Conditions: Psoriatic Arthritis
Keywords: Bimekizumab Psoriatic Arthritis PsA
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 184
Healthy volunteers: no

Brief summary:
This is a study to assess the long-term safety and tolerability of bimekizumab in subjects with psoriatic arthritis

Detailed description:

Arms:
arm 1: Subjects will receive bimekizumab up to 2 years.

Interventions: intervention 1: Bimekizumab
Intervention descriptions: intervention 1: Bimekizumab at a prespecified dose.

Protocol document:
Prot_000.pdf: 
UCB 
 
11 Dec 2019 
Clinical Study Protocol 
Bimekizumab 
 
PA0009 
 
 
 
Confidential 
Page 1 of 116 
PROTOCOL PA0009 AMENDMENT 3 
A MULTICENTER, OPEN-LABEL, FOLLOW-UP STUDY TO 
EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF 
BIMEKIZUMAB IN SUBJECTS WITH PSORIATIC ARTHRITIS  
PHASE 2B 
 
EudraCT Number: 2017-001003-74 
IND Number: 128708 
Sponsor: 
UCB Biopharma SRL 
Allée de la Recherche 60 
1070 Brussels 
BELGIUM 
Protocol/Amendment number 
Date 
Type of 
amendment 
Final protocol 
15 May 2017 
Not applicable 
Protocol amendment 1 
27 June 2017 
Not applicable 
Protocol amendment 2 
09 Mar 2018 
Substantial 
Protocol amendment 2.1 (Czech Republic) 
11 Jun 2018 
Substantial 
Protocol amendment 3 
11 Dec 2019 
Nonsubstantial 
Confidential Material 
Confidential 
This document is the property of UCB and may not – in full or in part – be passed on, 
reproduced, published, or otherwise used without the express permission of UCB. 
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Bimekizumab 
 
PA0009 
 
 
 
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STUDY CONTACT INFORMATION 
Sponsor 
UCB BIOPHARMA SRL 
Allée de la Recherche 60 
1070 Brussels 
BELGIUM 
Sponsor Study Physician 
Name: 
, MD  
Address: 
UCB  
208 Bath Road  
Slough, SL1 3WE 
UNITED KINGDOM  
Phone: 
 
Clinical Project Manager 
Name: 
 
Address: 
UCB  
208 Bath Road 
Slough SL1 3WE 
UNITED KINGDOM 
Phone: 
 
Clinical Trial Biostatistician 
Name: 
 
Address: 
UCB  
208 Bath Road 
Slough SL1 3WE 
UNITED KINGDOM 
Phone: 
 
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Clinical Monitoring Contract Research Organization 
Name: 
PRA Health Sciences 
Address: 
4130 Park Lake Avenue, Suite 400 
Raleigh, NC 27612 
UNITED STATES 
Phone: 
+1-919-786-8200 
Fax: 
+1-919-786-8201 
SERIOUS ADVERSE EVENT REPORTING 
Serious adverse event reporting (24h) 
Fax 
Europe and Rest of the World: +32 2 386 24 21 
USA and Canada: +1 800 880 6949 or +1 866 890 3175 
Email 
Global: DS_ICT@ucb.com  
 
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Bimekizumab 
 
PA0009 
 
 
 
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TABLE OF CONTENTS 
LIST OF ABBREVIATIONS .................................................................................................... 9 
1 
SUMMARY ..................................................................................................................... 13 
2 
INTRODUCTION ........................................................................................................... 13 
2.1 Psoriatic arthritis .............................................................................................................. 13 
2.1.1 
Clinical studies ..................................................................................................... 14 
2.1.2 
Nonclinical studies ............................................................................................... 16 
3 
STUDY OBJECTIVES .................................................................................................... 16 
3.1 Primary objective ............................................................................................................. 16 
3.2 Secondary objectives ....................................................................................................... 17 
3.3 Other objectives ............................................................................................................... 17 
4 
STUDY VARIABLES ..................................................................................................... 17 
4.1 Primary variables ............................................................................................................. 17 
4.1.1 
Primary safety variables ...................................................................................... 17 
4.2 Secondary variables ......................................................................................................... 17 
4.2.1 
Secondary safety variable .................................................................................... 17 
4.2.2 
Secondary efficacy variables ............................................................................... 17 
4.3 Other variables ................................................................................................................. 17 
4.3.1 
Safety variables .................................................................................................... 17 
4.3.2 
Efficacy variables ................................................................................................ 18 
4.3.3 
PK variable .......................................................................................................... 18 
4.3.4 
Immunological variable ....................................................................................... 18 
5 
STUDY DESIGN ............................................................................................................. 18 
5.1 Study description ............................................................................................................. 18 
5.1.1 
Rescue therapy ..................................................................................................... 19 
5.1.2 
Study duration per subject ................................................................................... 19 
5.1.3 
Planned number of subjects and sites .................................................................. 19 
5.1.4 
Anticipated regions and countries ....................................................................... 19 
5.2 Schedule of study assessments ......................................................................................... 19 
5.3 Schematic diagram ........................................................................................................... 23 
5.4 Rationale for study design and selection of dose ............................................................. 23 
6 
SELECTION AND WITHDRAWAL OF SUBJECTS ................................................... 24 
6.1 Inclusion criteria .............................................................................................................. 24 
6.2 Exclusion criteria ............................................................................................................. 25 
6.3 Withdrawal criteria .......................................................................................................... 25 
6.3.1 
Potential drug-induced liver injury investigational medicinal product 
discontinuation criteria ........................................................................................ 27 
7 
STUDY TREATMENT ................................................................................................... 27 
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7.1 Description of investigational medicinal product ............................................................ 27 
7.2 Treatment to be administered ........................................................................................... 28 
7.3 Packaging ......................................................................................................................... 28 
7.4 Labeling ........................................................................................................................... 28 
7.5 Handling and storage requirements.................................................................................. 29 
7.6 Drug accountability .......................................................................................................... 29 
7.7 Procedures for monitoring subject compliance ................................................................ 30 
7.8 Concomitant medications/treatments ............................................................................... 30 
7.8.1 
Permitted concomitant treatments (medications and therapies) .......................... 30 
7.8.2 
Prohibited concomitant treatments (medications and therapies) ......................... 32 
7.9 Blinding ............................................................................................................................ 33 
7.10 Randomization and numbering of subjects ...................................................................... 33 
8 
STUDY PROCEDURES BY VISIT ............................................................................... 33 
8.1 Visit 1 ............................................................................................................................... 33 
8.2 Week 4 (Visit 2) and Week 8 (Visit 3) ............................................................................ 34 
8.3 Week 12 (Visit 4), Week 24 (Visit 5), Week 36 (Visit 6), and Week 72 (Visit 9) .......... 35 
8.4 Week 16, Week 20, Week 28, Week 32, Week 40, Week 44, Week 52, Week 56, Week 
64, Week 68, Week 76, Week 80, Week 88, and Week 92 ............................................. 36 
8.5 Week 48 (Visit 7) and Week 96 (Visit 11) ...................................................................... 36 
8.6 Week 60 (Visit 8) and Week 84 (Visit 10) ...................................................................... 37 
8.7 Week 100 (Visit 12) ......................................................................................................... 38 
8.8 Week 104 (Visit 13) or Early Termination Visit ............................................................. 39 
8.9 SFU Visit (20 weeks after the final dose of IMP) ........................................................... 40 
8.10 Early Termination Visit ................................................................................................... 40 
8.11 Unscheduled Visit ............................................................................................................ 40 
9 
ASSESSMENT OF SAFETY .......................................................................................... 41 
9.1 Adverse events ................................................................................................................. 41 
9.1.1 
Definition of AE .................................................................................................. 41 
9.1.2 
AEs of special interest ......................................................................................... 41 
9.1.3 
Other safety topics of interest .............................................................................. 42 
9.1.4 
Procedures for reporting and recording AEs ....................................................... 42 
9.1.5 
Description of AEs .............................................................................................. 42 
9.1.6 
Follow-up of AEs ................................................................................................ 43 
9.1.7 
Rule for repetition of an AE ................................................................................ 43 
9.1.8 
Pregnancy ............................................................................................................ 43 
9.1.9 
Suspected transmission of an infectious agent via a medicinal product .............. 44 
9.1.10 
Overdose of investigational medicinal product ................................................... 44 
9.1.11 
Safety signal detection ......................................................................................... 44 
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9.2 Serious AEs ...................................................................................................................... 45 
9.2.1 
Definition of SAEs .............................................................................................. 45 
9.2.2 
Procedures for reporting serious adverse events ................................................. 46 
9.2.3 
Follow-up of SAEs .............................................................................................. 46 
9.3 Immediate reporting of AEs ............................................................................................. 46 
9.4 Anticipated SAEs ............................................................................................................. 47 
9.5 Laboratory measurements ................................................................................................ 47 
9.5.1 
Evaluation of PDILI ............................................................................................ 48 
9.5.1.1 
Consultation with Medical Monitor and local hepatologist ...................... 52 
9.5.1.2 
Immediate action: determination of IMP discontinuation ......................... 52 
9.5.1.3 
IMP restart/rechallenge ............................................................................. 52 
9.5.1.4 
Testing: identification/exclusion of alternative etiology ........................... 52 
9.5.1.5 
Follow-up evaluation ................................................................................. 54 
9.6 Other safety measurements .............................................................................................. 54 
9.6.1 
Vital signs ............................................................................................................ 54 
9.6.2 
Body weight ......................................................................................................... 55 
9.6.3 
Physical examination ........................................................................................... 55 
9.6.4 
12-lead ECG ........................................................................................................ 55 
9.6.5 
Tuberculosis and TB risk factor assessment and management ........................... 55 
9.6.5.1 
Tuberculosis assessment by IGRA ............................................................ 56 
9.6.5.2 
Tuberculosis questionnaire ........................................................................ 56 
9.6.5.3 
Tuberculosis management ......................................................................... 56 
9.6.6 
Pregnancy testing ................................................................................................. 57 
9.6.7 
Assessment of suicidal ideation and behavior ..................................................... 57 
10 ASSESSMENT OF EFFICACY ...................................................................................... 57 
10.1 78/76 joint evaluation for ACR response ......................................................................... 57 
10.2 28 joint evaluation for determination of DAS28(CRP) ................................................... 58 
10.3 Patient’s Global Assessment of Disease Activity ............................................................ 58 
10.4 Physician’s Global Assessment of Disease Activity ....................................................... 58 
10.5 Patient’s Assessment of Arthritis Pain ............................................................................. 58 
10.6 Health Assessment Questionnaire-Disability Index score ............................................... 59 
10.7 CRP levels ........................................................................................................................ 59 
10.8 ACR20, ACR50, and ACR70 response ........................................................................... 59 
10.9 BSA-PSO ......................................................................................................................... 59 
10.10 
Psoriasis Area and Severity Index (PASI) ............................................................. 60 
10.11 
MDA ...................................................................................................................... 60 
10.12 
DAS28(CRP) ......................................................................................................... 61 
10.13 
MASES .................................................................................................................. 61 
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10.14 
LDI ......................................................................................................................... 61 
10.15 
Hospital Anxiety and Depression Scale ................................................................. 61 
10.16 
PsAID-9 ................................................................................................................. 62 
10.17 
SF-36 ...................................................................................................................... 62 
11 ASSESSMENT OF IMMUNOGENICITY ..................................................................... 62 
12 STUDY MANAGEMENT AND ADMINISTRATION ................................................. 62 
12.1 Adherence to protocol ...................................................................................................... 62 
12.2 Monitoring ....................................................................................................................... 63 
12.2.1 
Definition of source data ..................................................................................... 63 
12.2.2 
Source data verification ....................................................................................... 63 
12.3 Data handling ................................................................................................................... 64 
12.3.1 
Case Report form completion .............................................................................. 64 
12.3.2 
Database entry and reconciliation ........................................................................ 64 
12.3.3 
Subject Screening and Enrollment log/Subject Identification Code list.............. 64 
12.4 Termination of the study .................................................................................................. 65 
12.5 Archiving and data retention ............................................................................................ 65 
12.6 Audit and inspection ........................................................................................................ 65 
12.7 Good Clinical Practice ..................................................................................................... 66 
13 STATISTICS ................................................................................................................... 66 
13.1 Definition of analysis sets ................................................................................................ 66 
13.2 General statistical considerations ..................................................................................... 66 
13.3 Planned safety analyses .................................................................................................... 66 
13.3.1 
Safety analyses ..................................................................................................... 66 
13.4 Planned efficacy analyses ................................................................................................ 67 
13.4.1 
Subgroup analysis ................................................................................................ 67 
13.5 Planned immunogenicity analyses ................................................................................... 67 
13.6 Other analyses .................................................................................................................. 68 
13.7 Handling of protocol deviations ....................................................................................... 68 
13.8 Handling of dropouts or missing data .............................................................................. 68 
13.9 Planned interim analysis and data monitoring ................................................................. 68 
13.10 
Determination of sample size ................................................................................. 68 
14 ETHICS AND REGULATORY REQUIREMENTS ...................................................... 68 
14.1 Informed consent ............................................................................................................. 68 
14.2 Subject identification cards .............................................................................................. 69 
14.3 Institutional Review Boards and Independent Ethics Committees .................................. 69 
14.4 Subject privacy ................................................................................................................. 70 
14.5 Protocol amendments ....................................................................................................... 70 
15 FINANCE, INSURANCE, AND PUBLICATION ......................................................... 70 
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Bimekizumab 
 
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16 REFERENCES ................................................................................................................ 71 
17 APPENDICES ................................................................................................................. 75 
17.1 Markedly abnormal laboratory values ............................................................................. 75 
17.2 Protocol Amendment 1 .................................................................................................... 76 
17.3 Protocol Amendment 2 .................................................................................................... 79 
17.4 Protocol Amendment 3 .................................................................................................... 96 
18 DECLARATION AND SIGNATURE OF INVESTIGATOR ..................................... 115 
19 SPONSOR DECLARATION ........................................................................................ 116 
 
LIST OF TABLES 
Table 5‒1: 
Schedule of study assessments......................................................................... 20 
Table 7-1: 
Prohibited or restricted medications ................................................................ 32 
Table 7-2: 
Additional prohibited psoriasis treatments ...................................................... 32 
Table 9‒1: 
Anticipated SAEs for the population of subjects with psoriatic arthritis ......... 47 
Table 9-2: 
Laboratory measurements ................................................................................ 48 
Table 9-3: 
Required investigations and follow-up for PDILI ........................................... 50 
Table 9‒4: 
PDILI laboratory measurements ...................................................................... 53 
Table 9‒5: 
PDILI information to be collected ................................................................... 54 
Table 10‒1: 
Swelling and tenderness grading ..................................................................... 58 
Table 10‒2: 
Body areas for calculation of percent BSA for PASI ...................................... 60 
Table 10‒3: 
MDA criteria in PsA ........................................................................................ 61 
Table 17-1: 
Definitions of markedly abnormal hematology values .................................... 75 
Table 17‒2: 
Definitions of markedly abnormal biochemistry values .................................. 75 
 
LIST OF FIGURES 
Figure 5‒1: 
Schematic diagram ........................................................................................... 23 
 
 
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LIST OF ABBREVIATIONS 
ACR 
American College of Rheumatology 
ACR20, 50, 70 
American College of Rheumatology 20, 50, 70% response criteria 
AE  
adverse event 
AESI 
adverse event of special interest 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
AS 
ankylosing spondylitis 
AST 
aspartate aminotransferase 
axSpA 
axial spondyloarthritis 
BP 
blood pressure 
BSA 
body surface area 
CD 
cluster of differentiation 
CDMS 
clinical data management system 
CHO 
Chinese Hamster Ovarian 
CI 
confidence interval 
COX-2 
cyclooxygenase-2 
CPM 
Clinical Project Manager 
CRO 
Contract Research Organization 
CRP 
C-reactive protein 
DAS28(CRP) 
Disease Activity Score-28 joint count C-reactive protein 
DMARD 
disease-modifying antirheumatic drug 
EAER 
exposure-adjusted event rate 
EAIR 
exposure-adjusted incidence rate 
ECG 
electrocardiogram 
eCRF 
electronic Case Report form 
eC-SSRS 
electronic Columbia-Suicide Severity Rating Scale 
EDC 
electronic data capture 
ES 
Enrolled Set 
ET 
Early Termination 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
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GI 
gastrointestinal 
GMP 
Good Manufacturing Practice 
HADS 
Hospital Anxiety and Depression Scale 
HADS-A 
Hospital Anxiety and Depression Scale—Anxiety  
HADS-D 
Hospital Anxiety and Depression Scale—Depression  
HAQ-DI 
Health Assessment Questionnaire—Disability Index 
HRQoL 
Health-Related Quality of Life 
IB 
Investigator’s Brochure 
IBD 
Inflammatory Bowel Disease 
ICH 
International Council for Harmonisation 
IEC 
Independent Ethics Committee 
IgG 
Immunoglobulin G 
IGRA 
interferon-gamma release assay 
IL 
interleukin 
IL-17-RA 
interleukin-17 receptor A 
IMP 
investigational medicinal product 
IP 
interphalangeal 
IRB 
Institutional Review Board 
IUD 
intrauterine device  
IUS 
intrauterine hormone-releasing system 
iv 
intravenous 
IXRS 
interactive web or voice response system  
LDI 
Leeds Dactylitis Index 
LTB 
latent tuberculosis 
MAb 
monoclonal antibody 
MASES 
Maastricht Ankylosing Spondylitis Enthesitis Index 
MCMC 
Markov Chain Monte Carlo 
MCP 
metacarpophalangeal 
MDA 
Minimal Disease Activity 
MedDRA 
Medical Dictionary for Regulatory Activities 
MI 
multiple imputation 
NOAEL 
no adverse effect level 
NRI 
nonresponder imputation 
NSAID 
nonsteroidal anti-inflammatory drug 
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NTMB 
nontuberculous mycobacteria 
OLE 
open-label extension 
PASI 
Psoriasis Area and Severity Index 
PASI75, PASI90, 
PASI100 
Psoriasis Area and Severity Index 75%, 90%, 100% 
PD 
pharmacodynamics 
PDILI 
potential drug-induced liver injury 
PFS 
prefilled syringe 
PGADA 
Patient’s Global Assessment of Disease Activity 
PhGADA 
Physician’s Global Assessment of Disease Activity 
PIP 
proximal interphalangeal 
PK 
pharmacokinetics 
PS 
Patient Safety 
PsA 
psoriatic arthritis 
PsAID-9 
Psoriatic Arthritis Impact of Disease-9 
PSO 
psoriasis 
PtAAP 
Patient’s Assessment of Arthritis Pain 
PUVA 
psoralen plus ultraviolet A light therapy 
Q4W 
every 4 weeks (monthly) 
RA 
rheumatoid arthritis 
RCTC 
Rheumatology Common Toxicity Criteria 
SAE 
serious adverse event 
sc 
subcutaneous(ly) 
SF-36 
Short-Form 36-item Health Survey 
SFU 
Safety Follow-up 
SJC 
swollen joint count 
SOP 
Standard Operating Procedure 
SS 
Safety Set 
t1/2 
half-life 
TEAE 
treatment-emergent adverse event 
TB 
tuberculosis 
Th17 
T helper 17 
TJC 
tender joint count 
TNF 
tumor necrosis factor 
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TNFα 
tumor necrosis factor-alpha 
ULN 
upper limit of normal 
UVA 
ultraviolet A 
VAS 
visual analog scale 
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1 
SUMMARY 
PA0009 is a multicenter, open-label extension (OLE) study evaluating the long-term safety, 
tolerability, and efficacy of bimekizumab in subjects with psoriatic arthritis (PsA). Only subjects 
who complete PA0008, a Phase 2b study are eligible for enrollment into PA0009. At Week 48 of 
PA0008, all subjects continuing into PA0009 will undergo the final PA0008 study assessments 
and any nonoverlapping PA0009 entry assessments and will then receive their first open-label 
dose of bimekizumab. 
PA0008 is a multicenter, Phase 2b, randomized, double-blind, placebo-controlled, 
parallel-group, dose-ranging study to evaluate the efficacy and safety of bimekizumab in 
200 subjects with active PsA.  
In the PA0009 OLE study, bimekizumab will be administered at a dose of 160mg every 4 weeks 
(Q4W) subcutaneously (sc) for all subjects regardless of treatment received in PA0008. 
Up to 200 subjects from PA0008 may be enrolled into this study at any of the sites participating 
in PA0008. 
The primary objective of PA0009 is to assess the long-term safety and tolerability of 
bimekizumab administered over a period of up to 100 weeks (~2 years). The primary safety 
variables are the incidences of treatment-emergent adverse events (TEAEs) and 
treatment-emergent serious adverse events (SAEs). 
The secondary objective is to assess the long-term efficacy of bimekizumab over a period of up 
to 104 weeks (~2 years). The secondary efficacy variables include the American College of 
Rheumatology 20% (ACR20) response at Week 48 (with a responder defined as a subject with 
an improvement from PA0008 Baseline of ≥20% in the swollen and tender joint counts and at 
least 3 of the other 5 components of the core set of American College of Rheumatology [ACR] 
response measures), American College of Rheumatology 50% (ACR50) response at Week 48; 
American College of Rheumatology 70% (ACR70) response at Week 48, change from PA0008 
Baseline in the Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48, 
change from PA0008 Baseline in the Leeds Dactylitis Index (LDI) at Week 48, the Psoriasis 
Area and Severity Index 75 (PASI75) response, and the Psoriasis Area and Severity Index 90 
(PASI90) response at Week 48. The secondary safety variable is the withdrawal due to TEAEs.  
Other objectives are to evaluate the impact on dactylitis, enthesitis, and patient-reported quality 
of life, and to assess the plasma concentrations and immunogenicity of bimekizumab.  
The study duration for each subject is estimated to be up to a maximum of 120 weeks: an 
Open-Label Treatment Period of up to 100 weeks (~2 years), followed by a Safety Follow-up 
(SFU) Visit 20 weeks after the final dose of bimekizumab. 
2 
INTRODUCTION 
2.1 
Psoriatic arthritis 
Psoriatic arthritis, a chronic inflammatory musculoskeletal disorder, occurs in approximately 6% 
to 41% of people affected by psoriasis (PSO) (Ogdie and Weiss, 2015). A substantial proportion 
of subjects have polyarthritis (McHugh et al, 2003). Disease-modifying antirheumatic drugs 
(DMARDs) and biological agents targeting tumor necrosis factor-alpha (TNFα), 
interleukin (IL)-17, and IL-12/23 are effective in PsA (Kavanaugh et al, 2012; 
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Kavanaugh et al, 2009; Gottlieb et al, 2009; Gladman et al, 2007; Genovese et al, 2007; 
Kavanaugh et al, 2006; Antoni et al, 2005a; Antoni et al, 2005b; Mease et al, 2005; 
Mease et al, 2004, McInnes et al, 2015; Mease et al, 2015). However, some subjects are not 
responsive to these treatments, do not maintain a clinical response (defined as achieving ACR20 
response criteria), or have contraindications or intolerance to these agents. 
Recent work has implicated various isoforms comprising the IL-17 cytokine family in the 
pathophysiology of PSO and of PsA (Raychaudhuri et al, 2012; Fujishima et al, 2010; 
Watanabe et al, 2009; Harper et al, 2009; Johansen et al, 2009). Numbers of IL-17A positive 
cells are increased and localized in psoriatic skin lesions (Fujishima et al, 2010; 
Watanabe et al, 2009; Harper et al, 2009; Johansen et al, 2009), and IL-17A and IL-17F are 
overexpressed in the serum and skin lesions of subjects with PSO (Johansen et al, 2009), while 
IL-17F in particular is a key inflammatory cytokine contributing to PSO pathology 
(Fujishima et al, 2010; Watanabe et al, 2009). Cluster of differentiation (CD) 4 + T helper 
17 (Th17) cells, IL-17A, and IL-17 receptor A (IL-17-RA) have recently been shown to play a 
role in PsA (Raychaudhuri et al, 2012). Anti-IL-17 antibodies have been shown to be effective 
treatments for PSO (Papp et al, 2012; Leonardi et al, 2012; Hueber et al, 2010) and have also 
shown activity in subjects with rheumatoid arthritis (RA), PsA, and ankylosing spondylitis (AS) 
(McInnes et al, 2014; Mease et al, 2015; Hueber et al, 2010; Genovese et al, 2010). Taken 
together these data suggest that inhibition of both IL-17A and IL-17F could be therapeutically 
effective in subjects with PSO, PsA, and axial spondyloarthritis (axSpA). 
Bimekizumab (UCB4940) is an engineered, humanized full-length monoclonal antibody (mAb) 
of immunoglobulin (IgG) 1 subclass of approximately 150,000 Dalton which is expressed in a 
genetically engineered Chinese Hamster Ovarian (CHO) 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. Therefore, it permits an evaluation of the potential for additional efficacy, 
which may be conferred by dual inhibition of both cytokines, in patients suffering from diseases 
in which both cytokines are active. 
2.1.1 
Clinical studies 
Four clinical studies of bimekizumab have been completed: UP0008 in 39 subjects with 
mild-to-moderate plaque PSO, RA0124 in 30 healthy volunteers, UP0031 in 12 healthy 
volunteers, and PA0007 in 53 subjects with PsA.  
UP0008 was a Phase 1, single ascending dose study in adults with mild-to-moderate PSO 
affecting ≤5% body surface area (BSA). In this blinded study, single doses of up to 640mg 
(approximately 8mg/kg in an 80kg adult) were evaluated. A total of 26 subjects with PSO with 
<5% of body surface involvement were treated with a range of single intravenous (iv) doses from 
8 to 640mg. The pharmacokinetics (PK) of bimekizumab was linear in the tested dose range. 
There were no clinically relevant safety findings identified at any dose and all doses were well 
tolerated. The prespecified exploratory assessment of disease activity showed clinically relevant 
and statistically significant improvements at the higher doses studied. 
RA0124 was a Phase 1, open-label, parallel-group, single-dose study in healthy subjects. The 
primary objective of this study was to determine the absolute bioavailability of single sc doses of 
bimekizumab (80 and 160mg). The secondary objectives were to evaluate the dose 
proportionality of bimekizumab 80 and 160mg sc and to evaluate the safety and tolerability of 
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these sc doses and 160mg given by iv infusion. In RA0124, the absolute bioavailability was 
similar for the 2 doses tested (0.656 and 0.631 for the bimekizumab 80mg and 160mg sc doses, 
respectively). The median half-life (t1/2) following sc administration was similar to that following 
iv administration (27.81 days and 28.25 days for bimekizumab 160mg sc and bimekizumab 
160mg iv, respectively). 
An additional Phase 1 study, UP0031, evaluated the relative bioavailability and safety and 
tolerability of 2 bimekizumab formulations (a 
-based formulation 2x80mg and an 
-based formulation 1x160mg) administered by sc injection to healthy volunteers. Results 
show similar geometric means for AUC between the 2 bimekizumab formulations 
(2x80mg=653.8day*μg/mL; 1x160mg=628.3day*μg/mL) and the relative bioavailability for the 
bimekizumab 1x160mg versus 2x80mg formulations was calculated as 96.1% with a 
95% confidence interval (CI): 72.7, 127.0. The wide 95% CI was expected due to the small 
sample size in UP0031. 
Bimekizumab has also been investigated in a Phase 1b, proof-of-concept, randomized, 
placebo-controlled, multiple-dose study (PA0007). A total of 53 subjects have been randomized. 
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 of bimekizumab 80, 160, 240, or 560mg at 
Week 1, and 2 additional doses of bimekizumab 40, 80, 160, or 320mg at Week 4 and Week 7. 
In each treatment group, subjects received a total of 3 doses of bimekizumab, administered every 
3 weeks. There were no unexpected clinically relevant safety findings and all doses were well 
tolerated. The PK was linear across the tested dose range and no change in PK was observed 
following multiple doses. Observed changes in inflammatory biomarkers were consistent with 
expectations based on the IL-17A and IL-17F mechanism of action. The exploratory analysis 
showed clinically relevant improvement in activity of PsA and in skin involvement in those 
subjects with concomitant active psoriatic lesions. Data from the top 3 bimekizumab dose groups 
pooled showed that, by Week 9, 80% (95% confidence interval [CI]: 62.7, 90.5) of subjects 
achieved an ACR20 response (vs 16.7% [95% CI: 4.7, 44.8] in the placebo group) and 100% 
(95% CI: 79.6, 100.0) of 26 subjects with active psoriatic lesions had achieved a PASI75 
response (vs 0% [95% CI: 0.0, 43.4] in the placebo group). 
Infections (mostly nasopharyngitis) were the most commonly reported events in both the 
active-treatment and the placebo group. None of the infections were considered serious or 
required treatment with antibiotics. Two subjects in the active-treatment group experienced 
1 local candida infection each (oropharyngitis and vulvovaginitis) that were nonserious and 
resolved with topical therapy. There was a 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 study medication. 
In the bimekizumab clinical studies to date, the most commonly reported gastrointestinal (GI) 
adverse events (AEs) were abdominal distension, abdominal pain, diarrhea, flatulence, nausea, 
and vomiting. All of these events, except 1 event of vomiting, were mild or moderate in 
intensity. T helper-17 and other IL-17-producing cell types are present in a high frequency in the 
physiologic, healthy state of the intestinal mucosa. Interleukin-17 is recognized as an important 
player in the pathophysiology of infectious and immune-mediated GI diseases and has been 
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shown to contribute to the gut barrier function (Ivanov et al, 2008). Clinical data with 
secukinumab suggest that the drug may worsen symptoms of coexisting Crohn’s disease in 
patients with psoriasis and ankylosing spondylitis (Baeten et al, 2015). 
Several additional studies of bimekizumab are ongoing. RA0123 is a Phase 2a, double-blind, 
randomized, placebo-controlled, multiple dose study to evaluate the safety, PK, 
pharmacodynamics (PD), and efficacy of multiple doses of bimekizumab administered as add-on 
therapy to stable certolizumab pegol (Cimzia®) therapy in subjects with moderate to severe RA. 
UC0011 is a Phase 2 study, which will evaluate the efficacy, safety, tolerability, and PK of an iv 
loading dose and 2 sc maintenance doses of bimekizumab in subjects with moderate to severe 
active ulcerative colitis. PS0010, PS0011, PS0016, and PS0018 are Phase 2 studies, which will 
evaluate the PD, PK, safety, and/or efficacy of bimekizumab administered sc to subjects with 
PSO. AS0008 is a Phase 2, double-blind, randomized, placebo-controlled, multiple-dose study to 
evaluate the efficacy and safety of bimekizumab in subjects with active AS. 
A Phase 2b dose-ranging study (PA0008) was designed to investigate the dose-response 
relationship, efficacy and safety of various bimekizumab dose regimens in subjects with active 
PsA. The current Phase 2b OLE study (PA0009) will allow access to bimekizumab for subjects 
who completed the lead-in study PA0008, while allowing the collection of further data on the 
long-term safety and efficacy of bimekizumab in this subject population.  
Additional information on the clinical data for bimekizumab is available in the current version of 
the Investigator’s Brochure (IB). 
2.1.2 
Nonclinical studies 
Parallel inhibition of IL-17A and IL-17F has shown potent effects 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 (NOAEL) of 
200mg/kg/week. The findings of note in toxicity studies were diarrhea related to infectious 
enteritis (observed in the single dose study) and asymptomatic mild colonic ulceration in a 
proportion of animals (in the repeat-dose study); this latter finding was not associated with 
hematology abnormalities. Data suggest that bimekizumab has induced primary lesions to the 
mucosa-associated lymphoid tissue via a pharmacologically related mechanism. In a second 
repeat-dose study, none of the minor apoptosis/necrosis findings observed in gut associated 
lymph nodes were seen. In animals given the highest dose of bimekizumab in the study 
(20mg/kg/week), a slightly higher number of protozoa (Balantidium coli) was observed in the 
cecum and colon as compared to the control animals and low dose animals. Therefore, gut 
associated lymph node lesions observed in the first study are considered to be accidental and/or 
linked to exaggerated pharmacology and proliferation of Balantidium coli and are considered the 
result of a change in local mucosal immunity.  
Additional information on the nonclinical data for bimekizumab is available in the current 
version of the IB. 
3 
STUDY OBJECTIVES 
3.1 
Primary objective 
The primary objective of this open-label study is to assess the long-term safety and tolerability of 
bimekizumab administered over a period of up to 100 weeks (~2 years). 
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3.2 
Secondary objectives 
The secondary objectives of the study are as follows: 
 To assess the long-term efficacy of bimekizumab  
3.3 
Other objectives 
The other objectives are: 
 To assess the impact on dactylitis and enthesitis 
 To assess the impact on patient-reported quality of life  
 To assess plasma concentrations of bimekizumab 
 To assess the immunogenicity of bimekizumab 
4 
STUDY VARIABLES 
All efficacy variables will be analyzed relative to the Baseline Visit of PA0008. Safety variables 
measured at the start of PA0009 will be referred to as PA0009 entry values. 
4.1 
Primary variables 
4.1.1 
Primary safety variables 
The primary safety variables are the incidences of TEAEs and treatment-emergent SAEs. 
4.2 
Secondary variables 
4.2.1 
Secondary safety variable 
The secondary safety variable is the withdrawal due to TEAEs. 
4.2.2 
Secondary efficacy variables 
The secondary efficacy variables are:  
 ACR20, ACR50, and ACR70 response at Week 48 
 Change from Baseline of PA0008 in MASES at Week 48 
 Change from Baseline of PA0008 in the LDI at Week 48 
 PASI75 and PASI90 response at Week 48 
4.3 
Other variables 
4.3.1 
Safety variables 
Other safety variables are listed below. 
 
Change from PA0009 Laboratory Baseline (defined as the earliest date in PA0009 at or prior 
to PA0009 Week 12) for clinical laboratory variables (hematology and biochemistry, 
excepting high-sensitivity C-reactive protein [CRP]) at each visit)  
 
Change from Baseline of PA0008 in vital signs (pulse, temperature, and blood pressure) and 
body weight 
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4.3.2 
Efficacy variables 
Other efficacy variables are listed below and will be evaluated at scheduled visits in accordance 
with the schedule of study assessments in Table 5‒1. 
 ACR20, ACR50, and ACR70 response  
 PASI75, PASI90, and PASI100 response 
 Minimal Disease Activity (MDA) as defined in Table 10‒3 
 Change from Baseline of PA0008 in the Disease Activity Score-28 based on C-reactive 
protein (DAS28[CRP]) by visit 
 Change from Baseline of PA0008 in MASES 
 Change from Baseline of PA0008 in the LDI 
 Change from Baseline of PA0008 in Psoriatic Arthritis Impact of Disease (PsAID)-9 
 Change from Baseline of PA0008 in Short Form 36-item Health Survey (SF-36) 
 Change from Baseline of PA0008 in the Hospital Anxiety and Depression Scale (HADS): 
HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D) scores 
 Depression and anxiety status “normal” as defined by HADS-D and HADS-A <8 
4.3.3 
PK variable 
The PK variable is the plasma concentration of bimekizumab evaluated at scheduled visits up to 
104 weeks (2 years) in accordance with the schedule of study assessments in Table 5‒1. 
4.3.4 
Immunological variable 
The immunological variable is the anti-bimekizumab antibody detection evaluated at scheduled 
visits up to 104 weeks (2 years) in accordance with the schedule of study assessments in 
Table 5‒1. 
5 
STUDY DESIGN 
5.1 
Study description 
PA0009 is a multicenter OLE study to assess the long-term safety, tolerability, and efficacy of 
bimekizumab in eligible adult subjects with PsA who completed the Phase 2b study PA0008. At 
Week 48 of PA0008, all eligible subjects continuing into PA0009 will undergo their final 
PA0008 study assessments and any nonoverlapping PA0009 entry assessments and will then 
receive their first open-label dose of bimekizumab. 
The OLE study will assess the safety, tolerability, and efficacy of bimekizumab for a period of 
up to 100 weeks (~2 years). Bimekizumab will be administered at a dose of 160mg Q4W upon 
entry into PA0009, regardless of the dose received in PA0008.  
Additionally, as described in (Section 5.1.1), other treatments may be used in addition to 
bimekizumab per Investigator discretion. Subjects not responding to treatment may be 
withdrawn from the treatment and study at the discretion of the Investigator. 
A schedule of study assessments is presented in Table 5‒1. 
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A study schematic diagram of PA0009 is presented in Figure 5‒1. 
5.1.1 
Rescue therapy 
In this OLE study, some subjects may require additional treatment in addition to medications 
received during PA0008 to control their PsA symptoms. The decision to implement such therapy 
will be at the discretion of the Investigator. Therapies that are permitted for their disease within 
the context of the study are provided in Section 7.8.1 (Permitted concomitant treatments). 
Concomitant medication that is currently not considered safe or best medical practice should be 
avoided. See Section 7.8.2 for medications that are specifically prohibited. 
5.1.2 
Study duration per subject 
The study duration for each subject is estimated to be up to a maximum of 120 weeks: 
 Open-Label Treatment Period: up to 100 weeks (~2 years) 
 SFU Visit: 20 weeks after the final dose of bimekizumab 
The subject may remain in the study until the study ends after 120 weeks, until the Sponsor 
decides to close the study, or until bimekizumab development is stopped by the Sponsor, 
whichever comes first. The Sponsor may consider transitioning the subject into another 
bimekizumab study or program. 
The end of the study is defined as the date of the last visit of the last subject in the study. 
5.1.3 
Planned number of subjects and sites 
Up to 200 subjects from the ongoing PA0008 Phase 2b study could be enrolled into this study at 
any of the sites participating in PA0008. 
5.1.4 
Anticipated regions and countries 
The regions planned for study conduct are the same as in PA0008 (Europe and North America).  
5.2 
Schedule of study assessments 
A schedule of study assessments is provided in Table 5‒1. 
 
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Table 5‒1: 
Schedule of study assessments 
Protocol activity 
Treatment Period 
 
SFU 
Weeksa 
EVb 
4 
12 
16 
24 
28 
36 
40 
48 
52 
60 
64 
72 
76 
84 
88 
96 
100 
W104/ 
- 
 
 
8 
 
20 
 
32 
 
44 
 
56 
 
68 
 
80 
 
92 
 
 
ET 
 
Visita 
1 
2/3 
4 
Hc 
5 
Hc 
6 
Hc 
7 
Hc 
8 
Hc 
9 
Hc 
10 
Hc 
11 
12 
13 
 
Informed consent 
Xd 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
Xe 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Concomitant medications 
Xf 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
Adverse events 
Xf 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
eC-SSRS 
Xe,f 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
HADS 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
HAQ-DI 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
SF-36 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
PGADA 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
PtAAP 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
PsAID-9 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
TB questionnaire 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
Vital signs (pulse, 
temperature, BP)g 
Xe 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
Body weight 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
Physical examinationh 
Xe,f 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
X 
X 
TJC (78) and SJC (76) 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
BSA affected by PSO (BSA 
palm method) 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
PASIi 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
MASES 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
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Table 5‒1: 
Schedule of study assessments 
Protocol activity 
Treatment Period 
 
SFU 
Weeksa 
EVb 
4 
12 
16 
24 
28 
36 
40 
48 
52 
60 
64 
72 
76 
84 
88 
96 
100 
W104/ 
- 
 
 
8 
 
20 
 
32 
 
44 
 
56 
 
68 
 
80 
 
92 
 
 
ET 
 
Visita 
1 
2/3 
4 
Hc 
5 
Hc 
6 
Hc 
7 
Hc 
8 
Hc 
9 
Hc 
10 
Hc 
11 
12 
13 
 
LDI 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
PhGADA 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
ECG 
Xe,f 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
X 
 
Hematology/biochemistry/ 
urine pregnancyj,k 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
Blood Sample for CRPk 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
Blood sample for 
bimekizumab plasma 
concentrationsk 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
X 
Blood sample for anti-
bimekizumab antibodiesk 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
X 
IGRA TB testl 
Xe 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
 
X 
IXRS  
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
Bimekizumab 
administration 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
BP=blood pressure; BSA=body surface area; CRP=C-reactive protein; eC-SSRS=electronic Columbia-Suicide Severity Rating Scale; 
ECG=electrocardiogram; ET=Early Termination; EV=Entry Visit; H=home; HADS=Hospital Anxiety and Depression Scale; HAQ-DI=Health Assessment 
Questionnaire—Disability Index; IGRA=interferon-gamma release assay; IXRS=interactive voice or web response system; LDI=Leeds Dactylitis Index; 
MASES= Maastricht Ankylosing Spondylitis Enthesitis Score; PASI=psoriasis area severity index; PGADA=Patient’s Global Assessment of Disease 
Activity; PhGADA=Physician’s Global Assessment of Disease Activity; PsAID=Psoriatic Arthritis Impact of Disease; PSO=psoriasis; PtAAP=Patient’s 
Assessment of Arthritis Pain; SF-36=Short Form 36-item Health Survey; SFU=Safety Follow-Up; SJC=swollen joint count; TB=tuberculosis; TJC=tender 
joint count 
Note: The SFU Visit will occur 20 weeks after the final dose of study medication. 
a Visit windows are ±7 days from the scheduled visit day (relative to the first dose) with a minimum of 21 days and a maximum of 35 days in between doses 
at all visits except the SFU Visit. For the SFU Visit (20 weeks after the final dose), the visit should occur no more than 3 days prior to the scheduled visit 
date and within 7 days after the scheduled visit date (-3 days/+7 days). 
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Table 5‒1: 
Schedule of study assessments 
Protocol activity 
Treatment Period 
 
SFU 
Weeksa 
EVb 
4 
12 
16 
24 
28 
36 
40 
48 
52 
60 
64 
72 
76 
84 
88 
96 
100 
W104/ 
- 
 
 
8 
 
20 
 
32 
 
44 
 
56 
 
68 
 
80 
 
92 
 
 
ET 
 
Visita 
1 
2/3 
4 
Hc 
5 
Hc 
6 
Hc 
7 
Hc 
8 
Hc 
9 
Hc 
10 
Hc 
11 
12 
13 
 
b PA0009 entry will occur at the end of the lead-study PA0008. At Week 48 of PA0008, all subjects continuing into PA0009 will undergo the final 
PA0008 study assessments and any nonoverlapping PA0009 entry assessments before receiving their first open-label dose of bimekizumab. 
c From the Entry Visit onwards, self-administration training will be provided to the subject/caregivers/appropriate designee by the study nurse. At Week 8 
and Week 12, the subject/caregiver/appropriate designee will perform administrations under the supervision of the site staff to ensure that study medication is 
being properly and safely injected. 
d Ensure that a separate Informed Consent form was completed by the subject for PA0009 prior to study entry. 
e To be performed prior to the first dose of open-label bimekizumab. 
f Assessment will be performed at Week 48 of the lead-in study PA0008 and will be used as the PA0009 entry value. 
g At PA0009 study entry collect pulse and BP prior to drug administration and then at 30 minutes and 1 hour after dosing. At all other visits collect pulse and 
BP prior to drug administration and once after dosing.  
h Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
i If the BSA affected by PSO was ≥3% at Baseline of PA0008, determine the PASI. 
j If there has been a delay in menses, perform a urine pregnancy test. 
k All blood samples are to be taken prior to dosing. 
l It is recommended that the QuantiFERON TB Test be performed. This assessment will be performed at study entry, unless an IGRA negative result is 
available from less than 6 weeks prior to the first dose of open-label bimekizumab. 
 
 
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5.3 
Schematic diagram 
A study schematic diagram of PA0009 is provided in Figure 5‒1. 
Figure 5‒1: Schematic diagram 
 
IMP=investigational medicinal product; Q4W=every 4 weeks; sc=subcutaneous; SFU=Safety Follow-up 
Note: Self-administration will be allowed after 3 months of treatment (from Week 16 onwards) as described in 
Table 5‒1.  
Note: Additionally, as described in (Section 5.1.1 and Section 7.8.1), other treatments may be used in addition to 
bimekizumab per Investigator discretion. Subjects not responding to treatment may be withdrawn from the study at 
the discretion of the Investigator. 
a Subjects will receive their final dose of study drug on Week 100 and the SFU Visit will be conducted 20 weeks 
after the last dose of IMP. 
5.4 
Rationale for study design and selection of dose 
A dose of 160mg Q4W was selected based on the current understanding of PK/PD of 
bimekizumab in PsA (data from PA0007). Based on this analysis, a dose of 160mg Q4W is 
expected to provide an optimal response in most of the subjects. Based on the modeling 
outcome, UCB expects that the ACR50 response would maximize at 160mg Q4W, and hence, 
this dose was selected for PA0009.  
A bimekizumab dose of 160mg Q4W is currently being used in ongoing Phase 2b clinical 
studies.  
Doses greater than 160mg have been previously studied in the development of bimekizumab. In 
the single ascending dose study, UP0008, a single dose of bimekizumab 640mg was tested. In 
the multiple dose study, PA0007, a bimekizumab 560mg loading dose followed by 2 subsequent 
320mg doses every 3 weeks was tested. At exposure levels achieved at these doses, the 
compound had no significant safety concerns. In the previous clinical studies, bimekizumab was 
administered iv and in the current study bimekizumab will be administered sc (bioavailability of 
bimekizumab is 64%). Due to lower bioavailability, bimekizumab exposure is expected to be 
lower with sc administration compared with after iv administration, therefore, the dose regimens 
are expected to be 
  
As more data for bimekizumab become available in this indication, doses and dosing regimen 
may be modified accordingly. 
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6 
SELECTION AND WITHDRAWAL OF SUBJECTS 
6.1 
Inclusion criteria 
To be eligible to participate in this study, all of the following criteria must be met: 
1a. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written 
Informed Consent form is signed and dated by the subject.  
2a. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand 
and complete questionnaires), visit schedule, or medication intake according to the judgment 
of the Investigator. 
3. In the opinion of the Investigator, the subject is expected to benefit from participation in an 
OLE study. 
4. Subject completed PA0008 without meeting any withdrawal criteria. 
5. Female subjects must be postmenopausal (at least 1 year), 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 until 20 weeks after last administration of study 
medication, and have a negative pregnancy test at the last visit of PA0008. The following 
methods are considered highly effective when used consistently and correctly: 
 combined (estrogen and progestogen) hormonal contraception associated with inhibition 
of ovulation (oral, intravaginal or transdermal)  
 progestogen-only hormonal contraception associated with inhibition of ovulation (oral, 
injectable, implantable) 
 intrauterine device (IUD) 
 intrauterine hormone-releasing system (IUS) 
 bilateral tubal occlusion 
 vasectomized partner  
 sexual abstinence if it is in accordance with a subject’s preferred and common lifestyle. 
Subjects who use abstinence as a form of birth control must agree to abstain from 
heterosexual intercourse until 20 weeks after the last dose of IMP. Study personnel must 
confirm the continued use of abstinence is still in accordance with the subject’s lifestyle 
at regular intervals during the study. 
Male subjects with a partner of childbearing potential must be willing to use a condom when 
sexually active, up until 20 weeks after the last administration of study medication 
(anticipated 5 half-lives). 
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6.2 
Exclusion criteria 
Subjects are not permitted to enroll in the study if any of the following criteria are met: 
1. Female subjects who plan to become pregnant during the study or within 20 weeks following 
last dose of study medication. Male subjects who are planning a partner pregnancy during the 
study or within 20 weeks following the last dose. 
2. Subjects with any current sign or symptom that may indicate a medically significant active 
infection (except for the common cold) or has had an infection requiring systemic antibiotics 
within 2 weeks of study entry. The medical monitor must be consulted prior to subject’s 
entry into PA0009 in such cases.  
3. Subjects who meet any withdrawal criteria in PA0008. For any subject with an ongoing SAE, 
or a history of serious infections (including hospitalizations) in the lead-in study, the Medical 
Monitor must be consulted prior to the subject’s entry into PA0009. 
6.3 
Withdrawal criteria 
Subjects are free to withdraw from the study at any time, without prejudice to their continued 
care. 
Subjects should be withdrawn from the study and will be asked to complete the Early 
Termination (ET) Visit and SFU Visit (20 weeks after the last received dose) if any of the 
following events occur: 
1. Subject withdraws his/her consent. 
2. There is confirmation of a pregnancy in a female subject during the study, as evidenced by a 
positive pregnancy test. 
3. The Sponsor or a regulatory agency requests withdrawal of the subject. 
4. Subject develops an illness that in the opinion of the Investigator would interfere with his/her 
continued participation, if the risk of continuing participation outweighs the potential benefit. 
5. Subject develops erythrodermic, guttate, or generalized pustular form of PSO. 
6. Subjects considered to have either a suspected new latent tuberculosis (LTB) infection or 
who develops an active tuberculosis (TB) or nontuberculosis mycobacterium infection during 
the study (including but not limited to, conversion demonstrated by interferon-gamma release 
assay (IGRA) or other diagnostic means) must be immediately discontinued from study 
medication and an unscheduled visit must be conducted 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 LTB infection 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.  
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7. 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. 
8. Subject uses prohibited concomitant medications as defined in Section 7.8.2 that may present 
a risk to the safety of the subject in the opinion of the Investigator and/or the Medical 
Monitor. 
9. Subject develops laboratory abnormalities (with or without clinical symptoms) of alanine 
aminotransferase (ALT) or aspartate aminotransferase (AST) as defined in Section 6.3.1; 
neutrophils <0.5x109/L (neutropenia); lymphocytes <0.5x109/L (lymphopenia). Any 
laboratory value or change judged to be clinically significant by the Investigator should 
prompt consideration of whether the subject should continue on the investigational medicinal 
product (IMP). For clarification, laboratory values that are markedly abnormal as per 
Table 17-1 and Table 17‒2 will be flagged to the Investigator and to the medical monitor but 
do not trigger mandatory withdrawal unless listed above. (Refer to Section 6.3.1 for 
withdrawal criteria in relation to potential drug-induced liver injury [PDILI].) 
10. Subject has active suicidal ideation as indicated by a positive response (“Yes”) to 
Questions 4 or 5 or to the suicidal behavior questions of the “Since Last Visit” version of the 
self-rated electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). The subject should 
be referred immediately to a Mental Healthcare Professional and must be withdrawn from the 
study. 
11. Subjects with a HADS-D score ≥15 must be withdrawn. Any subject who develops a 
HADS-D score of >10 during the study should be referred immediately to a Mental 
Healthcare Professional for further evaluation and potential withdrawal by the Investigator.  
12. 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 judgment 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. 
All subjects who withdraw from the study due to an AE must be followed until resolution of the 
event or until the event is considered stable. All subjects who withdraw from the study due to 
development of a laboratory abnormality must be closely monitored. 
Investigators should attempt to obtain information on subjects in the case of withdrawal or 
discontinuation. For subjects considered 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 
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documents. The electronic Case Report Form (eCRF) must document the primary reason for 
withdrawal or discontinuation. 
Investigators should contact the Medical Monitor, whenever possible, to discuss the withdrawal 
of a subject in advance. 
6.3.1 
Potential drug-induced liver injury investigational medicinal product 
discontinuation criteria 
Subjects with 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 discontinuation of IMP:   
Subjects with either of the following:  
 ALT or AST ≥5x upper limit of normal (ULN) 
 ALT or AST ≥3xULN and coexisting total bilirubin ≥2xULN  
 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%).  
The PDILI criterion below allows for subjects to continue on IMP at the discretion of the 
Investigator.  
 Subjects with ALT or AST ≥3xULN (and ≥2x Baseline) and <5xULN, 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 9.5.1.  
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 CRF must document the primary 
reason for IMP discontinuation. 
7 
STUDY TREATMENT 
7.1 
Description of investigational medicinal product 
Bimekizumab will be supplied by UCB Clinical Trial Supply Operations or designee. 
The IMP will consist of the following: 
 Bimekizumab will be supplied as a clear to opalescent, colorless to slightly brown, 
sterile, preservative-free solution in a 1mL prefilled syringe (PFS). 
 
