Treatment Period of PS0014. The 
table presentations will display descriptive statistics for the Baseline of the feeder study and the 
observed and change from Baseline study results by scheduled visit for PS0014.  
Responder efficacy variables (PASI75, PASI90, PASI100, IGA, DLQI score of 0 or 1, mNAPSI 
mNAPSI75, mNAPSI90, mNAPSI100, pp-IGA and scalp IGA) will be summarized 
descriptively in the feeder study and overall. The PASI responder variables are derived relative 
to the Baseline in the feeder study. 
Continuous efficacy variables based on the change from Baseline (PASI, DLQI, BSA affected by 
PSO, PHQ-9, PGADA, SF-36, the EQ-5D-3L PCS, MCS and domain scores, WPAI-SHP, PGA 
of PSO, and PASE) will be summarized using descriptive statistics by scheduled visit and the 
randomized treatment group in the feeder study and overall. The table presentations will display 
descriptive statistics for the Baseline of the feeder study and the observed and change from 
Baseline results by scheduled visit for PS0014. Figures for selected variables will also be 
generated in order to demonstrate the kinetics of response over time. 
In addition to the summaries described above, the impact of dose regimen adjustment on efficacy 
will be considered. This will be done primarily by summarizing efficacy variables by the 
2 adjuster groups described above. Furthermore, a supportive analysis specifically for dose 
adjusters will be performed in which PASI score will be summarized by visit, where Baseline is 
recalibrated for each individual subject and defined as the visit where the bimekizumab 320mg 
Q8W is initiated. The visits summarized will be in weeks relative to when the dosing regimen is 
decreased to Q8W, as opposed to the scheduled week of the PS0014 assessment. These 
summaries will be based on observed case only. 
Change #54 
Section 14.8 Handling of dropouts or missing data; paragraph 1 and 2 
For responder efficacy variables (PASI75, PASI90, PASI100, IGA, DLQI score of 0 or 1, 
mNAPSI, and scalp IGA), missing data will be handled by nonresponder imputation, meaning 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 166 of 216 
that subjects that discontinue early or who have missing data at a given time point are imputed as 
though they did not achieve the given response. Supportive summaries will be based on observed 
case data. 
For continuous efficacy variables based on the change from Baseline (PASI, DLQI, PHQ-9, 
PGADA, SF-36, the EQ-5D-3L PCS, MCS and domain scores, WPAI-SHP, PGA of PSO, and 
PASE), missing data will be handled by using multiple imputation via the Markov-Chain Monte 
Carlo method. Supportive summaries will be based on observed case data. 
Has been changed to: 
For responder efficacy variables (PASI75, PASI90, PASI100, IGA, DLQI score of 0 or 1, 
mNAPSImNAPSI75, mNAPSI90, mNAPSI100, pp-IGA and scalp IGA), missing data will be 
handled by nonresponder imputation, meaning that subjects that discontinue early or who have 
missing data at a given time point are imputed as though they did not achieve the given response. 
Supportive summaries will be based on observed case data. 
For continuous efficacy variables based on the change from Baseline (PASI, DLQI, BSA 
affected by PSO, PHQ-9, PGADA, SF-36, the EQ-5D-3L PCS, MCS and domain scores, 
WPAI-SHP, PGA of PSO, and PASE), missing data will be handled by using multiple 
imputation via the Markov-Chain Monte Carlo method. Supportive summaries will be based on 
observed case data. 
Change #55 
Section 14.9 Planned interim analysis and data monitoring 
After the final Week 48 visit, an interim analysis may 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 SFU visit) have been collected.  
Has been changed to: 
Interim analyses are planned at Week 24 and Week 48, details of which will be documented 
in the SAP. After the final Week 48144 visit, an interim analysis may 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 SFU visit) have been collected.  
Change #56 
Section 17  
References 
The following references were added: 
Atkinson MJ, Sinha A, Hass SL, Colman SS, Kumar RN, Brod M, Rowland CR. Validation 
of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 167 of 216 
for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life 
Outcomes. 2004;26;2:12. 
Bharmal M, Payne K, Atkinson MJ, Desrosiers MP, Morisky DE, Gemmen E. Validation 
of an abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among 
patients on antihypertensive medications. Health Qual Life Outcomes. 2009; 7:36. 
18.2 
Protocol Amendment 2 
Rationale for the amendment 
Change the dose regimen at Week 48 (or at the next scheduled clinic visit after implementation 
of Protocol Amendment #3 if the subject has already completed the Week 48 visit) from 
bimekizumab 320mg Q4W to bimekizumab 320mg Q8W, based on pooled data from the Phase 3 
studies (PS0008, PS0009, and PS0013), which demonstrated that during the maintenance period 
bimekizumab 320mg Q8W provided essentially the same efficacy as bimekizumab 320mg Q4W. 
Correct the omission of Canada from the list of countries where the PS0014 substudy evaluating 
the safe and effective use of self-injecting device presentations will be conducted. Correction of 
this error ensures consistency with the substudy protocol (DV0002). 
Added provision for collecting a concurrent sample for central laboratory testing if laboratory 
tests are performed locally. 
Align text pertaining to secondary efficacy variables, other safety variables, other efficacy 
variables, and statistical analyses with SAP. 
Change the sponsor company name from “UCB Biopharma SPRL” to “UCB Biopharma SRL” 
since the name of the legal form of the entity UCB Biopharma has changed into “société à 
responsabilité limitée” abbreviated “SRL.” 
In addition, minor corrections, including typographical/grammatical errors, have been made. 
Modifications and changes 
Global changes 
No global changes have been made. 
Specific changes 
Change #1 
Sponsor name on the title page and in the study contact information 
Sponsor 
UCB Biopharma SPRL 
Allée de la Recherche 60 
1070 Brussels 
BELGIUM 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 168 of 216 
Has been changed to: 
Sponsor 
UCB Biopharma SRL 
Allée de la Recherche 60 
1070 Brussels 
BELGIUM 
 
Change #2 
Section 1, Summary; Section 5.2.1, Treatment Period; and Section 7.2, Treatments to be 
administered 
At Week 48, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
subject’s dosing interval will change from 320mg Q4W to 320mg Q8W (default) unless, based 
on medical judgement, the investigator decides differently. 
Has been changed to: 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 48 or at the next scheduled clinic visit after 
implementation of Protocol Amendment #2 if the subject has already completed the 
Week 48 visit. 
Change #3 
Section 1, Summary, and Section 5.1, Study description, paragraph 3 
In addition, subjects may consent to participate in a PS0014 sub-study designed to evaluate the 
safe and effective use of self-injecting device presentations (ie, prefilled safety syringe and auto-
injector presentations) for sc self‑injection of bimekizumab by subjects in select sites in Europe, 
Japan, and the US. 
Has been changed to: 
In addition, subjects may consent to participate in a PS0014 sub-study designed to evaluate the 
safe and effective use of self-injecting device presentations (ie, prefilled safety syringe and auto-
injector presentations) for sc self‑injection of bimekizumab by subjects in select sites in Europe, 
Japan, Canada, and the US. 
Change #4 
Section 4.2.2, Secondary efficacy variables 
• IGA response at Week 144 
Has been changed to: 
• IGA 0/1 response at Week 144 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 169 of 216 
Change #5 
Section 4.3.1, other safety variables 
• Change from Baseline in clinical laboratory variables (chemistry, hematology, and 
urinalysis) 
Has been changed to: 
• Change from Baseline in clinical laboratory variables (chemistry and hematology)  
 
Change #6 
Section 4.3.2, other efficacy variables 
• Percentage of subjects with PASI ≤1, ≤2, ≤3 and ≤5 
• IGA response 
• Absolute and percent change from Baseline in PASI score 
• Change from Baseline in IGA score 
• Absolute and percent change from Baseline in the BSA affected by PSO 
Has been changed to: 
• Percentage of subjects with PASI ≤1, ≤2, ≤3 and ≤5 
• IGA response (Clear or Almost Clear with at least 2 category improvement relative to 
Baseline) 
• IGA response (Clear with at least 2 category improvement relative to Baseline) 
• Absolute and percent change from Baseline in PASI score 
• Absolute and percent change from Baseline in the BSA affected by PSO 
 
Change #7 
Section 5.6, schedule of study assessments 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 170 of 216 
Table 5-1: 
Schedule of study assessments – Year 1 (Weeks 0 to 44) 
Visit a/ 
Week 
Protocol activity 
Treatment Period-Year 1 
Stable Dosing 
Flexible Dosing b 
Baseline/Feeder 
Study Final  
Visit 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
Bimekizumab administrationm, n 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
n Only subjects receiving IMP Q4W are dosed on Week s 4, 12, 20, 28, 36, and 44. 
 
 
Table 5-2: 
Schedule of study assessments – Years 2 and 3 (Weeks 48 to 144) 
Visit a/ 
Week 
Protocol activity 
Treatment Period – Years 2 and 3 b 
 
 
48 
5
2 
H 
5
6 
H 
60 
6
4 
H 
6
8 
H 
72 
7
6 
H 
8
0 
H 
84 
8
8 
H 
9
2 
H 
96 
1
0
0 
H 
1
0
4 
H 
108 
1
1
2 
H 
1
1
6 
H 
120 
1
2
4 
H 
1
2
8 
H 
132 
1
3
6 
H 
1
4
0 
H 
W144 
/ 
PEOT 
SFUc 
DLQI 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
X 
 
 
X 
  
Bimekizumab self-
injection m,n 
Xo 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
n The last dose for subjects receiving bimekizumab 320mg Q4W will be Week 140 and the last dose for subjects receiving bimekizumab 320mg Q8W will be Week 136. 
o At Week 48, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the subject’s dosing interval will change from 320mg Q4W to 320mg Q8W (default) 
unless, based on medical judgement, the investigator decides differently. 
p If self-injected at home, the subject/caregiver will document the date, body location, kit number and time point of administration of study medication. All used syringes will be 
disposed of by subjects/caregivers as determined by the Investigator in an acceptable disposal (sharps) container directly after the administration. The subjects/caregivers 
return the documentation together with any used/unused containers at the next scheduled clinic visit. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 171 of 216 
Has been changed to: 
Table 5-1: 
Schedule of study assessments – Year 1 (Weeks 0 to 44) 
Visit a/ 
Week 
Protocol activity 
Treatment Period-Year 1 
Stable Dosing 
Flexible Dosing b 
Baseline/Feeder 
Study Final  
Visit 
4 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
Bimekizumab administration Q4Wm, n 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Bimekizumab administration Q8Wm, n 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
n Only subjects receiving IMP Q4W are dosed on Weeks 4, 12, 20, 28, 36, and 44. Subjects who are switched from IMP Q4W to IMP Q8W at Week 24 are dosed on 
Weeks 32 and 40 in the Flexible Dosing Period. 
 
