Conditions: Chronic Plaque Psoriasis
Keywords: Psoriasis Chronic Plaque Psoriasis Bimekizumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 49
Healthy volunteers: no

Brief summary:
This is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

Detailed description:

Arms:
arm 1: Subjects randomized in this arm will receive a combination of Bimekizumab and Placebo injections. arm 2: Subjects randomized in this arm will receive Bimekizumab injections.

Interventions: intervention 1: Bimekizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Based on their randomization subjects will receive a combination of several injections of Bimekizumab. intervention 2: Subjects will receive injections of Placebo.

Protocol document:
Prot_002.pdf: 
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PROTOCOL PS0016 AMENDMENT 3
A MULTICENTER, RANDOMIZED, SUBJECT-BLIND,
INVESTIGATOR-BLIND STUDY TO EVALUATE THE TIME 
COURSE OF PHARMACODYNAMIC RESPONSE, SAFETY
AND PHARMACOKINETICS OF BIMEKIZUMAB IN ADULT
SUBJECTS WITH MODERATE TO SEVERE CHRONIC
PLAQUE PSORIASIS
PHASE 2A
EudraCT Number: 2016-002368-15
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
06 Jun 2016
Not applicable
Protocol Amendment 1
04 Aug 2016
Not applicable
Protocol Amendment 2
06 Sep 2016
Nonsubstantial
Protocol Amendment 3
23 Sep 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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STUDY CONTACT INFORMATION
Sponsor
UCB Biopharma SPRL, Allée de la Recherche 60, B-1070 Brussels, Belgium
Sponsor Study Physician
Name:
Address:
UCB Celltech, 208 Bath Rd, Slough, Berkshire, SL1 3WE, UK
Phone:
Exploratory Project Manager
Name:
Address:
UCB Celltech, 208 Bath Rd, Slough, Berkshire, SL1 3WE, UK
Phone:
Fax:
Clinical Trial Biostatistician
Name:
Address:
UCB Celltech, 208 Bath Rd, Slough, Berkshire, SL1 3WE, UK
Phone:
Fax:
Clinical Monitoring Contract Research Organization
Name:
PAREXEL International (IRL) Limited
Address:
One Kilmainham Square; Inchicore Road; Kilmainham; 
Dublin 8; Ireland
Phone:
Fax:
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD


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SERIOUS ADVERSE EVENT REPORTING
Serious adverse event reporting (24h)
Fax
Europe and Rest of the World: 
USA and Canada:
or
Email
Global:
 
PPD
PPD
PPD
PPD


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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...........................................................................................................16
3
STUDY OBJECTIVES....................................................................................................17
3.1 Primary objective.............................................................................................................17
3.2 Secondary objectives .......................................................................................................17
3.3 Other objectives ...............................................................................................................17
4
STUDY VARIABLES.....................................................................................................17
4.1 Primary variables .............................................................................................................17
4.1.1
Primary efficacy variable.....................................................................................17
4.1.2
Primary pharmacokinetic variable.......................................................................17
4.1.3
Primary immunogenicity variable .......................................................................18
4.1.4
Primary safety variable........................................................................................18
4.2 Secondary variables .........................................................................................................18
4.3 Other variables.................................................................................................................18
4.3.1
Other efficacy variables.......................................................................................18
4.3.2
Other pharmacodynamic variable........................................................................18
4.3.3
Other safety variables ..........................................................................................18
4.3.4
RNA, proteins, and metabolite variables.............................................................19
4.4 Immunological variable ...................................................................................................19
5
STUDY DESIGN.............................................................................................................19
5.1 Study description .............................................................................................................19
5.1.1
Study Periods.......................................................................................................19
5.1.2
Study duration per subject ...................................................................................20
5.1.3
Planned number of subjects and sites ..................................................................20
5.1.4
Anticipated regions and countries .......................................................................20
5.2 Schedule of study assessments.........................................................................................20
5.3 Schematic diagram...........................................................................................................24
5.4 Rationale for study design and selection of dose.............................................................24
6
SELECTION AND WITHDRAWAL OF SUBJECTS...................................................25
6.1 Inclusion criteria ..............................................................................................................25


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6.2 Exclusion criteria .............................................................................................................26
6.3 Withdrawal criteria ..........................................................................................................29
6.3.1
Potential drug-induced liver injury IMP discontinuation criteria........................31
6.4 Study Stopping Rules.......................................................................................................31
6.5 Retesting/rescreening/replacement ..................................................................................32
7
STUDY TREATMENT(S) ..............................................................................................32
7.1 Description of investigational medicinal product(s)........................................................32
7.2 Treatments to be administered.........................................................................................32
7.3 Packaging.........................................................................................................................33
7.4 Labeling ...........................................................................................................................33
7.5 Handling and storage requirements..................................................................................33
7.6 Drug accountability..........................................................................................................33
7.7 Procedures for monitoring subject compliance................................................................34
7.8 Concomitant medication(s)/treatment(s)..........................................................................34
7.8.1
Permitted concomitant treatments (medications and therapies) ..........................34
7.8.2
Prohibited concomitant treatments (medications and therapies).........................35
7.9 Blinding............................................................................................................................36
7.9.1
Procedures for maintaining and breaking the treatment blind.............................36
7.9.1.1
Maintenance of study treatment blind.......................................................37
7.9.1.2
Breaking the treatment blind in an emergency situation...........................37
7.10 Randomization and numbering of subjects......................................................................37
8
STUDY PROCEDURES BY VISIT ...............................................................................38
8.1 Screening Visit.................................................................................................................38
8.2 Baseline Visit...................................................................................................................39
8.3 Week 2 (+/-3 days)...........................................................................................................40
8.4 Week 4 (+/-3 days)...........................................................................................................41
8.5 Week 8 (+/-3 days)...........................................................................................................41
8.6 Week 12 (+/-3 days).........................................................................................................42
8.7 Week 16 (+/-3 days).........................................................................................................42
8.8 Week 20 (+/-3 days).........................................................................................................43
8.9 Week 24 (+/-3 days).........................................................................................................44
8.10 Week 28 (+/-3 days).........................................................................................................44
8.11 Week 36/Safety Follow-Up Visit (20 weeks after the last dose).....................................45
8.12 Early Withdrawal Visit ....................................................................................................46
8.13 Unscheduled Visit............................................................................................................46
9
ASSESSMENT OF EFFICACY......................................................................................47
9.1 Psoriasis Area and Severity Index ...................................................................................47
9.2 BSA affected by psoriasis................................................................................................47


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9.3 Investigator’s Global Assessment....................................................................................48
9.4 Hospital Anxiety and Depression Score ..........................................................................48
10
ASSESSMENT OF PHARMACOKINETICS/ 
PHARMACODYNAMICS/PHARMACOGENOMICS.................................................48
10.1 Pharmacokinetic and pharmacodynamic variables..........................................................48
10.2 Non-hereditary pharmacogenomic variables ...................................................................49
10.2.1
RNA, proteins, and metabolites biomarkers........................................................49
11
ASSESSMENT OF IMMUNOLOGICAL VARIABLES...............................................49
11.1 Assessment of immunogenicity .......................................................................................49
11.2 Assessment of immunological variables..........................................................................49
12
ASSESSMENT OF SAFETY..........................................................................................50
12.1 Adverse events.................................................................................................................50
12.1.1
Definition of adverse event..................................................................................50
12.1.2
Adverse events of special interest........................................................................50
12.1.3
Adverse events for special monitoring ................................................................50
12.1.4
Procedures for reporting and recording adverse events.......................................51
12.1.5
Description of adverse events..............................................................................51
12.1.6
Follow up of adverse events ................................................................................51
12.1.7
Rule for repetition of an adverse event................................................................51
12.1.8
Pregnancy ............................................................................................................51
12.1.9
Suspected transmission of an infectious agent via a medicinal product..............52
12.1.10
Overdose of investigational medicinal product ...................................................53
12.1.11
Safety signal detection.........................................................................................53
12.2 Serious adverse events .....................................................................................................53
12.2.1
Definition of serious adverse event .....................................................................53
12.2.2
Procedures for reporting serious adverse events .................................................54
12.2.3
Follow up of serious adverse events....................................................................54
12.3 Immediate reporting of adverse events............................................................................55
12.4 Anticipated serious adverse events ..................................................................................55
12.5 Laboratory measurements................................................................................................55
12.5.1
Evaluation of PDILI ............................................................................................56
12.5.1.1
Consultation with Medical Monitor and local hepatologist ......................61
12.5.1.2
Immediate action: determination of IMP discontinuation.........................61
12.5.1.3
IMP restart/rechallenge .............................................................................61
12.5.1.4
Testing: identification/exclusion of alternative etiology...........................61
12.5.1.5
Follow-up evaluation.................................................................................63
12.6 Other safety measurements..............................................................................................63
12.6.1
Assessment and management of TB and TB risk factors....................................63