 
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Further details of the IMP and specifications are provided in the Investigational Medicinal 
Product Handling Manual. 
7.2 
Treatment to be administered 
All subjects will receive bimekizumab 160mg Q4W sc (Section 5.1).  
The IMP (bimekizumab) will be administered at the visits indicated in Table 5‒1. The minimum 
time between doses should be no less than 21 days and no more than 35 days for Q4W dosing. 
The IMP is to be administered as 1 sc injection for the 160mg dose. Administration will occur at 
the study site for the first 3 months of PA0009.  
Thereafter and in between the quarterly study visits at the site, the subjects will have the option 
to perform self-administration at home. From the Entry Visit onwards, self-administration 
training will be provided to the subject/caregivers/appropriate designee by the study nurse. At 
Week 8 and Week 12, the subject/caregiver/appropriate designee will perform administration 
under the supervision of the site staff to ensure that study medication is being properly and safely 
injected.  
Once subjects/caregivers/appropriate designees 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 injections at each visit needed to perform the monthly administrations at 
home. Subjects who are unable to or decide not to self‑administer or those without a family 
member/friend/caregiver (or appropriate designee) who can help will not be discontinued but 
may continue to visit the site for only study treatment administration. If administered at home, 
the subject/caregiver (or appropriate designee) will document the date, body location, and time 
point of administration of study medication.  
Suitable areas for sc injections are the lateral abdominal wall, upper outer thigh, and upper arm if 
the IMP is injected by a healthcare provider or a caregiver. Injection sites should be rotated and 
injections should not be given into areas where the skin is tender, bruised, red, or hard. It is also 
acceptable to inject in the upper arm if the preferred areas of the abdomen or thigh are covered in 
lesions, tender, or bruised. 
An IMP Handling Manual will be provided to each site containing instructions regarding drug 
preparation and dosing. 
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 
Clinical drug supplies 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. 
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7.5 
Handling and storage requirements 
Investigational Medicinal Product must be stored under refrigerated conditions (2ºC to 8ºC) 
protected from light. The IMP must not be frozen.  
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 communicated to the 
Clinical Project Manager (CPM) (or designee) before further use of the IMP. 
Investigational medicinal product 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.  
The Investigator (or designee) will instruct the subject 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; 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 schedule 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). Onsite destruction of used kits only may be 
allowed with prior approval from the Sponsor or designee after reconciliation. The 
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subjects/caregivers return the documentation together with any used/unused containers at the 
next scheduled clinic visit. 
Investigational medicinal product intended for the study cannot be used for any other purpose 
than that described in this protocol. 
7.7 
Procedures for monitoring subject compliance 
The IMP will be administered in the clinic during the first 3 months of treatment (Visit 1 [study 
entry] through Visit 4 [W12]) and compliance will be determined at the visit by study personnel. 
Thereafter, self-administration at home will be possible at Weeks 16, 20, 28, 32, 40, 44, 52, 56, 
64, 68, 76, 80, 88, and 92. Dates and time of self-administration will be captured using a subject 
diary. All used PFS will be disposed of by subjects/caregivers/appropriate designee 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. 
Drug accountability must be recorded on the Drug Accountability Form. 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. 
7.8 
Concomitant medications/treatments 
All concomitant medications, including over the counter products, herbal, traditional remedies, 
vitamin/mineral supplements, other dietary supplements, “nutraceuticals,” and hormones must be 
recorded in the subject’s source documentation (eg, clinical chart) and on the eCRF. This record 
should include the name of the drug, the dose, the route and date(s) of administration, and the 
indication for use. 
The Investigator should examine the acceptability of all concomitant procedures, medications, 
topical preparations, and dietary supplements not explicitly prohibited in this study, and if 
necessary, discuss with the Medical Monitor. 
In order to ensure that appropriate concomitant therapy is administered, subjects will be 
instructed to consult with the Investigator prior to taking any medication (either 
self-administered nonprescription drugs or prescription therapy prescribed by another physician). 
7.8.1 
Permitted concomitant treatments (medications and therapies) 
Medication changes are permitted at any time after enrollment into this extension study. 
Medication changes and additions are permitted with the following guidelines: 
 Nonsteroidal anti-inflammatory drugs (NSAIDs), DMARDs (methotrexate, sulfasalazine, 
leflunomide, apremilast), and/or joint injections may be given if deemed appropriate by the 
Investigator as outlined below. Subjects may receive these add-on therapies while continuing 
to receive bimekizumab. Under no circumstances should subjects have a concomitant 
biologic agent while receiving bimekizumab. 
 For subjects taking NSAIDs/cyclooxygenase-2 (COX-2) inhibitors, a change can be 
made to a different NSAID/COX-2. Changes from an NSAID to a COX-2 inhibitor or 
from a COX-2 inhibitor to an NSAID are permitted up to the maximum approved or 
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tolerated dose, whichever is less. Only 1 NSAID/COX-2 inhibitor may be taken at a 
given time. 
 For subjects not taking NSAID/COX-2 inhibitors, either can be initiated, up to the 
maximum approved or tolerated dose, whichever is lower. Only 1 NSAID/COX-2 may be 
taken at a given time. 
 Methotrexate may be added or increased to a maximum dose of 25mg/week, or the 
maximum tolerated dose, whichever is lower. The route of administration may be 
changed from oral to sc or from sc to oral. It is strongly recommended that subjects 
taking MTX should also take folic acid supplementation. 
 Sulfasalazine may be given up to a maximum dose of 3g/day, or the maximum tolerated 
dose, whichever is lower, for peripheral arthritis symptoms.  
 Leflunomide may be given at a maximum dose of 20mg/day (or an average of 20mg/day 
if not dosed daily), or the maximum tolerated dose, whichever is lower, for peripheral 
arthritis symptoms. Leflunomide should not be used concomitantly with MTX. 
 Apremilast may be given at a maximum dose of 30mg twice daily, or the maximum 
tolerated dose, whichever is lower. 
 Combination DMARDs (optimally 2) are allowed except that leflunomide and MTX may 
not be given together. 
 No other oral DMARDs are permitted during this OLE study. 
 Steroid tapers for disease activity or disease-related reasons are allowed with an average 
daily dose of 20mg prednisone or prednisone equivalent per day for a maximum of 14 days.  
 Up to 1 injection per joint for up to 3 discrete joints is permitted per 12-month period. 
Investigators should follow the guidance in the CRF instructions for proper scoring of the 
injected joints. 
 Intra-articular hyaluronic acid injections are permitted into joints for which they are approved 
as per local labels.  
 Intra-bursal corticosteroid injections are also permitted at the discretion of the Investigator. 
 A decrease in dose or dosing frequency of any agent is permitted at any time. 
 Subjects with persistent active disease in spite of added concomitant therapy/therapies 
mentioned above should be withdrawn from the study at the discretion of the Investigator. 
Psoriasis treatments 
For treatment of PSO, subjects may continue to use topical moisturizers, emollients, salicylic 
acid preparations, bath oils, and oatmeal bath preparations for skin conditions during the study, 
as needed. Over-the-counter shampoos for the treatment of PSO of the scalp are also permitted. 
Mild topical steroids are permitted for use limited to the face, axillae, and/or genitalia, as needed. 
More potent topical steroids, topical retinoids, vitamin D analogues, and/or coal tar preparations 
may be used as medically required to treat a flare. Use of psoralen and ultraviolet A light 
(PUVA/UVA) therapy for the treatment of PSO is discouraged through the duration of the study. 
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7.8.2 
Prohibited concomitant treatments (medications and therapies) 
Prohibited and/or restricted medications are summarized in Table 7-1 and Table 7-2. 
Table 7-1: 
Prohibited or restricted medications 
Drug class 
Dose 
Comments 
Analgesics, including opioid 
analgesics 
(acetaminophen/paracetamol, etc) 
Any dose  
Any ad hoc use in the 24 hours prior to 
any study visit is prohibited.  
 
Stable doses of analgesics (including 
opioids) permitted. 
TNF inhibitor: 
-infliximab  
-adalimumab  
-etanercept  
-golimumab  
-certolizumab pegol  
Any dose 
This applies to biosimilar versions of any 
TNF inhibitors. 
Any non-TNF biologic medications 
Any dose 
Any exposure history is prohibited. 
All other DMARDs 
Any dose 
Only permitted medications as per 
Section 7.8.1. 
DMARD=disease-modifying antirheumatic drug; TNF=tumor necrosis factor 
 
Table 7-2: 
Additional prohibited psoriasis treatments 
Drug class 
Phototherapy 
High potency topical steroid, vitamin D analogues, topical retinoids, keratolytics, coal tar, fumaric acid 
esters use except as detailed in Section 7.8.1 
Systemic retinoids 
Subjects who take prohibited medications may be withdrawn from study treatment 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. 
Vaccines 
Administration of live, attenuated vaccines is not allowed during the conduct of the study or for 
20 weeks after the last dose of study drug. Administration of non-live, inactivated vaccines is 
allowed during the study at the discretion of the Investigator. 
Live vaccinations include, but are not limited to, the following: anthrax vaccine, intranasal 
influenza vaccine, measles-mumps-rubella vaccine, polio live oral vaccine, smallpox vaccine, 
TB Bacillus Calmette-Guérin vaccine, typhoid live oral vaccine, varicella vaccine, and yellow 
fever vaccine. 
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7.9 
Blinding 
This is an open label study. All subjects’ treatment assignments during the lead-in studies will 
remain blinded until final database lock of PA0008. 
7.10 
Randomization and numbering of subjects 
This is an OLE study and no randomization will be performed. All subjects will receive 
bimekizumab 160mg Q4W sc. 
Subjects will continue with the 5-digit subject numbers assigned by the interactive web or voice 
response system (IXRS) in the preceding study.  
8 
STUDY PROCEDURES BY VISIT  
The schedule of study assessments (Table 5‒1) provides a general overview of study 
assessments. A list of procedures to be completed at each visit is provided in the sections that 
follow.  
 
Visit windows of ±7 days on either side of the scheduled dosing are permitted for all visits 
other than the SFU Visit (see below); however, the Investigator should try to keep the 
subjects on the original dosing schedule. The window of ±7 days is relative to the first dose 
(PA0009 entry) and applicable for all subsequent visits. Changes to the dosing schedule 
outside of the 14-day window must be discussed with the Medical Monitor. 
 
The minimum time between doses should be no less than 21 days and no more than 35 days 
for Q4W dosing. 
 
For the SFU Visit (20 weeks after the last dose), the visit should occur no more than 3 days 
prior to the scheduled visit date and within 7 days after the scheduled visit date 
(-3 days/+7 days). 
The Investigator should make efforts to maintain the original visit schedule. Changes to the 
dosing schedule outside of the allowed windows must be discussed with the Medical Monitor 
and may result in subject withdrawal.  
8.1 
Visit 1 
The PA0009 entry assessments noted with an “*” will be obtained at the Week 48 Visit of 
PA0008 and do not need to be recorded on the eCRF for this study.  
The following procedures or assessments will be completed prior to administration of IMP: 
 Ensure that a separate ICF is completed by the subject for PA0009 (must be done prior to any 
PA0009 study procedures) 
 Assessment of inclusion/exclusion criteria 
 Record concomitant medications* 
 Record AEs* 
 eC-SSRS* 
 HADS* 
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 Administer the Health Assessment Questionnaire—Disability Index (HAQ-DI)* 
 Administer the SF-36* 
 Administer the Patient’s Global Assessment of Disease Activity (PGADA)* 
 Administer the Patient’s Assessment of Arthritis Pain (PtAAP)* 
 Administer the PsAID-9* 
 Administer the TB questionnaire* 
 Measure vital signs (temperature, pulse, and blood pressure [BP])* 
 Measure body weight* 
 Perform a physical examination, including an evaluation for signs and symptoms of active 
TB and risk for exposure to TB* 
 Perform tender joint count (TJC)/swollen joint count (SJC)* 
 Determine BSA affected by PSO using the BSA palm method* 
 If the BSA affected by PSO is ≥3% at Baseline of PA0008, determine the Psoriasis Area and 
Severity Index (PASI)* 
 Determine the MASES* 
 Determine the LDI* 
 Perform the Physician’s Global Assessment of Disease Activity (PhGADA)* 
 Perform an electrocardiogram (ECG)* 
 Collect samples for hematology/biochemistry/urine pregnancy* 
 Collect blood sample for CRP* 
 Collect blood sample for bimekizumab plasma concentrations and anti-bimekizumab 
antibody detection* 
 Perform an IGRA TB test if applicable 
 Record visit in the IXRS 
 Bimekizumab will be administered after all of the above assessments have been completed 
The following procedures or assessments will be completed following administration of IMP: 
 Collect pulse and BP at 30 minutes and 1 hour after dosing 
 
8.2 
Week 4 (Visit 2) and Week 8 (Visit 3) 
The following procedures or assessments will be completed prior to administration of IMP: 
 Record concomitant medications 
 Record AEs 
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 eC-SSRS 
 Measure vital signs (temperature, pulse, and BP) 
 Record visit in the IXRS 
 Bimekizumab will be administered after all of the above assessments have been completed 
The following procedures or assessments will be completed following administration of IMP: 
 Collect pulse and BP once after dosing at any time 
 
8.3 
Week 12 (Visit 4), Week 24 (Visit 5), Week 36 (Visit 6), and 
Week 72 (Visit 9) 
The following procedures or assessments will be completed prior to administration of IMP: 
 Record concomitant medications 
 Record AEs 
 eC-SSRS 
 HADS 
 Administer the HAQ-DI  
 Administer the SF-36 
 Administer the PGADA 
 Administer the PtAAP  
 Administer the PsAID-9  
 Administer the TB questionnaire 
 Measure vital signs (temperature, pulse, and BP) 
 Measure body weight 
 Perform TJC/SJC 
 Determine BSA affected by PSO using the BSA palm method 
 If the BSA affected by PSO is ≥3% at Baseline of PA0008, determine the PASI 
 Determine the MASES 
 Determine the LDI 
 Perform the PhGADA 
 Collect samples for hematology/biochemistry 
 If there has been a delay in menses, perform a urine pregnancy test 
 Collect blood sample for CRP 
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 Collect blood sample for bimekizumab plasma concentrations and anti bimekizumab 
antibody detection 
 Record visit in the IXRS 
 Bimekizumab will be administered after all of the above assessments have been completed 
The following procedures or assessments will be completed following administration of IMP: 
 Collect pulse and BP once after dosing at any time  
 
8.4 
Week 16, Week 20, Week 28, Week 32, Week 40, Week 44, 
Week 52, Week 56, Week 64, Week 68, Week 76, Week 80, 
Week 88, and Week 92 
Subjects will be given the opportunity for self-administration of bimekizumab. Adverse events 
will be captured spontaneously if the subject decides to visit the site to receive the bimekizumab 
administration. 
 
8.5 
Week 48 (Visit 7) and Week 96 (Visit 11) 
The following procedures or assessments will be completed prior to administration of IMP: 
 Record concomitant medications 
 Record AEs 
 eC-SSRS 
 HADS  
 Administer the HAQ-DI  
 Administer the SF-36 
 Administer the PGADA 
 Administer the PtAAP  
 Administer the PsAID-9  
 Administer the TB questionnaire  
 Measure vital signs (temperature, pulse, and BP) 
 Measure body weight 
 Perform a physical examination, including an evaluation for signs and symptoms of active 
TB and risk for exposure to TB 
 Perform TJC/SJC 
 Determine BSA affected by PSO using the BSA palm method 
 If the BSA affected by PSO is ≥3% at Baseline of PA0008, determine the PASI 
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 Determine the MASES 
 Determine the LDI 
 Perform the PhGADA 
 Perform an ECG 
 Collect samples for hematology/biochemistry 
 If there has been a delay in menses, perform a urine pregnancy test 
 Collect blood sample for CRP 
 Collect blood sample for bimekizumab plasma concentrations and anti bimekizumab 
antibody detection 
 Perform an IGRA TB test 
 Record visit in the IXRS 
 Bimekizumab will be administered after all of the above assessments have been completed 
The following procedures or assessments will be completed following administration of IMP: 
 Collect pulse and BP once after dosing at any time 
 
8.6 
Week 60 (Visit 8) and Week 84 (Visit 10) 
The following procedures or assessments will be completed prior to administration of IMP: 
 Record concomitant medications 
 Record AEs 
 eC-SSRS 
 HADS  
 Administer the HAQ-DI  
 Administer the SF-36 
 Administer the PGADA 
 Administer the PtAAP  
 Administer the PsAID-9  
 Administer the TB questionnaire  
 Measure vital signs (temperature, pulse, and BP) 
 Measure body weight 
 Perform TJC/SJC 
 Determine BSA affected by PSO using the BSA palm method 
 If the BSA affected by PSO is ≥3% at Baseline of PA0008, determine the PASI 
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 Determine the LDI 
 Perform the PhGADA 
 Collect samples for hematology/biochemistry 
 If there has been a delay in menses, perform a urine pregnancy test 
 Collect blood sample for CRP 
 Record visit in the IXRS 
 Bimekizumab will be administered after all of the above assessments have been completed 
The following procedures or assessments will be completed following administration of IMP: 
 Collect pulse and BP once after dosing at any time 
 
8.7 
Week 100 (Visit 12) 
The following procedures or assessments will be completed prior to administration of IMP: 
 Record concomitant medications 
 Record AEs 
 eC-SSRS 
 HADS  
 Administer the HAQ-DI  
 Administer the SF-36 
 Administer the PGADA 
 Administer the PtAAP  
 Administer the PsAID-9  
 Administer the TB questionnaire  
 Measure vital signs (temperature, pulse, and BP) 
 Measure body weight 
 Perform TJC/SJC 
 Determine BSA affected by PSO using the BSA palm method 
 If the BSA affected by PSO is ≥3% at Baseline of PA0008, determine the PASI 
 Determine the LDI 
 Perform the PhGADA 
 Collect samples for hematology/biochemistry 
 If there has been a delay in menses, perform a urine pregnancy test 
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 Collect blood sample for CRP 
 Record visit in the IXRS 
 Bimekizumab will be administered after all of the above assessments have been completed 
The following procedures or assessments will be completed following administration of IMP: 
 Collect pulse and BP once after dosing at any time 
 
8.8 
Week 104 (Visit 13) or Early Termination Visit 
The following procedures or assessments will be completed: 
 Record concomitant medications 
 Record AEs 
 eC-SSRS 
 HADS  
 Administer the HAQ-DI  
 Administer the SF-36 
 Administer the PGADA 
 Administer the PtAAP  
 Administer the PsAID-9  
 Administer the TB questionnaire  
 Measure vital signs (temperature, pulse, and BP) 
 Measure body weight 
 Perform a physical examination, including an evaluation for signs and symptoms of active 
TB and risk for exposure to TB 
 Perform TJC/SJC 
 Determine BSA affected by PSO using the BSA palm method 
 If the BSA affected by PSO is ≥3% at Baseline of PA0008, determine the PASI 
 Determine the MASES 
 Determine the LDI 
 Perform the PhGADA 
 Perform an ECG 
 Collect samples for hematology/biochemistry 
 If there has been a delay in menses, perform a urine pregnancy test 
 Collect blood sample for CRP 
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 Collect blood sample for bimekizumab plasma concentrations and anti bimekizumab 
antibody detection 
 Record visit in the IXRS 
 
8.9 
SFU Visit (20 weeks after the final dose of IMP) 
The following procedures or assessments will be completed: 
 Record concomitant medications 
 Record AEs 
 eC-SSRS 
 Administer the TB questionnaire  
 Measure vital signs (temperature, pulse, and BP) 
 Measure body weight 
 Perform a physical examination, including an evaluation for signs and symptoms of active 
TB and risk for exposure to TB 
 Collect samples for hematology/biochemistry 
 If there has been a delay in menses, perform a urine pregnancy test 
 Collect blood sample for CRP 
 Collect blood sample for bimekizumab plasma concentrations and anti bimekizumab 
antibody detection 
 Perform an IGRA TB test 
 Record visit in the IXRS 
8.10 
Early Termination Visit 
Subjects withdrawing early from the study (see Section 6.3) will undergo the same assessments 
as the Week 104 Visit (see Section 8.8) and will enter the SFU Period. 
8.11 
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, replacement of lost medication, repeated 
collection of a laboratory specimen due to collection or analysis issues) an eC-SSRS will not be 
required at these visits. 
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At this visit, any of the following assessments may be performed, depending on the reason for 
the visit: 
 
Record concomitant medication 
 
Record AEs 
 
eC-SSRS 
 
Measure vital signs (temperature, pulse, and BP) 
 
Physical examination 
 
Record 12-lead ECG  
 
If medically indicated, obtain blood sample(s) for standard safety laboratory tests 
(hematology, serum chemistry)  
 
Obtain urine sample for standard safety laboratory tests (including urine pregnancy test in 
women of childbearing potential). 
9 
ASSESSMENT OF SAFETY 
9.1 
Adverse events 
9.1.1 
Definition of AE 
An AE is any untoward medical occurrence in a patient or clinical investigation subject 
administered a pharmaceutical product that does not necessarily have a causal relationship with 
this treatment. An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease temporally associated with the use of a 
medicinal (investigational) product, whether or not related to the medicinal (investigational) 
product. 
In order to ensure complete safety data collection, all AEs occurring during the study (ie, after 
the signing of the ICF), including any pretreatment and posttreatment periods required by the 
protocol, must be reported in the eCRF even if no IMP was taken but specific study procedures 
were conducted. This includes all AEs not present prior to the initial visit and all AEs that 
recurred or worsened after the initial visit. 
Signs or symptoms of the condition/disease for which the IMP is being studied should be 
recorded as AEs only if their nature changes considerably or their frequency or intensity 
increases in a clinically significant manner as compared to the clinical profile known to the 
investigator from the subject’s history or study entry. 
Adverse events that occurred during the PA0008 lead-in study and are still deemed ongoing at 
the time of enrolment (signed ICF) will be captured in the database and followed up, as 
described in Section 9.1.6. 
9.1.2 
AEs of special interest 
An AE of special interest (AESI) is any AE that a regulatory authority has mandated be reported 
on an expedited basis, regardless of the seriousness, expectedness, or relatedness of the AE to the 
administration of a UCB product/compound. 
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Potential Hy’s Law, defined as ≥3xULN ALT or AST with coexisting ≥2xULN total bilirubin in 
the absence of ≥2xULN alkaline phosphatase (ALP), with no alternative explanation for the 
biochemical abnormality, must ALWAYS be reported to UCB as an AESI (ie, without waiting 
for any additional etiologic investigations to have been concluded). Follow-up information 
should then be reported if an alternative etiology is identified during investigation and 
monitoring of the subject.  
9.1.3 
Other safety topics of interest 
Pre-specified safety topics of interest for the study are: infections (serious, opportunistic, fungal 
and TB), neutropenia, hypersensitivity, suicidal ideation and behavior, depression, major 
cardiovascular events, liver function test changes/enzyme elevations, malignancies, and 
inflammatory bowel diseases (with gastroenterology referral, as appropriate). This is based on 
findings from the IMP clinical program to date, potential risks generally associated with biologic 
immunomodulators, or findings from other medicines with a related mechanism of action. There 
are no specific AE reporting requirements for these topics, however special monitoring, 
additional data collection activities, and/or enhanced signal detection activities (within UCB) are 
in place. 
9.1.4 
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 visit to detect AEs. For example: 
“Did you notice anything unusual about your health (since your last visit)?” 
In addition, the Investigator should review any self-assessment procedures (eg, diary cards) 
employed in the study. 
9.1.5 
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 intensity of an AE in the CRF (ie, mild, moderate, or severe), the 
Investigator should use the following criteria: 
 Mild: the subject is aware of the sign or symptom (syndrome), but it does not interfere with 
his/her usual activities and/or is of no clinical consequence 
 Moderate: the AE interferes with the usual activities of the subject or it is of some clinical 
consequence 
 Severe: the subject is unable to work normally or to carry out his/her usual activities, or the 
AE is of definite clinical consequence 
Details for completion of the AE eCRF (including judgment of intensity and relationship to IMP) 
are described in the eCRF Completion Guidelines. 
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9.1.6 
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, AESIs, and other safety topics of interest; further 
details regarding follow-up of PDILI events are provided in Section 9.5.1.5. Information on 
SAEs obtained after clinical database lock will be captured through the Patient Safety (PS) 
database without limitation of time. 
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. 
9.1.7 
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 
9.1.8 
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 the ET Visit. 
 The subject should immediately stop the intake of the IMP. 
 An 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. 
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In cases where the partner of a male subject enrolled in a clinical study becomes pregnant, the 
Investigator or designee is asked to contact the subject to request consent of the partner via the 
Partner Pregnancy Consent Form that has been approved by the responsible IRB/IEC and should 
be available in the Investigator site file. In case of questions about the consent process, the 
Investigator may contact the UCB/Contract Research Organization (CRO) contract monitor for 
the study. The Investigator will complete the Pregnancy Report and Outcome Form and send it to 
UCB’s PS department (for contact details see 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 (e.g. when pregnancy is endangering life or health of woman or when 
fetus will be born with severe abnormalities), unintended pregnancy after hormonal 
contraceptive failure (if the hormonal contraceptive was correctly used), ectopic pregnancy, fetal 
demise, or any congenital anomaly/birth defect of the baby. Those SAEs must be additionally 
reported using the Investigator SAE Report form. 
9.1.9 
Suspected transmission of an infectious agent via a medicinal 
product 
For the purposes of reporting, any suspected transmission of an infectious agent via a medicinal 
product should be considered as an SAE; such cases must be reported immediately, recorded in 
the AE module of the eCRF, and followed as any other SAE. Any organism, virus, or infectious 
particle (eg, prion protein transmitting transmissible spongiform encephalopathy), pathogenic or 
nonpathogenic, is considered an infectious agent. 
9.1.10 
Overdose of investigational medicinal product 
Excessive dosing (beyond that prescribed in the protocol and including overdose) should be 
recorded in the eCRF. Any SAE or nonserious AE associated with excessive dosing must be 
followed as any other SAE or nonserious AE. These events are only considered AEs or SAEs if 
there are associated clinical signs and symptoms or if the act of taking the excess medicine itself 
is an AE or SAE (eg, suicide attempt). 
9.1.11 
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. 
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In addition, Cardiovascular and Neuropsychiatric Adjudication Committees will also periodically 
review and monitor the safety data from this study and advise UCB. Details are provided in the 
Adjudication Committee Charters. 
9.2 
Serious AEs 
9.2.1 
Definition of SAEs 
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 9.1.2], allergic bronchospasm requiring intensive treatment in an emergency room or 
at home, blood dyscrasias that do not result in inpatient hospitalization, or the development 
of drug dependency or drug abuse.) 
 Initial inpatient hospitalization or prolongation of hospitalization 
A patient admitted to a hospital, even if he/she is released on the same day, meets the criteria 
for the initial inpatient hospitalization. An emergency room visit that results in admission to 
the hospital would also qualify for the initial inpatient hospitalization criteria. However, 
emergency room visits that do not result in admission to the hospital would not qualify for 
this criteria and, instead, should be evaluated for 1 of the other criteria in the definition of 
serious (eg, life-threatening adverse experience, important medical event). 
Hospitalizations for reasons not associated with the occurrence of an AE (eg, preplanned 
surgery or elective surgery for a pre-existing condition that has not worsened or manifested 
in an unusual or uncharacteristic manner) do not qualify for reporting. For example, if a 
subject has a condition recorded on his/her medical history and later has a preplanned surgery 
for this condition, it is not appropriate to record the surgery or hospitalization as an SAE, 
since there is no AE upon which to assess the serious criteria. Please note that, if the 
pre-existing condition has worsened or manifested in an unusual or uncharacteristic manner, 
this would then qualify as an AE and, if necessary, the seriousness of the event would need to 
be determined. 
Note: Confirmed active TB is always to be considered as an SAE and must be captured on an 
SAE Report Form and provided to the Sponsor in accordance with SAE reporting requirements. 
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9.2.2 
Procedures for reporting serious adverse events 
If an SAE is reported, UCB must be informed within 24 hours of receipt of this information by 
the site (see contact information for SAE reporting listed in the 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 
to draw any conclusions. Information recorded on this form will be entered into the global PS 
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. 
9.2.3 
Follow-up of SAEs 
An SAE 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, AESIs, and other safety topics of interest; further 
details regarding follow-up of PDILI events are provided in Section 9.5.1.5. Information on 
SAEs obtained after clinical database lock will be captured through the PS database without 
limitation of time. 
9.3 
Immediate reporting of AEs 
The following AEs must be reported immediately: 
 SAE: AE that the Investigator classifies as serious by the above definitions regardless of 
causality 
 Suspected transmission of an infectious agent via a medicinal product 
 AEs of special interest as defined in Section 9.1.2  
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9.4 
Anticipated SAEs 
The following list of Anticipated SAEs (Table 9‒1) has been identified, as these events are 
anticipated to occur in the population studied in this protocol at some frequency that is 
independent of drug exposure. This original list will remain in effect for the duration of the 
protocol. Note that 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. 
This list does not change the Investigator’s obligation to report all SAEs (including Anticipated 
SAEs) as detailed in Section 9.2.2. 
Table 9‒1: 
Anticipated SAEs for the population of subjects with psoriatic 
arthritis 
MedDRA system organ class 
MedDRA preferred term 
Eye disorders 
Uveitis 
Cardiac disorders 
Myocardial infarction 
Atrial fibrillation 
Gastrointestinal disorders 
Crohn's disease 
Hepatobiliary disorders 
Non-alcoholic steatohepatitis 
Metabolism and Nutrition disorders 
Metabolic syndrome 
Diabetes mellitus 
Musculoskeletal and connective tissue disorders 
Psoriatic arthropathy 
Neoplasms benign, malignant and unspecified 
(incl cysts and polyps) 
Basal cell carcinoma 
Squamous cell carcinoma 
Nervous system disorders 
Embolic Stroke 
Ischaemic Stroke 
Psychiatric disorders 
Anxiety 
Depression 
Skin and subcutaneous tissue disorders 
Psoriasis 
MedDRA=Medical Dictionary for Regulatory Activities 
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.  
9.5 
Laboratory measurements 
Clinical laboratory assessments consist of serum chemistry, and hematology (Table 9-2). A 
centralized laboratory will be used to supply all laboratory test supplies and analyze all blood 
samples for hematology, and biochemistry measurements. Any unscheduled laboratory testing 
should also be collected using the central laboratory. 
Specific details regarding the handling and processing of serum chemistry, hematology, and 
urinalysis samples are provided in the study laboratory manuals. 
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Table 9-2: 
Laboratory measurements 
Hematology 
Chemistry 
Urinalysis 
Basophils 
Calcium 
Urine dipstick for pregnancy testing a 
Eosinophils 
Chloride 
Urinalysisb 
Lymphocytes 
Magnesium 
 
Atypical lymphocytes 
Potassium 
 
Monocytes 
Sodium 
 
Neutrophils 
Glucose (random) 
 
Hematocrit 
BUN 
 
Hemoglobin 
Creatinine 
 
MCH 
AST 
 
MCHC 
ALT 
 
MCV 
ALP 
 
Platelet count 
GGT 
 
RBC count  
Total bilirubin 
 
WBC count  
LDH 
 
 
Total cholesterol 
 
 
Uric acid 
 
 
CRP  
 
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea 
nitrogen; CRP=C-reactive protein; GGT=gamma glutamyltransferase; LDH=lactate dehydrogenase; 
MCH=mean corpuscular hemoglobin; MCHC=mean corpuscular hemoglobin concentration; MCV=mean 
corpuscular volume  
a A urine pregnancy test will be performed for women of childbearing potential if there is a suspicion of 
pregnancy or a delay in menses. A positive urine pregnancy test should always be confirmed with a serum 
pregnancy test. 
b These measurements will be performed only if a urinalysis is required for safety reasons. 
9.5.1 
Evaluation of PDILI 
The PDILI IMP discontinuation criteria for this study are provided in Section 6.3.1, with the 
accompanying required follow-up investigation and monitoring detailed below. All PDILI events 
must be reported as an AE and reported to the study site and sponsor within 24 hours of learning 
of their occurrence. Any PDILI event that meets the criterion for potential Hy’s Law must be 
reported as an AE of special interest (see Section 9.1.2), and, if applicable, also reported as an 
SAE (see Section 9.2.2).  
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 9.5.1.1). The local 
hepatologist is the expert usually consulted by the treating physician for assessment and 
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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 9.5.1.5).  
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. 
Rechallenge with a substance potentially causing drug-induced liver injury is dangerous, may be 
fatal, and must not occur. 
Table 9-3 summarizes the approach to investigate PDILI. 
 
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Table 9-3: 
Required investigations and follow-up for PDILI 
Laboratory value 
 
Immediate 
Follow-up 
ALT or 
AST 
Total 
bilirubin 
Symptomsa of 
hepatitis or 
hypersensitivity 
Consultation 
requirements 
Actions 
Testing 
Evaluation 
≥3xULN 
≥2xULNb 
NA 
 
 
Hepatology consult.c 
Medical Monitor must be 
notified within 24 hours 
(eg, by laboratory alert) 
and subject discussed with 
Medical Monitor ASAP. 
Immediate IMP 
discontinuation. 
 
Essential: Must have 
repeat liver chemistry 
values and additional 
testing completed 
ASAP (see 
Section 9.5.1.4); 
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 
≥5xULN 
NA 
NA 
Need for hepatology 
consult to be discussed.     
(required if ALT or AST 
≥8xULN) Medical 
Monitor must be notified 
within 24hours (eg, by 
laboratory alert) and 
subject discussed with 
Medical Monitor ASAP. 
Immediate IMP 
discontinuation 
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Table 9-3: 
Required investigations and follow-up for PDILI 
Laboratory value 
 
Immediate 
Follow-up 
ALT or 
AST 
Total 
bilirubin 
Symptomsa of 
hepatitis or 
hypersensitivity 
Consultation 
requirements 
Actions 
Testing 
Evaluation 
≥3xULN 
(and ≥2x 
baseline) and 
<5xULN 
(and ≥2x 
baseline) 
<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 9.5.1.2). 
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 
≥3xULN (and 
≥2xbaseline) after 2 
weeks of monitoring 
without evidence of 
resolution  
Essential: Every 
attempt must be 
made to have repeat 
liver chemistry 
values and additional 
testing completed 
within 48hours at the 
site with HCP (see 
Section 9.5.1.4). 
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:  
 
Discontinue IMP if levels remain 
≥3xULN (and ≥2x baseline) 
without evidence of resolutiond  
Continue to monitor until values 
normalize, stabilize, or return to within 
Baseline valuesd. 
 
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 9.5.1.1. The local hepatologist is the expert usually consulted by the treating physician for assessment and management of potential 
hepatic disease. This would usually be a hepatologist but may be a gastroenterologist. 
d Unless an alternative monitoring schedule is agreed by the investigator and UCB responsible physician. Determination of stabilization is at the discretion of the 
investigator in consultation with the hepatologist (as applicable) and UCB responsible physician, as needed. 
 
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9.5.1.1 
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 9.5.1.4) and SAE report (if applicable). 
9.5.1.2 
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 discontinuation (see Section 6.3.1 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. 
9.5.1.3 
IMP restart/rechallenge 
Rechallenge with a substance potentially causing drug-induced liver injury is dangerous, may be 
fatal, and must not occur. 
9.5.1.4 
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 included, but not 
limited to those listed 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 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 measurements to be assessed are detailed in Table 9‒4. 
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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 heterophil 
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 
Toxicology screen a 
Chemistry 
Amylase 
ALT, AST 
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 
PK sample 
ALT=alanine aminotransferase; AST=aspartate aminotransferase; CPK=creatine phosphokinase; 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 For detecting substances (ie, amphetamines, benzodiazepines, opioids, marijuana, cocaine, phencyclidine, and 
tricyclic antidepressants), additional tests may be performed based on the Investigator’s medical judgment and 
patient’s history. 
b Measured only for subjects with ALT >8xULN, elevations in total bilirubin, and symptoms of hepatitis or 
hypersensitivity. Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or 
tenderness; hypersensitivity symptoms include eosinophilia (>5%), rash, and fever (without clear alternative 
cause). 
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The following additional PDILI information is to be collected (Table 9‒5): 
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 
9.5.1.5 
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. 
9.6 
Other safety measurements 
9.6.1 
Vital signs 
The Investigator or designee should measure all vital signs (systolic and diastolic BP, 
temperature [oral, axillary, or otic], pulse rate) after the subject has been sitting for at least 
5 minutes, and the subject should remain seated during the measurements. Body temperature 
should be obtained prior to dosing with IMP at study visits when IMP is administered. At 
PA0009 study entry, collect pulse and BP prior to drug administration and then at 30 minutes 
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and 1 hour after dosing. At all other visits collect pulse and BP prior to drug administration and 
once after dosing (any time). 
9.6.2 
Body weight 
The Investigator or designee will measure the weight of the subject in kilograms at the time 
points listed in Table 5‒1. The same scale should be utilized throughout the study where 
possible. 
9.6.3 
Physical examination 
The physical examination should be conducted by the Investigator or designee at the time points 
listed in Table 5‒1 and will include general appearance; ear, nose, and throat; eyes, hair, and 
skin; respiratory; cardiovascular; gastrointestinal; musculoskeletal; hepatic; neurological 
(including limb reflexes); and mental status. Findings considered clinically significant changes 
since the physical examination at the Baseline of PA0008 will be recorded as AEs. 
9.6.4 
12-lead ECG 
The Investigator or designee will perform the ECG at the time points listed in Table 5‒1. The 
ECGs will be read locally.  
9.6.5 
Tuberculosis and TB risk factor assessment and management 
All subjects will be assessed for TB at prior to administration of IMP in PA0009 and at the time 
points specified in the schedule of study assessments (Table 5‒1) through physical examination 
for signs and symptoms of TB, laboratory testing (Section 9.6.5.1), and subject questionnaire 
(Section 9.6.5.2). 
Prior to administration of IMP, subjects will have an IGRA test (QuantiFERON TB Test is 
recommended) and examination for signs and symptoms of TB unless an IGRA negative result is 
available less than 6 weeks prior to the first dose of open-label bimekizumab. In addition, each 
subject will complete a TB questionnaire with questions directed at symptoms of TB and 
potential exposure to TB.  
Test Conversion 
Tuberculosis test conversion is defined as 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. In case of a TB test conversion, the subject must be considered as 
having either a suspected new latent or an active TB infection and be promptly referred to an 
appropriate specialist (eg, pulmonologist, infectious disease specialist) for further evaluation. If 
test conversion indicates LTB infection, active TB, or nontuberculous mycobacteria (NTMB) 
then, per UCB TB working instructions, TB test conversion (confirmed) should be classified 
adequately, either as due to LTB infection, active TB infection, or NTMB, respectively. 
Additional assessments (eg, blood tests or IGRA, chest x-rays, or other imaging) should be 
performed where medically relevant and documented. Such conversions should be reported to 
the UCB PS function. 
Latent TB 
In case the evaluation by the appropriate specialist indicates a new LTB infection during the 
study, a prophylactic TB treatment should be initiated, and the IMP can be continued no sooner 
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than 4 weeks after start of prophylactic TB treatment, if it is deemed likely by the Investigator 
that prophylactic TB treatment is continued to completion. 
If prophylaxis is not initiated, the subject must be withdrawn. 
Every related action should be discussed in advance with the Medical Monitor.  
Once withdrawn from study treatment, subjects should return for the ET Visit, complete all 
ET Visit assessments, and complete a SFU Visit (20 weeks after the last dose of IMP). 
Active TB or NTMB infection  
Subjects who develop active TB or NTMB infection during the study must be withdrawn from 
the study. The subject must be immediately discontinued from IMP and an ET Visit must be 
scheduled as soon as possible, but no later than the next scheduled visit. The subject should be 
encouraged to keep the SFU Visit as specified by the protocol. Treatment should be started 
immediately. 
Note that subjects with history of NTMB or active NTMB infection are excluded from the study 
regardless of prior or current therapy for this condition.  
9.6.5.1 
Tuberculosis assessment by IGRA 
During conduct of the study, the TB assessment by IGRA (QuantiFERON TB Test is 
recommended) will be performed at study entry (unless an IGRA negative result is available less 
than 4 weeks prior to the first dose of open-label bimekizumab) and should be repeated at 
Week 48, Week 96, and SFU Visits for all subjects. The test results will be reported as positive, 
negative, or indeterminate. 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.  
9.6.5.2 
Tuberculosis questionnaire  
The questionnaire “Evaluation of signs and symptoms of tuberculosis” should be used as a 
source document. The questionnaire will be completed at PA0009 entry, every 12 weeks 
throughout the study, at Week 104, and at the SFU Visit (Table 5‒1). The questionnaire will 
assist with the identification of subjects who may require therapy for TB. A “Yes” response to 
any of the questions during the study should trigger further assessments to determine if the 
subject has either LTB or active TB infection. 
Subjects with a confirmed latent TB (where no prophylactic treatment is initiated) or active TB 
infection must be withdrawn from the study (as further detailed in Section 9.6.5). 
9.6.5.3 
Tuberculosis management 
LTB infection and active TB identified during study 
During the study, subjects who develop evidence of LTB infection or active TB must 
immediately stop further administration of IMP and will be referred to an appropriate TB 
specialist (pulmonologist or infectious disease specialist) for further evaluation. Evidence of 
LTB infection is defined as subject’s IGRA test converts to positive or indeterminate (and 
confirmed indeterminate on repeat), or the subject’s questionnaire or history and physical 
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 
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situation, the subject should be carefully assessed by a TB specialist for active TB. Subjects 
diagnosed with active TB or LTB infection should be withdrawn from the study and receive 
appropriate TB or prophylaxis therapy.  
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 ET Visit as soon as possible, but no 
later than the next scheduled study visit and complete all ET Visit assessments.  
The subject should be encouraged to complete a SFU Visit (20 weeks after the last dose of IMP). 
If infection with NTMB is identified during the study, the same procedure as for active TB 
acquired during the study must be followed. 
9.6.6 
Pregnancy testing 
A urine pregnancy test will be performed at any scheduled or unscheduled visit if there is 
suspicion of pregnancy and will be confirmed with a serum pregnancy test if the urine test is 
positive. 
Pregnancy test results must be negative prior to administering IMP. 
9.6.7 
Assessment of suicidal ideation and behavior 
Suicidal ideation and behavior will be assessed by trained study personnel using the eC-SSRS. 
This scale will be used to assess suicidal ideation and behavior that may occur during the study. 
The visits at which the eC-SSRS assessments will be performed are specified in the schedule of 
study assessments (Table 5‒1). 
The eC-SSRS is a standardized and validated instrument developed for the assessment of the 
severity and frequency of suicidal ideation and behavior (Posner et al, 2011; Mundt et al, 2010). 
Subjects respond to standardized clinical questions that are presented in a uniform fashion. The 
eC-SSRS defines 5 subtypes of suicidal ideation and behavior in addition to self-injurious 
behavior with no suicidal intent. The eC-SSRS takes approximately 3 to 10 minutes to complete. 
10 
ASSESSMENT OF EFFICACY 
Several assessments must be completed in order to determine the ACR response. These include 
the TJC and SJC based on 78 and 76 joints, respectively, PGADA, PhGADA, PtAAP, HAQ-DI, 
and CRP. The methods for the component measures will be described first, followed by ACR 
response and assessments used in secondary and other efficacy variables.  
The timing for all assessments is specified in the schedule of study assessments (Table 5‒1).  
10.1 
78/76 joint evaluation for ACR response 
The Principal Investigator, another delegated physician, or an appropriately qualified medical 
professional (based on local requirements) who has had documented training on how to perform 
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these assessments correctly assesses the following joints for tenderness: the distal 
interphalangeal, proximal interphalangeal and metacarpophalangeal joints of the hands, and 
metatarsophalangeal joints of the feet, the carpometacarpal and wrist joints (counted separately), 
the elbows, shoulders, acromioclavicular, sternoclavicular, hip, knee, talo-tibial, and midtarsal 
joints. All of these except for the hips are assessed for swelling.  
Artificial and ankylosed joints, as well as missing joints (ie, amputated joints), are excluded from 
both tenderness and swelling assessments.  
One dactylitic digit is to be counted as 1 swollen joint (instead of counting as 3 in the finger or 
2 in the toe). 
Table 10‒1 summarizes the swelling and tenderness grading criteria. 
Table 10‒1: Swelling and tenderness grading 
Grade 
Swelling response (76) 
Tenderness response (78) 
0 
None 
Not tender 
1 
Detectable synovial thickening 
Tenderness present 
 
10.2 
28 joint evaluation for determination of DAS28(CRP) 
The following 28 joints will be used for calculation of the DAS28(CRP). 
 Upper extremity (26)-bilateral shoulders, elbows, wrists (includes radiocarpal, and carpal and 
carpometacarpal bones considered as a single unit), metacarpophalangeal (MCP) I, II, III, IV, 
and V, thumb interphalangeals (IP), proximal interphalangeal (PIP) II, III, IV, and V  
 Lower extremity (2)-knees 
10.3 
Patient’s Global Assessment of Disease Activity 
Subjects will score their Global Assessment of Disease Activity using a visual analog scale 
(VAS) where 0 is “very good, no symptoms” and 100 is “very poor, severe symptoms”. 
The subject should be asked to consider both joint and skin components in their response to this 
question. 
10.4 
Physician’s Global Assessment of Disease Activity 
The Investigator will assess the overall status of the subject with respect to their PsA signs and 
symptoms and functional capacity (considering both joint and skin components) using a VAS 
where 0 is “very good, asymptomatic and no limitation of normal activities” and 100 is “very 
poor, very severe symptoms which are intolerable and inability to carry out all normal activities”. 
This assessment by the Investigator should be made blind to the PGADA. 
10.5 
Patient’s Assessment of Arthritis Pain 
The Patient’s Assessment of Arthritis Pain VAS or ‘Pain VAS’ is part of the ACR core set of 
measures in arthritis (Felson et al, 1993). Subjects will assess their arthritis pain using a VAS 
where 0 is “no pain” and 100 is “most severe pain”.  
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10.6 
Health Assessment Questionnaire-Disability Index score  
The HAQ-DI contains 20 items divided into 8 domains that measure: dressing and grooming, 
arising, eating, walking, hygiene, reach, grip, and common daily activities. Subjects are required 
to indicate the degree of difficulty they have experienced in each domain in the past week on a 
4-point scale that ranges from 0 (without difficulty) to 3 (unable to do). Any individual score of 
less than 2 is adjusted to 2 if the activity requires assistance from another individual or the use of 
an assistive device. The highest score in each category is then summed (0 to 24) and divided by 
the number of categories scored to give a score that ranges from 0 to 3.  
10.7 
CRP levels 
C-reactive protein levels will be analyzed by the central laboratory. 
10.8 
ACR20, ACR50, and ACR70 response 
The ACR20, ACR50, and ACR70 response rates are based on a 20%, 50%, and 70% or greater 
improvement relative to Baseline of PA0008 in the following measures: 
 TJC based on 78 joints 
 SJC based on 76 joints 
 3 of the 5 remaining core set measures: 
 PGADA 
 PhGADA 
 PtAAP 
 HAQ-DI 
 CRP 
10.9 
BSA-PSO 
The BSA palm method will be used for the evaluation of BSA affected by PSO as follows: 
The subject’s hand, including the palm, fingers and thumb, is used as the reference point for 
measuring how much of their skin is affected by PSO, representing roughly 1% of the body’s 
surface.  
 Subject’s palm=1% 
 Head and neck=10% (10 palms) 
 Upper extremities=20 % (20 palms) 
 Trunk=30% (30 palms) 
 Lower extremities=40 % (40 palms)  
Total BSA=100% 
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10.10 
Psoriasis Area and Severity Index (PASI) 
Psoriasis Area and Severity Index will be assessed in all subjects with study entry BSA affected 
by PSO ≥3% at Baseline of PA0008 determined by the method described in Section 10.9 (ie, the 
BSA palm method).  
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 limbs, 
trunk, and lower limbs and then transferred into a grade (Table 10‒2).  
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body 
area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked.  
The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.  
Table 10‒2: Body areas for calculation of percent BSA for PASI 
Body area 
Details of area 
BSA 
Degree of 
involvement of 
body areaa 
Head 
Face, back of head 
10%  
0 to 6 
Upper limbs  
Left, right, upper lower, flexor 
surface, extensor surface 
20%  
0 to 6 
Trunk 
Front, back, groin 
30%  
0 to 6 
Lower limbs  
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 compared to Baseline in PA0008. Thereafter PASI will be 
analyzed for the purposes of determining response only in subjects with PSO involving at least 
3% of BSA at Baseline of PA0008.  
10.11 
MDA 
Minimal Disease Activity is a state of disease activity deemed a useful derived target of 
treatment by both the patient and physician, given current treatment possibilities and limitations. 
Criteria shown in Table 10‒3 covering all of the domains of the disease have been developed to 
determine whether or not a patient has reached MDA based on key outcome measures in PsA. 
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A subject is considered as having MDA if 5 or more of the following 7 criteria in Table 10‒3 are 
fulfilled:  
Table 10‒3: MDA criteria in PsA 
A subject is classified as in MDA when they meet 5 of 7 of the following criteria: 
 
Tender joint count ≤1 
 
Swollen joint count ≤1 
 
PASI ≤1 or BSA ≤3 
 
Patient pain VAS ≤15 
 
Patient global activity VAS ≤20 
 
HAQ ≤0.5 
 
Tender enthesial points ≤1 
 
BSA=body surface area; HAQ=Health Assessment Questionnaire; MDA=minimal disease activity; PASI=Psoriasis 
Area and Severity Index; VAS=visual analog scale 
Data sources: Mease, 2011; Coates et al, 2010 
 
In addition, a modified MDA will be determined using the criteria in Table 10‒3 by fulfilling the 
criterion PASI ≤1 or BSA ≤3 and 4 out of the 6 remaining criteria.  
10.12 
DAS28(CRP) 
The components for DAS28(CRP) include the TJC and SJC based on 28 joints (Section 10.2), 
CRP (Section 10.7) and the PGADA (Section 10.3). DAS28(CRP) is calculated as follows: 
 
10.13 
MASES 
The MASES is an index that measures the severity (ie, intensity and extent) of enthesitis through 
the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac 
spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the 
fifth lumbar vertebral body spinous process) (Heuft-Dorenbosch et al, 2003) each scored as 
0 or 1 and then summed for a possible score of 0 to 13. 
10.14 
LDI 
Dactylitis, the swelling of an entire digit related to articular and peri-articular inflammation, is a 
characteristic of inflammatory spondyloarthropathies, including PsA. Presence of dactylitis will 
be assessed using the LDI basic which evaluates for a ≥10% difference in the circumference of 
the digit compared to the opposite digit (Healy and Helliwell, 2007; Helliwell et al, 2005). This 
is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present). 
The digits involved and the matching contralateral digit will also be recorded at the same visits. 
10.15 
Hospital Anxiety and Depression Scale 
The HADS was chosen for its well-established psychometric properties and its use in clinical 
research on biological therapy in subjects with chronic plaque PSO (Langley et al, 2010; 
Dauden et al, 2009). The HADS scores for anxiety and for depression range from 0 to 21 with 
higher scores indicating worse state. A score below 8 is considered to be normal whereas a score 
of 15 and above is considered severe (Snaith and Zigmond, 1994). 