Table 5-2: 
Schedule of study assessments – Years 2 and 3 (Weeks 48 to 144) 
Visit a/ 
Week 
Protocol activity 
Treatment Period – Years 2 and 3 b 
 
 
48  
C 
5
2 
H 
5
6 
H 
60  
C 
6
4 
H 
6
8 
H 
72  
C 
7
6 
H 
8
0 
H 
84  
C 
8
8 
H 
9
2 
H 
96  
C 
1
0
0 
H 
1
0
4 
H 
108  
C 
1
1
2 
H 
1
1
6 
H 
120  
C 
1
2
4 
H 
1
2
8 
H 
132  
C 
1
3
6 
H 
1
4
0 
H 
W144 
/ 
PEOT 
SFUc 
DLQI 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
X 
 
 
X 
  
Bimekizumab self-
injection Q4W m,n,q 
Xo 
X 
X 
Xo 
X 
X 
Xo 
X 
X 
Xo 
X 
X 
Xo 
X 
X 
Xo 
X 
X 
Xo 
X 
X 
Xo 
X 
X 
 
 
Bimekizumab self-
injection Q8W m,n 
Xo 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 
n The last dose for subjects receiving bimekizumab 320mg Q8W will be Week 136. 
o The subject’s dosing interval will change from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W at Week 48, or at the next scheduled clinic visit (ie, Week 
60, Week 72, Week 84, Week 96, Week 108, Week 120, or Week 132) after implementation of Protocol Amendment #2 if the subject has already completed the 
Week 48 visit. 
q Q4W IMP administration only applies to those subjects who have not yet changed to Q8W at Week 48, or at the next scheduled clinic visit (ie, Week 60, Week 72, 
Week 84, Week 96, Week 108, Week 120, or Week 132) after implementation of Protocol Amendment #2 if the subject has already completed the Week 48 visit. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 172 of 216 
Change #8 
Section 5.7, Schematic diagram 
The study schematic diagram for PS0014 is presented in Figure 5-1. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 173 of 216 
Figure 5-1: Schematic diagram  
 
IMP=investigational medicinal product; PASI=Psoriasis Area Severity Index; Q4W=every 4 weeks; Q8W=every 8 weeks 
Note: Self-injection will be allowed from Week 48 onward. 
Note: At Week 28 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. 
a Subjects on placebo after a Week 16 response (≥PASI90) on bimekizumab 320mg Q4W during the Initial Treatment Period of the feeder study may enroll in PS0014.  
b Subjects on bimekizumab 320mg Q4W who achieved a PASI50 at Week 12 in the escape arm of the feeder study may enroll in PS0014. 
c Subjects on ustekinumab or bimekizumab 320mg Q4W in feeder studies who achieved PASI90 will be randomized, respectively, 1:1 or 4:1 to bimekizumab 320mg Q4W or 
320mg Q8W. 
d At Week 24, if PASI90 is achieved, Investigator may change the dosing interval from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W (optional).  
 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 174 of 216 
Has been changed to: 
The study schematic diagram for PS0014 from Screening through Week 48 is presented in 
Figure 5-1, and from Week 48 through Week 144 is presented in Figure 5-2. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 175 of 216 
Figure 5-1: Schematic diagram, Screening through Week 48 
 
IMP=investigational medicinal product; PASI=Psoriasis Area Severity Index; Q4W=every 4 weeks; Q8W=every 8 weeks 
Note: Self-injection will be allowed from Week 48 onward. 
Note: At Week 28 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. 
a Subjects on placebo after a Week 16 response (≥PASI90) on bimekizumab 320mg Q4W during the Initial Treatment Period of the feeder study may enroll in PS0014.  
b Subjects on bimekizumab 320mg Q4W who achieved a PASI50 at Week 12 in the escape arm of the feeder study may enroll in PS0014. 
c Subjects on ustekinumab or bimekizumab 320mg Q4W in feeder studies who achieved PASI90 will be randomized, respectively, 1:1 or 4:1 to bimekizumab 320mg Q4W or 
320mg Q8W. 
d At Week 24, if PASI90 is achieved, Investigator may change the dosing interval from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W (optional).  
e The subject’s dosing interval will change from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W at Week 48 or at the next scheduled clinic (ie, Week 60, Week 
72, Week 84, Week 96, Week 108, Week 120, or Week 132) visit if the subject has already completed the Week 48 visit prior to implementation of 
Protocol Amendment #2. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 176 of 216 
 
Figure 5-2: Schematic diagram, Years 2 and 3 (Week 48 through Week 144) 
 
Q4W=every 4 weeks; Q8W=every 8 weeks 
Note: Self-injection will be allowed from Week 48 onward. 
Note: The subject’s dosing interval will change from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W at Week 48 or at the next scheduled clinic visit (ie, Week 
60, Week 72, Week 84, Week 96, Week 108, Week 120, or Week 132) if the subject has already completed the Week 48 visit prior to implementation of 
Protocol Amendment #2. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 177 of 216 
Change #9 
Section 5.8, Rational for study design and selection of dose 
In PS0014, doses can be adjusted at Week 24 for subjects receiving bimekizumab 320mg Q4W 
at the discretion of the Investigator (optional). At Week 48, for subjects receiving bimekizumab 
320mg Q4W, if PASI90 is achieved, the subject’s dosing interval will change from 320mg Q4W 
to 320mg Q8W (default) unless, based on medical judgement, the investigator decides 
differently. 
Has been changed to: 
In PS0014, doses can be adjusted at Week 24 for subjects receiving bimekizumab 320mg Q4W 
at the discretion of the Investigator (optional).  
Based on pooled data from the Phase 3 studies (PS0008, PS0009, and PS0013), during the 
maintenance period bimekizumab 320mg Q8W provided efficacy results similar to 
bimekizumab 320mg Q4W. Therefore, at Week 48, subjects receiving 
bimekizumab 320mg Q4W will switch to receive bimekizumab 320mg Q8W. Subjects who 
are receiving bimekizumab 320mg Q4W treatment who already completed the Week 48 
visit at the time of implementation of Protocol Amendment #2 will be switched to 
bimekizumab 320mg Q8W at the next scheduled clinic visit. This change in dosing interval 
will reduce subject and site burden, while allowing collection of more long-term safety data 
on the bimekizumab 320mg Q8W dosing regimen. 
 
Change #10 
Section 7.2, Treatments to be administered 
The subject will receive the required number of syringes for injections at each visit needed to 
perform the Q4W or Q8W administrations at home. 
Has been changed to: 
The subject will receive the required number of syringes for injections at each visit needed to 
perform the Q8W administrations at home. 
 
Change #11 
Section 8.1.2.6, Week 48 Visit (±7 days relative to Baseline) 
At Week 48, for subjects receiving bimekizumab 320mg Q4W, if PASI90 is achieved, the 
subject’s dosing interval will change from 320mg Q4W to 320mg Q8W (default) unless, based 
on medical judgement, the investigator decides differently. 
Has been changed to: 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 48, or at the next scheduled clinic visit if the subject 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 178 of 216 
has already completed the Week 48 visit prior to implementation of 
Protocol Amendment #2.  
Subjects whose dosing interval is being changed to bimekizumab 320mg Q8W at Week 48 
should be dosed at this visit and should receive kits for home administration 8 weeks later 
(Table 8-1). 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 179 of 216 
Table 8-1: 
Dosing scheme, Years 2 and 3 (Weeks 48 to 144) 
Week 
 
Dose 
Assignment 
48 a,b 
Year 2 
Year 3 
52 
56 
60a,c 
64 
68 
72a,b 
76 
80 
84a,c 
88 
92 
96a,b 
100 
104 
108a,c 
112 
116 
120a,b 
124 
128 
132a,c 
136 
140 
C 
C/
H 
C/
H 
C 
C/
H 
C/
H 
C 
C/
H 
C/
H 
C 
C/
H 
C/
H 
C 
C/
H 
C/
H 
C 
C/
H 
C/
H 
C 
C/
H 
C/
H 
C 
C/
H 
C/
H 
Bimekizumab 
320mg Q4W 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
Bimekizumab 
320mg Q8W 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
●● 
 
C=Clinic; H=home; Q4W=every 4 weeks; Q8W=every 8 weeks 
Notes: A bimekizumab 160mg injection is depicted by a black circle (●). 
a The subject’s dosing interval will change from bimekizumab 320mg Q4W to bimekizumab 320mg Q8W at Week 48 or at the next scheduled clinic 
visit if the subject has already completed the Week 48 visit prior to implementation of Protocol Amendment #2. 
b Subjects whose dosing interval is changed to bimekizumab 320mg Q8W should be dosed at this visit and should receive kits for home 
administration 8 weeks later. 
c Subjects whose dosing interval is changed to bimekizumab 320mg Q8W should NOT be dosed at this visit and should receive kits for home 
administration 4 weeks later. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 180 of 216 
 
Change #12 
Section 8.1.2.7, Self-injection at home injection (Weeks 52, 56, 64, 68, 76, 80, 88, 92, 100, 
104, 112, 116, 124, 128, 136 and 140) 
Subjects receiving bimekizumab 320mg Q4W will be given the opportunity for self-injection of 
bimekizumab at home (described in Section 7.2) on the following weeks: Weeks 52, 56, 64, 68, 
76, 80, 88, 92, 100, 104, 112, 116, 124, 128, 136 and 140.  
Has been changed to:  
Section 8.1.2.7, Self-injection at home (Weeks 52, 56, 64, 68, 76, 80, 88, 92, 100, 104, 112, 
116, 124, 128, 136, and 140) 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 48 or at the next scheduled clinic visit if the subject has 
already completed the Week 48 visit prior to implementation of Protocol Amendment #2.  
Subjects receiving bimekizumab 320mg Q4W will be given the opportunity for self-injection of 
bimekizumab at home (described in Section 7.2) on the following weeks: Weeks 52, 56, 64, 68, 
76, 80, 88, 92, 100, 104, 112, 116, 124, 128, 136, and 140. This only applies to those subjects 
who have not yet changed to bimekizumab 320mg Q8W. 
 
