Conditions: Chronic Plaque Psoriasis
Keywords: Chronic plaque psoriasis Psoriasis Bimekizumab
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 217
Healthy volunteers: no

Brief summary:
This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

Detailed description:

Arms:
arm 1: Subjects with a PASI90 response at Week 12 and receiving Placebo in PS0010 entering PS0011 will receive Placebo. arm 2: Subjects with a PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 entering PS0011 will receive the same dosing regimen.

Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 will be assigned to a higher dosing regimen. arm 3: Subjects with a PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 entering PS0011 will receive the same dosing regimen.

Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 will be assigned to a higher dosing regimen. arm 4: Subjects that were initially randomized to bimekizumab dosage regimen 3, 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3.

Interventions: intervention 1: Bimekizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will receive bimekizumab injections every four weeks (Q4W) intervention 2: Subjects will receive Placebo injections every four weeks (Q4W)

Protocol document:
Prot_000.pdf: 
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Clinical Study Protocol
Bimekizumab
PS0011
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Page 1 of 125
PROTOCOL PS0011 AMENDMENT 1
A MULTICENTER, 48-WEEK, DOUBLE-BLIND, 
PLACEBO-CONTROLLED, PARALLEL-GROUP EXTENSION 
STUDY TO ASSESS THE LONG-TERM SAFETY, 
TOLERABILITY, AND EFFICACY OF BIMEKIZUMAB IN ADULT 
SUBJECTS WITH MODERATE TO SEVERE CHRONIC
PLAQUE PSORIASIS
PHASE 2B
EudraCT Number: 2016-001892-57
IND Number: 128707
Sponsor:
UCB Biopharma SPRL
Allée de la Recherche 60
B-1070 Brussels
BELGIUM
Protocol/Amendment number
Date
Type of 
amendment
Final Protocol
01 Jun 2016
Not applicable
Protocol Amendment 1
12 Aug 2016
Substantial
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
PS0011
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STUDY CONTACT INFORMATION
Sponsor
UCB Biopharma SPRL, Allée de la Recherche 60, B-1070 Brussels, Belgium
Sponsor Study Physician
Name:
Address:
UCB BioPharma SPRL, Allée de la Recherche, 60, Brussels, 
Belgium, B-1070
Phone:
Fax:
Clinical Project Manager
Name:
Address:
UCB BioPharma SPRL, Allée de la Recherche, 60, Brussels, 
Belgium, B-1070
Phone:
Fax:
Clinical Trial Biostatistician
Name:
Address:
UCB Biosciences, 8010 Arco Corporation Drive, Raleigh, NC 
27617
Phone:
Fax:
Clinical Monitoring Contract Research Organization
Name:
PAREXEL International (IRL) Limited-Ireland
Address:
Ireland Limited at 70 Sir John Rogerson’s Quay, Dublin 2, 
Ireland
Phone:
+353 (1) 477 3171
Fax:
+353 (1) 477 3308
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Bimekizumab
PS0011
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SERIOUS ADVERSE EVENT REPORTING
Serious adverse event reporting (24h)
Fax
Europe and Rest of the World: +32 2 386 24 21
USA: +1 800 880 6949
or +1 866 890 3175
Canada: +1 877 582 8842
Email
Global: DS_ICT@ucb.com (for interventional clinical studies)
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Bimekizumab
PS0011
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TABLE OF CONTENTS
LIST OF ABBREVIATIONS....................................................................................................9
1
SUMMARY.....................................................................................................................12
2
INTRODUCTION ...........................................................................................................13
2.1 Psoriasis ...........................................................................................................................13
2.1.1
Global epidemiology of psoriasis ........................................................................13
2.1.2
Current treatments for psoriasis...........................................................................14
2.2 Bimekizumab ...................................................................................................................15
2.2.1
Clinical.................................................................................................................15
2.2.2
Nonclinical...........................................................................................................17
3
STUDY OBJECTIVES....................................................................................................17
3.1 Primary objective.............................................................................................................17
3.2 Secondary objective.........................................................................................................17
3.3 Other objectives ...............................................................................................................17
4
STUDY VARIABLES.....................................................................................................18
4.1 Safety variables................................................................................................................18
4.1.1
Primary safety variable........................................................................................18
4.1.2
Other safety variables ..........................................................................................18
4.2 Pharmacokinetic variable.................................................................................................18
4.3 Immunological variable ...................................................................................................18
4.4 Efficacy variables.............................................................................................................18
4.4.1
Secondary efficacy variables ...............................................................................18
4.4.2
Other efficacy variables.......................................................................................18
5
STUDY DESIGN.............................................................................................................19
5.1 Study description .............................................................................................................19
5.1.1
Study duration per subject ...................................................................................20
5.1.2
Planned number of subjects and sites ..................................................................20
5.1.3
Anticipated regions and countries .......................................................................20
5.2 Schedule of study assessments.........................................................................................20
5.3 Schematic diagram...........................................................................................................23
5.4 Rationale for study design and selection of dose.............................................................26
6
SELECTION AND WITHDRAWAL OF SUBJECTS...................................................26
6.1 Inclusion criteria ..............................................................................................................26
6.2 Exclusion criteria .............................................................................................................27
6.3 Withdrawal criteria ..........................................................................................................27
6.3.1
PDILI IMP discontinuation criteria.....................................................................29
7
STUDY TREATMENT...................................................................................................30
7.1 Description of investigational medicinal product............................................................30
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7.2 Treatments to be administered.........................................................................................30
7.3 Packaging.........................................................................................................................30
7.4 Labeling ...........................................................................................................................31
7.5 Handling and storage requirements..................................................................................31
7.6 Drug accountability..........................................................................................................31
7.7 Procedures for monitoring subject compliance................................................................32
7.8 Concomitant medication(s)/treatment(s)..........................................................................32
7.8.1
Permitted concomitant treatments (medications and therapies) ..........................32
7.8.2
Prohibited concomitant treatments (medications and therapies).........................33
7.9 Blinding............................................................................................................................33
7.9.1
Procedures for maintaining and breaking the treatment blind.............................34
7.9.1.1
Maintenance of study treatment blind.......................................................34
7.9.1.2
Breaking the treatment blind in an emergency situation...........................34
7.10 Randomization and numbering of subjects......................................................................35
8
STUDY PROCEDURES BY VISIT ...............................................................................35
8.1 Baseline Visit...................................................................................................................35
8.2 Week 4 (±3 days).............................................................................................................36
8.3 Week 8 (±3 days); Week 16 (±3 days); Week 32 (±3 days); and Week 40 (±3 days) ....37
8.4 Week 12 (±3 days)...........................................................................................................38
8.5 Week 20 (±3 days); Week 28 (±3 days); and Week 44 (±3 days)...................................39
8.6 Week 24 (±3 days)...........................................................................................................39
8.7 Week 36 (±3 days)...........................................................................................................40
8.8 Week 48 (±3 days) Study Exit/Early Withdrawal ...........................................................41
8.9 SFU Visit (20 weeks after the last dose of bimekizumab or placebo; -3/+7 days)..........42
8.10 Early Withdrawal Visit ....................................................................................................42
8.11 Unscheduled Visit............................................................................................................42
9
ASSESSMENT OF SAFETY..........................................................................................43
9.1 Adverse events.................................................................................................................43
9.1.1
Definition of AE ..................................................................................................43
9.1.2
Procedures for reporting and recording AEs .......................................................44
9.1.3
Description of AEs ..............................................................................................44
9.1.4
Follow up of AEs.................................................................................................44
9.1.5
Rule for repetition of an AE ................................................................................44
9.1.6
Pregnancy ............................................................................................................44
9.1.7
Suspected transmission of an infectious agent via a medicinal product..............45
9.1.8
Overdose of investigational medicinal product ...................................................45
9.1.9
Safety signal detection.........................................................................................46
9.2 Serious adverse events .....................................................................................................46
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9.2.1
Definition of SAE................................................................................................46
9.2.2
Procedures for reporting SAEs ............................................................................47
9.2.3
Follow up of SAEs...............................................................................................48
9.3 Immediate reporting of AEs.............................................................................................48
9.4 Anticipated SAEs.............................................................................................................48
9.5 Adverse events of special interest....................................................................................48
9.6 Adverse events for special monitoring ............................................................................49
9.7 Laboratory measurements................................................................................................49
9.7.1
Evaluation of PDILI ............................................................................................50
9.7.1.1
Consultation with Medical Monitor and local hepatologist ......................54
9.7.1.2
Immediate action: determination of IMP discontinuation.........................54
9.7.1.3
Testing: identification/exclusion of alternative etiology...........................54
9.7.1.4
Follow-up evaluation.................................................................................56
9.8 Other safety measurements..............................................................................................56
9.8.1
Assessment and management of TB and TB risk factors....................................56
9.8.1.1
TB assessment by IGRA ...........................................................................58
9.8.1.2
Chest x-ray for TB.....................................................................................59
9.8.1.3
TB questionnaire .......................................................................................59
9.8.1.4
TB management ........................................................................................59
9.8.2
Pregnancy testing.................................................................................................60
9.8.3
Vital signs ............................................................................................................60
9.8.4
12-lead ECGs.......................................................................................................60
9.8.5
Physical examination...........................................................................................60
9.8.6
Assessment of suicidal ideation and behavior.....................................................60
9.8.7
Data Monitoring Committee................................................................................60
10
ASSESSMENT OF PHARMACOKINETIC VARIABLES...........................................61
11
ASSESSMENT OF IMMUNOLOGICAL VARIABLES...............................................61
12
ASSESSMENT OF EFFICACY......................................................................................61
12.1 Psoriasis Area and Severity Index ...................................................................................61
12.2 Investigator’s Global Assessment....................................................................................62
12.3 Dermatology Life Quality Index......................................................................................63
12.4 BSA affected by psoriasis................................................................................................63
12.5 Modified Nail Psoriasis Severity Index ...........................................................................63
12.6 Psoriasis Scalp Severity Index.........................................................................................63
12.7 PGADA for the arthritis VAS..........................................................................................64
12.8 36-Item Short Form Health Survey..................................................................................64
12.9 Hospital Anxiety and Depression Scale...........................................................................65
13
STUDY MANAGEMENT AND ADMINISTRATION.................................................65
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Bimekizumab
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13.1 Adherence to protocol......................................................................................................65
13.2 Monitoring .......................................................................................................................65
13.2.1
Definition of source data .....................................................................................66
13.2.2
Source data verification .......................................................................................66
13.3 Data handling...................................................................................................................66
13.3.1
eCRF completion.................................................................................................66
13.3.2
Database entry and reconciliation........................................................................67
13.3.3
Subject Enrollment log/Subject Identification Code list .....................................67
13.4 Termination of the study..................................................................................................67
13.5 Archiving and data retention............................................................................................67
13.6 Audit and inspection ........................................................................................................68
13.7 Good Clinical Practices....................................................................................................68
14
STATISTICS ...................................................................................................................68
14.1 Definition of analysis sets................................................................................................68
14.2 General statistical considerations.....................................................................................69
14.3 Planned safety analyses....................................................................................................70
14.3.1
Primary safety analysis........................................................................................70
14.3.2
Other safety analyses ...........................................................................................71
14.4 Planned PK analyses........................................................................................................71
14.5 Planned immunological analyses.....................................................................................71
14.6 Planned efficacy analyses ................................................................................................71
14.7 Planned interim analysis and data monitoring.................................................................72
14.8 Determination of sample size...........................................................................................72
15
ETHICS AND REGULATORY REQUIREMENTS......................................................72
15.1 Informed consent .............................................................................................................72
15.2 Subject identification cards..............................................................................................73
15.3 IRBs and IECs..................................................................................................................73
15.4 Subject privacy.................................................................................................................74
15.5 Protocol amendments.......................................................................................................74
16
FINANCE, INSURANCE, AND PUBLICATION.........................................................74
17
REFERENCES ................................................................................................................74
18
APPENDICES .................................................................................................................77
18.1 Protocol Amendment 1 ....................................................................................................77
19
DECLARATION AND SIGNATURE OF INVESTIGATOR .....................................124
20
SPONSOR DECLARATION ........................................................................................125
LIST OF TABLES
Table 5‒1:
Schedule of study assessments.........................................................................21
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Bimekizumab
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Table 7‒1:
Prohibited psoriasis medications during PS0011.............................................33
Table 9‒1:
Anticipated SAEs for the population of subjects with moderate to severe 
chronic plaque psoriasis...................................................................................48
Table 9‒2:
Laboratory measurements................................................................................49
Table 9-3:
Required investigations and follow-up for PDILI ...........................................52
Table 9-4:
PDILI laboratory measurements......................................................................55
Table 9-5:
PDILI information to be collected...................................................................56
Table 12‒1:
Body areas for calculation of percent BSA for PASI ......................................62
Table 12‒2:
Parameters assessed for the PSSI.....................................................................64
LIST OF FIGURES
Figure 5‒1:
Schematic diagram...........................................................................................24
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Bimekizumab
PS0011
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LIST OF ABBREVIATIONS
AE
adverse event
AESM
adverse event for special monitoring
ALP
alkaline phosphatase
ALT
alanine aminotransferase
AST
aspartate aminotransferase
BSA
body surface area (affected by psoriasis) 
cAMP
cyclic adenosine monophosphate
CRO
Contract Research Organization
CTCAE
Common Terminology Criteria for Adverse Events
DLQI
Dermatology Life Quality Index
DMC
Data Monitoring Committee
EAER
exposure adjusted event rate
EAIR
exposure adjusted incidence rate
ECG
electrocardiogram
eCRF
electronic Case Report Form
eC-SSRS
electronic Columbia-Suicide Severity Rating Scale
EDC
electronic data capture
FAS
Full Analysis Set
FDA
Food and Drug Administration
GCP
Good Clinical Practice
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
HLT
high level term
IB
Investigator’s Brochure
ICH
International Council for Harmonisation
IEC
Independent Ethics Committee
IGA
Investigator’s Global Assessment
IGRA
interferon gamma release assay  
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Bimekizumab
PS0011
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IL
interleukin
IMP
investigational medicinal product(s)
IRB
Institutional Review Board
iv
intravenous
IXRS
interactive voice or web response system
LTB
latent tuberculosis
mAb
monoclonal antibody
MCS
Mental Component Summary
mNAPSI
modified Nail Psoriasis Severity Index
NSAID
nonsteroidal anti-inflammatory drug
NTMB
nontuberculous mycobacterium
PASI
Psoriasis Area and Severity Index
PCS
Physical Component Summary 
PDE4
phosphodiesterase 4
PDILI
potential drug-induced liver injury
PGADA
Patient’s Global Assessment of Disease Activity
PK
pharmacokinetics
PK-PPS
Pharmacokinetics Per-Protocol Set
PRO
Patient Reported Outcome
PS
Patient Safety
PSSI
Psoriasis Scalp Severity Index
PT
preferred term
Q4W
every 4 weeks
QOL
quality of life
SAE
serious adverse event
sc
subcutaneous(ly)
SF-36
36-Item Short Form Health Survey
SFU
Safety Follow-Up
SOC
system organ class
SOP
Standard Operating Procedure
SS
Safety Set
TB
tuberculosis
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TEAE
treatment-emergent adverse event
TNF
tumor necrosis factor
ULN
upper limit of normal
VAS
visual analog scale
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Bimekizumab
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1
SUMMARY
PS0011 is a multicenter, 48-week, double-blind, placebo-controlled, parallel-group extension 
study to assess the long-term safety, tolerability, and efficacy of bimekizumab in eligible adult 
subjects with moderate to severe chronic plaque psoriasis who complete PS0010. At Week 12 of 
PS0010, all eligible subjects continuing into PS0011 will undergo the PS0010 Week 12 study
assessments and any additional PS0011 Baseline assessments, and will then receive their first 
dose of bimekizumab or placebo in PS0011.
During the Treatment Period, subjects will attend study visits at the study site every 4 weeks 
(Q4W) for study assessments and administration of bimekizumab or placebo by study site staff 
through Week 48. Any subject who does not achieve a Psoriasis Area and Severity Index (PASI) 
75 response (defined as a 75% reduction in the PASI score from the Baseline of PS0010) at 
Week 12 or later in PS0011 will be withdrawn from study treatment and will return to complete
the Early Withdrawal Visit assessments. Following completion or early withdrawal from the 
48-week Treatment Period, subjects will return for a Safety Follow-Up (SFU) Visit 20 weeks 
after their last dose of bimekizumab or placebo in PS0011.
Subjects withdrawing early from the study will undergo the Early Withdrawal Visit assessments 
and will enter the SFU Period.
Subjects who received placebo or bimekizumab 64mg, 160mg, or 320mg loading dose + 160mg 
Q4W in PS0010 must achieve PASI90 response at Week 12 in PS0010 to enter the PS0011 
extension study on the same treatment dose. Subjects who do not achieve PASI90 response at 
Week 12 in PS0010 while receiving placebo or bimekizumab 64mg Q4W will be assigned to 
receive bimekizumab 160mg Q4W on entering PS0011. Subjects who do not achieve PASI90 
response at Week 12 in PS0010 while receiving bimekizumab 160mg or 320mg loading dose 
+ 160mg Q4W will be assigned to receive bimekizumab 320mg Q4W on entering PS0011. 
Subjects who receive bimekizumab 320mg or 480mg Q4W in PS0010 will be assigned to receive 
bimekizumab 320mg Q4W on entering PS0011, regardless of their PASI90 response at Week 12 
in PS0010.
Up to 240 subjects are anticipated to enroll in PS0011 at approximately 40 sites in Europe, 
Canada, and the US, with possible extension to other regions and countries as required in 
PS0010.
The primary objective of the study is to assess the long-term safety and tolerability of 
bimekizumab. The secondary objective of the study is to assess the efficacy of bimekizumab
administered Q4W over 48 weeks. The other objectives of the study are to assess the 
pharmacokinetics (PK) and immunogenicity of bimekizumab.
The primary safety variable is the incidence of treatment-emergent adverse events (TEAEs) 
adjusted by duration of subject exposure to treatment. The other safety variables are change from 
Baseline of PS0010 and PS0011 in clinical laboratory values (chemistry, hematology, and 
urinalysis), vital signs, physical examination, and 12-lead electrocardiogram (ECG) results.
The PK variable is plasma concentrations of bimekizumab and the immunological variable is 
anti-bimekizumab antibody levels prior to and following study treatment. 
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The efficacy assessments are PASI, Investigator’s Global Assessment (IGA) Dermatology Life 
Quality Index (DLQI), body surface area (BSA) affected by psoriasis, modified Nail Psoriasis 
Severity Index (mNAPSI) score, Psoriasis Scalp Severity Index (PSSI), Patient's Global 
Assessment of Disease Activity (PGADA), 36-item Short Form Health Survey (SF-36), and the 
Hospital Anxiety and Depression Scale (HADS); a list of the secondary and other efficacy 
variables is presented in Section 4.4.
2
INTRODUCTION
2.1
Psoriasis
Psoriasis is a common, chronic inflammatory disease characterized by a series of linked cellular 
changes in the skin: hyperplasia of epidermal keratinocytes, vascular hyperplasia and ectasia, and 
infiltration of T lymphocytes, neutrophils, and other types of leukocytes in affected skin. Though 
the pathophysiology of psoriasis is not fully understood, the importance of T-cells and 
inflammatory cytokines has been demonstrated by the clinical benefit provided by therapies 
directed at these targets (Krueger and Ellis, 2005). 
There are a variety of forms including plaque, guttate, inverse, pustular, and erythrodermic. 
Plaque psoriasis is the most common, comprising approximately 80% to 90% of all cases. 
Approximately 17% of those with psoriasis have moderate to severe disease (Kurd et al, 2008).
In addition to the impact on skin, psoriasis has a multitude of psychosocial and emotional effects 
on patients, including increased self-consciousness, frustration, fatigue, depression, and suicidal 
ideation. As a result, patients frequently report sleeping problems, difficulties at work, problems 
interacting with family members, disrupted leisure activities, and sexual difficulties 
(Dowlatshahi et al, 2014; Gottlieb, 2005; Mukhtar et al, 2004; Ortonne, 2004; 
Krueger et al, 2001). 
A number of comorbidities have been associated with psoriasis, especially with more severe 
psoriasis. Psoriatic arthritis, cardiovascular disease, metabolic syndrome, chronic pulmonary 
disease, peptic ulcer disease, renal disease, and diabetes have all been demonstrated to have an 
increased prevalence in psoriasis patients (Yeung et al, 2013; Christophers et al, 2010; 
Gisondi et al, 2007; Gelfand et al, 2006).
2.1.1
Global epidemiology of psoriasis
Psoriasis affects approximately 3% of the adult US population (Rachakonda et al, 2014; 
Kurd and Gelfand, 2009) and its onset can begin at any age (Augustin et al, 2010; 
Icen et al, 2009). The reported worldwide incidence and prevalence of psoriasis varies greatly 
depending on age, gender, ethnicity, and geography primarily due to genetic and environmental 
factors. Estimates of incidence and prevalence include all types of psoriasis. Plaque psoriasis is 
the most common form of psoriasis therefore reported estimates of the magnitude of this 
condition are likely weighted heavily by this subtype. Both the incidence and prevalence of 
psoriasis are higher among Caucasians and those living in higher latitudes. Psoriasis affects 
approximately 2% to 4% of the population of western countries. Geographical differences are 
also influenced by case definition, study design, and the definition of prevalence 
(Parisi et al, 2013; Langley et al, 2005; Raychaudhuri and Gross, 2000).
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2.1.2
Current treatments for psoriasis
Therapy for patients with psoriasis varies according to the severity of disease. Limited or mild 
disease is often treated with topical therapies such as corticosteroids and vitamin D analogs. 
Patients with more severe disease are often treated with chemophototherapy, methotrexate, the 
oral phosphodiesterase 4 (PDE4) inhibitor (apremilast), or biologic agents, such as tumor 
necrosis factor (TNF) antagonists, interleukin (IL) 12/23 inhibitors, and IL-17A inhibitors. The 
effectiveness of TNF inhibitors in the treatment of psoriasis has been demonstrated in many 
Phase 3 clinical studies and has led to the approval of multiple TNF inhibitors for use in patients 
with moderate to severe psoriasis. Interleukin inhibitors include secukinumab and ixekizumab, 
IL-17A inhibitors approved for treatment of moderate to severe psoriasis. Ustekinumab is an 
IL-12/23 antagonist approved for use in patients with moderate to severe psoriasis, and 
brodalumab, an IL-17 receptor antagonist, has completed pivotal Phase 3 studies in psoriasis. 
Standard therapies for psoriasis are listed below:

Topical steroids (eg, triamcinolone, mometasone, clobetasol, betamethasone, hydrocortisone) 
are generally used as first-line treatment of psoriasis. High-strength steroids are typically 
reserved for use on the arms and legs. Areas such as the face and skin folds (axillary, 
inguinal regions, etc) are usually treated with a low potency steroid. Chronic use of topical 
steroids can lead to corticosteroid-related side effects and is generally discouraged.

Vitamin D analogs (eg, calcipotriol and tacalcitol) are commonly used to treat mild to 
moderate psoriasis, and work best within the mild patients. They are safe but lack efficacy 
for many moderate to severe patients.

Chemophototherapy is a frequent option for moderate to severe patients, but the 
inconvenience of multiple treatment visits and varying efficacy limits its use in the market. 

Methotrexate is a systemic immunosuppressant and is used in moderate to severe patients. 
Toxicity concerns, particularly in older patients, are a major drawback.

Apremilast is an oral small-molecule inhibitor of PDE4 that is also approved for treatment of 
adults with moderate to severe plaque psoriasis. Phosphodiesterase 4 inhibitors work 
intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators. 
Phosphodiesterase 4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the 
dominant PDE in inflammatory cells. Phosphodiesterase 4 inhibition elevates intracellular 
cAMP levels, which in turn down-regulates the inflammatory response by modulating the 
expression of TNFα, IL-23, IL-17, and other inflammatory cytokines.

Biologics, including TNFα inhibitors (adalimumab, etanercept, and infliximab), 
IL-12/23 inhibitors (ustekinumab), and IL-17A inhibitors are the treatment options of choice 
for patients with moderate to severe plaque psoriasis who are candidates for systemic therapy 
or phototherapy. These products are injected sc or delivered via intravenous (iv) infusion and 
while effective, TNFα inhibitors come with boxed warnings including the risk of serious 
infections and reports of lymphoma and malignancy in children and adolescent patients. The 
efficacy of TNFα inhibitors in treating psoriasis has been attributed to their inhibition of 
Th17-T cells. Different from the traditional systemic drugs that impact the entire immune 
system, biologics target specific parts of the immune system and offer reduced multi-organ 
toxicity and adverse effects associated with traditional treatments.
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Secukinumab has been approved in the US and the EU for the treatment of moderate to 
severe plaque psoriasis in adult patients who are candidates for systemic therapy or 
phototherapy. Secukinumab is a monoclonal antibody (mAb) that inhibits the activity of the 
IL-17A isoform and is the first approved drug in its class. Clinical study results have shown 
that secukinumab achieves higher efficacy response levels than other drugs historically, 
demonstrating that IL-17 is a very effective target for the development of drugs for the 
treatment of psoriasis. 
2.2
Bimekizumab
Bimekizumab (also known as UCB4940) is an engineered, humanized, full-length 
immunoglobulin G1 mAb with high affinity for human IL-17A and IL-17F, important 
proinflammatory cytokines of the IL-17 family believed to play important roles in autoimmune 
and inflammatory diseases. Interleukin-17A has been shown to have a role in pathogenesis of 
several autoimmune disorders and IL-17F has been increasingly recognized to contribute to the 
pathogenesis of a number of inflammatory diseases, including psoriasis, ulcerative colitis, 
asthma, ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis. While anti-IL-17A 
antibodies have demonstrated efficacy in patients with psoriasis, psoriatic arthritis, and 
ankylosing spondylitis, as yet, no therapeutic approach is available that fully inhibits the activity 
of IL-17F. Bimekizumab selectively and potently inhibits the activity of both IL-17A and IL-17F 
isoforms in vitro. Therefore, it permits an evaluation of the potential for additional efficacy, that 
may be conferred by dual inhibition of both cytokines, in patients suffering from diseases in 
which both cytokines are active.
2.2.1
Clinical
Three clinical studies of bimekizumab have been completed: UP0008 in 39 subjects with mild to 
moderate plaque psoriasis, RA0124 in 30 healthy volunteers, and PA0007 in 53 subjects with 
psoriatic arthritis. Two studies (RA0123 and UP0031) are ongoing in subjects with moderate to 
severe rheumatoid arthritis and in healthy subjects, respectively. 
UP0008 was a Phase 1, single ascending dose study in adults with mild to moderate psoriasis 
affecting ≤5% BSA. In this blinded study, single doses of up to 640mg (approximately 8mg/kg 
in an 80kg adult) were evaluated without any safety concerns. A total of 26 subjects with 
psoriasis with less than 5% of body surface involvement were treated with a range of single iv 
doses from 8 to 640mg. There were no clinically relevant safety findings identified at any dose 
and all doses were well tolerated. The pre-specified exploratory assessment of disease activity 
showed clinically relevant and statistically significant improvements at the higher doses studied.
RA0124 was a Phase 1, open-label, parallel-group, single-dose study in healthy subjects. The 
primary objective of this study was to determine the absolute bioavailability of single sc doses of 
bimekizumab (80mg and 160mg). The secondary objectives were to evaluate the dose 
proportionality of bimekizumab 80mg and 160mg sc, and to evaluate the safety and tolerability 
of these sc doses and 160mg given by iv infusion. In RA0124, the absolute bioavailability was 
similar for the 2 doses tested (0.656 and 0.631 for the bimekizumab 80mg and 160mg sc doses, 
respectively). The PK of bimekizumab was linear in the tested dose range and the median t1/2
following sc administration was similar to that following iv administration (27.81 days and 
28.25 days for bimekizumab 160mg sc and 160mg iv, respectively).  
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Bimekizumab has also been investigated in a Phase 1b, proof of concept, randomized, 
placebo-controlled, multiple dose study (PA0007). The primary objective of PA0007 was to 
assess the safety and PK of multiple dose administration of iv bimekizumab in subjects with 
psoriatic arthritis. Four active doses and a placebo were tested. Drug was administered as a 
loading dose at Week 0, and 2 additional doses were administered at Week 3 and Week 6. In 
each treatment group, subjects received a total of 3 doses of bimekizumab, administered every 
3 weeks as shown below:

80mg loading dose followed by 40mg at Weeks 3 and 6

160mg loading dose followed by 80mg at Weeks 3 and 6

240mg loading dose followed by 160 mg at Weeks 3 and 6

560mg loading dose followed by 320mg at Weeks 3 and 6
The results of this study demonstrated that all doses of bimekizumab were well tolerated and 
there were no unexpected clinically relevant safety findings. 
Infections (mostly nasopharyngitis) were the most commonly reported events in both the active 
treatment and the placebo group. None of the infections were considered serious or required 
treatment with antibiotics. Two subjects in the active treatment group experienced 1 local 
candida infection each (oropharhyngitis and vulvovaginitis, respectively) that were 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. The exploratory analysis showed 
clinically relevant improvement in activity of psoriatic arthritis and in skin involvement in those 
subjects with concomitant active psoriatic lesions.
Two 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, and efficacy of multiple doses of bimekizumab administered as add-on 
therapy to stable certolizumab pegol therapy in subjects with moderate to severe rheumatoid 
arthritis. UP0031 is a Phase 1 open-label, parallel-group, single-dose study to evaluate the 
relative bioavailability and tolerability of bimekizumab 160mg sc in healthy subjects.
Additional information on the clinical data for bimekizumab is available in the current version of 
the Investigator’s Brochure (IB).
The current study, PS0011, is a 48-week extension study for eligible subjects who complete 
PS0010, a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging 
study in adult subjects with moderate to severe chronic plaque psoriasis. In PS0010, subjects will 
be randomized 1:1:1:1:1:1 to receive the following blinded study treatment regimens for a 
treatment period of 12 weeks:

Bimekizumab 64mg administered sc Q4W

Bimekizumab 160mg administered sc Q4W

Bimekizumab 320mg loading dose administered sc at Baseline followed by 160mg dose 
administered sc Q4W.
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
Bimekizumab 320mg administered sc Q4W

Bimekizumab 480mg administered sc Q4W

Placebo administered sc Q4W
2.2.2
Nonclinical
Parallel inhibition of IL-17A and IL-17F has been shown to be efficacious in a variety of animal 
models of inflammatory disease. Intravenously administered bimekizumab was well tolerated in 
repeat dose toxicology studies in Cynomolgus monkeys with a no observed adverse effect level 
of 200mg/kg/week. The findings of note in toxicity studies were diarrhea related to infectious 
enteritis (observed in the single dose study) and asymptomatic mild colonic ulceration in a 
proportion of animals (in the repeat dose study); this latter finding was not associated with 
hematology abnormalities. Data suggest that bimekizumab has induced primary lesions to the 
mucosa-associated lymphoid tissue via a pharmacologically-related mechanism. In a second 
repeat-dose study, none of the minor apoptosis/necrosis findings observed in gut associated 
lymph nodes were revealed. In animals given the highest dose of bimekizumab in the study 
(20mg/kg/week), a slightly higher number of protozoa (Balantidium coli) was observed in the 
cecum and colon as compared to the control animals and low dose animals. Therefore gut 
associated lymph node lesions observed in the first study are considered to be accidental and/or 
linked to exaggerated pharmacology and proliferation of Balantidium coli and is considered the 
consequence of a change in local mucosal immunity. To date, similar findings have not been 
seen in studies in humans.
Additional information on the nonclinical data for bimekizumab is available in the current 
version of the IB.
3
STUDY OBJECTIVES
3.1
Primary objective
The primary objective of the study is to assess the long-term safety and tolerability of 
bimekizumab.
3.2
Secondary objective
The secondary objective of the study is to assess the efficacy of bimekizumab administered Q4W 
over 48 weeks.
3.3
Other objectives
The other objectives of the study are: 

To assess PK of bimekizumab

To assess the immunogenicity of bimekizumab
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4
STUDY VARIABLES
4.1
Safety variables
4.1.1
Primary safety variable
The primary safety variable is the incidence of TEAEs adjusted by duration of subject exposure 
to treatment.
4.1.2
Other safety variables
Change from Baseline variables will be defined relative to the Baseline measurements from both 
PS0010 and PS0011.
The other safety variables are:

Change from Baseline in clinical laboratory values (chemistry, hematology, and urinalysis) 

Change from Baseline in vital signs

Change from Baseline in physical examination

Change from Baseline in 12-lead ECG results
4.2
Pharmacokinetic variable
The PK variable is plasma concentrations of bimekizumab.
4.3
Immunological variable
The immunological variable is anti-bimekizumab antibody levels prior to and following study 
treatment.
4.4
Efficacy variables
Change from Baseline variables will be defined relative to the Baseline measurements from both 
PS0010 and PS0011.
4.4.1
Secondary efficacy variables
The secondary efficacy variables are:

PASI90 response over time

IGA response (Clear or Almost Clear with at least a 2 category improvement from Baseline 
on a 5-point scale) over time
4.4.2
Other efficacy variables
The efficacy variables are listed below and will be evaluated at all scheduled visits in accordance 
with the schedule of assessments in Table 5‒1. 