96
.0
1
ln
36
.0
014
.0
28
.0
56
.0
28










CRP
PGADA
SJC
TJC
CRP
DAS
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10.16 
PsAID-9 
The PsAID-9 is a patient-reported outcome measure for assessing the impact of PsA in 
9 physical and psychological domains, including pain, fatigue, skin problems, work and/or 
leisure activities, functional capacity, discomfort, sleep disturbance, coping, and 
anxiety/fear/uncertainty. Each domain is assessed with a single question using a 0 to 
10 numerical rating scale. Each domain score is multiplied by a weighting factor and the results 
are then summed to provide the total score. The total score ranges from 0 to 10, with higher 
scores indicating a worse status. The PsAID-9 demonstrated satisfactory psychometric properties 
in an international validation study; however, further validation is needed (Gossec et al, 2014). A 
score below 4 out of 10 is considered a patient-acceptable status. A change of 3 or more points is 
considered relevant absolute change.  
10.17 
SF-36 
The SF-36 (Version 2, standard recall) is a 36-item generic Health-Related Quality of Life 
(HRQoL) 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 HRQoL. 
In addition to domain scores, the Physical Component Summary and Mental Component 
Summary 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 2 component summary scores 
are standardized with a mean of 50 and a standard deviation of 10 in the general US population.  
11 
ASSESSMENT OF IMMUNOGENICITY 
The Investigator or designee will obtain blood samples for measurement of bimekizumab plasma 
concentrations and antibodies to bimekizumab at the time points specified in Table 5‒1. When 
these samples are required at a visit during which the subject is dosed with IMP, the blood 
samples will be drawn prior to dosing. Samples should 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. Any characterization of the 
anti-bimekizumab antibody response will be done using validated assays. Detailed information 
on sample analysis will be provided in a bioanalytical report. 
12 
STUDY MANAGEMENT AND ADMINISTRATION 
12.1 
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 
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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. 
12.2 
Monitoring 
UCB (or designee) will monitor the study to meet the sponsor’s monitoring Standard Operating 
Procedures (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 study participant). 
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. 
12.2.1 
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 quality of life 
questionnaires, for example. Source documents should be kept in a secure, limited access area. 
Sponsor or designee will review to ensure that computerized source documents produced by the 
site are compliant with Food and Drug Administration (FDA) Part 11 requirements and 
document appropriately. 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 must be saved and stored as instructed by UCB (or designee). 
12.2.2 
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 
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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 12.2.1. 
12.3 
Data handling 
12.3.1 
Case Report form completion 
This study will use electronic data capture (EDC); the Investigator is responsible for prompt 
reporting of accurate, complete, and legible data in the eCRF and in all required reports. 
This study will also use an electronic device (Site Tablet) to capture patient reported outcomes. 
Serious AE reporting will be done using the SAE Report Form (see Section 9.2.2) while also 
entering the event in the appropriate eCRF section. The safety database and the clinical database 
will be reconciled during the study and discrepancies will be corrected as needed. 
The Investigator should maintain a list of personnel authorized to enter data into the eCRF. 
Access to the EDC will be given after training has been received. A training certificate will be 
provided and filed. 
Detailed instructions on the use of the EDC will be provided in the eCRF Completion 
Guidelines. 
Corrections made after the Investigator’s review and approval (by means of a 
password/electronic signature) will be re-approved by the Investigator. Any change or correction 
to the eCRF after saving must be accompanied by a reason for the change. 
12.3.2 
Database entry and reconciliation 
Case Report forms/external electronic data will be entered/loaded into a validated electronic 
database using a clinical data management system (CDMS). Computerized data cleaning checks 
will be used in addition to manual review to check for discrepancies and to ensure consistency of 
the data. This study is performed using EDC: the data are entered into the eCRFs once and are 
subsequently verified. 
An electronic audit trail system will be maintained within the CDMS to track all data changes in 
the database once the data have been saved initially into the system or electronically loaded. 
Regular backups of the electronic data will be performed. 
12.3.3 
Subject Screening and Enrollment log/Subject Identification Code list 
The subject’s screening and enrollment will be recorded in the Subject Screening and Enrollment 
Log. 
The investigator will keep a Subject Identification Code list. This list remains with the 
investigator and is used for unambiguous identification of each subject. 
The subject’s consent and enrollment in the study must be recorded in the subject’s medical 
record. These data should identify the study and document the dates of the subject’s 
participation. 
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12.4 
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. 
12.5 
Archiving and data retention 
The investigator will maintain adequate records for the study, including eCRFs, medical records, 
laboratory results, Informed Consent documents, drug dispensing and disposition records, safety 
reports, information regarding participants who discontinued, and other pertinent data. 
All essential documents are to be retained by the investigator until at least 2 years after the last 
approval of a marketing application in an ICH region and until there are no pending or 
contemplated marketing applications in an ICH region, or at least 2 years have elapsed since the 
formal discontinuation of clinical development of the IMP. These documents should be retained 
for a longer period, however, if required by the applicable regulatory requirement(s) or by an 
agreement with UCB (CPMP/ICH/135/95, 2002 [Section 4.9.5]). The investigator will contact 
UCB for authorization prior to the destruction of any study records or in the event of accidental 
loss or destruction of any study records. The investigator will also notify UCB should he/she 
relocate or move the study-related files to a location other than that specified in the sponsor’s 
trial master file. 
12.6 
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). 
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12.7 
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. 
13 
STATISTICS 
A description of statistical methods follows and will be described in more detail in the Statistical 
Analysis Plan. 
13.1 
Definition of analysis sets 
The Enrolled Set (ES) will consist of all subjects who have given informed consent for PA0009. 
The Safety Set (SS) will consist of all subjects who receive at least 1 dose of the IMP in PA0009. 
The Full Analysis Set (FAS) will consist of all enrolled subjects who receive at least 1 dose of 
the IMP and have a valid measurement for at least 1 efficacy variable after PA0009 entry visit.  
13.2 
General statistical considerations 
Summary statistics will consist of frequency tables for categorical variables. For continuous 
variables, summary statistics will consist of number of available observations, arithmetic mean, 
standard deviation, median, minimum, and maximum unless stated otherwise. 
In general, summary statistics will be done by randomized treatment group and by treatment 
group at completion of PA0008 (ie, bimekizumab 160mg Q4W or bimekizumab 320mg Q4W).  
Two subpopulations will be defined for this study. Subpopulation 1 will consist of all subjects 
who do not receive rescue therapy according to the criteria outlined in Section 5.1.1. 
Subpopulation 2 will consist of all subjects who receive rescue therapy according to the criteria 
outlined in Section 5.1.1. Analyses of the primary and secondary variables will also be done on 
both subpopulations. 
Changes from Baseline will be calculated relative to the Baseline of PA0008. Variables 
measured at the start of PA0009 will be referred to as PA0009 entry values. 
13.3 
Planned safety analyses 
13.3.1 
Safety analyses 
Safety variables will be analyzed for all subjects in the SS.  
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities. 
Adverse events will be summarized descriptively by treatment group at completion of PA0008, 
primary system organ class, high level term, and preferred term. This summary will include raw 
incidence rates, exposure-adjusted incidence rates (EAIRs) with associated 95% CIs, and 
exposure-adjusted event rates (EAERs) where the EAIR and EAER are expressed per 
100 patient-years of exposure.  
Patient exposure at risk will be defined as date of last administration of study medication – date 
of first administration of bimekizumab +20 weeks. If a subject has an adverse event with fatal 
outcome, patient exposure at risk is censored at the date of death.  
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The extent of exposure to study medication in PA0009 will be summarized using descriptive 
statistics by treatment group at completion of PA0008. 
Change from PA0008 Baseline values in vital signs variables will be summarized descriptively 
by visit and by treatment group at completion of PA0008. Change from PA0009 Laboratory 
Baseline values in clinical laboratory variables (hematology and biochemistry, excepting high-
sensitivity CRP) will be summarized descriptively by visit and by treatment group at completion 
of PA0008. 
Due to a change in laboratory vendor between PA0008 and PA0009, laboratory values 
(excepting CRP) will use the PA0009 Laboratory Baseline, defined as the earliest post-entry visit 
value recorded in PA0009. Change from PA0009 Laboratory Baseline will be calculated for 
these parameters. (The CRP values from the 2 analyzing laboratories have been calibrated, so 
change from PA0008 Baseline will be calculated for that parameter.) 
All safety analyses will be conducted for both subpopulations. 
13.4 
Planned efficacy analyses 
Secondary and other efficacy variables will be summarized for all subjects in the FAS; efficacy 
analyses will be performed over 104 weeks (2 years).  
Responder variables (eg, ACR20 response) will be derived relative to the Baseline of PA0008 
and summarized descriptively. Percentages will be summarized descriptively by visit, by 
randomized treatment group, and by treatment group at PA0009 entry. 
Change from Baseline of PA0008 of all continuous variables will be summarized descriptively 
by visit, by randomized treatment group, and by treatment group at completion of PA0008. 
13.4.1 
Subgroup analysis 
Subgroup analyses will be performed on the efficacy variables. The following variables for 
subgroup analyses will be defined: 
 Region 
 Disease duration 
 Previous tumor necrosis factor (TNF) inhibitor agent exposure 
 Concomitant DMARD status at Baseline of PA0008 
13.5 
Planned immunogenicity analyses 
Immunogenicity variables will be analyzed for all subjects in the SS.  
Bimekizumab plasma concentration and anti-bimekizumab antibody appearance will be 
summarized by visit, by randomized treatment group, and by treatment group at completion of 
PA0008. The first occurrence of anti-bimekizumab antibody positivity as well as persistent and 
transient anti-bimekizumab antibody positivity will be summarized by visit, by randomized 
treatment group, and by treatment group at completion of PA0008. Figures on persistent and 
transient anti-bimekizumab antibody positivity over time and on the relationship between 
ACR20 response and anti-bimekizumab antibody positivity over time will be produced. 
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13.6 
Other analyses 
Other variables will be summarized using descriptive statistics using the treatment group at 
completion of PA0008. 
13.7 
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 safety or efficacy outcomes for an individual 
subject. The criteria for identifying important protocol deviations will be defined within the 
appropriate protocol-specific document. Important protocol deviations will be reviewed as part 
of the ongoing data cleaning process. 
13.8 
Handling of dropouts or missing data 
Missing binary efficacy variables will be imputed using nonresponder imputation (NRI). In NRI, 
each subject with missing data or who has prematurely finished the study will be counted as a 
nonresponder. 
For missing continuous efficacy variables, a multiple imputation (MI) approach will be used. In 
MI, the missing value is replaced by a set of plausible values, where each value is a Bayesian 
draw from the conditional distribution of the missing data given the observed data. 
Non-monotone missing data (ie, intermittent missing data) will be imputed several times with the 
Markov Chain Monte Carlo (MCMC) method and monotone missing data will be imputed using 
a monotone regression model. Each set of imputed data will then be summarized and the 
summaries will be combined into a single inference (Carpenter and Kenward, 2013). 
Safety data will not be imputed. 
As a sensitivity analysis, the ACR, PASI, LDI, MASES, and MDA efficacy variables will be 
analyzed based on observed data in addition to a sensitivity analysis based on multiple 
imputation of ACR component scores and PASI scores for the ACR and PASI response 
variables, respectively. Subjects with missing data or who have prematurely finished the study 
will be treated as missing. 
13.9 
Planned interim analysis and data monitoring 
No formal interim analysis is planned for this study. Additional data cuts may be prepared 
following regulatory requests or for publication purposes. 
13.10 
Determination of sample size 
There is no formal sample size for this study. The sample size is determined by the number of 
subjects eligible for PA0009 and rolling over from PA0008. Up to 200 subjects from PA0008 
could be enrolled into this study. 
14 
ETHICS AND REGULATORY REQUIREMENTS 
14.1 
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. 
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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 and by the person who conducted the informed consent discussion 
(investigator or designee). The subject 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. 
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. 
14.2 
Subject identification cards 
Upon signing the Informed Consent and Assent form (as applicable), the subject will be provided 
with a subject identification card in the language of the subject. The investigator will fill in the 
subject identifying information and medical emergency contact information. The investigator 
will instruct the subject to keep the card with him/her at all times. 
14.3 
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, Investigator’s Brochure, 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. 
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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. 
14.4 
Subject privacy 
UCB staff (or designee) will affirm and uphold the subject’s confidentiality. Throughout this 
study, all data forwarded to UCB (or designee) will be identified only by the subject number 
assigned at Screening. 
The investigator agrees that representatives of UCB, its designee, representatives of the relevant 
IRB/IEC, or representatives of regulatory authorities will be allowed to review that portion of the 
subject’s primary medical records that directly concerns this study (including, but not limited to, 
laboratory test result reports, ECG reports, admission/discharge summaries for hospital 
admissions occurring during a subject’s study participation, and autopsy reports for deaths 
occurring during the study). 
14.5 
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. 
15 
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. 
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placebo-controlled phase III trial. J Am Acad Dermatol. 2010;63(3):457-65. 
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Common Toxicity Criteria v.2.0. J Rheumatol. 2007;34:1401-14. 
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17 
APPENDICES 
17.1 
Markedly abnormal laboratory values 
Table 17-1: Definitions of markedly abnormal hematology values 
Parameter (RCTC units) 
Markedly Abnormal Definition 
Low 
High 
Hemoglobin (g/dL) 
<LLN 
AND 
>2.0 decrease from Baseline 
N/A 
Hemoglobin (g/dL) 
<8.0 
N/A 
Leukocytes (total x 1000) 
<2.0 
N/A 
Lymphocytes (x 1000) 
<0.5 
N/A 
Neutrophils (x 1000) 
<1.0a 
N/A 
Platelets (x 1000) 
<50 
N/A 
LLN=lower limit of normal; N/A = Not Applicable; RCTC= Rheumatology Common Toxicity Criteria 
Data source: modified from Appendix Rheumatology Common Toxicity Criteria v.2.0 presented in 
Woodworth et al, 2007 
a Withdrawal criteria for neutrophils is <0.5 (Section 6.3). 
 
Table 17‒2: Definitions of markedly abnormal biochemistry values 
Parameter (RCTC units) 
Markedly Abnormal Definition 
Low  
High 
Alkaline Phosphatase 
N/A 
>3 x ULN 
ALT 
N/A 
>3 x ULN 
AST 
N/A 
>3 x ULN 
Calcium (mg/dL) 
<7.0 
>12.5 
Creatinine (mg/dl) 
N/A 
>1.8 x ULN 
Glucose (mg/dL) 
<40 
>250 
Potassium (mmol/L) 
<3.0 
>6.4 
Sodium (mmol/L) 
<125 
N/A 
Total bilirubin 
N/A 
≥2 x ULN 
Uric acid 
N/A 
≥3 x ULN 
ALT=alanine aminotransferase; AST=aspartate aminotransferase; N/A=Not applicable; RCTC= Rheumatology 
Common Toxicity Criteria; ULN=upper limit of normal 
Data source: modified from Appendix Rheumatology Common Toxicity Criteria v.2.0 presented in 
Woodworth et al, 2007 
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17.2 
Protocol Amendment 1 
Rationale for the amendment 
The purpose of this amendment is the following: 
 To provide clarification that ACR and PASI responses are compared to both Baseline of 
PA0008 and PA0009 entry values. 
 To correct language regarding administration of live, inactivated vaccinations.  
 To remove inclusion of a Data Monitoring Committee.  
 To clarify guidance for Investigators when scoring injected joints.    
Modifications and changes 
Global changes 
No global changes have been made. Specific changes are listed below.  
Specific changes 
Change #1 
List of Abbreviations 
The following abbreviation has been deleted: 
DMC  
 
Data Monitoring Committee 
Change #2 
Summary, paragraph 6, sentence 2 
The secondary efficacy variables include the American College of Rheumatology 20% (ACR20) 
response at Week 48 (with a responder defined as a subject with an improvement from Baseline 
of ≥20% in the swollen and tender joint counts and at least 3 of the other 5 components of the 
core set of American College of Rheumatology [ACR] response measures), American College of 
Rheumatology 50% (ACR50) response at Week 48; American College of Rheumatology 70% 
(ACR70) response at Week 48, change from Baseline and PA0009 entry value in the Maastricht 
Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48, change from Baseline and 
PA0009 entry value in the Leeds Dactylitis Index (LDI) at Week 48, the Psoriasis Area and 
Severity Index 75 (PASI75) response, and the Psoriasis Area and Severity Index 90 (PASI90) 
response at Week 48. 
Has been changed to: 
The secondary efficacy variables include the American College of Rheumatology 20% (ACR20) 
response at Week 48 (with a responder defined as a subject with an improvement from PA0008 
Baseline and PA0009 entry value of ≥20% in the swollen and tender joint counts and at least 3 
of the other 5 components of the core set of American College of Rheumatology [ACR] response 
measures), American College of Rheumatology 50% (ACR50) response at Week 48; American 
College of Rheumatology 70% (ACR70) response at Week 48, change from Baseline and 
PA0009 entry value in the Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at 
Week 48, change from Baseline and PA0009 entry value in the Leeds Dactylitis Index (LDI) at 
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Week 48, the Psoriasis Area and Severity Index 75 (PASI75) response, and the Psoriasis Area 
and Severity Index 90 (PASI90) response at Week 48. 
 
Change #3 
Section 7.8.1  
Permitted concomitant treatments (medications and therapies), bullet point 
item 3 
 Up to 1 injection per joint for up to 3 discrete joints is permitted per 12-month period. 
Injected joints are censored for the joint examination.  
Has been changed to: 
 Up to 1 injection per joint for up to 3 discrete joints is permitted per 12-month period. 
Investigators should follow the guidance in the CRF instructions for proper scoring of 
the injected joints. 
 
Change #4 
Section 7.8.2  
Prohibited concomitant treatments (medications and therapies), Vaccines, 
paragraph 1 
Administration of live, attenuated vaccines is not allowed during the conduct of the study or for 
20 weeks after the last dose of study drug. Administration of non-live, attenuated vaccines is 
allowed during the study at the discretion of the Investigator. 
Has been changed to: 
Administration of live, attenuated vaccines is not allowed during the conduct of the study or for 
20 weeks after the last dose of study drug. Administration of non-live, inactivated vaccines is 
allowed during the study at the discretion of the Investigator. 
 
Change #5 
Section 9.1.11  
Safety signal detection, paragraph 3 
In addition, an independent Data Monitoring Committee (DMC) will periodically review and 
monitor the safety data from this study and advise UCB. Details are provided in the DMC 
Charter. Cardiovascular and Neuropsychiatric Adjudication Committees will also periodically 
review and monitor the safety data from this study and advise UCB. Details are provided in the 
Adjudication Committee Charters. 
Has been changed to: 
In addition, Cardiovascular and Neuropsychiatric Adjudication Committees will also periodically 
review and monitor the safety data from this study and advise UCB. Details are provided in the 
Adjudication Committee Charters. 
 
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Change #6 
Section 10.8  
ACR20, ACR50, and ACR70 response, paragraph 1 
The ACR20, ACR50, and ACR70 response rates are based on a 20%, 50%, and 70% or greater 
improvement relative to Baseline of PA0008 in the following measures: 
Has been changed to: 
The ACR20, ACR50, and ACR70 response rates are based on a 20%, 50%, and 70% or greater 
improvement relative to Baseline of PA0008 and PA0009 entry values in the following 
measures: 
 
Change #7 
Section 10.10  
Psoriasis Area and Severity Index (PASI), paragraph 6 
The PASI75, PASI90, and PASI100 responses are based on at least 75%, 90%, and 100% 
improvement in the PASI score compared to Baseline in PA0008. Thereafter PASI will be 
assessed for the purposes of determining response only in subjects with PSO involving at least 
3% of BSA at study entry.  
Has been changed to: 
The PASI75, PASI90, and PASI100 responses are based on at least 75%, 90%, and 100% 
improvement in the PASI score compared to Baseline in PA0008 and PA0009 entry values. 
Thereafter PASI will be assessed for the purposes of determining response only in subjects with 
PSO involving at least 3% of BSA at study entry.  
 
Change #8 
Section 10.11  
MDA 
The following text was added beneath Table 10-3: 
In addition, a modified MDA will be determined using the criteria in Table 10-3 by 
fulfilling the criterion PASI ≤1 or BSA ≤3 and 4 out of the 6 remaining criteria.
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17.3 
Protocol Amendment 2 
Rationale for the amendment 
The purpose of this substantial amendment is as follows:  
 To update the study contact details for the sponsor study physician and clinical trial 
biostatistician. 
 Amend the open-label treatment period for clarification, as per request from the regulatory 
agency. 
 Amend the study procedures and assessments to be performed at the Safety Follow-up visit. 
Efficacy assessments were removed since they are not required at the SFU visit. 
 Include additional wording to the inclusion criteria (criterion #5) listing acceptable methods 
of contraception for female subjects. 
 Amend the exclusion criteria (criterion #2) to include further clarification on when to consult 
the medical monitor.  
 To revise the withdrawal criteria section to provide instructions for the management of 
subjects with newly diagnosed IBD or with IBD flares during the study. 
 To revise and clarify the SAE criteria for pregnancy for consistency. 
 Amend the table for identification/exclusion of alternative etiology to include ALT and AST. 
 Amend and remove wording from the criteria determined for handling of dropouts or missing 
data. 
Modifications and changes 
Global change 
The following global change was made for the duration of the open-label treatment period and 
period for administration of bimekizumab:  
104 weeks (2 weeks)  
Has been changed to: 
100104 weeks (~2 weeks) 
 
Specific changes 
Change #1 
List of Abbreviations 
The following abbreviations have been added:  
IBD 
Inflammatory Bowel Disease 
IUD 
intrauterine device 
IUS 
intrauterine hormone-releasing system 
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MCMC 
Markov Chain Monte Carlo 
RCTC 
Rheumatology Common Toxicity Criteria 
 
Change #2 
Sponsor Study Physician 
Name: 
, MD 
Address: 
UCB BIOSCIENCES Inc. 
8010 Arco Corporate Drive 
Raleigh, NC 27617 
UNITED STATES 
Phone: 
 (office) 
 (mobile) 
Has been changed to:  
Name: 
 MD, MSc, PhD 
, MD 
Address: 
UCB Pharma Ltd. UCB BIOSCIENCES Inc. 
208 Bath Road 8010 Arco Corporate Drive 
Slough, SL1 3WE Raleigh, NC 27617 
UNITED KINGDOM UNITED STATES 
Phone: 
 (office) 
 (mobile) 
 
Change #3 
Study contact information 
Clinical Trial Biostatistician 
Name: 
Dr. 
, Senior Biostatistician 
Address: 
UCB BIOSCIENCES GmbH 
Alfred-Nobel-Str.10 
40789 Monheim am Rhein 
GERMANY 
Phone: 
 
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Has been changed to:  
Clinical Trial Biostatistician 
Name: 
, Senior 
Biostatistician 
Address: 
UCB BIOSCIENCES GmbH 
Alfred-Nobel-Str.10 
0789 Monheim am Rhein 
GERMANY  
Phone: 
 
 
Change #4 
Section 5.1 Study design, paragraph 3 
Additionally, as described in (Section 5.1.1), other treatments may be used in addition to 
bimekizumab per Investigator discretion. Subjects not responding to treatment may be 
withdrawn from the study at the discretion of the Investigator. 
Has been changed to:  
Additionally, as described in (Section 5.1.1), other treatments may be used in addition to 
bimekizumab per Investigator discretion. Subjects not responding to treatment may be 
withdrawn from the treatment and study at the discretion of the Investigator. 
 
Change #5 
Section 5.1.2 Study duration per subject  
The study duration for each subject is estimated to be up to a maximum of 120 weeks: 
 Open Label Treatment Period: up to 104 weeks (2 years) 
 SFU Visit: 20 weeks after the final dose of bimekizumab 
The subject may remain in the study until the study ends after 2 years (104 weeks of treatment), 
until the Sponsor decides to close the study, or until bimekizumab development is stopped by the 
Sponsor, whichever comes first. The Sponsor may consider transitioning the subject into another 
bimekizumab study or program. 
The end of the study is defined as the date of the last visit of the last subject in the study.  
Has been changed to:  
The study duration for each subject is estimated to be up to a maximum of 120 weeks: 
 Open-Label Treatment Period: up to 104100 weeks (~2 years) 
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 SFU Visit: 20 weeks after the final dose of bimekizumab 
The subject may remain in the study until the study ends after 2 years (104 weeks of treatment) 
120 weeks, until the Sponsor decides to close the study, or until bimekizumab development is 
stopped by the Sponsor, whichever comes first. The Sponsor may consider transitioning the 
subject into another bimekizumab study or program. 
The end of the study is defined as the date of the last visit of the last subject in the study.  
 
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Change #6 
Section 5.2 Schedule of study assessments, Table 5-1 
 
 
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Has been changed to:  
 
 
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Change #7 
Section 5.2 Schedule of study assessments, Table 5-1, Footnote ‘l’ 
l 
It is recommended that the QuantiFERON TB GOLD test be performed. This assessment will 
be performed at study entry, unless an IGRA negative result is available less than 4 weeks prior 
to the first dose of open-label bimekizumab. 
Has been changed to:  
l 
It is recommended that the QuantiFERON TB GOLD test Test be performed. This 
assessment will be performed at study entry, unless an IGRA negative result is available less 
than 64 weeks prior to the first dose of open-label bimekizumab. 
 
Change #8 
Section 6.1 Inclusion criteria (criterion #5) 
5. Female subjects must be postmenopausal (at least 1 year), 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 until 20 weeks after last administration of study 
medication, and have a negative pregnancy test at the last visit of PA0008. 
Male subjects with a partner of childbearing potential must be willing to use a condom when 
sexually active, up until 20 weeks after the last administration of study medication 
(anticipated 5 half-lives). 
Has been changed to:  
5. Female subjects must be postmenopausal (at least 1 year), 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 until 20 weeks after last administration of study 
medication, and have a negative pregnancy test at the last visit of PA0008. The following 
methods are considered highly effective when used consistently and correctly: 
 combined (estrogen and progestogen) hormonal contraception associated with 
inhibition of ovulation (oral, intravaginal or transdermal)  
 progestogen-only hormonal contraception associated with inhibition of ovulation 
(oral, injectable, implantable) 
 intrauterine device (IUD) 
 intrauterine hormone-releasing system (IUS) 
 bilateral tubal occlusion 
 vasectomized partner  
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 sexual abstinence if it is in accordance with a subject’s preferred and common 
lifestyle. Subjects who use abstinence as a form of birth control must agree to 
abstain from heterosexual intercourse until 20 weeks after the last dose of IMP. 
Study personnel must confirm the continued use of abstinence is still in accordance 
with the subject’s lifestyle at regular intervals during the study. 
Male subjects with a partner of childbearing potential must be willing to use a condom when 
sexually active, up until 20 weeks after the last administration of study medication 
(anticipated 5 half-lives). 
 
Change #9 
Section 6.2 Exclusion criteria (criterion #2) 
2. Subjects with any current sign or symptom that may indicate a medically significant active 
infection (except for the common cold) or has had an infection requiring systemic antibiotics 
within 2 weeks of study entry. 
Has been changed to:  
2. Subjects with any current sign or symptom that may indicate a medically significant active 
infection (except for the common cold) or has had an infection requiring systemic antibiotics 
within 2 weeks of study entry. The medical monitor must be consulted prior to subject’s 
entry into PA0009 in such cases. 
 
Change #10 
Section 6.3 Withdrawal criteria 
The following was added to the withdrawal criteria: 
12. 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 judgment 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. 
 
Change #11 
Section 8.9 SFU Visit (20 weeks after the final dose of IMP) 
The following procedures or assessments will be completed: 
 Record concomitant medications 
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 Record AEs 
 eC-SSRS 
 HADS  
 Administer the HAQ-DI  
 Administer the SF-36 
 Administer the PGADA 
 Administer the PtAAP  
 Administer the PsAID-9  
 Administer the TB questionnaire  
 Measure vital signs (temperature, pulse, and BP) 
 Measure body weight 
 Perform a physical examination, including an evaluation for signs and symptoms of active 
TB and risk for exposure to TB 
 Perform TJC/SJC 
 Determine BSA affected by PSO using the BSA palm method 
 If the BSA affected by PSO is ≥3%, determine the PASI 
 Determine the MASES 
 Determine the LDI 
 Perform the PhGADA 
 Collect samples for hematology/biochemistry 
 If there has been a delay in menses, perform a urine pregnancy test 
 Collect blood sample for CRP 
 Collect blood sample for bimekizumab plasma concentrations and anti bimekizumab 
antibody detection 
 Perform an IGRA TB test 
 Record visit in the IXRS 
Has been changed to:  
The following procedures or assessments will be completed: 
 Record concomitant medications 
 Record AEs 
 eC-SSRS 
 HADS  
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 Administer the HAQ-DI  
 Administer the SF-36 
 Administer the PGADA 
 Administer the PtAAP  
 Administer the PsAID-9  
 Administer the TB questionnaire  
 Measure vital signs (temperature, pulse, and BP) 
 Measure body weight 
 Perform a physical examination, including an evaluation for signs and symptoms of active 
TB and risk for exposure to TB 
 Perform TJC/SJC 
 Determine BSA affected by PSO using the BSA palm method 
 If the BSA affected by PSO is ≥3%, determine the PASI 
 Determine the MASES 
 Determine the LDI 
 Perform the PhGADA 
 Collect samples for hematology/biochemistry 
 If there has been a delay in menses, perform a urine pregnancy test 
 Collect blood sample for CRP 
 Collect blood sample for bimekizumab plasma concentrations and anti bimekizumab 
antibody detection 
 Perform an IGRA TB test 
 Record visit in the IXRS 
 
Change #12 
Section 9.1.1 Definition of AE 
The following was added to the definition of AEs: 
Adverse events that occurred during the PA0008 lead-in study and are still deemed 
ongoing at the time of enrolment (signed ICF) will be captured in the database and 
followed up, as described in Section 9.1.6. 
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Change #13 
Section 9.1.8 Pregnancy, paragraph 5 
A pregnancy becomes an SAE in the following circumstances: miscarriage, abortion (elective for 
a medical condition or spontaneous), unintended pregnancy after hormonal contraceptive failure 
(if the hormonal contraceptive was correctly used), ectopic pregnancy, fetal demise, or any 
congenital anomaly/birth defect of the baby. Those SAEs must be additionally reported using the 
Investigator SAE Report Form. 
Has been changed to:  
A pregnancy becomes an SAE in the following circumstances: miscarriage, elective 
abortion when medically indicated (e.g. when pregnancy is endangering life or health of 
woman or when fetus will be born with severe abnormalities), unintended pregnancy after 
hormonal contraceptive failure (if the hormonal contraceptive was correctly used), ectopic 
pregnancy, fetal demise, or any congenital anomaly/birth defect of the baby. Those SAEs 
must be additionally reported using the Investigator SAE Report form. 
 
Change #14 
Section 9.5.1.4 Testing: identification/exclusion of alternative etiology, 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 
Toxicology screena 
Chemistry 
Amylase 
If total bilirubin ≥1.5xULN, obtain fractionated bilirubin to obtain % direct 
bilirubin 
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Serum CPK and LDH to evaluate possible muscle injury causing transaminase 
elevation 
Additional 
Prothrombin time/INRb 
Serum pregnancy test 
PK sample 
ALT=alanine aminotransferase; CPK=creatine phosphokinase; 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 For detecting substances (ie, amphetamines, benzodiazepines, opioids, marijuana, cocaine, phencyclidine, and 
tricyclic antidepressants), additional tests may be performed based on the Investigator’s medical judgment and 
patient’s history. 
b Measured only for subjects with ALT >8xULN, elevations in total bilirubin, and symptoms of hepatitis or 
hypersensitivity. Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or 
tenderness; hypersensitivity symptoms include eosinophilia (>5%), rash, and fever (without clear alternative 
cause). 
Has been changed to:  
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 
Toxicology screena 
Chemistry 
Amylase 
ALT, AST 
If total bilirubin ≥1.5xULN, obtain fractionated bilirubin to obtain % direct 
bilirubin 
Serum CPK and LDH to evaluate possible muscle injury causing transaminase 
elevation 
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Additional 
Prothrombin time/INRb 
Serum pregnancy test 
PK sample 
ALT=alanine aminotransferase; AST=aspartate aminotransferase; CPK=creatine phosphokinase; 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 For detecting substances (ie, amphetamines, benzodiazepines, opioids, marijuana, cocaine, phencyclidine, and 
tricyclic antidepressants), additional tests may be performed based on the Investigator’s medical judgment and 
patient’s history. 
b Measured only for subjects with ALT >8xULN, elevations in total bilirubin, and symptoms of hepatitis or 
hypersensitivity. Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or 
tenderness; hypersensitivity symptoms include eosinophilia (>5%), rash, and fever (without clear alternative 
cause). 
 
Change #15 
Section 9.6.5  Tuberculosis and TB risk factor assessment and management, 2nd paragraph 
Prior to administration of IMP, subjects will have an IGRA test (QuantiFERON TB GOLD is 
recommended) and examination for signs and symptoms of TB unless an IGRA negative result is 
available less than 4 weeks prior to the first dose of open label bimekizumab. In addition, each 
subject will complete a TB questionnaire with questions directed at symptoms of TB and 
potential exposure to TB. 
Has been changed to: 
Prior to administration of IMP, subjects will have an IGRA test (QuantiFERON TB TestGOLD 
is recommended) and examination for signs and symptoms of TB unless an IGRA negative result 
is available less than 64 weeks prior to the first dose of open label bimekizumab. In addition, 
each subject will complete a TB questionnaire with questions directed at symptoms of TB and 
potential exposure to TB. 
 
Change #16 
Section 9.6.5.1 Tuberculosis assessment by IGRA 
During conduct of the study, the TB assessment by IGRA (QuantiFERON TB Test is 
recommended) will be performed at study entry (unless an IGRA negative result is available less 
than 4 weeks prior to the first dose of open-label bimekizumab) and should be repeated at 
Week 48, Week 96, and SFU Visits for all subjects. The test results will be reported as positive, 
negative, or indeterminate. 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. 
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Has been changed to: 
During conduct of the study, the TB assessment by IGRA (QuantiFERON TB GOLDTest is 
recommended) will be performed at study entry (unless an IGRA negative result is available less 
than 4 weeks prior to the first dose of open-label bimekizumab) and should be repeated at 
Week 48, Week 96, and SFU Visits for all subjects. The test results will be reported as positive, 
negative, or indeterminate. 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. 
 
Change #17 
Section 13.8  Handling of dropouts or missing data, paragraph 3  
Missing binary efficacy variables will be imputed using nonresponder imputation (NRI). In NRI, 
each subject with missing data or who has prematurely finished the study will be counted as a 
nonresponder. 
For missing continuous efficacy variables, a multiple imputation (MI) approach will be used. In 
MI, the missing value is replaced by a set of plausible values, where each value is a Bayesian 
draw from the conditional distribution of the missing data given the observed data. 
Non-monotone missing data (ie, intermittent missing data) will be imputed several times with the 
Markov Chain Monte Carlo (MCMC) method and monotone missing data will be imputed using 
a monotone regression model. Each set of imputed data will then be summarized and the 
summaries will be combined into a single inference (Carpenter and Kenward, 2013). 
Imputation of efficacy data will be performed for only those assessments that the patient had in 
PA0008. Safety data will not be imputed. 
As a sensitivity analysis, all efficacy variables will be analyzed based on observed data. Subjects 
with missing data or who have prematurely finished the study will be treated as missing. 
Has been changed to: 
Missing binary efficacy variables will be imputed using nonresponder imputation (NRI). In NRI, 
each subject with missing data or who has prematurely finished the study will be counted as a 
nonresponder. 
For missing continuous efficacy variables, a multiple imputation (MI) approach will be used. In 
MI, the missing value is replaced by a set of plausible values, where each value is a Bayesian 
draw from the conditional distribution of the missing data given the observed data. Non 
monotone missing data (ie, intermittent missing data) will be imputed several times with the 
Markov Chain Monte Carlo (MCMC) method and monotone missing data will be imputed using 
a monotone regression model. Each set of imputed data will then be summarized and the 
summaries will be combined into a single inference (Carpenter and Kenward, 2013). 
Imputation of efficacy data will be performed for only those assessments that the patient had in 
PA0008. Safety data will not be imputed. 
As a sensitivity analysis, all efficacy variables will be analyzed based on observed data. Subjects 
with missing data or who have prematurely finished the study will be treated as missing. 
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Change #18 
Section 17.1  Markedly abnormal laboratory values, Tables 17-1 (Definitions of markedly 
abnormal hematology values) and 17-2 (Definitions of markedly abnormal biochemistry values) 
Amended units in both table headers:  
Parameter (SI units) 
Markedly Abnormal Definition 
Low 
High 
  Has been changed to: 
Parameter (SIRCTC units) 
Markedly Abnormal Definition 
Low 
High 
 
Change #19 
Section 17.1  Markedly abnormal laboratory values, Table 17-1 (Definitions of markedly 
abnormal hematology values), abbreviations in table footer: 
LLN=lower limit of normal; N/A = Not Applicable; SI = standard international 
Has been changed to: 
LLN=lower limit of normal; N/A = Not Applicable; SI = standard international RCTC= 
Rheumatology Common Toxicity Criteria 
 
Change #20 
Section 17.1  Markedly abnormal laboratory values, Table 17-2 (Definitions of markedly 
abnormal biochemistry values), abbreviations in table footer: 
ALT=alanine aminotransferase; AST=aspartate aminotransferase; N/A=Not applicable; 
SI=standard international; ULN=upper limit of normal 
Has been changed to: 
LLN=lower limit of normal; N/A = Not Applicable; SI=standard international RCTC= 
Rheumatology Common Toxicity Criteria 
 
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17.4 
Protocol Amendment 3 
Rationale for the amendment 
The purpose of this nonsubstantial amendment is as follows:  
 To clarify that PASI will be analyzed in subjects with PSO involving at least 3% of BSA at 
Baseline of PA0008  
 To update study contact information 
 To make minor spelling, editorial, and formatting changes throughout the document  
Modifications and changes 
Global change 
The following global changes were made:  
 The company name was changed from UCB Biopharma SPRL to UCB Biopharma SRL 
 The term “legal representative” was deleted from protocol, as it is not applicable to 
PA0009 
 Throughout the protocol "Baseline" was changed to "Baseline of PA0008" or similar 
wording 
Specific changes 
Change #1 
Study Contact Information 
Sponsor 
UCB BIOPHARMA SPRL 
Allée de la Recherche 60 
1070 Brussels 
BELGIUM 
Sponsor Study Physician 
Name: 
, MD, MSc, PhD  
Address: 
UCB Pharma Ltd. 
208 Bath Road  
Slough, SL1 3WE 
UNITED KINGDOM  
Phone: 
 
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Clinical Project Manager 
Name: 
, Clinical Project Manager 
Address: 
UCB BIOSCIENCES Inc. 
8010 Arco Corporate Drive 
Raleigh, NC  27617 
UNITED STATES 
Phone: 
 
Clinical Trial Biostatistician 
Name: 
  
Address: 
UCB BIOSCIENCES GmbH 
Alfred-Nobel-Strasse 10 
40789 Monheim am Rhein 
GERMANY 
Phone: 
 
 
Has been changed to: 
Sponsor 
UCB BIOPHARMA SPRLSRL 
Allée de la Recherche 60 
1070 Brussels 
BELGIUM 
Sponsor Study Physician 
Name: 
, MD, MSc, PhD 
, MD 
Address: 
UCB Pharma Ltd. 
208 Bath Road  
Slough, SL1 3WE 
UNITED KINGDOM  
Phone: 
  
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Clinical Project Manager 
Name: 
, Clinical Project Manager 
 
Address: 
UCB BIOSCIENCES Inc. 
8010 Arco Corporate Drive 208 Bath Road 
Raleigh, NC  27617 Sough, SL1 3WE 
UNITED STATES UNITED KINGDOM 
Phone: 
 
Clinical Trial Biostatistician 
Name: 
 
Address: 
UCB BIOSCIENCES GmbH  
Alfred-Nobel-Strasse 10 208 Bath Road 
40789 Monheim am Rhein Slough SL1 3WE 
GERMANY UNITED KINGDOM 
Phone: 
 
 
Change #2 
List of Abbreviations 
The following abbreviations were added:  
PFS 
prefilled syringe 
TEAE 
treatment-emergent adverse event 
 
Change #3 
Section 1 Summary, paragraphs 5 and 6 
The primary objective of PA0009 is to assess the long-term safety and tolerability of 
bimekizumab administered over a period of up to 100 weeks (~2 years). The primary safety 
variables are the incidences of adverse events (AEs) and serious adverse events (SAEs). 
The secondary objective is to assess the long-term efficacy of bimekizumab over a period of up 
to 104 weeks (~2 years). The secondary efficacy variables include the American College of 
Rheumatology 20% (ACR20) response at Week 48 (with a responder defined as a subject with 
an improvement from PA0008 Baseline and PA0009 entry value of ≥20% in the swollen and 
tender joint counts and at least 3 of the other 5 components of the core set of American College 
of Rheumatology [ACR] response measures), American College of Rheumatology 50% 
(ACR50) response at Week 48; American College of Rheumatology 70% (ACR70) response at 
Week 48, change from Baseline and PA0009 entry value in the Maastricht Ankylosing 
Spondylitis Enthesitis Index (MASES) at Week 48, change from Baseline and PA0009 entry 
value in the Leeds Dactylitis Index (LDI) at Week 48, the Psoriasis Area and Severity Index 75 
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(PASI75) response, and the Psoriasis Area and Severity Index 90 (PASI90) response at Week 48. 
The secondary safety variable is the withdrawal due to AEs.  
Has been changed to:  
The primary objective of PA0009 is to assess the long-term safety and tolerability of 
bimekizumab administered over a period of up to 100 weeks (~2 years). The primary safety 
variables are the incidences of treatment-emergent adverse events (TEAEs) and 
treatment-emergent serious adverse events (SAEs). 
The secondary objective is to assess the long-term efficacy of bimekizumab over a period of up 
to 104 weeks (~2 years). The secondary efficacy variables include the American College of 
Rheumatology 20% (ACR20) response at Week 48 (with a responder defined as a subject with 
an improvement from PA0008 Baseline and PA0009 entry value of ≥20% in the swollen and 
tender joint counts and at least 3 of the other 5 components of the core set of American College 
of Rheumatology [ACR] response measures), American College of Rheumatology 50% 
(ACR50) response at Week 48; American College of Rheumatology 70% (ACR70) response at 
Week 48, change from PA0008 Baseline and PA0009 entry value in the Maastricht Ankylosing 
Spondylitis Enthesitis Index (MASES) at Week 48, change from PA0008 Baseline and PA0009 
entry value in the Leeds Dactylitis Index (LDI) at Week 48, the Psoriasis Area and Severity 
Index 75 (PASI75) response, and the Psoriasis Area and Severity Index 90 (PASI90) response at 
Week 48. The secondary safety variable is the withdrawal due to AEs TEAEs.  
 
Change #4 
Section 4 Study Variables 
Changes from Baseline will be analyzed relative to the Baseline Visit of PA0008. Variables 
measured at the start of PA0009 will be referred to as PA0009 entry values. 
Has been changed to:  
All efficacy variables Change from Baseline will be analyzed relative to the Baseline Visit of 
PA0008. Safety vVariables measured at the start of PA0009 will be referred to as PA0009 entry 
values. 
 
Change #5 
Section 4.1.1 Primary safety variables 
The primary safety variables are the incidences of AEs and SAEs. 
Has been changed to:  
The primary safety variables are the incidences of TEAEs and treatment-emergent SAEs. 
 
Change #6 
Section 4.2.1 Secondary safety variable 
The secondary safety variable is the withdrawal due to AEs. 
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Has been changed to:  
The secondary safety variable is the withdrawal due to AEsTEAEs. 
 
Change #7 
Section 4.2.2 Secondary efficacy variables 
The secondary efficacy variables are:  
 ACR20, ACR50, and ACR70 response at Week 48 
 Change from Baseline and PA0009 entry value in MASES at Week 48 
 Change from Baseline and PA0009 entry value in the LDI at Week 48 
 PASI75 and PASI90 response at Week 48 
Has been changed to:  
The secondary efficacy variables are:  
 ACR20, ACR50, and ACR70 response at Week 48 
 Change from Baseline of PA0008 and PA0009 entry value in MASES at Week 48 
 Change from Baseline of PA0008 and PA0009 entry value in the LDI at Week 48 
 PASI75 and PASI90 response at Week 48 
 
Change #8 
Section 4.3.1 Safety variables 
Other safety variables are listed below. 
 
Change from Baseline and PA0009 entry value in clinical laboratory variables (hematology 
and biochemistry) 
 
Change from Baseline and PA0009 entry value in vital signs (pulse, temperature, and blood 
pressure) and body weight 
Has been changed to:  
Other safety variables are listed below. 
 
Change from Baseline and PA0009 entry value in Laboratory Baseline (defined as the 
earliest date in PA0009 at or prior to PA0009 Week 12) for clinical laboratory variables 
(hematology and biochemistry, excepting high-sensitivity C-reactive protein [CRP]) at 
each visit) 
 
Change from Baseline of PA0008 and PA0009 entry value in vital signs (pulse, temperature, 
and blood pressure) and body weight 
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Change #9 
Section 4.3.2 Efficacy variables 
Other efficacy variables are listed below and will be evaluated at scheduled visits in accordance 
with the schedule of study assessments in Table 5-1. 
 ACR20, ACR50, and ACR70 response 
 PASI100 response 
 PASI75 and PASI90 response  
 Minimal Disease Activity (MDA) as defined in Table 10-3 
 Change from Baseline and PA0009 entry value in the Disease Activity Score-28 based on 
C-reactive protein (DAS28 [CRP]) by visit 
 Change from Baseline and PA0009 entry value in MASES 
 Change from Baseline and PA0009 entry value in the LDI 
 Change from Baseline and PA0009 entry value in Psoriatic Arthritis Impact of Disease 
(PsAID)-9 
 Change from Baseline and PA0009 entry value in Short Form 36-item Health Survey (SF-36) 
 Change from Baseline and PA0009 entry value in the Hospital Anxiety and Depression Scale 
(HADS): HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D) scores 
 Depression and anxiety status “normal” as defined by HADS-D and HADS-A <8 
Has been changed to: 
Other efficacy variables are listed below and will be evaluated at scheduled visits in accordance 
with the schedule of study assessments in Table 5-1. 
 ACR20, ACR50, and ACR70 response 
 PASI75, PASI90, and PASI100 response 
 PASI75 and PASI90 response  
 Minimal Disease Activity (MDA) as defined in Table 10-3 
 Change from Baseline of PA0008 and PA0009 entry value in the Disease Activity Score-28 
based on C-reactive protein (DAS28 [CRP]) by visit 
 Change from Baseline of PA0008 and PA0009 entry value in MASES 
 Change from Baseline of PA0008 and PA0009 entry value in the LDI 
 Change from Baseline of PA0008 and PA0009 entry value in Psoriatic Arthritis Impact of 
Disease (PsAID)-9 
 Change from Baseline of PA0008 and PA0009 entry value in Short Form 36-item Health 
Survey (SF-36) 
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 Change from Baseline of PA0008 and PA0009 entry value in the Hospital Anxiety and 
Depression Scale (HADS): HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D) 
scores 
 Depression and anxiety status “normal” as defined by HADS-D and HADS-A <8 
 
Change #10 
Table 5-1: Schedule of study assessments (footnote a) 
a Visit windows are ±7 days from the scheduled visit day (relative to the first dose) with a minimum of 21 days and 
a maximum of 35 days in between doses at all visits except the SFU Visit. The SFU Visit window is -3 to +7 days 
from last dose. 
 
Has been changed to:  
a Visit windows are ±7 days from the scheduled visit day (relative to the first dose) with a minimum of 21 days and 
a maximum of 35 days in between doses at all visits except the SFU Visit. For the SFU Visit, the visit should 
occur no more than window is 3 days prior to the scheduled visit date and within 7 days after the scheduled 
visit date (-3 days/ to +7 days) from last dose. 
 