Change #13 
Section 8.1.2.8, Week 60, Week 84, Week 108, and Week 132 Visit (±7 days relative to 
Baseline) 
The following procedures/assessments will be performed/recorded prior to administration of 
IMP: 
The following text has been changed to: 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W as follows: 
• At Week 60 if the subject has already completed the Week 48 visit prior to 
implementation of Protocol Amendment #2.  
• At Week 84 if the subject has already completed the Week 72 visit prior to 
implementation of Protocol Amendment #2.  
• At Week 108 if the subject has already completed the Week 96 visit prior to 
implementation of Protocol Amendment #2.  
• At Week 132 if the subject has already completed the Week 120 visit prior to 
implementation of Protocol Amendment #2.  
As depicted in Table 8-1, subjects whose dosing interval is being changed to 
bimekizumab 320mg Q8W at one of these visits should NOT be dosed at that visit, and 
should receive kits for home administration 4 weeks later. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 181 of 216 
 
The following procedures/assessments will be performed/recorded at this visit. If IMP is 
administered at this visit, they should be performed/recorded prior to administration of IMP: 
 
And the following text: 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W dosing will occur, preferably by self-injection. 
Has been changed to: 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W dosing will occur, preferably by self-injection. This only applies to those 
subjects who have not yet changed to Q8W after implementation of 
Protocol Amendment #2. 
 
Change #14 
Section 8.1.2.9, Week 72 Visit (±7 days relative to Baseline) 
The following text has been added: 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 72 if the subject had already completed the Week 48 
and Week 60 visits prior to implementation of Protocol Amendment #2. As depicted in 
Table 8-1, subjects whose dosing interval is being changed to bimekizumab 320mg Q8W at 
Week 72 should NOT be dosed at this visit, and should receive kits for home 
administration 8 weeks later. 
And the following text: 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W dosing will occur, preferably by self-injection. 
Has been changed to: 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W or Q8W dosing will occur, preferably by self-injection. The Q4W dosing only 
applies to those subjects who have not yet changed to Q8W after implementation of 
Protocol Amendment #2. 
 
Change #15 
Section 8.1.2.10, Week 96 Visit (±7 days relative to Baseline) 
The following text has been added: 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 96 if the subject had already completed the Week 84 
visit prior to implementation of Protocol Amendment #2. As depicted in Table 8-1, subjects 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 182 of 216 
 
whose dosing interval is being changed to bimekizumab 320mg Q8W at Week 96 should be 
dosed at this visit, and should receive kits for home administration 8 weeks later. 
And the following text: 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W dosing will occur, preferably by self-injection. 
Has been changed to: 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W dosing will occur, preferably by self-injection. The Q4W dosing only applies to 
those subjects who have not yet changed to Q8W after implementation of 
Protocol Amendment #2. 
 
Change #16 
Section 8.1.2.11, Week 120 Visit (±7 days relative to Baseline) 
The following text has been added: 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 120 if the subject had already completed the Week 108 
visit prior to implementation of Protocol Amendment #2. As depicted in Table 8-1, subjects 
whose dosing interval is being changed to bimekizumab 320mg Q8W at Week 120 should 
be dosed at this visit, and should receive kits for home administration 8 weeks later. 
And the following text: 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W dosing will occur, preferably by self-injection. 
Has been changed to: 
After completion of the above-mentioned procedures, bimekizumab administration for subjects 
receiving Q4W dosing will occur, preferably by self-injection. The Q4W dosing only applies to 
those subjects who have not yet changed to Q8W after implementation of 
Protocol Amendment #2. 
 
Change #17 
Section 9.2, Laboratory measurements 
The following text has been added: 
If tests are done locally, a concurrent sample should also be sent to the central laboratory 
whenever possible. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 183 of 216 
 
Change #18 
Section 14.1, Definition of analysis sets 
The Full Analysis Set (FAS) will consist of all enrolled subjects who receive at least 1 dose of 
the IMP and have a valid efficacy measurement for PASI at Baseline of PS0014. 
Has been changed to: 
The Full Analysis Set (FAS) will consist of all enrolled subjects who receive at least 1 dose of 
the IMP and have a valid efficacy measurement for PASI at Baseline of the Feeder Study and 
Baseline of PS0014. 
 
Change #19 
Section 14.3.2, Other safety analyses 
In order to evaluate if there is any difference in the TEAE profile of subjects who have dose 
adjustments, additional summaries will be generated and are described further here. With respect 
to dose adjustments, subjects will be classified into 1 of 2 groups: 
• Nonadjusters – This group consists of subjects who do not experience a dose adjustment 
during the study. 
• Adjusters – This group consists of subjects who experience a dose regimen adjustment at 
Week 24 or Week 48 during the study. This means that the subjects in this group had a dose 
adjustment from 320mg Q4W to 320mg Q8W at Week 24 or Week 48. 
Summaries based on these 2 groups will be done for the TEAE overview, incidence of TEAEs 
(by SOC, HLT, and PT), and incidence of treatment-emergent SAEs. 
Has been changed to: 
In order to evaluate if there is any difference in the TEAE profile of subjects who have dose 
adjustments, additional summaries will be generated. With respect to dose adjustments, for the 
Week 48 interim analysis, subjects will be classified into 1 of 2 groups: 
• Nonadjusters – This group consists of subjects who do not experience a dose adjustment 
prior to Week 48. 
• Adjusters – This group consists of subjects who experience a dose regimen adjustment at 
Week 24. This means that the subjects in this group had a dose adjustment from 320mg 
Q4W to 320mg Q8W at Week 24. 
For the full analysis, subjects will be categorized into those who did not experience a dose 
regimen adjustment during the study and those that experienced a dose regimen 
adjustment at any time. 
Summaries based on these groups will be done for the TEAE overview, incidence of TEAEs (by 
SOC, HLT, and PT), and incidence of treatment-emergent SAEs. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 184 of 216 
 
Change #20 
Section 14.4, Planned efficacy analyses 
In addition to the summaries described above, the impact of dose regimen adjustment on efficacy 
will be considered. This will be done primarily by summarizing efficacy variables by the adjuster 
groups described above. Furthermore, a supportive analysis specifically for dose adjusters will be 
performed in which PASI score will be summarized by visit, where Baseline is recalibrated for 
each individual subject and defined as the visit where the bimekizumab 320mg Q8W is initiated. 
The visits summarized will be in weeks relative to when the dosing regimen is decreased to 
Q8W, as opposed to the scheduled week of the PS0014 assessment. These summaries will be 
based on observed case only. 
Has been changed to: 
In addition to the summaries described above, the impact of dose regimen adjustment on efficacy 
will be considered. This will be done primarily by summarizing efficacy variables by the adjuster 
groups described above, for the Week 48 interim analysis and for the full analysis.  
 
Change #21 
Section 14.7, 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. 
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 key 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. 
 
Change #22 
Section 14.9, Planned interim analysis and data monitoring 
Interim analyses are planned at Week 24 and Week 48, details of which will be documented in 
the SAP. After the final Week 144 visit, an interim analysis may 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 SFU visit) have been collected.  
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 185 of 216 
 
Has been changed to: 
An interim analysis is planned at Week 48, details of which will be documented in the SAP. 
Additional interim analyses may be performed and corresponding interim CSRs may be 
written. A final analysis and updated final CSR will be prepared once all data (through the SFU 
visit) have been collected.  
18.3 
Protocol Amendment 3 
Rationale for the amendment 
Correct statement from “study subjects should NOT be dosed at this visit” to “study subjects 
should be dosed at this visit” in the description of study procedures by visit for Week 72 to align 
with change made in Protocol Amendment 2. 
Add DLQI at Week 120 and delete DLQI at Week 132 in description of study procedures by 
visit for consistency with the change made in Protocol Amendment 2. 
Removed statement regarding dosing interval change from the description of study procedures 
by visit for Weeks 52, 56, 64, 68, 76, 80, 88, 92, 100, 104, 112, 116, 124, 128, 136, and 140, in 
order to reduce potential for confusion if study subjects go to sites for injections instead of 
performing injections at home. 
In addition, minor corrections, including typographical and grammatical errors, changes to 
abbreviations, and administrative changes have been made. 
Modifications and changes 
Global changes 
No global changes have been made. 
Specific changes 
Change #1 
Section 8.1.2.7, Self-injection at home (Weeks 52, 56, 64, 68, 76, 80, 88, 92, 100, 104, 112, 
116, 124, 128, 136, and 140) 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 48 or at the next scheduled clinic visit if the subject has 
already completed the Week 48 visit prior to implementation of Protocol Amendment #2.  
Subjects receiving bimekizumab 320mg Q4W will be given the opportunity for self-injection of 
bimekizumab at home (described in Section 7.2) on the following weeks: Weeks 52, 56, 64, 68, 
76, 80, 88, 92, 100, 104, 112, 116, 124, 128, 136, and 140. This only applies to those subjects 
who have not yet changed to bimekizumab 320mg Q8W. 
Has been changed to:  
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 48 or at the next scheduled clinic visit if the subject has 
already completed the Week 48 visit prior to implementation of Protocol Amendment #2.  
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 186 of 216 
 
Subjects receiving bimekizumab 320mg Q4W will be given the opportunity for self-injection of 
bimekizumab at home (described in Section 7.2) on the following weeks: Weeks 52, 56, 64, 68, 
76, 80, 88, 92, 100, 104, 112, 116, 124, 128, 136, and 140. This only applies to those subjects 
who have not yet changed to bimekizumab 320mg Q8W. 
 
Change #2 
Section 8.1.2.8, Week 60, Week 84, Week 108, and Week 132 Visit (±7 days relative to 
Baseline) 
The following bullet has been deleted: 
• DLQI (Week 132 only) 
 
Change #3 
Section 8.1.2.9, Week 72 Visit (±7 days relative to Baseline) 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 72 if the subject had already completed the Week 48 and 
Week 60 visits prior to implementation of Protocol Amendment #2. As depicted in Table 8-1, 
subjects whose dosing interval is being changed to bimekizumab 320mg Q8W at Week 72 
should NOT be dosed at this visit, and should receive kits for home administration 8 weeks later. 
Has been changed to: 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 72 if the subject had already completed the Week 48 and 
Week 60 visits prior to implementation of Protocol Amendment #3. As depicted in Table 8-1, 
subjects whose dosing interval is being changed to bimekizumab 320mg Q8W at Week 72 
should NOT be dosed at this visit, and should receive kits for home administration 8 weeks later. 
 