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12.6.1.1
Tuberculosis assessment by IGRA............................................................65
12.6.1.2
Chest x-ray for tuberculosis ......................................................................66
12.6.1.3
Tuberculosis questionnaire........................................................................66
12.6.1.4
Tuberculosis management.........................................................................66
12.6.2
Pregnancy testing.................................................................................................67
12.6.3
Vital signs ............................................................................................................67
12.6.4
12-lead electrocardiograms..................................................................................67
12.6.5
Physical examination...........................................................................................67
12.6.6
Height and body weight.......................................................................................68
12.6.7
Assessment of suicidal ideation and behavior.....................................................68
12.7 Other study measurements...............................................................................................68
12.7.1
Demographic information....................................................................................68
12.7.2
Medical History ...................................................................................................68
12.7.3
Psoriasis History..................................................................................................68
12.7.4
Data Monitoring Committee................................................................................68
13
STUDY MANAGEMENT AND ADMINISTRATION.................................................69
13.1 Adherence to protocol......................................................................................................69
13.2 Monitoring .......................................................................................................................69
13.2.1
Definition of source data .....................................................................................69
13.2.2
Source data verification .......................................................................................70
13.3 Data handling...................................................................................................................70
13.3.1
Case Report Form completion.............................................................................70
13.3.2
Database entry and reconciliation........................................................................70
13.3.3
Subject Screening and Enrollment log/Subject Identification Code list..............70
13.4 Termination of the study..................................................................................................71
13.5 Archiving and data retention............................................................................................71
13.6 Audit and inspection ........................................................................................................71
13.7 Good Clinical Practice .....................................................................................................72
14
STATISTICS ...................................................................................................................72
14.1 Definition of analysis sets................................................................................................72
14.2 General statistical considerations.....................................................................................72
14.3 Planned efficacy analyses ................................................................................................72
14.3.1
Analysis of the primary efficacy variable............................................................72
14.3.2
Other efficacy analyses........................................................................................73
14.3.2.1
Analysis of the secondary efficacy variables ............................................73
14.3.2.2
Analysis of the other efficacy variables ....................................................73
14.3.2.3
PKPD analysis...........................................................................................73
14.3.3
Planned safety and other analyses .......................................................................73


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14.3.3.1
Safety analyses ..........................................................................................73
14.4 Handling of protocol deviations.......................................................................................74
14.5 Handling of dropouts or missing data..............................................................................74
14.6 Planned interim analysis and data monitoring.................................................................74
14.7 Determination of sample size...........................................................................................74
15
ETHICS AND REGULATORY REQUIREMENTS......................................................74
15.1 Informed consent .............................................................................................................74
15.2 Subject identification cards..............................................................................................75
15.3 Institutional Review Boards and Independent Ethics Committees..................................75
15.4 Subject privacy.................................................................................................................76
15.5 Protocol amendments.......................................................................................................76
16
FINANCE, INSURANCE, AND PUBLICATION.........................................................76
17
REFERENCES ................................................................................................................76
18
APPENDICES .................................................................................................................79
18.1 Protocol Amendment 1 ....................................................................................................79
18.2 Protocol Amendment 2 ..................................................................................................106
18.3 Protocol Amendment 3 ..................................................................................................110
19
DECLARATION AND SIGNATURE OF INVESTIGATOR .....................................115
20
SPONSOR DECLARATION ........................................................................................116
LIST OF TABLES
Table 5‒1:
Schedule of assessments ..................................................................................21
Table 7‒1:
Prohibited psoriasis medications......................................................................35
Table 9‒1:
Body areas for calculation of percent BSA for PASI ......................................47
Table 9‒2:
Five-point Investigator’s Global Assessment..................................................48
Table 12‒1:
Anticipated serious adverse events for the population of subjects with 
moderate to severe chronic plaque psoriasis....................................................55
Table 12‒2:
Laboratory measurements................................................................................56
Table 12‒3:
Required investigations and follow up for PDILI............................................58
Table 12‒4:
PDILI laboratory measurements......................................................................62
Table 12‒5:
PDILI information to be collected...................................................................63
LIST OF FIGURES
Figure 5‒1:
Schematic diagram of PS0016.........................................................................24


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LIST OF ABBREVIATIONS
AE
adverse event
AESI
adverse events of special interest
AESM
adverse events for special monitoring
ALP
alkaline phosphatase
ALT
alanine aminotransferase
AST
aspartate aminotransferase
BSA
body surface area (affected by psoriasis) 
cAMP
cyclic adenosine monophosphate
CDMS
clinical data management system
CPMP
Committee for Proprietary Medicinal Products
CRF
Case Report Form
CRP
C-reactive protein
eCRF
electronic Case Report Form
CRO
Contract Research Organization
C-SSRS
Columbia Suicide Severity Rating Scale
CTCAE
Common Terminology Criteria for Adverse Events
CV
cardiovascular
DAP
data analysis plan
DMC
Data Monitoring Committee
ECG
electrocardiogram
EDC
Electronic Data Capture
EPM
Exploratory Project Manager
ES
Enrolled Set
EudraCT
European Union Drug Regulating Authorities Clinical Trials
FACS
Fluorescence-activated cell sorting
FAS
Full Analysis Set
GCP
Good Clinical Practice
GI
gastrointestinal
GMP
Good Manufacturing Practice
HADS
Hospital Anxiety and Depression Scale
HBV
hepatitis B virus
HBcAb
anti-hepatitis B core antibody
HBsAg
hepatitis B surface antigen


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HCV
hepatitis C virus
HIV
human immunodeficiency virus
IB
Investigator’s Brochure
ICF
Informed Consent Form
ICH
International Council for Harmonisation
IEC
Independent Ethics Committee
IGA
Investigator’s Global Assessment
IgG1
immunoglobulin G1
IGRA
interferon-gamma release assay  
IL
interleukin
IMP
investigational medicinal product
IND
Investigational New Drug
IRB
Institutional Review Board
IUD
intrauterine device
IUS
intrauterine hormone-releasing system
iv
intravenous
IXRS
interactive voice or web response system (IVRS or IWRS)
kg
kilogram
LOCF
last observation carried forward
LTB
latent TB
mAb
monoclonal antibody
MCS
Mental Component Summary
MCID
minimal clinically important difference
MID
minimally important difference
MedDRA
Medical Dictionary for Regulatory Activities
mNAPSI
modified nail psoriasis severity index
NOAEL
no adverse effect level
NRI
non-responder imputation
NSAID
non-steroidal anti-inflammatory drug
PASI
Psoriasis Area and Severity Index
PBO
placebo
PD
pharmacodynamics 
PDE4
phosphodiesterase 4
PDILI
potential drug-induced liver injury


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PD-PPS
Pharmacodynamics Per-Protocol Set 
PK
pharmacokinetics
PK-PPS
Pharmacokinetics Per-Protocol Set
PPS
Per-Protocol Set
PS
Patient Safety
PSO
psoriasis
PSSI
Psoriasis Scalp Severity Index
RS
Randomized Set
SAE
serious adverse event
SAP
statistical analysis plan
sc
subcutaneous
SFU
Safety Follow-Up
SOC
System Organ Class
SOP
Standard Operating Procedure
SS
Safety Set
TB
tuberculosis
TNF
tumor necrosis factor
ULN
upper limit of normal
VAS
visual analog scale
Q4W
every 4 weeks


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1
SUMMARY
This is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to 
investigate the pharmacodynamics (PD), pharmacokinetics (PK), and safety of bimekizumab 
(also known as UCB4940) in adult subjects with moderate to severe chronic plaque psoriasis in 
order to guide the selection of doses and clinical indices in the Phase 3 development program.
The study population consists of adult subjects (≥18 years of age) with a diagnosis of moderate 
to severe chronic plaque psoriasis (Baseline Psoriasis Area and Severity Index [PASI] ≥12 and 
body surface area [BSA] affected by psoriasis ≥10% and Investigator’s Global Assessment 
[IGA] score ≥3 [on a 5-point scale]) who are a candidate for systemic psoriasis therapy and/or 
phototherapy and/or chemophototherapy.
Approximately 90 subjects will be screened in order to have 45 subjects randomized in the study. 
There will be approximately 30 subjects in treatment arm A and 15 subjects in treatment arm B. 
For each subject, the study will last a maximum of 40 weeks and will consist of 3 periods, a 
Screening Period (up to 4 weeks), a Treatment Period (28 weeks), and a Safety Follow-Up (SFU) 
Period (20 weeks after the last dose of study medication). Between Week 20 and the end of the 
28-week Treatment Period, eligible subjects will be allowed to enroll in an extension study. 
During the Treatment Period eligible subjects will be randomized 2:1 to receive the following 
blinded study treatment:

Treatment arm A: Bimekizumab 320mg administered subcutaneously (sc) at Baseline and 
Week 4, followed by placebo administration at Week 16

Treatment arm B: Bimekizumab 320mg administered sc at Baseline and Weeks 4 and 16 
Study medication will be administered in the clinic at Baseline, Week 4, and Week 16. 
Additional nondosing study visits will occur at Week 2, Week 8, Week 12, Week 20, Week 24, 
and Week 28. From Week 20 through Week 28, subjects who were previously PASI25 
responders but subsequently relapse (defined as returning to less than PASI25 response) will 
undergo the study assessments for that visit (ie, Week 20, Week 24, or Week 28) before 
receiving their first dose of study treatment in the extension study at Week 20, Week 24, or 
Week 28. Subjects eligible for the extension study must have the assessments for SFU conducted 
prior to entering the extension study. Subjects who have not achieved a PASI25 response at any 
visit prior to Week 20 will not be eligible to enter the extension study. All subjects not enrolling 
in the extension study will continue in PS0016 until the SFU Visit at Week 36.
The primary objective of this study is to evaluate the time-course of PASI over a 28-week period 
following the administration of bimekizumab given at Baseline and Week 4 to subjects with 
moderate to severe chronic plaque psoriasis. The secondary objectives of the study are to 
evaluate the time-course of PASI over a 28-week period following the administration of 
bimekizumab given at Baseline and Weeks 4 and 16 in subjects with moderate to severe plaque 
psoriasis, to assess the PK and immunogenicity of bimekizumab and to assess the safety and 
tolerability of bimekizumab.
The other objectives of the study are to assess the effect of bimekizumab on gene and protein 
expression, and explore the relationship between genomic, genetic, and proteomic biomarkers 
and disease biology, drug treatment and inflammatory and immune responses.