Change #11 
Table 5-1: Schedule of study assessments (footnote i) 
i If the BSA affected by PSO was ≥3% at this visit, determine the PASI. 
 
Has been changed to:  
i If the BSA affected by PSO was ≥3% at this visit Baseline of PA0008, determine the PASI. 
 
Change #12 
Section 6.1 Inclusion criteria, #1 and #2 
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written 
Informed Consent form is signed and dated by the subject or legal representative.  
2. Subject or legal representative is considered reliable and capable of adhering to the protocol 
(eg, able to understand and complete questionnaires), visit schedule, or medication intake 
according to the judgment of the Investigator. 
Has been changed to: 
1a. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written 
Informed Consent form is signed and dated by the subject or legal representative.  
2a. Subject or legal representative is considered reliable and capable of adhering to the protocol 
(eg, able to understand and complete questionnaires), visit schedule, or medication intake 
according to the judgment of the Investigator. 
 
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Change #13 
Section 6.3.1 Potential drug-induced liver injury investigational medicinal product 
discontinuation criteria, paragraph 2 
The PDILI criteria below require immediate and permanent discontinuation of IMP:   
Has been changed to: 
The PDILI criteria below require immediate and permanent discontinuation of IMP:   
 
Change #14 
Section 7.1 Description of investigational medicinal product 
The IMP will consist of the following: 
Bimekizumab will be supplied as a clear to opalescent, colorless to slightly brown, sterile, 
preservative-free solution in a 
 
 
Has been changed to: 
The IMP will consist of the following: 
 Bimekizumab will be supplied as a clear to opalescent, colorless to slightly brown, 
sterile, preservative-free solution in a 1mL prefilled syringe (PFS). 
 
 
 
 for sc injection. 
 
Change #15 
Section 8.1 Visit 1 
 If the BSA affected by PSO is ≥3%, determine the Psoriasis Area and Severity Index 
(PASI)* 
Has been changed to: 
 If the BSA affected by PSO is ≥3% at Baseline of PA0008, determine the Psoriasis Area and 
Severity Index (PASI)* 
 
Change #16 
Section 8.3 Week 12 (Visit 4), Week 24 (Visit 5), Week 36 (Visit 6), and Week 72 (Visit 9) 
 If the BSA affected by PSO is ≥3%, determine the PASI 
Has been changed to: 
 If the BSA affected by PSO is ≥3% at Baseline of PA0008, determine the PASI 
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Change #17 
Section 8.5 Week 48 (Visit 7) and Week 96 (Visit 11) 
 If the BSA affected by PSO is ≥3%, determine the PASI 
Has been changed to: 
 If the BSA affected by PSO is ≥3% at Baseline of PA0008, determine the PASI 
 
Change #18 
Section 8.6 Week 60 (Visit 8) and Week 84 (Visit 10) 
 If the BSA affected by PSO is ≥3%, determine the PASI 
Has been changed to: 
 If the BSA affected by PSO is ≥3% at Baseline of PA0008, determine the PASI 
 
Change #19 
Section 8.7 Week 100 (Visit 12) 
 If the BSA affected by PSO is ≥3%, determine the PASI 
Has been changed to: 
 If the BSA affected by PSO is ≥3% at Baseline of PA0008, determine the PASI 
 
Change #20 
Section 8.8 Week 104 (Visit 13) or Early Termination Visit 
 If the BSA affected by PSO is ≥3%, determine the PASI 
Has been changed to: 
 If the BSA affected by PSO is ≥3% at Baseline of PA0008, determine the PASI 
 
Change #21 
Section 9.1.3 AEs for special monitoring 
UCB has identified AEs for special monitoring (AESM). An AESM is an AE or safety topic for 
which special monitoring, additional data collection activities, and/or enhanced signal detection 
activities (within UCB), are considered appropriate. Identified AESM can be of particular 
concern based on findings from the IMP clinical program to date, potential risks generally 
associated with biologic immunomodulators, or comorbidities and risk factors prevalent in the 
study population. 
Adverse events for special monitoring for this study include: serious infections (including 
opportunistic infections and TB, see Section 9.6.5), cytopenias, hypersensitivities, suicide 
ideation or behavior (assessed using the eC-SSRS), depression and anxiety (assessed using the 
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HADS, see Section 10.15), major cardiovascular events and liver function test changes/enzyme 
elevations (ALT, AST, and bilirubin; see Section 9.1.5), malignancies, and inflammatory bowel 
diseases.  
Has been changed to: 
Section 9.1.3 AEs for special monitoring Other safety topics of interest 
UCB has identified AEs for special monitoring (AESM). An AESM is an AE or Pre-specified 
safety topics of interest for which special monitoring, additional data collection activities, and/or 
enhanced signal detection activities (within UCB), are considered appropriate. Identified AESM 
can be of particular concern the study are: infections (serious, opportunistic, fungal ,and TB), 
neutropenia, hypersensitivity, suicidal ideation and behavior, depression, major 
cardiovascular events, liver function test changes/enzyme elevations, malignancies, and 
inflammatory bowel diseases (with gastroenterology referral, as appropriate). This is based 
on findings from the IMP clinical program to date, potential risks generally associated with 
biologic immunomodulators, or comorbidities and risk factors prevalent in the study population 
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. 
Adverse events for special monitoring for this study include: serious infections (including 
opportunistic infections and TB, see Section 9.6.5), cytopenias, hypersensitivities, suicide 
ideation or behavior (assessed using the eC-SSRS), depression and anxiety (assessed using the 
HADS, see Section 10.15), major cardiovascular events and liver function test changes/enzyme 
elevations (ALT, AST, and bilirubin; see Section 9.1.5), malignancies, and inflammatory bowel 
diseases.  
Change #22 
Section 9.1.6 Follow-up of AEs, first paragraph 
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, AESIs, and AESMs; further details regarding 
follow-up of PDILI events are provided in Section 9.5.1.5. Information on SAEs obtained after 
clinical database lock will be captured through the Patient Safety (PS) database without 
limitation of time. 
Has been changed to: 
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, AESIs, and other safety topics of interestAESMs; 
further details regarding follow-up of PDILI events are provided in Section 9.5.1.5. Information 
on SAEs obtained after clinical database lock will be captured through the Patient Safety (PS) 
database without limitation of time. 
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Change #23 
Section 9.2.3 Follow-up of SAEs 
An SAE 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, AESIs, and AESMs; further details regarding 
follow-up of PDILI events are provided in Section 9.5.1.5. Information on SAEs obtained after 
clinical database lock will be captured through the PS database without limitation of time. 
Has been changed to: 
An SAE 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, AESIs, and AESMsother safety topics of interest; 
further details regarding follow-up of PDILI events are provided in Section 9.5.1.5. Information 
on SAEs obtained after clinical database lock will be captured through the PS database without 
limitation of time. 
 
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Change #24 
Table 9-3: 
Required investigations and follow-up for PDILI 
Laboratory value 
 
Immediate 
Follow-up 
ALT or 
AST 
Total 
bilirubin 
Symptomsa of 
hepatitis or 
hypersensitivity 
Consultation 
requirements 
Actions 
Testing 
Evaluation 
≥3xULN 
≥2xULNb 
NA 
 
 
Hepatology consult.c 
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 9.5.1.4); 
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 
≥5xULN 
NA 
NA 
Need for hepatology 
consult to be discussed.     
(required if ALT or AST 
≥8xULN) Medical 
Monitor must be notified 
within 24hours (eg, by 
laboratory alert) and 
subject discussed with 
Medical Monitor ASAP. 
Immediate, permanent 
IMP discontinuation 
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Table 9-3: 
Required investigations and follow-up for PDILI 
Laboratory value 
 
Immediate 
Follow-up 
ALT or 
AST 
Total 
bilirubin 
Symptomsa of 
hepatitis or 
hypersensitivity 
Consultation 
requirements 
Actions 
Testing 
Evaluation 
≥3xULN 
(and ≥2x 
baseline) and 
<5xULN 
(and ≥2x 
baseline) 
<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 9.5.1.2). 
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 
≥3xULN (and 
≥2xbaseline) after 2 
weeks of monitoring 
without evidence of 
resolution  
Essential: Every 
attempt must be 
made to have repeat 
liver chemistry 
values and additional 
testing completed 
within 48hours at the 
site with HCP (see 
Section 9.5.1.4). 
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:  
 
Discontinue IMP if levels remain 
≥3xULN (and ≥2x baseline) 
without evidence of resolutiond  
Continue to monitor until values 
normalize, stabilize, or return to within 
baseline valuesd. 
 
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Has been changed to:  
Table 9-3: 
Required investigations and follow-up for PDILI 
Laboratory value 
 
Immediate 
Follow-up 
ALT or 
AST 
Total 
bilirubin 
Symptomsa of 
hepatitis or 
hypersensitivity 
Consultation 
requirements 
Actions 
Testing 
Evaluation 
≥3xULN 
≥2xULNb 
NA 
 
 
Hepatology consult.c 
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 9.5.1.4); 
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 
≥5xULN 
NA 
NA 
Need for hepatology 
consult to be discussed.     
(required if ALT or AST 
≥8xULN) Medical 
Monitor must be notified 
within 24hours (eg, by 
laboratory alert) and 
subject discussed with 
Medical Monitor ASAP. 
Immediate, permanent 
IMP discontinuation 
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PA0009 
 
 
 
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Table 9-3: 
Required investigations and follow-up for PDILI 
Laboratory value 
 
Immediate 
Follow-up 
ALT or 
AST 
Total 
bilirubin 
Symptomsa of 
hepatitis or 
hypersensitivity 
Consultation 
requirements 
Actions 
Testing 
Evaluation 
≥3xULN 
(and ≥2x 
baseline) and 
<5xULN 
(and ≥2x 
baseline) 
<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 9.5.1.2). 
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 
≥3xULN (and 
≥2xbaseline) after 2 
weeks of monitoring 
without evidence of 
resolution  
Essential: Every 
attempt must be 
made to have repeat 
liver chemistry 
values and additional 
testing completed 
within 48hours at the 
site with HCP (see 
Section 9.5.1.4). 
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:  
 
Discontinue IMP if levels remain 
≥3xULN (and ≥2x baseline) 
without evidence of resolutiond  
Continue to monitor until values 
normalize, stabilize, or return to within 
Baseline valuesd. 
 
 
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Change #25 
Section 9.5.1.2 Immediate action: determination of IMP discontinuation, paragraph 2 
The immediate action is dependent on the laboratory values and symptoms of hepatitis or 
hypersensitivity and ranges from continuation of IMP (followed by immediate investigation) to 
immediate and permanent discontinuation (see Section 6.3.1 and Table 9-3 for details). 
Has been changed to: 
The immediate action is dependent on the laboratory values and symptoms of hepatitis or 
hypersensitivity and ranges from continuation of IMP (followed by immediate investigation) to 
immediate and permanent discontinuation (see Section 6.3.1 and Table 9-3 for details). 
 
Change #26 
Section 10.8 ACR20, ACR50, and ACR70 response, paragraph 1 
The ACR20, ACR50, and ACR70 response rates are based on a 20%, 50%, and 70% or greater 
improvement relative to Baseline of PA0008 and PA0009 entry values in the following 
measures: 
Has been changed to: 
The ACR20, ACR50, and ACR70 response rates are based on a 20%, 50%, and 70% or greater 
improvement relative to Baseline of PA0008 and PA0009 entry values in the following 
measures: 
 
Change #27 
Section 10.10 Psoriasis Area and Severity Index (PASI), paragraph 1 
Psoriasis Area and Severity Index will be assessed in all subjects with study entry BSA affected 
by PSO ≥3% determined by the method described in Section 10.9 (ie, the BSA palm method).  
Has been changed to: 
Psoriasis Area and Severity Index will be assessed in all subjects with study entry BSA affected 
by PSO ≥3% at Baseline of PA0008 determined by the method described in Section 10.9 (ie, the 
BSA palm method).  
 
Change #28 
Section 10.10 Psoriasis Area and Severity Index (PASI), last paragraph 
The PASI75, PASI90, and PASI100 responses are based on at least 75%, 90%, and 100% 
improvement in the PASI score compared to Baseline in PA0008 and PA0009 entry values. 
Thereafter PASI will be assessed for the purposes of determining response only in subjects with 
PSO involving at least 3% of BSA at study entry.  
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Has been changed to: 
The PASI75, PASI90, and PASI100 responses are based on at least 75%, 90%, and 100% 
improvement in the PASI score compared to Baseline in PA0008 and PA0009 entry values. 
Thereafter PASI will be assessed analyzed for the purposes of determining response only in 
subjects with PSO involving at least 3% of BSA at study entry Baseline of PA0008.  
 
Change #29 
Section 13.1 Definition of analysis sets, last paragraph 
The Full Analysis Set (FAS) will consist of all enrolled subjects who receive at least 1 dose of 
the IMP and have a valid measurement for at least 1 efficacy variable at PA0009 study entry.  
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 measurement for at least 1 efficacy variable at after PA0009 study 
entry visit.  
 
Change #30 
Section 13.3.1 Safety analyses, last 2 paragraphs  
Change from PA0009 entry values in laboratory and vital signs variables will be summarized 
descriptively by visit and by treatment group at completion of PA0008. 
All safety analyses will be conducted for both subpopulations. 
Has been changed to: 
Change from PA0009 entry PA0008 Baseline values in laboratory and vital signs variables will 
be summarized descriptively by visit and by treatment group at completion of PA0008. Change 
from PA0009 Laboratory Baseline values in clinical laboratory variables (hematology and 
biochemistry, excepting high-sensitivity CRP) will be summarized descriptively by visit and 
by treatment group at completion of PA0008. 
Due to a change in laboratory vendor between PA0008 and PA0009, laboratory values 
(excepting CRP) will use the PA0009 Laboratory Baseline, defined as the earliest post-
entry visit value recorded in PA0009. Change from PA0009 Laboratory Baseline will be 
calculated for these parameters. (The CRP values from the 2 analyzing laboratories have 
been calibrated, so change from PA0008 Baseline will be calculated for that parameter.) 
All safety analyses will be conducted for both subpopulations. 
 
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Change #31 
Section 13.4 Planned efficacy analyses, paragraphs 2 and 3 
Responder variables (eg, ACR20 response) will be derived relative to the Baseline and PA0009 
entry values, and summarized descriptively. Percentages will be summarized descriptively by 
visit, by randomized treatment group, and by treatment group at PA0009 entry. 
Change from Baseline or PA0009 entry values of all continuous variables will be summarized 
descriptively by visit, by randomized treatment group, and by treatment group at completion of 
PA0008. 
Has been changed to: 
Responder variables (eg, ACR20 response) will be derived relative to the Baseline of PA0008 
and PA0009 entry values, and summarized descriptively. Percentages will be summarized 
descriptively by visit, by randomized treatment group, and by treatment group at PA0009 entry. 
Change from Baseline of PA0008 or PA0009 entry values of all continuous variables will be 
summarized descriptively by visit, by randomized treatment group, and by treatment group at 
completion of PA0008. 
 
Change #32 
Section 13.4.1 Subgroup analysis, last bullet 
 Concomitant DMARD status at PA0009 entry 
Has been changed to: 
 Concomitant DMARD status at Baseline of PA0008 PA0009 entry 
 
Change #33 
Section 13.8 Handling of dropouts or missing data 
The following paragraph was added to the end of this section: 
As a sensitivity analysis, the ACR, PASI, LDI, MASES, and MDA efficacy variables will be 
analyzed based on observed data in addition to a sensitivity analysis based on multiple 
imputation of ACR component scores and PASI scores for the ACR and PASI response 
variables, respectively. Subjects with missing data or who have prematurely finished the 
study will be treated as missing. 
 
Change #34 
Section 13.9 Planned interim analysis and data monitoring 
No formal interim analysis is planned for this study. 
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Has been changed to: 
No formal interim analysis is planned for this study. Additional data cuts may be prepared 
following regulatory requests or for publication purposes. 
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18 
DECLARATION AND SIGNATURE OF INVESTIGATOR 
I confirm that I have carefully read and understood this protocol and agree to conduct this 
clinical study as outlined in this protocol, according to current Good Clinical Practice and local 
laws and requirements. 
I will ensure that all subinvestigators and other staff members read and understand all aspects of 
this protocol. 
I have received and read all study-related information provided to me. 
The objectives and content of this protocol as well as the results deriving from it will be treated 
confidentially and will not be made available to third parties without prior authorization by UCB. 
All rights of publication of the results reside with UCB, unless other agreements were made in a 
separate contract. 
Investigator: 
 
 
 
 
Printed name 
 
Date/Signature 
 
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19 
SPONSOR DECLARATION 
I confirm that I have carefully read and understand this protocol and agree to conduct this 
clinical study as outlined in this protocol and according to current Good Clinical Practice. 
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Approval Signatures
Name:
pa0009-protocol-amend-3
Version:
1. 0
Document Number:
CLIN-000143809
Title:
PA0009 Protocol Amendment 3
Approved Date:
13 Dec 2019
Document Approvals
Approval
Verdict: Approved
Name: 
Capacity: Medical
Date of Signature: 12-Dec-2019 15:54:05 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Subject Matter Expert
Date of Signature: 12-Dec-2019 16:46:36 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 13-Dec-2019 08:05:13 GMT+0000
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SAP_001.pdf: 
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04Nov2020 
Statistical Analysis Plan 
Bimekizumab 
PA0009 
 
 
 
Confidential 
Page 1 of 112 
STATISTICAL ANALYSIS PLAN 
Study: PA0009 
Product: Bimekizumab 
A MULTICENTER, PHASE 2B, OPEN-LABEL,  
FOLLOW-UP STUDY TO EVALUATE  
THE LONG-TERM SAFETY AND EFFICACY  
OF BIMEKIZUMAB IN SUBJECTS  
WITH PSORIATIC ARTHRITIS 
 
SAP/Amendment Number Date 
Final SAP 1.0 
09 Feb 2018 
Final SAP 2.0  
23 Mar 2018 
SAP Amendment 1 
04 Nov 2020 
Confidentiality Statement 
Confidential 
This document is the property of UCB and may not – in full or in part – be passed on, 
reproduced, published, or otherwise used without the express permission of UCB. 
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TABLE OF CONTENTS 
LIST OF ABBREVIATIONS .................................................................................................... 7 
1 
INTRODUCTION ........................................................................................................... 10 
2 
PROTOCOL SUMMARY ............................................................................................... 10 
2.1 
Study objectives ........................................................................................................... 10 
2.1.1 
Primary objective ................................................................................................. 10 
2.1.2 
Secondary objective ............................................................................................. 10 
2.1.3 
Other objectives ................................................................................................... 11 
2.2 
Study variables ............................................................................................................. 11 
2.2.1 
Safety variables .................................................................................................... 11 
2.2.1.1 
Primary safety variables ............................................................................ 11 
2.2.1.2 
Secondary safety variables ........................................................................ 11 
2.2.1.3 
Other safety variables ................................................................................ 11 
2.2.2 
Efficacy variables ................................................................................................ 11 
2.2.2.1 
Primary efficacy variable .......................................................................... 11 
2.2.2.2 
Secondary efficacy variables ..................................................................... 11 
2.2.2.3 
Other efficacy variables ............................................................................. 12 
2.2.3 
Pharmacokinetic/pharmacodynamic variables .................................................... 13 
2.2.3.1 
Other pharmacokinetic variable ................................................................ 13 
2.2.4 
Other pharmacogenomic variables ...................................................................... 13 
2.2.5 
Other immunological variable ............................................................................. 13 
2.3 
Study design and conduct ............................................................................................ 13 
2.4 
Determination of sample size ....................................................................................... 18 
3 
DATA ANALYSIS CONSIDERATIONS ...................................................................... 18 
3.1 
General presentation of summaries and analyses ........................................................ 18 
3.2 
General study level definitions .................................................................................... 20 
3.2.1 
Relative day ......................................................................................................... 20 
3.2.2 
Study periods ....................................................................................................... 20 
3.3 
Definition of Baseline values ....................................................................................... 21 
3.4 
Protocol deviations....................................................................................................... 21 
3.5 
Mapping of assessments .............................................................................................. 21 
3.6 
Analysis sets................................................................................................................. 23 
3.6.1 
Enrolled Set ......................................................................................................... 23 
3.6.2 
Safety Set ............................................................................................................. 23 
3.6.3 
Full Analysis Set .................................................................................................. 23 
3.7 
Treatment assignment and treatment groups ............................................................... 23 
3.8 
Center pooling strategy ................................................................................................ 25 
3.9 
Coding dictionaries ...................................................................................................... 26 
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3.10 
Changes to protocol-defined analyses ......................................................................... 26 
3.10.1 
Changes related to COVID-19 ............................................................................. 26 
4 
STATISTICAL/ANALYTICAL ISSUES ....................................................................... 27 
4.1 
Adjustments for covariates .......................................................................................... 27 
4.2 
Handling of missing data ............................................................................................. 27 
4.2.1 
Handling of missing data for efficacy analysis .................................................... 27 
4.2.2 
Additional rules for handling missing data for derivation of PASI response ...... 33 
4.2.3 
Handling of missing data for adverse events ....................................................... 34 
4.2.4 
Handling of missing data for prior and concomitant medication ........................ 35 
4.2.5 
Handling of partial treatment end dates ............................................................... 37 
4.3 
Interim analyses and data monitoring .......................................................................... 37 
4.4 
Multicenter studies ....................................................................................................... 37 
4.5 
Multiple comparisons/multiplicity ............................................................................... 38 
4.6 
Use of an efficacy subset of subjects ........................................................................... 38 
4.7 
Active-control studies intended to show equivalence .................................................. 38 
4.8 
Examination of subgroups ........................................................................................... 38 
5 
STUDY POPULATION CHARACTERISTICS ............................................................. 38 
5.1 
Subject disposition ....................................................................................................... 38 
5.1.1 
Impact of COVID-19 ........................................................................................... 39 
5.2 
Protocol deviations....................................................................................................... 40 
6 
DEMOGRAPHICS AND OTHER BASELINE CHARACTERISTICS ........................ 41 
6.1 
Demographics .............................................................................................................. 41 
6.2 
Other baseline characteristics ...................................................................................... 41 
6.3 
Medical history and concomitant diseases ................................................................... 42 
6.4 
Past, prior and concomitant medications ..................................................................... 43 
6.5 
Prohibited medication and rescue therapy ................................................................... 44 
6.6 
Concomitant medical procedures and procedure history ............................................. 45 
7 
MEASUREMENTS OF TREATMENT COMPLIANCE ............................................... 45 
8 
EFFICACY ANALYSES ................................................................................................ 46 
8.1 
Derivation of efficacy variables ................................................................................... 47 
8.1.1 
78/76-joint evaluation for ACR response ............................................................ 47 
8.1.2 
28-joint evaluation for determination of Disease Activity Score-28 (C-reactive 
Protein) ................................................................................................................ 49 
8.1.3 
Patient’s Global Assessment of Disease Activity ................................................ 49 
8.1.4 
Physician’s Global Assessment of Disease Activity ........................................... 50 
8.1.5 
Patient’s Assessment of Arthritis Pain ................................................................ 50 
8.1.6 
Health Assessment Questionnaire-Disability Index Score .................................. 50 
8.1.7 
High-sensitivity C-reactive protein levels ........................................................... 51 
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8.1.8 
American College of Rheumatology Response Criteria ...................................... 51 
8.1.9 
Body surface area affected by psoriasis ............................................................... 52 
8.1.10 
Psoriasis Area and Severity Index Response ....................................................... 52 
8.1.11 
Minimal Disease Activity .................................................................................... 54 
8.1.12 
Disease Activity Score-28 based on C-reactive Protein ...................................... 55 
8.1.13 
Maastricht Ankylosing Spondylitis Enthesitis Index .......................................... 56 
8.1.14 
Leeds Dactylitis Index ......................................................................................... 56 
8.1.15 
Hospital Anxiety and Depression Scale .............................................................. 57 
8.1.16 
Psoriatic Arthritis Impact of Disease-9 ................................................................ 57 
8.1.17 
Short Form – 36 Items Health Survey ................................................................. 58 
8.2 
Statistical analysis of secondary efficacy variables ..................................................... 58 
8.3 
Statistical analysis of other efficacy variables ............................................................. 59 
8.3.1 
Maintenance of response ..................................................................................... 60 
8.4 
Subgroup analysis ........................................................................................................ 60 
8.5 
Impact of COVID-19 ................................................................................................... 61 
9 
PHARMACOKINETICS AND PHARMACODYNAMICS .......................................... 61 
9.1 
Pharmacokinetics ......................................................................................................... 61 
9.2 
Pharmacodynamics and Immunogenicity .................................................................... 63 
10 SAFETY ANALYSES ..................................................................................................... 69 
10.1 
Extent of exposure ....................................................................................................... 69 
10.2 
Adverse events ............................................................................................................. 71 
10.2.1 
Adverse event duration and time since first/last dose.......................................... 76 
10.2.2 
Exposure-adjusted incidence rate and exposure-adjusted event rate ................... 77 
10.2.3 
Adverse events of special interest and safety topics of interest ........................... 78 
10.2.4 
Impact of COVID-19 ........................................................................................... 83 
10.3 
Clinical laboratory evaluations .................................................................................... 86 
10.4 
Potential drug-induced liver injury assessment ........................................................... 91 
10.5 
Vital signs and other observations related to safety ..................................................... 94 
10.5.1 
Vital signs ............................................................................................................ 94 
10.5.2 
Electrocardiograms .............................................................................................. 95 
10.5.3 
Other safety variables .......................................................................................... 95 
Assessment of Tuberculosis........................................................................................... 95 
Electronic Columbia Suicide Severity Rating Scale ...................................................... 96 
Health Care Provider Consultations .............................................................................. 96 
Extra-articular assessments ............................................................................................ 96 
10.5.4 
Comments ............................................................................................................ 97 
11 REFERENCES ................................................................................................................ 98 
12 APPENDIX ...................................................................................................................... 99 
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12.1 
American College of Rheumatology Response Criteria .............................................. 99 
12.2 
Minimal Disease Activity .......................................................................................... 101 
12.3 
Classification of the SF-36 questionnaire .................................................................. 101 
12.4 
Identification of Opportunistic infections .................................................................. 103 
12.5 
MedDRA algorithmic approach to anaphylaxis ........................................................ 104 
12.6 
COVID-19 data collection ......................................................................................... 106 
13 AMENDMENT TO THE STATISTICAL ANALYSIS PLAN .................................... 108 
13.1 
Amendment 1 ............................................................................................................. 108 
13.1.1 
Rationale for the amendment ............................................................................. 108 
13.1.2 
Modifications and changes ................................................................................ 108 
13.2 
Amendment 2 ............................................................................................................. 111 
STATISTICAL ANALYSIS PLAN SIGNATURE PAGE ................................................... 112 
 
LIST OF TABLES 
Table 2-1: 
Schedule of Study Assessments ....................................................................... 15 
Table 3-1: 
Decimal places for derived efficacy variables ................................................. 19 
Table 3-2: 
Treatment sequence assignment for safety summaries .................................... 25 
Table 4‒1: 
Allowable ranges for continuous efficacy variables ........................................ 30 
Table 4‒2: 
Missing data handling ...................................................................................... 32 
Table 8‒1: 
Swelling and tenderness grading criteria ......................................................... 48 
Table 8-2: 
Joint categorization and derived tenderness and swelling ............................... 48 
Table 8-3: 
Aid or device associated with health assessment questionnaire-disability 
index domain .................................................................................................... 50 
Table 8-4: 
Body areas for calculation of psoriasis area and severity index ...................... 53 
Table 8-5: 
Normative values for Leeds Dactylitis Index (mm) ........................................ 56 
Table 10-1: 
Study medication duration ............................................................................... 69 
Table 10-2: 
Exposure time at risk ....................................................................................... 70 
Table 10-3: 
Extended MACE types .................................................................................... 80 
Table 10-4: 
Inflammatory bowel disease types ................................................................... 81 
Table 10-5: 
Calculation of exposure time at risk in relation to COVID-19 ........................ 85 
Table 10‒6: 
Laboratory measurements ................................................................................ 87 
Table 10‒7: 
Definitions of markedly abnormal hematology values .................................... 88 
Table 10‒8: 
Definitions of markedly abnormal biochemistry values .................................. 88 
Table 10‒9: 
Definitions of CTCAE grade by hematology parameter ................................. 90 
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Table 10‒10: Definitions of CTCAE grade by biochemistry parameter ............................... 90 
Table 10‒11: Additional potential drug-induced liver injury information ............................ 92 
Table 10‒12: Potential drug-induced liver injury laboratory measurements ......................... 93 
Table 10‒13: Definitions of markedly abnormal blood pressure values ............................... 94 
Table 12-1: 
Handling Missing Data for American College of Rheumatology Response 
Criteria Derivation ........................................................................................... 99 
Table 12-2: 
Handling Missing Data for MDA Derivation ................................................ 101 
Table 12‒3: 
Classification of the SF-36 questionnaire ...................................................... 102 
 
LIST OF FIGURES 
Figure 2‒1: 
Schematic Diagram .......................................................................................... 14 
 
 
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LIST OF ABBREVIATIONS 
ACP 
above the cut point 
ACR 
American College of Rheumatology 
ACR20,50,70 
American College of Rheumatology 20, 50, 70% response criteria 
ADAb 
anti-bimekizumab antibody 
AE 
adverse event 
AESI 
adverse event of special interest 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
ATC 
anatomical therapeutic chemical 
BCP 
below the cut point 
BKZ 
bimekizumab 
BLQ 
below the limit of quantification 
BMI 
body mass index 
BSA 
body surface area 
BUN 
blood urea nitrogen 
CCP 
cyclic citrullinated peptide 
CI 
confidence interval 
COVID-19 
Coronavirus Disease 2019 
CP 
confirmed positive 
CRP 
high-sensitivity C-reactive protein 
Note: High-sensitivity CRP is referred to as CRP throughout the 
SAP and is therefore abbreviated as CRP. 
CTCAE 
Common Terminology Criteria for Adverse Events 
CV (%) 
coefficient of variation 
DAS28(CRP) 
Disease Activity Score-28 joint count C-reactive protein 
DIP 
distal interphalangeal joint 
DMARD 
disease modifying anti-rheumatic drug 
EAER 
exposure adjusted event rate 
EAIR 
exposure adjusted incidence rate 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
eC-SSRS 
electronic Columbia-Suicide Severity Rating Scale 
ES 
Enrolled Set 
ET 
Early Termination 
EV 
entry visit 
FAS 
Full Analysis Set 
GGT 
gamma glutamyltransferase 
HADS 
Hospital Anxiety and Depression Scale 
HADS-A 
Hospital Anxiety and Depression Scale - Anxiety 
HADS-D 
Hospital Anxiety and Depression Scale - Depression 
HAQ-DI 
Health Assessment Questionnaire – Disability Index 
HLGT 
high level group term 
HLT 
high level term 
HRQoL 
health-related quality of life 
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IBD 
Inflammatory bowel disease 
IGRA 
interferon-gamma release assay 
IMP 
investigational medicinal product 
IP 
interphalangeal 
IXRS 
interactive voice or web response system 
LD 
loading dose 
LDH 
lactate dehydrogenase 
LDI 
Leeds Dactylitis Index 
LLOQ 
lower limit of quantification 
MASES 
Maastricht Ankylosing Spondylitis Enthesitis Index 
MCH 
mean corpuscular hemoglobin 
MCHC 
mean corpuscular hemoglobin concentration 
MCMC 
Markov-Chain Monte Carlo 
MCP 
metacarpophalangeal 
MCS 
Mental Component Summary 
MCV 
mean corpuscular volume 
MDA 
Minimal Disease Activity 
MedDRA 
Medical Dictionary for Regulatory Activities 
MI 
multiple imputation 
MRD 
minimum required dilution 
MTP 
metatarsophalangeal 
MTX 
methotrexate 
n 
number of observations 
NCP 
not confirmed positive 
NRI 
nonresponder imputation 
NSAID 
nonsteroidal anti-inflammatory drug 
OC 
observed case 
OLE 
open-label extension 
PASI 
Psoriasis Area and Severity Index 
PASI75, PASI90, 
PASI100 
Psoriasis Area and Severity Index 75%, 90%, 100% 
PCS 
Physical Component Summary 
PDILI 
potential drug-induced liver injury 
PGADA 
Patient’s Global Assessment of Disease Activity 
PhGADA 
Physician’s Global Assessment of Disease Activity 
PIP 
proximal interphalangeal 
PsA 
psoriatic arthritis 
PsAID-9 
Psoriatic Arthritis Impact of Disease-9 
PT 
preferred term 
PtAAP 
Patient’s Assessment of Arthritis Pain 
Q4W 
every 4 weeks (monthly) 
QTcB 
QT interval corrected for heart rate using Bazett’s formula 
QTcF 
QT interval corrected for heart rate using Fridericia’s formula 
RBC 
red blood cell 
SAE 
serious adverse event 
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SAP 
statistical analysis plan 
sc 
subcutaneous(ly) 
SD 
standard deviation 
SF-36 
Short-Form 36-item Health Survey 
SFU 
Safety Follow-up 
SIB 
suicidal ideation and behavior 
SJC 
swollen joint count 
SMQ 
standardized MedDRA query 
SOC 
system organ class 
SS 
Safety Set 
TB 
tuberculosis 
TEAE 
treatment-emergent adverse event 
TJC 
tender joint count 
TNF 
tumor necrosis factor 
ULN 
upper limit of normal 
VAS 
visual analog scale 
WBC 
white blood cell 
WHO-DD 
World Health Organization Drug Dictionary  
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1 
INTRODUCTION 
The purpose of this statistical analysis plan (SAP) is to provide all necessary information to 
perform the required statistical analysis for PA0009. It also defines the summary tables, figures, 
and listings to be generated in the clinical study report according to the protocol.  
The SAP is based on the following study documents: 
• Final protocol, 15 May 2017. 
• Protocol Amendment 1, 27 June 2017. 
• Protocol Amendment 2, 09 Mar 2018. 
• Protocol Amendment 3, 11 Dec 2019. 
The content of this SAP is compatible with the International Council for Harmonisation/Food 
and Drug Administration E9 Guidance documents (1998). 
2 
PROTOCOL SUMMARY 
PA0009 is a multicenter, open-label extension (OLE) study evaluating the long-term safety, 
tolerability, and efficacy of bimekizumab (also known as UCB4940) in subjects with psoriatic 
arthritis (PsA). Only subjects who complete PA0008, a Phase 2b study, are eligible for 
enrollment into PA0009. At Week 48 of PA0008, all subjects continuing into PA0009 will 
undergo the final PA0008 study assessments and any nonoverlapping PA0009 entry assessments 
and will then receive their first open label dose of bimekizumab.  
PA0008 was a multicenter, Phase 2b, randomized, double blind, placebo-controlled, parallel 
group, dose ranging study to evaluate the efficacy and safety of bimekizumab in 200 subjects 
with active PsA. 
In the PA0009 OLE study, bimekizumab will be administered at a dose of 160mg every 4 weeks 
(Q4W) subcutaneously (sc) for all subjects regardless of treatment received in PA0008. 
Up to 200 subjects from PA0008 may be enrolled into this study at any of the sites participating 
in PA0008. 
The study duration for each subject is estimated to be up to a maximum of 120 weeks: an Open 
Label Treatment Period of up to 100 weeks (~2 years), followed by a Safety Follow up (SFU) 
Visit 20 weeks after the final dose of bimekizumab. 
2.1 
Study objectives 
2.1.1 
Primary objective 
The primary objective of this open-label study is to assess the long-term safety and tolerability of 
bimekizumab administered over a period of up to 100 weeks (~2 years). 
2.1.2 
Secondary objective 
The secondary objectives of the study are as follows: 
•  To assess the long-term efficacy of bimekizumab 
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2.1.3 
Other objectives 
The other objectives are: 
• To assess the impact on dactylitis and enthesitis 
• To assess the impact on patient-reported quality of life 
• To assess plasma concentrations of bimekizumab 
• To assess the immunogenicity of bimekizumab 
2.2 
Study variables 
2.2.1 
Safety variables 
2.2.1.1 
Primary safety variables 
The primary safety variables are the incidences of treatment-emergent adverse events (TEAEs) 
and treatment-emergent serious adverse events (SAEs). The latter is measured by the incidence 
of serious TEAEs. 
2.2.1.2 
Secondary safety variables 
The secondary safety variable is the withdrawal due to TEAEs. This is measured by the 
incidence of TEAEs leading to study discontinuation and/or permanent withdrawal of study 
medication. 
2.2.1.3 
Other safety variables 
Other safety variables are listed below: 
• Change from PA0009 Laboratory Baseline (defined as the earliest date in PA0009 at or prior 
to PA0009 Week 12) for clinical laboratory variables (hematology and biochemistry, 
excepting high-sensitivity C-reactive protein [CRP]) at each visit (PA0009 Week 24, 36, 48, 
60, 72, 84, 96, 100, 104, SFU). 
• Change from Baseline of PA0008 in vital signs (pulse, temperature, and blood pressure) 
(PA0009 Entry Visit [EV], Week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 100, 104, SFU) and 
body weight (PA0009 EV, Week 12, 24, 36, 48, 60, 72, 84, 96, 100, 104, SFU). 
2.2.2 
Efficacy variables 
2.2.2.1 
Primary efficacy variable 
There is no primary efficacy variable for this study because the primary objective is to assess 
long-term safety and tolerability.  
2.2.2.2 
Secondary efficacy variables 
The secondary efficacy variables are: 
• American College of Rheumatology (ACR) 20% response criterion (ACR20), ACR 50% 
response criterion (ACR50), and ACR 70% response criterion (ACR70) response at PA0009 
Week 48, relative to PA0008 Baseline. 
• Change from Baseline of PA0008 in Maastricht Ankylosing Spondylitis Enthesitis Index 
(MASES) at PA0009 Week 48. 
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• Change from Baseline of PA0008 in the Leeds Dactylitis Index (LDI) at PA0009 Week 48. 
• Psoriasis Area and Severity Index (PASI) 75% (PASI75) and PASI 90% (PASI90) response 
at PA0009 Week 48, relative to PA0008 Baseline. 
2.2.2.3 
Other efficacy variables 
The other efficacy variables are listed below and will be evaluated at scheduled visits in 
accordance with the schedule of study assessments in Table 2-1: 
• ACR20, ACR50, and ACR70 response at each visit (PA0009 EV, Week 12, 24, 36, 48, 60, 
72, 84, 96, 100, 104), relative to PA0008 Baseline. 
− ACR20, ACR50 and ACR70 response will also be reported at each post-PA0008 
Baseline visit in PA0008 through to PA0009 Week 104 (PA0008 Week 2, 4, 8, 12, 16, 
20, 24, 36 and PA0009 EV [PA0008 Week 48], Week 12, 24, 36, 48, 60, 72, 84, 96, 100, 
104), for subjects who were responders at PA0008 Week 12.  These are additional 
variables to those specified in the protocol and will be used to assess maintenance of 
response. 
• PASI75, PASI90 and PASI100 response at each visit (PA0009 EV, Week 12, 24, 36, 48, 60, 
72, 84, 96, 100, 104), relative to PA0008 Baseline. 
− PASI75, PASI90 and PASI100 response will also be reported at each post-PA0008 
Baseline visit in  PA0008  through to PA0009 Week 104 (PA0008 Week 2, 4, 8, 12, 24 
and 36 and PA0009 EV [PA0008 Week 48], Week 12, 24, 36, 48, 60, 72, 84, 96, 100, 
104), for subjects who were responders at PA0008 Week 12.  These are additional 
variables to those specified in the protocol and will be used to assess maintenance of 
response. 
− BSA at each visit in PA0009 will also be reported. This is additional to the protocol and 
was added as an additional method of assessing response in order to provide information 
at visits where the PASI data may be missing.  
• Minimal Disease Activity (MDA) at each visit (PA0009 EV, Week 12, 24, 36, 48, 72, 96, 
104). 
• Change from Baseline of PA0008 value in Disease Activity Score-28 based on C-reactive 
protein (DAS28[CRP]) at each visit (PA0009 EV, Week 12, 24, 36, 48, 60, 72, 84, 96, 100, 
104). 
• Change from Baseline of PA0008 in MASES at each visit (PA0009 EV, Week 12, 24, 36, 48, 
72, 96, 104). 
• Change from Baseline of PA0008 in the LDI at each visit (PA0009 EV, Week 12, 24, 36, 48, 
60, 72, 84, 96, 100, 104). 
• Change from Baseline of PA0008 in Psoriatic Arthritis Impact of Disease-9 (PsAID-9) at 
each visit (PA0009 EV, Week 12, 24, 36, 48, 60, 72, 84, 96, 100, 104). 
• Change from Baseline of PA0008 in Short Form 36-item Health Survey (SF-36) at each visit 
(PA0009 EV, Week 12, 24, 36, 48, 60, 72, 84, 96, 100, 104). 
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• Change from Baseline of PA0008 in Hospital Anxiety and Depression Scale 
(HADS)-Anxiety (HADS-A) and HADS-Depression (HADS-D) scores at each visit (PA0009 
EV, Week 12, 24, 36, 48, 60, 72, 84, 96, 100, 104). 
• Depression and anxiety status ‘normal’ as defined by HADS-D and HADS-A<8 at each visit 
(PA0009 EV, Week 12, 24, 36, 48, 60, 72, 84, 96, 100, 104). 
2.2.3 
Pharmacokinetic/pharmacodynamic variables 
2.2.3.1 
Other pharmacokinetic variable 
The pharmacokinetic (PK) variable is the plasma concentration of bimekizumab evaluated at 
scheduled visits up to 104 weeks (2 years) in accordance with the schedule of study assessments 
in Table 2-1 (PA0009 EV, Week 12, 24, 36, 48, 72, 96, 104, SFU). 
No pharmacodynamic variables are defined. 
2.2.4 
Other pharmacogenomic variables 
No analyses of genomic, genetic, proteomic, or metabolomic biomarkers relevant to disease 
biology and progression, response to therapy, and the inflammatory and immune response 
processes are specified. 
2.2.5 
Other immunological variable 
The immunological variable is the anti-bimekizumab antibody (ADAb) detection evaluated at 
scheduled visits up to 104 weeks (2 years) in accordance with the schedule of study assessments 
in Table 2-1 (PA0009 EV, Week 12, 24, 36, 48, 72, 96, 104, SFU). 
2.3 
Study design and conduct 
PA0009 is a multicenter OLE study to assess the long-term safety, tolerability, and efficacy of 
bimekizumab in eligible adult subjects with PsA who completed the Phase 2b study PA0008. At 
Week 48 of PA0008, all eligible subjects continuing into PA0009 will undergo their final 
PA0008 study assessments and any nonoverlapping PA0009 entry assessments and will then 
receive their first open-label dose of bimekizumab.  
The OLE study will assess the safety, tolerability, and efficacy of bimekizumab administered for 
a period of up to 100 weeks (~2 years). Bimekizumab will be administered at a dose of 160mg 
Q4W upon entry into PA0009, regardless of the dose received in PA0008. Additionally, other 
treatments may be used in addition to bimekizumab per Investigator discretion. Subjects not 
responding to treatment may be withdrawn from the treatment and study at the discretion of the 
Investigator. A study schematic diagram of PA0009 is provided in Figure 2‒1. 
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Figure 2‒1: Schematic Diagram 
 
Q4W=every 4 weeks; sc=subcutaneous; SFU=Safety Follow-up 
Note: Self-administration will be allowed after 3 months of treatment (from PA0009 Week 16 onwards) as described 
in Table 2-1. 
a Subjects will receive their final dose of study drug on PA0009 Week 100 and the SFU Visit will be conducted 20 
weeks after the last dose of investigation medicinal product (IMP). 
A schedule of study assessments is provided in Table 2-1. 
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Table 2-1: 
Schedule of Study Assessments 
Protocol activity 
Treatment Period 
SFU 
Weeksa 
EVb 
4 
12 
16 
24 
28 
36 
40 
48 
52 
60 
64 
72 
76 
84 
88 
96 
100 
W104/ 
 
 
 
8 
 
20 
 
32 
 
44 
 
56 
 
68 
 
80 
 
92 
 
 
ET 
 
Visita 
1 
2/3 
4 
Hc 
5 
Hc 
6 
Hc 
7 
Hc 
8 
Hc 
9 
Hc 
10 
Hc 
11 
12 
13 
 
Informed consent 
Xd 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
Xe 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Concomitant medications 
Xf 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
Adverse events 
Xf 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
eC-SSRS 
Xe,f 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
HADS 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
HAQ-DI 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
SF-36 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
PGADA 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
PtAAP 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
PsAID-9 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
TB questionnaire 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
Vital signs (pulse, 
temperature, BP)g 
Xe 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
Body weight 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
Physical examinationh 
Xe,f 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
X 
X 
TJC (78) and SJC (76) 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
BSA affected by PSO (BSA 
palm method) 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
PASIi 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
MASES 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
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Table 2-1: 
Schedule of Study Assessments 
Protocol activity 
Treatment Period 
SFU 
Weeksa 
EVb 
4 
12 
16 
24 
28 
36 
40 
48 
52 
60 
64 
72 
76 
84 
88 
96 
100 
W104/ 
 
 
 
8 
 
20 
 
32 
 
44 
 
56 
 
68 
 
80 
 
92 
 
 
ET 
 
Visita 
1 
2/3 
4 
Hc 
5 
Hc 
6 
Hc 
7 
Hc 
8 
Hc 
9 
Hc 
10 
Hc 
11 
12 
13 
 
LDI 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
PhGADA 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
ECG 
Xe,f 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
X 
 
Hematology/biochemistry/ 
urine pregnancyj,k 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
Blood Sample for CRPk 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
Blood sample for 
bimekizumab plasma 
concentrationsk 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
X 
Blood sample for anti-
bimekizumab antibodiesk 
Xe,f 
 
X 
 
X 
 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
X 
IGRA TB testl 
Xe 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
 
X 
IXRS  
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
Bimekizumab 
administration 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
BP=blood pressure; BSA=body surface area; CRP=C-reactive protein; eC-SSRS=electronic Columbia-Suicide Severity Rating Scale; 
ECG=electrocardiogram; ET=Early Termination; EV=Entry Visit; H=home; HADS=Hospital Anxiety and Depression Scale; HAQ-DI=Health Assessment 
Questionnaire—Disability Index; IGRA=interferon-gamma release assay; IXRS=interactive voice or web response system; LDI=Leeds Dactylitis Index; 
MASES= Maastricht Ankylosing Spondylitis Enthesitis Score; PASI=psoriasis area severity index; PGADA=Patient’s Global Assessment of Disease 
Activity; PhGADA=Physician’s Global Assessment of Disease Activity; PsAID=Psoriatic Arthritis Impact of Disease; PSO=psoriasis; PtAAP=Patient’s 
Assessment of Arthritis Pain; SF-36=Short Form 36-item Health Survey; SFU=Safety Follow-Up; SJC=swollen joint count; TB=tuberculosis; TJC=tender 
joint count 
Note: The SFU it Visit will occur 20 weeks after the final dose of study medication. 
a Visit windows are ±7 days from the scheduled visit day (relative to the first dose) with a minimum of 21 days and a maximum of 35 days in between doses 
at all visits except the SFU Visit. For the SFU Visit (20 weeks after the final dose), the visit should occur no more than 3 days prior to the scheduled visit 
date and within 7 days after the scheduled visit date (-3 days/+7 days). 
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Table 2-1: 
Schedule of Study Assessments 
Protocol activity 
Treatment Period 
SFU 
Weeksa 
EVb 
4 
12 
16 
24 
28 
36 
40 
48 
52 
60 
64 
72 
76 
84 
88 
96 
100 
W104/ 
 
 
 