Change #4 
Section 8.1.2.11, Week 120 Visit (±7 days relative to Baseline) 
The following bullet has been added: 
• DLQI 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 187 of 216 
 
18.4 
Protocol Amendment 3.3 
Rationale for the amendment 
The protocol has been amended for the following reasons: 
• To collect additional long-term safety data, 
• To explore safety data with subjects who have temporarily stopped bimekizumab and could 
have been exposed to other treatments, and  
• To provide an additional 48-week open-label treatment period for subjects continuing their 
current treatment or reinitiating treatment at Week 144/OLE2 Baseline. 
Modifications and changes 
Global changes 
The following global changes were made throughout the protocol: 
• An additional 48-week open label treatment period was added (OLE2 Period). 
The maximum duration of the study has been changed. For subjects participating in the OLE2 
Period, the maximum study duration will depend on the time between their participation in the 
Treatment Period until Week 144 and the start of the OLE2 Period: 204 weeks for subjects still 
being treated in the Treatment Period and who will directly roll over to the OLE2 Period at 
Week 144; 224 weeks for subjects who have attended Week 144 and who will have completed 
the SFU; these subjects will have a 4-week Screening Period before reinitiating treatment in the 
OLE2 Period; between 204 and 224 weeks for subjects who will have attended Week 144 and 
are participating in the SFU. For these subjects, the maximum study duration will depend upon 
when they will stop the 20-week SFU period to enter the 4-week Screening Period of the OLE2 
Period.  
• Implementation of a new schedule of assessments (Table 5-3) for the OLE2 Period has been 
made. Schematic diagram (Figure 5-3) for the for the OLE2 Period has been made. 
• A list of inclusion and exclusion criteria has been added for participating in the OLE2 Period. 
• The description of the treatment to be administered has been adapted to take into account the 
treatment to be administered in the OLE2 Period. 
• Addition of the study procedures by visit has been made for the OLE2 Period (Section 8.1.3). 
 
Specific changes 
Change #1 
Section 1 Summary 
Approximately 1120 subjects are expected to enroll in PS0014. For each subject, the study will 
last a maximum of 160 weeks and will consist of a Treatment Period (144 weeks) and a Safety 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 188 of 216 
 
Follow-Up (SFU) Period (20 weeks after the final dose of investigational medicinal product 
[IMP] 
Was changes to 
Approximately 1120 subjects are expected to enroll in PS0014. For each subject, the study will 
last a maximum of 192 weeks and will consist of a Treatment Period (144 weeks) and a Safety 
Follow-Up (SFU) Period (20 weeks after the final dose of investigational medicinal product 
[IMP] depending on subject’s participation in the Open-Label Extension (OLE2) Period; 
see paragraph below). 
Subjects participating in the OLE2 (implemented as part of Protocol Amendment #3.3) will 
enter the OLE2 Period after completing the Treatment Period (at Week 144), including 
subjects in the SFU period and subjects who have completed the SFU Period. The OLE2 
Period will be a 48-week open-label treatment period with final visit at OLE2 Week 48, 
followed by an SFU Period (SFU2, 20 weeks after the final dose of IMP administered in the 
OLE2 Period). 
Change #2 
Section 1 Summary 
The following  text was added: 
After the implementation of Protocol Amendment #3.3 (addition of a 48-week open-label 
treatment period, ie, OLE2 Period), subjects will be invited to continue or reinitiate 
bimekizumab treatment as per the following OLE2 Groups: 
• OLE2 Group A: Subjects in the Treatment Period at the time of Protocol Amendment 
#3.3 implementation will attend the Week 144 Visit and may directly roll over to the 
OLE2 Period. These subjects will continue receiving bimekizumab 320mg Q8W for 40 
additional weeks, starting from the first treatment visit of the OLE2 Period (ie, Week 
144/OLE2 Baseline Visit; the Week 144 Visit will coincide with the Week 144/OLE2 
Baseline Visit and data collected at this visit will be used as baseline data for subjects 
entering the OLE2 Period). 
• OLE2 Group B: Eligible subjects who have completed the Treatment Week 144 Visit 
and who are in the SFU or have completed the SFU at the time of Protocol Amendment 
#3.3 implementation may reinitiate bimekizumab treatment in the OLE2 Period after 
having undergone Screening assessments during a 4-week OLE2 Screening Period. The 
first dose will be administered at the Week 144/OLE2 Baseline Visit; data collected at 
this visit will be used as baseline data. Subjects with an IGA score ≥3 upon entry in the 
OLE2 Period will be treated with bimekizumab Q4W for the first 16 weeks, and will 
then switch to bimekizumab 320mg Q8W. Subjects in OLE2 Group B with an IGA 
score <3 upon entry will be treated with bimekizumab Q8W from the Week 144/OLE2 
Baseline Visit. 
During the OLE2 Period (Week 144/OLE2 Baseline to OLE2 Week 48), all subjects will 
attend visits at the site every 12 weeks for study assessments and subjects may self-inject 
IMP at home. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 189 of 216 
 
Following completion or early withdrawal from the OLE2 Period, subjects will return for 
the SFU of the OLE2 Period (SFU2) Visit 20 weeks after the last dose of IMP 
administration. 
Change #3 
Section 2.2.1.2 Ongoing studies 
Five additional studies of bimekizumab for 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. 
• PS0015 is a Phase 3b, double-blind, active comparator controlled, parallel group study to 
evaluate the efficacy and safety of bimekizumab compared with secukinumab in adult 
subjects with moderate to severe chronic PSO. 
Bimekizumab is also being evaluated in the treatment of other indications (eg, PsA, axSpA, 
hidradenitis suppurativa). Additional information on the clinical data for bimekizumab is 
available in the current version of the IB 
Was changed to  
All ongoing studies at the time of Protocol Amendment #3.3 implementation are presented 
and described in the current version of the IB  
Change #4 
Section 5.1 Study description 
The following paragraph was added: 
An OLE2 Period will be added in Canada and the US after the country-specific Protocol 
Amendment #3.3 implementation (addition of a 48-week open-label treatment period, ie, 
the OLE2 Period), and subjects will be invited to continue or reinitiate bimekizumab 
treatment for an additional 40 weeks. 
 
 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 190 of 216 
 
Change #5 
Section 5.2.1 Study periods 
PS0014 will include 2 periods, a Treatment Period (144 weeks) and a SFU Period (20 weeks 
after the final dose of IMP). 
Was changed to: 
PS0014 will include a Treatment Period of 144 weeks (from Baseline/Feeder Study Final 
Visit to Week 144 Visit) followed by a SFU Period of 20 weeks after the last dose of IMP in 
the Treatment Period. After the implementation of Protocol Amendment #3.3 (addition of a 
48-week open-label treatment period, ie, OLE2 Period), PS0014 will be prolonged by an 
OLE2 Period, during which eligible subjects will be invited to continue or reinitiate 
bimekizumab treatment for 40 weeks (from Week 144/OLE2 Baseline to OLE2 Week 48) 
and will be followed in a second SFU Period of 20 weeks after the final dose of IMP (SFU2 
Period), as appropriate. Subjects will be invited to continue or reinitiate bimekizumab 
treatment as per the following OLE2 Groups: 
• OLE2 Group A: Subjects in the Treatment Period at the time of Protocol Amendment 
#3.3 implementation will attend the Week 144 Visit and may directly roll over to the 
OLE2 Period. These subjects will continue receiving bimekizumab 320mg Q8W for 40 
additional weeks, starting from the first treatment visit of the OLE2 Period (ie, Week 
144/OLE2 Baseline Visit; the Week 144 Visit will coincide with the Week 144/OLE2 
Baseline Visit and data collected at this visit will be used as baseline data for subjects 
entering the OLE2 Period). 
• OLE2 Group B: Eligible subjects who have completed the Treatment Week 144 Visit 
and who are in the SFU or have completed the SFU at the time of Protocol Amendment 
#3.3 implementation may reinitiate bimekizumab treatment in the OLE2 Period after 
having undergone Screening assessments during a 4-week OLE2 Screening Period. The 
first dose will be administered at the Week 144/OLE2 Baseline Visit; data collected at 
this visit will be used as baseline data. Subjects with an IGA score ≥3 upon entry in the 
OLE2 Period will be treated with bimekizumab Q4W for the first 16 weeks, and will 
then switch to bimekizumab 320mg Q8W. Subjects in OLE2 Group B with an IGA 
score <3 upon entry will be treated with bimekizumab Q8W from the Week 144/OLE2 
Baseline Visit.  
 
Change #6 
Section 5.2.1 Treatment period 
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 48 or at the next scheduled clinic visit after implementation 
of Protocol Amendment #3 if the subject has already completed the Week 48 visit.  
During Year 1 of the Treatment Period (Weeks 0 to 44), IMP will be administered in the clinic 
by sc injection at the time points specified in the schedule of assessments (Table 5-1). During 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 191 of 216 
 
Years 2 and 3 of the Treatment Period (Weeks 48 to 144), subjects may self-inject IMP at home 
(described in Section 7.2) at the time points specified in the schedule of assessments (Table 5-2).  
The assessments to be performed at each Treatment Period Visit are presented in Table 5-1 and 
Table 5-2. 
Was changed to  
The subject’s dosing interval will change from bimekizumab 320mg Q4W to 
bimekizumab 320mg Q8W at Week 48 or at the next scheduled clinic visit after implementation 
of Protocol Amendment #3 if the subject has already completed the Week 48 visit. The last dose 
bimekizumab 320mg Q8W in the Treatment Period will be administered at Week 136. The 
End of Treatment Visit of the Treatment Period will be the Week 144 Visit. 
The assessments to be performed at each Treatment Period Visit are presented in Table 5-1 and 
Table 5-2. 
Change #7 
The following section was added: 
5.2.2 OLE2 Period 
Subjects enrolled as per Protocol Amendment #3 will be treated in the Treatment Period 
until Week 136 (last dose of bimekizumab 320mg Q8W) and will be followed in a SFU 
Period for 20 weeks after their last dose of IMP. After the implementation of Protocol 
Amendment #3.3 (addition of a 48-week open-label treatment period, ie, OLE2 Period), 
study subjects will be invited to continue or reinitiate bimekizumab treatment as per the 
following OLE2 Groups: 
• OLE2 Group A: Subjects in the Treatment Period at the time of Protocol Amendment 
#3.3 implementation will attend the Week 144 Visit and may directly roll over to the 
OLE2 Period. These subjects will continue receiving bimekizumab 320mg Q8W for 40 
additional weeks, starting from the first treatment visit of the OLE2 Period (ie, Week 
144/OLE2 Baseline Visit; the Week 144 Visit will coincide with the Week 144/OLE2 
Baseline Visit and data collected at this visit will be used as baseline data for subjects 
entering the OLE2 Period). 
• OLE2 Group B: Eligible subjects who have completed the Treatment Week 144 Visit 
and who are in the SFU or have completed the SFU at the time of Protocol Amendment 
#3.3 implementation may reinitiate bimekizumab treatment in the OLE2 Period after 
having undergone Screening assessments during a 4-week OLE2 Screening Period. The 
first dose will be administered at the Week 144/OLE2 Baseline Visit; data collected at 
this visit will be used as baseline data. Subjects with an IGA score ≥3 upon entry in the 
OLE2 Period will be treated with bimekizumab Q4W for the first 16 weeks, and will 
then switch to bimekizumab 320mg Q8W. Subjects in OLE2 Group B with an IGA 
score <3 upon entry will be treated with bimekizumab Q8W from the Week 144/OLE2 
Baseline Visit. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 192 of 216 
 