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The primary endpoint of this study is change from Baseline in PASI at Week 28. The secondary 
efficacy variables are PASI75, PASI90, and PASI100 response at Week 16, and IGA response 
(Clear or Almost Clear with at least a 2-category improvement from Baseline) at Week 16. The 
other efficacy variables are presented in Section 4.3.1.
Pharmacokinetic, PD, genomic, genetic, proteomic, and immunological variables will be 
evaluated to assess their relationship to treatment response. 
Safety variables to be assessed are adverse events (AEs), vital signs, electrocardiograms (ECGs), 
physical examination, and measurements of laboratory parameters.
2
INTRODUCTION
2.1
Psoriasis 
Psoriasis is a common, chronic inflammatory disease characterized by a series of linked cellular 
changes in the skin: hyperplasia of epidermal keratinocytes, vascular hyperplasia and ectasia, and 
infiltration of T lymphocytes, neutrophils, and other types of leukocytes in affected skin. Though 
the pathophysiology of 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. Plaques 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 


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definition, study design, and the definition of prevalence (Parisi et al, 2013; Langley et al, 2005; 
Raychaudhuri and Gross, 2000).
2.1.2
Current treatments for psoriasis
Therapy for patients with 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. PDE4 inhibitors work intracellularly to 
modulate a network of pro-inflammatory and anti-inflammatory mediators. PDE4 is a cyclic 
adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory 
cells. PDE4 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 plaques 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 


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immune system, biologics target specific parts of the immune system and offer reduced 
multi-organ toxicity and adverse effects associated with traditional treatments.
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. 
Ixekizumab, an IgG4 mAb, has been approved in the US and the EU for the treatment of 
moderate to severe plaque psoriasis in adult patients. Clinical study results have shown that 
ixekizumab is effective for the treatment of psoriasis.
2.2
Bimekizumab
Bimekizumab is an engineered, humanized, full-length immunoglobulin G1 (IgG1) 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 


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similar for the 2 doses tested (0.656 and 0.631 for the bimekizumab 80mg and 160mg sc doses, 
respectively). The PK of bimekizumab was linear in the tested dose range and the median t1/2
following sc administration was similar to that following iv administration (27.81 days and 
28.25 days for bimekizumab 160mg sc and 160mg iv, respectively). 
Bimekizumab has also been investigated in a Phase 1b, proof of concept, randomized,
placebo-controlled, multiple dose study (PA0007). The primary objective of PA0007 was to 
assess the safety and PK of multiple dose administration of iv bimekizumab in subjects with 
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 non-serious 
and resolved with topical therapy. There was a potential reduction in mean neutrophil count in 
the active treatment group, although this drop was not clinically relevant and a clear relationship 
with dose or time was not evident. Some increases in liver function tests were reported, but none 
had a convincing relationship to exposure to 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, PD, 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).
2.2.2
Nonclinical
Parallel inhibition of IL-17A and IL-17F has been shown to be efficacious in a variety of animal 
models of inflammatory disease. Intravenously administered bimekizumab was well tolerated in 
repeat dose toxicology studies in Cynomolgus monkeys with a no adverse effect level (NOAEL) 
of 200mg/kg/week. The findings of note in toxicity studies were diarrhea related to infectious 
enteritis (observed in the single dose study) and asymptomatic mild colonic ulceration in a 


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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 this study is to evaluate the time-course of PASI over a 28-week period 
following the administration of bimekizumab given at Baseline and Week 4 to subjects with 
moderate to severe chronic plaque psoriasis.
3.2
Secondary objectives
The secondary objectives of the study are to:

To evaluate  the time-course of PASI over a 28-week period following the administration of 
bimekizumab given at Baseline and Weeks 4 and 16 in subjects with moderate to severe 
plaque psoriasis

Assess the PK and immunogenicity of bimekizumab 

Assess the safety and tolerability of bimekizumab
3.3
Other objectives
The other objectives of the study are to:

Assess the effect of bimekizumab on gene and protein expression, and explore the 
relationship between genomic, genetic, and proteomic biomarkers and disease biology, drug 
treatment and inflammatory and immune responses.
4
STUDY VARIABLES
4.1
Primary variables
4.1.1
Primary efficacy variable
The primary endpoint of this study is change from Baseline in PASI at Week 28.
4.1.2
Primary pharmacokinetic variable
The primary PK variable is plasma concentration of bimekizumab.


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4.1.3
Primary immunogenicity variable
The primary immunological variable is anti-bimekizumab antibody detection prior to and 
following study treatment. 
4.1.4
Primary safety variable
The primary safety variable is incidence of AEs.
4.2
Secondary variables
The secondary efficacy variables are:

PASI75, PASI90, and PASI100 response at Week 16

IGA response (Clear or Almost Clear with at least a 2-category improvement from Baseline) 
at Week 16
4.3
Other variables
4.3.1
Other efficacy variables
The other efficacy variables are listed below and will be evaluated at all scheduled visits in 
accordance with the Schedule of Assessments in Table 5‒2. This excludes the primary and 
secondary variables as specified in Section 4.1 and Section 4.2.  

Absolute and % change from Baseline in PASI with time (Week 2 to Week 36)

PASI75, PASI90, and PASI100 response at Weeks 2, 4, 8, 12, 20, 24, 28, and 36

PASI25 and PASI50 response (Week 2 to 36)

IGA response (Clear or Almost Clear with at least 2-category improvement from Baseline) at 
Weeks 2, 4, 8, 12, 20, 24, 28, and 36

Change from Baseline in IGA score 

Change from Baseline in the BSA affected by psoriasis 

Change from Baseline in Hospital Anxiety and Depression Scale (HADS) HADS-A and 
HADS-D scores

Percentage of subjects with scores below 8 in HADS-A and HADS-D (subjects with normal 
scores)
4.3.2
Other pharmacodynamic variable
The PD variable is to determine the blood or blood derivative (eg, plasma) concentrations of 
cytokines of relevance to IL17-A/F signaling pathway and psoriasis biology, including but not 
limited to serum complement concentrations, mononuclear cell subtypes, and cytokines and 
other candidate biomarkers.
4.3.3
Other safety variables
Other safety variables to be assessed are:

Change from Baseline in clinical laboratory values (chemistry, hematology, and urinalysis) 

Change from Baseline in vital signs


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
Change from Baseline in physical examination

ECG results
4.3.4
RNA, proteins, and metabolite variables
Blood and tissue biopsy samples will be collected at specific time points and stored for up to 20 
years to allow for potential exploratory analyses of RNA, proteins, and metabolites biomarkers 
relevant to psoriasis and the inflammatory and immune response processes.
The nature and format of these tentative analyses will be determined at a later stage.
4.4
Immunological variable
The immunological variable is anti-bimekizumab antibody detection following study treatment. 
5
STUDY DESIGN
5.1
Study description
This is a Phase 2a, multicenter, randomized, subject-blind and investigator-blind study to 
evaluate the PD, PK, and safety of bimekizumab administered sc to subjects with psoriasis. To 
be eligible to participate in this study, subjects must be adults with a diagnosis of moderate to 
severe psoriasis (Baseline PASI ≥12 and BSA affected by psoriasis ≥10% and IGA score ≥3 [on 
a 5-point scale]) who are a candidate for systemic psoriasis therapy and/or phototherapy and/or 
chemophototherapy.
5.1.1
Study Periods
This study will include 3 periods: a Screening Period (up to 4 weeks), a Treatment Period 
(28 weeks), and a SFU Period (20 weeks after the last dose of study medication). Between Week 
20 and the end of the 28-week Treatment Period, eligible subjects will be allowed to enroll in an 
extension study. 
Screening Period
The Screening Period will last up to a total of 4 weeks in the event that applicable laboratory 
screening tests require retesting if the initial results are in error, borderline, or indeterminate.
During this time, laboratory data (hematology, urine, and biochemistry tests) will be obtained, 
the doses of non-steroidal anti-inflammatory drug (NSAIDs) (if used to treat psoriatic arthritis), 
will be verified as stable. 
Treatment Period
During the Treatment Period, subjects will be randomized 2:1 to receive the following blinded 
study treatment regimens:

Treatment arm A: Bimekizumab 320mg administered sc at Baseline and Week 4, and 
placebo administered at Week 16

Treatment arm B: Bimekizumab 320mg administered sc at Baseline and Weeks 4 and 16
There will be approximately 30 subjects in treatment arm A and 15 subjects in treatment arm B.
Bimekizumab will be administered in the clinic at Baseline and Week 4, and at Baseline, Week 
4, and Week 16 for those in treatment arm A and treatment arm B, respectively. Additional 


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nondosing study visits will occur at Week 2, Week 8, Week 12, Week 20, Week 24, and 
Week 28.
From Week 20 through Week 28, subjects who were previously PASI25 responders but 
subsequently relapse (defined as returning to a less than PASI25 response) will undergo the 
study assessments for that visit (ie, Week 20, Week 24, or Week 28) before receiving their first 
dose of study treatment in the extension study at Week 20, Week 24, or Week 28. Subjects 
eligible for the extension study must have the assessments for SFU conducted prior to entering 
the extension study. Subjects who have not achieved a PASI25 response at any visit prior to 
Week 20 will not be eligible to enter the extension study. All subjects not enrolling in the 
extension study will continue in PS0016 until the SFU Visit at Week 36. 
Subjects withdrawing early from the study will undergo the Early Withdrawal Visit assessments 
(ie, Week 36) and will enter the SFU Period.
The assessments at each Treatment Period Visit are presented in Table 5‒1.
Safety Follow-Up Period
All subjects not continuing in the extension study, including those withdrawn from study 
treatment, will have a SFU Visit 20 weeks after their last dose of study medication (ie, 
bimekizumab or placebo).
The assessments for the SFU Visit are presented in Table 5‒1.
5.1.2
Study duration per subject
For each subject, the study will last a maximum of up to 40 weeks. This includes the following 
study period durations:

Screening Period: up to 4 weeks 

Treatment Period: 28 weeks

Safety Follow-Up Period: a SFU Visit is planned 20 weeks after the last dose of study 
medication
The end of the study is defined as the date of the last visit of the last subject in the study.
5.1.3
Planned number of subjects and sites
A sufficient number of subjects (anticipated to be approximately 90 subjects) will be screened in 
order to have approximately 45 subjects randomized in the study; 30 to Treatment arm A and 15 
to Treatment arm B. The planned number of study sites is approximately 15.
5.1.4
Anticipated regions and countries
The regions planned for study conduct are Europe and North America, with possible extension to 
other regions and countries. 
5.2
Schedule of study assessments
A schedule of study assessments is provided in Table 5‒1.


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Table 5‒1:
Schedule of assessments
                                                
Visita/ Week
Protocol activity
Screeningb
Baseline 
Treatment Period
(Time after the first dose)
Wk 36
EWD/
SFUc
Wk 2
Wk 4
Wk 8
Wk 12
Wk 16
Wk 20
Wk 24
Wk 28
Informed consentd
X
Inclusion/exclusion
X
X
Demographic data
X
Psoriasis history
X
Significant past medical history 
and concomitant diseasese
X
X
Physical examination
X
X
Height
X
Body weight
X
X
X
X
Vital signsf
X
X
X
X
X
X
X
X
X
X
X
C-SSRS
X
X
X
X
X
X
X
X
X
X
X
HADS
X
X
X
X
X
X
X
X
X
X
Hematology/biochemistry/
urinalysis
X
Xg
X
X
X
X
X
X
X
X
X
12-lead ECGh
X
X
X
X
X
Pregnancy testingi
X
X
X
X
X
X
X
X
X
X
Hepatitis B and C testingj
X
HIV testing
X
Chest x-rayk
X
IGRA tuberculosis test l,m
X
X
Tuberculosis questionnaire
X
X
X
X


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Table 5‒1:
Schedule of assessments
                                                
Visita/ Week
Protocol activity
Screeningb
Baseline 
Treatment Period
(Time after the first dose)
Wk 36
EWD/
SFUc
Wk 2
Wk 4
Wk 8
Wk 12
Wk 16
Wk 20
Wk 24
Wk 28
Blood sample for bimekizumab 
plasma concentrationsn
X
X
X
X
X
X
X
X
X
X
Blood sample for anti-
bimekizumab antibodies n
X
X
X
X
X
X
X
X
X
Blood sample for cytokines, 
complement, candidate 
biomarker analysis, and flow 
cytometry n
X
X
X
X
X
Blood sample for RNA, 
proteins, and metabolites 
biomarkersn
X
X
X
X
X
X
X
Skin biopsyo
X (2)
X (2)
X (1)
X (1)
PASI 
X
X
X
X
X
X
X
X
X
X
X
IGA 
X
X
X
X
X
X
X
X
X
X
X
BSA affected by psoriasis
X
X
X
X
X
X
X
X
X
X
X
Concomitant medication
X
X
X
X
X
X
X
X
X
X
X
Adverse events
X
X
X
X
X
X
X
X
X
X
X
IXRS
X
X
X
X
Subject identification card
X
Bimekizumab or placebo 
administration
X
X
X


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Table 5‒1:
Schedule of assessments
                                                
Visita/ Week
Protocol activity
Screeningb
Baseline 
Treatment Period
(Time after the first dose)
Wk 36
EWD/
SFUc
Wk 2
Wk 4
Wk 8
Wk 12
Wk 16
Wk 20
Wk 24
Wk 28
BSA=body surface area; C-SSRS= Columbia Suicide Severity Rating Scale; ECG=electrocardiogram; EWD=Early Withdrawal; FSH=follicle stimulating 
hormone; HADS=Hospital Anxiety and Depression Scale; HIV=human immunodeficiency virus; IGA=Investigator’s Global Assessment; IGRA=interferon-
gamma release assay; IXRS=interactive voice or web response system; PASI=Psoriasis Area and Severity Index; PK=pharmacokinetics; SFU=Safety Follow-
Up; TB=tuberculosis; Wk=week
a Visit windows of ±3 days from the first dose at all visits except SFU. Safety Follow-Up Visit window is -3 and +7 days.
b The Screening  Period will last up to a total of 4 weeks.
c  The SFU Visit will occur 20 weeks after the last dose.
d A separate Informed Consent Form is required to be completed for the extension study.
e Ensure no significant changes in medical history.
f Vital signs (blood pressures, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where applicable.
g The FSH test should only be performed on postmenopausal females who have been postmenopausal for ≥1 year and last menstrual cycle occurred <2 years 
ago.
h At Baseline and Weeks 4 and 16, to be performed predose.
i Pregnancy testing will be serum testing at Screening and SFU. The pregnancy test will be urine at all other visits. If the subject is entering the extension study, 
a urine pregnancy test will be performed at SFU.
j  Subjects who have evidence of or test positive for hepatitis B by any of the following criteria: 1) positive for hepatitis B surface antigen (HBsAg+); 2) positive 
for anti-hepatitis B core antibody (HBcAb+) and negative for anti-hepatitis B surface antibody (HBsAb−) are excluded; a positive test for HCV is defined as: 
1) positive for hepatitis C antibody (anti-HCV Ab), and 2) positive via a confirmatory test for HCV (for example, HCV polymerase chain reaction) are also 
excluded.
k A chest x-ray must be performed at Screening or must occur within 3 months prior to Screening and results must be available at Baseline. MMR is not 
acceptable.
l Includes evaluation of signs and symptoms of active TB and risk for exposure to TB.
m It is recommended that the QuantiFERON TB GOLD test be performed.
n All blood samples taken prior to dosing. 
o Lesional and nonlesional biopsies to be obtained at Baseline and Week 8. Lesional biopsies to be obtained at Week 16 and Week 28.


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5.3
Schematic diagram
The study schematic diagram for PS0016 is presented in Figure 5‒1.
Figure 5‒1: Schematic diagram of PS0016
PASI= Psoriasis Area and Severity Index; SFU=Safety Follow-Up
From  Week 20 through Week 28, subjects who were previously PASI25 responders but subsequently relapse 
(defined as returning to less than PASI25 response) will undergo the study assessments for that visit (ie, Week 20, 
Week 24, or Week 28) before receiving their first dose of study treatment in the extension study at Week 20, 
Week 24, or Week 28. Subjects eligible for the extension study must have the assessments for SFU conducted prior 
to entering the extension study. Subjects who have not achieved a PASI25 response at any visit prior to Week 20 
will not be eligible to enter the extension study. All subjects not enrolling in the extension study will continue in 
PS0016 until the SFU Visit at Week 36.
5.4
Rationale for study design and selection of dose
PS0016 is a Phase 2a, a multicenter, randomized, subject-blind, investigator-blind  study to 
evaluate the PD, PK, and safety of  bimekizumab in adult subjects with moderate to severe 
chronic plaque psoriasis Treatment Period (28 weeks) and a SFU Period (20 weeks after the last 
dose of study medication).
The inclusion criteria are designed to ensure all subjects have moderate to severe disease 
activity. Some exclusion criteria are intended to eliminate subjects who may present an 
unacceptable safety risk were they to participate in this investigational study program. The full 
list of inclusion and exclusion criteria is provided in Section 6.