PASI75 and PASI100 response

Absolute and percent change from Baseline in PASI score

Shift from Baseline in IGA score

Change from Baseline in DLQI
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
Percent of subjects achieving a DLQI score of 0 or 1

Absolute and percent change from Baseline in the BSA affected by psoriasis

Change from Baseline in mNAPSI score (in the subgroup of subjects with psoriatic nail 
disease at Baseline)

Change from Baseline in the PSSI (in the subgroup of subjects with scalp psoriasis at 
Baseline)

Change from Baseline in the PGADA for the arthritis visual analog scale (VAS)

Change from Baseline in SF-36 Physical Component Summary (PCS) score, Mental 
Component Summary (MCS) score, and individual domains

Change from Baseline in the HADS Anxiety (HADS-A) and Depression (HADS-D) scores

Percentage of subjects with scores below 8 in HADS-A and HADS-D (subjects with normal 
scores)
5
STUDY DESIGN
5.1
Study description
PS0011 is a multicenter, 48-week, double-blind, placebo-controlled, parallel-group, extension 
study to assess the long-term safety, tolerability, and efficacy of bimekizumab in eligible adult 
subjects with moderate to severe chronic plaque psoriasis who complete PS0010. At Week 12 of 
PS0010, all eligible subjects continuing into PS0011 will undergo the PS0010 Week 12 study 
assessments and any additional PS0011 Baseline assessments, and will then receive their first 
dose of bimekizumab or placebo in PS0011.
During the Treatment Period, subjects will attend study visits at the study site Q4W for study 
assessments and administration of bimekizumab or placebo by study site staff through Week 48. 
Any subject who does not achieve PASI75 response at Week 12 or later in PS0011 will be 
withdrawn from study treatment and will return to complete the Early Withdrawal Visit 
assessments. Following completion or early withdrawal from the 48-week Treatment Period, 
subjects will return for a SFU Visit 20 weeks after their last dose of bimekizumab or placebo in 
PS0011.
Subjects withdrawing early from the study will undergo the Early Withdrawal Visit assessments 
and will enter the SFU Period.
Subjects who received placebo or bimekizumab 64mg, 160mg, or 320mg loading dose + 160mg 
Q4W in PS0010 must achieve PASI90 response at Week 12 in PS0010 to enter the PS0011 
extension study on the same treatment dose. Subjects who do not achieve PASI90 response at 
Week 12 in PS0010 while receiving placebo or bimekizumab 64mg Q4W will be assigned to 
receive bimekizumab 160mg Q4W on entering PS0011. Subjects who do not achieve PASI90 
response at Week 12 in PS0010 while receiving bimekizumab 160mg or 320mg loading dose 
+ 160mg Q4W will be assigned to receive bimekizumab 320mg Q4W on entering PS0011. 
Subjects who receive bimekizumab 320mg or 480mg Q4W in PS0010 will be assigned to receive 
bimekizumab 320mg Q4W on entering PS0011, regardless of their PASI90 response at Week 12 
in PS0010.  
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A schedule of study assessments in presented in Table 5‒1.
A study schematic diagram of PS0011 is presented in Figure 5‒1.
5.1.1
Study duration per subject
The study duration for each subject is estimated to be up to a maximum of 64 weeks:

Treatment Period: up to 48 weeks

SFU Visit: 20 weeks after the last dose of bimekizumab or placebo
The end of the study is defined as the date of the last visit of the last subject in the study.
5.1.2
Planned number of subjects and sites
Up to 240 subjects are anticipated to enroll in PS0011 at approximately 40 sites.
5.1.3
Anticipated regions and countries
The regions planned for study conduct are Europe, Canada, and the US, with possible extension 
to other regions and countries as required in PS0010.
5.2
Schedule of study assessments
A schedule of study assessments is presented in Table 5‒1.
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Table 5‒1:
Schedule of study assessments
Visit Week a
Protocol activity
PS0011 
Baseline
Treatment Period
Wk 
4
Wk 
8
Wk 
12
Wk 
16
Wk 
20
Wk 
24
Wk 
28
Wk 
32
Wk 
36
Wk 
40
Wk 
44
Wk 48/ 
WD
SFU b
Informed consent
X c
Inclusion/exclusion
X d
Physical exam e
X f
X
X
Body weight
X f
X
X
Vital signs g
X f
X
X
X
X
X
X
X
X
X
X
X
X
X
Hematology/biochemistry
X f
X
X
X
X
X
X
X
X
X
X
X
X
X
Urinalysis
Xf
X
X
X
X
X
12-lead ECG
X f
X
X
X
Pregnancy testing h
X f
X
X
X
X
X
X
X
X
X
X
X
X
X
eC-SSRS
X f
X
X
X
X
X
X
X
X
X
X
X
X
X
IGRA TB test i
j
X
TB questionnaire
X f
X
X
X
X
Blood sample for bimekizumab plasma 
concentrations k
X f
X
X
X
X
X
X
X
X
Blood sample for anti-bimekizumab 
antibodies k
X f
X
X
X
X
X
X
X
X
PASI
X f
X
X
X
X
X
X
X
X
X
X
X
X
X
IGA
X f
X
X
X
X
X
X
X
X
X
X
X
X
X
DLQI
X f
X
X
X
X
X
BSA
X f
X
X
X
X
X
X
X
X
X
X
X
X
mNAPSI
X f
X
X
X
X
X
PSSI
X f
X
X
X
X
X
PGADA
X f
X
X
X
X
SF-36
X f
X
X
X
X
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Table 5‒1:
Schedule of study assessments
Visit Week a
Protocol activity
PS0011 
Baseline
Treatment Period
Wk 
4
Wk 
8
Wk 
12
Wk 
16
Wk 
20
Wk 
24
Wk 
28
Wk 
32
Wk 
36
Wk 
40
Wk 
44
Wk 48/ 
WD
SFU b
HADS
X f
X
X
X
X
X
X
X
X
X
X
X
X
X
Concomitant medications
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Adverse events
X
X
X
X
X
X
X
X
X
X
X
X
X
X l
IXRS
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Bimekizumab administration m
X
X
X
X m
X m
X m
X m
X m
X m
X m
X m
X m
BSA=body surface area; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia-Suicide Severity Rating Scale; 
HADS=Hospital Anxiety and Depression Scale; IGA=Investigator’s Global Assessment; IGRA=interferon gamma release assay; IXRS=interactive voice or web 
response system; mNAPSI=modified Nail Psoriasis Severity Index; PASI=Psoriasis Area and Severity Index; PGADA=Patient's Global Assessment of Disease 
Activity; PSSI=Psoriasis Scalp Severity Index; Q4W=every 4 weeks; SF-36=36-item Short Form Health Survey; SFU=Safety Follow-Up; TB=tuberculosis; 
WD=withdrawal; Wk=week
a Visit windows of ±3 days from the first dose (Baseline) at all visits except SFU, which has a window of -3 and +7 days from scheduled visit date.
b The SFU Visit will occur 20 weeks after the last dose of bimekizumab or placebo.
c Ensure that the informed consent for PS0011 was completed by the subject during the Week 8 or Week 12 Visit of PS0010 (must be done before any study 
assessments are performed for PS0011).
d To be performed prior to the first dose of bimekizumab or placebo in PS0011.
e Includes evaluation of signs and symptoms of active TB and risk for exposure to TB.
f The noted PS0011 Baseline assessments will be obtained at the Week 12 Visit of PS0010 and do not need to be recorded on the case report form for this study.
g Vital signs (blood pressure, pulse rate, and temperature) are to be measured prior to blood sampling and prior to dosing, where applicable.
h Pregnancy testing will be urine testing at all visits except SFU, which will be a serum test.
i It is recommended that the QuantiFERON TB GOLD test be performed.
j Ensure that an IGRA test was performed during the Week 8 Visit of PS0010 and the result was negative.
k All blood samples are to be taken prior to dosing.
l Including assessment for the development of different forms of psoriasis at the SFU visit.
m Subjects who received placebo or bimekizumab 64mg, 160mg, or 320mg loading dose + 160mg Q4W in PS0010 must achieve PASI90 response at Week 12 in 
PS0010 to enter the PS0011 extension study on the same treatment dose. Subjects who do not achieve PASI90 response at Week 12 in PS0010 while receiving 
placebo or bimekizumab 64mg will be assigned to receive bimekizumab 160mg on entering PS0011. Subjects who do not achieve PASI90 response at Week 12 
in PS0010 while receiving bimekizumab 160mg or 320mg loading dose + 160mg will be assigned to receive bimekizumab 320mg Q4W on entering PS0011. 
Subjects who receive bimekizumab 320mg or 480mg Q4W in PS0010 will be assigned to receive bimekizumab 320mg Q4W on entering PS0011, regardless of 
their PASI90 response at Week 12 in PS0010. Any subject who does not achieve PASI75 response at Week 12 or later in PS0011 will be withdrawn from study 
treatment and will return to complete the Early Withdrawal Visit assessments.
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5.3
Schematic diagram
A study schematic diagram of PS0011 is presented in Figure 5‒1.
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Figure 5‒1: Schematic diagram
PASI=Psoriasis Area and Severity Index; Q4W=every 4 weeks; SFU=Safety Follow-Up
a Subjects who received placebo or bimekizumab 64mg, 160mg, or 320mg loading dose + 160mg Q4W in PS0010 must achieve PASI90 response at Week 12 in 
PS0010 to enter the PS0011 extension study on the same treatment dose. Subjects who do not achieve PASI90 response at Week 12 in PS0010 while receiving 
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placebo or bimekizumab 64mg will be assigned to receive bimekizumab 160mg on entering PS0011. Subjects who do not achieve PASI90 response at Week 12 
in PS0010 while receiving bimekizumab 160mg or 320mg loading dose + 160mg will be assigned to receive bimekizumab 320mg Q4W on entering PS0011. 
b Subjects who receive bimekizumab 320mg or 480mg Q4W in PS0010 will be assigned to receive bimekizumab 320mg Q4W on entering PS0011, regardless of 
their PASI90 response at Week 12 in PS0010.
c Any subject who does not achieve PASI75 response at Week 12 or later in PS0011 will be withdrawn from study treatment and will return to complete the 
Early Withdrawal Visit assessments.
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5.4
Rationale for study design and selection of dose
PS0011 is a 48-week, double-blind, placebo-controlled, parallel-group extension study for 
eligible subjects who complete PS0010, a Phase 2b, randomized, double-blind, 
placebo-controlled, parallel-group, dose-ranging study in adult subjects with moderate to severe 
chronic plaque psoriasis. Because some PS0010 subjects may have severe disease, the treatment 
in PS0011 provides more time to respond to a potentially efficacious treatment. PS0011 also 
provides an opportunity for nonresponding PS0010 placebo subjects to receive bimekizumab.
This study will allow the collection of further data on the long-term safety, tolerability, and 
efficacy of bimekizumab in this subject population.
The PS0011 design (Figure 5‒1) allows PASI90 responders in PS0010 to continue their dose in 
PS0011, thus permitting these subjects to remain on the dose that resulted in this response after 
12 weeks of initial treatment in PS0010. It also provides an opportunity for an increased dose 
among PS0010 nonresponders (ie, <PASI90). PASI90 was selected as the response criterion in 
PS0010 to ensure that a sufficiently high efficacy response was achieved. This type of dose 
escalation for those who do not achieve a desired response after 12 weeks is common in clinical 
practice. 
Regardless of PASI90 response at Week 12 of PS0010, subjects who received the 2 highest 
doses of bimekizumab (320mg and 480mg Q4W) in PS0010 will begin PS0011 on the 320mg 
Q4W dose. For those subjects who do achieve PASI90 response, this will allow a continuation of 
the PS0010 dose for subjects initially receiving 320mg Q4W and a dose down for subjects 
originally randomized to the 480mg Q4W dose. Because bimekizumab 480mg Q4W is the 
highest dose evaluated in PS0010 and because it requires 3 injections, it will be of interest to 
evaluate whether these subjects can maintain response in PS0011 with the lower 320mg dose, 
allowing the blind to be maintained with the use of only 2 injections at each study administration 
visit.
To protect against the possibility of exposing subjects to an ineffective treatment for extended 
periods of time, subjects across all treatment groups who have not achieved PASI75 response at 
Week 12 or later in PS0011 will be withdrawn from study treatment. Because this withdrawal 
decision is based strictly on the PASI response and not on the original study treatment, it can be 
done in such a way that will not unblind subjects or Investigators.
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:
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written 
Informed Consent form is signed and dated by the subject.
2. Subject is considered reliable and capable of adhering to the protocol and visit schedule 
according to the judgment of the Investigator.
3. Subject completes all dosing requirements in PS0010 without meeting any withdrawal 
criteria and completes the study.
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4. Female subjects of childbearing potential and male subjects with a partner of childbearing 
potential must continue to use an acceptable method of contraception (as detailed in PS0010) 
for up to 20 weeks after the last dose of study treatment in PS0011. 
6.2
Exclusion criteria
Subjects are not permitted to enroll in the study if any of the following criteria are met:
1. Subject has previously participated in this study.
2. Female subjects who plan to become pregnant during the study or within 20 weeks following 
last dose of study medication. Male subjects who are planning a partner pregnancy during the 
study or within 20 weeks following the last dose.
3. Subject has any medical or psychiatric condition that, in the opinion of the Investigator, 
could jeopardize or would compromise the subject’s ability to participate in this study. Note: 
For any subject with an ongoing serious adverse event (SAE), or a history of serious 
infections (including herpes zoster or hospitalizations) in PS0010, the Medical Monitor must 
be consulted prior to the subject’s entry into PS0011.
4. Subject must have a negative interferon gamma release assay (IGRA) as measured at Week 8 
of PS0010.
5. Any subject who meets any withdrawal criteria in the feeder study (PS0010) is excluded 
from participating in the extension study (PS0011).
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 
Withdrawal 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 pustular form of psoriasis.
6. Subjects considered to have either a suspected new latent tuberculosis (LTB) infection or 
who develop an active TB or NTMB infection during the study (including but not limited to, 
conversion demonstrated by IGRA or other diagnostic means) must be immediately 
discontinued from study medication; an Early Withdrawal Visit must be scheduled as soon as 
possible, but not later than the next regular visit.
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 
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follow-up reports should be completed as per protocol requirements until such time as the TB 
infection resolves. 
Additional information on TB policies are provided in Section 9.8.1.
7. Subject is noncompliant with the study procedures or medications in the opinion of the 
Investigator.
8. Subject uses prohibited concomitant medications, with the exception of topicals, as defined 
in this protocol (Section 7.8.2), that may present a risk to the safety of the subject in the 
opinion of the Investigator and/or the Medical Monitor.
9. Subject has a clinical laboratory value meeting the following criteria:

Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 and above:
subjects must be withdrawn regardless of relationship to study drug or duration of event. 

CTCAE Grade 2
◦
Subjects may remain in the study if the event is transient. If a subject has a Grade 2 
laboratory abnormality, a retest is required within 1 to 2 weeks at a scheduled or 
unscheduled visit. If the repeat value is below Grade 2, the subject may receive the 
next scheduled study treatment. If the value on the repeat is still Grade 2 or above, a 
second repeat test must be performed and results made available prior to the next 
scheduled study treatment. If this second repeat value is still Grade 2 or above, the 
subject must be withdrawn.
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. Subject does not achieve PASI75 at Week 12 or later following study treatment in PS0011.
13. Subject experiences an AE as described below: 

Any CTCAE Grade 3 and above adverse event (AE) that is assessed as related to study 
drug in the opinion of the Investigator 
◦
If the event is deemed to be not related to study drug by the Investigator, the subject 
may remain in the study after approval by the Medical Monitor. 

Any CTCAE Grade 2 event that is evaluated as related to study drug in the opinion of the 
Investigator, is persistent, and falls into any of the following System Organ Classes 
(SOCs): “Blood and lymphatic disorders,” “Cardiac disorders,” or “Vascular disorders.” 
◦
Persistent is defined as lasting 28 days or more, which spans at least 2 scheduled 
injections.
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Investigators should attempt to obtain information on subjects in the case of withdrawal. For 
subjects considered as lost to follow-up, the Investigator should make an effort (at least 1 phone 
call and 1 written message to the subject), and document his/her effort (date and summary of the 
phone call and copy of the written message in the source documents) to complete the final 
evaluation. All results of these evaluations and observations, together with a narrative description 
of the reason(s) for removing the subject, must be recorded in the source documents. The eCRF 
must document the primary reason for withdrawal.
Investigators should contact the Medical Monitor, whenever possible, to discuss the withdrawal 
of a subject in advance.
6.3.1
PDILI IMP discontinuation criteria
Subjects with PDILI must be assessed to determine if investigational medicinal product (IMP) 
must be discontinued. In addition, all concomitant medications and herbal supplements that are 
not medically necessary should also be discontinued. 
The PDILI criteria below require immediate and permanent discontinuation of IMP: 

Subjects with either of the following:

ALT or AST ≥5xULN

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 9.7.1. 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 eCRF must document the primary 
reason for IMP discontinuation.
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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.
7.5
Handling and storage requirements
Bimekizumab and placebo must be stored under refrigerated conditions (2ºC to 8ºC) and 
protected from light. The study drug 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 by controlling the temperature (eg, room, 
refrigeration unit) and by completion of a temperature log in accordance with local requirements 
on a regular basis per study manuals, showing actual and minimum/maximum temperatures 
reached over the time interval.
Study drug 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, as per 
instructions contained in the IMP Handling Manual. Authorization to use any out-of-range IMP 
must be documented and received prior to dispensing or administering the IMP at the study site.
7.6
Drug accountability
A Drug Accountability form will be used to record IMP dispensing and return information on a 
by-subject basis and will serve as source documentation during the course of the study. Details of 
any IMP lost, damaged (due to breakage or wastage), not used, partially used, disposed of at the 
study site, or returned to the Sponsor or designee must also be recorded on the appropriate forms. 
All supplies and pharmacy documentation must be made available throughout the study for UCB 
(or designee) to review.
In order to maintain the blind, all IMP documentation (eg, shipping receipts, drug accountability 
logs, interactive web or voice response system [IXRS] treatment assignments) must be 
maintained and accessed only by trained unblinded site personnel. Designated unblinded site 
personnel must be appropriately trained and licensed (per country guidelines) to administer 
injections. 
Blinded study staff may be delegated the responsibility to receive, inventory, and destroy the 
used kits. The packaging identifies each kit by a unique number that does not correlate to the 
contents and does not unblind study site staff. Unblinded study staff will be responsible for the
preparation (eg, breaking tamper proof sticker on kit) of the IMP, including recording the 
administration information on the source document.
The Investigator (or designee) is responsible for retaining all used, unused, and partially used 
containers of IMP until returned or destroyed.
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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 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. Investigational medicinal product intended for the study 
cannot be used for any other purpose than that described in this protocol.
7.7
Procedures for monitoring subject compliance
During the Treatment Period of this study, study medication will be administered in the clinic 
and compliance will be determined at the visit by study personnel. Drug accountability must be 
recorded on the Drug Accountability Form.
7.8
Concomitant medication(s)/treatment(s)
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)
Topical medications
Subjects may continue to use topical moisturizers or emollients, bath oils, or oatmeal bath 
preparations for skin conditions during the study, as needed. Over-the-counter shampoos for the 
treatment of psoriasis of the scalp are also permitted. 
Subjects will be allowed to use topical medications (corticosteroids, retinoids, Vitamin D analogs 
coal tar, etc) as needed during this extension study.
Other medications
Subjects who were already receiving an established nonsteroidal anti-inflammatory drug 
(NSAID) regimen during PS0010 may continue their use during this study. However, initiation 
of, or increase in dosage of, NSAIDs during the study (especially in subjects with a history of 
gastrointestinal [GI] intolerance to NSAIDs or a history of GI ulceration) should be done with 
caution. Intra-articular injections for arthritis of the knee are allowed.
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Subjects who were already receiving an established anti-depressant regimen during PS0010 may 
continue their use during this study.
7.8.2
Prohibited concomitant treatments (medications and therapies)
The list of prohibited concomitant medications is provided Table 7‒1.
Table 7‒1:
Prohibited psoriasis medications during PS0011
Drug
Systemic retinoids
Systemic treatment (non-biological):
systemic immunosuppressant agents (eg, methotrexate, cyclosporine, azathioprine, thioguanine)
systemic fumarate
systemic corticosteroids
phototherapy or chemophototherapy
Anti-TNFs:
infliximab (including biosimilar), golimumab
etanercept (including biosimilar)
certolizumab pegol
adalimumab (including biosimilar)
Other biologics and other systemic therapies:
apremilast
ustekinumab
Anti-IL-17 therapy
Any other antipsoriatic agent (systemic)
Any other antipsoriatic agent (topical) under investigation
IL=interleukin; TNF=tumor necrosis factor
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 (including attenuated) vaccines is not allowed during the conduct of the 
study or for 20 weeks after the last dose of study drug. Administration of inactivated vaccines is
allowed during the study at the discretion of the Investigator.
7.9
Blinding
Due to differences in presentation of the IMP (bimekizumab and placebo), special precautions 
will be taken to ensure study blinding, and study sites will have blinded and unblinded personnel.
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Bimekizumab and placebo injections will be prepared and administered at the study sites by 
unblinded dedicated study personnel who will only be responsible for dosing and drug 
accountability.
Study sites will be required to have a written blinding plan in place, signed by the Principal 
Investigator, which will detail the site’s steps for ensuring that the double-blind nature of the 
study is maintained. 
During the study, the Sponsor will provide blinded and unblinded site monitors for the purposes 
of verifying safety, efficacy, and drug administration and documentation records. Blinded study 
monitors and study site personnel, blinded to treatment assignment, will not discuss or have 
access to any drug-related information.
When the feeder (PS0010) study is unblinded, selected PS0010 study team members will have 
access to subject-level data. Because treatment assignment in PS0011 is based on PASI90 
response at Week 12 of PS0010 as opposed to randomization, Sponsor personnel with such 
access to the PS0010 data will know the treatment assignments of all PS0010 subjects including 
those continuing in PS0011. This operational unblinding to PS0011 treatment assignment will 
pertain to selected clinical PS0010 study team members (some of whom may be involved in 
PS0011) but will not extend to blinded staff at the investigational sites of PS0011. 
While the blinding of Sponsor clinical study team members is important for ensuring the 
integrity of data collection and analysis in a controlled study, this unblinding is considered 
acceptable because the primary evaluation of efficacy, upon which sample size calculations were 
based, will be performed in a blinded manner using Week 12 data of PS0010. Additionally, 
because investigational site staff collecting and recording study data remain blinded, those data 
will not be impacted by the unblinding of selected Sponsor clinical study team members. Finally, 
to ensure that unblinding of study team members did not impact the primary safety outcome of 
PS0011, sensitivity analyses will be outlined in the SAP to evaluate what, if any, impact there 
was on the results based on queries that resulted in changes to the AE data following the 
unblinding of PS0010.
Further details are provided in the study manuals and site blinding plan.
7.9.1
Procedures for maintaining and breaking the treatment blind
7.9.1.1
Maintenance of study treatment blind
All subject treatment details (bimekizumab or placebo) will be allocated and maintained by the 
IXRS.
7.9.1.2
Breaking the treatment blind in an emergency situation
The integrity of this clinical study must be maintained by observing the treatment blind. In the 
event of an emergency for which the appropriate treatment for a subject cannot be made without 
knowing the treatment assignment, it will be possible to determine to which treatment arm and 
dose the subject has been allocated by contacting the IXRS. All sites will be provided with 
details of how to contact the system for code breaking at the start of the study. The Medical 
Monitor or equivalent should be consulted prior to unblinding, whenever possible.
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The Clinical Project Manager will be informed immediately via the IXRS when a code is broken, 
but will remain blinded to specific treatment information. Any unblinding of the IMP performed 
by the Investigator must be recorded in the source documents and on the Study Termination 
eCRF page.
7.10
Randomization and numbering of subjects
No randomization will be performed in this study. An IXRS will be used for assigning eligible 
subjects to treatment based on a predetermined assignment schedule. An independent 
biostatistician or designee who is not involved in this study or the feeder study, PS0010, will 
produce this assignment schedule. Details of the study treatments in PS0011 are presented in 
Section 7.2. 
Subjects will continue with the 5-digit subject numbers assigned by IXRS in the preceding study.
8
STUDY PROCEDURES BY VISIT
Table 5‒1 (schedule of study assessments) provides a general overview of study assessments. A 
list of procedures to be completed at each visit is provided in the sections that follow. 

Visit windows of ±3 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 ±3 days is relative to the first dose 
(Baseline) and applicable for all subsequent visits. Changes to the dosing schedule outside of 
the 3-day window must be discussed with the Medical Monitor.

The minimum time between doses should be no less than 24 days and no more than 32 days 
for Q4W dosing.

For the SFU Visit (20 weeks after the last dose of bimekizumab or placebo), 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).
8.1
Baseline Visit
The Baseline assessments noted with an * will be obtained at the Week 12 Visit of PS0010 and 
do not need to be recorded on the eCRF for this study.
All procedures or assessments will be performed prior to administration of study drug, unless 
otherwise noted. The following procedures or assessments will be performed:

Ensure that a separate Informed Consent Form was completed by the subject for PS0011 
during the Week 8 or Week 12 Visit of PS0010 (must be done prior to any PS0011 study 
procedures)

Confirm that a TB test (IGRA) was performed at the Week 8 Visit of PS0010 and the results 
were negative

Assessment of inclusion/exclusion criteria

Vital signs (blood pressure, pulse rate, and temperature)*

Body weight*
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
Physical examination*

Record 12-lead ECG*

eC-SSRS*

TB questionnaire*

PASI*

IGA*

DLQI*

BSA*

mNAPSI*

PSSI*

PGADA*

SF-36*

HADS*

Obtain blood samples for:

Standard safety laboratory tests (hematology and biochemistry)*

Bimekizumab plasma concentration*

Anti-bimekizumab antibodies*

Obtain urine sample for: 

Standard safety laboratory tests (urinalysis)*

Urine pregnancy test for women of childbearing potential*

Concomitant medications

Record AEs

Contact the IXRS

Study medication administration (after all other visit assessments are completed)
8.2
Week 4 (±3 days)
All procedures or assessments will be performed prior to administration of study drug, unless 
otherwise noted. The following procedures or assessments will be performed:

Vital signs (blood pressure, pulse rate, and temperature)

eC-SSRS

PASI

IGA
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
DLQI

BSA

mNAPSI

PSSI

HADS

Obtain blood samples for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

Obtain urine sample for: 

Urine pregnancy test for women of childbearing potential

Concomitant medications

Record AEs

Contact the IXRS

Study medication administration (after all other visit assessments are completed)
8.3
Week 8 (±3 days); Week 16 (±3 days); Week 32 (±3 days); and 
Week 40 (±3 days)
All procedures or assessments will be performed prior to administration of study drug (if 
applicable), unless otherwise noted. The following procedures or assessments will be performed:

Vital signs (blood pressure, pulse rate, and temperature)

eC-SSRS

PASI

IGA

BSA

HADS

Obtain blood samples for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration (not collected at Week 32)

Anti-bimekizumab antibodies (not collected at Week 32)

Obtain urine sample for: 

Urine pregnancy test for women of childbearing potential
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
Concomitant medications

Record AEs

Contact the IXRS

Study medication administration (after all other visit assessments are completed)
8.4
Week 12 (±3 days)
The following procedures or assessments will be performed prior to administration of study drug
(if applicable):

Vital signs (blood pressure, pulse rate, and temperature)

eC-SSRS

TB questionnaire

PASI

IGA

DLQI

BSA

mNAPSI

PSSI

PGADA

SF-36

HADS

Obtain blood samples for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

Obtain urine sample for: 

Standard safety laboratory tests (urinalysis)

Urine pregnancy test for women of childbearing potential

Concomitant medications

Record AEs

Contact the IXRS

Study medication administration (after all other visit assessments are completed)
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8.5
Week 20 (±3 days); Week 28 (±3 days); and Week 44 (±3 days)
The following procedures or assessments will be performed prior to administration of study drug 
(if applicable):

Vital signs (blood pressure, pulse rate, and temperature)

eC-SSRS

PASI

IGA

BSA

HADS

Obtain blood samples for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration (collected only at Week 28)

Anti-bimekizumab antibodies (collected only at Week 28)

Obtain urine sample for: 

Urine pregnancy test for women of childbearing potential

Concomitant medications

Record AEs

Contact the IXRS

Study medication administration (after all other visit assessments are completed)
8.6
Week 24 (±3 days)
The following procedures or assessments will be performed prior to administration of study drug 
(if applicable):

Vital signs (blood pressure, pulse rate, and temperature)

Record 12-lead ECG

eC-SSRS

TB questionnaire

PASI

IGA

DLQI

BSA

mNAPSI
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
PSSI

PGADA

SF-36

HADS

Obtain blood sample for:

Standard safety laboratory tests (hematology and biochemistry)

Obtain urine sample for: 

Standard safety laboratory tests (urinalysis)

Urine pregnancy test for women of childbearing potential

Concomitant medications

Record AEs

Contact the IXRS

Study medication administration (after all other visit assessments are completed)
8.7
Week 36 (±3 days)
The following procedures or assessments will be performed prior to administration of study drug 
(if applicable):

Vital signs (blood pressure, pulse rate, and temperature)

eC-SSRS

TB questionnaire

PASI

IGA

DLQI

BSA

mNAPSI

PSSI

PGADA

SF-36

HADS

Obtain blood sample for:

Standard safety laboratory tests (hematology and biochemistry)

Obtain urine sample for: 
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
Standard safety laboratory tests (urinalysis)

Urine pregnancy test for women of childbearing potential

Concomitant medications

Record AEs

Contact the IXRS

Study medication administration (after all other visit assessments are completed)
8.8
Week 48 (±3 days) Study Exit/Early Withdrawal
The following procedures or assessments will be performed:

Vital signs (blood pressure, pulse rate, and temperature)

Body weight

Physical examination

Record 12-lead ECG

eC-SSRS

TB questionnaire

PASI

IGA

DLQI

BSA

mNAPSI

PSSI

PGADA

SF-36

HADS

Obtain blood samples for:

TB test (IGRA; QuantiFERON TB GOLD test is recommended)

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

Obtain urine sample for: 

Standard safety laboratory tests (urinalysis)

Urine pregnancy test for women of childbearing potential
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
Concomitant medications

Record AEs

Contact the IXRS
8.9
SFU Visit (20 weeks after the last dose of bimekizumab or 
placebo; -3/+7 days)
The following procedures or assessments will be performed:

Vital signs (blood pressure, pulse rate, and temperature)

Body weight

Physical examination

eC-SSRS

Record 12-lead ECG

PASI

IGA

HADS

Obtain blood samples for:

Standard safety laboratory tests (hematology and biochemistry)

Serum pregnancy test for women of childbearing potential

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

Obtain urine sample for: 

Standard safety laboratory tests (urinalysis)

Concomitant medications

Record AEs (including assessment for development of other forms of psoriasis)

Contact the IXRS
8.10
Early Withdrawal Visit
Subjects withdrawing early from the study (see Section 6.3) will undergo the same assessments 
as the Week 48 Visit (see Section 8.4) 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 additional visit (or 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 additional visit (or 
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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.
At this visit, any of the following assessments may be performed, depending on the reason for 
the visit:

Vital signs

Physical examination

Record 12-lead ECG 

eC-SSRS

If medically indicated, obtain blood sample(s) for:

Standard safety laboratory tests (hematology and biochemistry) 

The blood sample may also be used for PK assessments, if needed

Obtain urine sample for standard safety laboratory tests (urinalysis; including urine 
pregnancy test)

Concomitant medications

Record AEs
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 Informed Consent form), including any pretreatment and posttreatment periods 
required by the protocol, must be reported in the eCRF even if no IMP was taken but specific 
study procedures were conducted. This includes all AEs not present prior to the initial visit and 
all AEs that recurred or worsened after the initial visit.
Signs or symptoms of the condition/disease for which the IMP is being studied should be 
recorded as AEs only if their nature changes considerably or their frequency or intensity 
increases in a clinically significant manner as compared to the clinical profile known to the 
Investigator from the subject’s history or the Baseline Period.
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9.1.2
Procedures for reporting and recording AEs
The subject will be given the opportunity to report AEs spontaneously. A general prompt will 
also be given at each study 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 employed in the 
study.
9.1.3
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 and the corresponding medical terminology should be clarified in the 
source documentation.
When recording the severity of an AE in the CRF (ie, mild, moderate, or severe), the Investigator 
must refer to the CTCAE Version 4 
(http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm). Details for 
completion of the AE eCRF (including judgment of severity and relationship to IMP) are 
described in the eCRF Completion Guidelines.
9.1.4
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. Further 
details regarding follow up of PDILI events are provided in Section 9.7.1.4.
If an AE is ongoing at the end of the study for a subject, follow up should be provided until 
resolution/stable level of sequelae is achieved, or until the Investigator no longer deems that it is 
clinically significant, or until the subject is lost to follow up. If no follow up is provided, the 
Investigator must provide a justification. The follow up will usually be continued for 20 weeks
after the subject has discontinued his/her IMP.
9.1.5
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
9.1.6
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 Patient Safety (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:
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
The subject should return for an Early Withdrawal Visit.

The subject should immediately stop the intake of the IMP. 

A SFU Visit should be scheduled 20 weeks after the subject has discontinued her IMP.
The Investigator must inform the subject of information currently known about potential risks 
and about available treatment alternatives.
The pregnancy will be documented on the Pregnancy Report and Outcome form provided to the 
Investigator. The progression of the pregnancy and the eventual birth (if applicable) must be 
followed up using the Pregnancy Report and Outcome form in which the Investigator has to 
report on the health of the mother and of the child. Every reasonable attempt should be made to 
follow the health of the child for 30 days after birth for any significant medical issues. In certain 
circumstances, UCB may request that follow up is continued for a period longer than 30 days. If 
the subject is lost to follow up and/or refuses to give information, written documentation of 
attempts to contact the subject needs to be provided by the Investigator and filed at the site. 
UCB’s PS department is the primary contact for any questions related to the data collection for 
the pregnancy, eventual birth, and follow up.
In cases where the partner of a male subject enrolled in a clinical study becomes pregnant, the 
Investigator or designee is asked to contact the subject to request consent of the partner via the 
Partner Pregnancy Consent form that has been approved by the responsible IRB/IEC and should 
be available in the Investigator site file. In case of questions about the consent process, the 
Investigator may contact the UCB/Contract Research Organization (CRO) contract monitor for 
the study. The Investigator will complete the Pregnancy Report and Outcome form and send it to 
UCB’s PS department (for contact details see 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, abortion (elective or 
spontaneous), unintended pregnancy after hormonal contraceptive failure (if the hormonal 
contraceptive was correctly used), ectopic pregnancy, fetal demise, or any congenital 
anomaly/birth defect of the baby. Those SAEs must be additionally reported using the 
Investigator SAE Report form.
9.1.7
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.
9.1.8
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 
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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).
9.1.9
Safety signal detection
Selected data from this study will be reviewed periodically to detect as early as possible any
safety concern(s) related to the IMP so that Investigators, clinical study subjects, regulatory 
authorities, and IRBs/IECs will be informed appropriately and as early as possible.
In addition, an independent Data Monitoring Committee (DMC) will periodically review and 
monitor the safety data from this study and advise UCB. Details are provided in the DMC 
Charter. A Cardiovascular Adjudication Committee will also periodically review and monitor the 
safety data from this study and advise UCB. Details are provided in the Cardiovascular
Adjudication Committee Charter.
The Study Physician or medically qualified designee/equivalent will conduct an ongoing review 
of SAEs and perform ongoing SAE reconciliations in collaboration with the PS representative.
As appropriate for the stage of development and accumulated experience with the IMP, 
medically qualified personnel at UCB may identify additional safety measures (eg, AEs, vital 
signs, laboratory, or ECG results) for which data will be periodically reviewed during the course 
of the study.
9.2
Serious adverse events
9.2.1
Definition of SAE
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 9.5], 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
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(A patient admitted to a hospital, even if he/she is released on the same day, meets the 
criteria for the initial inpatient hospitalization. An emergency room visit that results in 
admission to the hospital would also qualify for the initial inpatient hospitalization criteria. 
However, emergency room visits that do not result in admission to the hospital would not 
qualify for this criteria and, instead, should be evaluated for 1 of the other criteria in the 
definition of serious [eg, life-threatening adverse experience, important medical event].
Hospitalizations for reasons not associated with the occurrence of an AE [eg, preplanned 
surgery or elective surgery for a pre-existing condition that has not worsened or manifested 
in an unusual or uncharacteristic manner] do not qualify for reporting. For example, if a 
subject has a condition recorded on his/her medical history and later has a preplanned surgery 
for this condition, it is not appropriate to record the surgery or hospitalization as an SAE, 
since there is no AE upon which to assess the serious criteria. Please note that, if the 
pre-existing condition has worsened or manifested in an unusual or uncharacteristic manner, 
this would then qualify as an AE and, if necessary, the seriousness of the event would need to 
be determined.)
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.
9.2.2
Procedures for reporting SAEs
If an SAE is reported, UCB must be informed within 24 hours of receipt of this information by 
the site (see contact information for SAE reporting listed in the SAE Reporting section at the 
front of the protocol). The Investigator must forward to UCB (or its representative) a duly 
completed “Investigator SAE Report Form for Development Drug” (SAE report form) provided 
by UCB, even if the data are incomplete, or if it is obvious that more data will be needed in order 
to draw any conclusions. Information recorded on this form will be entered into the global safety 
database.
An Investigator SAE report form will be provided to the Investigator. The Investigator SAE 
Report form must be completed in English. 
It is important for the Investigator, when completing the SAE report form, to include the 
assessment as to a causal relationship between the SAE and the IMP administration. This insight 
from the Investigator is very important for UCB to consider in assessing the safety of the IMP 
and in determining whether the SAE requires reporting to the regulatory authorities in an 
expedited manner.
Additional information (eg, autopsy or laboratory reports) received by the Investigator must be 
provided within 24 hours. All documents in the local language must be accompanied by a 
translation in English, or the relevant information included in the same document must be 
summarized in the Investigator SAE report form.
The Investigator is specifically requested to collect and report to UCB (or its representative) any 
SAEs (even if the Investigator is certain that they are in no way associated with the IMP), up to 
30 days from the end of the study for each subject, and to also inform participating subjects of 
the need to inform the Investigator of any SAE within this period. Serious AEs that the 
Investigator thinks may be associated with the IMP must be reported to UCB regardless of the 
time between the event and the end of the study.
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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. Further 
details regarding follow up of PDILI events is provided in Section 9.7.1.4.
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 definitions in Section 9.2.1
regardless of causality