During the OLE2 Period (Week 144/OLE2 Baseline to OLE2 Week 48), subjects may self-
inject IMP at home (described in Section 7.2) at the time points specified in the schedule of 
assessments (Table 5-3).  
Change #8 
Section 5.2.3 Safety Follow-up Periods 
The following text was added: 
Two SFU Periods are considered since Protocol Amendment #3.3 implementation. A first 
SFU following the Treatment Period and a second SFU (SFU2) following the OLE2 Period 
(added as per Protocol Amendment #3.3). 
…. 
Subjects still in the Treatment Period (not having attended Week 144 yet; OLE2 Group A) 
will have the opportunity to directly roll over in the OLE2. Subjects having attended Week 
144 Visit and who are participating in the SFU or have completed the SFU (OLE2 Group 
B) will be invited to reinitiate  treatment in the OLE2 Period. 
All subjects who have completed treatment in the OLE2 Period (ie, have completed the 
OLE2 Week 48 Visit), or have withdrawn from IMP during the OLE2 Period before OLE2 
Week 48, will return for a SFU2 Visit 20 weeks after their final dose of IMP. 
The assessments for the SFU2 are presented in Table 5-3. 
Change #9 
Section 5.2.4 Premature enrolment 
Subjects withdrawing early from the study will undergo the PEOT Visit assessments (see 
Section 8.2) and will enter the SFU. 
Was changed to: 
Subjects withdrawing early from the study will undergo the PEOT Visit assessments (see 
Section 8.2) and will enter the SFU or SFU2 Period depending on when subjects withdraw. 
Change #10 
Section 5.3 Study duration per subject 
Eligible subjects will continue to receive open-label bimekizumab in PS0014 for up to 
144 weeks or until the Sponsor decides to discontinue the study. The SFU Visit will be 
conducted 20 weeks after the final dose of bimekizumabThe end of the study is defined as the 
date of the last visit of the last subject in the study. 
Was changed to: 
For each subject, prior to Protocol Amendment 3.3 implementation, the study will last a 
maximum of 160 weeks and will consist of: 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 193 of 216 
 
• A Treatment Period during which subjects will continue to receive open-label 
bimekizumab in PS0014 for up to 144 weeks (the last dose will be administered at Week 
136 and Week 144 will be the End of Treatment Visit).  
• An SFU Period 20 weeks after the final dose of bimekizumab administered during the 
Treatment Period (subjects will enter the SFU after Week 144 Visit or after 
withdrawal). 
Subjects eligible for the OLE2 Period (added as part of Protocol Amendment #3.3) will 
enter the OLE2 after completing Week 144 of the Treatment Period. The OLE2 Period 
includes a 48-week open-label treatment period with a final visit at OLE2 Week 48, and an 
SFU Period (SFU2) of 20 weeks after the final dose of IMP administered in the OLE2 
Period.  
For subjects participating in the OLE2 Period, the maximum study duration will depend 
on the time between their participation in the Treatment Period until Week 144 and the 
start of the OLE2 Period:  
• 204 weeks for subjects still being treated in the Treatment Period and who will directly 
roll over to the OLE2 Period at Week 144. 
• 224 weeks for subjects who have attended Week 144 and who will have completed the 
SFU; these subjects will have a 4-week Screening Period before reinitiating treatment in 
the OLE2 Period. 
• Between 204 and 224 weeks for subjects who will have attended Week 144 and are 
participating the in the SFU. For these subjects, the maximum study duration will 
depend upon when they will stop the 20-week SFU period to enter the 4-week Screening 
Period of the OLE2 Period.  
The end of the study is defined as the date of the last visit of the last subject in the study. 
Change #11 
A table for study procedures for the OLE22 Period was added 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 194 of 216 
 
Table 5-3  Schedule of study assessments – OLE2 Period (from OLE2 Screening Visit or from Week 144/OLE2 
Visit to Week 48) 
 
 
Visit a/ 
Week 
 
OLE2 Periodb 
OLE2 W48/ 
PEOT 
SFU2c 
OLE2 
Screening 
W144/OLE2 
Baseline 
OLE2 W4  
OLE2 W 8 
OLE2 W 12 
OLE2 W 16 
OLE2 W 24  
OLE2 W 32  
OLE2 W 36 
OLE2 W 40 
C 
C/H 
C/H 
C 
C/H 
C 
C/H 
C 
C/H 
C 
Protocol activity 
 
 
OLE2 Groups A + B 
Informed consent 
Group B 
Group A 
 
 
 
 
 
 
 
 
 
 
Eligibility 
Group B 
Group A+B 
 
 
 
 
 
 
 
 
 
 
Urine drug screen 
Group B 
 
 
 
 
 
 
 
 
 
 
 
Significant past medical 
history and concomitant 
diseases d 
Group B d 
 
 
 
 
 
 
 
 
 
 
 
Physical exam e 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
Body weight 
 
Group Af + B 
 
 
 
 
 
 
 
 
X 
 
Vital signs g 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
Hematology and chemistry 
Group B 
Group Af + B 
 
 
 
 
X 
 
 
 
X 
X 
Urinalysis 
Group B 
Group Af + B 
 
 
 
 
X 
 
 
 
X 
X 
Pregnancy testing (urine) h 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
Hepatitis B and C testing 
Group B 
 
 
 
 
 
 
 
 
 
 
 
HIV testing i 
Group B 
 
 
 
 
 
 
 
 
 
 
 
IGRA TB test 
 
Group A f 
 
 
 
 
 
 
 
 
X 
 
Tuberculosis questionnaire 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
 
PASI 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 195 of 216 
 
Table 5-3  Schedule of study assessments – OLE2 Period (from OLE2 Screening Visit or from Week 144/OLE2 
Visit to Week 48) 
 
 
Visit a/ 
Week 
 
OLE2 Periodb 
OLE2 W48/ 
PEOT 
SFU2c 
OLE2 
Screening 
W144/OLE2 
Baseline 
OLE2 W4  
OLE2 W 8 
OLE2 W 12 
OLE2 W 16 
OLE2 W 24  
OLE2 W 32  
OLE2 W 36 
OLE2 W 40 
C 
C/H 
C/H 
C 
C/H 
C 
C/H 
C 
C/H 
C 
Protocol activity 
 
 
OLE2 Groups A + B 
Percentage of BSA 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
 
IGA 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
 
DLQI 
 
Group Af + B 
 
 
 
 
X 
 
 
 
X 
 
PHQ-9 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
ECG 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
Blood sample for 
bimekizumab plasma 
concentrations j 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
Blood sample for 
anti‑bimekizumab antibodies j 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
scalp IGA 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
mNAPSI 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
pp-IGA 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
EQ-5D-3L 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
PASE 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
PGADA 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
WPAI-SHP V2.0 
 
Group A f 
 
 
 
 
 
 
 
 
 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 196 of 216 
 
Table 5-3  Schedule of study assessments – OLE2 Period (from OLE2 Screening Visit or from Week 144/OLE2 
Visit to Week 48) 
 
 
Visit a/ 
Week 
 
OLE2 Periodb 
OLE2 W48/ 
PEOT 
SFU2c 
OLE2 
Screening 
W144/OLE2 
Baseline 
OLE2 W4  
OLE2 W 8 
OLE2 W 12 
OLE2 W 16 
OLE2 W 24  
OLE2 W 32  
OLE2 W 36 
OLE2 W 40 
C 
C/H 
C/H 
C 
C/H 
C 
C/H 
C 
C/H 
C 
Protocol activity 
 
 
OLE2 Groups A + B 
eC-SSRS 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
Concomitant medication 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
Adverse events 
Group B k 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
IRT 
Group B 
Group Af + B 
 
 
X 
 
X 
 
X 
 
X 
X 
Bimekizumab administration 
Q4W/Q8W l, m, n 
 
Group B l 
X 
X 
X 
X 
X 
X 
 
X 
 
 
Bimekizumab administration 
Q8W m, n 
 
Group A+B l 
 
X 
 
X 
X 
X 
 
X 
 
 
IMP accountability for self-
injection at home 
 
 
 
 
X 
 
X 
 
X 
 
X 
 
BSA=body surface area; C=clinic; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide Severity Rating Scale; 
EQ-5D-3L=Euro-Quality of Life 5-Dimensions 3-level; IGA=Investigator’s Global Assessment; H=home; HIV= human immunodeficiency virus; IGRA=interferon-gamma 
release assay; IMP=investigational medicinal product; IRT=interactive response technology; mNAPSI=modified Nail Psoriasis Severity Index; OLE=open label extension; 
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; Q4W=every 4 weeks; Q8W=every 8 weeks; SFU=Safety Follow-Up; SFU2=Safety Follow-Up #2; 
TB=tuberculosis; WPAI-SHP=Work Productivity and Activity Impairment Questionnaire-specific health problem; W=Week. 
Note: Subjects may self-inject IMP at home; self-injection training will be provided to the subject/caregivers by qualified site personnel.  
a Visit windows of ±14 days relative to the Week 144/OLE2 Baseline Visit all visits except SFU2. The SFU2 Visit window is ±7 days from final dose. 
b Assessment for the OLE2 Screening is applicable to subjects in OLE2 Group B, ie, subjects who agreed to reinitiate bimekizumab treatment after having completed the 
Week 144 Visit.  
c The SFU2 Visit will occur 20 weeks after the final dose. 
d Only applicable for subjects who completed the SFU period; only new or modified medical history since completing SFU will be entered in eCRF. 
e 
The physical examination will be performed as per Section 9.3.5. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 197 of 216 
 