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The study will evaluate 2 regimens of bimekizumab to understand the time course of PASI 
response following sc administration of bimekizuamb:
•
Treatment arm A: Bimekizumab 320mg at Week 0 and 4 administered sc, placebo 
administered at Week 16
•
Treatment arm B: Bimekizumab 320mg at Weeks 0, 4, and 16 administered sc 
The dose level and regimens were chosen based on the efficacy and safety data from the 
3 completed clinical studies of bimekizumab (UP0008, RA0124, and PA0007). The selected 
dosage regimens will in maximum likelihood provide information to evaluate the time-course of 
PASI response following administration of bimekizumab treatment in this patient population. 
All the subjects in the study will receive 320mg of bimekizumab as a sc injection at Baseline and 
Week 4. Based on our current understanding of PKPD of bimekizumab this will enable 
maximum PASI response in the subjects. Subjects will then be administered either placebo 
(Treatment arm A) or 320mg of bimekizumab at Week 16 (Treatment arm B), in order to 
evaluate the change in time course of PASI response. The proposed doses are expected to be safe 
since doses greater than 320mg (ie, up to 640mg) have been previously tested, via intravenous 
administration, in the development of bimekizumab and were found to be safe and well tolerated.
6
SELECTION AND WITHDRAWAL OF SUBJECTS
6.1
Inclusion criteria
To be eligible to participate in this study, all of the following criteria must be met at Screening 
and be re-confirmed at the Baseline Visit. (Note: the 1 exception relates to the laboratory tests 
performed at Baseline Visit, from which only the pregnancy test result needs to be known prior 
to administration of study medication.)
1a. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written 
Informed Consent Form is signed and dated by the subject. 
2a. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand 
and complete diaries), visit schedule, or medication intake according to the judgment of the 
Investigator.
3. Subject is at least 18 years of age and less than or equal to 70.
4. Subject has had chronic plaque psoriasis for at least 6 months prior to Screening.
5. Subject has PASI ≥12 and BSA ≥10% and IGA score ≥3 on a 5-point scale.
6. Subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or 
chemophototherapy.
7. Female subjects must be postmenopausal (at least 1 year; to be confirmed hormonally as part 
of the Screening process, 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 drug, and have a negative pregnancy test at Screening 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, implantable)

Intrauterine device (IUD) 

Intrauterine hormone-releasing system (IUS) 

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).
8. Subject agrees to not increase their usual sun exposure during the course of the study and to 
use ultraviolet A/ultraviolet B (UVA/UVB) sunscreens.
6.2
Exclusion criteria
Subjects are not permitted to enroll in the study if any of the following criteria is met:
1. Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the 
study or within 20 weeks following last dose of study drug. Male subjects who are planning a 
partner pregnancy during the study or within 20 weeks following the last dose.
2. Subjects previously participating in a bimekizumab clinical trial.
3. Subjects participating in another study of a medication or a medical device under 
investigation within the last 3 months or at least 5 half-lives, whichever is greater, or is 
currently participating in another study of a medication or medical device under 
investigation. 
4. Subjects with a known hypersensitivity to any excipients of bimekizumab.
5a. Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis.
6. Subjects with a history of chronic or recurrent infections, or a serious or life-threatening 
infection within the 6 months prior to the Baseline Visit (including herpes zoster). Subjects 
with a high risk of infection in the Investigator’s opinion (eg, subjects with leg ulcers, 
indwelling urinary catheter, persistent or recurrent chest infections, prior prosthetic joint 
infection at any time, subjects who are permanently bedridden or wheelchair assisted).
7. Subject has any current sign or symptom that may indicate an active infection (except for 
common cold), or has had an infection requiring systemic antibiotics within 2 weeks of 
baseline.


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8. Subjects with concurrent acute or chronic viral hepatitis B or C or human immunodeficiency 
virus (HIV) infection. Subjects who have evidence of, or tested positive for hepatitis B or 
hepatitis C are excluded. A positive test for the hepatitis B virus (HBV) is defined as: 1) 
positive for hepatitis B surface antigen (HBsAg+); or, 2) positive for anti-hepatitis B core 
antibody (HBcAb+). A positive test for the hepatitis C virus (HCV) is defined as: 1) positive 
for hepatitis C antibody (anti-HCV Ab), and 2) positive via a confirmatory test for HCV (for 
example, HCV polymerase chain reaction).
9. Subjects with known history of or current clinically active infection with Histoplasma, 
Coccidiodes, Paracoccidioides, Pneumocystis, nontuberculous mycobacteria, Blastomyces, 
or Aspergillus or current active Candidiasis (local or systemic).
10. Subjects receiving any live (includes attenuated) vaccination within the 8 weeks prior to 
Baseline (eg, inactivated influenza and pneumococcal vaccines are allowed but nasal 
influenza vaccination is not permitted). Live vaccines are not allowed during the study or for 
20 weeks after the last dose of study drug.
11. Subjects receiving Bacillus Calmette-Guerin (BCG) vaccinations within 1 year prior to study 
drug administration.
12. Subjects with a history of a lymphoproliferative disorder including lymphoma or current 
signs and symptoms suggestive of lymphoproliferative disease.
13. Subjects with primary immunosuppressive conditions, including subjects who are taking 
immunosuppressive therapy following an organ transplants.
14. Subjects with known TB infection, at high risk of acquiring TB infection, with latent TB
infection (LTBI), or current or history of NTMB infection (refer to Section 12.6.1 for details 
on determining full TB exclusion criteria).
15. Subjects who have had a splenectomy.
16. Subjects with concurrent malignancy or history of malignancy (including surgically resected 
uterine/cervical carcinoma-in-situ) during the past 5 years, will be excluded, with the 
following exceptions, that may be included. 
a.
≤3 excised or ablated, basal cell carcinomas of the skin
b. One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or 
ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of 
recurrence or metastases for more than 2 years prior to Screening 
c.
Actinic keratosis(-es)
d. Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 
6 months prior to Screening
17. Subjects having had major surgery (including joint surgery) within the 6 months prior to 
Screening, or planned surgery within 6 month after entering the study.
18. Subjects with a current or recent history, as determined by the Investigator, of severe, 
progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac 
(eg, congestive heart failure, New York Heart Association [NYHA] Grade 3 and 4), 


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gastrointestinal (GI) (note: subjects with active peptic ulcer disease are excluded; subjects 
with a history of peptic ulcer disease are allowed), or neurological disease.
19. Subject has a history of uncompensated heart failure, fluid overload, or myocardial 
infarction, or evidence of new onset ischemic heart disease or in the opinion of the 
Investigator other serious cardiac disease, within 12 weeks prior to Baseline.
20a. Subject has >2x upper limit of normal (ULN) of any of the following: alanine 
aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or 
>ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert’s syndrome). If subject has 
elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to 
identify possible undiagnosed Gilbert’s syndrome (ie, direct bilirubin <35%).
Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated 
once for confirmation during the Screening Period. Upon retesting, subjects whose ALT, 
AST, or ALP remain above the thresholds defined above, should not be randomized. 
For randomized subjects with a baseline result >ULN for ALT, AST, ALP, or total bilirubin, 
a baseline diagnosis and/or the cause of any clinically meaningful elevation must be 
understood and recorded in the Case Report form (CRF).
If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at screening, 
repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically 
relevant increase. In case of a clinically relevant increase, inclusion of the subject must be 
discussed with the Medical Monitor.
21. Subjects with clinically significant laboratory abnormalities (eg, creatinine >1.5xULN, 
neutropenia <1.5x109/L, hemoglobin <8.5g/dL, lymphocytes <1.0 x109/L, platelets <100 
x109/L). Individual screening tests for which the results are in error, borderline, or 
indeterminate for inclusion in the study, can be repeated once for confirmation during the 
screening period if they are within 25% of the exclusion limit. Upon retesting, subjects 
whose results remain outside this threshold should not be randomized.
22. Subjects with any other condition which, in the Investigator's judgment, would make the 
subject unsuitable for inclusion in the study.
23. Subjects have been exposed to more than 1 biological response modifier (limited to anti-TNF 
or IL-12/-23) or have received any biologic response modifier during the three months prior
to the Baseline Visit. The list of prohibited medications is presented in Section 7.8.2.
24. Subjects have received previous treatment with any anti-IL-17 therapy for the treatment of 
psoriasis or psoriatic arthritis.
25a.Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic 
arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic lupus 
erythematosus. Subjects with a diagnosis of Crohn’s disease or ulcerative colitis are allowed 
as long as they have no active symptomatic disease at Screening or Baseline.
26. Subjects taking psoriatic arthritis medications other than nonsteroidal anti-inflammatory 
drugs (NSAIDs) or analgesics. Subjects already receiving an established NSAID regimen (at 
least 8 weeks prior to Baseline) and who have been on a stable dose for at least 4 weeks prior 
to Baseline may continue their use during the study.