Suspected transmission of an infectious agent via a medicinal product

AEs of special interest as defined in Section 9.5
9.4
Anticipated SAEs
The following Anticipated SAEs (Table 9‒1) 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 moderate to 
severe chronic plaque psoriasis
MedDRA® system order class
MedDRA preferred term
Skin and subcutaneous tissue disorders
Any psoriatic condition HLT
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
HLT=high level term; MedDRA=Medical Dictionary for Regulatory Activities; SAE=serious adverse event
Note: Exception: Listed events will not be regarded as anticipated SAEs if they are life-threatening or if they result 
in the death of the study subject.
9.5
Adverse events of special interest
An AE of special interest is any AE that a regulatory authority has mandated be reported on an 
expedited basis, regardless of the seriousness, expectedness, or relatedness of the AE to the 
administration of a UCB product/compound.
Potential Hy’s Law, defined as ≥3xULN ALT or AST with coexisting ≥2xULN total bilirubin in 
the absence of ≥2xULN ALP, with no alternative explanation for the biochemical abnormality, 
must ALWAYS be reported to UCB as an AE of special interest (ie, without waiting for any 
additional etiologic investigations to have been concluded). Follow-up information should then 
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be reported if an alternative etiology is identified during investigation and monitoring of the 
subject.
9.6
Adverse events 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 
interest 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 9.8.1), cytopenias, hypersensitivities, suicide 
ideation or behavior (assessed using the eC-SSRS; see Section 9.8.6), depression and anxiety 
(assessed using the HADS; see Section 12.9), major cardiovascular events, and liver function test 
changes/enzyme elevations (ALT, AST, bilirubin; see Section 9.7.1), malignancies, and 
inflammatory bowel diseases.
9.7
Laboratory measurements
Clinical laboratory assessments consist of serum chemistry, hematology, and urinalysis. A 
centralized laboratory will be used to supply all laboratory test supplies and analyze all blood 
and urine samples for hematology, biochemistry, and urinalysis measurements. Any unscheduled 
laboratory testing should also be collected using the central laboratory. Laboratory parameters to 
be measured are listed in Table 9‒2. 
Specific details regarding the handling and processing of serum chemistry, hematology, and 
urinalysis samples are provided in the study laboratory manuals.
Table 9‒2:
Laboratory measurements
Hematology
Chemistry
Urinalysis
Basophils
Calcium
Albumin
Eosinophils
Chloride
Bacteria
Lymphocytes
CRP
Crystals
Atypical lymphocytes
Magnesium
Glucose
Monocytes
Potassium
pH
Neutrophils
Sodium
RBC
Hematocrit
Glucose
WBC
Hemoglobin
BUN
Urine dipstick for pregnancy testinga
MCH
Creatinine
MCHC
ALP
MCV
AST
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Table 9‒2:
Laboratory measurements
Hematology
Chemistry
Urinalysis
Platelet count
ALT
RBC count
GGT
WBC count
Total bilirubin
LDH
Total cholesterol
Serum pregnancy testing a
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; 
RBC=red blood cell; WBC=white blood cell
a Pregnancy testing will be done in all women of childbearing potential and will consist of serum testing at the 
Safety Follow-Up Visit and urine testing at all other visits.
Assessments of PK variables are described in Section 10. Assessments of immunological
variables are described in Section 11.
9.7.1
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 9.5), and, if applicable, also reported as an SAE 
(see Section 9.2.1). 
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 9.7.1.1). The local 
hepatologist is the expert usually consulted by the treating physician for assessment and 
management of potential hepatic disease. This would usually be a hepatologist, but may be a 
gastroenterologist. Additional investigation and monitoring may be required and adapted based 
on the diagnosis after the cause of the liver injury/abnormality is confirmed (details in 
Section 9.7.1.4). 
The results of all monitoring, including laboratory testing and other testing, should be made 
available to the study site and sponsor.
All initial tests resulting in abnormal hepatic laboratory values need to be repeated, but 
appropriate medical action must not be delayed waiting for the repeat result.
If tests are done locally for more rapid results, a concurrent sample should also be sent to the 
central laboratory whenever possible. Medical care decisions are to be made initially using the 
most rapidly available results and a conservative approach must be taken if the results from the 
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2 laboratory tests are significantly different. Data from the local and central laboratory are to be 
recorded on the applicable eCRF pages.
When IMP is discontinued, all concomitant medications and herbal supplements that are not 
medically necessary should also be discontinued. In these cases, the investigator should also 
consider dose reduction for medically necessary concomitant medication and consider changing 
any medically required concomitant medication known to be hepatotoxic to a suitable 
alternative.
When IMP is stopped due to PDILI (as described in Section 6.3.1), IMP must be permanently 
discontinued even if a subsequent alternative diagnosis fully explains the hepatic findings. 
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
Symptoms a of 
hepatitis or 
hypersensitivity
Immediate
Follow up
ALT or 
AST
Total 
bilirubin
Consultation 
requirements
Actions
Testing
Evaluation
≥3xULN
≥2xULN b
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 9.7.1.3); 
recommended to 
occur at the site 
with HCP.
Monitoring of liver 
chemistry values at least 
twice per week until values 
normalize, stabilize, or 
return to within baseline 
values. d
≥3xULN
NA
Yes
≥5xULN
NA
NA
Need for hepatology 
consult to be 
discussed (required if 
ALT or AST 
≥8xULN).
Medical Monitor 
must be notified 
within 24 hours 
(eg, by laboratory 
alert) and subject 
discussed with 
Medical Monitor
ASAP.
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Table 9-3:
Required investigations and follow-up for PDILI
Laboratory value
Symptoms a of 
hepatitis or 
hypersensitivity
Immediate
Follow up
ALT or 
AST
Total 
bilirubin
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 9.7.1.2).
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 
≥2x baseline) 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 48 hours at 
the site with HCP 
(see 
Section 9.7.1.3).
Monitoring of liver 
chemistry values at least 
twice per week for 
2 weeks. d
Immediate IMP 
discontinuation required if 
liver chemistry values 
continue to increase.
After 2 weeks of 
monitoring liver chemistry 
values:
Discontinue IMP if levels 
remain ≥3xULN (and 
≥2x baseline) without 
evidence of resolution d
Continue to monitor until 
values normalize, 
stabilize, or return to 
within baseline values. d
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 alkaline phosphatase, the possibility of an indication of biliary obstruction should be discussed with the Medical Monitor.
c Details provided in Section 9.7.1.1. 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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9.7.1.1
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 9.7.1.3) and SAE report (if applicable).
9.7.1.2
Immediate action: determination of IMP discontinuation
All PDILI events require immediate action, testing, and monitoring. 
The immediate action is dependent on the laboratory values and symptoms of hepatitis or 
hypersensitivity and ranges from continuation of IMP (followed by immediate investigation) to 
immediate and permanent discontinuation (see Section 6.3.1 and Table 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.
9.7.1.3
Testing: identification/exclusion of alternative etiology
The measurements and additional information required for the assessment of PDILI events when 
there is a reasonable possibility that they may have been caused by the IMP include, but are 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 laboratory measurements to be assessed are presented 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 
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/or quantitative)
Hematology
Eosinophil count
Urinalysis
Toxicology screena
Chemistry
Amylase
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
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).
Additional information to be collected is presented in Table 9-5.
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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
9.7.1.4
Follow-up evaluation
Potential drug-induced liver injury events require follow-up monitoring as described in 
Table 9-3. Monitoring should continue until liver chemistry values normalize, stabilize, or return 
to baseline. Determination of stabilization is at the discretion of the investigator in consultation 
with the hepatologist (as applicable) and UCB responsible physician, as needed.
9.8
Other safety measurements
9.8.1
Assessment and management of TB and TB risk factors
All subjects will be assessed for TB through physical examination for signs and symptoms of 
TB, laboratory testing (Section 9.8.1.1), and subject questionnaire (Section 9.8.1.3). A chest 
x-ray can be performed in PS0011, if warranted, to confirm or exclude TB (Section 9.8.1.2).
At the Baseline Visit of PS0011, all subjects will undergo physical examination for signs and 
symptoms of TB and must be confirmed to have undergone an IGRA test (QuantiFERON TB 
GOLD is recommended) at the Week 8 Visit of PS0010 with negative results. In addition, each 
subject will complete a TB questionnaire with questions directed at symptoms of TB and 
potential exposure to TB. 
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Exclusion criteria at Baseline of PS0011
Subjects with known TB infection, at high risk of acquiring TB infection, or latent TB infection 
are excluded. 
a.
Known TB infection whether present or past is defined as:

Active TB infection or clinical signs and symptoms suspicious for TB (pulmonary or 
extra-pulmonary)

History of active TB infection involving any organ system or findings in other organ 
systems consistent with TB infection, unless adequately treated and proven to be fully 
recovered upon consult with a TB specialist

Any evidence by radiography or other imaging modalities consistent with previously 
active TB infection that is not reported in the subject’s medical history
b. High risk of acquiring TB infection is defined as:

Known exposure to another person with active TB infection within the 3 months prior to 
enrollment

Time spent in a healthcare delivery setting or institution where individuals infected with 
TB are housed and where the risk of transmission of infection is high
c.
Latent TB infection is defined as:

The absence of signs, symptoms (ie, evidence of organ-specific involvement), or physical 
findings suggestive of TB infection with a positive IGRA test (or 2 indeterminate IGRA 
test results) and a chest x-ray (or other imaging) without evidence of TB infection. If the 
result of the IGRA test is indeterminate, the particular IGRA test previously performed 
may be repeated once; if positive or indeterminate on retest, the subject may not be 
enrolled in the study. The retest must be done prior to entry in PS0011.
Note: If available, respiratory or other specimens must also be smear and culture 
negative for TB (Centers for Disease Control diagnosis of LTB infection) 
http://www.cdc.gov/TB/topic /testing/default.htm)
d. Current or history of NTMB infection
Signs and Symptoms
The Investigator should consider all potential sites of infection when assessing for TB during the 
physical examination and other evaluations, and based on the subject’s medical or social history.
The most common primary focus of TB is the lung. Other sites may include GI system, 
bone/joints, lymph glands and meninges, etc. However, in immune compromised patients and/or 
patients treated with TNF inhibitors, extrapulmonary manifestations of TB are common 
compared to the normal population.
Some common symptoms that the subject may present are dependent on the primary focus of 
infection and may include cough, blood in sputum, night sweats, lymphadenitis, joint 
pain/swelling, spinal deformity, headache/confusion, abdominal pain (mimicking inflammatory 
bowel disease), etc. Unusual presentations should always be considered.
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Latent TB infection is defined in the “Exclusion Criteria” above. If the result of the IGRA is 
indeterminate, the particular IGRA previously performed may be repeated once; if positive or 
indeterminate on retest, the subject may not be enrolled in the study without further evaluation 
by a TB specialist. In the event of an indeterminate test result, the retest must be done prior to the 
next visit. If LTB infection or active TB is identified, subject must undergo appropriate study 
specified withdrawal procedures. Laboratory diagnosis should be undertaken via mycobacteria 
culture media (or if available by preferred nucleic acid amplification test such as the Xpert MTB 
RIF test) and the result must be negative for TB inducing pathogens.
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 study drug 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 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.
LTB
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 subject must be withdrawn from 
the study. Every related action should be discussed in advance with the Medical Monitor. 
Once withdrawn from study treatment, subjects should return for the Week 48/Withdrawal Visit, 
complete all Early Withdrawal Visit assessments, and complete a SFU Visit (20 weeks after the 
last dose of study medication).
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 study medication and an Early 
Withdrawal 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. 
9.8.1.1
TB assessment by IGRA
During conduct of the study, the TB assessment by IGRA (QuantiFERON TB GOLD is 
recommended) will be performed at Week 8 of PS0010 and should be repeated at Week 48/Early 
Withdrawal Visit 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, the subject must undergo appropriate study-specified withdrawal procedures. In the 
event of an indeterminate test result, the retest must be done prior to the next visit.
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9.8.2
Pregnancy testing
Pregnancy testing will consist of serum testing at the SFU Visit and urine testing at all other 
visits. 
The Baseline Visit urine pregnancy test result must be negative prior to enrollment of the subject. 
A negative urine pregnancy test result should be obtained immediately prior to each 
administration of study drug and at all subsequent visits. Pregnancy tests should be administered 
to all female subjects of childbearing potential, regardless of their use of birth control.
9.8.3
Vital signs
Vital signs will be collected at every visit and will include systolic and diastolic blood pressure, 
pulse rate, and body temperature (oral, axillary, or otic). Subjects should be sitting for 5 minutes 
before and during vital signs assessments. 
Vital signs are to be measured prior to blood sampling, and prior to dosing, where applicable. 
Body weight will be measured at the time points specified in the schedule of study assessments 
(Table 5‒1).
9.8.4
12-lead ECGs
Twelve-lead standard ECGs will be recorded at the visits specified in Table 5‒1, and read by a 
central ECG laboratory. 
Full details of ECG recording will be provided in the ECG Manual. 
9.8.5
Physical examination
The physical examination will include general appearance; ear, nose, and throat; eyes, hair, and 
skin; respiratory; cardiovascular; GI; musculoskeletal; hepatic; neurological (including limb 
reflexes); and mental status. Physical examination will be performed at the at the time points 
specified in the schedule of study assessments (Table 5‒1). Findings considered clinically 
significant changes since the physical examination at the Screening Visit of PS0010 will be 
recorded as AEs.
9.8.6
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 (Mundt et al, 2010; Posner et al, 2011). 
Subjects respond to standardized clinical questions that are presented in a uniform fashion. The 
eC-SSRS defines five subtypes of suicidal ideation and behavior in addition to self-injurious 
behavior with no suicidal intent. The eC-SSRS takes approximately 3 to 10 minutes to complete.
Refer to Section 6.3 for eCSSRS-related withdrawal criteria.
9.8.7
Data Monitoring Committee
The DMC membership includes clinicians knowledgeable about the disease or the treatment. The 
DMC will include a statistician, and at a minimum, specialists in dermatology and infectious 
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disease. All members have experience and expertise in clinical trials. Board members may not 
participate in the study as principal or co-Investigators, or as study subject care physicians. The 
duration of membership for the DMC will be inclusive of planned analyses for PS0011. The 
DMC may also be asked to provide a review of final study results, as deemed appropriate.
The detailed role, scope, responsibilities, and complete procedures, as well as the identity of the 
DMC members, will be described in a separate charter document.
The DMC procedures will ensure that data remain blind to the study team and Investigators at all 
times throughout the conduct of the study.
A Cardiovascular Adjudication Committee will also periodically review the safety data from this 
study. Details will be described in a separate charter document.
10
ASSESSMENT OF PHARMACOKINETIC VARIABLES
Blood samples for measurement of PK (Section 4.2) will be collected at the time points specified 
in the schedule of study assessments (Table 5‒1). 
At dosing visits, blood samples will be drawn prior to dosing, and will be drawn at the same time 
of the sampling for clinical laboratory tests. The time and date of collection will be recorded in 
the eCRF. 
Instructions pertaining to sample collection, processing, storage, labeling, and shipping are 
provided in the laboratory manual for this study. Detailed information on sample analysis will be 
provided in a bioanalytical report.
11
ASSESSMENT OF IMMUNOLOGICAL VARIABLES
Blood samples for measurement of antibodies to bimekizumab will be collected at the visits 
specified in Table 5‒1. The threshold for antibody positivity will be defined prior to analysis.
At dosing visits, blood samples will be drawn prior to dosing, and will be drawn at the same time 
of the sampling for clinical laboratory tests. The time and date of collection will be recorded in 
the eCRF. 
Instructions pertaining to sample collection, processing, storage, labeling, and shipping are 
provided in the laboratory manual for this study. The presence of antibodies to bimekizumab will 
be determined using a validated bioanalytical method. Detailed information on sample analysis 
will be provided in a bioanalytical report.
12
ASSESSMENT OF EFFICACY
12.1
Psoriasis Area and Severity Index
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 weighs these with the percentage of BSA involvement. 
The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower 
limbs and then transferred into a grade (Table 12‒1). 
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body 
area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. 
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The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. 
Table 12‒1: Body areas for calculation of percent BSA for PASI
Body area
Details of area
BSA
Degree of involvement of 
body area a
Head
Face, back of head
10% 
0 to 6
Upper 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 PASI50, PASI75, PASI90, and PASI100 responses are based on at least 50%, 75%, 90%, 
and 100% improvement in the PASI score. The improvement will be based on changes from the 
PASI score at the Baseline of PS0010.
The PASI will be completed at the visits specified in Table 5‒1.
12.2
Investigator’s Global Assessment
A static IGA for psoriasis will be used to assess disease severity in all subjects during the study. 
The IGA will be completed at the visits specified in Table 5‒1. 
The Investigator will assess the overall severity of psoriasis using the following 5-point scale:
5 point Investigator’s Global Assessment
Score
Short Descriptor
Detailed Descriptor
0
Clear
No signs of psoriasis; post-inflammatory hyperpigmentation may be 
present
1
Almost clear
No thickening; normal to pink coloration; no to minimal focal scaling
2
Mild
Just detectable to mild thickening; pink to light red coloration; 
predominately fine scaling
3
Moderate
Clearly distinguishable to moderate thickening; dull to bright red, 
clearly distinguishable to moderate thickening; moderate scaling
4
Severe
Severe thickening with hard edges; bright to deep dark red coloration; 
severe/coarse scaling covering almost all or all lesions
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12.3
Dermatology Life Quality Index
The DLQI is a questionnaire designed for use in adult subjects with psoriasis. The DLQI is a skin 
disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect 
patients’ health related quality of life (QOL). This instrument asks subjects about symptoms and 
feelings, daily activities, leisure, work and school, personal relationships and treatment. It has 
been shown to be valid and reproducible in psoriasis patients. The DLQI score ranges from 
0 to 30 with higher scores indicating lower health related QOL. A 5-point change in the DLQI 
score (DLQI response) has been reported to be meaningful for the patient (within-patient 
minimal important difference); while a DLQI absolute score of 0 or 1 indicates no or small 
impact of the disease on health related QOL. Subjects will be asked to complete the DLQI as 
outlined in the Schedule of Study Assessments (Table 5‒1). Study site personnel should ensure 
that each subject completes the instrument prior to leaving the study site. 
12.4
BSA affected by psoriasis
The BSA palm method will be used for the evaluation of BSA as follows:
Body surface area estimation uses the palm (subject’s flat hand and thumb together, fingers 
included) as representing around 1% of the total BSA.

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%
Evaluation of BSA will be completed at the visits specified in Table 5‒1.
12.5
Modified Nail Psoriasis Severity Index
Psoriatic nail disease will be evaluated at the Baseline Visit of PS0010 using the mNAPSI. All 
affected nails will be scored (0 to 3) for onycholysis/oil drop dyschromia, nail plate crumbling, 
and pitting and will be scored (0 for “no” or 1 for “yes”) for leukonychia, nail bed 
hyperkeratosis, splinter haemorrhages and red spots in the lunula. The score for an individual 
nail ranges from 0 to 13 with higher scores indicative of more severe nail disease. The total 
mNAPSI score is the sum of the scores for each individual nail. If a nail is unaffected, it will be 
recorded as such and will not contribute to the total mNAPSI score. Subjects with nail disease at 
Baseline are defined as those with an mNAPSI score >0 at Baseline of PS0010.
The mNAPSI will be assessed at the visits specified in Table 5‒1. 
12.6
Psoriasis Scalp Severity Index
The PSSI considers both the extent of the area of involvement and the severity based on the 
scoring scales outlined in Table 12‒2. The assessment considers erythema, induration, and 
desquamation on the scalp. For each of these 3 elements, the scores of the area and severity are 
multiplied. Then, the score from each element is totaled to obtain the PSSI score. As with the 
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PASI, the PSSI score ranges from 0 to 72 with a higher score indicating increased scalp disease 
severity.
The PSSI will be assessed at the visits specified in Table 5‒1. 
Table 12‒2: Parameters assessed for the PSSI
Assessment of extent of scalp psoriasis
Score
Definition
1
<10%
2
10-29%
3
30-49%
4
50-69%
5
70-89%
6
90-100%
Assessment of clinical symptoms 
(erythema, induration, and desquamation)
Score
Definition
0
Absent
1
Slight
2
Moderate
3
Severe
4
Severest possible
PSSI=Psoriasis Scalp Severity Index
12.7
PGADA for the arthritis VAS
The PGADA for the arthritis VAS will be used to provide an overall evaluation of arthritis 
disease symptoms. Subjects will respond to the question, “Considering all the ways your arthritis 
affects you, please mark a vertical line on the scale below to show how you are feeling today,” 
using a VAS where 0 is “very good, no symptoms” and 100 is “very poor, severe symptoms.”
Each subject will complete the PGADA at the visits specified in Table 5‒1.
12.8
36-Item Short Form Health Survey
The SF-36 (Version 2, standard recall) is a 36-item generic health-related QOL instrument that 
uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical 
Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), 
Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health 
(5 items), and 1 item for perceived stability or change in health (Health Transition) during the 
last year. The concepts represented by these domains contribute to physical, mental, and social 
aspects of health-related QOL. In addition to domain scores, the PCS and MCS scores are 
calculated from the 8 domains (excluding the Health Transition item). Component scores 
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appreciate the impact of each domain on physical and mental health status (Maruish, 2011). Each 
of the 8 domain scores and the component summary scores range from 0 to 100, with a higher 
score indicating a better health status. The domains and the 2 component summary scores are 
standardized with a mean of 50 and a standard deviation of 10 in the general USA population. 
The minimally important differences, in terms of T-score points, for SF-36 domains and 
component summaries are as follows: PCS, 2; MCS, 3; Physical Functioning, 3; Role-
Physical, 3; Bodily Pain, 3; General Health, 2; Vitality, 2; Social Functioning, 3; Role-
Emotional, 4; and Mental Health, 3 (Maruish, 2011).
The SF-36 will be completed by the subject the visits specified in Table 5‒1. 
12.9
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 (Dauden et al, 2009; 
Langley et al, 2010). 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 
(Snaith and Zigmond, 1994).
13
STUDY MANAGEMENT AND ADMINISTRATION 
13.1
Adherence to protocol
The Investigator should not deviate from the protocol. However, the Investigator should take any 
measure necessary in deviation from or not defined by the protocol in order to protect clinical 
study subjects from any immediate hazard to their health and safety. In this case, this action 
should be taken immediately, without prior notification of the regulatory authority, IRB/IEC, or 
Sponsor.
After implementation of such measure, the Investigator must notify the Clinical Project Manager 
of the Sponsor within 24 hours and follow any local regulatory requirements.
13.2
Monitoring
UCB (or designee) will monitor the study to meet the Sponsor’s monitoring 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.
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13.2.1
Definition of source data 
All source documents must be accurate, clear, unambiguous, permanent, and capable of being 
audited. Source documentation 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 of eCRFs are not considered 
acceptable source documents. Source documents are original records in which raw data are first 
recorded. These may include hospital/clinic/general practitioner records, charts, diaries, x-rays, 
laboratory results, printouts, pharmacy records, care records, ECG or other printouts, completed 
scales, or QOL questionnaires, for example. Source documents should be kept in a secure, 
limited access area.
The 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 
that are not FDA Part 11 compliant, must be printed for review by the monitor (eg, ECG reports). 
Once printed, these copies should be signed and dated by the Investigator and become a 
permanent part of the subject’s source documents. The Investigator will facilitate the process for 
enabling the monitor to compare the content of the printout and the data stored in the computer 
to ensure all data are consistent.
Electronic data records, such as Holter monitor records or electroencephalogram records, must 
be saved and stored as instructed by the Sponsor or designee. 
Patient Reported Outcome (PRO) measures (eg, DLQI, SF-36, and PGADA) will be completed 
by each subject utilizing electronic data capture.
13.2.2
Source data verification
Source data verification ensures accuracy and credibility of the data obtained. During monitoring 
visits, reported data are reviewed with regard to being accurate, complete, and verifiable from 
source documents (eg, subject files, recordings from automated instruments, tracings [ECG], 
x-ray films, laboratory notes). All data reported on the eCRF should be supported by source 
documents, unless otherwise specified in Section 13.2.1.
13.3
Data handling
13.3.1
eCRF 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 use an electronic device to capture patient reported outcomes (see 
Section 13.2.1).
Serious AE reporting will be done using the SAE 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.
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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.
13.3.2
Database entry and reconciliation
Case Report Forms/external electronic data will be entered/loaded into a validated electronic 
database using a clinical data management system. 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 to track all data changes in the database once 
the data have been saved initially into the system or electronically loaded. Regular backups of 
the electronic data will be performed.
13.3.3
Subject Enrollment log/Subject Identification Code list
The subject’s enrollment will be recorded in the Subject Enrollment Log.
The Investigator will keep a Subject Identification Code list. This list remains with the 
Investigator and is used for unambiguous identification of each subject.
The subject’s consent and enrollment in the study must be recorded in the subject’s medical 
record. These data should identify the study and document the dates of the subject’s 
participation.
13.4
Termination of the study
UCB reserves the right to temporarily suspend or prematurely discontinue this study either at a 
single site, multiple sites, or at all sites at any time for reasons including, but not limited to, 
safety or ethical issues, inaccurate or incomplete data recording, noncompliance, or 
unsatisfactory enrollment with respect to quality or quantity.
If the study is prematurely terminated or suspended, UCB (or its representative) will inform the 
Investigators/institutions and the regulatory authority(ies) of the termination or suspension and 
the reason(s) for the termination or suspension, in accordance with applicable regulatory 
requirement(s). The IRB/IEC should also be informed and provided with reason(s) for the 
termination or suspension by the Sponsor or by the Investigator/institution, as specified by the 
applicable regulatory requirement(s). In addition, arrangements will be made for the return of all 
unused IMP and other material in accordance with UCB procedures for the study.
13.5
Archiving and data retention
The Investigator will maintain adequate records for the study, including eCRFs, medical records, 
laboratory results, Informed Consent documents, drug dispensing and disposition records, safety 
reports, information regarding 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 
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formal discontinuation of clinical development of the IMP. These documents should be retained 
for a longer period, however, if required by the applicable regulatory requirement(s) or by an 
agreement with UCB (Committee for Proprietary Medicinal Products [CPMP]/ICH/135/95, 2002 
[Section 4.9.5]). The Investigator will contact UCB for authorization prior to the destruction of 
any study records or in the event of accidental loss or destruction of any study records. The 
Investigator will also notify UCB should he/she relocate or move the study-related files to a 
location other than that specified in the Sponsor’s study master file.
13.6
Audit and inspection
The Investigator will permit study-related audits mandated by UCB, after reasonable notice, and 
inspections by domestic or foreign regulatory authorities.
The main purposes of an audit or inspection are to confirm that the rights and well-being of the 
subjects enrolled have been protected, that enrolled subjects (ie, signing consent and undergoing 
study procedures) are appropriate for the study, and that all data relevant for the evaluation of the 
IMP have been processed and reported in compliance with the planned arrangements, the 
protocol, investigational site, and IRB/IEC SOPs, ICH GCP, and applicable regulatory 
requirements.
The Investigator will provide direct access to all study documents, source records, and source 
data. If an inspection by a regulatory authority is announced, the Investigator will immediately 
inform UCB (or designee).
13.7
Good Clinical Practices
Noncompliance with the protocol, ICH-GCP, or local regulatory requirements by the 
Investigator, institution, institution staff, or designees of the Sponsor will lead to prompt action 
by UCB to secure compliance. Continued noncompliance may result in the termination of the 
site’s involvement in the study.
14
STATISTICS
A description of statistical methods is presented below and will be described in more detail in the 
Statistical Analysis Plan (SAP).
14.1
Definition of analysis sets
The Enrolled Set (ES) will consist of all subjects who have given informed consent for PS0011.
The Safety Set (SS) will consist of all subjects who receive at least 1 dose of the study 
medication in PS0011.
The Full Analysis Set (FAS) will consist of all enrolled subjects who receive at least 1 dose of 
the study medication in PS0011 and have a valid efficacy measurement for PASI at Baseline of 
PS0011. 
The Pharmacokinetics Per-Protocol Set (PK-PPS) will consist of all enrolled subjects who 
receive at least 1 dose of the study medication in PS0011 and provide at least 1 quantifiable 
plasma concentration postdose in PS0011.
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14.2
General statistical considerations
No inferential statistical analyses are planned for this extension study. Instead, all variables will 
be presented using summary statistics. For categorical variables, counts and percentages will be 
displayed. For continuous variables, summary statistics will consist of the number of available 
observations, arithmetic mean, standard deviation, median, minimum, and maximum unless 
stated otherwise. 
Because subjects entering PS0011 may or may not be continuing on the same dose as that 
received in PS0010, there are various combinations of treatment that could be received when 
considering both PS0010 and PS0011 together. For describing the summaries to be produced, 
treatment groups will be categorized as either the PS0011 treatment groups or PS0010/PS0011 
treatment groups. These categorizations are outlined below.
PS0011 treatment groups
This refers to the study treatment assigned to the subject at the beginning of PS0011 and does not 
account for the treatment received in PS0010. The PS0011 treatment groups are as follows:

Placebo

Bimekizumab 64mg Q4W

Bimekizumab 160mg Q4W

Bimekizumab 320mg Q4W

All Bimekizumab (optional – to be used only if specified)
PS0010/PS0011 treatment groups
This refers to the combination of the randomized treatment in PS0010 and the treatment assigned 
at the beginning of PS0011. Some groups have been combined where it is considered appropriate 
to do so. The PS0010/PS0011 treatment groups with descriptions are as follows:

Placebo to Placebo – Subjects randomized to placebo in PS0010 who achieve PASI90 
response at Week 12 of PS0010 and continue to receive placebo in PS0011.

Placebo to Bimekizumab 160mg Q4W – Subjects randomized to placebo in PS0010 who do 
not achieve PASI90 response at Week 12 of PS0010 and are treated with bimekizumab 
160mg Q4W in PS0011.

Bimekizumab 64mg to Bimekizumab 64mg – Subjects randomized to bimekizumab 64mg 
Q4W in PS0010 who achieve PASI90 response at Week 12 of PS0010 and continue to 
receive bimekizumab 64mg Q4W in PS0011.

Bimekizumab 64mg to Bimekizumab 160mg – Subjects randomized to bimekizumab 64mg 
Q4W in PS0010 who do not achieve PASI90 response at Week 12 of PS0010 and are treated 
with bimekizumab 160mg Q4W in PS0011.

Bimekizumab 160mg Q4W to Bimekizumab 160mg Q4W – Subjects randomized to 
bimekizumab 160mg Q4W or bimekizumab 320mg loading dose + 160mg Q4W in PS0010 
who achieve PASI90 response at Week 12 of PS0010 and continue to receive bimekizumab 
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160mg Q4W in PS0011. Note that the PS0010 160mg Q4W groups with and without the 
loading dose are combined here.

Bimekizumab 160mg Q4W to Bimekizumab 320mg Q4W – Subjects randomized to 
bimekizumab 160mg Q4W or bimekizumab 320mg loading dose + 160mg Q4W in PS0010 
who do not achieve PASI90 response at Week 12 of PS0010 and are treated with 
bimekizumab 320mg Q4W in PS0011. Note that the PS0010 160mg Q4W groups with and 
without the loading dose are combined here.

Bimekizumab 320mg Q4W to Bimekizumab 320mg Q4W – Subjects randomized to 
bimekizumab 320mg Q4W in PS0010 and continue on 320mg Q4W in PS0011. No 
distinction will be made between subjects that were or were not PASI90 responders at 
Week 12 of PS0010.

Bimekizumab 480mg Q4W to Bimekizumab 320mg Q4W – Subjects randomized to 
bimekizumab 480mg Q4W in PS0010 and continue on 320mg Q4W in PS0011. No 
distinction will be made between subjects that were or were not PASI90 responders at 
Week 12 of PS0010.
The treatment groups to be used in the presentations of safety and efficacy will depend on the 
objective of the summaries and will be specified accordingly.
14.3
Planned 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 
(MedDRA®). Treatment-emergent AEs will be defined as events that have a start date on or 
following the first administration of study treatment in PS0011 through the final administration 
of study treatment +140 days (covering the 20-week SFU Period). Treatment-emergent AEs will 
be categorized by PS0011 treatment group. Tables will include columns for placebo, 
bimekizumab 64mg Q4W, bimekizumab 160mg Q4W, bimekizumab 320mg, and All 
bimekizumab (ie, any dose of bimekizumab). 
14.3.1
Primary safety analysis
All TEAEs will be summarized descriptively by PS0011 treatment group, primary SOC, high 
level term (HLT), and preferred term (PT). This summary will include the exposure adjusted 
incidence rate (EAIR) with associated 95% confidence interval and the exposure adjusted event 
rate (EAER). 
For EAIR, the numerator will be the total number of subjects experiencing the AE. The 
denominator will be 100 subject-years; that is, the total summation of individual subject-years at 
risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at 
risk for those subjects not experiencing that AE, divided by 100. Exposure adjusted incidence 
rates will be presented with a 95% exact confidence interval based upon the Chi-Square 
distribution (Ulm, 1990). 
For EAERs, the numerator will be the number of AEs including repeat occurrences in individual 
subjects; the denominator will be 100 subject-years. That is, the total summation of individual 
subject-years at risk divided by 100. No confidence interval will be computed for EAER. 
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Patient exposure at risk in days will be defined as date of last administration of study medication 
– date of first administration of study medication in PS0011 + 140 days (ie, the duration of the 
SFU Period). If a subject dies, patient exposure at risk is censored at the date of death. The sum 
of these exposure days at risk across subjects is converted to years for the EAIR and EAER 
calculations described above.
14.3.2
Other safety analyses
Additional tables will summarize TEAEs by intensity and relationship to study medication, 
TEAEs leading to withdrawal from the study, treatment-emergent SAEs, and deaths. Other AE 
summaries to be included will be specified in the SAP. All AE tables will be presented by 
PS0011 treatment group (including the All bimekizumab group).
Extent of exposure to study medication in PS0011 will be summarized using descriptive statistics
by PS0011 treatment group. 
Change from Baseline in laboratory values, ECGs, and vital signs will be presented using 
descriptive statistics by PS0010/PS0011 treatment group. As these variables are summarized 
over time and the initial values can be impacted by the randomized treatment in PS0010, the 
presentation by PS0010/PS0011 treatment group is intended to provide perspective on the 
change in these values starting with the initial PS0010 randomization through the 48-week 
Treatment Period of PS0011. The table presentations will display descriptive statistics for the 
PS0010 Baseline followed by descriptive statistics for the observed, change from PS0010 
Baseline, and change from PS0011 results by scheduled visit for PS0011.
14.4
Planned PK analyses
Pharmacokinetic variables will be analyzed for all subjects in the PK-PPS. 
Bimekizumab plasma concentrations will be summarized by PS0010/PS0011 treatment group at 
each scheduled visit. Descriptive statistics for the plasma concentrations at PS0010 Baseline will 
be presented followed by descriptive statistics for the observed, change from PS0010 Baseline, 
and change from PS0011 Baseline results for scheduled visits in PS0011. Summarizing in this 
manner based on the PS0010/PS0011 treatment group will allow for an evaluation of how 
changing doses (where applicable) impacted plasma concentrations relative to both the original 
(PS0010) Baseline as well as the new (PS0011) Baseline. For the descriptive statistics, geometric 
mean, geometric coefficient of variation, and 95% confidence interval for the geometric mean 
will be used instead of the arithmetic mean and standard deviation.
14.5
Planned immunological analyses
Immunological variables will be analyzed for all subjects in the PK-PPS. 
Anti-bimekizumab antibody data will be summarized by PS0010/PS0011 treatment group at 
each scheduled visit. The summary of anti-bimekizumab antibody levels will follow a similar 
approach to that used for the summary of bimekizumab plasma concentrations. Additional 
analyses related to antibody positivity will be performed and will be described in greater detail in 
the SAP.
14.6
Planned efficacy analyses
Efficacy variables will be summarized based on the FAS. The summaries described in this 
section will provide data on maintenance of effect of study treatment over 48 weeks. 
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Responder efficacy variables (PASI75, PASI90, PASI100, IGA, and DLQI score of 0 or 1) will 
be summarized descriptively using counts and percentages by scheduled visit and 
PS0010/PS0011 treatment group. The PASI responder variables will be derived relative to both 
the PS0010 Baseline and the PS0011 Baseline with responder rates being presented side-by-side 
in applicable summary tables. Missing data will be handled by using nonresponder imputation 
(NRI), meaning that subjects that discontinue early or who have missing data at a given time 
point are imputed as though they did not achieve the given response. Supportive summaries will 
be based on observed case data.
Continuous efficacy variables based on the change from Baseline (PASI, DLQI, BSA, mNAPSI, 
PSSI, PGADA, SF-36, and HADS) will be summarized using descriptive statistics by scheduled 
visit and PS0010/PS0011 treatment group. The table presentations will display descriptive 
statistics for the PS0010 Baseline, followed by descriptive statistics for the observed, change 
from PS0010 Baseline, and change from PS0011 Baseline results by scheduled visit for PS0011.
Figures for selected variables will also be generated in order to demonstrate the kinetics of 
response over time. Missing data will be handled by using multiple imputation (MI) via the 
Markov-Chain Monte Carlo (MCMC) method. Supportive summaries will be based on observed 
case data.
14.7
Planned interim analysis and data monitoring
A DMC will review the safety data on a recurring basis as outlined in the DMC charter. In 
addition to these ongoing reviews, an analysis combining safety data from PS0010 and PS0011 
will be performed when the PS0010 study database is locked. This analysis will account for data 
in PS0010 as well as the accrued safety data in PS0011 available at the time of the PS0010 
database lock. At the time of the interim analysis, the DMC will be unblinded; however, the 
Sponsor study team will remain blind. The details of this combined safety analysis of PS0010 
and PS0011, including the events of interest to be considered, will be outlined in the DMC 
charter.
14.8
Determination of sample size
Up to 240 subjects are anticipated to enroll in PS0011. This number is based on the fact that 
240 subjects are planned to be randomized in the feeder study, PS0010. The calculations to reach 
that sample size are outlined in the PS0010 protocol. As the primary objective of this study is to 
assess the long-term safety and tolerability of bimekizumab 320mg Q4W, the number of subjects 
anticipated is based on the number of subjects completing PS0010 and meeting eligibility 
requirements for PS0011.
15
ETHICS AND REGULATORY REQUIREMENTS
15.1
Informed consent
Subject’s informed consent must be obtained and documented in accordance with local 
regulations, ICH-GCP requirements, and the ethical principles that have their origin in the 
principles of the Declaration of Helsinki.
Prior to obtaining informed consent, information should be given in a language and at a level of 
complexity understandable to the subject in both oral and written form by the Investigator (or 
designee). Each subject will have the opportunity to discuss the study and its alternatives with 
the Investigator.
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Prior to participation in the study, the written 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.
15.2
Subject identification cards
Upon signing the Informed Consent, the subject will be provided with a subject identification 
card in the language of the subject. The Investigator will fill in the subject identifying 
information and medical emergency contact information. The Investigator will instruct the 
subject to keep the card with him/her at all times.
15.3
IRBs and IECs
The study will be conducted under the auspices of an IRB/IEC, as defined in local regulations, 
ICH-GCP, and in accordance with the ethical principles that have their origin in the Declaration 
of Helsinki.
The Investigator/UCB will ensure that an appropriately constituted IRB/IEC that complies with 
the requirements of the current ICH-GCP version or applicable country-specific regulations will 
be responsible for the initial and continuing review and approval of the clinical study. Prior to 
initiation of the study, the Investigator/UCB will forward copies of the protocol, Informed 
Consent Form, IB, Investigator’s curriculum vitae (if applicable), advertisement (if applicable), 
and all other subject-related documents to be used for the study to the IRB/IEC for its review and 
approval.
Before initiating a study, the Investigator will have written and dated full approval from the 
responsible IRB/IEC for the protocol.
The Investigator will also promptly report to the IRB/IEC all changes in the study, all 
unanticipated problems involving risks to human subjects or others, and any protocol deviations, 
to eliminate immediate hazards to subjects.
The Investigator will not make any changes in the study or study conduct without IRB/IEC 
approval, except where necessary to eliminate apparent immediate hazards to the subjects. For 
minor changes to a previously approved protocol during the period covered by the original 
approval, it may be possible for the Investigator to obtain an expedited review by the IRB/IEC as 
allowed.
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As part of the IRB/IEC requirements for continuing review of approved studies, the Investigator 
will be responsible for submitting periodic progress reports to the IRB/IEC (based on IRB/IEC 
requirements), at intervals appropriate to the degree of subject risk involved, but no less than 
once per year. The Investigator should provide a final report to the IRB/IEC following study 
completion.
UCB (or its representative) will communicate safety information to the appropriate regulatory 
authorities and all active Investigators in accordance with applicable regulatory requirements. 
The appropriate IRB/IEC will also be informed by the Investigator or the Sponsor, as specified 
by the applicable regulatory requirements in each concerned country. Where applicable, 
Investigators are to provide the Sponsor (or its representative) with evidence of such IRB/IEC 
notification.
15.4
Subject privacy
UCB staff (or designee) will affirm and uphold the subject’s confidentiality. Throughout this 
study, all data forwarded to UCB (or designee) will be identified only by the subject number 
assigned at Screening.
The Investigator agrees that representatives of UCB, its designee, representatives of the relevant 
IRB/IEC, or representatives of regulatory authorities will be allowed to review that portion of the 
subject’s primary medical records that directly concerns this study (including, but not limited to, 
laboratory test result reports, ECG reports, admission/discharge summaries for hospital 
admissions occurring during a subject’s study participation, and autopsy reports for deaths 
occurring during the study).
15.5
Protocol amendments
Protocol changes may affect the legal and ethical status of the study and may also affect the 
statistical evaluations of sample size and the likelihood of the study fulfilling its primary 
objective.
Significant changes to the protocol will only be made as an amendment to the protocol and must 
be approved by UCB, the IRB/IEC, and the regulatory authorities (if required), prior to being 
implemented.
16
FINANCE, INSURANCE, AND PUBLICATION
Insurance coverage will be handled according to local requirements.
Finance, insurance, and publication rights are addressed in the Investigator and/or CRO 
agreements, as applicable.
17
REFERENCES
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comorbidity of psoriasis in children. Br J Dermatol. 2010;162:633-6.
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psoriatic arthritis remains constant following initial diagnosis of psoriasis among patients seen in 
European dermatology clinics. J Eur Acad Dermatol Venereol. 2010;24:548-54.
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Health, National Cancer Institute, Division of Cancer Treatment and Diagnosis. 
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Gelfand JM, Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB. Risk of myocardial 
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Gottlieb AB. Psoriasis: Emerging therapeutic strategies. Nat Rev Drug Discov. 2005;4:19-34.
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Krueger G, Ellis CN. Psoriasis–recent advances in understanding its pathogenesis and treatment. 
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Krueger G, Koo J, Lebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on 
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Kurd SK, Smith N, VanVoorhees A, Troxel AB, Badmaev V, Seykora JT, et al. Oral curcumin 
in the treatment of moderate to severe psoriasis vulgaris: a prospective clinical trial. J Am Acad 
Dermatol. 2008;58:625-31.
Kurd SK, Gelfand JM. The prevalence of previously diagnosed and undiagnosed psoriasis in US 
adults: results from NHANES 2003-2004. J Am Acad Dermatol. 2009;60:218-24.
Langley RG, Krueger GG, Griffiths CEM. Psoriasis: epidemiology, clinical features, and quality 
of life. Ann Rheum Dis. 2005;64(Suppl II):ii18–ii23.
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, double-blind, 
placebo-controlled phase III trial. J Am Acad Dermatol. 2010;63(3):457-65.
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QualityMetric Incorporated; 2011.
Mukhtar R, Choi J, Koo JY. Quality of life issues in psoriasis. Dermatol Clin. 2004;22:389-95. 
Mundt JC, Greist JH, Gelenberg AJ, Katzelnick DJ, Jefferson JW, Model JG. Feasibility and 
validation of a computer-automated Columbia-Suicide Severity Rating Scale using Interactive 
Voice Response Technology. J Psychiatric Res. 2010;44:1224-1228.
Ortonne JP. Redefining clinical response in psoriasis: targeting the pathological basis of disease. 
J Drugs Dermatol. 2004;3:13-20.
Parisi R, Symmons DP, Griffiths CE, Ashcroft DM. Identification and Management of Psoriasis 
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Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, et al. The Columbia-
Suicide Severity Rating Scale: Initial validity and internal consistency findings from three 
multisite studies with adolescents and adults. Am J Psychiatry. 2011;168:1266-1277.
Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United 
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Raychaudhuri SP, Gross J. A comparative study of pediatric onset psoriasis with adult onset 
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and the prevalence of major medical comorbidity: a population-based study. JAMA Dermatol. 
2013;149:1173-9.
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18
APPENDICES
18.1
Protocol Amendment 1
This purpose of this substantial amendment is to revise the study design of PS0011 to allow 
subjects who were responding to placebo or the lowest dose of bimekizumab (64mg Q4W) in 
PS0010 to continue into PS0011 with no change in treatment, while protecting the study blind.
Thus, the study design changed from an open-label to a double-blind, placebo-controlled, 
parallel-group extension study with additional treatment groups included to be consistent with 
the feeder study, PS0010. 
The other changes in this amendment are as follows:

Provide details of the revised PS0011 study including the study type and description 

Clarify the treatments to be administered and the criteria for assigning subjects to treatment
in PS0011  

Reduce the number of secondary objectives to reflect the revised study design

Reassign the PK and immunological variables from secondary objectives to other objectives

Reassign the secondary safety variables to other safety variables

Remove severity and frequency of TEAEs as a safety variable

Remove the population PK from PS0011

Classify the efficacy variables into secondary efficacy variables and other efficacy variables 

Extend the timing of the SFU Visit to 20 weeks after the last dose of study medication

Extend the maximum duration of subject participation to 64 weeks

Increase the frequency of safety laboratory testing (hematology/biochemistry)

Clarify the frequency of safety laboratory testing (urinalysis) 

Revise the frequency of blood sampling for bimekizumab plasma concentrations and 
anti-bimekizumab antibody levels after Week 16

Revise the frequency of completion of HADS

Provide a rationale for the revised study design 

Remove references to legal representatives being able to provide consent on behalf of 
subjects. Subjects who lack the capacity to consent will not be included in the study

Remove specific details on contraception but clarify that continued use of an acceptable 
forms of contraception (as specified in PS0010) is required in PS0011 for up to 20 weeks 
after the last dose of study treatment 

Remove reference to subjects who may have a clinically active infection or medically 
significant infection as being excluded from the study   

Include the requirement that subjects must have a negative IGRA to be eligible for PS0011
(obtained in PS0010)
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
Clarify that subject must complete PS0010 to be eligible to participate in PS0011 

Provide more detail in the Withdrawal Criterion regarding subjects that develop illnesses that 
would interfere with study participation

Clarify that subjects who develop any form of pustular psoriasis (ie, localized or generalized) 
during the study will be withdrawn from the study

Clarify that topicals are not considered prohibited concomitant medication that would result 
in subject withdrawal in the Withdrawal Criteria 

Clarify the HADS thresholds for withdrawal of a subject in the Withdrawal Criteria

Provide more detail in the Withdrawal Criteria regarding the withdrawal of subjects due to
AEs and clinical laboratory values

Clarify the PASI threshold for withdrawal of a subject in the Withdrawal Criteria

Revised IMP description to include bimekizumab and placebo

Provide details on maintaining the blind during the study (eg, drug accountability, drug 
preparation and administration, and study monitoring) even though some clinical study team 
members will be unblinded to treatment assignments in PS0011

Provide details on the procedures for breaking the blind in an emergency situation

Provide further details on the assignment of subject to treatment by the IXRS

Provide additional detail and a reference for recording the severity of AEs

Extend the follow up of AE to 20 weeks after the last dose of IMP

Clarify the adverse events for special monitoring

Remove the requirement to test for alcohol in the PDILI urine toxicology screen

Remove reference to Screening Log for PS0011

Clarify in FAS and PK-PPS that 1 dose of study medication refers to the PS0011 to avoid 
confusion with study medication in PS0010

Add section (General statistical considerations) to provide details on what constitutes 
descriptive statistics and to define 2 different sets of treatment groups that will be used when 
summarizing the data

Update treatment emergent definition in the planned safety analyses to match with the 
revised 20-week SFU period and provide details on treatment groups used for summaries of 
AEs

Remove other safety analysis based on adjuster status as this is no longer applicable given 
the revised study design

Provide additional details to specify what types of summaries will be done for PK and 
immunogenicity data
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Modifications and changes
Global changes
The following changes were made throughout the protocol

The study design was changed from an open-label to a double-blind, placebo-controlled, 
parallel-group design to maintain the study blind

A detailed description of the revised study design was included (schematic diagram and 
scheduled of study assessments were updated)

Treatment groups were added to be consistent with the feeder study PS0010 (with the 
exception of the bimekizumab 480mg Q4W treatment group) 

Secondary objectives were reduced to just 1 efficacy objective

PK and immunological variables were assigned to other objectives

Secondary safety variables were designated as other safety variables 

The timing of the SFU Visit was changed from 17 weeks after the last dose of study 
medication to 20 weeks after the last dose of study medication

The maximum study duration for subjects was changed from 61 weeks to 64 weeks

The frequency of safety laboratory testing (hematology/biochemistry) was increased from 
every 8 weeks to every 4 weeks (at every visit), including the SFU Visit

The frequency of safety laboratory testing (urinalysis) was decreased from every 8 weeks to 
every 12 weeks, including the SFU Visit 

After the Week 16 Visit, the timing of blood samples for the measurement of PK and 
antibodies to bimekizumab was changed from every 8 weeks, followed by the SFU Visit to 
every 12 weeks (up to Week 40), followed by Week 48 and the SFU Visit

The frequency of the HADS assessment was changed from every 12 weeks to every 4 weeks 
(at every visit) and the SFU Visit

The term “photochemotherapy” was changed to “chemophototherapy” throughout for 
consistency

Changes made throughout the statistics section to clarify which treatment groups would be 
used when summarizing data.

Multiple changes made to account for the fact that summaries of change from Baseline 
variables would be calculated relative to the PS0010 Baseline and PS0011 Baseline, with 
both being presented in summary tables.

The List of Abbreviations was revised

Minor editorial revisions were made
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Change #1
TITLE
A MULTICENTER, 48-WEEK, OPEN-LABEL EXTENSION STUDY TO ASSESS THE 
LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF BIMEKIZUMAB IN 
ADULT SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
Has been changed to: 
A MULTICENTER, 48-WEEK, OPEN LABELDOUBLE-BLIND, 
PLACEBO-CONTROLLED, PARALLEL-GROUP EXTENSION STUDY TO ASSESS 
THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF BIMEKIZUMAB IN 
ADULT SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
Change #2
LIST OF ABBREVIATIONS
The following abbreviation has been added
CTCAE
Common Terminology Criteria for Adverse Events
Change #3
LIST OF ABBREVIATIONS
ICH
International Council on Harmonisation
Has been changed to:
ICH
International Council foron Harmonisation
Change #4
LIST OF ABBREVIATIONS
IMP
investigational medicinal product
Has been changed to:
IMP
investigational medicinal product(s)
Change #5
Section 1 Summary
PS0011 is a multicenter, 48-week, open-label extension study to assess the long-term safety, 
tolerability, and efficacy of bimekizumab in eligible adult subjects with moderate to severe 
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chronic plaque psoriasis who complete PS0010. At Week 12 of PS0010, all eligible subjects 
continuing into PS0011 will undergo the PS0010 Week 12 study assessments and PS0011 
Baseline assessments, and will then receive their first open-label dose of bimekizumab.
Has been changed to: 
PS0011 is a multicenter, 48-week, double-blind, placebo-controlled, parallel-group
open label extension study to assess the long-term safety, tolerability, and efficacy of 
bimekizumab in eligible adult subjects with moderate to severe chronic plaque psoriasis who 
complete PS0010. At Week 12 of PS0010, all eligible subjects continuing into PS0011 will 
undergo the PS0010 Week 12 study assessments and any additional PS0011 Baseline 
assessments, and will then receive their first open label dose of bimekizumab or placebo in 
PS0011.
Change #6
Section 1 Summary
During the Open-Label Treatment Period, subjects will attend study visits at the site every 
4 weeks (Q4W) for study assessments and administration of bimekizumab (if applicable) by 
study site staff through Week 48. Following completion or early withdrawal from the 48-week 
Open-Label Treatment Period, subjects will return for a Safety Follow-Up (SFU) Visit at 
17 weeks after their last dose of bimekizumab. Subjects withdrawing early from the study will 
undergo the Early Withdrawal Visit assessments and will enter the SFU Period.
Has been changed to: 
During the Open Label Treatment Period, subjects will attend study visits at the study site
every 4 weeks (Q4W) for study assessments and administration of bimekizumab or placebo (if 
applicable) by study site staff through Week 48. Any subject who does not achieve a Psoriasis 
Area and Severity Index (PASI) 75 response (defined as a 75% reduction in the PASI score 
from the Baseline of PS0010) at Week 12 or later in PS0011 will be withdrawn from study 
treatment and will return to complete the Early Withdrawal Visit assessments. Following 
completion or early withdrawal from the 48-week Open Label Treatment Period, subjects will 
return for a Safety Follow-Up (SFU) Visit at 17 20 weeks after their last dose of bimekizumab
or placebo in PS0011.
Subjects withdrawing early from the study will undergo the Early Withdrawal Visit assessments 
and will enter the SFU Period.
Change #7
Section 1 Summary
The following text has been deleted
Bimekizumab will initially be administered at a dose of 320mg Q4W subcutaneously (sc) 
during the 48 week Open Label Treatment Period, with an option to reduce the dose to 
160mg Q4W at the discretion of the Investigator if the subject achieves a Psoriasis Area 
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and Severity Index (PASI) 90 response (defined as a 90% reduction in the PASI score from 
the Baseline of PS0010) for at least 2 consecutive visits (not including the PS0011 Baseline 
Visit). If the subject’s disease is not adequately controlled on the 160mg Q4W dose, they 
may return to 320mg Q4W. The decision to return to 320mg Q4W dosing should be based 
upon treatment response, tolerability, and Investigator discretion, with the aim to use the 
dosing regimen that achieves the optimal benefit risk for each subject.
Change #8
Section 1 Summary
The following text has been added
Subjects who received placebo or bimekizumab 64mg, 160mg, or 320mg loading dose + 
160mg Q4W in PS0010 must achieve PASI90 response at Week 12 in PS0010 to enter the 
PS0011 extension study on the same treatment dose. Subjects who do not achieve PASI90 
response at Week 12 in PS0010 while receiving placebo or bimekizumab 64mg Q4W will be 
assigned to receive bimekizumab 160mg Q4W on entering PS0011. Subjects who do not 
achieve PASI90 response at Week 12 in PS0010 while receiving bimekizumab 160mg or 
320mg loading dose + 160mg Q4W will be assigned to receive bimekizumab 320mg Q4W 
on entering PS0011. Subjects who receive bimekizumab 320mg or 480mg Q4W in PS0010 
will be assigned to receive bimekizumab 320mg Q4W on entering PS0011, regardless of 
their PASI90 response at Week 12 in PS0010.
Change #9
Section 1 Summary
The primary objective of the study is to assess the long-term safety and tolerability of 
bimekizumab. Secondary objectives of the study are to assess the safety and tolerability of 
reduction of the dose of bimekizumab from 320mg Q4W to 160mg Q4W; to assess the 
pharmacokinetics (PK) of bimekizumab; to assess the immunogenicity of bimekizumab; and to 
assess the efficacy of open-label bimekizumab 320mg Q4W administered over 48 weeks with 
and without dose reduction.
Has been changed to: 
The primary objective of the study is to assess the long-term safety and tolerability of 
bimekizumab. The Ssecondary objectives of the study is are to assess the safety and 
tolerability of reduction of the dose of bimekizumab from 320mg Q4W to 160mg Q4W; to 
assess the pharmacokinetics (PK) of bimekizumab; to assess the pharmacokinetics (PK) of 
bimekizumab; to assess the immunogenicity of bimekizumab; and to assess the efficacy of 
open label bimekizumab 320mg Q4W administered Q4W over 48 weeks. with and without 
dose reduction. The other objectives of the study are to assess the pharmacokinetics (PK) 
and immunogenicity of bimekizumab.
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Change #10
Section 1 Summary
The primary safety variable is the incidence of treatment-emergent adverse events (TEAEs) 
adjusted by duration of subject exposure to treatment. The secondary safety variables are severity 
and frequency of TEAEs and change from Baseline of PS0010 in clinical laboratory values 
(chemistry, hematology, and urinalysis), vital signs, physical examination, and 12-lead 
electrocardiogram (ECG) results.
Has been changed to: 
The primary safety variable is the incidence of treatment-emergent adverse events (TEAEs) 
adjusted by duration of subject exposure to treatment. The other secondary safety variables are 
severity and frequency of TEAEs and change from Baseline of PS0010 and PS0011 in clinical 
laboratory values (chemistry, hematology, and urinalysis), vital signs, physical examination, and 
12-lead electrocardiogram (ECG) results.
Change #11
Section 1 Summary
Pharmacokinetic variables are plasma concentrations of bimekizumab and population PK (CL/F, 
V/F). The immunological variable is anti-bimekizumab antibody levels prior to and following 
study treatment.
Has been changed to: 
The Pharmacokinetic PK variables are is plasma concentrations of bimekizumab and
population PK (CL/F, V/F). Tthe immunological variable is anti-bimekizumab antibody levels 
prior to and following study treatment.
Change #12
Section 1 Summary
The efficacy assessments are PASI, Investigator’s Global Assessment (IGA), Dermatology Life 
Quality Index (DLQI), body surface area (BSA) affected by psoriasis, modified Nail Psoriasis 
Severity Index (mNAPSI) score, Psoriasis Scalp Severity Index (PSSI), Patient's Global 
Assessment of Disease Activity (PGADA), 36-item Short Form Health Survey (SF-36), and the 
Hospital Anxiety and Depression Scale (HADS); a detailed list of efficacy variables is presented 
in Section 4.4.
Has been changed to: 
The efficacy assessments are PASI, Investigator’s Global Assessment (IGA) Dermatology Life 
Quality Index (DLQI), body surface area (BSA) affected by psoriasis, modified Nail Psoriasis 
Severity Index (mNAPSI) score, Psoriasis Scalp Severity Index (PSSI), Patient's Global 
Assessment of Disease Activity (PGADA), 36-item Short Form Health Survey (SF-36), and the 
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Hospital Anxiety and Depression Scale (HADS); a detailed list of the secondary and other
efficacy variables is presented in Section 4.4.
Change #13
Section 2.1.2 Current treatments for psoriasis
Therapy for patients with psoriasis varies according to the severity of disease. Limited or mild 
disease is often treated with topical therapies such as corticosteroids and vitamin D analogs. 
Patients with more severe disease are often treated with photochemotherapy, methotrexate, the 
oral phosphodiesterase 4 (PDE4) inhibitor (apremilast), or biologic agents, such as tumor 
necrosis factor (TNF) antagonists, interleukin (IL) 12/23 inhibitors, and IL-17A inhibitors. The 
effectiveness of TNF inhibitors in the treatment of psoriasis has been demonstrated in many 
Phase 3 clinical studies and has led to the approval of multiple TNF inhibitors for use in patients 
with moderate to severe psoriasis. Interleukin inhibitors include secukinumab and ixekizumab, 
IL-17A inhibitors approved for treatment of moderate to severe psoriasis. Ustekinumab is an 
IL-12/23 antagonist approved for use in patients with moderate to severe psoriasis, and 
brodalumab, an IL-17 receptor antagonist, has completed pivotal Phase 3 studies in psoriasis. 
Standard therapies for psoriasis are listed below:
Has been changed to: 
Therapy for patients with psoriasis varies according to the severity of disease. Limited or mild 
disease is often treated with topical therapies such as corticosteroids and vitamin D analogs. 
Patients with more severe disease are often treated with photochemophototherapy, 
methotrexate, the oral phosphodiesterase 4 (PDE4) inhibitor (apremilast), or biologic agents, 
such as tumor necrosis factor (TNF) antagonists, interleukin (IL) 12/23 inhibitors, and IL-17A 
inhibitors. The effectiveness of TNF inhibitors in the treatment of psoriasis has been 
demonstrated in many Phase 3 clinical studies and has led to the approval of multiple TNF 
inhibitors for use in patients with moderate to severe psoriasis. Interleukin inhibitors include 
secukinumab and ixekizumab, IL-17A inhibitors approved for treatment of moderate to severe 
psoriasis. Ustekinumab is an IL-12/23 antagonist approved for use in patients with moderate to 
severe psoriasis, and brodalumab, an IL-17 receptor antagonist, has completed pivotal Phase 3 
studies in psoriasis. Standard therapies for psoriasis are listed below:
Change #14
Section 2.1.2 Current treatments for psoriasis

Photochemotherapy is a frequent option for moderate to severe patients, but the 
inconvenience of multiple treatment visits and varying efficacy limits its use in the market.
Has been changed to: 

PhotocChemophototherapy is a frequent option for moderate to severe patients, but the 
inconvenience of multiple treatment visits and varying efficacy limits its use in the market. 
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Change #15
Section 2.2.1 Clinical
The current study, PS0011, is a 48-week open-label extension study for eligible subjects who 
complete PS0010, a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, 
dose-ranging study in adult subjects with moderate to severe chronic plaque psoriasis. In 
PS0010, subjects will be randomized 1:1:1:1:1:1 to receive the following blinded study treatment 
regimens for a treatment period of 12 weeks:
Has been changed to: 
The current study, PS0011, is a 48-week open label extension study for eligible subjects who 
complete PS0010, a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, 
dose-ranging study in adult subjects with moderate to severe chronic plaque psoriasis. In 
PS0010, subjects will be randomized 1:1:1:1:1:1 to receive the following blinded study treatment 
regimens for a treatment period of 12 weeks:
Change #16
Section 3.2 Secondary objectives
Secondary objectives of the study are:

To assess the safety and tolerability of reduction of the dose of bimekizumab from 320mg 
Q4W to 160mg Q4W

To assess PK of bimekizumab

To assess the immunogenicity of bimekizumab

To assess the efficacy of open-label bimekizumab 320mg Q4W administered over 48 weeks 
with and without dose reduction 
Has been changed to: 
Section 3.2 Secondary objectives
The Ssecondary objectives of the study is are:

To assess the safety and tolerability of reduction of the dose of bimekizumab from 
320mg Q4W to 160mg Q4W

To assess PK of bimekizumab

To assess the immunogenicity of bimekizumab

tTo assess the efficacy of open labelbimekizumab 320mg Q4W administered Q4W over 
48 weeks. with and without dose reduction
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PS0011
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Change #17
Section 3.3 Other objectives (new section)
The other objectives of the study are: 

To assess PK of bimekizumab

To assess the immunogenicity of bimekizumab
Change #18
Section 4.1.2 Secondary safety variables
Change from Baseline variables will be defined relative to the Baseline measurement from 
PS0010. 
The secondary safety variables are:

Severity and frequency of TEAEs 

Change from Baseline in clinical laboratory values (chemistry, hematology, and urinalysis) 

Change from Baseline in vital signs

Change from Baseline in physical examination

Change from Baseline in 12-lead ECG results
Has been changed to: 
Section 4.1.2 Other Secondary safety variables
Change from Baseline variables will be defined relative to the Baseline measurements from both
PS0010 and PS0011.
The secondary other safety variables are:

Severity and frequency of TEAEs 

Change from Baseline in clinical laboratory values (chemistry, hematology, and urinalysis) 

Change from Baseline in vital signs

Change from Baseline in physical examination

Change from Baseline in 12-lead ECG results
Change #19
Section 4.2 Pharmacokinetic variables
The PK variables are:

Plasma concentrations of bimekizumab and population PK (CL/F, V/F)
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Has been changed to:
Section 4.2 Pharmacokinetic variables
The PK variables are: is Pplasma concentrations of bimekizumab and population PK (CL/F, 
V/F).
Change #20
Section 4.4 Efficacy variables
Change from Baseline variables will be defined relative to the Baseline measurement from 
PS0010.
Has been changed to:
Change from Baseline variables will be defined relative to the Baseline measurements from both
PS0010 and PS0011.
Change #21
Section 4.4.1 Secondary efficacy variables (new section)
The secondary efficacy variables are:

PASI90 response over time

IGA response (Clear or Almost Clear with at least a 2 category improvement from 
Baseline on a 5-point scale) over time
Change #22
Section 4.4.2 Other efficacy variables (new section; text previously under Section 4.4 
Efficacy variables)
The following variables have been designated as secondary efficacy variables and have 
been deleted from the list of other efficacy variables

PASI75, PASI90, and PASI100 response

IGA response (Clear or Almost Clear with at least a 2 category improvement from 
Baseline on a 5-point scale)
Change #23
Section 5.1 Study description
PS0011 is a multicenter, 48-week, open-label extension study to assess the long-term safety, 
tolerability, and efficacy of bimekizumab in eligible adult subjects with moderate to severe 
chronic plaque psoriasis who complete PS0010. At Week 12 of PS0010, all eligible subjects 
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PS0011
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continuing into PS0011 will undergo the PS0010 Week 12 study assessments and PS0011 
Baseline assessments, and will then receive their first open-label dose of bimekizumab.
Has been changed to:
PS0011 is a multicenter, 48-week, double-blind, placebo-controlled, parallel-group
open label extension study to assess the long-term safety, tolerability, and efficacy of 
bimekizumab in eligible adult subjects with moderate to severe chronic plaque psoriasis who 
complete PS0010. At Week 12 of PS0010, all eligible subjects continuing into PS0011 will 
undergo the PS0010 Week 12 study assessments and any additional PS0011 Baseline 
assessments, and will then receive their first open label dose of bimekizumab or placebo in 
PS0011.
Change #24
Section 5.1 Study description
During the Open-Label Treatment Period, subjects will attend study visits at the site Q4W for 
study assessments and administration of bimekizumab (if applicable) by study site staff through 
Week 48. Following completion or early withdrawal from the 48-week Open-Label Treatment 
Period, subjects will return for a SFU Visit at 17 weeks after their last dose of bimekizumab. 
Subjects withdrawing early from the study will undergo the Early Withdrawal Visit assessments 
and will enter the SFU Period.
Has been changed to:
During the Open Label Treatment Period, subjects will attend study visits at the study site
every 4 weeks (Q4W) for study assessments and administration of bimekizumab or placebo (if 
applicable) by study site staff through Week 48. Any subject who does not achieve PASI75 
response at Week 12 or later in PS0011 will be withdrawn from study treatment and will 
return to complete the Early Withdrawal Visit assessments. Following completion or early 
withdrawal from the 48-week Open Label Treatment Period, subjects will return for a Safety 
Follow-Up (SFU) Visit at 17 20 weeks after their last dose of bimekizumab or placebo in 
PS0011.
Subjects withdrawing early from the study will undergo the Early Withdrawal Visit assessments 
and will enter the SFU Period.
Change #25
Section 5.1 Study description
The following text has been deleted
Bimekizumab will initially be administered at a dose of 320mg Q4W sc during the 48 week 
Open Label Treatment Period, with an option to reduce the dose to 160mg Q4W at the 
discretion of the Investigator if the subject achieves a PASI90 response (90% reduction in 
the PASI score from the Baseline of PS0010) for at least 2 consecutive visits (not including 
the PS0011 Baseline Visit). If the subject’s disease is not adequately controlled on the 
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160mg Q4W dose, they may return to 320mg Q4W. The decision to return to 320mg Q4W 
dosing should be based upon treatment response, tolerability, and Investigator discretion, 
with the aim to use the dosing regimen that achieves the optimal benefit risk for each 
subject.
Change #26
Section 5.1 Study description
The following text has been added
Subjects who received placebo or bimekizumab 64mg, 160mg, or 320mg loading dose + 
160mg Q4W in PS0010 must achieve PASI90 response at Week 12 in PS0010 to enter the 
PS0011 extension study on the same treatment dose. Subjects who do not achieve PASI90 
response at Week 12 in PS0010 while receiving placebo or bimekizumab 64mg Q4W will be 
assigned to receive bimekizumab 160mg Q4W on entering PS0011. Subjects who do not 
achieve PASI90 response at Week 12 in PS0010 while receiving bimekizumab 160mg or 
320mg loading dose + 160mg Q4W will be assigned to receive bimekizumab 320mg Q4W 
on entering PS0011. Subjects who receive bimekizumab 320mg or 480mg Q4W in PS0010 
will be assigned to receive bimekizumab 320mg Q4W on entering PS0011, regardless of 
their PASI90 response at Week 12 in PS0010.
Change #27
Section 5.1.1 Study duration per subject
The study duration for each subject is estimated to be up to a maximum of 61 weeks:

Open-Label Treatment Period: up to 48 weeks

SFU Visit: 17 weeks after the last dose of bimekizumab
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 6164 weeks:

Open Label Treatment Period: up to 48 weeks

SFU Visit: 2017 weeks after the last dose of bimekizumab or placebo
The end of the study is defined as the date of the last visit of the last subject in the study.
Change #28
Table 5-1 Schedule of study assessments
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Table 5-1:
Schedule of study assessments
Visit Week a
Protocol activity
PS0011 
Baseline
Open-Label Treatment Period
Wk 
4
Wk 
8
Wk 
12
Wk 
16
Wk 
20
Wk 
24
Wk 
28
Wk 
32
Wk 
36
Wk 
40
Wk 
44
Wk 48/ 
WD
SFU b
Hematology/biochemistry/urinalysis
X f
X
X
X
X
X
X
X
Blood sample for bimekizumab plasma 
concentrations k
X f
X
X
X
X
X
X
X
X
X
Blood sample for anti-bimekizumab
antibodies k
X f
X
X
X
X
X
X
X
X
X
HADS
X f
X
X
X
X
Has been changed to:
Table 5-1:
Schedule of study assessments
Visit Week a
Protocol activity
PS0011 
Baseline
Open Label Treatment Period
Wk 
4
Wk 
8
Wk 
12
Wk 
16
Wk 
20
Wk 
24
Wk 
28
Wk 
32
Wk 
36
Wk 
40
Wk 
44
Wk 48/ 
WD
SFU b
Hematology/biochemistry/urinalysis
X f
X
X
X
X
X
X
X
X
X
X
X
X
X
Urinalysis
Xf
X
X
X
X
X
Blood sample for bimekizumab plasma 
concentrations k
X f
X
X
X
X
X
X
X
X
X
X
Blood sample for anti-bimekizumab
antibodies k
X f
X
X
X
X
X
X
X
X
X
X
HADS
X f
X
X
X
X
X
X
X
X
X
X
X
X
X
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Change #29
Table 5-1 Schedule of study assessments
b The SFU Visit will occur 17 weeks after the last dose.
Has been changed to:
b The SFU Visit will occur 2017 weeks after the last dose of bimekizumab or placebo.
Change #30
Table 5-1 Schedule of study assessments
d To be performed prior to the first dose of open-label bimekizumab.
Has been changed to:
d To be performed prior to the first dose of open label bimekizumab or placebo in PS0011.
Change #31
Table 5-1 Schedule of study assessments
The following footnote has been deleted
m Bimekizumab will be administered at a dose of 320mg Q4W with an option to reduce the 
dose to 160mg Q4W at the discretion of the Investigator if the subject achieves a PASI90 
response (90% reduction in the PASI score from the Baseline of PS0010) for at least 2 
consecutive visits (not including the PS0011 Baseline Visit). If the subject’s disease is not 
adequately controlled on the 160mg Q4W dose, they may return to 320mg Q4W based on 
treatment response, tolerability, and Investigator discretion, with the aim to use the 
dosing regimen that achieves the optimal benefit risk for each subject.
Change #32
Table 5-1 Schedule of study assessments
The following footnote has been added
m Subjects who received placebo or bimekizumab 64mg, 160mg, or 320mg loading dose + 
160mg Q4W in PS0010 must achieve PASI90 response at Week 12 in PS0010 to enter the 
PS0011 extension study on the same treatment dose. Subjects who do not achieve PASI90 
response at Week 12 in PS0010 while receiving placebo or bimekizumab 64mg Q4W will 
be assigned to receive bimekizumab 160mg Q4W on entering PS0011. Subjects who do 
not achieve PASI90 response at Week 12 in PS0010 while receiving bimekizumab 160mg 
or 320mg loading dose + 160mg Q4W will be assigned to receive bimekizumab 320mg 
Q4W on entering PS0011. Subjects who receive bimekizumab 320mg or 480mg Q4W in 
PS0010 will be assigned to receive bimekizumab 320mg Q4W on entering PS0011, 
regardless of their PASI90 response at Week 12 in PS0010. Any subject who does not 
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achieve PASI75 response at Week 12 or later in PS0011 will be withdrawn from study 
treatment and will return to complete the Early Withdrawal Visit assessments.
Change #33
Figure 5-1 Schematic diagram
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Has been changed to:
PASI=Psoriasis Area and Severity Index; Q4W=every 4 weeks; SFU=Safety Follow-Up
a Subjects who received placebo or bimekizumab 64mg, 160mg, or 320mg loading dose + 160mg Q4W in PS0010 must achieve PASI90 response at 
Week 12 in PS0010 to enter the PS0011 extension study on the same treatment dose. Subjects who do not achieve PASI90 response at Week 12 in 
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PS0010 while receiving placebo or bimekizumab 64mg will be assigned to receive bimekizumab 160mg on entering PS0011. Subjects who do not 
achieve PASI90 response at Week 12 in PS0010 while receiving bimekizumab 160mg or 320mg loading dose + 160mg will be assigned to receive 
bimekizumab 320mg Q4W on entering PS0011. 
b Subjects who receive bimekizumab 320mg or 480mg Q4W in PS0010 will be assigned to receive bimekizumab 320mg Q4W on entering PS0011, 
regardless of their PASI90 response at Week 12 in PS0010.
c Any subject who does not achieve PASI75 response at Week 12 or later in PS0011 will be withdrawn from study treatment and will return to complete 
the Early Withdrawal Visit assessments.
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Change #34
Section 5.4 Rationale for study design and dose selection
PS0011 is a 48-week open-label extension study for eligible subjects who complete PS0010, a 
Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study in 
adult subjects with moderate to severe chronic plaque psoriasis. This study will allow the 
collection of further data on the long-term safety, tolerability, and efficacy of bimekizumab in 
this subject population and access/continued access to bimekizumab for subjects who received 
either bimekizumab or placebo in the lead-in study.
Has been changed to:
PS0011 is a 48-week, double-blind, placebo-controlled, parallel-group open label extension 
study for eligible subjects who complete PS0010, a Phase 2b, randomized, double-blind, 
placebo-controlled, parallel-group, dose-ranging study in adult subjects with moderate to severe 
chronic plaque psoriasis. Because some PS0010 subjects may have severe disease, the 
treatment in PS0011 provides more time to respond to a potentially efficacious treatment. 
PS0011 also provides an opportunity for nonresponding PS0010 placebo subjects to receive 
bimekizumab. This study will allow the collection of further data on the long-term safety, 
tolerability, and efficacy of bimekizumab in this subject population. and access/continued 
access to bimekizumab for subjects who received either bimekizumab or placebo in the 
lead in study.
Change #35
Section 5.4 Rationale for study design and dose selection
The following rationale has been deleted
In this study, bimekizumab will initially be administered at a dose of 320mg Q4W sc, with 
an option to reduce the dose to 160mg Q4W at the discretion of the Investigator if the 
subject achieves a PASI90 response (90% reduction in the PASI score from the Baseline of 
PS0010) for at least 2 consecutive visits (not including the PS0011 Baseline Visit). If the 
subject’s disease is not adequately controlled on the 160mg Q4W dose, they may return to 
320mg Q4W. The decision to return to 320mg Q4W dosing should be based upon treatment 
response, tolerability, and Investigator discretion, with the aim to use the dosing regimen 
that achieves the optimal benefit risk for each subject. This will allow the assessment of 
safety, tolerability, and efficacy following a reduction in the bimekizumab dose to 160mg 
Q4W.
The rationale for the selection of the 320mg Q4W dose for this study is based on the 
following: 

The optimal therapeutic dose of bimekizumab will not yet be known at the time subjects 
begin entering PS0011 from PS0010.

Stratification of dosing in PS0011 based on prior dose in PS0010 would result in 
unblinding of PS0010. 
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
The 320mg Q4W dose is within the range of doses that have already been explored by iv 
administration. This dose was selected based on modeling using the currently available 
data and may be modified, if appropriate, as further data are collected on the optimal 
dose of bimekizumab. 

Based on currently available data and modeling, few subjects are expected to have a 
robust response to bimekizumab 64mg Q4W in PS0010. The 320mg Q4W dose allows 
subjects who received placebo or bimekizumab 64mg Q4W in PS0010 to receive a 
potentially effective dose in this extension study. Although some subjects may have had 
some response to a lower dose in PS0010 (eg, 64mg or 160mg), the increased dose in 
PS0011 could provide additional benefit, resulting in an improved response or 
remission. 