8 
 
20 
 
32 
 
44 
 
56 
 
68 
 
80 
 
92 
 
 
ET 
 
Visita 
1 
2/3 
4 
Hc 
5 
Hc 
6 
Hc 
7 
Hc 
8 
Hc 
9 
Hc 
10 
Hc 
11 
12 
13 
 
b PA0009 entry will occur at the end of the lead-study PA0008. At Week 48 of PA0008, all subjects continuing into PA0009 will undergo the final PA0008 
study assessments and any nonoverlapping PA0009 entry assessments before receiving their first open-label dose of bimekizumab. 
c From the Entry Visit onwards, self-administration training will be provided to the subject/caregivers/appropriate designee by the study nurse. At Week 8 
and Week 12, the subject/caregiver/appropriate designee will perform administrations under the supervision of the site staff to ensure that study medication is 
being properly and safely injected. 
d Ensure that a separate Informed Consent form was completed by the subject for PA0009 prior to study entry. 
e To be performed prior to the first dose of open-label bimekizumab. 
f Assessment will be performed at Week 48 of the lead-in study PA0008 and will be used as the PA0009 Entry Visit value. 
g At PA0009 study entry collect pulse and BP prior to drug administration and then at 30 minutes and 1 hour after dosing. At all other visits collect pulse and 
BP prior to drug administration and once after dosing.  
h Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
i If the BSA affected by PSO was ≥3% at Baseline of PA0008, determine the PASI. 
j If there has been a delay in menses, perform a urine pregnancy test. 
k All blood samples are to be taken prior to dosing. 
l It is recommended that the QuantiFERON TB Test be performed. This assessment will be performed at study entry, unless an IGRA negative result is 
available less than 6 weeks prior to the first dose of open-label bimekizumab. 
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2.4 
Determination of sample size 
There is no formal sample size calculation for this study. The sample size is determined by the 
number of subjects eligible for PA0009 and rolling over from PA0008. Up to 200 subjects from 
PA0008 could be enrolled into this study. 
3 
DATA ANALYSIS CONSIDERATIONS 
3.1 
General presentation of summaries and analyses 
All computations and generation of outputs will be performed using SAS® Version 9.3 or later.  
UCB uses SAS in a 64-bit Windows environment, and it is well-documented that in this 
environment the maximum accuracy of any numeric value is 15 significant digits. However, SAS 
by default does not limit the accuracy of numeric values to 15 significant digits which, in certain 
instances, may result in inaccurate representation of the data and cause errors when used in 
subsequent calculations, particularly when comparing a value to a chosen threshold. This, in 
turn, could potentially result in a change in classification of a subject from a responder to a 
nonresponder (and vice versa) if these values occur on a threshold used in the evaluation of 
response (or a critical laboratory value for example). 
Therefore, in order to avoid issues caused by inaccurate floating point representation of numeric 
values, temporary variables are created (ie, for absolute values, change and percentage change 
from Baseline) during programming which are rounded to 12 decimal places prior to comparison 
to a specific threshold in the derivation of a response parameter. This does not imply inherent 
rounding on the ADaM variables AVAL (absolute value), CHG (change) or PCHG (percentage 
change) which are retained unrounded in the final ADaM dataset. Thus, rounding is applied 
exclusively during the derivation of new response parameters or critical value variables, and the 
rounded values are created on a temporary basis only. 
All tables and listings will use Courier New font size 9. 
Descriptive statistics will be displayed to provide an overview of the study results.  For 
categorical variables, the number and percentage of subjects in each category will be presented. 
The denominator for percentages will be based on the number of subjects included in the 
respective analysis set. For observed case (OC) summaries, or summaries of data where no 
imputation is made for missing data, subjects with missing data will be accounted for by 
including a “Missing” category (corresponding to subjects with missing data for the variable 
being summarized) as the last row in the list of categories being summarized.  Percentages will 
be presented to 1 decimal place.  If the percentage is 100%, no decimal will be presented. If the 
percentage is 0, no percentage will be presented. The % sign will be presented in the column 
header, but not with each individual value.     
For continuous variables, descriptive statistics will include number of subjects with available 
measurements (n), mean, standard deviation (SD), median, minimum, and maximum. Decimal 
places for descriptive statistics will apply the following rules: 
• “n” will be an integer. 
• Arithmetic and geometric mean, SD, and median will use 1 additional decimal place 
compared to the original data. 
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• Coefficient of variation (CV [%]) will be presented with 1 decimal place. 
• Minimum and maximum will have the same number of decimal places as the original value. 
The number of decimal places used for derived efficacy variables is shown in Table 3-1. 
Table 3-1: 
Decimal places for derived efficacy variables  
Variable 
Decimal places used for 
minimum and maximum 
Decimal places used for 
mean, SD and median 
MASES 
1 
2 
LDI 
0 
1 
SJC, TJC 
0 
1 
DAS28(CRP) 
2 
3 
PsAID-9 
2 
3 
SF-36 MCS 
2 
3 
SF-36 PCS 
2 
3 
HADS-A 
0 
1 
HADS-D 
0 
1 
HAQ-DI 
2 
3 
DAS28(CRP)=Disease Activity Score 28 joint count C-reactive protein; HADS-A=Hospital Anxiety and Depression 
Scale – Anxiety; HADS-D=Hospital Anxiety and Depression Scale – Depression; HAQ-DI=Health Assessment 
Questionnaire - Disability Index; LDI=Leeds Dactylitis Index; MASES=Maastricht Ankylosing Spondylitis 
Enthesitis Index; PsAID-9=Psoriatic Arthritis Impact of Disease-9; SD=standard deviation; SF-36 MCS=Short Form 
36-Item – Mental Component Summary; SF-36 PCS=Short Form 36-Item – Physical Component Summary; 
SJC=swollen joint count; TJC=tender joint count. 
The abbreviation BKZ will be used for bimekizumab in table and listings headers. 
All data will be presented in by-subject data listings sorted by planned (randomized) treatment 
group at completion of PA0008 (for efficacy listings) or actual treatment group at completion of 
PA0008 (for all other listings), site, subject number, variable (where applicable), and visit (where 
applicable). All listings will include scheduled, repeated and unscheduled measurements in 
chronological order. Dates will be presented in the format ‘YYYY-MM-DD’ and times will be 
presented in 24-hour clock format as ‘hh:mm’. 
In all listings (where applicable) the subject level demographic information (ie, gender, age, race, 
weight) will be based on the data reported at PA0008 Baseline. 
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3.2 
General study level definitions 
3.2.1 
Relative day 
Two relative days will be calculated, these will be relative to the following reference dates; the 
first relative to the start date of study medication (placebo or bimekizumab) in PA0008 and the 
second relative to the start date of study medication in PA0009.  Relative day will be calculated 
as: 
𝐶𝑢𝑟𝑟𝑒𝑛𝑡 𝑑𝑎𝑡𝑒−𝑟𝑒𝑓𝑒𝑟𝑒𝑛𝑐𝑒 𝑑𝑎𝑡𝑒+ 1 
(1) 
for dates on or after the reference date, and: 
𝐶𝑢𝑟𝑟𝑒𝑛𝑡 𝑑𝑎𝑡𝑒−𝑟𝑒𝑓𝑒𝑟𝑒𝑛𝑐𝑒 𝑑𝑎𝑡𝑒 
(2) 
for dates before the reference date. 
Additional character relative day variables will be derived for inclusion in listings: 
𝐶𝑢𝑟𝑟𝑒𝑛𝑡 𝑑𝑎𝑡𝑒−𝑟𝑒𝑓𝑒𝑟𝑒𝑛𝑐𝑒 𝑑𝑎𝑡𝑒+ 1 
(3) 
for dates on or after the reference date and on or before the end date of study medication (no 
prefix), 
𝐶𝑢𝑟𝑟𝑒𝑛𝑡 𝑑𝑎𝑡𝑒−𝑟𝑒𝑓𝑒𝑟𝑒𝑛𝑐𝑒 𝑑𝑎𝑡𝑒 
(4) 
for dates before the reference date (‘-‘ prefix), and: 
𝐶𝑢𝑟𝑟𝑒𝑛𝑡 𝑑𝑎𝑡𝑒−𝑒𝑛𝑑 𝑑𝑎𝑡𝑒 𝑜𝑓 𝑠𝑡𝑢𝑑𝑦 𝑚𝑒𝑑𝑖𝑐𝑎𝑡𝑖𝑜𝑛 𝑖𝑛 𝑃𝐴0009 
(5) 
for dates after the end date of study medication (with ‘+’ prefix). 
Relative day will not be calculated if dates are partial or missing.  
3.2.2 
Study periods 
The following study periods are defined: 
• Treatment Period: The Treatment Period (100 weeks) starts at the start date of study 
medication in PA0009 and ends at the end date of study medication. 
• Dosing period:  The dosing period starts at the start date of study medication in PA0009 and 
ends at 1 dosing interval (28 days) after the end date of study medication. 
• SFU Period: The SFU Period starts on the day after the end date of study medication and 
ends at the SFU visit scheduled for 20 weeks after the end date of study medication. 
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3.3 
Definition of Baseline values 
The Baseline value defined in the PA0008 database will be used as a Baseline for PA0009, 
without additional derivation. The change from PA0008 Baseline will be calculated. 
Due to a change in laboratory vendor between PA0008 and PA0009, laboratory values (with the 
exception of CRP) will use the PA0009 Laboratory Baseline, defined as the earliest post-EV 
value recorded in PA0009 at or prior to PA0009 Week 12). Change from PA0009 Laboratory 
Baseline will be calculated for these parameters. 
The CRP values from the 2 analyzing laboratories have been calibrated, so change from PA0008 
Baseline will be calculated for CRP. 
3.4 
Protocol deviations 
Important protocol deviations are defined as those likely to have a meaningful impact on study 
conduct or on the safety or efficacy outcomes for an individual subject. The criteria for 
identifying protocol deviations and classifying them as important will be defined within the 
appropriate protocol-specific document. All potential protocol deviations will be reviewed as 
part of the ongoing data cleaning process and documented prior to database lock. 
All deviations will be identified and classified as important or not important.  Important protocol 
deviations will be identified and classified by the deviation types: 
• Inclusion criteria deviation 
• Exclusion criteria deviation 
• Withdrawal criteria deviation 
• Prohibited concomitant medication use 
• Incorrect treatment or dose 
• Treatment non-compliance 
• Procedural non-compliance 
The process for identifying and categorizing prohibited medications is described in Section 6.5. 
The impact of the COVID-19 pandemic on study procedures/conduct (eg, missed visits, remote 
visits, interruption of study treatment) will be documented using the information collected on a 
dedicated eCRF page, the details for which are included in Section 12.6. 
3.5 
Mapping of assessments 
Study assessments at an Early Termination (ET) visit where the visit date is within the 
protocol-defined visit window of a scheduled site visit will be mapped to that scheduled site visit 
(this does not include home visits). Visit windows will be calculated relative to the date of first 
dose in PA0009 (planned at the PA0009 EV), but if the dose was missed at that visit, the date of 
the PA0009 EV will be used instead. The following rules will also be applied: 
• If there is an existing scheduled site visit in the window and the specific assessment was 
performed at that scheduled visit, then the relevant assessments at the ET visit will be 
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mapped to the next scheduled site visit (regardless of whether this is within the 
protocol-defined visit window for that site visit).  
• Study assessments at an ET visit that does not fall into the protocol-defined visit window of a 
scheduled site visit will be assigned to the next scheduled site visit after the date of the ET 
visit (regardless of whether this is within the protocol-defined visit window for that site 
visit).  
• Mapping of an assessment to a scheduled visit will occur regardless of whether the 
assessment was planned to be conducted at that visit (with the exception of ADAb). For 
ADAb however, data will only be mapped to scheduled site visits where ADAb levels are 
planned to be measured. Any PK samples taken at the same ET visit will be mapped to the 
same scheduled visit as the ADAb. 
• Additional rules regarding visit windows for PK and ADAb summaries are included in 
Section 9.1 and Section 9.2. 
Unscheduled assessments where the visit date is within the protocol-defined visit window of a 
scheduled site visit will be mapped to that scheduled site visit (this does not include home visits). 
Visit windows will be calculated relative to the date of first dose in PA0009, but if the dose was 
missed at that visit, the date of the PA0009 EV will be used instead. The following rules will also 
be applied: 
• If there is an existing assessment with a non-missing response (from a scheduled site visit or 
ET visit) in the window, the assessment will be left as unscheduled.  
• Unscheduled assessments which do not fall within a protocol-defined visit window based on 
time since first dose (or date of PA0009 EV if the first dose was missed) will be left as 
unscheduled. 
• Unscheduled assessments obtained at specific time points (eg, vital signs) will only be 
mapped to a scheduled site visit for the equivalent time point. Thus, if an assessment falls 
within the protocol-defined visit window of a scheduled site visit but the scheduled visit does 
not have a corresponding time point, the measurement will be left as unscheduled (eg, if the 
unscheduled time point was ‘1 HOUR POST DOSE’ this will not be mapped to a visit at 
which only ‘PRE DOSE’ time points are scheduled). 
• Unscheduled PK and ADAb assessments may also be mapped to a scheduled site visit if the 
visit date is within the protocol-defined visit window of that visit. For ADAb this will only 
apply to scheduled site visits where ADAb levels are planned to be measured. For any PK 
samples obtained at the same unscheduled visit, these will be mapped to the same scheduled 
visit as the ADAb. 
If there are multiple unscheduled assessments in a specific visit window, the first non-missing 
assessment will be mapped to the scheduled visit and used for summary statistics or frequency 
counts. Similarly, if there are multiple scheduled assessments performed on the same visit date, 
the first non-missing assessment will be used for summary statistics or frequency counts. 
Assessments will be reported according to the planned Schedule of Assessments (Table 2-1) and 
each scheduled visit summary will include actual data and any data mapped from an ET visit to 
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that scheduled visit.  The final visit will be labeled “Week 104”. Data obtained at scheduled 
visits will be reported as per the database (ie, these will not be remapped as described above).  
Assessments mapped to visits at which the assessment was not planned and unscheduled 
assessments that are not mapped to a scheduled visit at which the assessment was planned will be 
listed only. 
3.6 
Analysis sets 
Three analysis sets will be defined for this study. 
3.6.1 
Enrolled Set 
The Enrolled Set (ES) will consist of all subjects who have given informed consent for PA0009. 
3.6.2 
Safety Set 
The Safety Set (SS) will consist of all subjects in the ES who received at least one dose of study 
medication in PA0009. 
All safety variables will be summarized for the SS. Pharmacokinetic and immunological 
variables will also be summarized on the SS. 
Two Sub-populations of the SS will be defined for this study: SS Sub-population 1 will consist 
of all subjects in the SS who took no concomitant rescue medication in PA0009, and SS 
Sub-population 2 will consist of all subjects in the SS who took concomitant rescue medication 
in PA0009, as outlined in Section 6.5. Rescue medications will be identified in the study 
database using the flag collected in the electronic case report form (eCRF). Concomitant 
medications are defined in Section 6.4. 
Selected summaries of the primary and secondary safety variables will be repeated for both SS 
Sub-populations only in the event that the number of subjects receiving rescue medication is 
≥10% of the total number of subjects in the SS. 
3.6.3 
Full Analysis Set 
The Full Analysis Set (FAS) will consist of all subjects in the ES who received at least 1 dose of 
study medication in PA0009 and have a valid measurement for at least 1 efficacy variable after 
PA0009 EV. 
Secondary and other efficacy variables will be summarized for the FAS. Immunological 
variables will also be summarized on the FAS where specified in Section 9.2. 
3.7 
Treatment assignment and treatment groups 
This is an open label, single arm study. 
Treatment group at the completion of PA0008 (presented as ‘BKZ 160mg’ or ‘BKZ 320mg’) and 
an overall ‘BKZ Total’ column will be used to summarize data in PA0009. 
The endpoints assessing maintenance of ACR and PASI response over time will be summarized 
by treatment sequence across PA0008 and PA0009. Treatment sequences take the form ‘A/B/C’, 
where A is the treatment in the first 12 weeks of PA0008, B is the treatment from Week 12 to 
Week 48 of PA0008, and C is the treatment in PA0009. The seven planned treatment sequences 
are as follows:  
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• Placebo/BKZ 160mg/BKZ 160mg. 
• Placebo/BKZ 320mg/BKZ 160mg. 
• BKZ 16mg/BKZ 160mg/BKZ 160mg. 
• BKZ 16mg/BKZ 320mg/BKZ 160mg. 
• BKZ 160mg loading dose (LD)/BKZ 160mg/BKZ 160mg. 
• BKZ 160mg/BKZ 160mg/BKZ 160mg. 
• BKZ 320mg/BKZ 320mg/BKZ 160mg. 
For safety summaries the following will be presented: 
• Safety summaries including PA0009 data only will be presented by treatment group at the 
completion of PA0008 and overall.   
• Safety summaries including data from both PA0008 and PA0009 combined will be presented 
for ‘BKZ 160mg’, ‘BKZ 320mg’, and 'BKZ Total’. The assignment of each of the sequences 
to the columns in this table is presented in Table 3-2. 
− The ‘BKZ 160mg’ treatment column in these tables will include subjects in both the BKZ 
160mgLD and BKZ 160mg treatment groups. 
− For each column, only those periods for which the specified treatment is received will 
contribute to the summary ie, for sequence BKZ 16mg/BKZ 320mg/BKZ 160mg, the 
16mg period will contribute to the BKZ Total column only, the BKZ 320mg period will 
contribute to the BKZ 320mg column and the BKZ Total column only, and the BKZ 
160mg period will contribute to the BKZ 160mg column and the BKZ Total column 
only.  
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Table 3-2: 
Treatment sequence assignment for safety summaries 
Sequence 
BKZ 160mg 
BKZ 320mg 
BKZ Total 
Placebo/BKZ 
160mg/BKZ 160mg 
X 
 
X 
Placebo/BKZ 
320mg/BKZ 160mg 
X 
X 
X 
BKZ 16mg/BKZ 
160mg/BKZ 160mg 
X 
 
X 
BKZ 16mg/BKZ 
320mg/BKZ 160mg 
X 
X 
X 
BKZ 160mg LD/BKZ 
160mg/BKZ 160mg 
X 
 
X 
BKZ 160mg/BKZ 
160mg/BKZ 160mg 
X 
 
X 
BKZ 320mg/BKZ 
320mg/BKZ 160mg 
X 
X 
X 
BKZ=bimekizumab; LD=loading dose. 
• For all safety summaries, subjects who took bimekizumab 320mg during PA0008 will 
contribute to all 3 columns. Subjects who did not take 320mg in PA0008 will contribute to 
the ‘BKZ 160mg’ and ‘BKZ Total’ columns.  
• The combined summaries will include all data from PA0008 in addition to PA0009 only for 
subjects who were enrolled in PA0009.  
• The PA0009 only summaries will include only data collected in PA0009 (unless otherwise 
stated). 
Subjects will be summarized based on the actual/received treatment or the planned treatment for 
different analysis sets as follows: 
• ES: planned treatment. 
• SS and SS Sub-populations: actual treatment. 
• FAS: planned treatment. 
For actual and planned treatments in PA0008, the data will be used directly from the PA0008 
analysis database without any rederivation of treatment assignments in each period. 
In PA0009 it will be assumed that all subjects received the correct treatment as the dose level of 
bimekizumab is the same for all subjects and throughout the study (160mg). If a subject missed a 
dose at PA0008 Week 48, they will also be considered to have received the planned treatment. 
Thus for all subjects in PA0009, the actual treatment will be the same as the planned treatment. 
3.8 
Center pooling strategy 
Centers at PA0008 Baseline will be grouped into the geographic regions of North America 
(county code USA) and Europe (country codes CZE, DEU, HUN, POL, RUS) for use as a 
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covariate in statistical analyses and for subgroup analyses (see Section 4.1 and Section 8.4).  An 
additional region grouping of North America (county code USA), Eastern Europe (country codes 
CZE, HUN, POL, RUS) and Western Europe (country code DEU) will be derived in the datasets 
for possible use in future integration. 
3.9 
Coding dictionaries 
Medical history and AEs will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA) version 19.0. Medical history conditions and will be classified by primary system 
organ class (SOC) and preferred term (PT). AEs will be classified by primary system organ class 
(SOC), high level term (HLT) and preferred term (PT). 
Prior and concomitant medications will be coded using version SEP2015 of the World Health 
Organization Drug Dictionary and will be classified by Anatomical Main Group, 
Pharmacological Subgroup, and PT. 
Medical procedures will not be coded. 
3.10 
Changes to protocol-defined analyses 
The following changes have been made to the protocol-defined analyses: 
• Summaries of ACR20, ACR50, ACR70, PASI75, PASI90, and PASI100 response at each 
post-PA0008 Baseline visit have been added for subjects who were responders at PA0008 
Week 12. These summaries include all post-Baseline PA0008 visits through to PA0009 
Week 104 and will be used to assess maintenance of response. 
• Summaries of BSA at each visit in PA0009 have been added as an additional method of 
assessing response in order to provide information at visits where the PASI data may be 
missing.  
• Summaries by randomized treatment in PA0008 will not be produced, as subjects will have 
been on a constant dose of bimekizumab 160mg or 320mg for at least 36 weeks prior to 
PA0009 entry. Maintenance of response displays will be split by treatment sequence across 
PA0008 and PA0009. Safety displays using PA0008 information will incorporate exposure in 
PA0008. 
• The protocol stated that all safety analyses would be performed for both SS Sub-populations; 
instead only key safety analyses will be repeated by SS Sub-population as identified in 
Section 10. These analyses will be performed only in the event that the number of subjects 
receiving rescue medication is ≥10% of the total number of subjects in the SS. 
• The protocol stated that figures presenting the relationship between ACR20 response and 
ADAb positivity over time would be produced. This has been changed to use the ACR50 
response instead as this is considered to be the key efficacy endpoint with respect to ACR. 
3.10.1 
Changes related to COVID-19 
The impact of the COVID-19 pandemic on study procedures/conduct and on the primary safety 
endpoints (TEAEs, serious TEAEs, and study withdrawal due to TEAEs) will be investigated 
and additional outputs provided as appropriate. These analyses were not planned as part of the 
protocol as the pandemic was not ongoing at the time of protocol finalization. 
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The additional analyses are described in the following sections of the SAP: 
• Subject disposition, including details of impacted visits and effects on collection and 
reporting of efficacy data (Section 5.1.1) 
• Adverse events (Section 10.2.4) 
4 
STATISTICAL/ANALYTICAL ISSUES 
4.1 
Adjustments for covariates 
All multiple imputation (MI) models (see Section 4.2.1) will include the following covariates: 
• Geographic region at PA0008 Baseline (North America, Europe), as defined in Section 3.8. 
• Previous (past) tumor necrosis factor (TNF) inhibitor agent exposure in PA0008. The value 
in the PA0008 database for past anti-TNF therapy (as collected on the eCRF) will be used for 
PA0009, without additional derivation. 
Missing efficacy data will be handled as described in Section 4.2.1.  No imputation will be made 
for missing safety or background data, except as described in Section 4.2.3 and Section 4.2.4. 
4.2 
Handling of missing data 
4.2.1 
Handling of missing data for efficacy analysis 
Calculation of derived efficacy variables in the presence of missing data is described in 
individual subsections of Section 8.1.  All derived efficacy variables will be calculated using 
observed data, and any resulting missing data will be handled as described in this section. All 
nonresponder imputation (NRI) and MI imputation as described below will be performed only 
for subjects in the FAS for PA0009.  
Additional methods for deriving the PASI response in the presence of missing data are described 
in Section 4.2.2. 
For assessments missing during PA0008, which were to be used in PA0009 for reporting 
maintenance of response, the following approach will be used: 
• For summaries of binary data following NRI, the imputed value from the PA0008 database 
will be used. 
• For summaries of non-imputed (OC) data, the assessment will be left as missing. 
For all visits in PA0009 (including PA0009 EV), missing values for binary secondary/other 
efficacy variables (ACR20, ACR50, ACR70, PASI75, PASI90, PASI100, MDA) or values, 
which cannot be constructed (eg, for ACR either tender joint count [TJC]/swollen joint count 
[SJC] are missing or >2 out of the 5 remaining core set measures are missing) will be imputed 
using NRI. For each visit, subjects with missing data or who have dropped out of the study will 
be counted as nonresponders. This includes any subjects with missing Baseline values. For PASI 
response, NRI will be implemented only for subjects with BSA ≥3% at PA0008 Baseline. 
For missing continuous secondary/other efficacy variables an MI approach will be used. This 
will be performed for the following endpoints: 
• TJC and SJC 
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• Psoriasis Area and Severity Index (PASI) 
− For PASI the MI model will be restricted to subjects with a BSA affected by psoriasis of 
≥3% at PA0008 Baseline. Subjects with a BSA affected by psoriasis of <3% at PA0008 
Baseline will be excluded prior to performing the procedure outlined below. 
• Patient’s Global Assessment of Disease Activity (PGADA) 
• Physician’s Global Assessment of Disease Activity (PhGADA) 
• Patient’s Assessments of Arthritis Pain (PtAAP) 
• Health Assessment Questionnaire – Disability Index (HAQ-DI) 
• CRP 
− For CRP, the rules for handling measurements that are below the limit of quantification 
should be followed as per Section 8.1.7. Thus, if any imputed values are <0.16mg/L, 
these will be replaced with 0.08mg/L prior to any subsequent reporting. 
• MASES 
− For MASES, the MI model will be restricted to subjects with a MASES score >0 at 
PA0008 Baseline. Subjects with a MASES score of 0 at PA0008 Baseline will be 
excluded prior to performing the procedure outlined below. 
• LDI 
− For LDI, the MI model will be restricted to subjects with LDI scores >0 at PA0008 
Baseline. Subjects with LDI scores of 0 at PA0008 Baseline will be excluded prior to 
performing the procedure outlined below. 
• DAS28[CRP] 
• PsAID-9 
• SF-36 
− For SF-36, this will be performed for the Physical Component Summary (PCS) score and 
Mental Component Summary (MCS) score only. 
• HADS-A and HADS-D 
− Incidence of normal HADS-A and HADS-D scores (defined as having HADS-D<8 and 
HADS-A<8 at the same visit) will be derived at each visit using the values for HADS-A 
and HADS-D obtained after MI 
The missing absolute value (not the change from Baseline) will be replaced by one of a set of 
plausible values, where each value is a Bayesian draw from the conditional distribution of the 
missing data given the observed data. The basic assumption in MI is that the underlying missing 
data mechanism is ignorable, eg, the missing data are missing at random.  
All MI procedures will be performed using data from both PA0008 and PA0009 such that 
missing data across both studies will be imputed (in general, only data from PA0009 will be 
presented in the summary tables, with the exception of the summaries of maintenance of 
response where all visits in PA0008 and PA0009 will be presented). Any previous imputation 
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(MI or last observation carried forward [LOCF] or other imputation) performed in PA0008 will 
not be considered for PA0009 such that the procedure will use OC data only across both studies. 
Thus, the results presented in the maintenance tables for visits in PA0008 may differ from those 
previously reported as part of the PA0008 clinical study report. 
As the PA0008 Week 48 time point is synonymous with the PA0009 EV time point, this will be 
incorporated once only into the model. 
The SAS® PROC MI procedure will be used for the imputation. 
The MI consists of 3 steps: 
• The missing data are imputed m times to create m complete datasets. 
• The m datasets are summarized. 
• The results of the m summaries are combined into a single result. 
The MI method will be applied as follows: 
Step 1  
• Create a data set, sorted by treatment group at completion of PA0008, of subjects with 
observed values and missing values needing imputation. Missing values will be separated 
into non-monotone (ie, intermittent missing values between completed assessments) and 
monotone (ie, missing values after the subject dropped out). The procedure will sequentially 
estimate an imputation model for the efficacy variable at each post-PA0008 Baseline visit 
where efficacy variables are collected, with PA0008 Baseline, geographic region, and past 
TNF inhibitor exposure (as collected on the eCRF in PA0008 for past anti-TNF exposure) as 
covariates, separately for each treatment group at the completion of PA0008. 
• Intermittent missing data will be imputed by draws from the imputation model using the 
Markov-Chain Monte Carlo (MCMC) method with multiple chains and monotone imputing. 
A total number of imputations will be 100. The seed used for these imputations will be 2017.  
Note: All MI procedures described in this SAP will use the same seed. 
• The post-PA0008 Baseline values will be specified in chronological order in the imputation 
model so that the SAS® PROC MI imputes variables from left to right.  If a PA0008 
Baseline raw value is missing, the study participant will be excluded. The imputation model 
based on the MCMC method will only allow multivariate normal variables as predictors.  
Therefore, past TNF inhibitor exposure and geographic region will be re-coded as indicator 
variables. For past TNF exposure, this will be 0 for no past exposure and 1 for past TNF 
exposure. Similarly, for region, this will be 1 for subjects from Europe and 0 for all other 
subjects. The order for the covariates in the model will be as follows: region indicator 
variable (Europe = 1, North America = 0), past TNF exposure (Yes = 1, No = 0), Baseline 
value, and visit variables. 
• Once the intermittent missing data are imputed, the monotone missing data will be imputed 
including covariates as defined above, based on the datasets created by the intermittent 
missing data MI. Since this dataset already has 100 imputed values at each visit, only 1 
imputation will be performed. 
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Step 2 
The dataset with the imputed results for each treatment arm will be combined into 1 complete 
dataset including each of the 100 imputations.  If any imputed value is less than the lower limit 
of the allowable range for that parameter (as shown in Table 4‒1), it will be changed to the lower 
limit of the range, and similarly for values higher than the allowable range. This dataset will be 
used to calculate the change from PA0008 Baseline variable where appropriate.   
Table 4‒1: 
Allowable ranges for continuous efficacy variables 
Variable 
Minimum 
Maximum 
MASES 
0 
13 
PASI 
0 
72 
LDI 
0 
NA 
DAS28(CRP) 
0.988a 
NA 
CRPb 
0.08 
NA 
PsAID-9 
0 
10 
SF-36 MCS 
-3.33 
80.09 
SF-36 PCS 
5.02 
79.78 
HADS-A 
0 
21 
HADS-D 
0 
21 
TJC 
0 
78 
SJC 
0 
76 
HAQ-DI 
0 
3 
PtAAP 
0 
100 
PhGADA 
0 
100 
PGADA 
0 
100 
CRP=high sensitivity C-reactive protein; DAS28(CRP)=Disease Activity Score 28 joint count C-reactive protein; 
HADS-A=Hospital Anxiety and Depression Scale – Anxiety; HADS-D=Hospital Anxiety and Depression Scale – 
Depression; HAQ-DI=Health Assessment Questionnaire - Disability Index; LDI=Leeds Dactylitis Index; 
LLOQ=lower limit of quantification; MASES=Maastricht Ankylosing Spondylitis Enthesitis Index; NA=not 
applicable; PASI=Psoriasis Area and Severity Index; PGADA=Patient’s Global Assessment of Disease Activity; 
PhGADA=Physician’s Global Assessment of Disease Activity; PsAID-9=Psoriatic Arthritis Impact of Disease-9; 
PtAAP=Patient's Assessment of Arthritis Pain; SF-36 MCS=Short Form 36-Item – Mental Component Summary;  
SF-36 PCS=Short Form 36-Item – Physical Component Summary; SJC=swollen joint count; TJC=tender joint 
count. 
a For the purpose of the analysis, the actual minimum value will be set to the calculated value of 0.36*ln(CRP+1) 
+0.96 using the minimum CRP of 0.08mg/L. 
b For the purpose of the MI any numerical CRP values obtained in PA0009 that were <0.16 mg/L will be substituted 
with half the lower limit of quantification (LLOQ) LLOQ from PA0008 (ie, 0.08 mg/L) prior to performing the 
MI. Subsequently any imputed values of <0.16mg/L will be replaced by the value of 0.08mg/L for the purpose of 
summaries based on imputed data. Listings will display the original result. Any CRP values of ≥500mg/L will be 
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set to missing prior to performing the MI procedure; the subsequently imputed CRP value will be included in the 
summary tables. 
Step 3 (Excluding CRP) 
The 100 imputed datasets will be combined, and simple means and standard errors will be 
calculated using Rubin’s rules (via SAS® PROC MIANALYZE). For calculation of other 
descriptive statistics (median, minimum and maximum), Rubin’s rules do not apply. Multiple 
imputation estimates will be computed by calculating arithmetic means of the estimates from the 
multiple repetitions of the imputation algorithm. Thus, for median, minimum and maximum the 
following approach will apply: 
• The data will be summarized by treatment, visit and imputation and the summary statistics 
will be computed.  
• Results will be summarized by taking the mean value of each summary statistic at each visit 
across all imputations.  
The number of decimal places will remain the same as the original for display purposes (ie, if the 
mean was presented to 1 decimal place, the mean of the means will also be presented to 1 
decimal place). 
Step 3 (CRP only) 
The CRP data will be presented using the geometric mean, 95% confidence interval (CI) for the 
geometric mean, median, Q1, Q3, minimum and maximum. The change from Baseline will be 
expressed as the ratio to Baseline in the summaries. The following approach will be applied: 
• Following the MI procedure the ratio to Baseline will be calculated for any of the imputed 
values  
• The natural logarithm of the absolute values and of the ratios to Baseline will be calculated 
• The logged values will be summarized by treatment, visit and imputation  
• The datasets will be combined using PROC MIANALYZE in order to get the mean and 95% 
CI estimates from the absolute values and ratios to Baseline (based on logged data) across 
imputations  
• The estimates of the mean and 95% CI will be back-transformed to obtain the geometric 
mean and 95% CI on the original scale 
• For the median, Q1, Q3, minimum and maximum the procedure outlined above for the other 
endpoints will be followed 
As a sensitivity analysis, certain efficacy variables will be summarized based on observed data 
(see Section 8).  
As a further sensitivity analysis for ACR and PASI responses, the response variables will be 
derived following MI of the individual components for ACR or following MI of the overall PASI 
score.  The ACR and PASI responses will then be derived for each subject and each imputation 
(where each imputation is performed across all individual components for ACR) and the number 
and percentage of subjects with each ACR and PASI response in each imputation will be 
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calculated. The mean value (across imputations) for the percentage of subjects with each ACR or 
PASI response will be reported.  
A similar approach will be followed for the calculation and summary of the number and 
percentage of subjects with normal HADS scores (defined as having HADS-D and HADS-A <8 
at the same visit) based on the HADS-D and HADS-A values after MI. 
Primary and sensitivity analyses are summarized in Table 4‒2. All summaries presenting data 
following MI will include only visits from PA0009 EV onwards (although the MI procedure will 
incorporate data from both PA0008 and PA0009). 
Table 4‒2: 
Missing data handling 
Variable 
Type 
Missing data handling approach 
NRI 
MI/MCMC 
(monotone 
regression) 
OC 
ACR20, 50, 70 
Responder 
P 
Sa 
S 
MASES 
Continuous 
 
P 
S 
LDI 
Continuous 
 
P 
S 
PASI75, 90, 100 
Responder 
P 
Sa 
S 
MDA 
Responder 
P 
 
S 
DAS28 (CRP) 
Continuous 
 
P 
 
CRP 
Continuous 
 
P 
 
PsAID-9 
Continuous 
 
P 
 
SF-36 PCS, MCS 
Continuous 
 
P 
 
HADS-A, HADS-D 
Continuous 
 
P 
 
Incidence of normal depression/anxiety 
status (using HADS) 
Responder 
 
Pa 
 
TJC, SJC 
Continuous 
 
P 
 
HAQ-DI 
Continuous 
 
P 
 
PtAAP 
Continuous 
 
P 
 
PGADA 
Continuous 
 
P 
 
PhGADA 
Continuous 
 
P 
 
ACR=American College of Rheumatology 20, 50, 70% response criteria; CRP=high sensitivity C-reactive protein; 
DAS28(CRP)=Disease Activity Score 28 joint count C-reactive protein; HADS-A=Hospital Anxiety and Depression 
Scale – Anxiety; HADS-D=Hospital Anxiety and Depression Scale – Depression; HAQ-DI=Health Assessment 
Questionnaire - Disability Index; LDI=Leeds Dactylitis Index; LLOQ=lower limit of quantification; 
MASES=Maastricht Ankylosing Spondylitis Enthesitis Index; MCMC=Markov-Chain Monte Carlo;  
MDA=Minimal Disease Activity; MI=multiple imputation; NRI=nonresponder imputation; OC=observed case; 
P=primary method; PASI 75, 90, 100=Psoriasis Area and Severity Index 75%, 90% and 100%; PGADA=Patient’s 
Global Assessment of Disease Activity; PhGADA=Physician’s Global Assessment of Disease Activity; PsAID-
9=Psoriatic Arthritis Impact of Disease-9; PtAAP=Patient’s Assessment of Arthritis Pain; S=secondary method; 
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SF-36 MCS=Short Form 36-Item – Mental Component Summary;  SF-36 PCS=Short Form 36-Item – Physical 
Component Summary; SJC=swollen joint count; TJC=tender joint count. 
a Imputation method is applied on continuous data, and response variable is derived from the continuous data based 
on complete dataset. 
 
In the event that the MI model fails to converge or will not run for other reasons (eg, data issues, 
data distribution), alternative approaches may be considered including LOCF and /or OC 
summaries as appropriate. For some efficacy endpoints, these approaches may be planned 
already as part of the existing analyses or sensitivity analyses, and therefore it may not be 
necessary in all cases to provide additional summaries. 
4.2.2 
Additional rules for handling missing data for derivation of PASI 
response 
Supplementary supporting analyses will be performed for the PASI response in order to take into 
account missing PASI data during the study. PASI data are known to be missing for some 
subjects/visits due to an error in the original protocol schedule of events which stated that PASI 
would only be determined at a given visit if the BSA affected by psoriasis at that visit was ≥3%. 
The protocol was subsequently updated (Amendment 3) to correct the schedule of events such 
that PASI is assessed at all visits for subjects with BSA affected by psoriasis of ≥3% at PA0008 
Baseline. 
These supporting analyses will be performed in addition to those described in Section 4.2.1 and 
will utilize the BSA assessments to provide surrogate information regarding the PASI response. 
Two different approaches will be used in this regard: 
• For any visit where the derived total PASI score is missing the subject will be considered as a 
PASI responder if the corresponding BSA assessment at the same visit is 0%. A BSA of 0% 
will therefore be considered to meet the criteria for PASI75, PASI90, and PASI100 
responses. 
• For any visit where the derived total PASI score is missing, the PASI response will be 
imputed using LOCF (based on OC data) only if the BSA has not worsened at any interim 
time point or the current time point compared to the last visit at which both PASI response 
and BSA were non-missing (including unscheduled/repeat assessments).  
For example, if the PASI score is missing at Visit 4 (Week 12), the response (PASI75, 
PASI90, or PASI100) at Visit 1 EV will be carried forward and used in the summary, if BSA 
at Visit 4 ≤BSA at Visit 1. If BSA at Visit 4 >BSA at Visit 1, the response will be left as 
missing. 
− If the data at the PA0009 EV are missing the LOCF will be taken from the last available 
assessment obtained in PA0008 (based on OC data). 
− The approach above will be followed regardless of the BSA value at the corresponding 
visit, ie, if the BSA=0% at the visit, the previous PASI response will be carried forward 
for each variable (PASI75, PASI90, and PASI100) and may be Yes or No. 
For both approaches above, the rules will be applied to PA0009 data only and only for subjects 
in the FAS. In addition, this will be implemented only for subjects with BSA ≥3% at PA0008 
Baseline. 
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4.2.3 
Handling of missing data for adverse events 
A complete date must be established to correctly identify the AE as treatment-emergent. For 
purposes of imputing missing components of partially reported start and stop dates for AEs, the 
algorithms listed below will be followed. Start and stop dates of AEs will be displayed as 
reported in the subject data listings (ie, no imputed values will be displayed in data listings). 
Partial or missing start dates for events recorded during PA0008 (including those which were 
ongoing at the start of PA0009) will be imputed using the imputed start date from the PA0008 
database. 
Imputation of partial AE start dates for events reported in PA0009 only will follow the rules 
below (treatment switching rules refer to PA0008 only and data were used directly from the 
PA0008 database): 
• If only the month and year of the AE start date are specified, and the month and year of the 
start date of study medication in PA0009 are not the same as the month and year of the AE 
start date, and the subject did not switch treatment during that month and year, then use the 
1st of the month of the AE start date.  
• If only the month and year of the AE start date are specified, and the month and year of the 
start date of study medication in PA0009 are not the same as the month and year of the AE 
start date, and the subject switched treatment during the month and year of the AE start date, 
then use the date of treatment switch.  
• If only the month and year of the AE start date are specified, and the month and year of the 
start date of study medication in PA0009 are the same as the month and year of the AE start 
date, then use the start date of study medication in PA0009 (regardless of treatment 
switching). If this results in a start date after a known end date use the 1st of the month of the 
AE start date. 
• If only the year of the AE start date is specified, and the year of the start date of study 
medication in PA0009 is not the same as the year of the AE start date, and the subject did not 
switch treatment during the year of the AE start date, then use the 1st of January of the year 
of the AE start date. 
• If only the year of the AE start date is specified, and the year of the start date of study 
medication in PA0009 is not the same as the year of the AE start date, and the subject 
switched treatment during the year of the AE start date, then use the date of treatment switch.  
• If only the year of the AE start date is specified, and the year of the start date of study 
medication in PA0009 is the same as the year of the AE start date, then use the start date of 
study medication in PA0009 (regardless of treatment switching). If this results in a start date 
after a known end date use the 1st of January of the year of the AE start date. 
• If only the year and day of the AE start date are specified, and the year of the start date of 
study medication in PA0009 is not the same as the year of the AE start date, then use January 
of the year of the AE start date together with the known day. 
• If only the year and day of the AE start date are specified, and the year of the start date of 
study medication in PA0009 is the same as the year of the AE start date, then use the start 
month of study medication in PA0009 together with the known day.  
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− If this results in a start date after a known end date use January of the year of the AE start 
date together with the known day. 
− If this results in a start date prior to the start date of study medication in PA0009 (in the 
imputed month) the event will be considered to be treatment-emergent. 
• If the AE start date is completely unknown and the AE stop date is unknown or not prior to 
the start date of study medication in PA0009, then use the start date of study medication in 
PA0009. 
Imputation of partial AE stop date: 
• If only the month and year of the AE stop date are specified, then use the last day of that 
month and that year. 
• If only the day and year are specified, then use December of that year 
• If only the year of the AE stop date is specified, then use December 31st of that year. 
• If the AE stop date is completely unknown, do not impute the stop date. 
In the event of ambiguity or incomplete data which makes it impossible to determine whether the 
AE was treatment-emergent, the AE will be considered treatment-emergent. For subjects who 
may have died during the study, imputed dates will be truncated at the date of death. 
If the intensity of an AE is unknown, it is considered as severe. If the relationship to study drug 
is missing, it is considered as related. 
If the seriousness of an AE is unknown, no imputation will be performed. Such events will 
therefore be excluded from any listings or summaries of SAEs.  
4.2.4 
Handling of missing data for prior and concomitant medication 
A complete start and stop date must be established to correctly identify the medication as prior or 
concomitant. For purposes of imputing missing components of partially reported start and stop 
dates for medications, the algorithms listed below will be followed. Start and stop dates of 
medications will be displayed as reported in the subject data listings (ie, no imputed values will 
be displayed in data listings). 
Partial start dates for medications which started during PA0008 and were ongoing at the start of 
PA0009 will be taken from the PA0008 database based on the dedicated eCRF page for imported 
medications in PA0009. 
Imputation of all partial start dates for medications (including those reported on the ‘imported’ 
page) will follow the rules below (treatment switching rules refer to PA0008 only): 
• If only the month and year of the medication start date are specified, and the month and year 
of the start date of study medication in PA0009 are not the same as the month and year of the 
medication start date, and the subject did not switch treatment during that month and year, 
then use the 1st of the month of the medication start date. 
• If only the month and year of the medication start date are specified, and the month and year 
of the start date of study medication in PA0009 are not the same as the month and year of the 
medication start date, and the subject switched treatment during the month and year of the 
medication start date, then use the date of treatment switch.  
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• If only the month and year of the medication start date are specified, and the month and year 
of the start date of study medication in PA0009 are the same as the month and year of the 
medication start date, then use the start date of study medication in PA0009 (regardless of 
treatment switching). If this results in a start date after a known end date use the 1st of the 
month of the medication start date 
• If only the year of the medication start date is specified, and the year of start date of study 
medication in PA0009 is not the same as the year of the medication start date, and the subject 
did not switch treatment during the year of the medication start date, then use the 1st of 
January of the year of the medication start date. 
• If only the year of the medication start date is specified, and the year of the start date of study 
medication in PA0009 is not the same as the year of the medication start date, and the subject 
switched treatment during the year of the medication start date, then use the date of treatment 
switch.  
• If only the year of the medication start date is specified, and the year of the start date of study 
medication in PA0009 is the same as the year of the medication start date, then use the start 
date of study medication in PA0009 (regardless of treatment switching). If this results in a 
start date after a known end date use the 1st of January of the year of the medication start 
date. 
• If only the year and day of the medication start date are specified, and the year of the start 
date of study medication in PA0009 is not the same as the year of the medication start date, 
then use January of the year of the medication start date together with the known day. 
• If only the year and day of the medication start date are specified, and the year of the start 
date of study medication in PA0009 is the same as the year of the medication start date, then 
use the start month of study medication in PA0009 together with the known day.  
− If this results in a start date after a known end date use January of the year of the 
medication start date together with the known day. 
− If this results in a start date prior to the start date of study medication in PA0009 (in the 
imputed month) the medication will be considered to be concomitant. 
• If the medication start date is completely unknown and the medication stop date is unknown 
or not prior to the start date of study medication in PA0009, then use the start date of study 
medication in PA0009. 
Imputation of partial medication stop dates: 
• If only the month and year of the medication stop date are specified, then use the last day of 
that month and that year. 
• If only the day and year are specified, then use December of that year 
• If only the year of the medication stop date is specified, then use December 31st of that year. 
• If the medication stop date is completely unknown, do not impute the stop date. 
In the event of ambiguity or incomplete data which makes it impossible to determine whether the 
medication was prior or concomitant, the medication will be considered concomitant. For 
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subjects who may have died during the study, imputed dates will be truncated at the date of 
death. 
There will be no imputation of any other missing data for concomitant medications. 
4.2.5 
Handling of partial treatment end dates 
The date of last study drug administration in PA0009 may be completely unknown (eg, if the 
subject is lost to follow-up) or partially known. In the latter case, it is possible to enter a known 
month and year into the database but to leave the day as missing (ie, YYY-MMM-XX) on the 
study termination page of the eCRF.  
Missing or partial treatment end dates will be handled according to the following rules: 
• For subjects for whom the treatment end date is completely missing on the study termination 
page, the date of last dose in PA0009 will be the date/time of the last known dose as reported 
on the study medication administration page of the eCRF. 
• For subjects for whom the treatment end date is partially missing (ie, only the month and 
year are known) the following rules will be applied: 
− The treatment end date will be imputed as date of last known study medication 
administration + 28 days (ie, equivalent to the dosing interval), assuming this gives an 
imputed date in the known month and year 
− If the above rule results in an imputed date that is not in the known month and year the 
following will apply: 
◦ 
If the date of last known study medication +28 days results in a month PRIOR to the 
month of the partial date, then the imputed date of last dose will be set to the 1st of the 
known month ie, YYYY-MMM-01. 
◦ 
If the date of last known study medication +28 days results in a month AFTER the 
month of the partial date, then the imputed date of last dose will be set to the last day 
of the known month eg, YYYY-MM-31 (modified according to the calendar month). 
In the listings the date of last study drug administration will be displayed as received in the data 
ie, without imputation. 
4.3 
Interim analyses and data monitoring 
No formal interim analysis is planned for this study. Additional data cuts may be prepared 
following regulatory requests or for publication purposes. 
A snapshot of data will be taken after the final subject has reached PA0009 Week 60 and used to 
create displays in this SAP, based on one year's exposure in the study.  No change to study 
conduct is expected as a result. 
4.4 
Multicenter studies 
The data from all centers will be pooled for the purposes of analysis. There will be no formal 
statistical evaluation of the effect of center on the results obtained. 
Centers will be grouped into the geographic regions of North America and Europe as described 
in Section 3.8 for use as a covariate in statistical analyses and for subgroup analyses. 
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4.5 
Multiple comparisons/multiplicity 
Not applicable. 
4.6 
Use of an efficacy subset of subjects 
Not applicable. 
4.7 
Active-control studies intended to show equivalence 
Not applicable. 
4.8 
Examination of subgroups 
Subgroup summaries of the efficacy variables of ACR20, ACR50, ACR70 and PASI75 and 
PASI90 response at PA0009 Week 48 will be performed. The following subgroups will be used: 
• Geographic region at PA0008 Baseline (North America, Europe), as defined in Section 3.8. 
• Previous (past) TNF inhibitor agent exposure in PA0008. The value in the PA0008 database 
for past anti-TNF therapy (as collected on the eCRF) will be used for PA0009, without 
additional derivation. 
• Disease duration at start of PA0008 (<2 years, ≥2 years). The value in the PA0008 database 
will be used for PA0009, without additional derivation. 
• Concomitant DMARD status at start of PA0008 (yes, no). The value in the PA0008 database 
will be used for PA0009, without additional derivation. 
5 
STUDY POPULATION CHARACTERISTICS 
5.1 
Subject disposition 
Subject disposition (date of first and last subject visit, number of subjects included in each 
analysis set [ES, SS, and FAS]) will be presented overall, by region and for each site, and by 
treatment group at completion of PA0008 and overall for the ES. 
The number and percentage of subjects in each analysis set (ES, SS and SS Sub-populations, and 
FAS) will be presented by treatment group at completion of PA0008 and overall. 
The number and percentage of subjects who started, completed and discontinued the study, along 
with the primary reason for discontinuation will be presented by treatment group at completion 
of PA0008 and overall for the SS (a subject will be considered to have completed the study if 
they attended Visit 13 [Week 104]). For the purposes of the summaries the data will be taken 
directly from the eCRF page for study termination. 
The number and percentage of subjects who started, completed and discontinued study 
medication, along with the primary reason for medication discontinuation will be presented by 
treatment group at completion of PA0008 and overall for the SS (a subject will be considered to 
have completed study treatment if they received a dose at Visit 12 [Week 100]). For the purposes 
of the summaries the data will be taken directly from the eCRF page for study medication 
discontinuation. 
For any subjects where the data on the study termination and study medication discontinuation 
eCRF pages are inconsistent, the data reported on the study termination page will be considered 
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as primary ie, if a subject is reported as discontinuing from the study, they will be regarded as 
discontinuing study medication as well (regardless of whether this is reported in the eCRF). 
Discontinuations due to AEs will be summarized by treatment group at completion of PA0008 
and overall for the SS.  
Subjects who did not meet the eligibility criteria and the inclusion and/or exclusion criteria not 
met will be listed for the ES. 
Subject disposition (subject status, date of informed consent, date of enrollment into PA0009, 
treatment sequence across PA0008 and PA0009, treatment received at the completion of 
PA0008, start and end date/time and relative days of study medication in PA0009, date of 
premature study discontinuation and date of final contact) will be listed for the ES. Days relative 
to the start date of study medication in PA0008 and to the start of study medication in PA0009 
will be included for the end date of study medication.  
Subject inclusion in each analysis set will be listed for the ES. 
Subjects excluded from at least 1 analysis set, with reason for exclusion, will be listed for the ES.  
Subjects who were excluded from the SS will have a reason of ‘Subject did not receive at least 
one dose of study medication during PA0009’, and subjects who were excluded from the FAS 
will have a reason of ‘Subject did not have a valid measurement of at least one efficacy variable 
after PA0009 study entry’. 
Study and treatment discontinuation reasons and the name of any subsequent treatment will be 
listed for the ES. Total days on study medication from the start date in PA0008 and from the start 
date in PA0009 will be included. These will be calculated as described below: 
 
𝑇𝑜𝑡𝑎𝑙 𝑑𝑎𝑦𝑠 𝑜𝑛 𝑠𝑡𝑢𝑑𝑦 𝑚𝑒𝑑𝑖𝑐𝑎𝑡𝑖𝑜𝑛 𝑓𝑟𝑜𝑚 𝑠𝑡𝑎𝑟𝑡 𝑑𝑎𝑡𝑒 𝑖𝑛 𝑃𝐴0009
= (𝐷𝑎𝑡𝑒 𝑜𝑓 𝑙𝑎𝑠𝑡 𝑑𝑜𝑠𝑒 𝑖𝑛 𝑃𝐴0009 − 𝐷𝑎𝑡𝑒 𝑜𝑓 𝑓𝑖𝑟𝑠𝑡 𝑑𝑜𝑠𝑒 𝑖𝑛 𝑃𝐴0009)
+ 1 
(6) 
 