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27. Subject has a history of chronic alcohol or drug abuse within the previous 6 months.
28. Subject has 12-lead ECG with changes considered to be clinically significant upon medical 
review (eg, QT corrected for heart rate [QTc] using Fridericia’s correction [QTcF] >450ms, 
bundle branch block, evidence of myocardial ischemia).
29a. Presence of significant uncontrolled neuropsychiatric disorder, active suicidal ideation, or 
positive suicide behavior using the “Baseline” version of the C-SSRS and the HADS with 
either of the following criteria:

Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted 
attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by 
a positive response (“Yes”) to either Question 4 or Question 5 of the 
“Screening/Baseline” version of the C-SSRS at Screening.

HADS Depression score >10 or Anxiety score ≥15
30. Subject is an Investigator site worker directly affiliated with this study and/or an immediate 
family member. Immediate family is defined as a spouse, parent, child or sibling, whether 
biological or legally adopted.
31. Subject is a UCB employee or employee of third-party organizations involved in the study.
32. Subjects who have been admitted to a mental hospital or other institution by an order of the 
court
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 encouraged to come for the SFU visit 
(20 weeks after the last received dose) if any of the following events occur:
1. Subject withdraws his/her consent.
2. The Sponsor or a regulatory agency requests withdrawal of the subject.
Subjects should be withdrawn from all study treatment and will be asked to return for the SFU
Visit (20 weeks after the last received dose) if any of the following events occur:
1. There is confirmation of a pregnancy during the study, as evidenced by a positive pregnancy 
test.
2a. 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. 
3a. Subject develops erythrodermic, guttate, or pustular form of psoriasis.
4. Subject considered as having either a suspected new LTB infection or who develop active TB 
or nontuberculosis mycobacterium (NTMB) infection during the study (including but not 
limited to, conversion demonstrated by interferon-gamma release assay [IGRA] or other 
diagnostic means) must be immediately discontinued from study medication, an Early 
Withdrawal Visit must be scheduled as soon as possible, but not later than the next regular 
visit.


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Confirmed active TB is a serious adverse event (SAE) and must be captured on an SAE 
Report Form and provided to the Sponsor in accordance with SAE reporting requirements. 
As with all SAEs, periodic follow-up reports should be completed as per protocol 
requirements until such time as the TB infection resolves. 
Additional information on TB policies are provided in Section 12.6.1.
5. Subject is noncompliant with the study procedures or medications in the opinion of the 
Investigator.
6. 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.
8a.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 
Columbia Suicide Severity Rating Scale (C-SSRS). The subject should be referred 
immediately to a Mental Healthcare Professional and must be withdrawn from the study.
9a. 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.
10. Subject experiences an AE as described below: 

Any Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 and above 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.
11. 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 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. 


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Investigators should attempt to obtain information on subjects in the case of withdrawal or 
discontinuation. For subjects considered as lost to follow-up, the Investigator should make an 
effort (at least 1 phone call and 1 written message to the subject), and document his/her effort 
(date and summary of the phone call and copy of the written message in the source documents), 
to complete the final evaluation. All results of these evaluations and observations, together with a 
narrative description of the reason(s) for removing the subject, must be recorded in the source 
documents. The Case Report Form (CRF) must document the primary reason for withdrawal or 
discontinuation.
Investigators should contact the Medical Monitor, whenever possible, to discuss the withdrawal 
of a subject in advance.
6.3.1
Potential drug-induced liver injury IMP discontinuation criteria
Subjects with potential drug-induced liver injury (PDILI) must be assessed to determine if IMP 
must be discontinued. In addition, all concomitant medications and herbal supplements that are 
not medically necessary should also be discontinued.
The PDILI criteria below require immediate and permanent discontinuation of IMP: 

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 12.5.1. If subjects are unable to 
comply with the applicable monitoring schedule, IMP must be discontinued immediately.
Investigators should attempt to obtain information on subjects in the case of IMP discontinuation 
to complete the final evaluation. Subjects with PDILI should not be withdrawn from the study 
until investigation and monitoring are complete. All results of these evaluations and 
observations, as well as the reason(s) for IMP discontinuation and subject withdrawal (if 
applicable), must be recorded in the source documents. The CRF must document the primary 
reason for IMP discontinuation.
6.4
Study Stopping Rules
During the study, planned dosing and procedures may be discontinued or suspended for all 
subjects in any part of the study and appropriate follow up procedures established. Where it is 


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possible to do so without threatening the safety of subjects, such discontinuation/suspension 
should be discussed with the UCB Study Physician prior to its implementation.
Possible reasons for discontinuation or suspension of the study include (but are not limited to):

A pattern of AEs occurs that contraindicates the further dosing of enrolled/additional 
subjects, including (but not limited to):

More than 1 subject meets any individual Withdrawal Criteria 4, 8a, 9a, 10 or 11 (as 
provided in Section 6.3), regardless of whether they met the same or different criteria.

Once a second subject meets any of those criteria, referral to the DMC may not be 
delayed while awaiting the outcome of either case.
If the above criteria are reached, the DMC will meet as soon as possible to determine 
whether discontinuation or suspension of the study should occur, and to determine what 
investigations, analyses, procedural amendments, or other actions should occur, before 
making any recommendation regarding the possibility of recommencing the study. Further 
details on the role of the DMC are provided in Section 12.1.11 and Section 12.7.4. 

If the Sponsor or its designees judges it necessary for medical, safety, regulatory, or any 
other reasons consistent with applicable laws, regulations, and GCP.
6.5
Retesting/rescreening/replacement
In the event of an isolated exclusionary laboratory value outside the laboratory’s normal range, 
the evaluation may be repeated on 1 occasion during the Screening Period. If the value from the 
repeated test is within the Screening-specified ranges, the subject maybe enrolled. Subjects 
whose Screening Period expires may be rescreened. Subjects who withdraw from the study may 
be replaced, up to a maximum of 10 subjects.
7
STUDY TREATMENT(S)
7.1
Description of investigational medicinal product(s)
The investigational medicinal products (IMPs) used in this study are bimekizumab and placebo. 
Bimekizumab will be supplied as a clear to opalescent, colorless to slightly brown, sterile, 
preservative free solution in 2mL Type I, colorless glass vials (1.0mL extractable volume) closed 
with a rubber stopper and sealed with an aluminum cap overseal. Each single-use dose vial 
contains 160mg/mL bimekizumab in 55mM sodium acetate, 220mM glycine and 0.04% (w/v) 
polysorbate 80 at pH 5.0.  
Placebo will be supplied as 0.9% sodium chloride aqueous solution (physiological saline, 
preservative free) of pharmacopoeia (USP/Ph.Eur) quality appropriate for injection.
Further details of the study medications and their specifications are provided in the IMP 
Handling Manual.
7.2
Treatments to be administered
The study medication is to be administered in the clinic by study site staff as 2 sc injections. 
Suitable areas for sc injections are the lateral abdominal wall and upper outer thigh. During each 
dosing visit, each of the 2 sc injections should be administered at a separate injection site. 


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Injection sites should be rotated and injections should not be given into areas where the skin is 
tender, bruised, red or hard. The injection should last approximately 20 seconds.
In treatment arm A, bimekizumab will be administered at Baseline and Week 4, and placebo 
administered at Week 16. For treatment arm B, bimekizumab medication will be administered at 
Baseline, Week 4, and Week 16. The first dose of study treatment in the extension study will be 
at Week 20, Week 24, or Week 28. The minimum of time between doses should be no less than 
24 days.
An IMP Handling Manual will be provided to each site containing instructions regarding drug 
preparation and dosing.
7.3
Packaging
Bimekizumab and placebo will be packaged and labeled according to Good Manufacturing 
Practice (GMP) guidelines and applicable laws or regulations. They will be suitably packaged in 
such a way as to protect the product from deterioration during transport and storage. Further 
information regarding storage and transport conditions are provided in the IMP Handling 
Manual.
7.4
Labeling
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. Details 
on labeling will be provided in the IMP Handling Manual.
7.5
Handling and storage requirements
Study drug product (IMP) 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.
Appropriate storage conditions must be ensured by controlled temperature and by completion of 
a temperature log in accordance with local requirements on a regular basis per study manuals, 
showing minimum and 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, 
immediately. Authorization to use any out-of-range IMP must be documented and received prior 
to dispensing or administering the IMP at the study site. 
7.6
Drug accountability
A Drug Accountability form will be used to record IMP dispensing and return information on a 
by-subject basis and will serve as source documentation during the course of the study. Details of 
any IMP lost (due to breakage or wastage), not 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.