The 320mg Q4W dose decreases the risk that subjects who responded to treatment in 
PS0010 experience a loss of efficacy due to a dose reduction upon entry into PS0011. 
Importantly, subjects who are nonresponders after 12 weeks of treatment in PS0011 
will be withdrawn. This minimizes exposure to a possibly noneffective treatment.
Change #36
Section 5.4 Rationale for study design and dose selection
The following rationale has been added
The PS0011 design (Figure 5-1) allows PASI90 responders in PS0010 to continue their dose 
in PS0011, thus permitting these subjects to remain on the dose that resulted in this 
response after 12 weeks of initial treatment in PS0010. It also provides an opportunity for 
an increased dose among PS0010 nonresponders (ie, <PASI90). PASI90 was selected as the 
response criterion in PS0010 to ensure that a sufficiently high efficacy response was 
achieved. This type of dose escalation for those who do not achieve a desired response after 
12 weeks is common in clinical practice. 
Regardless of PASI90 response at Week 12 of PS0010, subjects who received the 2 highest 
doses of bimekizumab (320mg and 480mg Q4W) in PS0010 will begin PS0011 on the 320mg 
Q4W dose. For those subjects who do achieve PASI90 response, this will allow a 
continuation of the PS0010 dose for subjects initially receiving 320mg Q4W and a dose 
down for subjects originally randomized to the 480mg Q4W dose. Because bimekizumab 
480mg Q4W is the highest dose evaluated in PS0010 and because it requires 3 injections, it 
will be of interest to evaluate whether these subjects can maintain response in PS0011 with 
the lower 320mg dose, allowing the blind to be maintained with the use of only 2 injections 
at each study administration visit.
To protect against the possibility of exposing subjects to an ineffective treatment for 
extended periods of time, subjects across all treatment groups who have not achieved 
PASI75 response at Week 12 or later in PS0011 will be withdrawn from study treatment. 
Because this withdrawal decision is based strictly on the PASI response and not on the 
original study treatment, it can be done in such a way that will not unblind subjects or 
Investigators.
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Change #37
Section 6.1 Inclusion criteria 
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written 
Informed Consent form is signed and dated by the subject or by the parent(s) or legal 
representative.
Has been changed to:
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written 
Informed Consent form is signed and dated by the subject. or by the parent(s) or legal 
representative.
Change #38
Section 6.1 Inclusion criteria
2. Subject/legal representative is considered reliable and capable of adhering to the protocol and 
visit schedule according to the judgment of the Investigator.
Has been changed to:
2. Subject/legal representative is considered reliable and capable of adhering to the protocol and 
visit schedule according to the judgment of the Investigator.
Change #39
Section 6.1 Inclusion criteria
3. Subject completes all dosing requirements in PS0010 without meeting any withdrawal criteria.
Has been changed to:
3. Subject completes all dosing requirements in PS0010 without meeting any withdrawal criteria
and completes the study.
Change #40
Section 6.1 Inclusion criteria
4. Female subjects must be postmenopausal (at least 1 year; to be confirmed hormonally at 
the PS0011 Baseline Visit, if less than 2 years since last menstrual period), permanently
sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of 
childbearing potential, must be willing to use a highly effective method of contraception 
up until 20 weeks after last administration of study medication (anticipated 5 half lives), 
and have a negative pregnancy test at Visit 1 (Baseline) and immediately prior to first 
dose. The following methods are considered highly effective when used consistently and 
correctly:
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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, or implantable)

intrauterine device 
intrauterine hormone releasing system 
bilateral tubal occlusion

vasectomized partner (where postvasectomy testing had demonstrated sperm 
clearance).
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 study 
medication. 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 till 20 weeks after the last administration of study medication 
(anticipated 5 half lives).
Has been changed to:
4. Female subjects of childbearing potential and male subjects with a partner of 
childbearing potential must continue to use an acceptable method of contraception (as 
detailed in PS0010) for up to 20 weeks after the last dose of study treatment in PS0011.
Change #41
Section 6.2 Exclusion criteria
Exclusion criterion #4 has been deleted
4. Subject has any current sign or symptom that may indicate a medically significant 
infection.
Change #42
Section 6.2 Exclusion criteria
Exclusion criterion #5 has been deleted
5. Subject has current clinically active infection with Histoplasma, Coccidiodes, 
Paracoccidioides, Pneumocystis, tuberculosis (TB), nontuberculous mycobacteria 
(NTMB), Blastomyces, Aspergillus, or Candidiasis (systemic). Any subject diagnosed 
with Histoplasmosis, Coccidiodes, Paracoccidiodes, Pneumocystis, TB, NTMB, 
Blastomyces, Aspergillus, or Candidiasis (systemic) during PS0010 is excluded from 
PS0011 even if treatment has been completed.
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Change #43
Section 6.2 Exclusion criteria
The following exclusion criterion has been added 
4. Subject must have a negative interferon gamma release assay (IGRA) as measured at 
Week 8 of PS0010.
Change #44
Section 6.2 Exclusion criteria (now exclusion criterion #5; previously exclusion criterion #6)
6. Any subject who meets any withdrawal criteria in the feeder study (PS0010) is excluded from 
participating in the open-label extension study (PS0011).
Has been changed to:
5. Any subject who meets any withdrawal criteria in the feeder study (PS0010) is excluded from 
participating in the open label extension study (PS0011).
Change #45
Section 6.3 Withdrawal criteria
Subjects should be withdrawn from the study and will be asked to complete the Early 
Withdrawal Visit and SFU Visit (17 weeks after the last received dose) if any of the following 
events occur:
Has been changed to:
Subjects should be withdrawn from the study and will be asked to complete the Early 
Withdrawal Visit and SFU Visit (17 20 weeks after the last received dose) if any of the following 
events occur:
Change #46
Section 6.3 Withdrawal criteria
4. Subject develops an illness that would interfere with his/her continued participation.
Has been changed to:
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.
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Change #47
Section 6.3 Withdrawal criteria
5. Subject develops erythrodermic, guttate, or generalized pustular form of psoriasis.
Has been changed to:
5. Subject develops erythrodermic, guttate, or generalized pustular form of psoriasis.
Change #48
Section 6.3 Withdrawal criteria
The following text has been added to withdrawal criterion #6
Additional information on TB policies are provided in Section 9.8.1. 
Change #49
Section 6.3 Withdrawal criteria
8. Subject uses prohibited concomitant medications that may present a risk to the safety of the 
subject in the opinion of the Investigator and/or the Medical Monitor
Has been changed to:
8. Subject uses prohibited concomitant medications, with the exception of topicals, as defined 
in this protocol (Section 7.8.2), that may present a risk to the safety of the subject in the 
opinion of the Investigator and/or the Medical Monitor.
Change #50
Section 6.3 Withdrawal criteria
9. Subject develops laboratory abnormalities (with or without clinical symptoms) of 
neutropenia <1.0x109/L, lymphopenia <0.5x109/L, or other clinically relevant laboratory 
abnormalities consistent with rheumatology Common Terminology Criteria (CTC) 
Grade 3 or higher. (Refer to Section 6.3.1 for withdrawal criteria in relation to potential 
drug induced liver injury [PDILI]).
Has been changed to:
9. Subject has a clinical laboratory value meeting the following criteria:

CTCAE Grade 3 and above: subjects must be withdrawn regardless of relationship 
to study drug or duration of event. 

CTCAE Grade 2
◦
Subjects may remain in the study if the event is transient. If a subject has a 
Grade 2 laboratory abnormality, a retest is required within 1 to 2 weeks at a 
scheduled or unscheduled visit. If the repeat value is below Grade 2, the subject 
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may receive the next scheduled study treatment. If the value on the repeat is still 
Grade 2 or above, a second repeat test must be performed and results made 
available prior to the next scheduled study treatment. If this second repeat value 
is still Grade 2 or above, the subject must be withdrawn. 
Change #51
Section 6.3 Withdrawal criteria
11. Subjects with a HADS-D score ≥15 must be withdrawn. Any subject who has a HADS-D 
score of ≥10 should be referred immediately to a Mental Healthcare Professional for further 
evaluation and potential withdrawal by the Investigator.
Has been changed to:
11. Subjects with a HADS-D score ≥15 must be withdrawn. Any subject who develops has a 
HADS-D score of ≥10 >10 during the study should be referred immediately to a Mental 
Healthcare Professional for further evaluation and potential withdrawal by the Investigator.
Change #52
Section 6.3 Withdrawal criteria
12. Subject does not achieve a PASI50 at Week 12 or later following open-label treatment in 
PS0011.
Has been changed to:
12. Subject does not achieve a PASI50 PASI75 at Week 12 or later following open label study
treatment in PS0011.
Change #53
Section 6.3 Withdrawal criteria
The following withdrawal criterion for AEs has been added
13. Subject experiences an AE as described below: 

Any CTCAE Grade 3 and above adverse event (AE) that is assessed as related to study 
drug in the opinion of the Investigator 
◦
If the event is deemed to be not related to study drug by the Investigator, the subject 
may remain in the study after approval by the Medical Monitor. 

Any CTCAE Grade 2 event that is evaluated as related to study drug in the opinion of the 
Investigator, is persistent, and falls into any of the following System Organ Classes 
(SOCs): “Blood and lymphatic disorders,” “Cardiac disorders,” or “Vascular disorders.” 
◦
Persistent is defined as lasting 28 days or more, which spans at least 2 scheduled 
injections.
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Change #54
Section 7.1 Description of investigational medicinal product
The IMP used in this study is bimekizumab. 
Has been changed to:
The IMP used in this study is are bimekizumab and placebo.
Change #55
Section 7.1 Description of investigational medicinal product
The following description of placebo has been added
Placebo will be supplied as 0.9% sodium chloride aqueous solution (physiological saline, 
preservative free) of pharmacopoeia (USP/Ph.Eur) quality appropriate for injection.
Change #56
Section 7.2 Treatments to be administered
During the Treatment Period, all subjects will receive bimekizumab 320mg Q4W sc 
administered for up to 48 weeks in an open-label manner. At the discretion of the Investigator, 
and if the subject achieves PASI90 response (90% reduction in the PASI score from the Baseline 
of PS0010) for at least for at least 2 consecutive visits (not including the PS0011 Baseline Visit), 
the bimekizumab dose may be reduced to 160mg Q4W sc. If the subject’s disease is not 
adequately controlled on the 160mg Q4W dose, they may return to 320mg Q4W. The decision to 
return to 320mg Q4W dosing should be based upon treatment response, tolerability, and 
Investigator discretion, with the aim to use the dosing regimen that achieves the optimal benefit-
risk for each subject.
Has been changed to:
During the Treatment Period, all subjects will receive bimekizumab or placebo 320mg Q4W sc
administered sc for up to 48 weeks in an open label manner. (refer to Figure 5-1 for further 
details). At the discretion of the Investigator, and if the subject achieves a PASI90 response 
(90% reduction in the PASI score from the Baseline of PS0010) for at least for at least 
2 consecutive visits (not including the PS0011 Baseline Visit), the bimekizumab dose may 
be reduced to 160mg Q4W sc. If the subject’s disease is not adequately controlled on the 
160mg Q4W dose, they may return to 320mg Q4W. The decision to return to 320mg Q4W 
dosing should be based upon treatment response, tolerability, and Investigator discretion, 
with the aim to use the dosing regimen that achieves the optimal benefit risk for each 
subject.
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Change #57
Section 7.2 Treatments to be administered
The following text has been added
Subjects who received placebo or bimekizumab 64mg, 160mg, or 320mg loading dose + 
160mg Q4W in PS0010 must achieve PASI90 response at Week 12 in PS0010 to enter the 
PS0011 extension study on the same treatment dose. Subjects who do not achieve PASI90 
response at Week 12 in PS0010 while on these treatments will be assigned to receive 
bimekizumab 160mg or 320mg Q4W at Baseline in PS0011 as follows:

Subjects receiving placebo and bimekizumab 64mg Q4W in PS0010 will be assigned to 
bimekizumab 160mg Q4W in PS0011.

Subjects receiving bimekizumab 160mg Q4W and 320mg loading dose + 160mg Q4W in 
PS0010 will be assigned to bimekizumab 320mg Q4W in PS0011.
Subjects who receive bimekizumab 320mg or 480mg Q4W in PS0010 will be assigned to 
receive bimekizumab 320mg Q4W on entering PS0011, regardless of their PASI90 response 
at Week 12 in PS0010.
Change #58
Section 7.2 Treatments to be administered
The study medication is to be administered in the clinic by study site staff as 2 sc injections for 
the 320mg dose or 1 sc injection for the 160mg dose. Suitable areas for sc injections are the 
lateral abdominal wall and upper outer thigh. Injection sites should be rotated and injections 
should not be given into areas where the skin is tender, bruised, red, or hard.
Has been changed to:
The study medication is to be administered in the clinic by study site staff as 2 sc injections for 
the 320mg dose or 1 sc injection for the 160mg dose for all study treatments in PS0011.
Suitable areas for sc injections are the lateral abdominal wall and upper outer thigh. Injection 
sites should be rotated, and injections should not be given into areas where the skin is tender, 
bruised, red, or hard.
Change #59
Section 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.
Has been changed to:
Bimekizumab and placebo will be packaged and labeled according to Good Manufacturing 
Practice (GMP) guidelines and applicable laws or regulations. It will be suitably packaged in 
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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.
Change #60
Section 7.4 Labeling
Clinical drug supplies will be labeled in accordance with the current International Council on 
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.
Has been changed to:
Clinical drug supplies will be labeled in accordance with the current International Council onfor
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.
Change #61
Section 7.5 Handling and storage requirements
The IMP must be stored under refrigerated conditions (2ºC to 8ºC) and protected from light. The 
study drug must not be frozen.
Has been changed to:
The IMP Bimekizumab and placebo must be stored under refrigerated conditions (2ºC to 8ºC) 
and protected from light. The study drug must not be frozen.
Change #62
Section 7.6 Drug Accountability
The following text has been added
In order to maintain the blind, all IMP documentation (eg, shipping receipts, drug 
accountability logs, interactive web or voice response system [IXRS] treatment 
assignments) must be maintained and accessed only by trained unblinded site personnel. 
Designated unblinded site personnel must be appropriately trained and licensed (per 
country guidelines) to administer injections. 
Blinded study staff may be delegated the responsibility to receive, inventory, and destroy 
the used kits. The packaging identifies each kit by a unique number that does not correlate 
to the contents and does not unblind study site staff. Unblinded study staff will be
responsible for the preparation (eg, breaking tamper proof sticker on kit) of the IMP, 
including recording the administration information on the source document.
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Change #63
Section 7.8.1 Permitted concomitant treatments (medications and therapies)
Topical medications
Subjects will be allowed to use topical medications (corticosteroids, retinoids, Vitamin D analogs 
coal tar, etc) as needed during this open-label extension.
Has been changed to:
Topical medications
Subjects will be allowed to use topical medications (corticosteroids, retinoids, Vitamin D analogs 
coal tar, etc) as needed during this open label extension study.
Change #64
Section 7.9 Prohibited concomitant treatments (medications and therapies)
The following text has been deleted
Subjects who use prohibited medications will be withdrawn from study treatment but 
followed until the SFU Visit.
Change #65
Table 7-1 Prohibited psoriasis medications during PS0011
phototherapy or photochemotherapy
Has been changed to:
phototherapy or chemophototherapy photochemotherapy
Change #66
Section 7.9 Blinding
The following text has been deleted
This is an open label extension study and no blinding will be performed. All subjects’ treatment 
assignments during PS0010 will remain blinded until database lock of PS0010.
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Change #67
Section 7.9 Blinding
The following text has been added
Due to differences in presentation of the IMP (bimekizumab and placebo), special 
precautions will be taken to ensure study blinding, and study sites will have blinded and 
unblinded personnel.
Bimekizumab and placebo injections will be prepared and administered at the study sites 
by unblinded dedicated study personnel who will only have responsibility for dosing and 
drug accountability.
Study sites will be required to have a written blinding plan in place, signed by the Principal 
Investigator, which will detail the site’s steps for ensuring that the double-blind nature of 
the study is maintained. 
During the study, the Sponsor will provide blinded and unblinded site monitors for the 
purposes of verifying safety, efficacy, and drug administration and documentation records. 
Blinded study monitors and study site personnel, blinded to treatment assignment, will not 
discuss or have access to any drug-related information.
When the feeder (PS0010) study is unblinded, selected PS0010 study team members will 
have access to subject-level data. Because treatment assignment in PS0011 is based on 
PASI90 response at Week 12 of PS0010 as opposed to randomization, Sponsor personnel
with such access to the PS0010 data will know the treatment assignments of all PS0010 
subjects including those continuing in PS0011. This operational unblinding to PS0011 
treatment assignment will pertain to selected clinical PS0010 study team members (some of 
whom may be involved in PS0011) but will not extend to blinded staff at the investigational 
sites of PS0011. 
While the blinding of Sponsor clinical study team members is important for ensuring the 
integrity of data collection and analysis in a controlled study, this unblinding is considered 
acceptable because the primary evaluation of efficacy, upon which sample size calculations 
were based, will be performed in a blinded manner using Week 12 data of PS0010. 
Additionally, because investigational site staff collecting and recording study data remain 
blinded, those data will not be impacted by the unblinding of selected Sponsor clinical 
study team members. Finally, to ensure that unblinding of study team members did not 
impact the primary safety outcome of PS0011, sensitivity analyses will be outlined in the 
SAP to evaluate what, if any, impact there was on the results based on queries that resulted 
in changes to the AE data following the unblinding of PS0010.
Further details are provided in the study manuals and site blinding plan.
Change #68
Section 7.9.1 Procedures for maintaining and breaking the treatment blind (new section)
This new section has been added and subdivided (see Change #69 and Change #70)
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Change #69
Section 7.9.1.1 Maintenance of study treatment blind (new subsection)
The following text has been added
All subject treatment details (bimekizumab or placebo) will be allocated and maintained by 
the IXRS.
Change #70
Section 7.9.1.2 Breaking the treatment blind in an emergency situation (new subsection)
The following text has been added
The integrity of this clinical study must be maintained by observing the treatment blind. In 
the event of an emergency for which the appropriate treatment for a subject cannot be 
made without knowing the treatment assignment, it will be possible to determine to which 
treatment arm and dose the subject has been allocated by contacting the IXRS. All sites 
will be provided with details of how to contact the system for code breaking at the start of 
the study. The Medical Monitor or equivalent should be consulted prior to unblinding, 
whenever possible.
The Clinical Project Manager will be informed immediately via the IXRS when a code is 
broken, but will remain blinded to specific treatment information. Any unblinding of the 
IMP performed by the Investigator must be recorded in the source documents and on the 
Study Termination eCRF page.
Change #71
Section 7.10 Randomization and numbering of subjects
This is an open-label extension study and no randomization will be performed. All subjects will 
receive bimekizumab 320mg Q4W sc with an option to reduce the dose to 160mg Q4W at the 
discretion of the Investigator (see Section 7.2 for further details).
Subjects will continue with the 5-digit subject numbers assigned by the interactive web or voice 
response system (IXRS) in the preceding study. The randomization number must be incorporated 
into the eCRF.
Has been changed to:
This is an open label extension study and nNo randomization will be performed in this study. 
An IXRS will be used for assigning eligible subjects to study treatment based on a 
predetermined assignment schedule. An independent biostatistician or designee who is not 
involved in this study or the feeder study, PS0010, will produce this assignment schedule. 
Details of the study treatments in PS0011 are presented in Section 7.2. All subjects will 
receive bimekizumab 320mg Q4W sc with an option to reduce the dose to 160mg Q4W at 
the discretion of the Investigator (see Section 7.2 for further details).
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Subjects will continue with the 5-digit subject numbers assigned by the interactive web or voice 
response system (IXRS) in the preceding study. The randomization number must be 
incorporated into the eCRF.
Change #72
Section 8 Study procedures by visit

For the SFU Visit (17 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).
Has been changed to:

For the SFU Visit (2017 weeks after the last dose of bimekizumab or placebo), the visit 
should occur no more than 3 days prior to the scheduled visit date and within 7 days after the 
scheduled visit date (-3 days/+7 days).
Change #73
Section 8.2 Week 4 (±3 days)
The following assessment has been added

HADS
Change #74
Section 8.2 Week 4 (±3 days)
A blood sample for safety laboratory testing has been added

Obtain blood samples for:

Standard safety laboratory tests (hematology and biochemistry)
Change #75
Section 8.3 Week 8 (±3 days); Week 16 (±3 days); Week 32 (±3 days); and Week 40 
(±3 days)
The following assessment has been added

HADS
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Change #76
Section 8.3 Week 8 (±3 days); Week 16 (±3 days); Week 32 (±3 days); and Week 40 
(±3 days)

Obtain blood samples for:

Bimekizumab plasma concentration

Anti-bimekizumab antibodies
Has been changed to:

Obtain blood samples for:

Bimekizumab plasma concentration (not collected at Week 32)

Anti-bimekizumab antibodies (not collected at Week 32)
Change #77
Section 8.3 Week 8 (±3 days); Week 16 (±3 days); Week 32 (±3 days); and Week 40 
(±3 days)
A urine sample for safety laboratory testing has been deleted

Obtain a urine sample for:

Standard safety laboratory tests (urinalysis)
Change #78
Section 8.4 Week 12 (±3 days)
A blood sample for safety laboratory testing has been added

Obtain blood samples for: 

Standard safety laboratory tests (hematology and biochemistry)
Change #79
Section 8.4 Week 12 (±3 days)
A urine sample for safety laboratory testing has been added

Obtain urine sample for: 

Standard safety laboratory tests (urinalysis)
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Change #80
Section 8.5 Week 20 (±3 days); Week 28 (±3 days); and Week 44 (±3 days)
The following assessment has been added

HADS
Change #81
Section 8.5 Week 20 (±3 days); Week 28 (±3 days); and Week 44 (±3 days)
Blood samples for safety laboratory testing and for measuring PK and antibodies to 
bimekizumab have been added 

Obtain blood samples for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration (collected only at Week 28)

Anti-bimekizumab antibodies (collected only at Week 28)
Change #82
Section 8.6 Week 24 (±3 days)
A blood sample for measuring PK and antibodies to bimekizumab has been deleted 

Obtain blood samples for:
Bimekizumab plasma concentration

Anti bimekizumab antibodies
Change #83
Section 8.7 Week 36 (±3 days)
A blood sample for safety laboratory testing has been added

Obtain blood sample for:

Standard safety laboratory tests (hematology and biochemistry)
Change #84
Section 8.7 Week 36 (±3 days)
A urine sample for safety laboratory testing has been added

Obtain a urine sample for:

Standard safety laboratory tests (urinalysis)
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Change #85
Section 8.9 SFU Visit (17 weeks after the last dose; -3/+7 days)
Has been changed to:
Section 8.9 SFU Visit (1720 weeks after the last dose of bimekizumab or 
placebo; -3/+7 days)
Change #86
Section 8.9 SFU Visit (17 weeks after the last dose; -3/+7 days)
The following assessment has been added

HADS
Change #87
Section 9.1.3 Description of AEs
Details for completion of the AE eCRF (including judgment of relationship to IMP) are 
described in the eCRF Completion Guidelines.
Has been changed to:
When recording the severity of an AE in the CRF (ie, mild, moderate, or severe), the 
Investigator must refer to the CTCAE Version 4 
(http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm). Details for 
completion of the AE eCRF (including judgment of severity and relationship to IMP) are 
described in the eCRF Completion Guidelines.
Change #88
Section 9.1.4 Follow up of AEs
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 17 weeks 
after the subject has discontinued his/her IMP.
Has been changed to:
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 1720 weeks 
after the subject has discontinued his/her IMP.
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Change #89
Section 9.1.6 Pregnancy

A SFU Visit should be scheduled 17 weeks after the subject has discontinued her IMP.
Has been changed to:

A SFU Visit should be scheduled 1720 weeks after the subject has discontinued her IMP.
Change #90
Section 9.6 Adverse events for special monitoring
Adverse events for special monitoring for this study include: serious infections (including 
opportunistic infections and TB; see Section 9.8.1), cytopenias, hypersensitivities, suicide 
ideation or behavior (assessed using the eC-SSRS; see Section 9.8.6), depression and anxiety 
(assessed using the HADS; see Section 12.9), major cardiac events, and liver function test 
changes/enzyme elevations (ALT, AST, bilirubin; see Section 9.7.1), malignancies, and 
inflammatory bowel diseases.
Has been changed to:
Adverse events for special monitoring for this study include: serious infections (including 
opportunistic infections and TB; see Section 9.8.1), cytopenias, hypersensitivities, suicide 
ideation or behavior (assessed using the eC-SSRS; see Section 9.8.6), depression and anxiety 
(assessed using the HADS; see Section 12.9), major cardiac cardiovascular events, and liver 
function test changes/enzyme elevations (ALT, AST, bilirubin; see Section 9.7.1), malignancies, 
and inflammatory bowel diseases.
Change #91
Table 9-4 PDILI laboratory measurements
a For detecting substances (ie, alcohol, 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.
Has been changed to:
a For detecting substances (ie, alcohol 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.
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Change #92
Section 9.8.1 Assessment and management of TB and TB risk factors
LTB
Once withdrawn from study treatment, subjects should return for the Week 48/Withdrawal Visit, 
complete all Early Withdrawal Visit assessments, and complete a SFU Visit (17 weeks after the 
last dose of study medication).
Has been changed to:
Once withdrawn from study treatment, subjects should return for the Week 48/Withdrawal Visit, 
complete all Early Withdrawal Visit assessments, and complete a SFU Visit (2017 weeks after 
the last dose of study medication).
Change #93
Section 9.8.1.4 TB management
LTB infection and active TB identified during study
The subject should be encouraged to complete a SFU Visit (17 weeks after the last dose of study 
medication).
Has been changed to:
The subject should be encouraged to complete a SFU Visit (2017 weeks after the last dose of 
study medication).
Change #94
Section 13.3.3 Subject Screening and Enrollment log/Subject Identification Code list
The subject’s screening and enrollment will be recorded in the Subject Screening and Enrollment 
Log.
Has been changed to:
Section 13.3.3 Subject Screening and Enrollment log/Subject Identification Code list
The subject’s screening and enrollment will be recorded in the Subject Screening and
Enrollment Log.
Change #95
Section 14.1 Definition of analysis sets
The Full Analysis Set (FAS) will consist of all enrolled subjects who receive at least 1 dose of 
the study medication and have a valid efficacy measurement for PASI at Baseline of PS0011.
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Has been changed to:
The Full Analysis Set (FAS) will consist of all enrolled subjects who receive at least 1 dose of 
the study medication in PS0011 and have a valid efficacy measurement for PASI at Baseline of 
PS0011.
Change #96
Section 14.1 Definition of analysis sets
The Pharmacokinetics Per-Protocol Set (PK-PPS) will consist of all enrolled subjects who 
receive at least 1 dose of the study medication and provide at least 1 quantifiable plasma 
concentration postdose in PS0011.
Has been changed to:
The Pharmacokinetics Per-Protocol Set (PK-PPS) will consist of all enrolled subjects who 
receive at least 1 dose of the study medication in PS0011 and provide at least 1 quantifiable 
plasma concentration postdose in PS0011.
Change #97
Section 14.2 General statistical considerations (new section)
The following text has been added
No inferential statistical analyses are planned for this extension study. Instead, all variables 
will be presented using summary statistics. For categorical variables, counts and 
percentages will be displayed. For continuous variables, summary statistics will consist of 
the number of available observations, arithmetic mean, standard deviation, median, 
minimum, and maximum unless stated otherwise. 
Because subjects entering PS0011 may or may not be continuing on the same dose as that 
received in PS0010, there are various combinations of treatment that could be received 
when considering both PS0010 and PS0011 together. For describing the summaries to be 
produced, treatment groups will be categorized as either the PS0011 treatment groups or 
PS0010/PS0011 treatment groups. These categorizations are outlined below.
PS0011 treatment groups
This refers to the study treatment assigned to the subject at the beginning of PS0011 and 
does not account for the treatment received in PS0010. The PS0011 treatment groups are 
as follows:

Placebo

Bimekizumab 64mg Q4W

Bimekizumab 160mg Q4W

Bimekizumab 320mg Q4W

All Bimekizumab (optional – to be used only if specified)
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PS0010/PS0011 treatment groups
This refers to the combination of the randomized treatment in PS0010 and the treatment 
assigned at the beginning of PS0011. Some groups have been combined where it is 
considered appropriate to do so. The PS0010/PS0011 treatment groups with descriptions 
are as follows:

Placebo to Placebo – Subjects randomized to placebo in PS0010 who achieve PASI90 
response at Week 12 of PS0010 and continue to receive placebo in PS0011.

Placebo to Bimekizumab 160mg Q4W – Subjects randomized to placebo in PS0010 who 
do not achieve PASI90 response at Week 12 of PS0010 and are treated with 
bimekizumab 160mg Q4W in PS0011.

Bimekizumab 64mg to Bimekizumab 64mg – Subjects randomized to bimekizumab 
64mg Q4W in PS0010 who achieve PASI90 response at Week 12 of PS0010 and 
continue to receive bimekizumab 64mg Q4W in PS0011.

Bimekizumab 64mg to Bimekizumab 160mg – Subjects randomized to bimekizumab 
64mg Q4W in PS0010 who do not achieve PASI90 response at Week 12 of PS0010 and 
are treated with bimekizumab 160mg Q4W in PS0011.

Bimekizumab 160mg Q4W to Bimekizumab 160mg Q4W – Subjects randomized to 
bimekizumab 160mg Q4W or bimekizumab 320mg loading dose + 160mg Q4W in 
PS0010 who achieve PASI90 response at Week 12 of PS0010 and continue to receive 
bimekizumab 160mg Q4W in PS0011. Note that the PS0010 160mg Q4W groups with 
and without the loading dose are combined here.

Bimekizumab 160mg Q4W to Bimekizumab 320mg Q4W – Subjects randomized to 
bimekizumab 160mg Q4W or bimekizumab 320mg loading dose + 160mg Q4W in 
PS0010 who do not achieve PASI90 response at Week 12 of PS0010 and are treated 
with bimekizumab 320mg Q4W in PS0011. Note that the PS0010 160mg Q4W groups 
with and without the loading dose are combined here.

Bimekizumab 320mg Q4W to Bimekizumab 320mg Q4W – Subjects randomized to 
bimekizumab 320mg Q4W in PS0010 and continue on 320mg Q4W in PS0011. No 
distinction will be made between subjects that were or were not PASI90 responders at 
Week 12 of PS0010.

Bimekizumab 480mg Q4W to Bimekizumab 320mg Q4W – Subjects randomized to 
bimekizumab 480mg Q4W in PS0010 and continue on 320mg Q4W in PS0011. No 
distinction will be made between subjects that were or were not PASI90 responders at 
Week 12 of PS0010.
The treatment groups to be used in the presentations of safety and efficacy will depend on 
the objective of the summaries and will be specified accordingly.
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Change #98
Section 14.2 Planned safety analyses (now Section 14.3)
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities 
(MedDRA®). Treatment-emergent AEs will be defined as events that have a start date on or 
following the first administration of study treatment in PS0011 through the final administration 
of study treatment +119 days (covering the 17-week SFU Period). Treatment-emergent AEs will 
be categorized to treatment group based on the dose being received at the time of onset of the 
event. Tables will include columns for bimekizumab 320mg Q4W, bimekizumab 160mg Q4W, 
and All bimekizumab (ie, either dose of bimekizumab). 
Change from Baseline variables will be defined relative to the Baseline measurement from 
PS0010.
Has been changed to: 
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities 
(MedDRA®). Treatment-emergent AEs will be defined as events that have a start date on or 
following the first administration of study treatment in PS0011 through the final administration 
of study treatment + 119 140 days (covering the 1720-week SFU Period). Treatment-emergent 
AEs will be categorized to by PS0011 treatment group based on the dose being received at the 
time of onset of the event. Tables will include columns for placebo, bimekizumab 64mg 
Q4W, bimekizumab 160mg Q4W, bimekizumab 320mg, and All bimekizumab (ie, any dose 
of bimekizumab) bimekizumab 320mg Q4W, bimekizumab 160mg Q4W, and All 
bimekizumab (ie, either dose of bimekizumab).
Change from Baseline variables will be defined relative to the Baseline measurement from 
PS0010.
Change #99
Section 14.2.1 Primary safety analysis (now Section 14.3.1)
All TEAEs will be summarized descriptively by treatment group, primary system organ class 
(SOC), high level term (HLT), and preferred term (PT). This summary will include the exposure 
adjusted incidence rate (EAIR) with associated 95% confidence interval and the exposure 
adjusted event rate (EAER). 
Has been changed to:
All TEAEs will be summarized descriptively by PS0011 treatment group, primary SOC system 
organ class (SOC), high level term (HLT), and preferred term (PT). This summary will include 
the exposure adjusted incidence rate (EAIR) with associated 95% confidence interval and the 
exposure adjusted event rate (EAER). 
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Change #100
Section 14.2.1 Primary safety analysis (now Section 14.3.1)
Patient exposure at risk in days will be defined as date of last administration of study medication 
– date of first administration of study medication + 119 days (ie, the duration of the SFU Period). 
If a subject dies, patient exposure at risk is censored at the date of death. The sum of these 
exposure days at risk across subjects is converted to years for the EAIR and EAER calculations 
described above.
Has been changed to:
Patient exposure at risk in days will be defined as date of last administration of study medication
– date of first administration of study medication in PS0011 + 119 140 days (ie, the duration of 
the SFU Period). If a subject dies, patient exposure at risk is censored at the date of death. The 
sum of these exposure days at risk across subjects is converted to years for the EAIR and EAER 
calculations described above.
Change #101
Section 14.2.2 Other safety analyses (now Section 14.3.2)
Additional tables will summarize TEAEs by intensity and relationship to study medication, 
TEAEs leading to withdrawal from the study, treatment-emergent SAEs, and deaths. 
Has been changed to:
Additional tables will summarize TEAEs by intensity and relationship to study medication, 
TEAEs leading to withdrawal from the study, treatment-emergent SAEs, and deaths. Other AE 
summaries to be included will be specified in the SAP. All AE tables will be presented by 
PS0011 treatment group (including the All bimekizumab group).
Change #102
Section 14.2.2 Other safety analyses (now Section 14.3.2)
The following text has been deleted
In order to evaluate if there is any difference in the TEAE profile of subjects who have dose 
adjustments, additional summaries will be generated and are described further here. With 
respect to dose adjustments, subjects will be classified into 1 of the following 3 groups:

Nonadjusters
This group consists of subjects who do not experience a dose adjustment 
during the study.

Single adjusters
This group consists of subjects who experience just one dose 
adjustment during the study. Per the protocol, if just a single adjustment occurs, then 
that adjustment must be to go from bimekizumab 320mg Q4W to 160mg Q4W.