Table 5-3  Schedule of study assessments – OLE2 Period (from OLE2 Screening Visit or from Week 144/OLE2 
Visit to Week 48) 
 
 
Visit a/ 
Week 
 
OLE2 Periodb 
OLE2 W48/ 
PEOT 
SFU2c 
OLE2 
Screening 
W144/OLE2 
Baseline 
OLE2 W4  
OLE2 W 8 
OLE2 W 12 
OLE2 W 16 
OLE2 W 24  
OLE2 W 32  
OLE2 W 36 
OLE2 W 40 
C 
C/H 
C/H 
C 
C/H 
C 
C/H 
C 
C/H 
C 
Protocol activity 
 
 
OLE2 Groups A + B 
f 
These tests are performed as part of the Week 144 visit (the Week 144 Visit coincides with the Week 144/OLE2 Baseline Visit for subjects in Group A, ie, direct enrollers 
from Treatment Period to OLE2 Period). 
g Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable. 
h Urine pregnancy testing will be performed at all visits. Pregnancy test results must be negative prior to administering IMP.  
i 
The HIV test results will not be recorded in the eCRF. 
j 
All blood samples taken prior to dosing. 
k Collected only from subjects in the SFU Period. 
l 
Q4W IMP administration only applies to those subjects who have entered the OLE2 Period as part of Group B and had an IGA ≥3 upon entry of OLE2 Period. These 
subjects will receive Q4W dosing for 16 weeks, then will change from Q4W to Q8W dosing. Subjects who have entered the OLE2 Period as part of Group B with an IGA 
<3 upon entry of OLE2 Period will receive Q8W dosing from the OLE2 Screening Visit onwards. 
m The dosing window is ±14 days relative to the Week 144/OLE2 Baseline Visit. 
n If self-injected at home, the subject/caregiver will document the date, body location, kit number, and time point of administration of study medication. All used syringes will 
be disposed of by subjects/caregivers as determined by the Investigator in an acceptable disposal (sharps) container directly after the administration. The subjects/caregivers 
return the documentation together with any used/unused containers at the next scheduled clinic visit. 
 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 198 of 216 
 
Change #12 
A new schematic diagram  was made for the OLE2 Period. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
 
Confidential 
Page 199 of 216 
 
Figure 5-3 Schematic diagram, OLE2 Period (From OLE2 Screening through OLE2 Week 48) 
 
IGA=Investigator’s Global Assessment; IMP=investigational medicinal product; OLE=Open Label Extension; Q4W=every 4 weeks; Q8W=every 8 weeks; 
SFU2=Safety follow-up; W=week 
Note: Q4W/Q8W IMP administration only applies to those subjects who have entered the OLE2 Period as part of Group B, and had an IGA ≥3 upon entry of 
OLE2 Period. These subjects will receive Q4W dosing for 16 weeks, then will change from Q4W to Q8W dosing. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 200 of 216 
Change #13 
The following sections were added: 
6.3 Eligibility criteria for the OLE2 Period 
Prior to initiating the OLE2 Period assessments, all subjects will be asked to read and sign a 
separate Informed Consent Form (ICF).  
6.3.1  All subjects (OLE2 Groups A and B) 
To be eligible to participate in the OLE2 Period, all of the following inclusion criteria must be 
confirmed for all subjects: 
13. Subject provided informed consent.  
14. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand 
and complete diaries), visit schedule, and medication intake according to the judgment of the 
Investigator. 
15. Subject completes the Treatment Period to Week 144 without meeting any withdrawal 
criteria defined in Section 6.4. 
6.3.2  OLE2 Period Group A subjects 
To participate in the OLE2 Period, subjects still treated and who completed the Week 144 Visit 
by the time of Protocol Amendment #3.3 implementation will not need to fulfil other eligibility 
criteria than those listed in Section 6.3.1 and will continue treatment from the Week 144/OLE2 
Baseline Visit if they do not meet any of the withdrawal criteria defined in Section 6.4. 
6.3.3  OLE2 Period Group B subjects 
Inclusion criteria 
To be eligible to participate in the OLE2 Period, all of the additional following inclusion criteria 
must be confirmed during the OLE2 Screening Period for subjects who have attended Week 144 
and are in the SFU or have completed the SFU before Protocol Amendment #3.3 implementation 
(OLE2 Group B subjects): 
16. Female subjects must be: 
− Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for 
which there is no other obvious pathological or physiological cause. 
− Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) 
− Or, if of childbearing potential (and engaged in sexual activity that could result in 
procreation), must be willing to use a highly effective method of contraception 
throughout the duration of the study until 20 weeks after last administration of IMP, and 
have a negative pregnancy test at OLE2 Screening. The following methods are 
considered highly effective when used consistently and correctly 
o Combined (estrogen and progestogen) hormonal contraception associated with 
inhibition of ovulation (oral, intravaginal, or transdermal) 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 201 of 216 
o Progestogen-only hormonal contraception associated with inhibition of ovulation 
(oral, injectable, implantable) 
o Intrauterine device  
o Intrauterine hormone-releasing system  
o Vasectomized partner 
o Abstinence as a form of birth control is generally not allowed in the study unless 
abstinence is in accordance with a subject’s preferred and common lifestyle. Study 
personnel must confirm the continued use of abstinence is still in accordance with the 
subject’s lifestyle at regular intervals during the study. 
17. Subjects with a diagnosis of Crohn’s disease or ulcerative colitis are allowed as long as they 
have no active symptomatic disease. 
 
Exclusion criteria 
Subjects in the OLE2 Group B are not permitted to enroll in the OLE2 Period if any of the 
following exclusion criteria are met: 
18. Female subjects who plan to become pregnant during the OLE2 Period or within 20 weeks 
following final dose of study medication. 
19. Subject has developed any medical or psychiatric condition that, in the opinion of the 
Investigator, could jeopardize or would compromise the subject’s ability to participate in the 
OLE2 Period. 
20. Any subjects with an ongoing SAE, or a history of serious infections, the Medical Monitor 
must be consulted prior to the subject’s entry in the OLE2 Period, although the decision on 
whether to enroll the subject remains with the Investigator. 
21. Subject had a positive or indeterminate IGRA in the Treatment Period to Week 144, unless 
appropriately evaluated and treated as per Section 12.3.1. 
22. Subject may not participate in another study of a medicinal product or device under 
investigation  
23. Subject has a history of chronic alcohol or drug abuse within 6 months prior to reentry as 
assessed by medical history, site interview, and/or results of the urine drug screen. 
24. Subjects who have used systemic treatments for PSO after Week 144 must have stopped this 
treatment 1 month prior to receiving the first bimekizumab injection in the OLE2 Period (See 
Section 7.8.2 regarding prohibited medications). 
25. Subject has erythrodermic, guttate, or pustular form of PSO. 
26. Subject is noncompliant with the study procedures or medications in the opinion of the 
Investigator. 
27. Subject has a clinical laboratory value meeting any of the following criteria: 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 202 of 216 
f. ≥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) 
g. A laboratory value meeting any of the following criteria: 
◦ 
Absolute neutrophil count <1.0x103/μL 
◦ 
Absolute lymphocyte count <0.2x103/μL 
Subjects may enter the OLE2 Period if the result is transient. If a retest is required, it must be 
done within 1 to 2 weeks. 
28. Subject has concurrent acute or chronic viral hepatitis B or C or HIV infection. Subjects who 
have evidence of, or tested positive for hepatitis B or hepatitis C are excluded. A positive test 
for the hepatitis B virus is defined as: (1) positive for hepatitis B surface antigen, or (2) 
positive for anti-hepatitis B core antibody. A positive test for the hepatitis C virus is defined 
as: (1) positive for hepatitis C antibody, and (2) positive via a confirmatory test for hepatitis 
C virus (for example, hepatitis C virus polymerase chain reaction). 
29. There is confirmation of a pregnancy, as evidenced by a positive pregnancy test (see 
Section 9.1.4 for more information regarding pregnancies). 
30. Subjects showing: 
• Suicidal ideation in the past month prior to the OLE2 Screening Visit as indicated by a 
positive response ("Yes") to either Question 4 or Question 5 of the electronic Columbia 
Suicide Severity Rating Scale (eC SSRS). 
• Any suicidal behavior since last visit. 
31. Subject has presence of moderately severe or severe major depression, indicated by a score 
≥15 on the PHQ-9. Medication used to treat depression should be stable for 4 weeks prior to 
Week 144/OLE2 Baseline. 
32. Subject has developed any active malignancy or history of malignancy prior to the OLE2 
Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell 
carcinoma, or in situ cervical cancer. 
33.  Subject has received any live (includes attenuated) vaccination within the 8 weeks prior to 
the Week 144/OLE2 Baseline Visit. 
 