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In order to maintain the blind, all study drug documentation (eg, shipping receipts, drug 
accountability logs, IXRS randomization materials) must be maintained and accessed by 
unblinded, trained site personnel only. Designated 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 therefore, does not unblind study site staff. Unblinded study staff will be 
responsible for preparation (breaking tamper proof sticker on kit, etc) of the clinical trial 
material.
The Investigator (or designee) is responsible for retaining all used, unused, and partially used 
containers of IMP until returned or destroyed.
The Investigator may assign some of the Investigator’s duties for drug accountability at the study 
site to an appropriate pharmacist/designee.
The Investigator must ensure that the IMP is used only in accordance with the protocol.
Periodically, and/or after completion of the clinical phase of the study, all used (including empty 
containers) and unused IMP containers must be reconciled and returned to UCB (or designee), 
preferably in their original package. 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 electronic Case 
Report Form (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 non-prescription drugs or prescription therapy prescribed by another 
physician).
7.8.1
Permitted concomitant treatments (medications and therapies)
Topical medications


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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 who use prohibited topical medications will be allowed to stay in the study but will be 
counseled to not use them further. No other topical preparations are allowed in the 2 weeks 
before randomization or during the study unless medically required to treat an AE.
Other medications
Subjects who are already receiving an established NSAID regimen (at least 8 weeks prior to 
Baseline) and have been on a stable dose for at least 4 weeks prior to Baseline may continue their 
use during the study. However, initiation of, or increase in dosage of, NSAIDs during the study 
(especially in subjects with a history of GI intolerance to NSAIDs or a history of GI ulceration) 
should be done with caution. Intra-articular steroid injections for arthritis of the knee are 
allowed.
Subjects who are already receiving an established anti-depressant regimen should be on a stable 
dose of anti-depressant for 12 weeks prior to Baseline.
7.8.2
Prohibited concomitant treatments (medications and therapies)
The list of prohibited concomitant medications is provided Table 7‒1.
As noted above, subjects who use prohibited topical medications will be allowed to stay in the 
study but will be counseled to not take them further.
Table 7‒1:
Prohibited psoriasis medications
Drug
Exclusion criteria prior to 
Baseline Visit
Systemic retinoids
12 weeks 
Systemic treatment (non-biological):
systemic immunosuppressant agents (eg, methotrexate, 
cyclosporine, azathioprine, thioguanine)
systemic fumarate
systemic corticosteroids
phototherapy or chemophototherapy
8 weeks for methotrexate, 
azathioprine, and cyclosporine
4 weeks for everything other than 
methotrexate, azathioprine, and 
cyclosporine
Anti-TNFs:
infliximab (including biosimilar), golimumab
etanercept (including biosimilar)
certolizumab pegol
adalimumab (including biosimilar)
4 weeks for etanercept
12 weeks for everything other 
than etanercept
Other biologics and other systemic therapies:
apremilast
ustekinumab
12 weeks for apremilast
24 weeks for ustekinumab
Anti-IL-17 therapy
Any previous exposure excluded


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Table 7‒1:
Prohibited psoriasis medications
Drug
Exclusion criteria prior to 
Baseline Visit
Any other antipsoriatic agent (systemic) under investigation (or 
approved after the protocol is approved)
24 weeks 
Topical corticosteroids for dermatological use
Vitamin D analogues and topical retinoids
Keratolytic and coal tar
2 weeks 
Any other antipsoriatic agent (topical) under investigation
4 weeks 
IL-17=interleukin 17; TNF=tumor necrosis factor
Subjects who take prohibited medications, except topical therapies, may be withdrawn from 
study treatment but followed until the Safety Follow-Up. The decision to withdraw a subject for 
taking prohibited medications should be made in consultation with the Medical Monitor. As 
noted above, subjects that use prohibited topical medications will be allowed to stay in the study 
but will be counseled to not use them further.
Vaccines
Administration of live, attenuated vaccines is not allowed during the conduct of the study or for 
20 weeks after the last dose of study drug (see Exclusion Criterion #10, Section 6.2). 
Administration of inactivated vaccines is allowed during the study at the discretion of the 
Investigator.
7.9
Blinding
Due to differences in presentation of the IMPs (bimekizumab and placebo), special precautions 
will be taken to ensure study blinding.
Bimekizumab and placebo injections will be prepared at the investigational sites by unblinded, 
dedicated study personnel. The unblinded personnel will not be involved in the study in any way 
other than assuring the medication is taken from the correct kit.
During the study, the Sponsor will provide blinded and unblinded site monitors for the purposes 
of verifying safety, efficacy, and study drug administration and documentation records. Blinded 
study monitors and study site personnel, blinded to treatment assignment, will not discuss or 
have access to any study drug-related information.
Further details are provided in the study manuals and site blinding plan.
7.9.1
Procedures for maintaining and breaking the treatment blind
The IMP handling manual describes the handling of bimekizumab and placebo. Appropriate 
training will be given to the site personnel to avoid any unblinding. In case the Investigator 
becomes unblinded for any subject, another assessor will do the remaining evaluations for that 
subject.
All Sponsor and Investigator site personnel involved in the study will be blinded to the 
randomized IMP (bimekizumab or placebo) assignment with the following exceptions:


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
Sponsor Clinical Study Supplies manager and qualified personnel

Sponsor Patient Safety (PS) staff reporting SAEs to the regulatory authorities

Site pharmacist involved in IMP preparation and dispensing

Unblinded monitor who reviews the IMP related documentation and drug accountability

Bioanalytical staff analyzing blood samples for bimekizumab and anti-bimekizumab 
antibody determination

Any Sponsor staff and/or designee who are responsible for data analyses for the unblinded 
data cuts. This will be restricted to the UCB modeling and simulation team and UCB 
programming team.

Unblinded programming team at Parexel for the purpose of sending unblinded data cuts
If necessary, the results of any planned analysis may be shared with key Sponsor’s personnel in 
order to facilitate additional Clinical Planning or Portfolio Management decisions. Only 
unblinded summary results will be provided, and individual subject data will be kept blinded. All 
individuals seeing unblinded summary data will be documented in the Trial Master File (TMF).
7.9.1.1
Maintenance of study treatment blind
All subject treatment details (bimekizumab or placebo) will be allocated and maintained by the 
interactive voice or web response system (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.
The Exploratory Project Manager (EPM) 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
An IXRS will be used for assigning eligible subjects to a treatment regimen based on a 
predetermined production randomization and/or packaging schedule provided by the Sponsor. 
The randomization schedule will be produced by an independent biostatistician with the Contract 
Research Organization (CRO) who is otherwise not involved in this study. The IXRS will 
generate individual assignments for subject kits of IMP, as appropriate, according to the visit 
schedule.
At Screening, each subject will be assigned a 5 digit number that serves as the subject identifier 
throughout the study. The subject number will be required in all communication between the 
Investigator or designee and the IXRS regarding a particular subject. 


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At the Baseline Visit, a subject will be randomized into the study. The Investigator or designee 
will use the IXRS for randomization. The IXRS will automatically inform the Investigator or 
designee of the subject’s ID number. The IXRS will allocate kit numbers to the subject based on 
the subject number during the course of the study.
Subject numbers and kit numbers will be tracked via the IXRS.
8
STUDY PROCEDURES BY VISIT 
Table 5‒1 (schedule of study assessments) provides a general overview of study assessments. A 
list of procedures to be completed at each visit is described below. 

Visit windows of ±3 days on either side of the scheduled dosing are permitted; however, 
the Investigator should try to keep the subjects on the original dosing schedule. The 
window of ±3 days is relative to Baseline and applicable for all subsequent visits. 
Changes to the dosing schedule outside of the 3-day window must be discussed with the 
Medical Monitor.

For the Safety Follow-Up Visit (20 weeks after the last dose), the visit should occur no 
more than 3 days prior to the scheduled visit date and within 7 days after the scheduled 
visit date (-3 days/+7 days).
8.1
Screening Visit
Prior to any study specific activities, subjects will be asked to read, sign, and date an ICF that has 
been approved by the Sponsor and an IEC/IRB, and that complies with regulatory requirements. 
Subjects will be given adequate time to consider any information concerning the study given to 
them by the Investigator or designee. As part of the informed consent procedure, subjects will be 
given the opportunity to ask the Investigator any questions regarding potential risks and benefits 
of participation in the study.
The following procedures or assessments will be performed at the Screening Visit:

Obtain written informed consent

Assessment of inclusion/exclusion criteria

Demographic data

Significant medical and procedure history and concomitant disease, including psoriasis 
disease history

Concomitant medications

Body height and weight

Physical examination

Vital signs (blood pressure, pulse rate, and temperature)

Columbia Suicide Severity Rating Scale (C-SSRS)

Hospital Anxiety and Depression Scale (HADS)

Record 12-lead ECG 


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
Chest x-ray (not necessary if performed within 3 months prior to Screening Visit and report 
is available)

TB questionnaire

PASI

IGA

BSA

Obtain blood sample(s) for:

TB test (interferon gamma release assay; IGRA; it is recommended that the 
QuantiFERON TB GOLD test be performed)

Serum pregnancy test for women of childbearing potential 

Standard safety laboratory tests (hematology and biochemistry)

Hepatitis B and C testing

HIV

RNA, proteins, and metabolites biomarkers

Obtain urine sample for standard safety laboratory tests

Record AEs

Contact the IXRS

Subject identification card
Individual screening tests for which the results are borderline for inclusion in the study may be 
repeated if necessary without complete rescreening of all tests.
8.2
Baseline Visit
The following procedures or assessments will be performed/recorded prior to administration of 
study drug:

Confirm inclusion/exclusion criteria 

Ensure no significant changes in medical procedure history and concomitant disease, 
including psoriasis disease history

Vital signs (blood pressure, pulse rate, and temperature)

Body weight

Record 12-lead ECG 

TB questionnaire

C-SSRS

HADS

PASI


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
IGA

BSA

Obtain blood sample(s) for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

Cytokines, complement, candidate biomarker analysis, and flow cytometry

RNA, proteins, and metabolites biomarkers

Obtain urine sample for:

Standard safety laboratory tests 

Urine pregnancy test for women of childbearing potential. (Note: A negative result must 
be received prior to administration of study medication.)