Multiple adjusters
This group consists of subjects who experience more than 1 dose 
adjustment during the study. This means that the subjects in this group dose adjust 
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from bimekizumab 320mg Q4W to 160mg Q4W and then adjust back to 320mg Q4W 
(with further dose adjustments possible).
Summaries based on these 3 groups will be done for the TEAE overview, incidence of 
TEAEs (by SOC, HLT, and PT), and incidence of treatment emergent SAEs.
Change #103
Section 14.2.2 Other safety analyses (now Section 14.3.2)
Extent of exposure to study medication in PS0011 will be summarized using descriptive 
statistics. As with the primary summaries of TEAEs, extent of exposure will be presented with 
columns for bimekizumab 320mg Q4W, bimekizumab 160mg Q4W, and All bimekizumab
Has been changed to:
Extent of exposure to study medication in PS0011 will be summarized using descriptive statistics
by PS0011 treatment group. As with the primary summaries of TEAEs, extent of exposure 
will be presented with columns for bimekizumab 320mg Q4W, bimekizumab 160mg Q4W, 
and All bimekizumab.
Change #104
Section 14.2.2 Other safety analyses (now Section 14.3.2)
Change from Baseline in laboratory values, ECGs, and vital signs will be presented using 
descriptive statistics by PS0010 randomized treatment group and overall. As these variables are 
summarized over time and the initial values can be impacted by the randomized treatment in 
PS0010, the presentation by PS0010 randomized treatment group is intended to provide 
perspective on the change in these values starting with the initial PS0010 randomization through 
the 48-week Open-Label Treatment Period of PS0011. The table presentations will display 
descriptive statistics for the PS0010 Baseline and the observed and change from PS0010 
Baseline results by scheduled visit for PS0011.
Has been changed to:
Change from Baseline in laboratory values, ECGs, and vital signs will be presented using 
descriptive statistics by PS0010/PS0011 randomized treatment group and overall. As these 
variables are summarized over time and the initial values can be impacted by the randomized 
treatment in PS0010, the presentation by PS0010/PS0011 randomized treatment group is 
intended to provide perspective on the change in these values starting with the initial PS0010 
randomization through the 48-week Open Label Treatment Period of PS0011. The table 
presentations will display descriptive statistics for the PS0010 Baseline followed by descriptive 
statistics for the observed, change from PS0010 Baseline, and change from PS0011 results by 
scheduled visit for PS0011
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Change #105
Section 14.3 Planned PK analyses (now Section 14.4)
Bimekizumab plasma concentrations will be summarized for each treatment at each scheduled 
visit.
Has been changed to:
Bimekizumab plasma concentrations will be summarized for each treatment by 
PS0010/PS0011 treatment group at each scheduled visit. Descriptive statistics for the plasma 
concentrations at PS0010 Baseline will be presented followed by descriptive statistics for 
the observed, change from PS0010 Baseline, and change from PS0011 Baseline results for 
scheduled visits in PS0011. Summarizing in this manner based on the PS0010/PS0011 
treatment group will allow for an evaluation of how changing doses (where applicable) 
impacted plasma concentrations relative to both the original (PS0010) Baseline as well as 
the new (PS0011) Baseline. For the descriptive statistics, geometric mean, geometric 
coefficient of variation, and 95% confidence interval for the geometric mean will be used 
instead of the arithmetic mean and standard deviation.
Change #106
Section 14.4 Planned immunological analyses (now Section 14.5)
Anti-bimekizumab antibody data will be summarized for each treatment at each scheduled visit.
Has been changed to:
Anti-bimekizumab antibody data will be summarized by PS0010/PS0011 treatment group for 
each treatment at each scheduled visit. The summary of anti-bimekizumab antibody levels 
will follow a similar approach to that used for the summary of bimekizumab plasma 
concentrations. Additional analyses related to antibody positivity will be performed and 
will be described in greater detail in the SAP.
Change #107
Section 14.5 Planned efficacy analyses (now Section 14.6)
Efficacy variables will be summarized based on the FAS. The summaries described in this 
section will provide data on maintenance of effect of open-label bimekizumab over 48 weeks. 
Additionally, it will allow an assessment of the impact of dose adjustments on efficacy results.
Has been changed to:
Efficacy variables will be summarized based on the FAS. The summaries described in this 
section will provide data on maintenance of effect of open label bimekizumab study treatment
over 48 weeks. Additionally, it will allow an assessment of the impact of dose adjustments 
on efficacy results.
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Change #108
Section 14.5 Planned efficacy analyses (now Section 14.6)
Responder efficacy variables (PASI75, PASI90, PASI100, IGA, and DLQI score of 0 or 1) will 
be summarized descriptively using counts and percentages by scheduled visit and PS0010 
randomized treatment group and overall. The PASI responder variables are derived relative to 
the PS0010 Baseline. Missing data will be handled by using nonresponder imputation (NRI), 
meaning that subjects that discontinue early or who have missing data at a given time point are 
imputed as though they did not achieve the given response. Supportive summaries will be based 
on observed case data.
Has been changed to:
Responder efficacy variables (PASI75, PASI90, PASI100, IGA, and DLQI score of 0 or 1) will 
be summarized descriptively using counts and percentages by scheduled visit and 
PS0010/PS0011 randomized treatment group and overall. The PASI responder variables will 
be derived relative to both the PS0010 Baseline and the PS0011 Baseline with responder rates 
being presented side-by-side in applicable summary tables. Missing data will be handled by 
using nonresponder imputation (NRI), meaning that subjects that discontinue early or who have 
missing data at a given time point are imputed as though they did not achieve the given response. 
Supportive summaries will be based on observed case data.
Change #109
Section 14.5 Planned efficacy analyses (now Section 14.6)
Continuous efficacy variables based on the change from Baseline (PASI, DLQI, BSA, mNAPSI, 
PSSI, PGADA, SF-36, and HADS) will be summarized using descriptive statistics by scheduled 
visit and PS0010 randomized treatment group and overall. The table presentations will display 
descriptive statistics for the PS0010 Baseline and the observed and change from PS0010 
Baseline results by scheduled visit for PS0011. Figures for selected variables will also be 
generated in order to demonstrate the kinetics of response over time. Missing data will be 
handled by using multiple imputation (MI) via the Markov-Chain Monte Carlo (MCMC) 
method. Supportive summaries will be based on observed case data.
Has been changed to:
Continuous efficacy variables based on the change from Baseline (PASI, DLQI, BSA, mNAPSI, 
PSSI, PGADA, SF-36, and HADS) will be summarized using descriptive statistics by scheduled 
visit and PS0010/PS0011 randomized treatment group and overall. The table presentations will 
display descriptive statistics for the PS0010 Baseline, followed by descriptive statistics for the
and the observed, and change from PS0010 Baseline, and change from PS0011 Baseline
results by scheduled visit for PS0011. Figures for selected variables will also be generated in 
order to demonstrate the kinetics of response over time. Missing data will be handled by using 
multiple imputation (MI) via the Markov-Chain Monte Carlo (MCMC) method. Supportive 
summaries will be based on observed case data.
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Change #110
Section 14.5 Planned efficacy analyses (now Section 14.6)
The following text has been deleted
In addition to the summaries described above, the impact of dose adjustment on efficacy 
will be considered. This will be done primarily by summarizing efficacy variables by the 
3 adjuster groups as defined in Section 14.3.2. Furthermore, a supportive analysis 
specifically for single adjusters will be performed in which PASI score will be summarized 
by visit, where Baseline is recalibrated for each individual subject and defined as the visit 
where the bimekizumab 160mg Q4W dose is initiated. The visits summarized will be in 
weeks relative to when the 160mg Q4W dose was started as opposed to the scheduled week 
of the PS0011 assessment. These summaries will be based on observed data only.
Change #111
Section 14.6 Planned interim analysis and data monitoring (now Section 14.7)
A DMC will review the safety data on a recurring basis as outlined in the DMC charter. In 
addition to these ongoing reviews, an analysis combining safety data from PS0010 and PS0011 
will be performed when the PS0010 study database is locked. This review will account for data 
in PS0010 as well as the accrued safety data in PS0011 available at the time of the PS0010 
database lock. The details of this combined safety review of PS0010 and PS0011, including the 
events of interest to be considered, will be outlined in the DMC charter.
Has been changed to:
A DMC will review the safety data on a recurring basis as outlined in the DMC charter. In 
addition to these ongoing reviews, an analysis combining safety data from PS0010 and PS0011 
will be performed when the PS0010 study database is locked. This review analysis will account 
for data in PS0010 as well as the accrued safety data in PS0011 available at the time of the 
PS0010 database lock. At the time of the interim analysis, the DMC will be unblinded; 
however, the Sponsor study team will remain blind. The details of this combined safety 
review analysis of PS0010 and PS0011, including the events of interest to be considered, will be 
outlined in the DMC charter.
Change #112
Section 15.1 Informed consent
Prior to participation in the study, the written Informed Consent Form should be signed and 
personally dated by the subject, or his/her legal representative, and by the person who conducted 
the informed consent discussion (Investigator or designee). The subject or his/her legal 
representative must receive a copy of the signed and dated Informed Consent Form. As part of 
the consent process, each subject must consent to direct access to his/her medical records for 
study-related monitoring, auditing, IRB/IEC review, and regulatory inspection.
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Has been changed to:
Prior to participation in the study, the written Informed Consent Form should be signed and 
personally dated by the subject, or his/her legal representative, and by the person who 
conducted the informed consent discussion (Investigator or designee). The subject or his/her 
legal representative must receive a copy of the signed and dated Informed Consent Form. As 
part of the consent process, each subject must consent to direct access to his/her medical records 
for study-related monitoring, auditing, IRB/IEC review, and regulatory inspection.
Change #113
Section 15.2 Subject identification cards
Upon signing the Informed Consent and Assent form (as applicable), the subject or legal 
representative will be provided with a subject identification card in the language of the subject. 
The Investigator will fill in the subject identifying information and medical emergency contact 
information. The Investigator will instruct the subject to keep the card with him/her at all times.
Has been changed to:
Upon signing the Informed Consent and Assent form (as applicable), the subject or legal 
representative will be provided with a subject identification card in the language of the subject. 
The Investigator will fill in the subject identifying information and medical emergency contact 
information. The Investigator will instruct the subject to keep the card with him/her at all times.
Change #114
Section 17 References
The following reference was added
Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. National 
Institutes of Health, National Cancer Institute, Division of Cancer Treatment and 
Diagnosis. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm. 
Updated 26 Jul 2016.
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19
DECLARATION AND SIGNATURE OF INVESTIGATOR
I confirm that I have carefully read and understood this protocol and agree to conduct this 
clinical study as outlined in this protocol, according to current Good Clinical Practice and local 
laws and requirements.
I will ensure that all subinvestigators and other staff members read and understand all aspects of 
this protocol.
I have received and read all study-related information provided to me.
The objectives and content of this protocol as well as the results deriving from it will be treated 
confidentially, and will not be made available to third parties without prior authorization by 
UCB.
All rights of publication of the results reside with UCB, unless other agreements were made in a 
separate contract.
Investigator:
Printed name
Date/Signature
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Clinical Study Protocol
Bimekizumab
PS0011
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20
SPONSOR DECLARATION
I confirm that I have carefully read and understand this protocol and agree to conduct this 
clinical study as outlined in this protocol and according to current Good Clinical Practice.
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SAP_001.pdf: 
UCB 
7 June 2018 
Statistical Analysis Plan 
Bimekizumab 
PS0011 
Confidential 
Page 1 of 55 
STATISTICAL ANALYSIS PLAN 
Study: PS0011 
Product: BIMEKIZUMAB 
A MULTICENTER, 48-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-
GROUP EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY, TOLERABILITY, 
AND EFFICACY OF BIMEKIZUMAB IN ADULT SUBJECTS WITH MODERATE TO 
SEVERE CHRONIC PLAQUE PSORIASIS 
SAP/Amendment Number Date 
Final SAP 
31 March 2017 
SAP Amendment 1 
7 June 2018 
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 .................................................................................................... 6 
1 
INTRODUCTION ............................................................................................................. 8 
2 
PROTOCOL SUMMARY ................................................................................................. 8 
2.1 
Study objectives ............................................................................................................. 8 
2.1.1 
Primary objective ................................................................................................... 8 
2.1.2 
Secondary objective ............................................................................................... 8 
2.1.3 
Other objectives ..................................................................................................... 8 
2.2 
Study variable(s) ............................................................................................................ 8 
2.2.1 
Safety variables ...................................................................................................... 8 
2.2.1.1 
Primary safety variable ................................................................................ 8 
2.2.1.2 
Other safety variables .................................................................................. 8 
2.2.2 
Pharmacokinetic variable ....................................................................................... 8 
2.2.3 
Immunological variable ......................................................................................... 9 
2.2.4 
Efficacy variables .................................................................................................. 9 
2.2.4.1 
Secondary efficacy variables ....................................................................... 9 
2.2.4.2 
Other efficacy variables ............................................................................... 9 
2.3 
Study design and conduct ............................................................................................ 10 
2.3.1 
Study description ................................................................................................. 10 
2.3.2 
Study periods ....................................................................................................... 10 
2.3.3 
Study duration per subject ................................................................................... 10 
2.4 
Determination of sample size ....................................................................................... 11 
3 
DATA ANALYSIS CONSIDERATIONS ...................................................................... 11 
3.1 
General presentation of summaries and analyses ........................................................ 11 
3.2 
Definition of Baseline values ....................................................................................... 11 
3.3 
Mapping of assessments performed at early study withdrawal visit ........................... 12 
3.4 
Protocol deviations....................................................................................................... 12 
3.5 
Analysis sets................................................................................................................. 12 
3.5.1 
Enrolled Set ......................................................................................................... 12 
3.5.2 
Safety Set ............................................................................................................. 12 
3.5.3 
Full Analysis Set .................................................................................................. 12 
3.5.4 
Other analysis sets ............................................................................................... 13 
3.5.4.1 
Pharmacokinetics Per Protocol Set ............................................................ 13 
3.6 
Treatment assignment and treatment groups ............................................................... 13 
3.7 
Center pooling strategy ................................................................................................ 14 
3.8 
Coding dictionaries ...................................................................................................... 14 
3.9 
Analysis time points ..................................................................................................... 14 
3.9.1 
Double-blind treatment period ............................................................................. 14 
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3.9.2 
Follow-up period ................................................................................................. 14 
3.10 
Relative day ................................................................................................................. 15 
3.11 
Changes to protocol-defined analyses ......................................................................... 15 
4 
STATISTICAL/ANALYTICAL ISSUES ....................................................................... 15 
4.1 
Adjustments for covariates .......................................................................................... 15 
4.2 
Handling of dropouts or missing data .......................................................................... 15 
4.2.1 
Handling missing data for the safety analyses ..................................................... 15 
4.2.2 
Handling missing data for the efficacy analyses ................................................. 16 
4.3 
Interim analyses and data monitoring .......................................................................... 17 
4.4 
Multicenter studies ....................................................................................................... 17 
4.5 
Multiple comparisons/multiplicity ............................................................................... 17 
4.6 
Active-control studies intended to show equivalence .................................................. 17 
4.7 
Examination of subgroups ........................................................................................... 17 
5 
STUDY POPULATION CHARACTERISTICS ............................................................. 18 
5.1 
Subject disposition ....................................................................................................... 18 
5.2 
Protocol deviations....................................................................................................... 18 
6 
DEMOGRAPHICS AND OTHER BASELINE CHARACTERISTICS ........................ 18 
6.1 
Demographics .............................................................................................................. 18 
6.2 
Other Baseline characteristics ...................................................................................... 19 
6.3 
Medical history and concomitant diseases ................................................................... 20 
6.4 
Prior and concomitant medications .............................................................................. 20 
7 
MEASUREMENTS OF TREATMENT COMPLIANCE ............................................... 20 
8 
SAFETY ANALYSES ..................................................................................................... 21 
8.1 
Statistical analysis of the primary safety variable ........................................................ 21 
8.1.1 
Derivation of TEAEs ........................................................................................... 21 
8.1.2 
Derivation of Duration of Exposure .................................................................... 21 
8.1.3 
Derivation of exposure at risk .............................................................................. 22 
8.1.4 
Derivation of EAIR .............................................................................................. 22 
8.1.5 
Derivation of EAER ............................................................................................ 23 
8.1.6 
Analysis of the primary safety variable ............................................................... 23 
8.2 
Other safety analysis .................................................................................................... 23 
8.2.1 
TEAEs .................................................................................................................. 23 
8.2.2 
Clinical laboratory evaluations ............................................................................ 27 
8.2.3 
Vital signs ............................................................................................................ 30 
8.2.4 
Physical examination ........................................................................................... 31 
8.2.5 
Electrocardiograms .............................................................................................. 31 
8.2.6 
Exposure .............................................................................................................. 32 
8.2.7 
Assessment and management of TB and TB risk factors .................................... 32 
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8.2.8 
Electronic Columbia Suicide Severity Rating Scale ........................................... 32 
9 
PHARMACOKINETICS ................................................................................................. 33 
9.1 
Pharmacokinetics ......................................................................................................... 33 
9.2 
Immunogenicity ........................................................................................................... 33 
9.2.1 
Anti-bimekizumab antibodies .............................................................................. 33 
10 EFFICACY ANALYSES ................................................................................................ 33 
10.1 
Statistical analysis of the efficacy variables ................................................................ 33 
10.1.1 
PASI score and response ..................................................................................... 34 
10.1.1.1 
Derivation of PASI score and response ..................................................... 34 
10.1.1.2 
Analysis of PASI score and response ........................................................ 35 
10.1.2 
IGA response ....................................................................................................... 36 
10.1.2.1 
Derivation of IGA response....................................................................... 36 
10.1.2.2 
Analysis of IGA response .......................................................................... 36 
10.1.3 
Analysis of BSA .................................................................................................. 37 
10.1.4 
DLQI .................................................................................................................... 37 
10.1.4.1 
Derivation of DLQI ................................................................................... 37 
10.1.4.2 
Analysis of DLQI ...................................................................................... 38 
10.1.5 
mNAPSI ............................................................................................................... 38 
10.1.5.1 
Derivation of mNAPSI .............................................................................. 38 
10.1.5.2 
Analysis of mNAPSI ................................................................................. 39 
10.1.6 
PGADA for the arthritis VAS .............................................................................. 39 
10.1.6.1 
Derivation of PGADA for the arthritis VAS ............................................. 39 
10.1.6.2 
Analysis of PGADA for the arthritis VAS ................................................ 39 
10.1.7 
PSSI ..................................................................................................................... 40 
10.1.7.1 
Derivation of PSSI ..................................................................................... 40 
10.1.7.2 
Analysis of PSSI ........................................................................................ 40 
10.1.8 
SF-36 .................................................................................................................... 41 
10.1.8.1 
Derivation of SF-36 ................................................................................... 41 
10.1.8.2 
Analysis of SF-36 ...................................................................................... 41 
10.1.9 
HADS .................................................................................................................. 42 
10.1.9.1 
Definition of HADS .................................................................................. 42 
10.1.9.2 
Analysis of HADS ..................................................................................... 42 
11 REFERENCES ................................................................................................................ 43 
12 APPENDICES ................................................................................................................. 44 
12.1 
Classification of the SF-36v2 questionnaire ................................................................ 44 
12.2 
AESM Opportunistic infections ................................................................................... 46 
12.3 
MedDRA algorithmic approach to anaphylaxis .......................................................... 46 
13 AMENDMENT TO THE STATISTICAL ANALYSIS PLAN ...................................... 49 
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STATISTICAL ANALYSIS PLAN SIGNATURE PAGE ..................................................... 55 
 
 
 
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Bimekizumab 
PS0011 
 
 
 
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LIST OF ABBREVIATIONS 
AE 
adverse event 
AESM 
adverse events of special monitoring 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
ATC 
Anatomical Therapeutic Chemical 
BKZ 
Bimekizumab 
BLQ 
below level of quantification 
BMI 
Body Mass Index 
BSA 
body surface area 
CV 
coefficient of variation 
DLQI 
Dermatology Life Quality Index 
DMC 
Data Monitoring Committee 
EAER 
exposure adjusted event rate 
EAIR 
exposure adjusted incidence rate 
ECG 
electrocardiogram 
ES 
Enrolled Set 
FAS 
Full Analysis Set 
GGT 
gamma glutamyltransferase 
HADS-A 
Hospital Anxiety and Depression Scale-Anxiety 
HADS-D 
Hospital Anxiety and Depression Scale-Depression 
HLGT 
high level group term 
HLT 
high level term 
IGA 
Investigator’s Global Assessment 
LLQ 
lower level of quantification 
MAR 
Missing at random 
MedDRA 
Medical Dictionary for Regulatory Activities 
MCMC 
Markov-Chain Monte Carlo 
MCS 
Mental Component Score 
MI 
multiple imputation 
mNAPSI 
modified Nail Psoriasis Severity Index 
NRI 
non-responder imputation 
PASI 
Psoriasis Area and Severity Index 
PCS 
Physical Component Score 
PGADA 
Patient’s Global Assessment of Disease Activity 
PK 
pharmacokinetic 
PK-PPS 
Pharmacokinetic Per Protocol Set 
PSSI 
Psoriasis Scalp Severity Index 
PT 
preferred term 
Q4W 
every four weeks 
SAP 
Statistical Analysis Plan 
SD 
standard deviation 
SF-36 
Short Form 36 item Health Survey 
SFU 
Safety Follow-Up 
SMQ 
standard MedDRA query 
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PS0011 
 
 
 
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SOC 
system organ class 
SOP 
standard operating procedure 
SS 
Safety Set 
TEAE 
treatment-emergent adverse event 
VAS 
visual analog scale 
WBC 
white blood cell 
WHO 
World Health Organization 
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1 
INTRODUCTION 
This statistical analysis plan (SAP) defines the summary tables, figures, and listings to be 
generated for the clinical study report and is based on the protocol amendment 1 (12 Aug 2016). 
2 
PROTOCOL SUMMARY 
2.1 
Study objectives 
2.1.1 
Primary objective 
The primary objective of the study is to assess the long-term safety and tolerability of 
bimekizumab. 
2.1.2 
Secondary objective 
The secondary objective of the study is to assess the efficacy of bimekizumab administered every 
four weeks (Q4W) over 48 weeks. 
2.1.3 
Other objectives 
The other objectives of the study are to: 
 Assess the pharmacokinetics (PKs) of bimekizumab 
 Assess the immunogenicity of bimekizumab. 
2.2 
Study variable(s) 
2.2.1 
Safety variables 
2.2.1.1 
Primary safety variable 
The primary safety variable is the incidence of treatment-emergent adverse events (TEAEs) 
adjusted by duration of subject exposure to treatment. 
2.2.1.2 
Other safety variables 
Change from Baseline variables will be defined relative to the Baseline measurements from 
PS0011. 
The other safety variables are: 
 Change from Baseline in clinical laboratory values (chemistry, hematology, and urinalysis) 
 Change from Baseline in vital signs 
 Change from Baseline in physical examination 
 Change from Baseline in 12-lead Electrocardiogram (ECG) results. 
2.2.2 
Pharmacokinetic variable 
The PK variable is plasma concentrations of bimekizumab. 
 
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2.2.3 
Immunological variable  
The immunological variable is anti-bimekizumab antibody levels prior to and following study 
treatment. 
2.2.4 
Efficacy variables 
Change from Baseline and responder variables will be defined relative to the PS0010 Baseline 
for subjects who are PS0010 Week 12 PASI90 responders and relative to both the PS0010 and 
PS0011 Baselines for subjects who are PS0010 Week 12 PASI90 non-responders). 
2.2.4.1 
Secondary efficacy variables 
The secondary efficacy variables are: 
 Psoriasis Area and Severity Index (PASI)90 response (defined as a subject that achieves 90% 
reduction in the PASI score from the Baseline of PS0010) over time 
 Investigator’s Global Assessment (IGA) response (Clear or Almost Clear with at least a 2 
category improvement from Baseline on a 5-point scale) over time. 
2.2.4.2 
Other efficacy variables 
The efficacy variables detailed below will be evaluated at all scheduled visits in accordance with 
the Schedule of Assessment (see study protocol Table 5-1): 
 PASI75 and PASI100 response 
 Absolute and percent change from Baseline in PASI score 
 Shift from PS0011 Baseline in IGA score 
 Change from Baseline in Dermatology Life Quality Index (DLQI) 
 Percent of subjects achieving a DLQI score of 0 or 1 
 Absolute and percent change from Baseline in the body surface area (BSA) affected by 
psoriasis 
 Change from Baseline in modified Nail Psoriasis Severity Index (mNAPSI) score (in the 
subgroup of subjects with psoriatic nail disease at Baseline) 
 Change from Baseline in the Psoriasis Scalp Severity Index (PSSI) (in the subgroup of 
subjects with scalp psoriasis at Baseline) 
 Change from Baseline in the Patient’s Global Assessment of Disease Activity (PGADA) for 
the arthritis visual analog scale (VAS) 
 Change from Baseline in Short Form 36 item Health Survey (SF-36) Physical Component 
Summary (PCS) score, Mental Component Summary (MCS) score, and individual domains 
 Change from Baseline in the Hospital Anxiety and Depression Scale Anxiety (HADS-A) and 
Depression (HADS-D) scores 
 Percentage of subjects with scores below 8 in HADS-A and HADS-D (subjects with normal 
scores). 
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2.3 
Study design and conduct 
2.3.1 
Study description 
This is a Phase 2b, multicenter, 48-week, double-blind, placebo-controlled, parallel-group 
extension study to assess the long-term safety, tolerability, and efficacy of bimekizumab 
administered subcutaneously in eligible adult subjects with moderate to severe chronic psoriasis 
who complete PS0010.  
2.3.2 
Study periods 
This study will include two periods: 
 Treatment Period (48 weeks) 
 Safety Follow-Up (SFU) Period (20 weeks after the last dose of study medication). 
Treatment Period 
To be eligible to participate in this study: 
 Subjects in PS0010 who received placebo or bimekizumab 64mg, 160mg, or 320mg loading 
dose + 160mg Q4W must achieve PASI90 response at Week 12 before entering PS0011 
extension study on the same treatment dose 
 Subjects who do not achieve PASI90 response at Week 12 in PS0010 while receiving 
placebo or bimekizumab 64mg Q4W will be assigned to receive bimekizumab 160mg on 
entering PS0011 
 Subjects who do not achieve PASI90 response at Week 12 in PS0010 while receiving 
bimekizumab 160mg or 320mg loading dose + 160mg Q4W will be assigned to receive 
bimekizumab 320mg Q4W on entering PS0011 
 Subjects who receive bimekizumab 320mg or 480mg Q4W in PS0010 will be assigned to 
receive bimekizumab 320mg Q4W on entering PS0011, regardless of their PASI90 response 
at Week 12 in PS0010. 
Up to 240 subjects are anticipated to enroll in the study and the study medication will be 
administered in the clinic Q4W. 
Subjects withdrawing early from the study will undergo the Early Withdrawal visit assessments 
and will enter the SFU Period. 
Safety Follow-Up Period 
Following completion or early withdrawal from the 48-week Treatment Period, subjects will 
return for a SFU visit 20 weeks after their last dose of study medication. 
2.3.3 
Study duration per subject 
For each subject, the study is expected to last for a maximum of 64 weeks. This includes the 
following study period durations: 
 Double-blind, placebo-controlled Treatment Period: up to 48 weeks 
 SFU Period: 20 weeks after the last dose of study medication. 
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The end of the study is defined as the date of the last visit of the last subject in the study. 
2.4 
Determination of sample size 
Up to 240 subjects are anticipated to enroll in PS0011. This number is based on the 240 subjects 
that are planned to be randomized in the feeder study, PS0010. The calculations to reach this 
sample size are outlined in the PS0010 protocol and SAP. As the primary objective of this study 
is to assess the long-term safety and tolerability of bimekizumab, the number of subjects 
anticipated is based on the number of subjects completing PS0010 and meeting eligibility 
requirements for PS0011. 
3 
DATA ANALYSIS CONSIDERATIONS 
3.1 
General presentation of summaries and analyses 
Statistical analysis and generation of tables, figures, subject data listings, and statistical output 
will be performed using SAS Version 9.3 or higher. All tables and listings will use Courier New 
font size 9. 
Descriptive statistics will be displayed to provide an overview of the study results. For 
categorical variables, the number and percentage of subjects in each category will be presented. 
Unless otherwise noted, all percentages will be displayed to one decimal place. No percentage 
will be displayed for zero counts, and no decimal will be presented when the percentage is 100%. 
For continuous variables, descriptive statistics will include number of subjects with available 
measurements (n), arithmetic mean, standard deviation (SD), median, minimum, and maximum. 
For bimekizumab PK concentrations, summary statistics will include geometric mean, geometric 
coefficient of variation (CV), 95% confidence interval for the geometric mean, median, 
minimum, and maximum. All summaries of PK variables will be based on the observed values. 
No imputation will be used. 
Decimal places for descriptive statistics will always apply the following rules: 
 “n” will be an integer 
 Mean, SD, and median will use one additional decimal place compared to the original data 
 CV[%] will be presented with one decimal place 
 Minimum and maximum will have the same number of decimal places as the original value. 
A complete set of data listings containing all documented data as well as calculated data (eg, 
change from Baseline) will be generated and will be presented by PS0010/PS0011 treatment 
group. 
3.2 
Definition of Baseline values 
Two separate baseline values are defined for use in this study: 
PS0010 Baseline 
The last valid measurement before study medication administration in the double-blind period of 
PS0010 will be used as the PS0010 Baseline value. If a Baseline visit measurement is missing, 
and a PS0010 Screening visit measurement is available, the Screening value will be utilized as 
Baseline. If a scheduled Baseline assessment is taken on the same day as first administration of 
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PS0010 study medication, it will be assumed to have been taken prior to PS0010 study 
medication. 
PS0011 Baseline 
The last valid measurement before study medication administration in the double-blind period of 
PS0011 will be used as the PS0011 Baseline value. If a Baseline visit measurement is missing, 
the most recent PS0010 assessment value will be utilized as Baseline. If a scheduled Baseline 
assessment is taken on the same day as first administration of PS0011 study medication, it will 
be assumed to have been taken prior to PS0011 study medication. 
3.3 
Mapping of assessments performed at early study withdrawal 
visit 
Study assessments at an early withdrawal visit where the early withdrawal visit date matches the 
visit date of a scheduled visit will be summarized at the scheduled visit with the same visit date. 
Premature withdrawal visit assessments that do not have a scheduled visit with a matching date 
will be assigned to the next scheduled site visit following the last visit where assessments were 
available. The only exception to this rule is for anti-Bimekizumab (BKZ) antibody assessments, 
where all premature withdrawal visit assessments will be assigned to the next scheduled visit at 
which anti-BKZ antibodies are assessed.  
All by-visit summaries will contain nominal visits only. Unscheduled visits will not be mapped 
to scheduled visits. 
3.4 
Protocol deviations 
Important protocol deviations are defined as those deviations from the protocol likely to have a 
meaningful impact on the efficacy, safety, or PK outcomes for an individual subject. The criteria 
for identifying important protocol deviations will be defined within the appropriate protocol-
specific document. All protocol deviations will be reviewed as part of the ongoing data cleaning 
process and all important deviations will be identified and documented in a separate protocol 
deviation tracker prior to unblinding to confirm any exclusions from the Pharmacokinetics Per 
Protocol Set (PK-PPS).  
3.5 
Analysis sets 
All safety variables will be summarized using the Safety Set (SS). All efficacy analyses will be 
based on the Full Analysis Set (FAS).  
3.5.1 
Enrolled Set 
The Enrolled Set (ES) will consist of all subjects who have given informed consent for PS0011. 
3.5.2 
Safety Set 
The SS will consist of all subjects who receive at least one dose of the study medication in 
PS0011. 
3.5.3 
Full Analysis Set 
The FAS will consist of all enrolled subjects who receive at least one dose of the study 
medication in PS0011 and have a valid efficacy measurement for PASI at Baseline of PS0011. 
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3.5.4 
Other analysis sets 
3.5.4.1 
Pharmacokinetics Per Protocol Set 
The PK-PPS is a subset of the FAS, consisting of those subjects who had no important protocol 
deviations affecting the pharmacokinetic variables, as confirmed during ongoing data cleaning 
meetings prior to database lock. 
3.6 
Treatment assignment and treatment groups 
At Baseline, eligible subjects will be assigned as described in Section 2.3.2. Summaries using the 
FAS will be based on treatments according to the assignment and not actual treatment received. 
It is expected that subjects will receive treatment as assigned. Hence, safety analyses should be 
based on assigned treatment for the SS. However, if it is determined after unblinding that 
subjects assigned to placebo received bimekizumab at any time, then these subjects will be 
reallocated to the appropriate bimekizumab group and will be summarized accordingly from the 
time point at which the misallocation occurred. If a subject receives different doses of 
bimekizumab at different time points, then the subject will be allocated to the highest dose 
received. If the highest dose was received earlier than the other(s), then all safety data will be 
summarized under that dose. If the highest dose was received later than the other(s), then safety 
data will be summarized under that dose starting from the time point at which it was first 
received. Since the period of exposure at risk includes an additional 140 days following the last 
dose of study medication, no consideration is given to the time at which exposure to misallocated 
doses can be considered complete. 
Subjects assigned to a bimekizumab group will only be reallocated to the placebo treatment 
group if they never received bimekizumab. 
Because subjects entering PS0011 may or may not be continuing on the same dose as that 
received in PS0010, there are various combinations of treatment that could be received when 
considering both PS0010 and PS0011 together. For describing the summaries to be produced, 
treatment groups will be categorized as either the PS0011 treatment groups or PS0010/PS0011 
treatment groups. The categorizations are outlined below. 
PS0011 treatment groups 
This refers to the study treatment assigned to the subject at the beginning of PS0011 and does not 
account for the treatment received in PS0010. The PS0011 treatment groups are as follows: 
 Placebo 
 Bimekizumab 64mg Q4W 
 Bimekizumab 160mg Q4W 
 Bimekizumab 320mg Q4W 
 All Bimekizumab (optional – to be used only if specified) 
PS0010/PS0011 treatment groups 
This refers to the combination of the randomized treatment in PS0010 and the treatment assigned 
at the beginning of PS0011. Some groups have been combined where it is considered appropriate 
to do so. The PS0010/PS0011 treatment groups are as follows: 
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 Placebo to Placebo 
 Placebo to Bimekizumab 160mg Q4W 
 Bimekizumab 64mg Q4W to Bimekizumab 64mg Q4W 
 Bimekizumab 64mg Q4W to Bimekizumab 160mg Q4W 
 Bimekizumab 160mg Q4W to Bimekizumab 160mg Q4W – note that the PS0010 160mg 
Q4W groups with and without the loading dose are both included here 
 Bimekizumab 160mg Q4W to Bimekizumab 320mg Q4W – note that the PS0010 160mg 
Q4W groups with and without the loading dose are both included here 
 Bimekizumab 320mg Q4W to Bimekizumab 320mg Q4W  
 Bimekizumab 480mg Q4W to Bimekizumab 320mg Q4W 
The treatment groups to be used in the presentations of safety and efficacy will depend on the 
objective of the summaries and will be specified accordingly. 
3.7 
Center pooling strategy 
Centers will be pooled into regions for analysis purposes. Centers will be grouped in the 
following regions: North America, Europe and Asia. These regions include the following 
countries: 
 North America: Canada, USA 
 Europe and Asia: Czech Republic, Hungary, Poland, Japan 
3.8 
Coding dictionaries 
All prior and concomitant medications other than study drug will be classified by World Health 
Organization (WHO) Anatomical Therapeutic Chemical (ATC) Classification, presenting 
Anatomical Main Group (ATC Level 1), Pharmacological Subgroup (ATC Level 3), and 
preferred term, using version SEP/2015 of the WHO Drug Dictionary, according to UCB 
standard operating procedures (SOPs). 
All adverse events (AEs) will be classified by primary system organ class (SOC), high level term 
(HLT) and preferred term (PT) using version 19.0 of the Medical Dictionary for Regulatory 
Activities (MedDRA®) according to UCB SOPs. Previous and ongoing medical history will be 
classified by MedDRA® SOC and PT. 
3.9 
Analysis time points 
3.9.1 
Double-blind treatment period 
The double-blind treatment period begins at the Baseline visit (Week 0) at the time of first study 
medication administration (inclusive) and ends at the Week 48/withdrawal visit. 
Subjects will be classified as completing the study if they complete the Week 48 visit without 
withdrawal from the study. This is regardless of whether they attend the SFU visit. 
3.9.2 
Follow-up period 
The SFU visit will take place 20 weeks after the last dose of study medication. 
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3.10 
Relative day 
The relative day will be included in different listings and will be calculated as follows: 
 If the start (stop) date occurred on or after the first dose, but prior to the double-blind drug 
stop date, relative day is calculated as start (stop) date minus first dose + 1 
 If the start (stop) date occurred after the last dose of double-blind drug, the relative day to the 
most recent dose is calculated as start (stop) date minus most recent dose date. The relative 
day in this situation should be preceded by a ‘+’ 
 If the start (stop) occurred before the first dose, the relative day is calculated as start (stop) 
date minus first dose date. The relative day in this situation should be preceded by a ‘-‘. 
3.11 
Changes to protocol-defined analyses 
There have been no changes to the protocol-defined analyses. 
4 
STATISTICAL/ANALYTICAL ISSUES 
4.1 
Adjustments for covariates 
Not applicable. 
4.2 
Handling of dropouts or missing data 
4.2.1 
Handling missing data for the safety analyses 
For analyses of AEs and concomitant medication usage, a complete date must be established in 
order to correctly identify the AE or medication as occurring during treatment or not. For 
purposes of imputing missing components of partially-reported start and stop dates for AEs and 
for medication use, the algorithms listed below will be followed. Start and stop dates of AEs or 
concomitant medication will be displayed as reported in the subject data listings (ie, no imputed 
values will be displayed in data listings). 
Partial AE and concomitant medication start dates will be imputed as follows: 
Imputation of Partial Start Dates 
 If only the month and year are specified and the month and year of first dose is not the same 
as the month and year of start date, then use the 1st of the month 
 If only the month and year are specified and the month and year of first dose is the same as 
the month and year of the start, then use the date of first dose 
 If only the year is specified, and the year of first dose is not the same as the year of the start 
date, then use the 1st of January of the year of the start date 
 If only the year is specified, and the year of first dose is the same as the year of the start date, 
then use the date of first dose 
 If the start date is completely unknown and the stop date is unknown or not prior to the date 
of first dose, then use the date of first dose. 
Imputation of Partial Stop Dates 
 If only the month and year are specified, then use the last day of the month 
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 If only the year is specified, then use December 31st of that year 
 If the stop date is completely unknown, do not impute the stop date. 
In the event of ambiguity or incomplete data which makes it impossible to determine whether a 
medication was concomitant or an adverse event was treatment emergent, the medication will be 
considered as concomitant or the adverse event will be considered treatment emergent. 
4.2.2 
Handling missing data for the efficacy analyses 
For the planned efficacy analysis, missing responder data will be imputed using non-responder 
imputation (NRI). That is, subjects that discontinue study medication early or who have missing 
data at a given time point will be counted as non-responders. Summaries based on observed case 
data will also be prepared. 
Continuous efficacy variables will be imputed using multiple imputation (MI) via the Markov-
Chain Monte Carlo (MCMC) method. Summaries based on observed case data will also be 
prepared. 
The MI procedure for continuous efficacy variables (based on MCMC) will be applied as 
follows: 
1. Create a dataset, one for each treatment group, of subjects with observed values and those 
needing estimation by multiple imputation. The missing values in each dataset will be 
filled in using the MCMC method with a total of 100 sets of imputations being 
performed. Values at Baseline and at each post-Baseline visit will be included in the 
imputation model in chronological order with prior biologic exposure and region as 
factors. The resulting datasets for each treatment arm will be combined into one complete 
dataset based on each of the 100 imputations. 
Note: The imputation model based on the MCMC method will only allow continuous 
variables in the imputation model. Therefore, prior biologic exposure and region will be 
re-coded as indicator variables (with values of 0 or 1 for each level of the variable). In 
order to achieve model convergence, prior biological exposure may be dropped from the 
model, if convergence is still not obtained then region may also be dropped from the 
model. 
2. The relevant change from Baseline (or percent change from Baseline) values will then be 
derived based on the imputed datasets and will be summarized by imputation. 
3. The summary statistics from each of the 100 imputed datasets will be combined for the 
calculation of means and standard deviations using Rubin’s rules, which account for the 
uncertainty associated with the imputed values (Rubin, 1987). This will be done using 
SAS PROC MIANALYZE. For calculation of other descriptive statistics such as the 
median, min and max, Rubin's rules do not apply. Multiple imputation estimates will be 
computed by simply averaging the estimates from the 𝑚= 1, … , 𝑀 independent 
repetitions of the imputation algorithm: 
𝜃̅ = 1
𝑀∑𝜃̂𝑚
𝑀
𝑚=1
 