𝑇𝑜𝑡𝑎𝑙 𝑑𝑎𝑦𝑠 𝑜𝑛 𝑠𝑡𝑢𝑑𝑦 𝑚𝑒𝑑𝑖𝑐𝑎𝑡𝑖𝑜𝑛 𝑓𝑟𝑜𝑚 𝑠𝑡𝑎𝑟𝑡 𝑑𝑎𝑡𝑒 𝑖𝑛 𝑃𝐴0008
= (𝐷𝑎𝑡𝑒 𝑜𝑓 𝑙𝑎𝑠𝑡 𝑑𝑜𝑠𝑒 𝑖𝑛 𝑃𝐴0009 − 𝐷𝑎𝑡𝑒 𝑜𝑓 𝑓𝑖𝑟𝑠𝑡 𝑑𝑜𝑠𝑒 𝑖𝑛 𝑃𝐴0008)
+ 1 
(7) 
For the total days on study medication in PA0008 this will be calculated from the first dose of 
any medication received regardless of treatment assignment. 
Visit dates, including the day relative to the start of study medication in PA0008 and in PA0009, 
will be listed for the ES. 
5.1.1 
Impact of COVID-19 
A listing of all visits affected by COVID-19 will be presented based on the Enrolled Set 
including the visit, date of visit, relationship to COVID-19, impact category and a narrative 
(short description) of the event. This data will be summarized by treatment group at completion 
of PA0008, and overall for the ES for the following: 
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• Impact of COVID-19 for any reason 
• Impact of COVID-19 for any reason by country 
In addition, in order to assess the potential impact of COVID-19 on the collection and reporting 
of efficacy data a separate listing and summary will be presented to display missing data and data 
collected via an alternative modality (eg, phone, video call). For the purpose of these displays, 
missing data will be presented only for visits affected by COVID-19 (as reported on the 
dedicated eCRF page) ie, missing data at other visits and for other reasons will not be included. 
The following efficacy assessments may be collected remotely: 
• HADS 
• HAQ-DI 
• SF-36 
• PGADA 
• PtAAP 
• PsAID-9 
For visits conducted remotely (as reported on the dedicated eCRF page), it is not possible to 
assess MASES, PhGADA, BSA, PASI, LDI, TJC or SJC, and therefore these assessments will 
be missing at the specified visit. In addition, for any missed visit or a visit conducted remotely, 
the CRP assessment will also be missing. Such assessments will be considered to be missing as a 
result of COVID-19. For these visits, it will therefore not be possible to assess DAS28(CRP) and 
may not be possible to classify the subject as an ACR responder or nonresponder. 
A listing will be presented showing each impacted visit based on the FAS. This will include the 
planned visit, the visit date, and details of the assessments conducted remotely and/or those 
missing as a result of COVID-19. 
These data will be presented in a summary table by treatment group at completion of PA0008 
and overall for the FAS. 
For both the listing and the summary table, only visits at which efficacy assessments are 
scheduled will be included. 
5.2 
Protocol deviations 
The number and percentage of subjects with an important protocol deviation and with each 
category of important protocol deviation (as described in Section 3.4) will be presented by 
treatment group at completion of PA0008 and overall for the ES. 
Important protocol deviations, including deviation type and description, will be listed for the ES. 
A separate listing of COVID-19 related important protocol deviations will be presented, based on 
the ES. COVID-19 related important deviations will be identified by the prefix of ‘COVID’ in 
the deviation verbatim text. 
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6 
DEMOGRAPHICS AND OTHER BASELINE 
CHARACTERISTICS 
6.1 
Demographics 
Demographic variables (age [at time of informed consent], gender, racial group, ethnicity, 
weight, height, body mass index [BMI], country, and geographic region) will be summarized by 
treatment group at completion of PA0008 and overall for the SS. 
One summary table will be produced for PA0008 Baseline values. Age, sex, weight and BMI 
will be collected at EV or recalculated in PA0009 and will be listed only. 
Age and BMI will be summarized as continuous and as categorical variables: 
Age will be categorized as: 
• ≤18, 19 to <65, ≥65 years (clinicaltrials.gov requirement). 
• 18-<65, 65 to <85, ≥85 years (EudraCT requirement). 
• 18 to <45, ≥45 to <65, ≥65 years (bimekizumab program conventions). 
BMI (kg/m2) is calculated based on the height (in m) and the weight (in kg) using the formula: 
𝐵𝑀𝐼= 𝑤𝑒𝑖𝑔ℎ𝑡
ℎ𝑒𝑖𝑔ℎ𝑡2 
(8) 
Even if available in the database, BMI will be re-calculated. BMI is rounded to 1 decimal place. 
BMI will be categorized as follows: <25, 25 to <30, ≥30 kg/m2. 
Demographic data, including PA0008 Baseline and PA0009 EV values for the repeated 
variables, will be listed for the ES. 
6.2 
Other baseline characteristics 
PsA history (date of first diagnosis, time since first diagnosis of PsA [at time of enrolment in 
PA0008 and at time of enrolment in PA0009], age at first diagnosis date, and PsA subtype 
[polyarticular – symmetric arthritis, oligoarticular – asymmetric arthritis, distal interphalangeal, 
joint predominant, spondylitis predominant, arthritis mutilans]) will be summarized by treatment 
group at completion of PA0008 and overall for the SS. 
Time since first diagnosis of PsA will be summarized as a continuous variable and as a 
categorical variable. Time since first diagnosis of PsA at time of enrolment in PA0008 will be 
taken from the PA0008 database.  Time since first diagnosis of PsA at time of enrolment in 
PA0009 will be calculated as below, where date of diagnosis will be taken from the PA0008 
database: 
𝑇𝑖𝑚𝑒 𝑠𝑖𝑛𝑐𝑒 𝑓𝑖𝑟𝑠𝑡 𝑑𝑖𝑎𝑔𝑛𝑜𝑠𝑖𝑠
= 𝑑𝑎𝑡𝑒 𝑜𝑓 𝑖𝑛𝑓𝑜𝑟𝑚𝑒𝑑 𝑐𝑜𝑛𝑠𝑒𝑛𝑡 𝑖𝑛 𝑃𝐴0009
− 𝑑𝑎𝑡𝑒 𝑜𝑓 𝑓𝑖𝑟𝑠𝑡 𝑑𝑖𝑎𝑔𝑛𝑜𝑠𝑖𝑠 𝑖𝑛 𝑃𝐴0008 
(9) 
Time since first diagnosis for each study will be categorized as: <2, ≥2 years. 
Age at first diagnosis will be taken from the PA0008 database. 
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PsA history will be listed for the ES. 
The following Baseline characteristics will be summarized by treatment group at completion of 
PA0008 and overall for the SS: 
• TJC. 
• SJC. 
• CRP. 
• Rheumatoid factor (Positive, Negative). 
• Anti-cyclic citrullinated peptide (CCP) antibodies (Positive, Negative). 
• NSAID therapy prior to first dose in PA0008 (yes, no). The value in the PA0008 database for 
past NSAID therapy (as collected on the eCRF) will be used for PA0009, without additional 
derivation. 
• Anti-TNF therapy prior to first dose in PA0008 (yes, no). The value in the PA0008 database 
for past anti-TNF therapy (as collected on the eCRF) will be used for PA0009, without 
additional derivation. 
• Psoriasis BSA category (<3%, ≥3% to <10%, ≥10%). 
• Nail psoriasis (yes, no). 
• Dactylitis (yes, no). 
• Enthesitis (yes, no). 
• Current number of NSAID therapies (0, 1, 2, ≥3). 
• Current synthetic DMARDs (methotrexate [MTX], sulfasalazine, hydroxychloroquine) (yes, 
no). 
One summary table will be produced for PA0008 Baseline values and another for PA0009 EV 
values. Rheumatoid factor, anti-CCP antibodies, nail psoriasis, dactylitis and NSAID and 
anti-TNF therapy prior to first dose in PA0008 will be based on data collected in PA0008 and 
will be included in the PA0008 Baseline table only.  
TJC, SJC, CRP, psoriasis BSA and current NSAID and synthetic DMARD therapy will be 
included in both tables. CRP values at PA0009 EV will be taken from the Week 48 record in the 
PA0008 database. For the summary of PA0009 EV data, current NSAID and synthetic DMARD 
therapy are defined as medications that are ongoing at the PA0009 EV, or that started on the date 
of the PA0009 EV. This does not include medications that were stopped on the date of the 
PA0009 EV. 
Baseline characteristics, including PA0008 Baseline and PA0009 EV values for the repeated 
variables, will be listed for the ES. 
6.3 
Medical history and concomitant diseases 
Medical history and ongoing medical conditions collected prior to the start date of study 
medication in PA0008 and any additional conditions collected prior to the start date of study 
medication in PA0009 will be summarized together.  The number and percentage of subjects 
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with any condition, and with each condition in each MedDRA SOC and PT, will be presented by 
treatment group at completion of PA0008 and overall, for the SS. 
Medical history and ongoing medical conditions, including the start date and end date (or 
ongoing if applicable), will be listed for the SS.  The listing will indicate whether the condition 
was reported in PA0009. 
A glossary of all medical history conditions including the reported term, PT, and SOC will also 
be presented.  
The number and percentage of subjects with a history of each category of extra-articular 
manifestations (uveitis, inflammatory bowel disease [IBD], psoriasis, peripheral arthritis, 
enthesitis, dactylitis) will be summarized by treatment group at completion of PA0008 and 
overall, for the SS, based on data collected at the PA0009 EV. The number and percentage of 
subjects with an occurrence of extra-articular manifestations (uveitis, IBD) post-PA0009 EV will 
be summarized by treatment group at completion of PA0008 and overall, for the SS. 
Extra-articular assessments will be listed for the SS. 
6.4 
Past, prior and concomitant medications 
Only medications that were ongoing at the end of PA0008 or were started during PA0009 will be 
reported. 
Concomitant medications are medications taken on at least 1 day in common with the dosing 
period of PA0009 (as defined in Section 3.2.2). A medication is classed as concomitant if the 
start date is no later than the end date of study medication in PA0009 + 28 days, and the stop 
date is either missing or on or after the start date of study medication in PA0009. This includes 
medications that started prior to dosing in PA0009 and continued after. 
For the purposes of the analysis, past medications are medications that started and stopped prior 
to dosing in PA0008. This includes past TNF therapy as used for subgroup analyses, MI 
modelling and Baseline characteristics and past NSAID therapy (for Baseline characteristics). 
Missing or partial medication start and stop dates will be imputed as described in Section 4.2.3. 
Imputations will be performed before calculation of relative study days and classification as 
concomitant.  
The number and percentage of subjects taking concomitant medications will be summarized by 
anatomical therapeutic chemical (ATC) class, presenting Anatomical Main Group (ATC 
Level 1), Pharmacological Subgroup (ATC level 3), and PT in separate tables for PsA 
concomitant medications and other concomitant medications, by treatment group at completion 
of PA0008, and overall for the SS. The complete list of PsA concomitant medications is included 
in the protocol Section 7.8.1 and includes: NSAIDS, corticosteroids, DMARDs, (MTX, 
sulfasalazine, leflunomide and apremilast), and joint injections.  
PsA concomitant medications will be identified following the procedure outlined in Section 6.5.  
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All medications reported in PA0009, including flags to identify concomitant, PsA and rescue 
medications, start and stop days relative to the start date of study medication in PA0008, and 
start and stop days relative to the start of study medication in PA0009, will be listed for the ES. 
A glossary of all medications including the Anatomical Main Group (ATC Level 1), 
Pharmacological Subgroup (ATC level 3) PT and reported term will also be presented, based on 
the ES. 
6.5 
Prohibited medication and rescue therapy 
The following medication categories will be identified: 
• Rescue medications as defined below.  Subjects in the category ‘Any concomitant rescue 
therapy in PA0009’ will be considered SS Sub-population 2 and other subjects will be 
considered SS Sub-population 1. Rescue medications will be identified in the study database 
using the flag collected in the eCRF. 
• DMARDs to identify subgroups/covariates. 
• PsA medications as defined in the protocol Section 7.8.1 (this includes DMARDs). 
• Prohibited medications. 
Rescue medication, DMARDs, and PsA medications will be classified into subcategories for 
reporting purposes. These will be reviewed and confirmed by the study physician in order to 
ensure that the classifications are correct.  
The number and percentage of subjects who receive the following categories of rescue 
medication will be summarized by treatment group at completion of PA0008 and overall for the 
SS. 
• Any rescue medication in PA0009 that is classified as a concomitant medication as defined in 
Section 6.4. 
• NSAID at PA0009 EV. 
• No NSAID at PA0009 EV. 
− No NSAID at PA0009 EV and initiate NSAID [but not Cox-2 inhibitors] in PA0009 
(only the initiation of NSAIDs that are classified as concomitant medications as defined 
in Section 6.4 will be included). 
− No NSAID at PA0009 EV and initiate Cox-2 inhibitors in PA0009 (only the initiation of 
Cox-2 inhibitors that are classified as concomitant medications as defined in Section 6.4 
will be included). 
• Use of MTX, sulfasalazine, leflunomide, apremilast or DMARD combinations in PA0009 
(with the exception of MTX and leflunomide together). Only concomitant medications will 
be included as defined in Section 6.4. For the programming of combination medications the 
following rules will be applied: 
− If any combination of DMARDs is taken at least once during the study the subject will be 
counted in the ‘combination of DMARDs’ main category 
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− If LEF and MTX are taken in combination (with or without another DMARD) at least 
once during the study the subject will be counted in the ‘combination of LEF and MTX’ 
subcategory  
− If LEF is taken in combination with another DMARD (not MTX) at least once during the 
study the subject will be counted in the ‘combination of DMARDs (except LEF and 
MTX together)’ subcategory  
− If MTX is taken in combination with another DMARD (not LEF) at least once during the 
study the subject will be counted in the ‘combination of DMARDs (except LEF and 
MTX together)’ subcategory  
− If any other combination of DMARDs is taken (not including LEF or MTX) at least once 
during the study the subject will be counted in the ‘combination of DMARDs (except 
LEF and MTX together)’ subcategory  
− For all the above, medications taken in combination will be defined as those with at least 
one concomitant study day in common (after imputation of partial dates as described in 
Section 4.2.4) and both classified as concomitant medications 
− If more than 1 DMARD medication is taken but the dates are not overlapping, these will 
be counted in both the relevant individual categories in the table only (eg, LEF and MTX 
individual categories) 
Subjects will be counted in all applicable categories and subcategories in the table ie, if a 
subject receives both LEF and apremilast and these have at least 1 study day in common, 
these will be counted in both the combination rows and the individual medication rows. 
Subjects will be counted only once in each category. 
• Intra-articular corticosteroid in PA0009 that is classified as a concomitant medication as 
defined in Section 6.4. 
• Oral corticosteroid in PA0009 that is classified as a concomitant medication as defined in 
Section 6.4. 
• Analgesics in PA0009 that are classified as concomitant as defined in Section 6.4.  
Rescue therapy category and medication name, start date, and day relative to start of study 
medication in PA0008 and PA0009 will be listed for the SS. 
PRN analgesic and PRN opioid analgesic use within 24 hours prior to study visits will be listed 
for the ES, based on the dedicated eCRF page for prohibited medications. 
6.6 
 Concomitant medical procedures and procedure history 
A listing of concomitant medical procedures and a separate listing of procedure history will be 
presented for the ES. 
7 
MEASUREMENTS OF TREATMENT COMPLIANCE 
Compliance will be summarized using the number of doses received relative to the number of 
doses expected: 
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𝑃𝑒𝑟𝑐𝑒𝑛𝑡 𝑡𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡 𝑐𝑜𝑚𝑝𝑙𝑖𝑎𝑛𝑐𝑒= 100 ∗Number of doses received
Number of doses expected 
(10) 
where the total number of expected doses is derived relative to when the subject finishes 
treatment. If a subject completes treatment 26 doses are expected (EV and every fourth week 
afterwards until PA0009 Week 100). If a subject discontinues early, then the number of expected 
doses is based on the time of study discontinuation relative to the planned dosing visits (taking 
into account the permitted visit window). If the date of study discontinuation is missing the final 
contact date (as reported on the eCRF) will be used instead. 
A summary of percent treatment compliance, both continuous and categorized as ≤75% and 
>75%, will be provided by treatment group at completion of PA0008 and overall for the SS. 
Treatment compliance will be listed for the SS. A separate listing of study medication 
administration (including injection dates and times, kit numbers, who performed the injection 
and the location of the injection) will be presented. 
8 
EFFICACY ANALYSES 
Missing efficacy data will be imputed as described in Section 4.2.1 prior to reporting. As a 
sensitivity analysis, summaries will be repeated based on non-imputed (OC) data for the 
following variables: 
• ACR20, ACR50 and ACR70 response relative to PA0008 Baseline at each visit in PA0009. 
• PASI75, PASI90 and PASI100 response relative to PA0008 Baseline at each visit in 
PA0009. 
• MDA at each visit in PA0009. 
• Change from PA0008 Baseline in MASES at each visit in PA0009. 
• Change from PA0008 Baseline in LDI at each visit in PA0009. 
A further sensitivity analysis will be performed for ACR20, ACR50 and ACR70, PASI75, 
PASI90 and PASI100 responses relative to PA0008 Baseline at each visit.  The response 
endpoint will be re-derived and summarized based on the mean value (across multiple 
imputations) of the ACR component scores or PASI total score after imputation for missing data. 
Efficacy variables will be summarized and listed (including individual raw data and derived 
domain and total scores, where applicable) for the FAS. Summaries of MASES will be restricted 
to subjects with a MASES >0 at PA0008 Baseline, of LDI will be restricted to subjects with a 
LDI >0 at PA0008 Baseline, and of PASI responses will be restricted to subjects with a BSA 
affected by psoriasis of ≥3% at PA0008 Baseline. Maintenance of response summaries will be 
restricted to subjects with a response at PA0008 Week 12 for the specific endpoint (where 
response at PA0008 Week 12 is taken directly from the PA0008 datasets). 
Responder variables (eg, ACR20 response) will be derived relative to the PA0008 Baseline and 
summarized using n and percentage at each visit, by treatment group at completion of PA0008 
and overall. 
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Maintenance of response will be assessed for ACR20, ACR50, ACR70, PASI75, PASI90 and 
PASI100. The responses will be derived relative to PA0008 Baseline and summarized using n 
and percentage at each post-PA0008 Baseline visit, by treatment sequence across PA0008 and 
PA0009. These summaries will therefore include PA0008 Week 2, 4, 8, 12, 16 (for ACR only), 
20 (for ACR only), 24, and 36 and PA0009 EV [PA0008 Week 48], Week 12, 24, 36, 48, 60, 72, 
84, 96, 100, and 104, for subjects who were responders at PA0008 Week 12. 
Absolute and change from PA0008 Baseline for all continuous efficacy variables will be 
summarized descriptively by visit, by treatment group at completion of PA0008, and overall. 
In the event that the MI model fails to converge or will not run for other reasons, alternative 
approaches may be considered as described in Section 4.2.1 and additional outputs will be 
provided. The planned MI tables will be retained in the final delivery outputs with the following 
text included in the table body: ‘Multiple imputation procedure was not possible to perform due 
to insufficient data and/or data distribution issues’. 
8.1 
Derivation of efficacy variables 
Derived efficacy variables at PA0008 Baseline will be taken from the PA0008 database.  
Derivations described below will only be performed for data in the PA0009 database (which 
includes PA0008 Week 48 relabeled as PA0009 EV). 
For composite endpoints, component assessments will be combined based on the visit 
assignment following any mapping as described in Section 3.5.  Assessments from the same 
assigned visit will be used, regardless of actual assessment date. 
8.1.1 
78/76-joint evaluation for ACR response 
The following joints are assessed for tenderness: 
• Temporomandibular joints (x2)  
• Sternoclavicular joints (x2)  
• Acromioclavicular joints (x2)  
• Shoulder joints (x2) 
• Elbow joints (x2)  
• Wrist joints (x2)  
• Carpometacarpal joints of the thumb (x2) 
• Metacarpophalangeal (MCP) joints of the hands (x10)  
• Proximal interphalangeal (PIP) joints of the hands (x8) and interphalangeal (IP) joints of the 
thumbs (x2) 
• Distal interphalangeal (DIP) joints of the hands (x8) 
• Hip joints (x2)  
• Knee joints (x2)  
• Talotibial (ankle) joints (x2) 
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• Tarsal joints (x2)  
• Metatarsophalangeal (MTP) joints of the feet (x10) 
• PIP joints of the feet (x8) and IP joints of the big toes (x2)  
• DIP joints of the toes (x8) 
All, except for the hips, are assessed for swelling. 
The swelling and tenderness grading criteria are summarized in Table 8‒1 . 
Table 8‒1: 
Swelling and tenderness grading criteria  
Grade 
Swelling response (76) 
Tenderness response (78) 
0 
None 
Not tender 
1 
Detectable synovial thickening with or 
without loss of bony contours, or 
bulging synovial proliferation with or 
without cystic characteristics 
Positive response to questioning (tender), 
spontaneous response elicited (tender and 
winced) or withdrawal by subject on 
examination (tender, winced, and 
withdrew) 
Table 8-2 summarizes the joint categorization and derived tenderness and swelling categories at 
each visit. 
Table 8-2: 
Joint categorization and derived tenderness and swelling 
Joint Category 
 
Swelling category 
Tenderness category 
-1 
Missing/not recorded. 
Missing 
Missing 
0 
No symptoms. 
0 
0 
1 
Pain/tender only. 
0 
1 
2 
Swollen only. 
1 
0 
3 
Pain/tender and 
swollen. 
1 
1 
4 
Permanently not 
evaluable. 
Missing 
Missing 
5 
Temporarily not 
evaluable. 
Missing 
Missing 
6 
Injection. 
1 
1 
For the purposes of calculating total tender and swollen joint counts, joints will be handled as 
follows: 
• Category 4 joints will be considered missing for both tender and swollen joint counts at the 
visit at which the category was recorded and all subsequent visits.  Joints in category 4 at any 
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time in PA0008 will be considered missing for both tender and swollen joint counts at all 
visits in PA0009. 
• Category 6 joints will be considered tender and swollen at the visit at which the category was 
recorded and subsequent visits up to 364 days following the date of the visit.  Joints that were 
in category 6 in PA0008 will be considered tender and swollen at all PA0009 visits up to 364 
days following the date of the assessment in PA0008. 
The TJC and SJC are weighted joint counts. If there are missing observations in the tender or 
swollen joint assessments, then the remaining observations will be assessed and weighted by the 
number of the assessed joints:  
𝑆𝐽𝐶= 𝑛∗ ∑𝑆𝐽
𝑛
𝑖=1
∑𝐴𝐽
𝑛
𝑖=1
⁄
 
(11) 
𝑇𝐽𝐶= 𝑛∗ ∑𝑇𝐽
𝑛
𝑖=1
∑𝐴𝐽
𝑛
𝑖=1
⁄
 
(12) 
where n is the total number of joints, SJ is a swollen joint, TJ is a tender joint and AJ is an 
assessed joint. 
If more than 50% of the planned tender joint assessments (ie, more than 39 assessments) or more 
than 50% of the planned swollen joint assessments (ie, more than 38 assessments) are missing at 
a visit, then the TJC or SJC will be set to missing for that visit. 
8.1.2 
28-joint evaluation for determination of Disease Activity Score-28 
(C-reactive Protein) 
The following 28 joints will be used for calculation of the DAS28(CRP). 
• Shoulder joints (x2) 
• Elbow joints (x2)  
• Wrist joints (x2)  
• MCP joints of the hands (x10)  
• PIP joints of the hands (x8) and IP joints of the thumbs (x2) 
• Knee joints (x2)  
Joints will be categorized and handled in the same way as for the 76/78-joint evaluation 
(Section 8.1.1). 
8.1.3 
Patient’s Global Assessment of Disease Activity 
Subjects will complete the PGADA using a visual analog scale (VAS) where 0mm is “very good, 
no symptoms” and 100mm is “very poor, severe symptoms”. The subject should be asked to 
consider both joint and skin components in their response to this question. 
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8.1.4 
Physician’s Global Assessment of Disease Activity 
The Investigator will complete the PhGADA by assessing the overall status of the subject with 
respect to their PsA signs and symptoms and functional capacity (considering both joint and skin 
components) using a VAS where 0mm is “very good, asymptomatic and no limitation of normal 
activities” and 100mm is “very poor, very severe symptoms which are intolerable and inability to 
carry out all normal activities”. 
8.1.5 
Patient’s Assessment of Arthritis Pain 
The PtAAP VAS is part of the ACR core set of measures in arthritis (Felson et al, 1993). 
Subjects will assess their arthritis pain using a VAS where 0mm is “no pain” and 100mm is 
“most severe pain”. 
8.1.6 
Health Assessment Questionnaire-Disability Index Score 
The HAQ-DI contains 20 items divided into 8 domains that measure: dressing and grooming (2 
items), arising (2 items), eating (3 items), walking (2 items), hygiene (3 items), reach (2 items), 
grip (3 items), and common daily activities (3 items). Subjects are required to indicate the degree 
of difficulty they have experienced in each domain in the past week on a 4-point scale that 
ranges from 0 (without difficulty) to 3 (unable to do). 
Each category is given a score by taking the maximum score of each question (the question in 
each category with the highest score is the score for that category).  
If the maximum score equals 0 or 1, but a device related to that category is used, or help from 
another person is provided for the category, then the category score is increased to 2. If the 
category score is already a 2, and a device related to that category is used, or help from another 
person is provided for the category, the score for that category remains 2. 
The association of each aid and device with the category scores is shown in Table 8-3. The use 
of devices classed as ‘Other’ will not be accounted for in the final score. 
Table 8-3: 
Aid or device associated with health assessment questionnaire-
disability index domain 
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If all questions within a given category are unanswered, no score will be provided for that 
category (this rule applies even if aids and devices are non-missing). 
The HAQ-DI score (range 0 to 3) will be calculated by dividing the sum of the highest score in 
each category (0 to 24) by the number of categories with at least 1 question answered. If fewer 
than 6 categories have responses, no HAQ-DI score will be calculated. A lower HAQ-DI score 
indicates an improvement in function. 
8.1.7 
High-sensitivity C-reactive protein levels 
Note that high sensitivity C-reactive protein is referred to as CRP throughout this SAP. CRP 
levels will be analyzed by the central laboratory. 
Due to a change in laboratory vendor between PA0008 and PA0009, CRP values from the 
PA0009 laboratory have been calibrated to match those from the PA0008 laboratory, and these 
values will be used for all CRP summaries and listings.  
In PA0008, the LLOQ was 0.16mg/L; however, in PA0009, it was possible to measure 
concentrations below this value and report these as a numeric result. The LLOQ in PA0008 will 
therefore be applied to the PA0009 data in order to retain consistency in reporting across the 
studies. Thus, numeric values of less than 0.16mg/L (<0.16mg/L) in PA0009 will be imputed 
with half the LLOQ from PA0008 (ie, 0.08mg/L) prior to summary reporting or any derivation 
of composite parameters. The original values will be included in the listing. 
Any CRP values ≥500mg/L will be set to missing prior to performing the MI procedure 
(Table 4‒1) as these are considered to be extreme outliers. 
CRP values at PA0008 Baseline and PA0009 EV will be taken from the PA0008 database 
(Baseline and Week 48 records respectively). 
8.1.8 
American College of Rheumatology Response Criteria 
ACR20 response is defined as at least a 20% improvement (decrease) from PA0008 Baseline 
values for each of the following: 
• TJC (based on 78 joints). 
• SJC (based on 76 joints). 
• At least 3 of the 5 remaining core set measures: 
− Disease activity as assessed by PGADA. 
− Disease activity as assessed by PhGADA. 
− Pain as assessed by PtAAP. 
− Physical function as assessed by the HAQ-DI. 
− Acute phase response as assessed by the CRP. 
ACR response will be assessed using component assessments from the same analysis visit, ie, 
after applying any visit mapping as outlined in Section 3.5. 
The following rules will be applied: 
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• For component scores with a Baseline value of 0, the percentage improvement is not 
calculable and will be considered as not having met the criteria for improvement at each visit. 
This will be applied and considered to be part of the OC analysis. 
• In the case of partial data at a specific visit, if there are sufficient data to calculate a response 
eg, if results are available for TJC, SJC and at least 3 of the remaining core set assessments 
and these fulfil the criteria for percentage improvement (eg, 20% improvement for ACR20), 
this subject will be included in the summary of OC results as an ACR20 responder at the 
specific visit.  
• Similarly, if there are sufficient data to calculate nonresponse regardless of missing data, this 
subject will be included in the summary of OC results as a nonresponder at the specific visit. 
• For all non-missed visits, if it is not possible to determine response or nonresponse due to 
missing component scores, this subject will be excluded from the OC analysis at the specific 
visit, and regarded as a nonresponse in the NRI analysis. 
Further details regarding these calculation algorithms and rules for handling missing components 
are provided in Section 12.1. 
ACR50 and ACR70 are defined similarly, using a 50% or 70% improvement from Baseline, 
respectively. An ACR70 responder at a given visit is therefore also an ACR50 and an ACR20 
responder. 
8.1.9 
Body surface area affected by psoriasis 
The BSA palm method will be used for the evaluation of BSA affected by psoriasis. The 
subject’s hand, including the palm, fingers, and thumb, is used as the reference point for 
measuring how much of their skin is affected by psoriasis, representing roughly 1% of the body’s 
surface.  The full and regional BSA percentage affected will be calculated as multipliers of the 
percentage of the palm affected as follows: 
• Head and neck=10% (10 palms) 
• Upper extremities=20% (20 palms) 
• Trunk=30% (30 palms) 
• Lower extremities=40% (40 palms) 
• Total BSA=100% (100 palms). 
8.1.10 
Psoriasis Area and Severity Index Response 
The PASI is the most commonly used and validated assessment for grading the severity of 
psoriasis in clinical studies (Feldman, 2004). The PASI quantifies the severity and extent of the 
disease and weights these with the percentage of BSA involvement. 
The body is divided into 4 sections as described in Table 8-4. Each of these sections is scored by 
itself, and then the 4 scores are combined into the final PASI.  
For each section, the percent of area of skin affected (A), is estimated and then transformed into 
a grade from 0 to 6: 
− 0: 0% of area affected. 
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− 1: < 10% of area affected. 
− 2: 10-<30% of area affected. 
− 3: 30-<50% of area affected. 
− 4: 50-<70% of area affected. 
− 5: 70-<90% of area affected. 
− 6: ≥90% of area affected. 
Table 8-4: 
Body areas for calculation of psoriasis area and severity index 
Body area 
Details of area 
BSA 
Degree of involvement 
of body areaa 
Head (h) 
Face, back of head 
10% 
0 to 6 
Upper limbs (u) 
Left, right, upper lower, 
flexor 
surface, extensor 
surface 
20% 
0 to 6 
Trunk (t) 
Front, back, groin 
30% 
0 to 6 
Lower limbs (l) 
Left, right, upper lower, 
flexor surface, extensor 
surface, including 
buttocks 
40% 
0 to 6 
Total 
 
100% 
 
BSA =- body surface area. 
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% affected. 
 
Within each body area, the severity is estimated by 3 clinical signs: redness (R), thickness (T), 
and scaliness (S) (each on a 5-point scale: 0=none, 1=slight, 2=moderate, 3=marked, and 4=very 
marked). The PASI is a measure of the average redness, thickness, and scaliness of the psoriatic 
skin lesions, multiplied by the involved psoriasis area score of the respective section, and 
weighted by the percentage person’s skin for the respective section: 
𝑃𝐴𝑆𝐼= 0.1 ∗𝐴ℎ∗(𝑅ℎ+ 𝑇ℎ+ 𝑆ℎ) + 0.2 ∗𝐴𝑢∗(𝑅𝑢+ 𝑇𝑢+ 𝑆𝑢) + 0.3 ∗𝐴𝑡
∗(𝑅𝑡+ 𝑇𝑡+ 𝑆𝑡) + 0.4 ∗𝐴𝑙∗(𝑅𝑙+ 𝑇𝑙+ 𝑆𝑙) 
(13) 
where  
• Rh, Ru, Rt, and Rl is the redness score of plaques on the head, upper limbs, trunk, and lower 
limbs; 
• Th, Tu, Tt, and Tl is the thickness score of plaques on the head, upper limbs, trunk, and lower 
limbs; 
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• Sh, Su, St, and Sl is the scaliness score of plaques on the head, upper limbs, trunk, and lower 
limbs; 
• Ah, Au, At, and Al is the degree of involvement for the head, upper limbs, trunk, and lower 
limbs. 
The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. 
The following calculation rules will be applied: 
• If 2 or fewer severity (redness, thickness, or scaliness) measurements are missing for a 
certain region, the average of the remaining non-missing assessments will be utilized to 
substitute the missing assessment(s).  
• If the area of affected skin and/or all severity measurements for 2 or fewer body areas are 
missing, the missing (R+T+S) x A for a body area will be substituted by the average of the 
available (R+T+S) x A. Otherwise the PASI will be set to missing. 
The percent improvement in PASI scores from PA0008 Baseline will be computed as follows:   
𝑃𝑒𝑟𝑐𝑒𝑛𝑡 𝑖𝑚𝑝𝑟𝑜𝑣𝑒𝑚𝑒𝑛𝑡= 100 ∗ 𝑏𝑎𝑠𝑒𝑙𝑖𝑛𝑒 𝑃𝐴𝑆𝐼−𝑃𝐴𝑆𝐼
𝑏𝑎𝑠𝑒𝑙𝑖𝑛𝑒 𝑃𝐴𝑆𝐼
 
(14) 
If a subject has experienced an improvement, this measure will be positive. If a subject has 
experienced a worsening in their condition, this measure will be negative.   
The PASI75, PASI90, and PASI100 responses will be 1 if there was at least 75%, 90%, and 
100% (respectively) improvement from PA0008 Baseline in the PASI score, and 0 if there was 
less than the cut-off value. A PASI100 responder at a given visit is therefore also a PASI90 and a 
PASI75 responder. 
If BSA affected by psoriasis (determined by the BSA palm method described in Section 8.1.9) is 
<3% at PA0008 Baseline (or BSA at PA0008 Baseline is missing) then the PASI response will 
be set to missing. 
Summaries of PASI responses will be restricted to subjects with a BSA affected by psoriasis of 
≥3% at PA0008 Baseline. 
8.1.11 
Minimal Disease Activity 
Minimal disease activity is a state of disease activity deemed a useful target of treatment by both 
the patient and physician, given current treatment possibilities and limitations. Criteria have been 
developed to determine whether a patient has reached MDA based on key outcome measures in 
PsA. 
MDA will be assessed using component assessments from the same analysis visit, ie, after 
applying any visit mapping as outlined in Section 3.5.  MDA will only be assessed for visits at 
which all assessments (with the exception of BSA and PASI, see below) were planned to be 
collected. 
A subject will be considered as having MDA if 5 or more of the following 7 criteria are fulfilled: 
• TJC≤1 
• SJC≤1 
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• PASI≤1 or BSA≤3 
• PtAAP≤15mm 
• PGADA≤20mm 
• HAQ-DI≤0.5 
• Tender enthesial joints≤1 
The following additional rules will be applied: 
• PASI or BSA 
− The criteria “PASI ≤1 or BSA ≤3” will be considered to be met if either of the 2 
subcriteria are satisfied, even if the other assessment is missing. Note that a separate rule 
(as defined below) is applied for subjects with BSA affected by psoriasis of <3% at 
PA0008 Baseline. 
− The criteria “PASI ≤1 or BSA ≤3” will be considered as a missing component (for OC) if 
only 1 subcriterion is available and this does not meet the condition for MDA 
− A subject with BSA affected by psoriasis of <3% at PA0008 Baseline will always be 
considered to have met the criteria “PASI ≤1 or BSA ≤3”. This is the case because PASI 
and BSA are not planned to be measured at post-Baseline visits for subjects with BSA <3 
at PA0008 Baseline. However, if for some reason, PASI or BSA are measured post-
PA0008 Baseline for such subjects, and the results indicate a PASI>1 or BSA>3, then 
this criterion will be considered as not having been met. 
• The MASES items will be used to assess whether a subject has ≤1 tender enthesial joint: if 
the total derived MASES score is ≤1 then the criterion will be considered met. 
• If any component is missing then the criteria for that component will be considered to have 
not been met. 
• In the case of partial data at a specific visit, if there are sufficient data to derive MDA as 
having been met eg, if results are available for 5 out of the 7 assessments and these fulfill the 
criteria above, this subject will be counted as having achieved MDA in the summary of 
observed case results. Similarly, if there are sufficient data to calculate non-response 
regardless of missing data, this subject will be included in the summary of OC results as not 
having MDA at the specific visit 
Further details regarding these calculation algorithms and rules for handling missing components 
are provided in Section 12.2). 
8.1.12 
Disease Activity Score-28 based on C-reactive Protein 
The components for DAS28(CRP) include the TJC and SJC based on 28 joints (see 
Section 8.1.2), CRP (mg/L), and the PGADA (mm). Any CRP values less than 0.16mg/L will be 
substituted as described in Section 8.1.7 prior to calculating the DAS28(CRP) score. 
If more than 50% of the planned joint assessments (ie, more than 14 assessments) are missing at 
a visit, then the TJC or SJC will be set to missing for that visit for the purposes of DAS28(CRP) 
calculation. 
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DAS28(CRP) is calculated as follows (where ‘ln’ represents the natural logarithm function): 
𝐷𝐴𝑆28(𝐶𝑅𝑃) = 0.56 ∗√𝑇𝐽𝐶+ 0.28 ∗√𝑆𝐽𝐶+ 0.014 ∗𝑃𝐺𝐴𝐷𝐴+ 0.36
∗ln(𝐶𝑅𝑃+ 1) + 0.96 
(15) 
DAS28 (CRP) will be assessed using component assessments from the same analysis visit, ie, 
after applying any visit mapping as outlined in Section 3.5. 
If any individual component score is missing, the DAS28(CRP) will be missing. 
8.1.13 
Maastricht Ankylosing Spondylitis Enthesitis Index 
The MASES Index comprises six two-sided and one one-sided item (bilateral costochondral 1, 
costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal 
insertion of the achilles tendon sites, and the fifth lumbar vertebral body spinous process) (Heuft-
Dorenbosch et al, 2003) each scored as 0 = not tender or 1 = tender and then summed for a 
possible score of 0 to 13, with higher scores indicating worse enthesitis.  
If 7 or more items are available, MASES will be calculated by dividing the summed score with 
the number of assessments and multiplying the result by 13. If less than 7 items are available, 
MASES will be treated as missing. 
Summaries of MASES will be restricted to subjects with a MASES >0 at PA0008 Baseline. 
8.1.14 
Leeds Dactylitis Index 
Dactylitis, the swelling of an entire digit related to articular and periarticular inflammation, is a 
characteristic of inflammatory spondyloarthropathies, including PsA.  Presence of dactylitis will 
be assessed using the LDI basic, which evaluates for a ≥10% difference in the circumference of 
the affected digit compared to the opposite digit (Healy and Helliwell, 2007, Helliwell, 2005). 
The percent difference in circumference (mm) between each affected digit and its opposite will 
be multiplied by a tenderness score for the affected digit (0 for non-tender, 1 for tender). The 
results from each digit with dactylitis will be summed to produce a final score at each visit. 
If matching digits are both affected, the circumference of each digit will be compared to the 
normative value in Table 8-5. If both digits have a difference in circumference from the 
normative value of ≥10%, then both digits will contribute to the LDI score (if they are both 
tender). 
If the circumference of the affected digit is smaller than the unaffected digit, then the affected 
digit will be compared to the normative value. If a digit is affected and the circumference of the 
opposite digit is missing, the affected digit will be compared with the normative value. 
Table 8-5: 
Normative values for Leeds Dactylitis Index (mm) 
 
Digit 
Men 
Women 
Hand 
Thumb 
70 
58 
Index 
63 
54 
Middle 
63 
54 
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Table 8-5: 
Normative values for Leeds Dactylitis Index (mm) 
 
Digit 
Men 
Women 
Ring 
59 
50 
Little 
52 
44 
Foot 
Great toe 
82 
72 
Second 
52 
46 
Middle 
50 
44 
Fourth 
50 
44 
Little 
52 
45 
 