Change #14 
Section 7.2 Treatment to be administered 
OLE2 Period dosing  
After the implementation of Protocol Amendment #3.3 (addition of a 48-week open-label 
treatment period, ie, OLE2 Period), subjects will be invited to continue or reinitiate  treatment as 
per the following OLE2 Groups: 
• OLE2 Group A: Subjects in the Treatment Period at the time of Protocol Amendment #3.3 
implementation will attend the Week 144 Visit and may directly roll over to the OLE2 
Period. These subjects will continue receiving bimekizumab 320mg Q8W for 40 additional 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 203 of 216 
weeks, starting from the first treatment visit of the OLE2 Period (ie, Week 144/OLE2 
Baseline Visit; the Week 144 Visit will coincide with the Week 144/OLE2 Baseline Visit and 
data collected at this visit will be used as baseline data for subjects entering the OLE2 
Period). 
• OLE2 Group B: Eligible subjects who have completed the Treatment Week 144 Visit and 
who are in the SFU or have completed the SFU at the time of Protocol Amendment #3.3 
implementation may reinitiate bimekizumab treatment in the OLE2 Period after having 
undergone Screening assessments during a 4-week OLE2 Screening Period. The first dose 
will be administered at the Week 144/OLE2 Baseline Visit; data collected at this visit will be 
used as baseline data. Subjects with an IGA score ≥3 upon entry in the OLE2 Period will be 
treated with bimekizumab Q4W for the first 16 weeks, and will then switch to bimekizumab 
320mg Q8W. Subjects in OLE2 Group B with an IGA score <3 upon entry will be treated 
with bimekizumab Q8W from the Week 144/OLE2 Baseline Visit. 
During the OLE2 Period (Week 144/OLE2 Baseline to OLE2 Week 48), all subjects will attend 
study visits at the study site every 12 weeks for study assessments and subjects may self-inject 
IMP at home. 
Change #15 
Section 7.7  
Procedures for monitoring subject compliance 
After Week 48, self-injection at home will be possible at the following weeks: Weeks 52, 56, 64, 
68, 76, 80, 88, 92, 100, 104, 112, 116, 124, 128, 136, and 140. 
Was changed to: 
After Week 48, self-injection at home will be possible at the following weeks: Weeks 52, 56, 64, 
68, 76, 80, 88, 92, 100, 104, 112, 116, 124, 128, 136, 140, and at the OLE2 Weeks 4, 8, 16, 32, 
and 40. 
Change #16 
Section 7.8.2 Prohibited concomitant treatments (medications and therapies) 
Table 7 1: Prohibited PSO medications 
Subjects who take prohibited medications may be withdrawn from IMP but followed until the 
SFU Visit. The decision to withdraw a subject for taking prohibited medications should be made 
in consultation with the Medical Monitor. 
Was changed to: 
Up to Week 144 
Subjects who take prohibited medications may be withdrawn from IMP but followed until the 
SFU Visit. The decision to withdraw a subject for taking prohibited medications should be made 
in consultation with the Medical Monitor. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 204 of 216 
Post Week 144 (OLE2 Period) 
Subjects who have used systemic treatments for PSO after Week 144 must have stopped 
this treatment 1 month prior to receiving the first bimekizumab injection in the OLE2 
Period. Subjects receiving systemic immunomodulatory medications for an indication other 
than PSO must have their eligibility confirmed by the Medical Monitor prior to enrollment 
in the OLE2 Period. 
Subjects who take prohibited medications during the OLE2 Period may be withdrawn 
from IMP but followed until the SFU2 Visit. The decision to withdraw a subject for taking 
prohibited medications should be made in consultation with the Medical Monitor. 
Change #17 
Section 7.10 Randomization and numbering of subjects 
The following paragraph was added 
Subjects who roll over directly from the Treatment Period into the OLE2 Period will 
continue receiving bimekizumab 320mg Q8W and will keep their unique 5-digit 
identification number. Subjects who reinitiate bimekizumab after having completed 
treatment (subjects in the SFU of the Treatment Period or who have completed the SFU of 
the Treatment Period) will receive either bimekizumab 320mg Q4W/Q8W or bimekizumab 
320mg Q8W depending on their disease activity at time of reentry (bimekizumab 320mg 
Q4W/Q8W for subjects with IGA score ≥3 or bimekizumab 320mg Q8W for subjects with 
IGA score <3). For these subjects, the same unique 5-digit identification number used in 
the study will be reused. 
Change #18 
Section 8 STUDY PROCEDURES BY VISIT 
Table 5-1 (Schedule of study assessments) provides a general overview of study assessments in 
Year 1 (Weeks 0 to 44). Table 5-2 (Schedule of study assessments) provides a general overview 
of study assessments in Years 2 and 3 (Weeks 48 to 144). A list of procedures to be completed at 
each visit is described below. 
• Visit windows of ±7 days on either side of the scheduled dosing are permitted; however, the 
Investigator should try to keep the subjects on the original dosing schedule. The window of 
±7 days is relative to Baseline and applicable for all subsequent visits. Changes to the dosing 
schedule outside of the visit window must be discussed with the Medical Monitor. 
• The dosing window is ±7 days relative to the scheduled dosing visit. 
•  Visit (20 weeks after the final dose), the visit window is ±7 days relative to the scheduled 
visit date. 
Was changed to  
Table 5-1 (Schedule of study assessments) provides a general overview of study assessments in 
Year 1 (Weeks 0 to 44). Table 5-2 (Schedule of study assessments) provides a general overview 
of study assessments in Years 2 and 3 (Weeks 48 to 144). Table 5-3 (Schedule of study 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 205 of 216 
assessments) provides a general overview of study assessments in OLE2 Period (from 
OLE2 Screening or Week 144/OLE2 Baseline to OLE2 Week 48).  
A list of procedures to be completed at each visit up to Week 144 is described below. 
• Visit windows of ±7 days on either side of the scheduled dosing are permitted; however, the 
Investigator should try to keep the subjects on the original dosing schedule. The window of 
±7 days is relative to Baseline and applicable for all subsequent visits. Changes to the dosing 
schedule outside of the visit 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 final dose), the visit window is ±7 days relative to 
the scheduled visit date. 
A list of procedures to be completed at each visit of the OLE2 Period is described below. 
• Visit windows of ±14 days on either side of the scheduled dosing are permitted; 
however, the Investigator should try to keep the subjects on the original dosing 
schedule. The window of ±14 days is relative to Week 144/OLE2 Baseline and 
applicable for all subsequent visits. Changes to the dosing schedule outside of the visit 
window must be discussed with the Medical Monitor. 
• The dosing window is ±14 days relative to the scheduled dosing visit. 
• For the SFU2 Visit (20 weeks after the final dose), the visit window is ±7 days relative to 
the scheduled visit date. 
Change #19 
Section 8.1.2.12 Week 144 Visit (±7 days relative to Baseline) 
The following text was added: 
If Protocol Amendment #3.3 is implemented at the time study subjects are treated in the 
Treatment Period (ie, up to Week 144; OLE2 Group A subjects), these subjects will be 
invited to participate in the OLE2 Period and may directly roll over and continue 
bimekizumab treatment from the Week 144/OLE2 Baseline Visit as long as they do not 
meet any of the withdrawal criteria and have provided informed consent. 
If Protocol Amendment #3.3 is implemented at the time subjects have completed the Week 
144 Visit and are in the SFU Period of the Treatment Period or have completed the SFU of 
the Treatment Period (Group B subjects), these subjects will be invited to enter the OLE2 
Period to reinitiate bimekizumab treatment in the OLE2 Period. However, before receiving 
the first dose at the Week 144/OLE2 Baseline Visit, they will first undergo screening during 
the 4-week OLE2 Screening Period (see Section 8.1.3.1 for the procedures that will apply 
for the Screening of the OLE2 Period). 
 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 206 of 216 
Change #20 
The following sections were added: 
8.1.3 OLE2 Period  
8.1.3.1 OLE2 Screening (up to 4 weeks) – applicable for OLE2 Group B only 
Prior to any study specific activities of the OLE2 Period, subjects who completed the Week 144 
Visit and are in the SFU or have completed the SFU of the Treatment Period (OLE2 Group B) 
will undergo screening. Subjects who have used systemic treatments for PSO after Week 144 
must have stopped this treatment 1 month prior to receiving the first bimekizumab injection in 
the OLE2 Period. Screening procedures may be performed during this time. Subjects receiving 
systemic immunomodulatory medications for an indication other than PSO must have their 
eligibility confirmed by the Medical Monitor prior to enrollment in the OLE2 Period. 
At the Screening Visit of the OLE2 Period (OLE2 Screening Visit), subjects will be asked to 
read, sign, and date an ICF that has been approved by the Sponsor and an IRB/IEC and that 
complies with regulatory requirements. Subjects will be given adequate time to consider any 
information concerning the study given to them by the Investigator or designee. As part of the 
informed consent procedure, subjects will be given the opportunity to ask the Investigator any 
questions regarding potential risks and benefits of continued participation in the study. 
The following procedures/assessments will be performed at the OLE2 Screening Visit for 
subjects in the OLE2 Group B: 
• Informed consent 
• Inclusion/exclusion 
• Urine drug screen 
• Significant past medical history including clinically relevant past or coexisting medical 
conditions and surgeries (only applicable for subjects who completed the SFU; only new or 
modified medical history since completing the SFU should be entered in eCRF) 
• Physical exam 
• 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: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
− Hepatitis B and Hepatitis C 
− HIV 
• Tuberculosis questionnaire 
• PASI 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 207 of 216 
• Percentage of BSA 
• IGA 
• PHQ-9 
• eC-SSRS 
• Prior and concomitant medication (including new or modified medications initiated after 
SFU) 
• AE (only for subjects in the SFU) 
• Contact IRT 
8.1.3.2 Dosing in the OLE2 Period 
Subjects will be dosed in the OLE2 Period according to the dosing schedule presented in 
Table 8-2. 
Table 8-2 Dosing scheme, OLE2 Period  
 
OLE2 Period 
Visits/Week 
 
 
 
 
Dose Assignment 
Week 144/OLE2 
Baseline 
OLE2 W4 
OLE2 W8 
OLE2 W12 a 
OLE2 W16 
OLE2 W24 b 
OLE2 W32 
OLE2 W36 c 
OLE2 W40 
C 
H 
H 
C 
H 
C 
H 
C 
H 
Bimekizumab 320mg 
Q4W/Q8W d 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
●● 
Bimekizumab 320mg Q8W 
●● 
 
●● 
 
●● 
●● 
●● 
 
●● 
C=Clinic; H=home; IGA= Investigator’s Global Assessment; IMP=investigational medicinal product; OLE=open 
label extension; Q4W/Q8W=every 4 weeks for 16 weeks, followed by every 8 weeks; Q8W=every 8 weeks 
Notes: A bimekizumab 160mg injection is depicted by a black circle (●). 
a Subjects will receive kits for home administration 4 weeks later. 
b Subjects will receive kits for home administration 8 weeks later. 
c Subjects should NOT be dosed at this visit and will receive kits for home administration 4 weeks later. 
d Q4W/Q8W IMP administration only applies to those subjects who have entered the OLE2 Period as part of 
Group B and had an IGA ≥3 upon entry of the OLE2 Period. These subjects will receive Q4W dosing for 
16 weeks until OLE2 Week 16, then will change from Q4W to Q8W and will receive their next dose at the 
scheduled clinic visit OLE2 Week 24. 
 