where 𝜃̂𝑚= estimate of 𝜃 from the completed dataset 𝑚= 1, … , 𝑀. 
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There may be cases where the multiple imputation model fails to converge (eg, sparse 
subgroups). In such situation, the LOCF approach will instead be used to impute missing data. If 
LOCF is used instead of multiple imputation for this reason, this will be clearly specified in the 
corresponding table summary. Should there be no missing data for a study variable then only 
observed case data will be produced. 
4.3 
Interim analyses and data monitoring 
When PS0010 is unblinded, Sponsor study team members from PS0011 with access to the 
PS0010 data will be unblinded. However, subjects and investigators will remain blinded. This 
operational unblinding to PS0011 treatment assignment will pertain to selected clinical PS0010 
study team members (some of whom may be involved in PS0011). PS0010 and PS0011 will 
have the same blinded programming teams for reporting and will remain blinded to PS0010 and 
PS0011 treatment assignment. An independent programming team will be used for the final 
unblinding for PS0010 reporting. 
A Data Monitoring Committee (DMC) will review the safety data on a recurring basis as 
outlined in the DMC charter. The outputs reviewed by the DMC will include the accrued data 
from both PS0010 and PS0011, allowing for summaries of the combined data across the studies. 
The details of the outputs to be prepared are described in a separate DMC SAP. 
An interim analysis focusing on PS0011 only will take place once all subjects have completed 
the Week 48 visit, but not including the SFU visit. The Clinical Study Report will be updated at a 
later date in order to incorporate the SFU data once available. 
4.4 
Multicenter studies 
This is a multicenter study with sites in Europe, Canada, Japan and USA. 
4.5 
Multiple comparisons/multiplicity 
Not applicable. 
4.6 
Active-control studies intended to show equivalence 
Not applicable. 
4.7 
Examination of subgroups 
Subgroup analyses will be performed on the secondary efficacy variables. 
The following subgroup analyses will be performed: 
 Age (<65 years, ≥65 years) 
 Gender (male, female) 
 Duration of disease at PS0010 Baseline (<median, ≥median) 
 Region (North America [Canada, USA], Europe and Asia [Czech Republic, Hungary, 
Poland, Japan]) 
 Body weight at PS0010 Baseline (<100 kg, ≥100 kg) 
 Body Mass Index (BMI) at PS0010 Baseline (<25 kg/m², 25 to <30 kg/m², ≥30 kg/m²) 
 Prior biologic systemic therapy at PS0010 Baseline (yes, no) 
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 Prior anti-TNF therapy at PS0010 Baseline (yes, no) 
 Any prior systemic therapy at PS0010 Baseline (yes, no) 
 Anti-bimekizumab antibody positivity at any time on treatment during PS0010 or PS0011 
(yes, no) 
 PASI score at PS0010 baseline (<20, ≥20) 
 Psoriasis BSA at PS0010 baseline (<20%, ≥20%). 
These summaries, using the FAS, will be based on imputed data (NRI) and will include 
descriptive statistics only. If there are less than 2 subjects in any subgroup category/treatment 
group, then that subgroup category will not be summarized. If it is possible to collapse subgroups 
with more than 2 categories, then collapsing may be done to get categories with no less than 2 
subjects per subgroup category/treatment group. 
5 
STUDY POPULATION CHARACTERISTICS 
5.1 
Subject disposition 
Summaries of the disposition of subjects (for all subjects enrolled in PS0011) as well as the 
subjects who discontinued due to AEs (for the FAS) will be produced based on the PS0011 
treatment group. The disposition of subjects for all subjects enrolled will include the number of 
subjects included in each analysis set (FAS, SS and PK-PPS) overall and by site. 
In addition, the number and percentage of subjects who discontinued the study, including a 
breakdown of the main reasons for discontinuation, will be presented for subjects in the FAS. 
5.2 
Protocol deviations 
A summary, using the ES, of the number and percentage of subjects with an important protocol 
deviation (including a summary of subjects excluded from the PK-PPS due to important protocol 
deviations) by PS0011 treatment group, overall and by type of deviation will be provided. 
If the dosing for a visit is +/- 7 days out of window, then the plasma concentration from that visit 
and all subsequent visits will be excluded from the PK summary. The number and percentage of 
subjects with at least one measurement excluded from the PK analysis will be summarized by 
PS0010/PS0011 treatment group. 
A by-subject listing of important protocol deviations will be provided. 
6 
DEMOGRAPHICS AND OTHER BASELINE 
CHARACTERISTICS 
Unless specified otherwise, all summaries detailed in this section will be performed on the SS, 
where Baseline is defined relative to PS0010.  
6.1 
Demographics 
Demographic variables will be summarized by PS0011 treatment group and overall. 
The following continuous variables will be summarized using descriptive statistics (number of 
subjects, mean, SD, median, minimum and maximum): 
 Age at the time of study entry (years) 
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 Weight (kg) 
 Height (cm) 
 BMI (kg/m²) 
BMI (kg/m²) will be calculated as: 
BMI = Weight
Height2                                                                     (1) 
where weight is given in kg and height is given in m. 
The following categorical variables will be summarized using frequency counts and percentages: 
 Age group (≤18 years, 19 to <65 years, ≥65 years) 
 Age group (18 to <65 years, 65 to <85 years, ≥85 years) 
 Age group (<40 years, 40 to <65 years, ≥65 years) 
 Gender 
 Race 
 Ethnicity 
 Weight (<100 kg, ≥100 kg) 
 BMI (<25 kg/m², 25 to <30 kg/m², ≥30 kg/m²). 
By-subject listings of demographics will be provided. 
6.2 
Other Baseline characteristics 
Baseline characteristics (including Baseline clinical measurements) will be summarized by 
PS0011 treatment group and overall. 
The following continuous variables will be summarized using descriptive statistics (number of 
subjects, mean, SD, minimum, median and maximum): 
 Psoriasis BSA (%) 
 Duration of disease (years) 
 PASI score 
 DLQI total score. 
Duration of disease (years) will be calculated as: 
Duration of disease
= (Date of informed consent −Date of onset of plaque psoriasis1)
365.25
               (2) 
¹If the date of onset of plaque psoriasis is partial, it should be imputed to the most feasible date (ie, last day of the 
month if only day is missing, or the last day of the year if day and month are missing). 
The following categorical variables will be summarized using frequency counts and percentages: 
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 Duration of disease (<median, ≥median) 
 Region (North America [Canada, USA], Europe and Asia [Czech Republic, Hungary, 
Poland, Japan]) 
 Country 
 Prior systemic phototherapy or chemophototherapy (yes, no) 
 Prior nonbiologic systemic therapy (yes, no) 
 Prior biologic systemic therapy (yes, no) 
 Prior anti-TNF therapy (yes, no) 
 Any prior systemic therapy (yes, no) 
 PASI score (<20, ≥20) 
 Psoriasis BSA (<20%, ≥20%) 
 IGA score (0, 1, 2, 3, 4). 
6.3 
Medical history and concomitant diseases 
All medical history will be listed and the number and percentage of subjects with any medical 
history will be summarized by PS0011 treatment group, SOC and PT. 
6.4 
Prior and concomitant medications 
Medication start and stop dates will be compared to the date of first dose of both PS0010 and 
PS0011 treatments to allow medications to be classified as either Prior or Concomitant. 
Prior medications include any medications that started prior to the start date of study medication. 
Concomitant medications are medications taken at least one day in common with the study 
medication dosing period. 
Details of imputation methods for missing or partial dates are described in Section 4.2.1. 
The number and percentage of subjects taking Prior medications (excluding past psoriasis 
medications) will be summarized by PS0011 treatment group, overall and by ATC class, 
presenting Anatomical Main Group (ATC Level 1), Pharmacological Subgroup (ATC Level 3), 
and preferred term. 
The number and percentage of subjects taking Concomitant medications will be summarized 
similarly. 
A by-subject listing of all Prior and Concomitant medications will be provided. 
7 
MEASUREMENTS OF TREATMENT COMPLIANCE 
All summaries detailed in this section will be performed on the SS. 
Due to the method of administration of the treatments, compliance will be examined in terms of 
completed injections, where two injections will be considered as one complete treatment 
administration (ie, one dose). 
Treatment compliance will be calculated as: 
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Treatment compliance = total number of completed injections
total number of expected injections × 100                   (3) 
where the total number of expected injections is derived relative to when the subject finishes 
treatment. If a subject completes treatment, 24 injections are expected (two at each Q4W). If a 
subject discontinues early, then the number of expected injections is based on the time of early 
discontinuation relative to the dosing visits. 
A summary of percent treatment compliance categorized as ≤80% and >80% will be provided by 
PS0011 treatment group. 
A by-subject listing of treatment compliance will be provided. 
8 
SAFETY ANALYSES 
All safety summaries and listings will be performed using all subjects in the SS. 
8.1 
Statistical analysis of the primary safety variable 
8.1.1 
Derivation of TEAEs 
An AE is any untoward medical occurrence in a subject or clinical investigation subject 
administered with 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. 
TEAEs are defined as those AEs that have a start date on or following the first administration of 
study treatment in PS0011 through the final administration of study treatment + 140 days 
(covering the 20-week SFU period). If it is not possible (due to partial dates) to determine 
whether or not an AE is treatment-emergent then it will be assumed to be a TEAE. TEAEs will 
be categorized to the treatment group based on the dose being received at the time of onset of the 
event. 
8.1.2 
Derivation of Duration of Exposure 
The duration of exposure (in days) will be calculated as: 
 Duration of exposure
= Date of last dose in PS0011 −Date of first dose in PS0011 + 28                 (4) 
Should the date of the last dose plus 28 days equate to a date that is beyond the Week 48 visit 
date then the exposure will be calculated as: 
                  Duration of exposure = Week 48 visit date −Date of first dose in PS0011           (5) 
For subjects who have died and the date of last dose plus 28 days extends beyond the date of 
death, the exposure will be as follows: 
                   Duration of exposure = Date of death −Date of first dose in PS0011 + 1            (6) 
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8.1.3 
Derivation of exposure at risk 
Throughout this section, date of last clinical contact for each subject is defined as the maximum 
of [last visit date including SFU visits, last imputed AE start date, date of study termination or 
completion, last date of study drug administration]. 
In general, exposure days at risk will be calculated as: 
Exposure days at risk
= Date of last dose in PS0011 −Date of first dose in PS0011 + 140              (7) 
Alternatively, for subjects who die or are lost to follow-up prior to the Week 48 visit, total 
exposure days at risk will be calculated as: 
Exposure days at risk
= Date of last clinical contact in PS0011 −Date of first dose in PS0011
+ 1                                                                                                                                        (8) 
For the analysis based on data through to the last Week 48 visit (see Section 4.3), there may be 
subjects who are still ongoing in the SFU period at the time of data cut-off. For such subjects, 
exposure days at risk will be calculated as follows: 
           Exposure days at risk = Data cutoff date −Date of first dose in PS0011 + 1              (9) 
8.1.4 
Derivation of EAIR 
The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a 
specific AE adjusted for the exposure and will be scaled to 100 subject-years: 
                                                               EAIR = 100𝑛
∑𝑇𝐸𝑥𝑝(𝑖)
𝑁
𝑖=1
⁄
                                                       (10) 
where the numerator is the total number of subjects experiencing the AE and the denominator is 
the total time at risk scaled to 100 subject-years; that is, the total summation of individual 
subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total 
subject-years at risk for those subjects not experiencing that AE, divided by 100. 
If a subject has multiple events, the time of exposure is calculated to the first occurrence of the 
AE being considered. If a subject has no events, the total time at risk is used as defined in 
Section 8.1.3. 
Exact Poisson 95% confidence intervals for incidence rates are calculated using the relationship 
between the Poisson and the Chi-square distribution (Ulm, 1990): 
LCL = 𝜒2
2𝑛,𝛼2
⁄
2
⁄                                                                 (11) 
UCL = 𝜒2
2(𝑛+1),1−𝛼2
⁄
2
⁄                                                           (12) 
where n is the number of subjects with a specific AE for the incidence rate of interest and is the 
basis for the number of degrees of freedom for the chi-square quantile for the upper tail 
probability 𝜒2. 
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8.1.5 
Derivation of EAER 
The exposure adjusted event rate (EAER) will be the number of AEs including repeat 
occurrences in individual subjects divided by the total time at risk scaled to 100 subject-years 
and calculated using: 
                                                              EAER = 100𝑁𝐴𝐸
∑𝑇𝑅𝑖𝑠𝑘,𝑖
𝑁
𝑖=1
⁄
                                                    (13) 
where NAE is the total number of AEs. 
No confidence interval will be computed for EAER. 
8.1.6 
Analysis of the primary safety variable 
All TEAEs will be summarized descriptively by PS0011 treatment group, primary SOC, HLT, 
and PT. This summary will include the number and percentage of subjects experiencing the 
event, the number of events, EAIR with associated 95% confidence interval based upon the Chi-
Square distribution (Ulm, 1990), and the EAER.  
8.2 
Other safety analysis 
8.2.1 
TEAEs 
The following summaries will be provided by PS0011 treatment group and for the “All 
bimekizumab” group. In addition, all summaries of TEAEs “per 100 subject years” will display 
EAIR and EAER: 
 Incidence of TEAEs – Overview 
 Incidence of TEAEs per 100 subject years by SOC, HLT and PT 
 Incidence of TEAEs per 100 subject years by SOC, HLT, PT and by Timing of Onset 
Relative to Anti-bimekizumab Antibody Status 
 Incidence of TEAEs by Decreasing Frequency of PT 
 Incidence of TEAEs by Maximum Severity, SOC, HLT and PT 
 Incidence of Non-Serious TEAEs by SOC, HLT and PT 
 Incidence of Non-Serious TEAEs Above Reporting Threshold of 5% by SOC and PT 
The incidence of TEAEs per 100 subject years will also be summarized for PS0010 and PS0011 
combined, where treatment emergence and exposure at risk are relative to the first dose of study 
drug in PS0010. In the case of a subject that switches study treatment when starting PS0011, 
exposure at risk to PS0010 treatment will end the day prior to the first PS0011 dose. Adverse 
events that occur on the PS0011 baseline visit date will be attributed to the PS0010 treatment. 
The only exception to this definition is for the following types of events: 
 Those that code to a High Level Term (HLT) of “Injection Site Reactions” 
 Those which have been designated as an Injection Reaction on the AE CRF and do not code 
to a System Organ Class (SOC) of “Investigations” 
 Those which have been identified as a hypersensitivity reaction or an anaphylactic reaction 
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When any of these events occur on the date of treatment switch at PS0011 Baseline, the AE will 
be attributed to the treatment initiated in PS0011. 
All AE summaries will be ordered alphabetically by SOC and HLT within SOC and in terms of 
decreasing frequency for PT within HLT in the “All bimekizumab” treatment group. 
For each subject and each AE, the worst severity recorded will be attributed and used in the by-
severity summaries. Similarly, the worst causality (most related to treatment) will be attributed 
and used in the by-causality summaries. If severity or causality is missing, the worst case will be 
assumed. 
If the intensity of an AE is unknown, it will be considered as severe. If the relationship to study 
drug is missing, it will be considered as related.  
Additional tables will summarize TEAEs by relationship to study medication, TEAEs leading to 
withdrawal from the study, treatment-emergent SAEs, and deaths: 
 Incidence of TEAEs by Relationship, SOC, HLT and PT 
 Incidence of Non-Serious TEAEs by Relationship, SOC, HLT and PT 
 Incidence of Non-Serious TEAEs Above Reporting Threshold of 5% by Relationship, SOC 
and PT 
 Incidence of Serious TEAEs per 100 subject years by SOC, HLT and PT 
 Incidence of Serious TEAEs by Relationship, SOC, HLT and PT 
 Incidence of TEAEs Leading to Discontinuation by SOC, HLT and PT 
 Incidence of TEAEs Leading to Death by SOC, HLT and PT 
 Incidence of TEAEs Leading to Death by Relationship, SOC, HLT and PT 
The incidence of serious TEAEs per 100 subject years will also be summarized for PS0010 and 
PS0011 combined, where treatment emergence and exposure at risk are relative to the first dose 
of study drug in PS0010. In the case of a subject that switches study treatment when starting 
PS0011, exposure at risk to PS0010 treatment will end the day prior to the first PS0011 dose. 
Adverse events that occur on the PS0011 baseline visit date will be attributed to the PS0010 
treatment. The only exception to this definition is for the following types of events: 
 Those that code to a High Level Term (HLT) of “Injection Site Reactions” 
 Those which have been designated as an Injection Reaction on the AE CRF and do not code 
to a System Organ Class (SOC) of “Investigations” 
 Those which have been identified as a hypersensitivity reaction or an anaphylactic reaction 
When any of these events occur on the date of treatment switch at PS0011 Baseline, the AE will 
be attributed to the treatment initiated in PS0011. 
The following by-subject listings will be provided: 
 All serious TEAEs 
 All TEAEs leading to discontinuation of study treatment 
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 All death data 
 All TEAEs and all non-TEAEs 
 All treatment-emergent adverse drug reactions 
 All AEs of special monitoring (AESM). 
The following are AESM that require special statistical analyses: 
1.  Serious infections, opportunistic infections including TB and fungal infections 
Serious infections will be identified based on MedDRA classification (SOC “Infections and 
infestations”) using the “Any SAE” table. A separate table does not need to be produced to 
summarize these events. 
Fungal infections will be summarized in a stand-alone table which presents EAIR and EAER. 
The table will include all TEAEs which code into the high level group term (HLGT) of “Fungal 
infectious disorders”. 
The number and percentage of subjects experiencing fungal infections will be summarized by 
region and country by PS0011 treatment group. This summary will also include the number and 
percentage of subjects experiencing the PT “Oral Candidiasis” by region and country.  
Opportunistic infections (including tuberculosis) will be summarized in a stand-alone table 
which presents EAIR and EAER. The table will include all TEAEs identified using UCB-defined 
search criteria as described in Section 12.2. 
2.  Malignancies, including lymphomas 
These events will be presented in two stand-alone tables which include EAIR and EAER: 
 One table will be based on the criteria standard MedDRA query (SMQ) = “Malignant or 
unspecified tumours (SMQ)” 
 One table will be based on the criteria SMQ = “Malignant tumours (SMQ)”. 
Note that the events included in the “Malignant tumours” table will be a subset of the events 
included in the “Malignant or unspecified tumours” table. The SMQ search should include all 
TEAEs which code to a PT included in the Scope = Narrow group within each SMQ. 
The output tables will include two different overall incidence rows. The first overall incidence 
row will summarize “Any malignancies (including unspecified)” or “Any malignancies” 
(depending on the table) and this row will summarize the incidence of all AEs flagged for 
inclusion in the table, regardless of the HLT it codes to. The second overall incidence row will 
summarize “Any malignancy (including unspecified, excluding non-melanomic skin cancers)” or 
“Any malignancy (excluding non-melanomic skin cancers)” (depending on the table) and this 
row will summarize the incidence of AEs flagged for inclusion in the table, excluding those 
which code to an HLT of “skin neoplasms malignant and unspecified (excl melanoma)” 
3.  Major cardiovascular events 
Major cardiovascular events will be presented in a stand-alone table which includes EAIR and 
EAER. The table will include TEAEs that are identified using the following UCB-defined search 
criteria: 
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 All serious TEAEs which code to a PT included in the Scope = Broad and/or Scope = 
Narrow groups of the following SMQs: 
 Haemorrhagic central nervous system vascular conditions (SMQ) 
 Ischaemic central nervous system vascular conditions (SMQ). 
 All serious TEAEs which code to a PT included in the HLT “Ischaemic coronary artery 
disorders” except events coding to a PT “Chest pain” or “Chest discomfort” 
  All serious TEAEs which code to a PT included in any of the following HLTs: Heart 
Failures NEC, Left Ventricular Failures, or Right Ventricular Failures and which also 
code to the SOC of Cardiac Disorders as Primary SOC. 
4.  Cytopenias 
These events will be presented in a stand-alone table that is based on the SMQ = 
“Haematopoietic cytopenias”. The SMQ search should include all serious TEAEs which code to 
a PT included in the Scope = Broad and/or Scope = Narrow groups within the SMQ. 
5.  Neuropsychiatric events (in particular depression and suicide) 
These events will be presented in a stand-alone table including EAIR and EAER. The table will 
be based on the SMQ = “Depression and suicide/self-injury (SMQ)”. The SMQ search will 
include all TEAEs which code to a PT included in the Scope = Broad and/or Scope = Narrow 
groups within the SMQ. 
6.  Inflammatory bowel disease 
These events will be presented in a stand-alone table which includes EAIR and EAER. The table 
will include all TEAEs which code into the HLGT of “Colitis (excl infective)”. 
7.  Anaphylactic reaction 
Anaphylactic reactions will be summarized together in a stand-alone table. 
The first row within the body of the table will be labeled “Any hypersensitivity 
reaction/anaphylactic reaction” and will represent the overall incidence of subjects who reported 
at least one hypersensitivity reaction or at least one anaphylactic reaction. 
The second row within the body of the table will be labeled “Any hypersensitivity reaction” and 
will represent the overall incidence of subjects who reported at least one hypersensitivity 
reaction. 
The third row within the body of the table will be labeled “Any anaphylactic reaction” and will 
represent the overall incidence of subjects who reported at least one anaphylactic reaction. 
Following these three overall incidence rows, all TEAEs that have been identified as either a 
hypersensitivity reaction or an anaphylactic reaction will be summarized (together – not broken 
out by type) by SOC, HLT and PT. 
Hypersensitivity reactions and anaphylactic reactions will be identified as follows: 
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a) Hypersensitivity reactions 
All TEAEs that either emerged on the same day as when a study medication injection reaction 
was received, or that emerged one day after a study medication injection was received, which 
code to a PT which contains the term “hypersensitivity” will be considered to be a 
hypersensitivity reaction and included in the summary table as such. 
b) Anaphylactic reactions 
An algorithmic approach will be used to identify TEAEs that are considered to be anaphylactic 
reactions. PTs are separated into the four distinct categories (A, B, C, D) prior to the algorithmic 
approach being applied. 
All TEAEs that either emerged on the same day as when a study medication injection reaction 
was received, or that emerged one day after a study medication injection was received, and 
which fulfill any of the three criteria described in Section 12.3 will be included in the summary 
table. 
8.  Hepatic events and DILI 
Although not officially considered to be AEs of special monitoring, hepatic events are 
nonetheless considered to be interesting enough to be summarized in stand-alone tables. 
Hepatic events will be summarized in a stand-alone table that includes all TEAEs in the SMQ 
“Drug related hepatic disorders – comprehensive search (SMQ)”. Note that the following two 
sub-SMQs are to be excluded: “Liver neoplasms, benign (incl cysts and polyps)” and “Liver 
neoplasms, malignant and unspecified (SMQ)”. 
The SMQ search should include all TEAEs (regardless of whether they have been judged as 
related to study medication or not) which code to a PT included in the Scope = Narrow group 
within each SMQ. 
Hy’s Law cases are to be reported separately in the liver function test summary table (with 
adjudication for “Potential drug-induced liver injury” cases). 
Additional tables will summarize TEAEs by responder status (defined as PS0010 Week 12 
PASI90 response): 
 Incidence of TEAEs – Overview 
 Incidence of TEAEs per 100 subject years by SOC, HLT and PT 
 Incidence of Serious TEAEs per 100 subject years by SOC, HLT and PT  
 Incidence of Fungal Infectious Disorders per 100 subject years by SOC, HLT and PT 
8.2.2 
Clinical laboratory evaluations 
All laboratory data recorded in the electronic case report form (eCRF) will be summarized. If 
any additional analytes to those in Table 8-1 are also recorded then these will be listed only. 
Table 8-1: 
Laboratory measurements 
Hematology 
Chemistry 
Urinalysis 
Basophils 
Calcium 
Albumin 
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Hematology 
Chemistry 
Urinalysis 
Eosinophils 
Chloride 
Bacteria 
Lymphocytes 
C-reactive protein 
Crystals 
Monocytes 
Magnesium 
Glucose 
Neutrophils 
Potassium 
pH 
Hematocrit 
Sodium 
Red blood cell 
Hemoglobin 
Glucose 
White blood cell (WBC) 
Mean corpuscular hemoglobin 
Blood urea nitrogen 
Urine dipstick for pregnancy 
testinga 
Mean corpuscular hemoglobin 
concentration 
Creatinine 
 
Mean corpuscular volume 
Alkaline phosphatase 
 
Platelet count 
Aspartate aminotransferase 
(AST) 
 
Red blood cell count 
Alanine aminotransferase (ALT) 
 
White blood cell count 
Gamma glutamyltransferase 
(GGT) 
 
 
Total bilirubin 
 
 
Lactate dehydrogenase 
 
 
Total cholesterol 
 
 
Serum pregnancy testinga 
 
a Pregnancy testing will be done in all women of childbearing potential and will consist of serum testing at the 
Safety Follow-Up visit and urine testing at all other visits. 
For tables where data are summarized by visit, unscheduled and repeat visits will not be 
summarized, but these data will be included in listings. For tables where multiple measurements 
over a period of time are considered (as in shift tables), unscheduled and repeat visits will be 
considered as long as they were collected during the treatment period. All summaries will be 
presented in International System of units and will be based on observed case values. In the case 
where laboratory values are below the lower limit of quantification, then these will be set to the 
midpoint between zero and the lower limit of quantification for the purpose of summarizing the 
data.  
The change from Baseline tables will be presented using descriptive statistics by PS0011 
treatment group. The table presentations will display descriptive statistics for the PS0011 
Baseline followed by descriptive statistics for the change from PS0011 Baseline results by 
scheduled visit for PS0011. 
The following summaries will be provided: 
 The observed and change from Baseline values in each laboratory variable by PS0011 
treatment group and visit 
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 The number and percentage of subjects experiencing markedly abnormal values by 
laboratory variable, PS0011 treatment group and visit 
 A shift table of the number and percentage of subjects experiencing low, normal or high 
values at Baseline to maximum post-Baseline value (ie, low, normal, high), by laboratory 
variable and PS0011 treatment group 
 A shift table of the number and percentage of subjects experiencing low, normal or high 
values at Baseline to minimum post-Baseline value (ie, low, normal, high), by laboratory 
variable and PS0011 treatment group 
 A shift table of the number and percentage of subjects experiencing low, normal or high 
values at Baseline to the End of Treatment1 value (ie, low, normal, high), by laboratory 
variable and PS0011 treatment group. 
1The End of Treatment value refers to the value from the last observed non-missing post baseline visit prior to the 
end of treatment. 
A by-subject listing of all laboratory data will be provided. This listing will be presented by 
PS0011 treatment group and will include: center, subject identifier, age, gender, race, weight, 
visit, laboratory variable, result (with abnormal values flagged as “L” or “H” accordingly) and 
unit. 
A summary table highlighting the potential cases of Hy’s Law within each PS0011 treatment 
group will be presented. Hy’s Law is defined as: 
 AST > 3xULN or ALT >3xULN and 
 Total Bilirubin ≥2xULN. 
Markedly abnormal values are defined as those with a severity of Grade 3 and above based on 
the common terminology criteria for adverse events criteria (U.S. Department of Health and 
Human Services 2010). The markedly abnormal laboratory data will be summarized by visit and 
for any visit while on treatment. Definitions of markedly abnormal values using the Grade 3 
cutpoints are given in the tables below for age ranges of ≥ 17 years (Table 8-2 for markedly 
abnormal liver function test values, Table 8-3 for markedly abnormal hematology values and 
Table 8-4 for markedly abnormal biochemistry values). The laboratory results classified as 
Grade 3 or 4 will be listed separately. 
Table 8‒2: 
Definitions of Marked Abnormal Liver Function Tests 
Parameter name 
Conventional 
Standard 
 
Unit 
Criteria 
Unit 
Criteria 
Abnormal Designation 
Alkaline Phosphatase 
 
≥5.0 x ULN 
 
≥5.0 x ULN 
AH 
ALT 
U/L 
≥5.0 x ULN 
U/L 
≥5.0 x ULN 
AH 
AST 
U/L 
≥5.0 x ULN 
U/L 
≥5.0 x ULN 
AH 
Total Bilirubin 
mg/dL 
≥3.0 x ULN 
umol/L 
≥3.0 x ULN 
AH 
GGT 
U/L 
≥5.0 x ULN 
U/L 
≥5.0 x ULN 
AH 
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Table 8‒3: 
Definitions of Marked Abnormal Clinical Chemistry Values 
Parameter name 
Conventional 
Standard 
 
Unit 
Criteria 
Unit 
Criteria 
Abnormal Designation 
Albumin 
g/dL 
<2.0 
g/L 
<20 
AL 
Creatinine 
mg/dL 
>3.0 x ULN 
umol/L 
>3.0 x ULN 
AH 
Glucose 
mg/dL 
<30 
>250 
umol/L 
<1.7 
>13.9 
AL 
AH 
Calcium 
mg/dL 
<7.0 
>12.5 
umol/L 
<1.75 
>12.5 
AL 
AH 
Magnesium 
mg/dL 
<0.9 
>3.0 
umol/L 
<0.4 
>1.23 
AL 
AH 
Potassium 
umol/L 
<3.0 
>6.0 
umol/L 
<3.0 
>6.0 
AL 
AH 
Sodium 
umol/L 
<130 
>155 
umol/L 
<130 
>155 
AL 
AH 
Total Cholesterol 
mg/dL 
>400 
umol/L 
>10.34 
AH 
Table 8‒4: 
Definitions of Marked Abnormal Hematology Values 
Parameter name 
Conventional 
Standard 
 