Summaries of LDI will be restricted to subjects with LDI scores >0 at PA0008 Baseline. PA0008 
Baseline LDI will be taken directly from the PA0008 database without derivation. Digits that are 
included in the calculation of the LDI score (both tender and non-tender) will be flagged in the 
relevant analysis dataset. 
8.1.15 
Hospital Anxiety and Depression Scale 
The HADS was chosen for its well-established psychometric properties and its use in clinical 
research on biological therapy in subjects with chronic plaque psoriasis (Langley et al, 2010; 
Dauden et al, 2009). The HADS consists of 14 items, each scored from 0 to 3. 
HADS-A will be calculated as the sum of the scores for items 1, 3, 5, 7, 9, 11, 13, and HADS-D 
will be calculated as the sum of the scores for items 2, 4, 6, 8, 10, 12, 14.  Each score ranges 
from 0 to 21 with higher scores indicating a worse state. A score below 8 is considered normal 
and a score of 15 and above is considered severe (Snaith and Zigmund, 1994). If any of the 7 
items required to calculate the HADS-A or HADS-D are missing, then the HADS-A or HADS-D 
will be treated as missing. 
A flag to identify “normal” depression and anxiety status at each visit (defined as having 
HADS-D <8 and HADS-A <8 at the same visit) will be derived. 
8.1.16 
Psoriatic Arthritis Impact of Disease-9 
The PsAID-9 is a patient-reported outcome measure for assessing the impact of PsA in 9 
physical and psychological domains, including pain, fatigue, skin problems, work and/or leisure 
activities, functional capacity, discomfort, sleep disturbance, coping, and 
anxiety/fear/uncertainty.  
Each domain is assessed with a single question using a 0 to 10 numerical rating scale. Each 
domain score is multiplied by a weighting factor and the results are then summed to provide the 
total score.  
𝑃𝑠𝐴𝐼𝐷−9 = 𝑃𝑎𝑖𝑛∗0.174 + 𝐹𝑎𝑡𝑖𝑔𝑢𝑒∗0.131 + 𝑆𝑘𝑖𝑛∗0.121
+ 𝑊𝑜𝑟𝑘 𝑎𝑛𝑑/𝑜𝑟 𝐿𝑒𝑖𝑠𝑢𝑟𝑒 𝐴𝑐𝑡𝑖𝑣𝑖𝑡𝑖𝑒𝑠∗0.110 + 𝐹𝑢𝑛𝑐𝑡𝑖𝑜𝑛
∗0.107 + 𝐷𝑖𝑠𝑐𝑜𝑚𝑓𝑜𝑟𝑡∗0.098 + 𝑆𝑙𝑒𝑒𝑝∗0.089 + 𝐶𝑜𝑝𝑖𝑛𝑔
∗0.087 + 𝐴𝑛𝑥𝑖𝑒𝑡𝑦∗0.085   
(16) 
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The total score ranges from 0 to 10, with higher scores indicating a worse status. A score below 
or equal to 4 out of 10 is considered a patient-acceptable status. A decrease of 3 or more points 
from PA0008 Baseline is considered a minimal clinically important difference (MCID). 
If 1 of the 9 domains is missing, the missing value is imputed using the mean of the raw values 
(prior to weighting) from the 8 other (non-missing) domains. If 2 or more of the domains are 
missing, the PsAID-9 score will be missing. 
8.1.17 
Short Form – 36 Items Health Survey 
The SF-36 (Version 2, standard recall) is a 36 item generic health-related quality of life 
(HRQoL) instrument that uses a recall period of 4 weeks. Items are grouped into 8 component 
scales 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 a further unscaled single item (Question 2) for 
perceived stability or change in health (Health Transition) during the last year. The concepts 
represented by these scales contribute to physical, mental, and social aspects of HRQoL. The 
classification of the questionnaire items to the health scales is shown in Section 12.3. 
The SF-36 PCS score and MCS score are used to measure the 2 broad components, or aspects, of 
health: physical and mental. PCS and MCS scores are based on the aggregate of the 8 health 
concepts described above and all of the 8 health scales are used to score both components. 
For the calculation of the SF-36 scale scores and the component summary scores PCS and MCS, 
the scoring software Optum’s PRO CoRE will be used (Version 1.4). The norm-based scores 
(based on the US 2009 general population) will be utilized for analysis. The latest updates to the 
software use improved methods for missing data estimation through the following:  
• Dropping the previous ‘half-scale’ rule, so that scale scores (except the Physical Functioning 
scale) will be estimated when the respondent has provided a response to at least one item in 
the same scale. 
• Using item response theory to develop a model for estimating a score on the Physical 
Functioning scale. 
• Using regression methods to estimate the PCS and MCS on the basis of the available scales. 
8.2 
Statistical analysis of secondary efficacy variables 
The following secondary efficacy variables will be summarized for the FAS, by treatment group 
at the completion of PA0008 and overall: 
• ACR20, ACR50, and ACR70 response relative to PA0008 Baseline at PA0009 Week 48. 
• Change from PA0008 Baseline value in MASES at PA0009 Week 48.  
− Only subjects with MASES >0 at PA0008 Baseline will be included. 
• Change from PA0008 Baseline value in LDI at PA0009 Week 48.  
− Only subjects with LDI >0 at PA0008 Baseline will be included. 
• PASI75 and PASI90 response relative to PA0008 Baseline at PA0009 Week 48.  
− Only subjects with BSA affected by psoriasis ≥3% at PA0008 Baseline will be included. 
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For ACR and PASI responses, one set of summaries will be produced using data following NRI 
and another set using OC data.  For MASES and LDI, summaries will be produced using data 
following MI. 
8.3 
Statistical analysis of other efficacy variables 
The following other efficacy variables will be summarized for the FAS at scheduled visits in 
accordance with the schedule of study assessments in Table 2-1, by treatment group, at the 
completion of PA0008 and overall: 
• ACR20, ACR50, and ACR70 response at each visit in PA0009, relative to PA0008 Baseline. 
• PASI75, PASI90 and PASI100 response at each visit in PA0009, relative to PA0008 
Baseline.  
− Only subjects with BSA affected by psoriasis ≥3% at PA0008 Baseline will be included. 
• BSA at each visit in PA0009 
− The number and percentage of subjects with a BSA in the following categories at each 
visit will be summarized based on OC data: 0%, 1 to 3%, >3 to 10%, >10 to 20%. >20 to 
30%, >30 to 40%, >40 to 50%, >50 to 60%, >60 to 70%, >70 to 80%, >80 to 90%, and 
>90% to 100%. 
− Only subjects with BSA affected by psoriasis ≥3% at PA0008 Baseline will be included. 
• MDA at each visit in PA0009. 
• Change from PA0008 Baseline in DAS28(CRP) at each visit in PA0009. 
• Change from PA0008 Baseline in CRP (expressed as ratio to Baseline) at each visit in 
PA0009. 
− For CRP the rules for handling values that are lower than the LLOQ identified in PA0008 
will be followed as per Section 8.1.7  
• Change from PA0008 Baseline in MASES at each visit in PA0009. 
− Only subjects with MASES >0 at PA0008 Baseline will be included. 
• Change from PA0008 Baseline in LDI at each visit in PA0009.  
− Only subjects with LDI >0 at PA0008 Baseline will be included. 
• Change from PA0008 Baseline in PsAID-9 score at each visit in PA0009. 
• Change from PA0008 Baseline in SF-36 PCS and MCS scores at each visit in PA0009. 
• Change from PA0008 Baseline in HADS-A and HADS-D scores at each visit in PA0009. 
• Incidence of depression and anxiety status “normal” as defined by both HADS-D<8 and 
HADS-A<8 at each visit in PA0009. 
• Change from PA0008 Baseline in TJC at each visit in PA0009. 
• Change from PA0008 Baseline in SJC at each visit in PA0009. 
• Change from PA0008 Baseline in HAQ-DI score at each visit in PA0009. 
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• Change from PA0008 Baseline in PtAAP at each visit in PA0009. 
• Change from PA0008 Baseline in PhGADA at each visit in PA0009. 
• Change from PA0008 Baseline in PGADA at each visit in PA0009. 
One set of summaries will be produced for all of the above parameters using data following NRI 
(for binary endpoints) or MI (for continuous endpoints) as appropriate, as described in 
Section 4.2.1. For BSA the summary will be based on OC data only. 
For each of the following variables, an additional set of summaries will be produced using OC 
data: 
• ACR 
• PASI 
• MDA 
• MASES 
• LDI 
For each of the following variables, an additional set of summaries will be produced after the 
response variables have been derived following MI of components: 
• ACR 
• PASI 
Finally, for PASI, supplementary summary tables will be presented for the following based on 
the imputation rules described in Section 4.2.2: 
• PASI response derived using LOCF  
• PASI response derived based on the BSA observed at the corresponding visit 
The summary tables for CRP will display the absolute value and ratio to PA0008 Baseline and 
will contain n, geometric mean (and 95% CI), median, first and third quartiles (Q1 and Q3), 
minimum and maximum. Any values for the ratio to PA0008 Baseline below 0.01 will be 
presented as <0.01 in the listing and summary table. 
8.3.1 
Maintenance of response 
ACR20, ACR50, ACR70, PASI75, PASI90 and PASI100 response relative to PA0008 Baseline 
will, in addition, be summarized at each post-Baseline visit in PA0008 through to PA0009 
Week 104, by treatment sequence, as defined in Section 3.7. These summaries will be restricted 
to subjects in the FAS and who were responders for the relevant endpoint at PA0008 Week 12, 
and data will be reported following NRI.  
8.4 
Subgroup analysis 
Subgroup summaries will be performed for the efficacy variables of ACR and PASI response at 
PA0009 Week 48 for the FAS. Subgroups are defined in Section 4.8. 
Subgroup summaries will be based on data following NRI only. 
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8.5 
Impact of COVID-19 
Additional sensitivity analyses as a result of the global COVID-19 pandemic are not anticipated 
as the onset of the pandemic was subsequent to all subjects completing Week 48; therefore, there 
is no impact on the analysis of the secondary efficacy endpoint. 
9 
PHARMACOKINETICS AND PHARMACODYNAMICS  
9.1 
Pharmacokinetics 
Bimekizumab plasma concentrations will be summarized at each scheduled visit in PA0009 by 
treatment at completion of PA0008 and overall, using the SS. 
If bimekizumab plasma concentration measurements are deemed to be below the level of 
quantification (BLQ), then for calculation of the derived statistics this sample result will be set to 
half the LLOQ. Descriptive statistics will be calculated only if at least 2/3 of the values are above 
the LLOQ at a given visit. If this is not the case, only median, minimum, and maximum will be 
presented. 
In addition, geometric mean bimekizumab plasma concentration (with 95% CI) time curves will 
be plotted versus time on linear and semi-logarithmic scales by treatment group at completion of 
PA0008.  
The summary tables for bimekizumab plasma concentrations will display n, geometric mean 
(and 95% CI), geometric CV%, arithmetic mean, SD, median, minimum, and maximum, where 
the geometric CV% is calculated using the following formula: 
𝐶𝑉% = √𝑒𝑆𝐷𝑙𝑛
2 −1 × 100 
(17) 
where SDln represents the standard deviation of the ln-transformed plasma concentration values.  
Geometric mean plots will be repeated by cumulative ADAb positivity and treatment: 
• The ADAb positive status will be considered in a cumulative manner at each time point (ie, if 
a subject has had at least 1 positive sample at any time point up to and including the given 
time point, that subject would be counted as positive at that time point, regardless of any 
subsequent negative measurements). Thus, the number of subjects included in the geometric 
mean for positive and negative categories will vary by time point for each treatment. 
• Two plots will be presented each displaying bimekizumab plasma concentration data in 
PA0009 only: 
− Considering cumulative ADAb status in PA0009 only at each time point in PA0009 
− Considering cumulative ADAb status in PA0008 and PA0009 at each time point in 
PA0009 
• Each plot (linear and semi-logarithmic) will be presented by treatment group at completion 
of PA0008 and ADAb positive status (4 lines per plot) 
The following rules will be implemented for PK concentration summaries and corresponding 
figures: 
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• If the dosing for a visit is performed more than 14 days prior to, or more than 14 days after 
the scheduled dosing interval (28 days), then the plasma concentration obtained at that dosing 
visit will be excluded from the PK summaries and figures. Thus, if the dosing interval is less 
than 14 days or greater than 42 days, this rule will apply. This will also apply to doses 
administered at an unscheduled visit. 
• If a PK sample is collected >14 days after the preceding dose and up to 1 hour after the dose 
at the current visit, the PK concentration for that sample will be associated with the current 
visit and summarized accordingly. This will include unscheduled assessments as described in 
Section 3.5 (if a dose was administered at an unscheduled visit). Samples collected outside 
this window will be excluded from the PK summaries and figures and will be listed only.  
• Individual samples collected at a scheduled visit at which dosing was not performed (eg, due 
to AE) will be retained in the PK summaries and figures for the specific visit if these are 
collected >14 days and <42 days after the preceding dose, as these reflect the trough 
concentration from the preceding dose. The sample obtained at the subsequent scheduled 
visit will be excluded from the summaries (regardless of dosing) as this will not reflect a 
steady-state trough concentration (as the previous dose was not administered). Thereafter PK 
samples will be included in the summaries assuming dosing has resumed and the sample was 
obtained within the required window of >14 days after the preceding dose and up to 1 hour 
after the dose at the current visit. 
− Note samples collected at Week 104 will be retained in the PK summaries and figures if 
they are collected >14 days and <42 days after the last dose received  
− Note samples collected at the ET visit will be retained in the PK summaries and figures if 
they are collected >14 days and <42 days after the last dose received 
These rules will not apply for the SFU visit as no dosing is planned at this visit. All 
concentrations obtained at the SFU visit will be included in the summary tables (but will not be 
included in the figures). 
Bimekizumab plasma concentrations will be listed for the SS, separately for PA0009 and for data 
from PA0008 and PA0009 combined. All concentrations will be listed as received, prior to 
substitution of any BLQ values. The listing of the PA0009 data will include flags for 
concentrations that were excluded from the summary statistics where the reason for exclusion 
will be one of the following: 
• Dosing performed out of window 
• Sample collected out of window relative to current dose 
• Sample collected out of window relative to previous dose 
• Missed dose at preceding visit (in conjunction with one of the above reasons) 
• More than one sample obtained at the same visit 
All plasma concentration data will be reported in ug/mL in the tables, figures, and listings. 
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9.2 
Pharmacodynamics and Immunogenicity 
The immunological variable is ADAb evaluated at scheduled visits up to 104 weeks in 
accordance with the schedule of study assessments (Table 2-1). 
ADAb will be assessed using a tiered approach: screening, confirmatory, and titer assays will be 
used.  
Samples will first be evaluated in the screening assay using a false positivity rate of 5% (reported 
as ‘above the cut-point’ ACP or ‘below the cut-point’ [BCP]), followed by analysis of screened 
positive samples (reported as ACP) in the confirmatory assay (which is a drug depletion assay) 
to confirm the true positivity of the samples (reported as either ‘confirmed positive’ [CP] or ‘not 
confirmed positive’ [NCP]). Samples that are CP will be evaluated in a titration assay to quantify 
the ADA level and will be reported as titer (reciprocal dilution factor including minimum 
required dilution [MRD]). Screening, confirmatory and titer cut points of the respective assays 
will be determined by the bioanalytical laboratory which will report the bioanalytical result from 
the respective assays. 
The following rule will be implemented for by-visit ADAb summaries where applicable: 
• If the ADAb sample is collected within ±21 days relative to the visit date at which the drug 
was administered (or ±21 days from a scheduled visit at which dosing was not performed), 
the ADAb result for that sample will be associated with the scheduled visit and summarized 
accordingly. This will include unscheduled assessments as described in Section 3.5 (if a dose 
was administered at an unscheduled visit). Samples collected outside this window will be 
excluded from the ADAb summaries and figures and will be listed only.  
The rule above will apply to by-visit summaries only; summaries of cumulative ADAb status and 
time to treatment-emergent positivity will use all available data. This rule will not apply for 
Visit 13 (Week 104), ET visit or the SFU visit as no dosing is planned at these time points. All 
ADAb data obtained at these visits will be included in the by-visit summaries. 
ADAb status will be derived as follows:  
• Samples that are either BCP or ACP and NCP will be defined as ADAb negative. 
• Sample values that are ACP and CP will be defined as ADAb positive (regardless of whether 
or not a titer is available) 
In addition, the ADAb status will be further classified on a subject level as outlined below: 
• Pre ADAb negative – treatment emergent ADAb negative (Category 1):  
− Considering PA0009 data only (Category 1a): includes subjects who are ADAb negative 
at PA0008 Baseline and ADAb negative at all sampling points in PA0009 (including 
SFU). 
− Considering PA0008 and PA0009 data (Category 1b): includes subjects who are negative 
at PA0008 Baseline and ADAb negative at all sampling points in PA0008 and PA0009 
(including PA0009 SFU). 
• Pre ADAb negative – treatment emergent ADAb positive (Category 2):  
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− Considering PA0009 data only (Category 2a): Includes subjects who are negative at 
PA0008 Baseline and ADAb positive at any sampling point post treatment in PA0009 (up 
to and including SFU and including the PA0009 EV). This group also includes subjects 
who have a missing pre-treatment sample (either missing or insufficient volume) at 
PA0008 Baseline with one or more ADAb positive samples in PA0009. 
− Considering PA0008 and PA0009 data (Category 2b):  Includes subjects who are 
negative at PA0008 Baseline and ADAb positive at any sampling point post treatment in 
PA0008 (up to and including PA0009 SFU). This group also includes subjects who have 
a missing pre-treatment sample (either missing or insufficient volume) at PA0008 
Baseline with one or more ADAb positive samples in PA0008 or PA0009. 
• Pre ADAb positive – treatment emergent reduced ADAb (Category 3):  
− Considering PA0009 data only (Category 3a): Includes subjects who are positive at 
PA0008 Baseline, and ADAb negative at all sampling points in PA0009 (including 
SFU).  
− Considering PA0008 and PA0009 data (Category 3b): Includes subjects who are positive 
at PA0008 Baseline, and ADAb negative at all sampling points in PA0008 and PA0009 
(including SFU).  
• Pre ADAb positive – treatment emergent unaffected ADAb positive (Category 4):  
− Considering PA0009 data only (Category 4a): Includes subjects who are positive at 
PA0008 Baseline and are positive at any sampling point in PA0009 (including SFU) with 
titer values of the same magnitude as PA0008 Baseline (ie, less than a predefined fold 
increase from the PA0008 Baseline value defined within the validation of the assay). 
− Considering PA0008 and PA0009 data (Category 4b): Includes subjects who are positive 
at PA0008 Baseline and are positive at any sampling point in PA0008 or PA0009 
(including SFU) with titer values of the same magnitude as PA0008 Baseline (ie, less 
than a predefined fold increase from the PA0008 Baseline value defined within the 
validation of the assay). 
For the purposes of this study, this is set at an increase of less than or equal to a 3-fold 
difference from PA0008 Baseline.  
• Pre ADAb positive – treatment emergent ADAb boosted positive (Category 5):  
− Considering PA0009 data only (Category 5a): Includes subjects who are positive at 
PA0008 Baseline and are positive at any sampling point post treatment in PA0009 
(including PA0009 EV and SFU) with increased titer values compared to PA0008 
Baseline.  
− Considering PA0008 and PA0009 data (Category 5b): Includes subjects who are positive 
at PA0008 Baseline and are positive at any sampling point post treatment in PA0008 or 
PA0009 (including SFU) with increased titer values compared to PA0008 Baseline.  
The increase in titer values is defined as an increase greater than a predefined fold increase 
from PA0008 Baseline value which is defined within the validation of the assay. For the 
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purposes of this study, this is set at an increase greater than a 3-fold difference (ie, a 
minimum of a 4-fold increase). 
Note: For any subject who is positive at PA0008 Baseline and positive at a post-Baseline 
time point, but for whom titers are not available to determine treatment unaffected or 
treatment boosted status, the subject will be considered as treatment boosted (ie, Category 5), 
assuming no other samples are available. 
• Inconclusive (Category 6):  
− Considering PA0009 data only (Category 6a): Includes subjects who have a positive pre-
treatment sample at PA0008 Baseline and some PA0009 samples are missing, while other 
PA0009 samples are ADAb negative. 
− Considering PA0008 and PA0009 data (Category 6b): Includes subjects who have a 
positive pre-treatment sample at PA0008 Baseline and some PA0008 or PA0009 samples 
are missing, while other PA0008 and PA0009 samples are all ADAb negative. 
• Total treatment-emergent (Category 7 [Categories 2 and 5 combined]):  
− Considering PA0009 data only (Category 8a): Includes subjects who are pre ADAb 
negative – treatment emergent ADAb positive (Category 2a) and pre ADAb positive – 
treatment boosted ADAb positive (Category 5a).  
− Considering PA0008 and PA0009 data (Category 8b): Includes subjects who are pre 
ADAb negative – treatment emergent ADAb positive (Category 2b) and pre ADAb 
positive – treatment boosted ADAb positive (Category 5b).  
• Total pre ADAb positive (Category 8 [Categories 3, 4, 5 and 6 combined]): Subjects that 
are tested ADAb positive at PA0008 Baseline. 
• Missing (Category 9):  
− Considering PA0009 data only (Category 9a): Includes subjects who have a missing or 
negative pre-treatment sample at PA0008 Baseline and some PA0009 samples are 
missing, while other PA0009 samples are ADAb negative. 
− Considering PA0008 and PA0009 data (Category 9b): Includes subjects who have a 
missing or negative pre-treatment sample at PA0008 Baseline and some PA0008 or 
PA0009 samples are missing, while other PA0008 and PA0009 samples are all ADAb 
negative. 
 The following summaries, figures and listings will be produced: 
• Summary tables displaying the number and percentage of subjects with a positive ADAb 
status at each PA0009 visit and at any visit by treatment group at completion of PA0008. 
Two tables will be presented: 
− Considering ADAb status in PA0009 only  
− Considering ADAb status in PA0008 and PA0009 (this table will include only the overall 
summary visits as detailed below). 
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For the overall summary at any visit 2 summaries will be presented as follows (all summaries 
exclude data obtained at PA0008 Baseline): 
− PA0009 data only: Including any visit during the PA0009 treatment period (as defined in 
Section 3.2.2). Thus, this summary will exclude data obtained at the SFU visit and will 
include data obtained at the PA0009 EV. 
− PA0009 data only: Including any visit during PA0009. Thus, this summary will include 
both data obtained at the SFU visit and at the PA0009 EV. 
− PA0008 and PA0009 data: Including any visit during the PA0008 and PA0009 treatment 
period. Thus, this summary will exclude data obtained at the PA0009 SFU visit. 
− PA0008 and PA0009 data: Including any visit during PA0008 and PA0009. Thus, this 
summary will include data obtained at the PA0009 SFU visit. 
• Summary tables (by treatment at completion of PA0008) of the time point of the first 
occurrence of ADAb treatment-emergent positivity during PA0009, including the PA0009 
EV and the SFU visit. This summary will include the following categories: 
− Category 2: Pre ADAb negative – treatment-emergent ADAb positive 
− Category 5: Pre ADAb positive – treatment-boosted ADAb positive 
The table will summarize the number and percentage of subjects who are either treatment-
emergent ADAb positive or treatment-boosted ADAb positive for the first time at the 
specified time point in PA0009 and will include the cumulative number and percentage of 
subjects with treatment-emergent ADAb positive results at each time point. 
The table will be repeated considering ADAb status at each visit in both PA0008 and 
PA0009 and will therefore display all visits in both PA0008 and PA0009. 
An additional table will be presented considering ADAb status at each visit in both PA0008 
and PA0009, and will be presented by treatment at randomization in PA0008. 
• Summary tables displaying the number and percentage of subjects in each of the ADAb 
categories as defined above by treatment at completion of PA0008. Two tables will be 
presented: 
− Considering data from PA0009 only 
− Considering data from PA0008 and PA0009 
• The time to achieving treatment-emergent ADAb positivity in PA0009, separated by 
treatment group at completion of PA0008, will be graphically presented. Subjects will be 
considered to have an event at the time point at which treatment-emergent ADAb positivity is 
first achieved. The plot will display the cumulative percentage of subjects with treatment-
emergent positivity and will include the following categories (4 lines per plot): 
− Category 2: Pre ADAb negative – treatment-emergent ADAb positive 
− Category 5: Pre ADAb positive – treatment-boosted ADAb positive 
◦ 
Category 2 and Category 5 subjects will be combined in 1 group (2 lines per plot) if 
the percentage of subjects in each treatment group in Category 5 is <10%. 
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The figure will be repeated considering data from both PA0008 and PA0009 and will 
therefore display all visits in both PA0008 and PA0009.  
In the event that ≥10% of subjects in either treatment group are classified as Category 5 the 
figure will be presented by treatment and ADAb status (4 lines per plot). This will be 
implemented for both plots (considering only PA0009 and considering data from both 
PA0008 and PA0009). 
An additional figure will be presented considering data from both PA0008 and PA0009, and 
will be presented by treatment at randomization in PA0008 (for this figure the 160mgLD and 
160mg treatments will be pooled). This figure will be presented as follows: 
− If <10% of subjects in each treatment group (based on treatment at randomization) are 
classified as Category 5, the figure will be presented with 5 lines on 1 plot (1 for each 
treatment) and both categories combined 
− If ≥10% of subjects in any treatment group (based on treatment at randomization) are 
classified as Category 5, the figure will be presented by category and treatment at 
randomization with separate plots (each with 5 lines) for each category 
• A summary of efficacy response (ACR50 responders [based on NRI]) as a function of ADAb 
titer will be presented graphically. The x-axis will display the ADAb titer at the Week 48 
time point (categorized as negative, Q1, Q2, Q3 and Q4 where the latter represents the 
quartiles for the ADAb titers at Week 48) and the y-axis will display percentage of ACR50 
responders at the Week 48 time point within each titer category.  
Subjects with negative ADAb results at the Week 48 time point will be included in the 
‘negative’ category on the x-axis; subjects with missing ADAb data at the Week 48 time 
point will be excluded from the plot. The figure will be based on the FAS. 
• A summary of efficacy response (ACR50 responders) versus time will be presented 
graphically including the following ADAb groups (3 lines per plot): 
− ADAb positive 
◦ 
Defined as subjects having at least 2 ADAb positive samples during PA0009 
(including PA0009 EV and SFU) regardless of other ADAb negative samples and/or 
missing or inconclusive samples 
− ADAb negative 
◦ 
Defined as subjects for whom either (1) all samples in PA0009 (including PA0009 
EV and SFU) are ADAb negative and there are no missing or inconclusive samples or 
(2) only 1 sample in PA0009 is ADAb positive and all other samples in PA0009 
(including PA0009 EV and SFU) are ADAb negative or missing/inconclusive or (3) 
only 1 sample is missing/inconclusive and the remaining samples are ADAb negative. 
− Missing 
◦ 
Defined as subjects who do not fulfil the criteria for one of the 2 groups listed above. 
The figure will be repeated considering ADAb status based PA0008 and PA0009 combined, 
with the following definitions: 
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− ADAb positive 
◦ 
Defined as subjects having at least 2 ADAb positive samples during PA0008 and 
PA0009 (excluding PA0008 Baseline and including PA0009 EV and SFU) regardless 
of other ADAb negative samples and/or missing or inconclusive samples 
− ADAb negative 
◦ 
Defined as subjects for whom either (1) all samples in PA0008 and PA0009 
(excluding PA0008 Baseline and including PA0009 EV and SFU) are ADAb negative 
and there are no missing or inconclusive samples or (2) only 1 sample in PA0008 or 
PA0009 is ADAb positive and all other samples in PA0008 and PA0009 (including 
PA0009 EV and SFU) are ADAb negative or missing/inconclusive or (3) only 1 
sample is missing/inconclusive and the remaining samples in PA0008 and PA0009 
are ADAb negative. 
− Missing 
◦ 
Defined as subjects who do not fulfil the criteria for one of the 2 groups listed above. 
Both figures described above will be based on the FAS and the data for ACR responders will 
be based on NRI. If the percentage of subjects in the missing category is ≤5%, this category 
will be omitted from the plot. 
• Spaghetti plots of ADAb titer (y-axis) versus time (x-axis), separated by treatment group at 
completion of PA0008 for all ADAb positive subjects. This plot will include the following 
ADAb categories, based on data collected in PA0009: 
− Category 2: Pre ADAb negative – treatment-emergent ADAb positive 
− Category 5: Pre ADAb positive – treatment-boosted ADAb positive 
Separate plots will be presented for each treatment group with both categories on the same 
plot. Plots will be presented using a semi-logarithmic scale for the ADAb titers (ADAb 
negative samples will therefore be excluded from the plot). The x-axis will reflect time from 
the PA0009 EV. 
• Listings of individual subject-level ADAb results will be presented for the following: 
− Including only data from PA0009. 
− Including data from both PA0008 and PA0009.  
The listing of PA0009 data will also include flags for ADAb measurements that were 
excluded from the by-visit summaries. The reason for exclusion will be one of the following: 
− Sample collected out of window relative to current dose or visit 
− More than one sample obtained at the same visit 
Any ADAb measurements that were outside the tolerance limit of the assay will also be 
flagged in the listing. 
All outputs described in this section will be presented using the SS, unless otherwise stated. 
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10 
SAFETY ANALYSES 
AEs will be coded according to MedDRA.  
AEs will be summarized by treatment group at completion of PA0008 and overall, by primary 
SOC, HLT, and PT in alphabetical order. This summary will include incidence, exposure-
adjusted incidence rates (EAIRs) with associated 95% CIs, and exposure-adjusted event rates 
(EAERs) where the EAIR and EAER are expressed per 100 subject-years of exposure. Subject 
exposure at risk is defined in Section 10.1. 
Change from PA0009 Laboratory Baseline values in laboratory variables (except CRP) will be 
summarized descriptively by visit and by treatment group at completion of PA0008 and overall. 
Change from PA0008 Baseline values in ECG and vital signs variables will be summarized 
descriptively by visit and by treatment group at completion of PA0008 and overall. 
Safety variables will be reported for the SS.  Key safety analyses will be repeated for both SS 
Sub-populations (see Section 3.6.2) and/or will include data from PA0008 for subjects who 
continued in to PA0009, as described below.  
10.1 
Extent of exposure 
Study medication duration will be calculated for each of the following using the imputation rules 
in Section 4.2.5 for partial treatment end dates:  
• Total bimekizumab duration: Between the first dose of bimekizumab in PA0008 and last 
dose of bimekizumab in PA0009. 
• Total duration on bimekizumab 160mg and 160mgLD combined (required for AE summaries 
only): Between the first dose of bimekizumab 160mgLD or 160mg and last dose of 
bimekizumab 160mg (in PA0008 or PA0009). 
• Duration on bimekizumab 320mg: Between the first dose of bimekizumab 320mg in PA0008 
and first dose of bimekizumab 160mg in PA0009 (calculated only for subjects who took 
bimekizumab 320mg in PA0008). 
• Duration on bimekizumab 160mg in PA0009: Between the first and last dose of 
bimekizumab 160mg in PA0009. 
The duration of exposure will be calculated as outlined in Table 10-1.   
Table 10-1: Study medication duration 
Duration Category 
Start Date 
End Date 
Study Medication 
Duration 
Total BKZ duration 
First dose of BKZ in 
PA0008 
Last dose of BKZ in 
PA0009 
End date – start date + 28a 
Total duration on BKZ 
160mgLD and BKZ 
160mg 
First dose of BKZ 
160mgLD or 160mg 
in PA0008 or 
PA0009 
Last dose of BKZ 
160mg in PA0009 
End date – start date + 28a 
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Table 10-1: Study medication duration 
Duration Category 
Start Date 
End Date 
Study Medication 
Duration 
Duration on BKZ 
320mg 
First dose of BKZ 
320mg in PA0008 
First dose of BKZ 
160mg in PA0009 
End date – start date + 1 
Duration on BKZ 
160mg in PA0009 
First dose of BKZ 
160mg in PA0009 
Last dose of BKZ 
160mg in PA0009 
End date – start date + 28a 
Subjects who diedb 
Start date for each 
option as above 
Date of death 
End date – start date + 1 
BKZ=bimekizumab; LD=loading dose. 
a 28 days refer to one half-life of BKZ. 
b For subjects who died, the date of death will be used to replace the end date in the calculation of study medication 
duration only if the subject died within the dosing interval (ie, within 28 days following the last dose [not 
applicable for duration on BKZ 320mg]) or if the subject died before dosing in PA0009 (for duration on BKZ 
320mg). If the subject died more than 28 days after the last dose of BKZ in PA0009 the study medication duration 
will be calculated using the dosing interval of 28 days. 
The exposure time at risk will be calculated as outlined in Table 10-2. 
Table 10-2: Exposure time at risk 
Exposure Category 
Start Date 
End Date 
Duration of Exposure 
Total BKZ exposure 
First dose of BKZ in 
PA0008 
Last dose of BKZ in 
PA0009 
Minimum of (End date – 
start date + 140a) and 
(Date of last clinical 
contactb – start date + 1) 
Total exposure to BKZ 
160mgLD and 160mg 
First dose of BKZ 
160mgLD or 160mg 
in PA0008 or 
PA0009 
Last dose of BKZ 160mg 
in PA0009 
Minimum of (End date – 
start date + 140a) and 
(Date of last clinical 
contactb – start date + 1) 
Exposure to BKZ 
320mg 
First dose of BKZ 
320mg in PA0008 
First dose of BKZ 160mg 
in PA0009 for subjects 
who were dosed in 
PA0009c. 
 
Last dose of BKZ 320mg 
in PA0008 for subjects 
who were not dosed in 
PA0009 
(End date – start date + 
1) for subjects who were 
dosed in PA0009. 
 
Minimum of (End date – 
start date + 140a) and 
(Date of last clinical 
contactb – start date + 1) 
for subjects who were 
not dosed in PA0009. 
Exposure to BKZ 
160mg in PA0009 
First dose of BKZ 
160mg in PA0009 
Last dose of BKZ 160mg 
in PA0009 
Minimum of (End date – 
start date + 140a) and 
(Date of last clinical 
contactb – start date + 1) 
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Table 10-2: Exposure time at risk 
Exposure Category 
Start Date 
End Date 
Duration of Exposure 
Subjects who diedd 
Start date for each 
option as above 
Date of death 
End date – start date + 1 
BKZ=bimekizumab; LD=loading dose. 
a 140 days refer to 5 half-lives of BKZ. 
b Date of last clinical contact for each subject is defined as the maximum of [last visit date including SFU visit, last 
AE start date (including imputed AE start dates), date of study termination or completion, last date of study drug 
administration following rules for partial treatment end dates as per Section 4.2.5]. 
c In the event that the first dose in PA0009 was more than 140 days after the last dose in PA0008, the exposure time 
at risk for 320mg will be calculated using PA0008 end date – PA0008 start date + 140 days. 
d For subjects who died, the date of death will be used to replace the end date in the calculation of exposure time at 
risk only if the subject died within the ‘at risk’ interval (ie, within 140 days following the last dose [not applicable 
for duration on BKZ 320mg]) or if the subject died before dosing in PA0009 (for time at risk on BKZ 320mg). If 
the subject died more than 140 days after the last dose of BKZ in PA0009 the exposure time at risk will be 
calculated using the ‘at risk’ interval of 140 days. Note that date of death should be equivalent to date of last 
clinical contact. 
In the event that a subject received an incorrect (unplanned) treatment sequence the calculations 
for study medication duration and exposure time at risk will be adjusted accordingly following 
the principles outlined above and this will be documented in the relevant dataset specifications. 
Three summaries of exposure will be provided: 2 for exposure in PA0009 and 1 for exposure in 
PA0008 and PA0009 combined: 
• For the PA0009 summary, durations of exposure and times at risk will be summarized by 
treatment group at completion of PA0008 and overall. This summary will be repeated by SS 
Sub-population. 
• For the PA0008 and PA0009 combined table, the duration of exposure and time at risk for 
‘BKZ 160mg/BKZ 160mgLD combined’, ‘BKZ 320mg’ and ‘BKZ Total’ will be 
summarized. Subjects who took bimekizumab 320mg during PA0008 will contribute to all 
three columns. Subjects who did not take 320mg in PA0008 will contribute to the 
‘BKZ 160mg/BKZ 160mgLD’ and ‘BKZ Total’ columns. 
The total time at risk in years will be included in the exposure tables. This will be calculated by 
summing the time at risk across all subjects (per treatment group) and will be expressed in years 
and presented to 1 decimal place. 
Start date of study medication in PA0008, start and end dates of study medication in PA0009, the 
durations of exposure and the times at risk will be listed. 
10.2 
Adverse events 
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. 
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AEs that occurred during the PA0008 study and are ongoing at the time of enrolment (signed 
informed consent) in PA0009 will be captured in the PA0009 database and followed up until the 
AEs have resolved, have 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, AEs of special interest (AESI), and AEs 
defined as Safety Topics of Interest; further details regarding follow-up of Potential Drug-
induced Liver Injury (PDILI) events are provided in the protocol Section 9.5.1. Information on 
SAEs obtained after clinical database lock will be captured through the Patient Safety database 
without limitation of time. 
If an AE is ongoing at the end of the PA0009 study, 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. 
All AEs occurring during the PA0009 study (ie, after signature of the informed consent 
document) will be recorded in the eCRF. For each AE the following information will be recorded 
in the eCRF: AE term (verbatim term), date of onset, whether or not the AE was classified as a 
SAE, as an AESI, intensity, relationship to study medication, action taken with study medication, 
other action taken, outcome, date of outcome, and whether the AE led to study drug 
discontinuation or to study discontinuation. 
The following code lists will be used for AE recording: 
• Pattern of event: intermittent or continuous. 
• Intensity of event: mild, moderate or severe. 
• Relationship: related or not related. 
• Action taken with IMP: dose not changed, dose reduced, dose increased, drug temporarily, 
interrupted, drug permanently withdrawn or not applicable. 
• Outcome: resolving, not resolved, resolved, resolved with sequelae, worsened, fatal or 
unknown. 
AEs (including SAEs) are characterized as either non-treatment-emergent or treatment emergent 
according to the following criteria: 
• Non-treatment emergent AEs are those with onset date after a 140-day period after the end 
date of study medication. 
− Any AE occurring more than 140 days after the last administration of study medication in 
PA0008 and prior to the first administration of study medication in PA0009 will also be 
considered as non-treatment emergent, and will therefore be excluded from the summary 
tables. Such events will be included in the listings. 
• TEAEs are those with onset date on or after the start date of study medication in PA0009. 
• Events that were ongoing at the end of PA0008 will have their treatment-emergent status 
taken from the PA0008 database. 
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For all AEs the following variables will be calculated (see Section 10.2.1): 
• Duration. 
• Time since first bimekizumab dose. 
• Time since last/latest bimekizumab dose. 
AE summaries will, in general, include only events with onset on or after the start date of study 
treatment in PA0009. Certain displays will be repeated including all AEs in PA0008 (with the 
exception of those with onset during placebo treatment) and PA0009 as outlined below. These 
displays will include only subjects from PA0008 who were enrolled in PA0009.  
In general, the attributes of these events (for AEs that started and were resolved in PA0008) will 
be taken from the PA0008 database. However, the identification of Safety Topics of Interest will 
be made across all events in PA0008 and PA0009 using the criteria defined in this SAP.  
For events which were ongoing at the end of PA0008, the following rules will be implemented: 
• Onset date (and derived variables) will be taken from the PA0008 database 
• End date, outcome, actions taken and seriousness will be taken from the PA0009 database. 
• In order to ensure that AEs are not duplicated in the outputs these will be merged across the 
studies by Subject ID, verbatim term (AETERM), dictionary-derived term (AEDECOD), 
start date (AESTDTC), relationship (AEREL) and severity (AESEV) to create one record for 
the specific event. 
Summaries of AEs in PA0008 and PA0009 combined will include AEs with onset on the first 
dose of bimekizumab in PA0008 up to 140 days after the last dose of bimekizumab in PA0009. 
AEs which occur on the day of a treatment switch will be considered to have begun on the 
previous treatment, with the exception of the following AEs which will be considered to have 
begun on the new treatment: 
• Events that fulfill the anaphylaxis criteria for acute events (see Section 10.2.3). 
• Events that fulfill the hypersensitivity reaction criteria for (see Section 10.2.3). 
• Events with a HLT of “Administration site reactions NEC”. 
• Events with an HLT of “Injection site reactions”. 
AEs that occur on the first day of bimekizumab treatment in PA0008 following initial treatment 
with placebo will not be included in the summaries, unless they fulfill 1 of the 4 exception 
criteria above. AEs that occur after the last dose of bimekizumab in PA0009 and up to 140 days 
after the last dose of bimekizumab in PA0009 will be assigned to bimekizumab 160mg. 
AEs will be presented as “number of subjects (percentage of subjects) [number of events]”. 
“[number of events]” will include all cases of an AE including repeat occurrences in individual 
subjects, while “number of subjects” will count each subject only once.  
An overview of TEAE (number and percentage of subjects with any TEAE, serious TEAE, 
TEAE leading to study discontinuation, TEAE leading to permanent withdrawal of study 
medication, drug-related TEAE, severe TEAE, fatal AE [see note below], fatal TEAE and TEAE 
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with missing seriousness) will be provided by treatment group at completion of PA0008 and 
overall. This summary will be repeated by SS Sub-population.  
This table will be repeated including all TEAEs in PA0008 and PA0009 reported for subjects in 
the PA0009 SS (with the exception of those with onset during placebo treatment) combined. The 
‘BKZ 160mg’ treatment column in this table will include subjects in both the BKZ 160mgLD 
and BKZ 160mg treatment groups. 
The category for fatal AEs will be based on all subjects enrolled in PA0009 in all the above 
summaries. 
The following categories of TEAE will be summarized by MedDRA SOC, HLT and PT, 
including EAIR and EAER (calculated as described in Section 10.2.2), where all summaries refer 
to AEs reported in PA0009 only except where stated: 
• All TEAEs by treatment group at completion of PA0008 and overall.  
• All TEAEs by treatment group at completion of PA0008 and overall, by SS Sub-population. 
• Serious TEAEs by treatment group at completion of PA0008 and overall. 
• Serious TEAEs by treatment group at completion of PA0008 and overall, by SS Sub-
population. 
• All TEAEs in PA0008 and PA0009 by treatment at time of AE onset (BKZ 160mg, BKZ 
320mg and BKZ Total). 
− The ‘BKZ 160mg’ treatment column in this table will include subjects in both the BKZ 
160mgLD and BKZ 160mg treatment groups. 
• Serious TEAEs in PA0008 and PA0009 by treatment at time of AE onset (BKZ 160mg, BKZ 
320mg and BKZ Total). 
− The ‘BKZ 160mg’ treatment column in this table will include subjects in both the BKZ 
160mgLD and BKZ 160mg treatment groups. 
• All TEAEs by timing of onset relative to ADAb status in PA0009. This will include columns 
for the following (regardless of PA0008 Baseline ADAb status): 
− TEAEs starting before the first ADAb positive result in PA0009 including the PA0009 
EV (includes ADAb Categories 2a, 4a and 5a). 
− TEAEs starting on the same date or after the first ADAb positive result in PA0009 
including the PA0009 EV (includes ADAb Categories 2a, 4a and 5a). 
− TEAEs for subjects who are ADAb negative at all time points in PA0009 including the 
PA0009 EV (includes ADAb Categories 1a and 3a). 
The following categories of TEAE will be summarized by MedDRA SOC, HLT, and PT, by 
treatment group at completion of PA0008 and overall: 
• TEAEs leading to study discontinuation and/or permanent withdrawal of study medication. 
• TEAEs leading to permanent withdrawal of study medication. 
• TEAEs with a fatal outcome. 
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• All TEAEs by maximum relationship.  
• Serious TEAEs by maximum relationship.  
• TEAEs with a fatal outcome by maximum relationship.  
• All TEAEs by maximum intensity. 
• Non-serious TEAEs reported by more than the reporting threshold of 5% of subjects. The 
cut-off will be applied before rounding on each treatment group and overall. 
A further summary will be presented by treatment group at completion of PA0008 and overall 
displaying the frequency of TEAEs by descending frequency of PT. 
An additional table will be presented by MedDRA SOC, HLT and PT, by treatment at time of 
AE onset (BKZ 160mg, BKZ 320mg and BKZ Total) for all TEAEs in PA0009 and all TEAEs 
that were ongoing from PA0008 at the time of the PA0009 EV. Ongoing TEAEs are defined as 
TEAEs that started prior to the PA0009 EV and continued after the first dose of study medication 
in PA0009. The ‘BKZ 160mg’ treatment column in this table will include subjects in both the 
BKZ 160mgLD and BKZ 160mg treatment groups. 
TEAEs classified as Safety Topics of Interest and associated tables are defined in Section 10.2.3. 
The following AE listings will be provided based on the ES: 
• Glossary table for all AEs (this listing will include all events in PA0008 and PA0009 for 
subjects that were enrolled in PA0009 [with the exception of AEs with onset during placebo 
treatment]). 
• All AEs (this listing will include all events in PA0008 and PA0009 for subjects that were 
enrolled in PA0009 [with the exception of AEs with onset during placebo treatment]). 
• All SAEs (this listing will include all events in PA0008 and PA0009 for subjects that were 
enrolled in PA0009 [with the exception of AEs with onset during placebo treatment]). 
• All AEs leading to study discontinuation.  
• All deaths. 
The following listings will be provided based on the SS: 
• Serious infections TEAEs. 
• Fungal infectious disorder TEAEs. 
• Opportunistic infection (including tuberculosis) TEAEs. 
• Malignant or unspecified tumor TEAEs. 
• Malignant tumor TEAEs. 
• Adjudicated cardiovascular TEAEs by event type. 
• Adjudicated cardiovascular TEAEs by event type for major adverse cardiac events (MACE)  
• Adjudicated cardiovascular TEAEs by event type for extended MACE 
• TEAEs identified for potential review by the Cardiovascular Event Adjudication Committee. 
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• Neutropenia TEAEs. 
• Suicidal ideation and behavior TEAEs. 
• TEAEs identified for potential review by the Neuropsychiatric Adjudication Committee. 
• TEAEs adjudicated by the Neuropsychiatric Adjudication Committee. 
• Inflammatory bowel disease TEAEs. 
• Hypersensitivity reaction TEAEs. 
• Anaphylactic reaction TEAEs. 
• Hepatic events TEAEs.  
• Hospitalization/Emergency Room Visits. 
10.2.1 
Adverse event duration and time since first/last dose 
Missing start or end dates will be imputed as described in  Section 4.2.3 prior to any calculation 
described in this section. 
The duration of each AE will be calculated as: 
𝐷𝑢𝑟𝑎𝑡𝑖𝑜𝑛 (𝑑𝑎𝑦𝑠) = 𝑑𝑎𝑡𝑒 𝑜𝑓 𝑜𝑢𝑡𝑐𝑜𝑚𝑒−𝑑𝑎𝑡𝑒 𝑜𝑓 𝑜𝑛𝑠𝑒𝑡+ 1 
(18) 
The time since first bimekizumab dose for each TEAE will be calculated three times:  
• Relative to the date of first administration of bimekizumab in PA0008. 
• Relative to the date of the first dose of bimekizumab 160mg or 160mgLD, only for AEs with 
onset during treatment with bimekizumab 160mg or 160mg LD OR  
• Relative to the date of the first dose of bimekizumab 320mg, only for AEs with onset during 
treatment with bimekizumab 320mg.  
− For these criteria during treatment refers to TEAEs with onset up to 140 days after the 
last dose on that treatment. 
• Relative to the start date of study medication in PA0009.   
Time since first dose will be calculated as follows for AEs occurring on or after the reference 
date (as defined above): 
𝑇𝑖𝑚𝑒 𝑠𝑖𝑛𝑐𝑒 𝑓𝑖𝑟𝑠𝑡 𝐵𝐾𝑍 𝑑𝑜𝑠𝑒 (𝑑𝑎𝑦𝑠)
= 𝐷𝑎𝑡𝑒 𝑜𝑓 𝑜𝑛𝑠𝑒𝑡−𝑅𝑒𝑓𝑒𝑟𝑒𝑛𝑐𝑒 𝑑𝑎𝑡𝑒+ 1  
(19) 
The time since most recent bimekizumab dose for each TEAE will be calculated as follows for 
AEs occurring on or after the reference date (as defined above): 
𝑇𝑖𝑚𝑒 𝑠𝑖𝑛𝑐𝑒 𝑚𝑜𝑠𝑡 𝑟𝑒𝑐𝑒𝑛𝑡 𝐵𝐾𝑍 𝑑𝑜𝑠𝑒 (𝑑𝑎𝑦𝑠)
= 𝐷𝑎𝑡𝑒 𝑜𝑓 𝐴𝐸 𝑜𝑛𝑠𝑒𝑡
−𝐷𝑎𝑡𝑒 𝑜𝑓 𝑚𝑜𝑠𝑡 𝑟𝑒𝑐𝑒𝑛𝑡 𝑑𝑜𝑠𝑒 𝑝𝑟𝑖𝑜𝑟 𝑡𝑜 𝐴𝐸+ 1  
(20) 
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For any AE occurring on the same day as a given dosing occasion the most recent dose will be 
considered to be the dose given on the same day ie, time since most recent dose would be equal 
to 1 for all such AEs. 
For AEs occurring prior to the reference date (as defined above) the time since dosing will be 
calculated as follows for first/most recent BKZ dose: 
𝑇𝑖𝑚𝑒 𝑠𝑖𝑛𝑐𝑒 𝐵𝐾𝑍 𝑑𝑜𝑠𝑒 (𝑑𝑎𝑦𝑠) = 𝐷𝑎𝑡𝑒 𝑜𝑓 𝐴𝐸 𝑜𝑛𝑠𝑒𝑡−𝑅𝑒𝑓𝑒𝑟𝑒𝑛𝑐𝑒 𝑑𝑎𝑡𝑒 
(21) 
Days on treatment at AE onset will be calculated three times using the same three reference dates 
as for time since first dose. Days on treatment at AE onset will be calculated as: 
𝐷𝑎𝑦𝑠 𝑜𝑛 𝑡𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡 𝑎𝑡 𝐴𝐸 𝑜𝑛𝑠𝑒𝑡
= 𝐷𝑎𝑡𝑒 𝑜𝑓 𝑙𝑎𝑠𝑡 𝑜𝑟 𝑙𝑎𝑡𝑒𝑠𝑡 𝑑𝑜𝑠𝑒 𝑝𝑟𝑖𝑜𝑟 𝑡𝑜 𝐴𝐸 𝑜𝑛𝑠𝑒𝑡
−𝑅𝑒𝑓𝑒𝑟𝑒𝑛𝑐𝑒 𝑑𝑎𝑡𝑒+ 1 
 
(22) 
As above, for any AE occurring on the same day as a given dosing occasion the last or latest 
dose prior to AE onset will be considered to be the dose given on the same day as the event. 
For AEs occurring prior to the reference date, the days on treatment will be 0. 
10.2.2 
Exposure-adjusted incidence rate and exposure-adjusted event rate 
The time at risk (in days) at AE onset is the same as the time since first bimekizumab dose as 
described in Section 10.2.1 .  
Total time at risk (as defined in Section 10.1) and time at risk at AE onset will be divided by 
365.25 to give years at risk. 
EAIR and EAER will be calculated separately for tables including all events in PA0008 and 
PA009 combined, and for tables including events with onset in PA0009 only.  The former tables 
will use time at risk relative to the start date of bimekizumab 160mg/160mgLD or 320mg (for 
the ‘BKZ 160mg’ [this includes both BKZ 160mg and BKZ 160mgLD] and ‘BKZ 320mg’ 
columns) and time at risk relative to the date of the first dose of bimekizumab (for the ‘BKZ 
Total’ column). The latter table will use time at risk relative to the start date of study medication 
in PA0009. 
The EAIR is defined as the number of subjects with a specific AE adjusted for exposure and will 
be scaled to 100 subject-years: 
𝐸𝐴𝐼𝑅= 100 ∗
𝑛𝐴𝐸
∑
𝑇𝐸𝑥𝑝,𝑖
𝑛𝐴𝐸
𝑖=1
+ ∑
𝑇𝑅𝑖𝑠𝑘,𝑗
𝑛𝑛𝑜𝐴𝐸
𝑗=1
 
 
(23) 
where 𝑛𝐴𝐸 is the number of subjects with the AE, 𝑇𝐸𝑥𝑝,𝑖 is a subject’s time at risk at AE onset in 
years (equation [16] in years) and 𝑇𝑅𝑖𝑠𝑘,𝑗 is the total time at risk in years for subjects who did not 
experience the AE of interest.  
If a subject has multiple events at the level of coding evaluated, the time at risk at AE onset is 
calculated from the first occurrence of the AE. 
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Exact Poisson 95% CIs for incidence rates are calculated using the relationship between the 
Poisson and the chi-square distribution (Ulm, 1990; Fay and Feuer, 1997): 
𝐿𝐶𝐿= 
𝜒2𝑛,𝛼
2
2
2  
(24) 
𝑈𝐶𝐿= 
𝜒2(𝑛+1),1−𝛼/2
2
2
 
(25) 
𝐶𝐼𝐿𝑜𝑤𝑒𝑟= 100 ∗ 
𝐿𝐶𝐿
∑
𝑇𝐸𝑥𝑝,𝑖
𝑛𝐴𝐸
𝑖=1
+ ∑
𝑇𝑅𝑖𝑠𝑘,𝑗
𝑛𝑛𝑜𝐴𝐸
𝑗=1
 
 
(26) 
𝐶𝐼𝑈𝑝𝑝𝑒𝑟=  100 ∗
𝑈𝐶𝐿
∑
𝑇𝐸𝑥𝑝,𝑖
𝑛𝐴𝐸
𝑖=1
+ ∑
𝑇𝑅𝑖𝑠𝑘,𝑗
𝑛𝑛𝑜𝐴𝐸
𝑗=1
 
(27) 
where 𝑛𝐴𝐸 is the number of subjects with the AE and is the basis for the number of the degrees of 
freedom for the chi-square quantile for the upper tail probability χ2, 𝑇𝐸𝑥𝑝,𝑖 is a subject’s time at 
risk at AE onset in years, 𝑛𝑛𝑜𝐴𝐸 is the number of subjects without the AE and 𝑇𝑅𝑖𝑠𝑘,𝑗 the total 
time at risk for subjects who did not experience the AE. 
The EAER is defined as the number of AEs reported up to 140 days after last dose, including 
repeat occurrences in individual subjects, and adjusted for exposure, and will be scaled to 100 
subject-years: 
𝐸𝐴𝐸𝑅=  100 ∗
𝑁𝐴𝐸
∑
𝑇𝑅𝑖𝑠𝑘,𝑗
𝑛𝐴𝑙𝑙
𝑗=1
 
(28) 
where 𝑁𝐴𝐸 is the total number of AEs, 𝑇𝑅𝑖𝑠𝑘,𝑗 is a subject’s total time at risk in years and 𝑛𝐴𝑙𝑙 the 
number of subjects. 
No CI will be computed for EAER. 
10.2.3 
Adverse events of special interest and safety topics of interest 
AESI (in the opinion of the investigator) will be flagged in the study database.  In addition, an 
AESI is considered to have occurred if any TEAE which meets the Hy’s Law criteria, defined as 
≥3x upper limit of normal (ULN) alanine aminotransferase (ALT) or aspartate aminotransferase 
(AST) with coexisting ≥2xULN total bilirubin in the absence of ≥2xULN alkaline phosphatase 
(ALP), with no alternative explanation for the biochemical abnormality.  Hy’s law criteria will 
be summarized as described in Section 10.3. 
TEAEs are defined as Safety Topics of Interest and reported as follows: 
1. Infections (serious, opportunistic, fungal and TB)   
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• Serious infections will be identified based on MedDRA classification (SOC “Infections and 
infestations”).  (Although not required by the ‘Safety Topics of Interest for the Bimekizumab 
Program’ document, a separate table will be created for these events.) 
• Fungal infections will be summarized in a stand-alone table. The table will include all 
TEAEs (serious and non-serious) which code into the High Level Group Term “Fungal 
infectious disorders”.  
• Opportunistic infections (including TB) will be summarized in a stand-alone table. The table 
will include all opportunistic infection TEAEs identified using UCB-defined search criteria 
which were adjudicated as opportunistic infections. The process for identifying opportunistic 
infections is outlined in Section 12.4.  
 
2. Malignancies   
• One table will be based on the criteria standardized MedDRA query (SMQ)=“Malignant or 
unspecified tumours (SMQ)”.  
• One table will be based on the criteria SMQ=”Malignant tumours (SMQ)”.  
SMQ search should include all TEAEs which code to a PT included in the Scope=Narrow group 
within each SMQ.  
Note that the events included in the “Malignancies” table will be a subset of the events included 
in the “Malignancies (including unspecified)” table. While the “Malignant tumours (SMQ)” is 
most relevant, “Malignant or unspecified tumours (SMQ)” must be reviewed for potential 
malignancies.  
The output tables will include 2 different overall incidence rows:  
• The first overall incidence row will summarize “Any Malignancy” and this row will 
summarize the incidence of all AEs flagged for inclusion in the table (using the appropriate 
SMQ depending on the table), regardless of the HLT it codes to.   
• The second overall incidence row will summarize “Any Malignancy excluding non 
melanomic skin cancers HLT” and this row will summarize the incidence of AEs flagged for 
inclusion in the table (using the appropriate SMQ depending on the table), excluding those 
which code to an HLT of “skin neoplasms malignant and unspecified (excl melanoma)”.   
 
3. MACE 
Major adverse cardiac events will be presented in a table. The classification of an event as 
MACE is determined by an external cardiovascular event adjudication committee.   
A separate table and listing will present adjudicated cardiovascular events by type. For each 
cardiovascular event type (24 in total), the individual PTs which fall within each event type will 
be summarized.   
Extended MACE events will be presented in a separate table and listing. All events which are 
classified by the adjudication committee as any of the event types in Table 10-3 will be 
considered an extended MACE event. 
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Table 10-3: Extended MACE types 
Event Type Code 
Event Type 
1 
Non-Fatal Myocardial Infarction (MI) 
2 
Non-Fatal Stroke: hemorrhagic 
3 
Non-Fatal Stroke: ischemic 
4 
Non-Fatal Stroke: embolic 
5 
Non-Fatal Stroke: undeterminable 
6 
Hospitalization or ER for Unstable Angina with 
urgent revascularization 
8 
Hospitalization for Heart Failure 
10 
Coronary Revascularization Procedures (e.g. 
percutaneous coronary intervention, coronary artery 
bypass grafting) 
11 
Urgent Revascularization Procedures (i.e. due to 
symptoms of brain ischemia or pending infarction) 
18 
Death due to Myocardial Infarction (MI) 
19 
Death due to Stroke 
20 
Sudden Cardiac Death 
21 
Other CV Death (e.g. heart failure, pulmonary 
embolism, cardiovascular procedure-related) 
22 
Cardiovascular Undetermined Cause of Death (ie, 
cause of death unknown) 
CV=cardiovascular; ER=emergency room; MI=myocardial infarction. 
Additionally, a listing of all events identified for potential review by the cardiovascular event 
adjudication committee will be produced. This listing will indicate whether each event was 
escalated to the committee for formal review/adjudication.   
 
4. Neutropenia  
A table will be created based on the following PTs (regardless of seriousness):  
• Autoimmune neutropenia  
• Band neutrophil count decreased  
• Cyclic neutropenia  
• Febrile neutropenia  
• Idiopathic neutropenia  
• Neutropenia  
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• Neutropenic infection  
• Neutropenic sepsis  
• Neutrophil count decreased  
 
5. Suicidal Ideation and Behavior   
An external neuropsychiatric adjudication committee will evaluate potential neuropsychiatric 
events and determine whether any of those events were associated with suicidal ideation and 
behavior (SIB). A table and listing for SIB events as determined by the adjudication committee 
will be produced.  
Additionally, a listing of all events identified for potential review by the neuropsychiatric 
adjudication committee will be produced. This listing will indicate whether each event was 
escalated to the committee for formal review/adjudication. A separate listing will also be 
produced to summarize the adjudicated results of all events escalated to the full committee.  
 
6. Inflammatory bowel disease  
An external IBD adjudication committee will evaluate potential IBD events and will classify 
these according to the event type in Table 10-4. 
 