8.1.3.2.1 Week 144/OLE2 Baseline Visit 
Subjects who will still be treated in the Treatment Period at the time of implementing Protocol 
Amendment #3.3 (OLE2 Group A subjects) will attend Week 144 Visit and directly roll over to 
the OLE2 Period to continue treatment (bimekizumab 320mg Q8W). They will undergo all study 
assessments of the Week 144 Visit and will receive bimekizumab 320mg Q8W at this visit, 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 208 of 216 
which will also coincide with the first visit of the OLE2 Period, ie, the Week 144/OLE2 Baseline 
Visit. 
Subjects who have completed Week 144 Visit and are in the SFU of the Treatment Period or 
have completed the SFU Period at the time of Protocol Amendment #3.3 implementation (OLE2 
Group B subjects) will reinitiate bimekizumab treatment at the Week 144/OLE2 Baseline Visit, 
and will be assigned a treatment regimen based on disease severity at the Week 144/OLE2 
Baseline Visit (bimekizumab 320mg Q4W/Q8W for subjects with IGA score ≥3 or bimekizumab 
320mg Q8W for subjects with IGA score <3). 
Applicable for OLE2 Groups A and B: 
• Confirmation of eligibility  
• Physical exam 
• 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: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
• eC-SSRS 
• Tuberculosis questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• PHQ-9 
• DLQI 
• Concomitant medication 
• AEs 
• Contact IRT 
 
Additional Procedures/assessments applicable for OLE2 Group A  
• Informed Consent  
• ECG 
• Blood sample for bimekizumab plasma concentrations 
• Blood sample for anti‑bimekizumab antibodies 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 209 of 216 
• IGRA TB test 
• scalp IGA 
• mNAPSI 
• pp-IGA 
• EQ-5D-3L 
• PASE 
• PGADA 
• WPAI-SHP V2.0 
 
At the Week 144/OLE2 Baseline Visit, after completion of the above-mentioned procedures, 
administration of IMP will occur, preferably by self-injection under supervision of the site 
personnel. 
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. 
8.1.3.2.2 Self-injection at home (OLE2 Weeks 4, 8, 16, 32, and 40) 
Subjects receiving bimekizumab 320mg Q8W will be given the opportunity for self-injection of 
bimekizumab at home on the following weeks: OLE2 Weeks 8, 16, 32, and 40. 
Subjects receiving bimekizumab 320mg Q4W/Q8W will be given the opportunity for self-
injection of bimekizumab at home on the following weeks: OLE2 Weeks 4, 8, and 16. At OLE2 
Week 16, subjects receiving bimekizumab 320mg Q4W/Q8W will switch to bimekizumab 
320mg Q8W regimen and will be given the opportunity for self-injection of bimekizumab at 
home at OLE2 Weeks 32 and 40. 
Adverse events will be captured spontaneously if the subject decides to visit the site to receive 
the bimekizumab administration.  
All used syringes will be disposed of by subjects/caregivers as determined by the Investigator in 
an acceptable disposal (sharps) container directly after the administration. The 
subjects/caregivers return the documentation together with any used/unused containers at the 
next scheduled clinic visit. 
 
8.1.3.2.3 OLE2 Week 12, Week 24, and Week 36 Visits (±14 days relative to OLE2 
Baseline) 
As depicted in Table 8-2, subjects receiving bimekizumab 320mg  Q4W/Q8W should receive 
IMP at the OLE2 Week 12 Visit, and all subjects will receive kits for home administration 
4 weeks later at OLE2 Week 16. All subjects will receive IMP administration at the OLE2 
Week 24 Visit, and will receive kits for home administration 8 weeks later. At the OLE2 Week 
36 Visit, subjects will not be dosed and will receive kits for home administration 4 weeks later at 
OLE2 Week 40. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 210 of 216 
The following procedures/assessments will be performed/recorded at every clinic visit prior to 
administration of IMP: 
• Physical exam 
• Vital signs (sitting systolic and diastolic BP, pulse rate, and body temperature) should be 
obtained prior to blood sampling 
• Urine pregnancy test, for applicable subjects 
• Tuberculosis questionnaire  
• PASI 
• Percentage of BSA  
• IGA 
• PHQ-9  
• eC-SSRS  
• Concomitant medication  
• AEs  
• Contact IRT  
 
The following additional assessments will be performed / recorded every 24 weeks (ie, at OLE2 
Week 24 Visit) prior to administration of IMP: 
• Collection of blood and urine samples for the following tests should be obtained prior to 
dosing: 
− Hematology and chemistry 
− Urinalysis 
• DLQI  
 
At the OLE2 Week 12 (OLE2 Group B subjects on Q4W/Q8W dosing only) and Week 24 Visit, 
after completion of the above-mentioned procedures, administration of IMP will occur, 
preferably by self-injection under supervision of the site personnel. 
Distribution of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. 
8.1.3.3 OLE2 Week 48 Visit (±14 days relative to OLE2 Baseline) 
The following procedures/assessments will be performed/recorded: 
• Physical exam 
• Body weight 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 211 of 216 
• Vital signs (sitting systolic BP 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: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
− IGRA TB test 
• Tuberculosis questionnaire 
• PASI 
• Percentage of BSA 
• IGA 
• DLQI 
• PHQ-9 
• eC-SSRS 
• Concomitant medication 
• AEs 
• Contact IRT 
Return of IMP and accountability activities for home administration to be performed as 
described in Section 7.2, Section 7.5, and Section 7.7. 
Change #21 
Section 8.2Premature End of Treatment Visit 
The following text was added: 
If a subject is withdrawn from the study during the OLE2 Period: 
• The subject will be withdrawn from IMP, will undergo the same assessments as the 
OLE2 Week 48 visit (see Section 8.1.3.3), and will enter the SFU2 Period. 
• The subject will be encouraged to return for the SFU2 Visit (20 weeks after the last 
received dose; see Section 8.4). 
 
 
 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 212 of 216 
Change #22 
8.4 Safety Follow-Up Visit 2 (20 weeks after final dose of the OLE2 Period, ±7 days) 
The following procedures/assessments will be performed/recorded: 
• Physical exam  
• 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 tests should be obtained at this visit: 
− Hematology and chemistry 
− Urinalysis 
− Urine pregnancy test 
• PHQ-9 
• eC-SSRS 
• Concomitant medication 
• AEs 
• Contact IRT 
 
Change #23 
Section 18.5 Laboratory measurements 
The following test were added 
Table 9-2 Laboratory measurements 
Hematology 
Chemistry 
Urinalysis dipsticka 
 
HIV d 
 
 
Hepatitis B and C d 
 
d Only for Group B; only at the OLE2 Screening Visit. 
 
 
 
 
 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 213 of 216 
Change #24 
Section 18.5 Unscheduled Visit 
At the Investigator’s discretion, an Unscheduled Visit may be completed at any time during the 
study, but prior to the SFU Visit, if deemed necessary for the subject’s safety and well-being. 
Was changed to  
At the Investigator’s discretion, an Unscheduled Visit may be completed at any time during the 
study, but prior to the SFU Visit or SFU2 Visit (depending on which period [Treatment 
Period or OLE2 Period] the subject is in), if deemed necessary for the subject’s safety and 
well-being. 
 
Change #25 
11 ASSESSMENT OF PHARMACOKINETIC VARIABLES 
11.1 
Pharmacokinetic variables 
The following sentence was added: 
Blood samples for the measurement of PK assessments will not be collected in the OLE2 
Period. 
Change #26 
12 ASSESSMENT OF IMMUNOLOGICAL VARIABLES 
The following sentence was added: 
Blood samples for the measurement of antibodies to bimekizumab will not be collected in 
the OLE2 Period. 
 
Change #27 
Section 14.1 Definition of analysis sets 
The following sentence was added: 
The OLE2 Period Set (OL2S) will consist of all subjects that receive at least 1 dose of IMP 
at Week 144/OLE2 or later in the OLE2 Period (including the Week 144/OLE2 Baseline 
dose). 
Change #28 
14.3 
Planned safety analyses 
Safety variables will be analyzed for all subjects in the SS. 
Was changed to  
Safety variables will be analyzed for all subjects in the SS and selected summaries will be 
provided for subjects in the OLE2 Period (OL2S). 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 214 of 216 
Change #29 
14.4 
Planned efficacy analyses 
Efficacy analyses will be summarized based on the FAS. The summaries described in this 
section will provide data on maintenance of effect of open-label bimekizumab over 144 weeks 
and beyond. Additionally, it will allow an assessment of the impact of dose adjustments on 
efficacy results. As these variables are summarized over time and the initial values can be 
impacted by the treatment in the feeder study, the presentation using a combination of 
feeder/extension study treatment groups is intended to provide perspective on the change in these 
values from the feeder study through the Treatment Period of PS0014. The table presentations 
will display descriptive statistics for the Baseline of the feeder study and the observed and 
change from Baseline study results by scheduled visit for PS0014.  
Was changed to 
Efficacy analyses will be summarized based on the FAS during the Treatment Period. The 
summaries described in this section will provide data on maintenance of effect of open-label 
bimekizumab over 144 weeks and beyond. Additionally, it will allow an assessment of the 
impact of dose adjustments on efficacy results. As these variables are summarized over time and 
the initial values can be impacted by the treatment in the feeder study, the presentation using a 
combination of feeder/extension study treatment groups is intended to provide perspective on the 
change in these values from the feeder study through the Treatment Period of PS0014. The table 
presentations will display descriptive statistics for the Baseline of the feeder study and the 
observed and change from Baseline study results by scheduled visit for PS0014. Selected 
efficacy summaries during the OLE2 Period may also be provided for selected efficacy 
variables. 
 
Change #30 
14.9 
Planned interim analysis and data monitoring 
An interim analysis is planned at Week 48, details of which will be documented in the SAP. 
Additional interim analyses may be performed and corresponding interim Clinical Study Reports 
(CSRs) may be written. A final analysis and updated final CSR will be prepared once all data 
through the SFU visit) have been collected. 
Was changed to 
An interim analysis is planned at Week 48 and Week 144, details of which will be documented 
in the SAP. Additional interim analyses may be performed (details of which will be 
documented in the SAP). Corresponding interim Clinical Study Reports (CSRs) may be 
written. A final analysis and updated final CSR will be prepared once all data through the SFU 
visit) OLE2 Period and SFU2 Visit have been collected. 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 215 of 216 
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 
 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

UCB 
 
12 Oct 2021 
Clinical Study Protocol 
Bimekizumab 
PS0014 
 
 
 
Confidential 
Page 216 of 216 
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. 
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.

Approval Signatures
Name:
ps0014-protocol-amend-3.3
Version:
1. 0
Document Number:
CLIN-000177639
Title:
ps0014-protocol-amend-3.3
Approved Date:
13 Oct 2021
Document Approvals
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 12-Oct-2021 15:56:50 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 12-Oct-2021 16:01:48 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 13-Oct-2021 09:22:07 GMT+0000
PUBLIC COPY 
This document cannot be used to support any marketing authorization 
application and any extensions or variations thereof.