Unit 
Criteria 
Unit 
Criteria 
Abnormal Designation 
Hemoglobin 
g/dL 
<8.0 
>4.0 above 
ULN 
g/L 
<80 
>40 above 
ULN 
AL 
AH 
Lymphocytes Absolute 
109/L 
<0.5 
>20.0 
109/L 
<0.5 
>20.0 
AL 
AH 
Neutrophils Absolute 
109/L 
<1.0 
109/L 
<1.0 
AL 
Platelets 
109/L 
<50 
109/L 
<50 
AL 
WBC/Leukocytes 
109/L 
<2.0 
>100 
109/L 
<2.0 
>100 
AL 
AH 
8.2.3 
Vital signs 
The following vital signs variables will be summarized: systolic blood pressure (mmHg), 
diastolic blood pressure (mmHg), body temperature (OC) and pulse rate (beats/min).  
The change from Baseline table will be presented using descriptive statistics by PS0011 
treatment group. The table presentations will display descriptive statistics for the PS0011 
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Baseline followed by descriptive statistics for the change from PS0011 Baseline results by 
scheduled visit for PS0011. 
The following summaries will be provided: 
 A summary of the absolute and change from PS0011 Baseline value for each vital sign 
variable by PS0011 treatment group and visit 
 A summary of the number and percentage of subjects experiencing at least one markedly 
abnormal value for a vital sign variable as defined in Table 8-5, by PS0011 treatment group 
and visit. 
Table 8‒5: 
Definitions of markedly abnormal blood pressure values 
Parameter (unit) 
Markedly Abnormal Low 
Markedly Abnormal High 
Systolic blood pressure (mmHg) 
<90 and a decrease from 
Baseline of  ≥20 
>180 and an increase from 
Baseline of  ≥20 
Diastolic blood pressure (mmHg) 
<50 and a decrease from 
Baseline of  ≥15 
>105 and an increase from 
Baseline of  ≥15 
A by-subject listing of all vital signs data will be provided. This listing will be presented by 
PS0011 treatment group and will include: center, subject identifier, age, gender, race, weight, 
visit, vital sign variable and result (with abnormal values flagged as “L” or “H” accordingly). 
8.2.4 
Physical examination 
A physical examination is conducted at PS0011 Baseline, Week 48 visit and SFU visit. Findings 
are collected as AEs and will be listed as such. 
8.2.5 
Electrocardiograms 
A summary of the number and percentage of subjects with normal, abnormal not clinically 
significant and abnormal clinically significant ECG results at all applicable visits will be 
presented by PS0011 treatment group. 
The change from Baseline tables will be presented using descriptive statistics by PS0011 
treatment group. The table presentations will display descriptive statistics for the PS0011 
Baseline followed by descriptive statistics for the observed and change from PS0011 Baseline 
results by scheduled visit for PS0011. 
The following ECG variables will be summarized (observed values and change from PS0011 
Baseline) by visit: QTcF, RR, PR, QRS, and QT. 
QTc abnormalities are defined as QTcF values following dosing that are greater than 450 ms or 
are increases from PS0011 Baseline greater than 30 ms. QTcF outliers will be highlighted in the 
data listings and summarized using the following categories: 
 Values >450 ms, >480 ms, >500 ms 
 Increase from PS0011 Baseline of >30 ms, increase from PS0011 Baseline of >60 ms, 
increase from PS0011 Baseline of >90 ms 
 Values >450 ms and increases from PS0011 Baseline of >30 ms, values >500 ms and 
increases from PS0011 Baseline of >60 ms. 
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The number and percentage of subjects who meet the ECG outlier criteria at any assessment 
post-date of first dose in PS0011 will be summarized by PS0011 treatment group. 
A by-subject listing of all 12-Lead ECG data will be provided. 
8.2.6 
Exposure 
The number of doses received will be summarized by PS0011 treatment group over the 48 week 
administration period. Each dose should consist of two injections. 
Extent of exposure to study medication in PS0011 will be summarized using descriptive statistics 
by PS0011 treatment group. 
Subject exposure at risk in days in PS0011 will also be summarized using descriptive statistics 
by PS0011 treatment group. Total subject exposure at risk in years for each PS0011 treatment 
group will also be provided. 
8.2.7 
Assessment and management of TB and TB risk factors 
A by-subject listing of all the “Evaluation of signs and symptoms of tuberculosis” questionnaire 
data will be provided. 
8.2.8 
Electronic Columbia Suicide Severity Rating Scale 
The results of the Columbia Suicide Severity Rating Scale (C-SSRS) will be summarized using 
number of subjects and percentages with (i) events in suicidal behavior, (ii) suicidal ideation, (iii) 
suicidal behavior and ideation, and (iv) self-injurious behavior without suicidal intent. 
Self-injurious behaviour without suicidal intent is defined as an event in the category non-
suicidal self-injurious behavior. 
The incidence of subjects with suicidal behavior and self-injurious behavior will be summarized 
by PS0011 treatment group and visit. A by-subject listing of the electronic C-SSRS questionnaire 
data will be provided. 
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9 
PHARMACOKINETICS  
9.1 
Pharmacokinetics 
Descriptive statistics for the plasma concentrations at PS0011 Baseline will be presented 
followed by descriptive statistics for the observed and change from PS0011 Baseline results for 
scheduled visits in PS0011. For the descriptive statistics, geometric mean, geometric coefficient 
of variation, and 95% confidence interval for the geometric mean will be used instead of the 
arithmetic mean and standard deviation. The median, minimum, and maximum will also be 
displayed. 
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 lower level of quantification (LLQ). The subjects with at least one result that is defined 
as BLQ will also be listed within the respective analysis table. Descriptive statistics will be 
calculated if at least 2/3 of the values are above the LLQ. If this is not the case, only median, 
minimum, and maximum will be presented. 
If the dosing for a visit is +/- 7 days out of window, then the plasma concentration from that visit 
and all subsequent visits will be excluded from the PK summary. 
The bimekizumab concentrations, including the concentrations excluded from the summaries, 
will also be listed. 
9.2 
Immunogenicity 
9.2.1 
Anti-bimekizumab antibodies 
Subjects with a positive on-treatment (i.e, excluding PS0010 Baseline) anti-BKZ antibody result 
in either PS0010 or PS0011 will be classified as anti-BKZ positive. 
Anti-BKZ antibody status will be summarized for each PS0010/PS0011 treatment group at each 
scheduled PS0010 and PS0011 visit using the PK-PPS analysis set. The first occurrence of anti-
BKZ antibody positivity will also be presented for each PS0010/PS0011 treatment group at each 
scheduled PS0010 and PS0011 visit. 
The anti-BKZ antibody status will be determined for each visit where samples are taken for drug 
concentration means. The cut point for determining whether the anti-bimekizumab antibody level 
is sufficiently high to be considered anti-BKZ antibody positive is not yet known. However, this 
will be determined prior to the database lock of the PK and anti-BKZ antibody data.  
A line plot of the percentage of anti-BKZ antibody positive subjects at each visit will be 
produced by PS0010/PS0011 treatment group. All individual subject-level anti-BKZ antibody 
results will be listed. 
10 
EFFICACY ANALYSES 
10.1 
Statistical analysis of the efficacy variables 
Efficacy variables will be analyzed for all subjects in the FAS. 
Also, summary tables of each endpoint by visit and treatment will be provided. 
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Unless otherwise specified, summary tables for efficacy endpoints by PS0010/PS0011 treatment 
group will present data separately by responder status (defined as PS0010 Week 12 PASI90 
response). 
Efficacy endpoints will also be listed. 
10.1.1 
PASI score and response 
10.1.1.1 
Derivation of PASI score and response 
PASI scoring of psoriatic plaques is based on three criteria: redness (R), thickness (T), and 
scaliness (S). Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement, up 
to 4 for very marked involvement). The body is divided into four areas comprising the head (h), 
upper extremities (u), trunk (t), and lower extremities (l). In each of these areas, the fraction of 
total surface area affected is graded on a 0-6 scale (0 for no involvement, up to 6 for 90%-100% 
involvement). 
The various body regions are weighted to reflect their respective proportion of BSA. The 
composite PASI score is then calculated by multiplying the sum of the individual-severity scores 
for each area by the weighted area-of-involvement score for that respective area, and then 
summing the four resulting quantities. PASI is therefore calculated as (note that the R, T, and S 
scores are as follows: 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked): 
PASI = (0.1 × (𝑅ℎ+ 𝑇ℎ+ 𝑆ℎ) × 𝐴ℎ) + (0.2 × (𝑅𝑢+ 𝑇𝑢+ 𝑆𝑢) × 𝐴𝑢)
+ (0.3 × (𝑅𝑡+ 𝑇𝑡+ 𝑆𝑡) × 𝐴𝑡)
+ (0.4 × (𝑅𝑙+ 𝑇𝑙+ 𝑆𝑙) × 𝐴𝑙)                                                                                     (14) 
where 
Rh, Ru, Rt, Rl = redness score of plaques on the head, upper extremities, trunk, and lower 
extremities, scored 0-4 respectively 
Th, Tu, Tt, Tl = thickness score of plaques on the head, upper extremities, trunk, and lower 
extremities, scored 0-4 respectively 
Sh, Su, St, Sl = scaliness score of plaques on the head, upper extremities, trunk, and lower 
extremities, scored 0-4 respectively 
Ah, Au, At, Al = numerical value translation of % area of psoriatic involvement score for the 
head, upper extremities, trunk, and lower extremities respectively (where 0 = 0% [clear], 1 = 
>0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to <90%, and 6 
= 90% to 100%). 
The highest potential PASI score is 72 for severe disease and the lowest is 0 for no psoriasis 
lesions. PASI scores are treated as a continuous score, with 0.1 increments within these values. 
The percent improvement in PASI scores from Baseline will be computed as: 
Percent improvement in PASI
= 100 × Baseline PASI −Post⎼Baseline PASI
Baseline PASI
                                                    (15) 
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. 
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If a subject is missing one or two severity measurements for a certain region, the average of the 
remaining severity measurement(s) within that region will be utilized to substitute for the 
missing severity measurement(s) in that region. If the area of affected skin and/or all severity 
measurements for up to two regions are missing, then the missing (R + T + S) x A for a region 
will be substituted by the average of the available (R + T + S) x A. Otherwise, the PASI will be 
set to missing. 
A categorical variable, PASI90 response, is defined to be equal to 1 if the percentage 
improvement from Baseline in the PASI scores is 90% or greater and 0 if the percentage 
improvement from Baseline is less than 90%. This definition is introduced for the purpose of 
identifying subjects who respond to the treatment (1 = responder, 0 = non-responder). Similarly, 
the categorical efficacy variables PASI75 and PASI100 response are equal to 1 for subjects with 
improvements of 75% or greater and 100% from Baseline in PASI score respectively, and equal 
to 0 otherwise. 
10.1.1.2 
Analysis of PASI score and response 
Summaries of the PASI75, PASI90 and PASI100 response will be summarized descriptively 
using counts and percentages by PS0010/PS0011 treatment group and visit. In general, 
summaries of PASI score and response will include only PS0011 visits. PS0010 visits will be 
added for select summaries as specified. 
The PASI responder variables will be derived relative to both the PS0010 Baseline and the 
PS0011 Baseline for subjects who are PS0010 Week 12PASI90 non-responders at PS0010 Week 
12 in the following treatment groups: Placebo to BKZ 160mg, BKZ 64mg to BKZ 160mg, BKZ 
160mg to BKZ 320mg, BKZ 320mg to BKZ 320mg, and BKZ 480mg to BKZ 320mg. PASI 
response will be calculated relative to the original PS0010 Baseline only for subjects who are 
PS0010 Week 12 PASI90 responders in the following treatment groups: Placebo to Placebo, 
BKZ 64mg to BKZ 64mg, BKZ 160mg to BKZ 160mg, BKZ 320mg to BKZ 320mg, and BKZ 
480mg to BKZ 320mg. Missing data will be imputed via NRI. Summaries for PASI90 and 
PASI100 response will include PS0010 visits. 
In addition, PASI90 and PASI100 response relative to the PS0010 Baseline will also be 
summarized descriptively using counts and percentages by PS0011 treatment group and visit. 
Missing data will be imputed via NRI. 
Change from Baseline in PASI score will be summarized using descriptive statistics by 
PS0010/PS0011 treatment group and visit separately by PS0010 Week 12 PASI90 response. The 
table will display descriptive statistics for the PS0010 Baseline, followed by descriptive statistics 
for the change from PS0010 Baseline for all treatment groups. The change from PS0011 
Baseline will also be displayed for subjects who are PS0010 Week 12 PASI90 non-responders at 
PS0010 Week 12 in the following treatment groups: Placebo to BKZ 160mg, BKZ 64mg to BKZ 
160mg,  BKZ 160mg to BKZ 320mg, BKZ 320mg to BKZ 320mg, and BKZ 480mg to BKZ 
320mg. A similar summary will be presented for the percent change from Baseline in PASI 
score. 
Missing data for the continuous change from Baseline and percent change from Baseline 
variables will be handled by using MI via the MCMC method specified in Section 4.2.2. 
Supportive summaries will be based on observed data. 
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In addition, the percent change from PS0010 Baseline in PASI score will also be presented using 
descriptive statistics by PS0011 treatment group and visit. Missing data will be handled using the 
same multiple imputation as described above. 
A line plot of the mean percentage change from PS0010 Baseline in PASI score over time using 
MI via the MCMC method specified in Section 4.2.2, by PS0010/PS0011 treatment group will 
be produced. 
The number and percentage of subjects who achieve an absolute PASI score ≤1, ≤2, ≤3, and ≤5 
at each visit will be summarized by both PS0010/PS0011 treatment group and PS0011 treatment 
group. Missing data will be imputed using NRI. These summaries will include PS0010 visits. 
10.1.2 
IGA response 
10.1.2.1 
Derivation of IGA response 
A static IGA for psoriasis will be used to assess disease severity in all subjects during the study. 
The Investigator will assess the overall severity of psoriasis using the following five-point scale 
(see Table 10-1): 
Table 10‒1: Five-point Investigator's Global Assessment 
Score 
Short Descriptor 
Detailed Descriptor 
0 
Clear 
No signs of psoriasis; post-inflammatory hyperpigmentation may be 
present 
1 
Almost clear 
No thickening; normal to pink coloration; no to minimal focal scaling 
2 
Mild 
Just detectable to mild thickening; pink to light red coloration; 
predominately fine scaling 
3 
Moderate 
Clearly distinguishable to moderate thickening; dull to bright red, 
clearly distinguishable to moderate thickening; moderate scaling 
4 
Severe 
Severe thickening with hard edges; bright to deep dark red coloration; 
severe/coarse scaling covering almost all or all lesions 
IGA response is defined as clear (0) or almost clear (1) with at least a two category improvement 
from Baseline. 
10.1.2.2 
Analysis of IGA response 
The number and percentage of subjects achieving an IGA response (defined as clear (0) or 
almost clear (1) with at least two category improvement from Baseline) will be summarized 
descriptively using counts and percentages by PS0010/PS0011 treatment group and visit.  In 
general, summaries of PASI score and response will include only PS0011 visits. PS0010 visits 
will be added for select summaries as specified. 
The IGA response variables will be derived relative to both the PS0010 Baseline and the PS0011 
Baseline for subjects who are PS0010 Week 12 PASI90 non-responders in the following 
treatment groups: Placebo to BKZ 160mg, BKZ 64mg to BKZ 160mg, BKZ 160mg to BKZ 
320mg, BKZ 320mg to BKZ 320mg, and BKZ 480 mg to BKZ 320mg. PASI response will be 
calculated relative to the original PS0010 Baseline only for subjects who are PS0010 Week 12 
PASI90 responders in the following treatment groups: Placebo to Placebo, BKZ 64mg Q4W to 
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BKZ 64mg Q4W, BKZ 160mg Q4W to BKZ 160mg Q4W, BKZ 320mg Q4W to BKZ 320mg 
Q4W, and BKZ 480mg Q4W to BKZ 320mg Q4W. Missing data will be imputed via NRI. 
Summaries for IGA response will include PS0010 visits. 
IGA response relative to the PS0010 Baseline will also be summarized descriptively using 
counts and percentages by PS0011 treatment group and visit. Missing data will be imputed via 
NRI. 
In addition, a shift table of IGA response compared to PS0010 Baseline will be summarized by 
PS0010/PS0011 treatment group based on observed data. 
10.1.3 
Analysis of BSA 
Change from Baseline in BSA affected by psoriasis will be summarized using descriptive 
statistics by PS0010/PS0011 treatment group and visit separately by PS0010 Week 12 PASI90 
response. The table will display descriptive statistics for the PS0010 Baseline, followed by 
descriptive statistics for the change from PS0010 Baseline for all treatment groups. The change 
from PS0011 Baseline will also be displayed for subjects who are PS0010 Week 12 PASI90 non-
responders in the following treatment groups: Placebo to BKZ 160mg, BKZ 64mg to BKZ 
160mg, BKZ 160mg to BKZ 320mg, BKZ 320mg to BKZ 320mg, and BKZ 480mg to BKZ 
320mg. A similar summary will be presented for the percent change from Baseline in BSA. 
Missing data for the continuous change from Baseline and percent change from Baseline 
variables will be handled by using MI via the MCMC method specified in Section 4.2.2. 
Supportive summaries will be based on observed data. 
The percent change from PS0010 Baseline in BSA will also be presented using descriptive 
statistics by PS0011 treatment group and visit. Missing data will be handled using the same 
multiple imputation as described above. 
The number and percentage of subjects who achieve BSA =0%, ≤1%, ≤3%, and ≤5% at each 
visit will be summarized by both PS0010/PS0011 treatment group and PS0011 treatment group.  
Missing data will be imputed using NRI. These summaries will include PS0010 visits. 
10.1.4 
DLQI 
10.1.4.1 
Derivation of DLQI 
The DLQI questionnaire is used for patients with psoriasis and consists of 10 questions. Question 
7 consists of a sub-question which is only to be answered following a “No” response to the main 
question. The questions are scored as shown below in Table 10-2, and the DLQI score is 
categorized as shown in Table 10-3. 
Table 10‒2: DLQI Scoring 
Question Number 
0 points 
1 point 
2 points 
3 points 
1, 2 
Not at all 
A little 
A lot 
Very much 
3, 4, 5, 6, 8, 9, 10 
Not at all/Not 
relevant 
A little 
A lot 
Very much 
7 
No – Not at all/Not 
relevant 
No – A little 
No – A lot 
Yes 
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Table 10‒3: DLQI - Categorization 
Category 
Score Range 
No Effect 
0-1 
Small Effect 
2-5 
Moderate Effect 
6-10 
Very Large Effect 
11-20 
Extremely Large Effect 
21-30 
In the case of one missing value the result imputed for that question will be 0 and the DLQI 
score created as normal. Should two or more questions be unanswered then the DLQI score will 
be set to missing. For question 7, if “Not relevant” is selected then the score for the question will 
be 0, if the question is answered “No” but the second half of the question is incomplete then the 
question will still be scaled as 0. 
A DLQI absolute score of 0 or 1 indicates no or small impact of the disease on health related 
quality of life. 
10.1.4.2 
Analysis of DLQI 
The number and percentage of subjects achieving a DLQI score of 0 or 1 at each visit will be 
summarized descriptively using counts and percentages by PS0010/PS0011 treatment group and 
visit. Missing data will be imputed via NRI. 
The number and percentage of subjects achieving a DLQI score of 0 or 1 at each visit will also 
be summarized descriptively using counts and percentages by PS0011 treatment group and visit. 
Missing data will be imputed via NRI. 
Change from Baseline in DLQI score will be summarized using descriptive statistics by 
PS0010/PS0011 treatment group and visit. The table will display descriptive statistics for the 
PS0010 Baseline, followed by descriptive statistics for the change from PS0010 Baseline for all 
treatment groups. The change from PS0011 Baseline will also be displayed for subjects who are 
PS0010 Week 12 PASI90 non-responders in the following treatment groups: Placebo to BKZ 
160mg, BKZ 64mg to BKZ 160mg, BKZ 160mg to BKZ 320mg, BKZ 320mg to BKZ 320mg, 
and BKZ 480 mg to BKZ 320mg. 
Missing data for the continuous change from Baseline variable will be handled by using MI via 
the MCMC method specified in Section 4.2.2. Supportive summaries will be based on observed 
data. 
A line plot of the mean change from PS0010 Baseline in DLQI response over time using MI via 
the MCMC method specified in Section 4.2.2, by PS0010/PS0011 treatment group will be 
produced. 
10.1.5 
mNAPSI 
10.1.5.1 
Derivation of mNAPSI 
Psoriatic nail disease will be evaluated at the Baseline visit using the mNAPSI. All affected nails 
will be scored (0 to 3) for onycholysis/oil drop dyschromia, nail plate crumbling, and pitting and 
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will be scored (0 for “no” or 1 for “yes”) for leukonychia, nail bed hyperkeratosis, splinter 
haemorrhages and red spots in the lunula. The score for an individual nail ranges from 0 to 13 
with higher scores indicative of more severe nail disease. The total mNAPSI score is the sum of 
the scores for each individual nail. If a nail is unaffected, it will be recorded as such and will not 
contribute to the total mNAPSI score. Subjects with nail disease at Baseline are defined as those 
with a mNAPSI score >0 at Baseline. 
If 1 or 2 response items scored on the 0 to 1 scale are missing, the missing response(s) will be 
imputed by the average of the available responses. Otherwise, the total mNAPSI score will be set 
to missing. 
10.1.5.2 
Analysis of mNAPSI 
Change from Baseline in mNAPSI scores for the subset of subjects with psoriatic nail disease at 
PS0010 Baseline will be summarized using descriptive statistics by PS0010/PS0011 treatment 
group and visit. The table will display descriptive statistics for the PS0010 Baseline, followed by 
descriptive statistics for the change from PS0010 Baseline for all treatment groups. The change 
from PS0011 Baseline will also be displayed for subjects who are PS0010 Week 12 PASI90 non-
responders in the following treatment groups: Placebo to BKZ 160mg, BKZ 64mg to BKZ 
160mg, BKZ 160mg to BKZ 320mg, BKZ 320mg to BKZ 320mg, and BKZ 480 mg to BKZ 
320mg. 
Missing data for the continuous change from Baseline variable will be handled by using MI via 
the MCMC method specified in Section 4.2.2. Supportive summaries will be based on observed 
data. 
10.1.6 
PGADA for the arthritis VAS 
10.1.6.1 
Derivation of PGADA for the arthritis VAS 
The PGADA for the arthritis VAS will be used to provide an overall evaluation of arthritis 
disease symptoms. Subjects will respond to the question, “Considering all the ways your arthritis 
affect you, please mark a vertical line on the scale below to show how you are feeling today”, 
using a VAS where 0 is “very good, no symptoms” and 100 is “very poor, severe symptoms”. 
10.1.6.2 
Analysis of PGADA for the arthritis VAS 
Change from Baseline in PGADA VAS scores will be summarized using descriptive statistics by 
PS0010/PS0011 treatment group and visit. The table will display descriptive statistics for the 
PS0010 Baseline, followed by descriptive statistics for the change from PS0010 Baseline for all 
treatment groups. The change from PS0011 Baseline will also be displayed for subjects who are 
PS0010 Week 12 PASI90 non-responders in the following treatment groups: Placebo to BKZ 
160mg, BKZ 64mg to BKZ 160mg, BKZ 160mg to BKZ 320mg, BKZ 320mg to BKZ 320mg, 
and BKZ 480 mg to BKZ 320mg. 
Missing data for the continuous change from Baseline variable will be handled by using MI via 
the MCMC method specified in Section 4.2.2. Supportive summaries will be based on observed 
data. 
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10.1.7 
PSSI 
10.1.7.1 
Derivation of PSSI 
The PSSI considers both the extent of the scalp area of involvement and the severity based on the 
scoring scales outlined in Table 10-4 and Table 10-5. 
The assessment considers erythema, induration and desquamation on the scalp. For each of these 
three elements, the scores of the area and severity are multiplied. Then, the score from each 
element is totaled to obtain the PSSI score. As with the PASI, the PSSI score ranges from 0 to 72 
with a higher score indicating increased scalp disease severity. 
If a subject is missing one severity measurement, the average of the remaining severity 
measurements will be utilized to substitute for the missing severity measurement. If the area of 
affected skin is missing or if two or more severity measurements are missing, then the PSSI 
score will be set to missing. 
Table 10‒4: PSSI assessment of extent of scalp psoriasis 
Score 
Definition 
1 
<10% 
2 
10 – 29% 
3 
30 – 49% 
4 
50 – 69% 
5 
70 – 89% 
6 
90 – 100% 
Table 10‒5: PSSI assessment of clinical symptoms 
Score 
Definition 
0 
Absent 
1 
Slight 
2 
Moderate 
3 
Severe 
4 
Severest possible 
10.1.7.2 
Analysis of PSSI 
Change from Baseline in PSSI for the subset of subjects with scalp psoriasis at PS0010 Baseline 
will be summarized using descriptive statistics by PS0010/PS0011 treatment group and visit. The 
table will display descriptive statistics for the PS0010 Baseline, followed by descriptive statistics 
for the change from PS0010 Baseline for all treatment groups. The change from PS0011 
Baseline will also be displayed for subjects who are PS00010 Week 12 PASI90 non-responders 
in the following treatment groups: Placebo to BKZ 160mg, BKZ 64mg to BKZ 160mg, BKZ 
160mg to BKZ 320mg, BKZ 320mg to BKZ 320mg, and BKZ 480 mg to BKZ 320mg. A similar 
summary will be presented for the percent change from Baseline. 
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Missing data for the continuous change from Baseline variable will be handled by using MI via 
the MCMC method specified in Section 4.2.2. Supportive summaries will be based on observed 
data. 
A line plot of the mean percent change from PS0010 Baseline in PSSI over time using MI via the 
MCMC method (or LOCF if necessary, as determined in Section 4.2.2),, by PS0010/PS0011 
treatment group will be produced. 
The percent change from PS0010 Baseline in PSSI score will also be presented using descriptive 
statistics by PS0011 treatment group and visit. Missing data will be handled using the same 
multiple imputation as described above. 
10.1.8 
SF-36 
10.1.8.1 
Derivation of SF-36 
The SF-36v2, standard recall, measures the following eight health domains as rated by the 
subjects over the past four weeks: Physical Functioning, Role Physical, Bodily Pain, General 
Health, Vitality, Social Functioning, Role Emotional, and Mental Health. The classification of 
the questionnaire items to the health domains is shown in Section 12.1. 
The SF-36 PCS and MCS scores are used to measure the two broad components, or aspects, of 
health-physical and mental. PCS and MCS are based on the aggregate of the eight health 
concepts described above and all of the eight health domain scales are used to score both 
components summary measures. 
One additional item asks responders about health change over the past year. 
The SF-36 will be used using QualityMetric’s Health Outcomes™ Scoring Software. The 
software uses updated 2009 U.S. population norms and applies a Full Missing Score Estimation 
(Full MSE) method as follows: 
 A health domain score (except the PF domain) will be estimated provided that at least one 
non-missing response is available within that domain 
 For the PF domain item, response theory will be used to develop a model for estimates of the 
missing score 
 Regression methods are then applied to estimate the PCS and the MCS on the basis of the 
available domains. 
10.1.8.2 
Analysis of SF-36 
Change from Baseline in the SF-36 PCS and MCS scores as well as for the individual domain 
scores will be summarized using descriptive statistics by PS0010/PS0011 treatment group and 
visit. The table will display descriptive statistics for the PS0010 Baseline, followed by 
descriptive statistics for the change from PS0010 Baseline for all treatment groups. The change 
from PS0011 Baseline will also be displayed for subjects who are PS0010 Week 12 PASI90 non-
responders the following treatment groups: Placebo to BKZ 160mg, BKZ 64mg to BKZ 160mg, 
BKZ 160mg to BKZ 320mg, BKZ 320mg to BKZ 320mg, and BKZ 480 mg to BKZ 320mg. 
Missing data for the continuous change from Baseline variable will be handed by using MI via 
the MCMC method specified in Section 4.2.2. Supportive summaries will be based on observed 
data. 
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10.1.9 
HADS 
10.1.9.1 
Definition of HADS 
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 (Snaith et al, 1994). The 
HADS scores for anxiety and for depression range from 0 to 21 with higher scores indicating 
worse state. The HADS scores and the severity based on the scoring scales are outlined in Table 
10-6 (Langley et al, 2009). 
Table 10‒6: HADS Assessment of clinical symptoms 
Score 
Definition 
<8 
Normal 
8 - 10 
Mild 
11 - 14 
Moderate 
≥15 
Severe 
10.1.9.2 
Analysis of HADS 
Change from Baseline in HADS-A and HADS-D will be summarized using descriptive statistics 
by PS0010/PS0011 treatment group and visit. The table will display descriptive statistics for the 
PS0010 Baseline, followed by descriptive statistics for the change from PS0010 Baseline for all 
treatment groups. The change from PS0011 Baseline will also be displayed for subjects who are 
PS0010 Week 12 PASI90 non-responders in the following treatment groups: Placebo to BKZ 
160mg, BKZ 64mg to BKZ 160mg, BKZ 160mg to BKZ 320mg, BKZ 320mg to BKZ 320mg, 
and BKZ 480 mg to BKZ 320mg. 
Missing data for the continuous change from Baseline variable will be handed by using MI via 
the MCMC method specified in Section 4.2.2. Supportive summaries will be based on observed 
data. 
In addition the percentage of subjects with scores below 8 in HADS-A and HADS-D will be 
summarized by visit and treatment group for imputed data (NRI) and observed cases. 
 
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11 
REFERENCES 
Langley, R. G., Feldman, S. R., Han, C., Schenkel, B., Szapary, P., Hsu, M. C., et al., 
Ustekinumab significantly improves symptoms of anxiety, depression, and skin-related quality of 
life in patients with moderate-to-sever psoriasis: Results from a randomized, doubleblind, 
placebo controlled phase III trial. J Am Acad Dermatol., 2010; 63(3), 457-65. 
Ratitch, B., Lipkovich, I., O’Kelly, M., Combining Analysis Results from Multiply Imputed 
Categorical Data. PharmaSUG, 2013. 
Rubin D.B. 1987. Multiple Imputation for Nonresponse in Surveys. New York: John Wiley and 
Sons. 
Snaith, R. P., & Zigmond, A. S., The hospital anxiety and depression scale, with the irritability-
dpression-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(12), 373-375 
U.S. Department of Health and Human Services, Common Terminology Criteria for Adverse 
Events (CTCAE), Version 4.0, June 2010. 
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12.2 
AESM Opportunistic infections 
Opportunistic infections are identified in two steps: 
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. 
All serious TEAEs in the study database which code to a PT flagged with a single ‘x’ and all 
TEAEs in the study database which code to a PT flagged with a double ‘xx’ will be summarized 
as an opportunistic infection in the stand-alone table. 
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 it is a true 
opportunistic infection or not. The process for physician review is as follows: 
1. Study programming team creates a spreadsheet which lists all of the subjects with a 
TEAE present in the database which codes to a PT identified as case-by-case. 
Information from the AE dataset to be included in the spreadsheet: Subject ID, AE 
verbatim term, SOC, HLT, LLT, PT, AE start date, AE end date, seriousness, severity, 
relationship to study medication, action taken. Additionally, a column will be included 
where the study physician can document their decision on the case 
2. Study physician reviews the cases in the spreadsheet and indicates in the additional 
column which AEs are confirmed to be opportunistic infections via a single ‘x’ 
3. Study programming team incorporates these decisions into the AE dataset by merging the 
study physician decisions for individual subjects/PTs and flagging the confirmed 
opportunistic infections as such in the dataset. 
All subjects with a case-by-case PT reported that has been confirmed by the study physician to 
be an opportunistic infection will be summarized as such in the stand-alone table, along with all 
of the events identified in Step 1 of this process. 
The timing and frequency of Step 2 should be outlines and agreed to by the study team at the 
beginning of the study. It is suggested that this process be executed multiple times throughout the 
course of the study, more frequently in the weeks leading up to database lock, and one final time 
immediately prior to database lock. 
Following the initial physician review of case-by-case events, subsequent reviews will be based 
on the cumulative set of case-by-case events present in the database at each time point of 
spreadsheet creation. Physician decisions from previous runs should be retained in each 
subsequent run. The final run of the spreadsheet, with all study physician decisions on the full set 
of case-by-case events, will be archived at the conclusion of the study. 
12.3 
MedDRA algorithmic approach to anaphylaxis 
The SMQ Anaphylactic reaction consists of three parts: 
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 A narrow search: If a subject reports any TEAE which codes to a PT included in 
Category A, then the event will be flagged as an anaphylactic reaction and summarized as 
such in the table 
- 
Category A 
 
 A broad search: If a subject reports any TEAE which codes to a PT included in 
Category B AND reports any TEAE which codes to a PT included in Category C, and 
both TEAEs have the same start date, then both events will be flagged as anaphylactic 
reactions and summarized as such in the table 
- 
Category B 
 
 
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- 
Category C 
 
- 
Category D 
 
 An algorithmic approach: If a subject reports any TEAE which codes to a PT included 
in Category D AND reports (either a TEAE which codes to a PT included in Category B 
OR a TEAE which codes to a PT included in Category C), and both TEAEs have the 
same start date, then both events will be flagged an anaphylactic reactions and 
summarized as such in the table. 
 
 
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13 
AMENDMENT TO THE STATISTICAL ANALYSIS PLAN 
Rationale for the amendment 
The purpose of this amendment is to apply modifications as a result of conclusions made at Data 
Evaluation Meetings 1/2 and 3. 
Global changes 
Various spelling and formatting amendments were made. 
Due to the small population size in the Asia region, Asia was combined with Europe in all cases. 
Efficacy analysis summaries were updated to group subjects by responder status (defined as 
PS0010 Week 12 PASI90 response) instead of by whether or not a subject switched treatment 
from PS0010 to PS0010. 
Efficacy analysis summaries were added by PS0011 treatment groups for the following 
endpoints: 
 PASI90 and PASI100 response 
 IGA response (defined as clear (0) or almost clear (1) with at least two category 
improvement from Baseline) 
 DLQI (0,1) response 
 Percent change in PASI, BSA, PSSI 
The MI procedure for continuous efficacy endpoints was clarified to refer to Section 4.2.2: 
Missing data for the continuous change from Baseline and percent change from Baseline 
variables will be handled by using MI via the MCMC method specified in Section 4.2.2 
Specific changes 
Change #1 
Page 9 Section 2.2.4 Efficacy Variable, the following text was updated 
From 
Change from Baseline and responder variables will be defined relative to the PS0010 Baseline 
for subjects who do not change treatment between PS0010 and PS0011 (non-switchers) and 
relative to both the PS0010 and PS0011 Baselines for subjects who change treatments 
(switchers). 
To 
Change from Baseline and responder variables will be defined relative to the PS0010 Baseline 
for subjects who are PS0010 Week 12 PASI90 responders and relative to both the PS0010 and 
PS0011 Baselines for subjects who are PS0010 Week 12 PASI90 non-responders). 
Change #2 
Page 13 Section 3.6 Treatment assignment and treatment groups, updated the text for 
PS0010/PS0011 treatment groups 
From 
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This refers to the combination of the randomized treatment in PS0010 and the treatment assigned 
at the beginning of PS0011. Some groups have been combined where it is considered appropriate 
to do so. The PS0010/PS0011 treatment groups are as follows: 
 Placebo to Placebo 
 Placebo to Bimekizumab 160mg Q4W 
 Bimekizumab 64mg Q4W to Bimekizumab 64mg Q4W 
 Bimekizumab 64mg Q4W to Bimekizumab 160mg Q4W 
 Bimekizumab 160mg Q4W to Bimekizumab 160mg Q4W – note that the PS0010 160mg 
Q4W groups with and without the loading dose are both included here 
 Bimekizumab 160mg Q4W to Bimekizumab 320mg Q4W – note that the PS0010 160mg 
Q4W groups with and without the loading dose are both included here 
 Bimekizumab 320mg or greater to Bimekizumab 320mg Q4W - note that PS0010 320mg 
Q4W and 480mg Q4W are both included here. 
To 
This refers to the combination of the randomized treatment in PS0010 and the treatment assigned 
at the beginning of PS0011. Some groups have been combined where it is considered appropriate 
to do so. The PS0010/PS0011 treatment groups are as follows: 
 Placebo to Placebo 
 Placebo to Bimekizumab 160mg Q4W 
 Bimekizumab 64mg Q4W to Bimekizumab 64mg Q4W 
 Bimekizumab 64mg Q4W to Bimekizumab 160mg Q4W 
 Bimekizumab 160mg Q4W to Bimekizumab 160mg Q4W – note that the PS0010 160mg 
Q4W groups with and without the loading dose are both included here 
 Bimekizumab 160mg Q4W to Bimekizumab 320mg Q4W – note that the PS0010 160mg 
Q4W groups with and without the loading dose are both included here 
 Bimekizumab 320mg Q4W to Bimekizumab 320mg Q4W  
 Bimekizumab 480mg Q4W to Bimekizumab 320mg Q4W 
 
Change #3 
Page 15 Section 4.2.2 Handling of Missing Data for the Efficacy Analyses, the following 
paragraphs were added: 
Note: The imputation model based on the MCMC method will only allow continuous variables 
in the imputation model. Therefore, prior biologic exposure and region will be re-coded as 
indicator variables (with values of 0 or 1 for each level of the variable). In order to achieve 
model convergence, prior biological exposure may be dropped from the model, if convergence is 
still not obtained then region may also be dropped from the model. 
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There may be cases where the multiple imputation model fails to converge (eg, sparse 
subgroups). In such situation, the LOCF approach will instead be used to impute missing data. If 
LOCF is used instead of multiple imputation for this reason, this will be clearly specified in the 
corresponding table summary. Should there be no missing data for a study variable then only 
observed case data will be produced. 
Change #4 
Page 17 Section 5.2 Protocol Deviations, the analysis set used to summarize protocol deviations 
was changed from FAS to ES. The following text was added. 
If the dosing for a visit is +/- 7 days out of window, then the plasma concentration from that visit 
and all subsequent visits will be excluded from the PK summary. The number and percentage of 
subjects with at least one measurement excluded from the PK analysis will be summarized by 
PS0010/PS0011 treatment group. 
Change #5 
Page 19 Section 6.2 Other Baseline Characteristics, deleted the text “Prior biologic therapy (yes, 
no) 
Change #6 
Page 20 Section 8.1.2 Derivation of Duration of Exposure, added the text, “and the date of last 
dose plus 28 days extends beyond the date of death.” 
Change #7 
Page 20 Section 8.1.3 Derivation of exposure at risk, added the text, “Throughout this section, 
date of last clinical contact for each subject is defined as the maximum of [last visit date 
including SFU visits, last imputed AE start date, date of study termination or completion, last 
date of study drug administration].” 
Change #8 
Page 232 Section 8.2.1 TEAEs, added the following text.  
Adverse events that occur on the PS0011 baseline visit date will be attributed to the PS0010 
treatment. The only exception to this definition is for the following types of events: 
 Those that code to a High Level Term (HLT) of “Injection Site Reactions” 
 Those which have been designated as an Injection Reaction on the AE CRF and do not code 
to a System Organ Class (SOC) of “Investigations” 
 Those which have been identified as a hypersensitivity reaction or an anaphylactic reaction 
When any of these events occur on the date of treatment switch at PS0011 Baseline, the AE will 
be attributed to the treatment initiated in PS0011. 
Change #9 
Page 24 Section 8.2.1 TEAEs, added the text, “The number and percentage of subjects 
experiencing fungal infections will be summarized by region and country by PS0011 treatment 
group. This summary will also include the number and percentage of subjects experiencing the 
PT “Oral Candidiasis” by region and country.”  
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Statistical Analysis Plan 
Bimekizumab 
PS0011 
 
 
 
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Page 52 of 55 
Change #10 
Page 26 Section 8.2.1 TEAEs, added the text:  
“Additional tables will summarize TEAEs by responder status (defined as PS0010 Week 12 
PASI90 response): 
 Incidence of TEAEs – Overview 
 Incidence of TEAEs per 100 subject years by SOC, HLT and PT 
 Incidence of Serious TEAEs per 100 subject years by SOC, HLT and PT  
 Incidence of Fungal Infectious Disorders per 100 subject years by SOC, HLT and PT” 
Change #11 
Page 26 Section 8.2.2 Clinical laboratory evaluations, removed “Atypical lymphocytes” from 
laboratory measurements in Table 8-1.  
Change #12 
Page 32 Section 9.1, Pharmacokinetics, the following text was added, “If the dosing for a visit is 
+/- 7 days out of window, then the plasma concentration from that visit and all subsequent visits 
will be excluded from the analysis.” 
Change #13 
Page 32 Section 9.1, Pharmacokinetics, the following text was changed 
From 
The bimekizumab concentrations will also be listed. 
To 
The bimekizumab concentrations, including the concentrations excluded from the summaries, 
will also be listed. 
Change #14 
Pages 32-33 Section 9.2.1 Anti-bimekizumab antibodies, the following sentences were deleted. 
“The impact of positive anti-BKZ antibody status on corresponding ctrough concentrations will be 
summarized for each PS0010/PS0011 treatment group and overall.” 
“Similar line plots will be produced showing the percentage of persistent and transient anti-BKZ 
positive antibody subjects.” 
Change #15 
Page 33 Section 10.1 Statistical analysis of the efficacy variables, added the text “Unless 
otherwise specified, summary tables for efficacy endpoints by PS0010/PS0011 treatment group 
will present data separately by responder status (defined as PS0010 Week 12 PASI90 response).” 
Change #16 
Pages 34-35 Section 10.1.1.2 Analysis of PASI score and response, the following text was 
added:  
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Statistical Analysis Plan 
Bimekizumab 
PS0011 
 
 
 
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Page 53 of 55 
“Summaries of PASI score and response will include PS0011 visits. PS0010 visits will be shown 
for select summaries as specified.” 
“Summaries for PASI90 and PASI100 response will include PS0010 visits.” 
“PASI90 and PASI100 response relative to the PS0010 Baseline will also be summarized 
descriptively using counts and percentages by PS0011 treatment group and visit. Missing data 
will be imputed via NRI.” 
“The percent change from PS0010 Baseline in PASI score will also be presented using 
descriptive statistics by PS0011 treatment group and visit. Missing data will be handled using the 
same multiple imputation as described above.” 
“The number and percentage of subjects who achieve an absolute PASI score ≤1, ≤2, ≤3, and ≤5 
at each visit will be summarized by both PS0010/PS0011 treatment group and PS0011 treatment 
group. Missing data will be imputed using NRI. These summaries will include PS0010 visits.” 
Change #17 
Page 36 Section 10.1.1.2 Analysis of PASI score and response, the following text was changed: 
From 
Missing data for the continuous change from Baseline and percent change from Baseline 
variables will be handled by using MI via the MCMC method. Details on how the descriptive 
statistics are to be derived are included in Section 4.2.2. Supportive summaries will be based on 
observed data. 
To 
Missing data for the continuous change from Baseline and percent change from Baseline 
variables will be handled by using MI via the MCMC method specified in Section 4.2.2. 
Supportive summaries will be based on observed data. 
Change #18 
Page 36 Section 10.1.2.2 Analysis of IGA response, the following text was changed 
From 
The number and percentage of subjects achieving an IGA response (defined as clear (0) or 
almost clear (1) with at least two category improvement from Baseline) will be summarized 
descriptively using counts and percentages by PS0010/PS0011 treatment group and visit. 
Missing data will be imputed via NRI. 
To 
The number and percentage of subjects achieving an IGA response (defined as clear (0) or 
almost clear (1) with at least two category improvement from Baseline) will be summarized 
descriptively using counts and percentages by PS0010/PS0011 treatment group and visit. 
Summaries of PASI score and response will include PS0011 visits. PS0010 visits will be shown 
for select summaries as specified. 
The following text was added: 
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Statistical Analysis Plan 
Bimekizumab 
PS0011 
 
 
 
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Page 54 of 55 
“The IGA response variables will be derived relative to both the PS0010 Baseline and the 
PS0011 Baseline for subjects who are not PS0010 Week 12 PASI90 responders in the following 
treatment groups: Placebo to BKZ 160mg, BKZ 64mg to BKZ 160mg, BKZ 160mg to BKZ 
320mg, BKZ 320mg to BKZ 320mg, and BKZ 480 mg to BKZ 320mg. PASI response will be 
calculated relative to the original PS0010 Baseline only for subjects who are PS0010 Week 12 
PASI90 responders in the following treatment groups: Placebo to Placebo, BKZ 64mg Q4W to 
BKZ 64mg Q4W, BKZ 160mg Q4W to BKZ 160mg Q4W, BKZ 320mg Q4W to BKZ 320mg 
Q4W, and BKZ 480mg Q4W to BKZ 320mg Q4W. Missing data will be imputed via NRI. 
Summaries for IGA response will include PS0010 visits. 
IGA response relative to the PS0010 Baseline will also be summarized descriptively using 
counts and percentages by PS0011 treatment group and visit. Missing data will be imputed via 
NRI.” 
Change #18 
Page 36 Section 10.1.3 Analysis of BSA, added the following text 
“The percent change from PS0010 Baseline in BSA will also be presented using descriptive 
statistics by PS0011 treatment group and visit. Missing data will be handled using the same 
multiple imputation as described above.” 
“The number and percentage of subjects who achieve BSA =0%, ≤1%, ≤3%, and ≤5% at each 
visit will be summarized by both PS0010/PS0011 treatment group and PS0011 treatment group. 
Missing data will be imputed using NRI. These summaries will include PS0010 visits.” 
Change #19 
Page 38 Section 10.1.4.2 Analysis of DLQI, added the text, “The number and percentage of 
subjects achieving a DLQI score of 0 or 1 at each visit will also be summarized descriptively 
using counts and percentages by PS0011 treatment group and visit. Missing data will be imputed 
via NRI.” 
Change #20 
Page 40 Section 10.1.7.2 Analysis of PSSI, added the text, “The percent change from PS0010 
Baseline in PSSI score will also be presented using descriptive statistics by PS0011 treatment 
group and visit. Missing data will be handled using the same multiple imputation as described 
above.” 
 
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Statistical Analysis Plan 
Bimekizumab 
PS0011 
 
 
 
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Page 55 of 55 
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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