Table 10-4: Inflammatory bowel disease types 
Event Type Code 
Event Type 
1 
Possible IBD – Crohn’s Disease 
2 
Probable IBD – Crohn’s Disease 
3 
Definite IBD – Crohn’s Disease 
4 
Possible IBD – Ulcerative Colitis 
5 
Probable IBD – Ulcerative Colitis 
6 
Definite IBD - Ulcerative Colitis 
7 
Possible IBD - Unclassified 
8 
Probable IBD - Unclassified 
9 
Definite IBD - Unclassified 
10 
Symptoms not consistent with IBD 
11 
Possible IBD – Microscopic Colitis 
12 
Probable IBD – Microscopic Colitis 
13 
Definite IBD - Microscopic Colitis 
14 
Possible IBD – no further differentiation possible 
15 
Probable IBD – no further differentiation possible 
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Table 10-4: Inflammatory bowel disease types 
Event Type Code 
Event Type 
16 
Definite IBD - no further differentiation possible 
99 
Not enough information to adjudicate 
IBD=inflammatory bowel disease. 
 
A table for adjudicated definite IBD events (including event type codes 3, 6, 9, 13 and 16), as 
determined by the adjudication committee, will be presented for all subjects and stratified by 
previous medical history of IBD. Previous medical history of IBD will be determined using the 
information recorded on the Extra-Articular Assessment form at Screening in PA0008 ("Does 
subject have a history of IBD?”). 
Similar tables will be presented for adjudicated probable IBD events (including event type codes 
2, 5, 8, 12 and 15) and adjudicated possible IBD events (including event type codes 1, 4, 7, 11 
and 14). These tables will be produced for all subjects and stratified by previous medical history 
of IBD as defined above. 
A listing of all events identified for potential review by the IBD adjudication committee will be 
presented. This listing will indicate whether each event was escalated to the committee for 
formal review and adjudication. 
A separate table and listing will present the adjudicated IBD events by type. For each of the 17 
IBD event types (event type codes 1 through 16 and 99), the individual PTs which fall within 
each event type will be summarized. 
Finally, a separate listing will be presented showing individual diagnostic criteria met for each 
adjudicated IBD event. 
 
7. Hypersensitivity (including Anaphylaxis)   
A separate table will be prepared based on the MedDRA anaphylaxis algorithm (Section 12.5) 
for acute anaphylactic events (reported on the same day as when an injection was administered 
or one day after). An AE glossary table will also be produced to summarize the MedDRA coding 
for these events. The glossary table will include the following fields: reported term, PT, LLT, 
HLT, and SOC. 
A separate table will be prepared to summarize hypersensitivity events, identified using the SMQ 
“Hypersensitivity (SMQ)”. All TEAEs which code to a PT included in the Scope=Narrow search 
will be included in this table. An AE glossary table will also be produced to summarize the 
MedDRA coding for these events. The glossary table will include the following fields: reported 
term, PT, LLT, HLT, and SOC. 
Injection site reactions will be evaluated based on the “any TEAE” table by looking under the 
following HLTs: “Administration site reactions NEC” and “Injection site reactions”.  
 
8. Hepatic events and DILI   
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A table for hepatic events will be created based on the SMQ of “Drug related hepatic disorders - 
comprehensive search (SMQ)”. However, these 2 sub-SMQs are to be excluded: “Liver 
neoplasms, benign (incl cysts and polyps) (SMQ)” and “Liver neoplasms, malignant and 
unspecified (SMQ)”. For each of the above SMQs, all TEAEs will be included which code to a 
PT included in the Scope=Broad and/or Scope=Narrow.   
Note that all AEs meeting the above criteria will be included and will not be limited to events 
that the Investigator determined to be related to study drug.  
The incidence of AEs defined as Safety Topics of Interest will be summarized by MedDRA 
SOC, HLT, and PT (apart from the summary of each cardiovascular event type which will use 
PT only). The EAIR with associated 95% CI and the EAER will be included in the summary 
tables. 
10.2.4 
Impact of COVID-19 
In order to assess the impact of the COVID-19 global pandemic on the primary safety endpoint 
of incidence of TEAEs and serious TEAEs, additional listings and summaries will be presented. 
For reporting purposes AEs will be assigned to ‘Prior to COVID-19 pandemic’ or ‘During the 
COVID-19 pandemic’ based on the following: 
• If the date of AE onset (based on imputed start date) is prior to 11 March 2020 the AE will be 
assigned as ‘Prior to COVID-19 pandemic’ 
• If the date of AE onset (based on imputed start date) on or after 11 March 2020 the AE will 
be assigned as ‘During the COVID-19 pandemic’ 
− The date of 11 March 2020 is chosen as the date the World Health Organization declared 
COVID-19 as a pandemic. 
A ‘Post the COVID-19 pandemic’ phase will not be assigned for AE reporting as the pandemic is 
expected to be ongoing at the time of last subject last visit.  
The following categories of TEAE will be summarized by MedDRA SOC, HLT and PT, 
including EAIR and EAER: 
• All TEAEs by time of onset relative to COVID-19 pandemic (‘Prior to COVID-19 
pandemic’ and ‘During the COVID-19 pandemic’)  
• All TEAEs by time of onset relative to COVID-19 pandemic (‘Prior to COVID-19 
pandemic’ and ‘During the COVID-19 pandemic’) and by region  
• All serious TEAEs by time of onset relative to COVID-19 pandemic (‘Prior to COVID-19 
pandemic’ and ‘During the COVID-19 pandemic’)  
• All serious TEAEs by time of onset relative to COVID-19 pandemic (‘Prior to COVID-19 
pandemic’ and ‘During the COVID-19 pandemic’) and by region  
• All COVID-19 related TEAEs by treatment at completion of PA0008 and overall 
− COVID-19 related TEAEs will be identified based on the verbatim term including the 
text string ‘COVID’. These will include confirmed or suspected COVID-19 infections. 
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• All COVID-19 related TEAEs by treatment at completion of PA0008 and overall, and by 
region 
The following categories of TEAE will be summarized by MedDRA SOC, HLT and PT: 
• TEAEs leading to study discontinuation and/or permanent withdrawal of study medication by 
time of onset relative to COVID-19 pandemic (‘Prior to COVID-19 pandemic’ and ‘During 
the COVID-19 pandemic’) 
• TEAEs leading to study discontinuation and/or permanent withdrawal of study medication by 
time of onset relative to COVID-19 pandemic (‘Prior to COVID-19 pandemic’ and ‘During 
the COVID-19 pandemic’) and by region  
A separate listing of all COVID-19 related AEs will be presented, where COVID-related AEs are 
identified as described above. In addition, the time of onset of each AE relative to the COVID-19 
pandemic will be flagged in all AE listings. 
For the purpose of calculating EAIR and EAER prior to and during the COVID-19 pandemic the 
rules in Table 10-5 will be applied in the calculation of exposure time at risk. An individual 
subject may therefore be counted in the denominator for both periods ('Prior to COVID-19 
pandemic' and 'During the COVID-19 pandemic') dependent on whether the subject is still 
considered at risk on 11 March 2020. In this case time at risk will be calculated separately for 
each period. Subjects who have discontinued study medication prior to 11 March 2020 may be 
included in the denominator for the 'During the COVID-19 pandemic' period if they are still 
considered to be at risk following the last dose of study medication in the 'Prior to COVID-19 
pandemic' period. 
Subjects who are no longer in the exposure time at risk period (Table 10-2) on 11 March 2020, 
will not be counted in the denominator for the 'During the COVID-19 pandemic' period.  
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Table 10-5: Calculation of exposure time at risk in relation to COVID-19 
Study Period 
Start Date 
End Date 
Duration of Exposure 
Prior to 
COVID-19 
pandemic 
First dose of BKZ 
160mg in PA0009 
10MAR2020 
For subjects who did not discontinue 
medication in the ‘Prior to COVID-19 
pandemic’ phase (ie, where the last dose 
of BKZ 160mg is on or after 
11MAR2020): 
(End date – start date + 1) 
For subjects who discontinued medication 
in the ‘Prior to COVID-19 pandemic’ 
phase (ie, where the last dose of BKZ 
160mg is prior to 11MAR2020): 
If the following is true: 
Minimum of (Last dose date in PA0009 + 
140a) and (Date of last clinical contactb) is 
≥11MAR2020  
Then the duration of exposure will be 
calculated as follows: 
(End date – start date + 1) 
Else duration of exposure will be 
calculated as follows: 
Minimum of (Last dose date in PA0009 – 
First dose date in PA0009 + 140a) and 
(Date of last clinical contactb – First dose 
date in PA0009 + 1) 
For subjects that died on or before 
10MAR2020: 
Date of death – Start date + 1 
Note: If the date of death is later than 140 
days following the last dose of BKZ, this 
rule does not apply. 
 
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Table 10-5: Calculation of exposure time at risk in relation to COVID-19 
Study Period 
Start Date 
End Date 
Duration of Exposure 
During the 
COVID-19 
pandemic 
11MAR2020 
Last dose of BKZ 
160mg in PA0009 
For subjects who did not discontinue 
medication in the ‘Prior to COVID-19 
pandemic’ phase (ie, where the last dose 
of BKZ 160mg is on or after 
11MAR2020): 
Minimum of (Last dose date in PA0009 – 
11MAR2020 + 140a) and (Date of last 
clinical contactb – 11MAR2020 + 1) 
For subjects that died: 
Date of death – 11MAR2020 + 1. 
Note: If the date of death is later than 140 
days following the last dose of BKZ, this 
rule does not apply. 
For subjects who discontinued medication 
in the ‘Prior to COVID-19 pandemic’ 
phase (ie, where the last dose of BKZ 
160mg is prior to 11MAR2020): 
If the following is true: 
Minimum of (Last dose date in PA0009 + 
140a) and (Date of last clinical contactb) is 
≥11MAR2020  
Then the duration of exposure will be 
calculated as follows: 
[Minimum of (Last dose date in PA0009 
– 11MAR2020 + 140a) and (Date of last 
clinical contactb – 11MAR2020 +1)] 
For subjects that died within 140 days 
following the last dose of BKZ this rule 
be adjusted to: 
Date of death – 11MAR2020 + 1 
AE=adverse event; BKZ=bimekizumab; SFU=Safety Follow-Up. 
a 140 days refer to 5 half-lives of BKZ. 
b Date of last clinical contact for each subject is defined as the maximum of [last visit date including SFU visit, last 
AE start date (including imputed AE start dates), date of study termination or completion, last date of study drug 
administration following rules for partial treatment end dates as per Section 4.2.5]. 
10.3 
Clinical laboratory evaluations 
The routine clinical laboratory evaluations specified in Table 10‒6 will be summarized. If any 
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additional analytes are recorded, they will be listed only. 
Table 10‒6: Laboratory measurements 
Hematology 
Biochemistry 
Urinalysis 
Basophils  
Calcium 
Urine dipstick for pregnancy testinga 
Eosinophils 
Chloride 
Urinalysisb 
Lymphocytes 
Magnesium 
 
Atypical lymphocytes 
Potassium 
 
Monocytes 
Sodium 
 
Neutrophils 
Glucose (random) 
 
Hematocrit 
BUN 
 
Hemoglobin 
Creatinine 
 
MCH 
AST 
 
MCHC 
ALT 
 
MCV 
ALP 
 
Platelet count 
GGT 
 
RBC count 
Total bilirubin 
 
WBC count 
LDH 
 
 
Total cholesterol 
 
 
Uric acid 
 
 
CRP 
 
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea 
nitrogen; CRP=high sensitivity C-reactive protein; GGT=gamma glutamyltransferase; LDH=lactate dehydrogenase; 
MCH=mean corpuscular hemoglobin; MCHC=mean corpuscular hemoglobin concentration; MCV=mean 
corpuscular volume 
a A urine pregnancy test will be performed for women of childbearing potential if there is a suspicion of pregnancy. 
A positive urine pregnancy test should always be confirmed with a serum pregnancy test. 
b These measurements will be performed only if a urinalysis is required for safety reasons. 
 
 
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Separate summary tables for hematology and biochemistry variables will be provided, based on 
data from scheduled visits. Observed values and changes from PA0009 Laboratory Baseline will 
be summarized, by treatment group at completion of PA0008 and overall. CRP will be 
summarized separately as described in Section 8.3. 
Any laboratory values (with the exception of CRP) reported as <xx or >xx in the database will be 
imputed as the value of ‘xx’ for the purpose of calculating changes from baseline and for 
summary statistics. The original value will be reported in any listings. 
Summary tables of the number and percentage of subjects experiencing at least 1 on-treatment 
markedly abnormal value during the Treatment Period (excluding any measurements that 
occurred prior to the first administration of study medication in PA0009 or more than 140 days 
after the last administration of study medication) for each hematology and biochemistry variable 
will be presented by treatment group at completion of PA0008 and overall. Markedly abnormal 
values for hematology and biochemistry are defined in Table 10‒7 and Table 10‒8. 
Tables of markedly abnormal laboratory data subject numbers will be provided including all 
values classified as markedly abnormal at scheduled and unscheduled visits. 
Table 10‒7: Definitions of markedly abnormal hematology values 
Variable (SI Units) 
Markedly Abnormal Definition 
Low 
High 
Hemoglobin (g/L) 
<80 
>40 above ULN 
Lymphocytes (109/L) 
<0.5 
>20.0 
Neutrophils (109/L) 
<1.0 a 
N/A 
Platelets (109/L) 
<50 
N/A 
Leukocytes (109/L) 
<2.0 
>100 
N/A=not applicable; ULN=upper limit of normal 
Data source: modified from Appendix Rheumatology Common Toxicity Criteria v.2.0 presented in 
Woodworth et al, 2007  
a Withdrawal criteria for neutrophils is <0.5. 
 
Table 10‒8: Definitions of markedly abnormal biochemistry values 
Variable (SI Units) 
Markedly Abnormal Definition 
Low 
High 
ALP 
N/A 
>5.0 x ULN 
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Table 10‒8: Definitions of markedly abnormal biochemistry values 
Variable (SI Units) 
Markedly Abnormal Definition 
Low 
High 
ALT 
N/A 
>5.0 x ULN 
AST 
N/A 
>5.0 x ULN 
Total bilirubin 
N/A 
>3.0 x ULN 
GGT 
N/A 
>5.0 x ULN 
Creatinine  
N/A 
>3.0 x ULN 
Glucose (mmol/L) 
<1.7 
>13.9 
Calcium (mmol/L) 
<1.75 
>3.1 
Magnesium (mmo/L) 
<0.4 
>1.23 
Potassium (mmol/L) 
<3.0 
>6.0 
Sodium (mmol/L) 
<130 
>155 
Total cholesterol (mmol/L) 
N/A 
>10.34 
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma 
glutamyl transferase; N/A=Not applicable; ULN=upper limit of normal. 
A summary of the number and percentage of subjects with a given Common Terminology 
Criteria for Adverse Events (CTCAE) grade (0, 1, 2, 3 or 4) based on minimum/maximum 
on-treatment value in PA0009 (excluding any measurements that occurred prior to the first 
administration of study medication in PA0009 or more than 140 days after the last administration 
of study medication), will be presented by laboratory variable and treatment group at completion 
of PA0008. This summary will be provided only for selected laboratory variables. Definitions of 
CTCAE grades are given in Table 10‒9 and Table 10‒10. 
A shift table of the number and percentage of subjects experiencing CTCAE grade 0, 1, 2, 3 or 4 
values (as applicable) at PA0009 Laboratory Baseline to minimum/maximum post-PA0009 
Laboratory Baseline CTCAE grade will be presented by laboratory variable and treatment group 
at completion of PA0008. The minimum/maximum post-PA0009 Laboratory Baseline CTCAE 
grade will include all on-treatment scheduled and unscheduled assessments (excluding any 
measurements that occurred prior to the first administration of study medication in PA0009 or 
more than 140 days after the last administration of study medication). 
 
 
 
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Table 10‒9: Definitions of CTCAE grade by hematology parameter 
Parameter (unit) 
Definition 
Unit 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Hemoglobin 
Low 
g/L 
100-<LLN 
80-<100 
<80 
N/A 
Hemoglobin 
High 
g/L 
>0-20 above 
ULN 
>20-40 
above ULN 
>40 above 
ULN 
N/A 
Platelets 
Low 
109/L 
75-<LLN 
50-<75 
25-<50 
<25 
WBC 
Low 
109/L 
3-<LLN 
2-<3 
1-<2 
<1 
WBC 
High 
109/L 
N/A 
N/A 
>100 
N/A 
Lymphocytes 
Low 
109/L 
0.8-<LLN 
0.5-<0.8 
0.2-<0.5 
<0.2 
Lymphocytes 
High 
109/L 
N/A 
>4-20 
>20 
N/A 
Neutrophils 
Low 
109/L 
1.5-<LLN 
1.0-<1.5 
0.5-<1.0 
<0.5 
LLN=lower limit of normal, N/A=not applicable; ULN=upper limit of normal; WBC=white blood cell 
 
Table 10‒10: 
Definitions of CTCAE grade by biochemistry parameter 
Parameter (unit) 
Definition 
Unit 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Creatinine 
High 
umol/L 
>ULN-1.5 x 
ULN 
(>1.5 – 3.0) 
x ULN 
(>3.0 – 6.0) 
x ULN 
>6.0 x ULN 
Sodium 
Low 
mmol/L 
130-<LLN 
N/A 
120-<130 
<120 
Sodium 
High 
mmol/L 
>ULN-150 
>150-155 
>155-160 
>160 
Potassium 
Low 
mmol/L 
3.0-<LLN 
3.0-<LLN 
2.5-<3.0 
<2.5 
Potassium 
High 
mmol/L 
>ULN-5.5 
>5.5-6.0 
>6.0-7.0 
>7.0 
Calcium 
Low 
mmol/L 
2.0-<LLN 
1.75-<2.0 
1.5-<1.75 
<1.5 
Calcium 
High 
mmol/L 
>ULN-2.9 
>2.9-3.1 
>3.1-3.4 
>3.4 
Magnesium 
Low 
mmol/L 
0.5-<LLN 
0.4-<0.5 
0.3-<0.4 
<0.3 
Magnesium 
High 
mmol/L 
>ULN-1.23 
N/A 
>1.23-3.30 
>3.30 
Total cholesterol 
High 
mmol/L 
>ULN-7.75 
>7.75-10.34 
>10.34-12.92 
>12.92 
LLN=lower limit of normal, N/A=not applicable; ULN=upper limit of normal. 
Note that subjects who meet the decreased potassium criterion of 3.0-<LLN, which is specified as the decreased 
potassium lab criterion for both CTCAE Grade 1 and Grade 2, will be counted as Grade 2. 
The number and percentage of subjects with elevated liver function tests will be presented by 
treatment group at completion of PA0008 and overall, using on-treatment assessments from all 
visits in PA0009 (excluding any measurements that occurred prior to the first administration of 
study medication in PA0009 or more than 140 days after the last administration of study 
medication) from all visits in PA0009 including those at PA0009 Laboratory Baseline, 
unscheduled, ET and SFU visits. Each subject will be counted once only. The number and 
percentage of subjects in the following categories at any time during the study will be presented:  
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• AST:  >3xULN, >5xULN, >8xULN, >10xULN, >20xULN. 
• ALT:  >3xULN, >5xULN, >8xULN, >10xULN, >20xULN. 
• AST or ALT: >3xULN, >5xULN, >8xULN, >10xULN, >20xULN. 
• Total bilirubin: >1.5xULN, >2xULN. 
The number and percentage of subjects who meet Hy’s Law criteria (Section 10.2.3) will be 
presented by treatment group at completion of PA0008 and overall, using on-treatment 
assessments (excluding any measurements that occurred prior to the first administration of study 
medication in PA0009 or more than 140 days after the last administration of study medication) 
from all visits including PA0009 Laboratory Baseline, unscheduled, ET and SFU visits. Hy’s 
Law criteria are displayed below: 
•  (AST ≥3xULN or ALT ≥3xULN) and Total Bilirubin ≥2xULN in the absence of ALP 
≥2xULN. 
To meet the above criterion, a subject must experience the elevation in total bilirubin and ALT or 
AST and the absence of ALP elevation at the same visit.    
All hematology and biochemistry laboratory data (except CRP) will be listed, including age, sex, 
race, weight, changes from PA0009 Laboratory Baseline for numeric variables, flags for 
measurements outside the normal ranges, flags for measurements meeting the criteria for each 
CTCAE grade (Table 10‒9 and Table 10‒10), the relative study day, a flag for whether the test 
was not done and a flag for whether the subject was fasting.  
CRP will be listed separately as described in Section 8. 
Values that are below the lower limit of the reference range will be flagged as ‘L’ (low) and 
values that are above the upper limit of the reference range will be flagged as ‘H’ (high) in 
listings. Values that meet the criteria for each CTCAE grade will be flagged as ‘LGrx’ or ‘HGrx’ 
accordingly. 
The markedly abnormal laboratory results will be listed separately. 
Any additional laboratory assessments performed during the study will be listed separately. 
10.4 
Potential drug-induced liver injury assessment 
All PDILI events require immediate action, testing, and monitoring. 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 study medication are included but not limited 
to those listed in Table 10‒11 and Table 10‒12. 
PDILI laboratory results and additional PDILI information will be listed by treatment group at 
completion of PA0008 and subject. Where appropriate data will be included in the standard 
listings as indicated below:  
• Family medical history, including any DILI-relevant medical conditions or inheritable 
disorders, start year and end year (or ongoing if applicable) (presented in the demographics 
section only for subjects with PDILI events) 
• Study medication administration, including the date and time of most recent study 
medication administration, whether the subject discontinued study medication and the reason 
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for discontinuation (presented in the compliance and drug concentration data section with a 
separate listing for PDILI events). 
• Blood sample collection for PK including the variable, unit, date and time the sample was 
taken, and the result (presented in the compliance and drug concentration data section as part 
of the standard listing). 
• Laboratory tests as detailed in Table 10‒6 (presented in the laboratory measurements section 
with a separate listing of PDILI events). 
• Vital signs (presented in the safety analysis section as part of the standard listing) 
• Lifestyle, including whether the subject has used alcohol in the past 6 months and whether 
the subject has used illicit drugs in the past 6 months (presented in the demographics section 
only for subjects with PDILI events). 
• Hepatic event medical history, including any medical conditions which could have 
contributed to the suspected hepatic event prior to study entry will be listed together with all 
medical history data (presented in the demographics section). 
• Symptoms of hepatitis and hypersensitivity, including whether the subject has taken any 
potentially hepatotoxic medications, whether the subject is experiencing symptoms of 
hepatitis, and whether the subject is experiencing symptoms of hypersensitivity (presented in 
the safety analysis section only for subjects with PDILI events). 
Table 10‒11: 
Additional potential drug-induced liver injury information 
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) 
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ALT=alanine aminotransferase; AST=aspartate aminotransferase. 
 
Table 10‒12: 
Potential drug-induced liver injury 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 
heterophil 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 
Toxicology screena 
Chemistry 
Amylase 
ALT, AST 
If total bilirubin ≥1.5xULN, obtain fractionated bilirubin to obtain % direct 
bilirubin 
Serum CPK and LDH to evaluate possible muscle injury causing 
transaminase elevation 
Additional 
Prothrombin time/INRb 
Serum pregnancy test 
PK sample 
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 
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Table 10‒12: 
Potential drug-induced liver injury laboratory measurements 
ALT=alanine aminotransferase; AST=aspartate aminotransferase; CPK=creatine phosphokinase; 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 For detecting substances (ie, amphetamines, benzodiazepines, opioids, marijuana, cocaine, phencyclidine, and 
tricyclic antidepressants), additional tests may be performed based on the Investigator’s medical judgment and 
patient’s history. 
b Measured only for subjects with ALT >8xULN, elevations in total bilirubin, and symptoms of hepatitis or 
hypersensitivity. Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or tenderness; 
hypersensitivity symptoms include eosinophilia (>5%), rash, and fever (without clear alternative cause). 
10.5 
Vital signs and other observations related to safety 
10.5.1 
Vital signs 
The following vital signs measurements will be assessed: 
• Systolic blood pressure (mmHg). 
• Diastolic blood pressure (mmHg). 
• Pulse rate (bpm). 
• Temperature (°C). 
• Body weight (kg) 
The following summaries will be provided:  
• A summary of the absolute and change from PA0008 Baseline for each vital sign variable at 
each visit, by treatment group at the completion of PA0008 and overall. 
− This summary will include the derived BMI at each time point. 
• A summary of the number and percentage of subjects experiencing at least 1 on-treatment 
markedly abnormal value, as defined in Table 10‒13, for a vital sign variable during the 
Treatment Period (excluding any measurements that occurred prior to the first administration 
of study medication in PA0009 or more than 140 days after the last administration of study 
medication) by treatment group at the completion of PA0008 and overall (based on change 
from PA0008 Baseline). 
Table 10‒13: 
Definitions of markedly abnormal blood pressure values 
Variable (Unit) 
Markedly abnormal low 
Markedly abnormal high 
Systolic blood pressure (mmHg)  
<90 and a decrease from PA0008 
Baseline of ≥20 
>180 and an increase from 
PA0008 Baseline of ≥20 
Diastolic blood pressure (mmHg) 
<50 and a decrease from 
PA0008 Baseline of ≥15 
>105 and an increase from 
PA0008 Baseline of ≥15 
Vital signs measurements, including age, sex, race, weight, and flags to identify markedly 
abnormal values, will be listed. The listing will include the derived BMI at each time point. 
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10.5.2 
Electrocardiograms 
A summary of the number and percentage of subjects with normal, abnormal not clinically 
significant, and abnormal clinically significant ECG results by visit will be presented by 
treatment group at completion of PA0008 and overall. 
The following ECG variables will be summarized by visit (absolute values and change from 
PA0008 Baseline), by treatment group at completion of PA0008 and overall: 
• QTcF interval (ms) 
• QTcB interval (ms) 
• RR interval (ms) 
• PR interval (ms) 
• QRS duration (ms) 
• QT interval (ms) 
Outliers in QTcF and QTcB are defined as values meeting the following criteria at any time in 
PA0009: 
• QTcF or QTcB >450 ms OR 
• QTcF or QTcB change from PA0008 Baseline >30 ms 
Outliers will be summarized using the following categories: 
• Values >450 ms, >480 ms and >500 ms 
• Increase from PA0008 Baseline of >30 ms, >60 ms and >90 ms 
• Value >450 ms AND increase from PA0008 Baseline of >30 ms 
• Value >500 ms AND increase from PA0008 Baseline of >60 ms 
The summary will include the number and percentage of subjects who meet the criteria above at 
any on-treatment (scheduled or unscheduled) assessment (excluding any measurements that 
occurred prior to the first administration of study medication in PA0009 or more than 140 days 
after the last administration of study medication). 
All ECG variables will be listed. A separate listing of ECG findings will be presented together 
with the interpretation (normal, abnormal not clinically significant, or abnormal clinically 
significant). 
10.5.3 
Other safety variables 
Assessment of Tuberculosis 
Scheduled TB laboratory test results will be included in the laboratory data listings. Results of 
unscheduled TB testing at local laboratories will be listed separately. The response to the first 
question of the ‘Evaluation of signs and symptoms of tuberculosis’ questionnaire data will be 
listed. 
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Electronic Columbia Suicide Severity Rating Scale 
The electronic Columbia-Suicide Severity Rating Scale (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). 
Suicidal ideation is defined as an event in any of the following 5 categories:  
Suicidal behavior is defined as an event in any of the following 4 categories:  
Suicidal ideation or behavior is defined as an event in any of the above 9 categories.  
Self-injurious behavior without suicidal intent will also be reported. 
The eC-SSRS can be administered to assess suicidal ideation and behavior over a lifetime, or 
since the last time it was assessed.  The intent in this OLE study was to assess suicidal ideation 
and behavior since the last time it was assessed and refer back to the lifetime assessment 
conducted at the start of PA0008.  However, some subjects completed the 'lifetime' assessment 
(in error) at one or more visits in PA0009 and recorded positive responses to some questions. 
Based on a review of their original lifetime assessment in PA0008, these positive responses are 
not considered to represent a change in suicidal ideation and behavior during the study.  The 
summary tables will include only the ‘since last assessment’ responses; all responses will be 
listed. 
The incidence of subjects with suicidal ideation, suicidal behavior, suicidal ideation or behavior 
and self-injurious behavior at any on-treatment assessment (excluding any measurements that 
occurred prior to the first administration of study medication in PA0009 or more than 140 days 
after the last administration of study medication), will be summarized by treatment group at 
completion of PA0008.  
eC-SSRS data will be listed. 
Health Care Provider Consultations 
Out-patient non-protocol health care provider consultations will be listed. 
Extra-articular assessments 
Extra-articular assessments performed after the PA0009 EV will be listed separately for the SS. 
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10.5.4 
Comments 
A listing of comments will be presented, based on the ES. This listing will include comments 
received from the laboratory vendors (including safety laboratory data, PK data, and ADAb 
data). 
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11 
REFERENCES 
Dauden E, Griffiths CE, Ortonne JP, Kragballe K, Molta CT, Robertson D, et al. Improvements 
in patient-reported outcomes in moderate-to-severe psoriasis patients receiving continuous or 
paused etanercept treatment over 54 weeks: the CRYSTEL study. J Eur Acad Dermatol 
Venereol. 2009;23(12):1374-82. 
Fay MP, Feuer EJ. Confidence intervals for directly standardized rates: a method based on the 
Gamma distribution. Statistics in Medicine. 1997;16(7), 791-801. 
Feldman SR. A quantitative definition of severe psoriasis for use in clinical trials. J Dermatolog 
Treat. 2004;15(1):27-9. 
Felson DT, Anderson JJ, Boers M, Bombardier C, Chernoff M, Fried B, et al. The American 
College of Rheumatology preliminary core set of disease activity measures for rheumatoid 
arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical 
Trials. Arthritis Rheum. 1993;36(6):729-40. 
Healy PJ, Helliwell PS. Measuring dactylitis in clinical trials: Which is the best instrument to 
use? J Rheumatol. 2007;34(6):1302-6. 
Helliwell PS, Firth J, Ibrahim GH, Melsom RD, Shah I, Turner DE. Development of an 
assessment tool for dactylitis in patients with psoriatic arthritis. J Rheumatol. 2005;32(9):1745-
50. 
Heuft-Dorenbosch L, Spoorenberg A, van Tubergen A, Landewé R, van der Tempel H, Mielants 
H, et al. Assessment of enthesitis in ankylosing spondylitis. Ann Rheum Dis. 2003;62(2);127-
132.International Conference on Harmonization/ Food and Drug Administration E9 Guidance 
documents; 1998. 
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9
_Guideline.pdf 
Langley RG, Feldman SR, Han C, Schenkel B, Szapary P, Hsu MC, et al. Ustekinumab 
significantly improves symptoms of anxiety, depression, and skin-related quality of life in 
patients with moderate-to-severe psoriasis: Results from a randomized, doubleblind, placebo-
controlled phase III trial. J Am Acad Dermatol. 2010;63(3):457-65. 
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 Dec;44(16):1224-8. 
Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin 
GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity 
and internal consistency findings from three multisite studies with adolescents and adults. Am J 
Psychiatry. 2011 Dec;168(12):1266-77. 
Snaith RP, Zigmond AS. The hospital anxiety and depression scale, with the irritability 
depression-anxiety scale and the Leeds situational anxiety scale manual. 1994.  
Ulm K. A simple method to calculate the confidence interval of a standardized mortality ratio. 
American Journal of Epidemiology. 1990;131(2), 373-375. 
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12 
APPENDIX 
12.1 
American College of Rheumatology Response Criteria 
The rules for handling missing data in relation to defining the achievement of ACR20 response 
are provided in Table 12-1. Similar rules will apply for the definition of ACR50 and ACR70. 
This table also indicates, where appropriate, the imputation as a nonresponder (DTYPE = WC) in 
the analysis datasets for the NRI analyses. For tables presented on OC data, the data selected will 
include all instances where DTYPE is not populated in the analysis datasets. 
Table 12-1: Handling Missing Data for American College of Rheumatology 
Response Criteria Derivation 
Components – 
Joint Counts 
Other 
Components 
Other Component Status 
ACR 
DTYPE 
TJC and SJC both 
missing, or one is 
missing and the 
other improved 
≥20% 
3 or more 
components 
present 
3 or more components ≥20% 
improvement 
N 
WC 
TJC and SJC both 
missing, or one is 
missing and the 
other improved 
≥20% 
5 components 
present 
2 or fewer components 
≥20% improvement  
N 
 
TJC and SJC both 
missing, or one is 
missing and the 
other improved 
≥20% 
4 components 
present 
2 or more components ≥20% 
improvement 
N 
WC 
TJC and SJC both 
missing, or one is 
missing and the 
other improved 
≥20% 
4 components 
present 
1 or no components ≥20% 
improvement 
N 
 
TJC and SJC both 
missing, or one is 
missing and the 
other improved 
≥20% 
3 components 
present 
2 or 1 components ≥20% 
improvement 
N 
WC 
TJC and SJC both 
missing, or one is 
missing and the 
other improved 
≥20% 
3 components 
present 
No components with 
improvement ≥20% 
N 
 
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Table 12-1: Handling Missing Data for American College of Rheumatology 
Response Criteria Derivation 
Components – 
Joint Counts 
Other 
Components 
Other Component Status 
ACR 
DTYPE 
TJC and SJC both 
missing, or one is 
missing and the 
other improved 
≥20% 
0, 1 or 2 
components 
present 
Any 
N 
WC 
TJC or SJC 
missing and the 
component 
present did not 
improve ≥20% 
Any or none 
Any 
N 
 
TJC and SJC 
present but one or 
fewer ≥20% 
improvement 
Any or none 
Any 
N 
 
TJC and SJC 
present and both 
≥20% 
improvement 
All 5 components 
present 
3 or more components ≥20% 
improvement 
Y 
 
 
 
Fewer than 3 components 
≥20% improvement 
N 
 
 
4 components 
present 
3 or more components ≥20% 
improvement 
Y 
 
 
 
2 components ≥20% 
improvement 
N 
WC 
 
 
1 or fewer components 
≥20% improvement 
N 
 
 
3 components 
present 
3 components ≥20% 
improvement 
Y 
 
 
 
2 or 1 components ≥20% 
improvement 
N 
WC 
 
 
No components ≥20% 
improvement 
N 
 
 
0, 1 or 2 
components 
present 
Any 
N 
WC 
 
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12.2 
Minimal Disease Activity 
The rules for handling missing data in relation to defining the achievement of MDA are provided 
in Table 12-2. This table also indicates, where appropriate, the imputation as a nonresponder 
(DTYPE = WC [worst case]) in the analysis datasets for the NRI analyses. For tables presented 
on OC data, the data selected will include all instances where DTYPE is not populated in the 
analysis datasets. 
Table 12-2: Handling Missing Data for MDA Derivation 
Components 
Component Status 
MDA 
DTYPE 
All 7 components 
present 
5 or more meet criteria 
for MDA 
Y 
 
 
Less than 5 meet 
criteria for MDA 
N 
 
6 components present 
5 or more meet criteria 
for MDA 
Y 
 
 
4 meet criteria for 
MDA 
N 
WC 
 
3 or fewer meet criteria 
for MDA 
N 
 
5 components present 
All meet criteria for 
MDA 
Y 
 
 
3 or 4 meet criteria for 
MDA 
N 
WC 
 
2 or fewer meet criteria 
for MDA 
N 
 
4 components present 
4, 3 or 2 meet criteria 
for MDA 
N 
WC 
 
1 or fewer meet criteria 
for MDA 
N 
 
3 components present 
Any meet criteria for 
MDA 
N 
WC 
 
None meet criteria for 
MDA 
N 
 
0, 1 or 2 components 
present 
Any 
N 
WC 
12.3 
Classification of the SF-36 questionnaire 
The 8 different scores calculated from the SF-36 questionnaire are presented in Table 12‒3.     
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Table 12‒3: Classification of the SF-36 questionnaire 
Scales 
Physical Functioning 
Role-Physical 
Bodily Pain 
General Health 
Vitality 
Social Functioning 
Role-Emotional 
Mental Health 
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12.4 
Identification of Opportunistic infections 
Opportunistic infections are identified based on a reference spreadsheet (OI - MedDRA V 
19.0.xlsx) 
Identification Process 
The two steps below outline two ways in which opportunistic infections (or potential 
opportunistic infections) can be identified: Step 1: Refer to column B of the spreadsheet  which 
identifies the PTs to be classified as opportunistic infections using either a single ‘x’ or a double 
‘xx’. 
• TEAEs which code to a PT flagged with a single ‘x’ need to also be serious in order to be 
considered an opportunistic infection. 
• All TEAEs which code to a PT flagged with a double ‘xx’ are considered to be an 
opportunistic infection, regardless of seriousness. 
Step 2: Refer to column C of the spreadsheet which identifies the PTs that need to be evaluated 
on a case-by-case basis by the study physician in order to determine whether or not it is an 
opportunistic infection. If Column C has a single ‘x’, then the corresponding preferred term 
should be flagged for case-by-case review by the study physician. 
Review Process  
Opportunistic infections for a given study will be reviewed on the following occasions:  
At quarterly Infectious Disease Committee (IDC) Meetings, listings will be produced for each 
study (see details below) and reviewed by the corresponding study physician ahead of the IDC 
Meeting. The IDC will then agree on the final adjudication for each potential opportunistic 
infection.  
A final listing for opportunistic infections (in the format described below) will be produced and 
agreed upon between the study physician and the IDC prior to finalizing the database.  
In each of the circumstances described above, the study programming team will produce an 
Excel listing that will be provided to the project lead statistician, project lead programmer, and to 
the study physician (who will subsequently provide it to the IDC). The Excel listing will contain 
the following columns (using the descriptions below as the column headings in the Excel listing):  
• Study ID  
• Unique Subject ID  
• AE Term (Verbatim)  
• AE Preferred Term  
• AE System Organ Class  
• AE High Level Term  
• AE Low Level Term  
• Date of Onset  
• Outcome of Adverse Event  
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• Date of Outcome  
• TEAE Flag  
• Serious Adverse Event?  
• Relationship to Study Medication   
• Intensity  
• Action Taken with IMP  
• Opportunistic Infection – Automatic  
• Opportunistic Infection – Manual Review  
• Flag  
• Data Cut Date  
• Opportunistic Infection – Final Adjudication  
Note the following about the final 5 variables in this listing:  
Opportunistic Infection – Automatic: This is flagged as “Y” if the criteria for automatic selection 
as described in “Step 1” of the identification process are met.  
Opportunistic Infection – Manual Review: This is flagged as “Y” if the criteria for case-by-case 
selection as described in “Step 2” of the identification process are met.  
Flag – This has a value of either “NEW” or “OLD”. It is marked as “NEW” if the event is 
appearing for the first time in that run of the listing. Otherwise, if it has appeared previously, it is 
marked as “OLD”. Unique records are determined by USUBJID AESPID for purposes of 
identifying whether an event has been modified from a previous run.  
Date – Only for cases where Flag is “NEW”, this field will be populated with the data cut date 
for that particular run of the listing.  
Opportunistic Infection – Final Adjudication – For new events, this is always left blank by the 
programmers. It should be completed by the study physician/IDC for every event that appears in 
the listing. For events adjudicated as opportunistic, the field should be populated with a “Y”.   
Following each review by the study physician and IDC, the Opportunistic Infection – Final 
Adjudication column will be completed (as described above), and the spreadsheets for each study 
will be returned to the study programming team via e-mail (coordinated by the IDC secretary). 
Then, for subsequent runs of the listing, the study programming teams will incorporate 
adjudications from previous runs. 
12.5 
MedDRA algorithmic approach to anaphylaxis 
The SMQ Anaphylactic reaction consists of three parts: 
• A narrow search containing PTs that represent core anaphylactic reaction terms  
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• A broad search that contains additional terms that are added to those included in the narrow 
search. These additional terms are signs and symptoms possibly indicative of anaphylactic 
reaction and categorized in B, C or D 
− Cat B 
 
 
− Cat C 
 
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− Cat D 
 
• An algorithmic approach which combines a number of anaphylactic reaction symptoms in 
order to increase specificity. A case must include one of the following where both occur on 
either the same day as when an injection was administered or one day after, and for scenarios 
where two events must have been reported, both events must have occurred within one day of 
each other:  
− A narrow term or a term from Category A;  
− A term from Category B - (Upper Airway/Respiratory) AND a term from Category C - 
(Angioedema/Urticaria/Pruritus/Flush);  
− A term from Category D - (Cardiovascular/Hypotension) AND [a term from Category B - 
(Upper Airway/Respiratory) OR a term from Category C - (Angioedema/Urticaria/ 
Pruritus/Flush)]  
• Hypersensitivity events will be identified using the “Hypersensitivity (SMQ)”. All TEAEs 
which code to a PT included in the Scope=Narrow search will be included.   
12.6 
COVID-19 data collection 
For study visits impacted by COVID-19, additional data will be collected on a separate dedicated 
eCRF page.  
The following information will be reported: 
• Specification of the impacted visit (eg, Visit 5) 
• Date of the impacted visit 
• Category of the impact (multiple categories may apply to the same visit) 
− Visit not done 
− Visit performed out of window 
− Home visit 
− Visit performed by video call 
− Visit performed by telephone 
− Investigational product shipped to study participant 
− Home administration of investigational product by participant or caregiver 
− Home administration of investigational product by a healthcare professional 
− Missed study drug administration/dispensation 
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− Temporary discontinuation of study drug 
− Permanent discontinuation of study drug 
− Termination of study participation 
− Other 
• Relationship to COVID-19 
− Confirmed COVID-19 infection 
− Suspected COVID-19 infection 
− General circumstances around COVID-19 without infection 
− Other 
A narrative of the event will also be collected. 
 
 
 
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13 
AMENDMENT TO THE STATISTICAL ANALYSIS PLAN 
13.1 
Amendment 1 
13.1.1 
Rationale for the amendment 
The main objective of this SAP amendment is to incorporate relevant updates based on Protocol 
Amendment 2, dated 09 Mar 2018 and Protocol Amendment 3, dated 11 Dec 2019. Additional 
details and modifications have been made throughout the document in order to align with the 
most recent bimekizumab program conventions. 
13.1.2 
Modifications and changes 
The SAP has been amended to: 
• Amend the study procedures and assessments to be performed at the SFU visit. Efficacy 
assessments were removed since they are not required at the SFU visit. 
• Key inclusion criteria have been removed from the SAP as these are available in the final 
protocol and not relevant to the analyses described within the SAP. 
• Change from PA0009 EV for safety and efficacy variables will no longer be presented, since 
the EV assessment is made after 36 or 48 weeks of bimekizumab treatment and there is 
unlikely to be any further important change. 
• Change from PA0008 Baseline and from PA0009 EV for laboratory parameters (apart from 
CRP) will not be presented, due to a change in laboratory vendor between PA0008 and 
PA0009. Laboratory Baseline is defined as the earliest value in PA0009 at or prior to 
PA0009 Week 12. 
• Summaries of ACR20, ACR50, ACR70, PASI75, PASI90 and PASI100 response at each 
post-PA0008 Baseline visit through to PA0009 Week 104, for subjects who were responders 
at PA0008 Week 12 have been added.  These summaries will be used to assess maintenance 
of response. 
• A summary of BSA at each visit in PA0009 has been added 
• The relative day will now be calculated twice, once relative to the start of study medication 
in PA0008 and once relative to the start of study medication in PA0009. 
• A definition of the dosing period has been added. 
• Baseline values (with the exception of PA0009-Laboratory Baseline values) will now be 
taken directly from PA0008 database, and not re-derived. 
• The previous version of the SAP stated that ET visits would be mapped to a scheduled site 
visit if they fell on the scheduled date for that visit. This has been updated to say that they 
will be mapped to a scheduled visit if they fall within the protocol-defined visit window for 
that visit, unless there is an existing scheduled site visit in that window, in which case they 
will be mapped to the next scheduled site visit. Unscheduled visits will now also mapped to 
scheduled visits if they fall within the protocol-defined window for that visit, unless there is 
already a scheduled site visit or ET visit in that window. The wording has been clarified 
regarding unscheduled assessments performed at specific time points. 
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• The definition of the sub-populations for the SS has been clarified to be based on 
concomitant rescue medications only. 
• Sub-populations of the SS are used to report only TEAEs, serious TEAEs, AE Overview and 
Exposure rather than all primary and secondary safety variables. 
• Summaries based on sub-populations of the SS will only be reported in the event that the 
number of subjects receiving rescue medication is ≥10% of the total number of subjects in 
the SS. 
• The previous definition of the FAS included all enrolled subjects who received at least 1 dose 
of IMP and have a valid measurement for at least 1 efficacy variable at PA0009 study entry. 
This has been updated to include all subjects in the ES who received at least one dose of 
study medication in PA0009 and have a valid measurement for at least one efficacy variable 
after PA0009 EV in order to identify subjects who have had assessments during PA0009. 
• Summaries by randomized treatment in PA0008 will not be produced, as subjects will have 
been on a constant dose of bimekizumab 160mg or 320mg for at least 36 weeks prior to 
PA0009 entry. Maintenance of response displays will be split by treatment sequence across 
PA0008 and PA0009. Safety displays using PA0008 information will incorporate exposure in 
PA0008. 
• For summaries of AEs including data from both PA0008 and PA0009, the 160mgLD and 
160mg treatments have been combined. 
• The subgroup definition of ‘Concomitant disease-modifying anti-rheumatic drug (DMARD) 
status at PA0009 entry’ has been updated to ‘Concomitant DMARD status at start of 
PA0008’.  
• The rules for NRI and MI for missing efficacy data have been clarified to state that 
imputations will only be performed for subjects in the FAS for PA0009. In addition the SAP 
has been updated to state that for NRI, the imputation will be re-derived at the PA0009 EV 
instead of using the PA0008 Week 48 imputed value; this is due to slight differences in the 
derivation rules for some endpoints between the PA0008 and PA0009 SAPs. 
• The MI procedures have been updated for all endpoints to use OC data from both PA0008 
and PA0009 studies such that missing data across both studies will be imputed. Thus, the 
procedure will estimate an imputation model at each post-PA0008 Baseline visit where 
efficacy variables are collected. The covariate for PA0009 EV has therefore been deleted 
from the model. 
• Additional imputation rules have been added for PASI responder data 
• The endpoints/components for which MI will be performed have been clarified in the section 
on handling missing data for the efficacy analyses. 
• The presentation of CRP data following MI has been updated to use the geometric mean and 
95% CI for the geometric mean. 
• The handling of missing data for AEs and concomitant medications has been updated to 
clarify the rules in the presence of a partial start date and a known end date. 
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• For summaries based on MI of missing data, the covariates in the MI model will no longer 
include disease duration and concomitant DMARD status. 
• The seed used for all MI procedures has been updated to 2017. 
• A summary of study medication discontinuation and a listing of subjects excluded from at 
least one analysis set have been added. 
• Methods for calculating total days on study medication have been added to the SAP 
• Tables and listings presenting the impact of COVID-19 on the study data collection have 
been added 
• The listing of lifestyle data has been removed, as this data is not generally collected in 
PA0009. Lifestyle data may be collected for PDILI cases, and this data will be listed. 
• The categories and rules for identifying rescue medications have been updated. 
• Efficacy data collected after a subject has used a prohibited medication will no longer be 
treated as missing since the primary purpose of this study is to assess safety. 
• Compliance categories have been updated from ≤80% and >80% to ≤75% and > 75% to 
match the overall program conventions for bimekizumab. 
• Sensitivity analyses based on OC data were restricted to ACR, PASI, MDA, LDI and 
MASES. Additional sensitivity analyses based on MI of component scores were added for 
ACR and PASI response variables.  
• Summaries of MASES were restricted to subjects with enthesitis (MASES > 0) at PA0008 
Baseline.  Summaries of LDI were restricted to subjects with dactylitis (LDI > 0) at PA0008 
Baseline. 
• Summaries of ACR component scores (TJC, SJC, HAQ-DI, PtAAP, PhGADA and PGADA) 
were added. 
• CRP values below the LLOQ will now be set to half LLOQ (0.08mg/L) prior to reporting  
• Plots of geometric mean bimekizumab plasma concentration versus time by treatment group 
and cumulative ADAb status have been added based on ADAb status in PA0008 and 
PA0009. 
• ADAb status categories have been redefined and appropriate plots and summaries have been 
added based on the most recent bimekizumab program conventions. 
• Summaries of all TEAEs and serious TEAEs in PA0008 and PA0009 combined, a 
corresponding AE overview table and a table of exposure across PA0008 and PA0009 have 
been added. 
• Summaries have been added for fatal TEAEs; TEAEs leading to permanent withdrawal of 
study medication; serious TEAEs by maximum relationship and fatal TEAEs by maximum 
relationship. The Adverse Drug Reaction summary has been removed. A listing of 
Hospital/ER visits has been added. 
• A summary of TEAEs by descending frequency of PT has been added 
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UCB 
 
04Nov2020 
Statistical Analysis Plan 
Bimekizumab 
PA0009 
 
 
 
Confidential 
Page 111 of 112 
• A summary of TEAEs in PA0009 and ongoing TEAEs from PA0008 has been added 
• Tables and listings have been added to evaluate the effect of COVID-19 on reporting of 
TEAEs 
• The summaries and listings for AEs of special interest have been updated to match more 
recent guidelines. 
• Further clarification has been added to the definitions of EAIR and EAER. 
• Summaries and shift tables of subjects experiencing a given CTCAE grade for selected 
laboratory parameters have been added. 
• Summaries presenting outliers for QTcB and QTcB have been added. 
• A listing of ECG findings has been added. 
• Body weight and BMI have been added to the listing and summary table for vital signs 
variables 
• Physical examination data will no longer be listed as this data is not collected. 
• A listing of healthcare provider consultations listing has been added. 
• A listing of comments has been added. 
• A listing of procedure history has been added. 
• The appendices containing the copies of the individual questionnaires have been removed 
13.2 
Amendment 2 
Not applicable. 
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UCB 
 
04Nov2020 
Statistical Analysis Plan 
Bimekizumab 
PA0009 
 
 
 
Confidential 
Page 112 of 112 
STATISTICAL ANALYSIS PLAN SIGNATURE PAGE 
This document has been reviewed and approved per the Review and Approval of Clinical 
Documents Standard Operating Procedures. Signatures indicate that the final version of the 
Statistical Analysis Plan (SAP) or amended SAP is released for execution. 
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Approval Signatures
Name:
pa0009-sap-amendment-1
Version:
1. 0
Document Number:
CLIN-000121165
Title:
Statistical Analysis Plan (Amendment 1)
Approved Date:
07 Nov 2020
Document Approvals
Approval
Verdict: Approved
Name: 
Capacity: Subject Matter Expert
Date of Signature: 04-Nov-2020 17:06:36 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 07-Nov-2020 15:00:49 GMT+0000
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