Obtain skin biopsy (lesional and nonlesional)

Concomitant medications

Record AEs

Contact the IXRS

Study medication administration (after all other visit assessments completed)
8.3
Week 2 (+/-3 days)
The following procedures or assessments will be performed/recorded:

Vital signs (blood pressure, pulse rate, and temperature)

C-SSRS

PASI

IGA

BSA

Obtain blood sample(s) for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Obtain urine sample for:

standard safety laboratory tests 

Concomitant medications

Record AEs


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8.4
Week 4 (+/-3 days)
The following procedures or assessments will be performed/recorded prior to administration of 
study drug:

Vital signs (blood pressure, pulse rate, and temperature)

C-SSRS

HADS

Record 12-lead ECG 

PASI

IGA

BSA

Obtain blood sample(s) for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

Obtain urine sample for:

Standard safety laboratory tests 

Urine pregnancy test for women of childbearing potential

Concomitant medications

Record AEs

Contact the IXRS

Study medication administration (after all other visit assessments completed)
8.5
Week 8 (+/-3 days)
The following procedures or assessments will be performed/recorded:

Vital signs (blood pressure, pulse rate, and temperature)

C-SSRS

HADS

PASI

IGA

BSA

Obtain blood sample(s) for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration


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
Anti-bimekizumab antibodies

Cytokines, complement, candidate biomarker analysis, and flow cytometry 

RNA, proteins, and metabolites biomarkers

Obtain urine sample for:

Standard safety laboratory tests 

Urine pregnancy test for women of childbearing potential

Obtain skin biopsy (lesional and nonlesional)

Concomitant medications

Record AEs
8.6
Week 12 (+/-3 days)
The following procedures or assessments will be performed/recorded:

Vital signs (blood pressure, pulse rate, and temperature)

C-SSRS

HADS

PASI

IGA

BSA

Obtain blood sample(s) for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

Cytokines, complement, candidate biomarker analysis, and flow cytometry 

RNA, proteins, and metabolites biomarkers

Obtain urine sample for:

Standard safety laboratory tests

Urine pregnancy test for women of childbearing potential

Concomitant medications

Record AEs
8.7
Week 16 (+/-3 days) 
The following procedures or assessments will be performed prior to administration of study 
drug:


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
Body weight

Vital signs (blood pressure, pulse rate, and temperature)

C-SSRS

HADS

Record 12-lead ECG 

PASI

IGA

BSA

Obtain blood sample(s) for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

Cytokines, complement, candidate biomarker analysis, and flow cytometry 

RNA, proteins, and metabolites biomarkers

Obtain urine sample for: 

Standard safety laboratory tests 

Urine pregnancy test for women of childbearing potential

Obtain skin biopsy (lesional)

Concomitant medications

Record AEs

Contact the IXRS

Study medication administration (after all other visit assessments completed)
8.8
Week 20 (+/-3 days)
The following procedures or assessments will be performed:

Vital signs (blood pressure, pulse rate, and temperature)

C-SSRS

HADS

TB questionnaire

PASI

IGA

BSA


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
Obtain blood sample(s) for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

Obtain urine sample for: 

Standard safety laboratory tests 

Urine pregnancy test for women of childbearing potential

Concomitant medications

Record AEs
8.9
Week 24 (+/-3 days)
The following procedures or assessments will be performed:

Vital signs (blood pressure, pulse rate, and temperature)

C-SSRS

HADS

PASI

IGA

BSA

Obtain blood sample(s) for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies 

Obtain urine sample for: 

Standard safety laboratory tests 

Urine pregnancy test for women of childbearing potential

Concomitant medications

Record AEs
8.10
Week 28 (+/-3 days)
The following procedures or assessments will be performed:

Vital signs (blood pressure, pulse rate, and temperature)

C-SSRS


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
HADS

PASI

IGA

BSA

Obtain blood sample(s) for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

RNA, proteins, and metabolites biomarkers

Obtain urine sample for: 

Standard safety laboratory tests 

Urine pregnancy test for women of childbearing potential

Obtain skin biopsy (lesional)

Concomitant medications

Record AEs
8.11
Week 36/Safety Follow-Up Visit (20 weeks after the last dose)
All subjects not continuing in the extension study, including those withdrawn from study 
treatment, will have a SFU Visit at 20 weeks after their last dose of study medication.
The SFU Visit should occur no more than 3 days prior to the scheduled visit date and within 
7 days after the scheduled visit date (-3 days/+7 days).
The following procedures or assessments will be performed at the SFU Visit:

Vital signs (blood pressure, pulse rate, and temperature)

C-SSRS

HADS

Body weight

Physical examination

Record 12-lead ECG 

TB questionnaire

PASI

IGA

BSA

Obtain blood sample(s) for:


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
TB test (interferon gamma release assay; IGRA; it is recommended that the 
QuantiFERON TB GOLD test be performed)

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

Cytokines, complement, candidate biomarker analysis, and flow cytometry 

RNA, proteins, and metabolites biomarkers

Serum pregnancy test for women of childbearing potential. If the subject is entering the 
extension study, a urine pregnancy test will be performed. 

Obtain urine sample for standard safety laboratory tests 

Concomitant medications

Record AEs
8.12
Early Withdrawal Visit
Subjects withdrawing early from the study (see Section 6.3) should undergo the same 
assessments scheduled for the Week 36 Visit (see Section 8.11) as soon as possible after 
withdrawal (as an Early Withdrawal Visit) and then enter the SFU Period, completing study 
participation with the SFU Visit (Week 36 Visit assessments again) 20 weeks after their last dose 
of study medication.
8.13
Unscheduled Visit
At the Investigator’s discretion, an Unscheduled Visit may be completed at any time during the 
study but prior to the SFU Visit, if deemed necessary for the subject’s safety and well-being. 
If an Unscheduled Visit is conducted due to safety or efficacy reasons, a C-SSRS assessment will 
be performed with the subject during the visit. If an Unscheduled Visit is conducted for reasons 
other than safety or efficacy concerns (eg, repeated collection of a laboratory specimen due to 
collection or analysis issues), an C-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 

C-SSRS

Physical examination

Record 12-lead ECG 

If medically indicated, obtain blood sample(s) for:

Standard safety laboratory tests (hematology, serum chemistry) 

The blood sample may also be used for PK/PD assessments, if needed.

Obtain urine sample for standard safety laboratory tests (including urine pregnancy test)


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
Record concomitant medication

Record AEs
9
ASSESSMENT OF EFFICACY
9.1
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 percent area of involvement (BSA%) is estimated across 4 body areas; head, upper limbs, 
trunk, and lower limbs and then transferred into a grade (Table 9‒1). 
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body 
area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. 
The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. 
Table 9‒1:
Body areas for calculation of percent BSA for PASI
Body area
Details of area
BSA
Degree of 
involvement of 
body areaa
Head
Face, back of head
10% 
0 to 6
Upper 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 PASI25, PASI50, PASI75, PASI90, and PASI100 responses are based on at least 25%, 50%, 
75%, 90%, and 100% improvement in the PASI score.
The PASI will be completed at the visits specified in Table 5‒1.
9.2
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)


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
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.
9.3
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 
presented in Table 9‒2.
Table 9‒2:
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
9.4
Hospital Anxiety and Depression Score
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 whereas a score 
of 15 and above is considered severe (Snaith and Zigmond, 1994).
10
ASSESSMENT OF PHARMACOKINETICS/ 
PHARMACODYNAMICS/PHARMACOGENOMICS
10.1
Pharmacokinetic and pharmacodynamic variables
Blood samples for measurement of PK and PD variableswill be collected at the time points 
specified in the schedule of study assessments (Table 5‒1). 
Flow cytometry by fluorescence-activated cell sorting (FACS) analysis might include, but is not 
limited to: CD3, CD19, CD4, CD8, and CD69.
Candidate biomarkers might include, but are not limited to: IL-17A/IL17-F pathway signaling 
and psoriasis biology (eg, IL-17A, IL-17F, IL-23, IL-6, TNF, DC-STAMP, and circulating 
osteoclast precursors). 


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At dosing visits, blood samples will be drawn prior to dosing, and will be drawn at the same time 
of the sampling for clinical laboratory tests. The time and date of collection will be recorded in 
the eCRF. 
Instructions pertaining to sample collection, processing, storage, labeling, and shipping are 
provided in the laboratory manual for this study. Detailed information on sample analysis will be 
provided in a bioanalytical report.
10.2
Non-hereditary pharmacogenomic variables
10.2.1
RNA, proteins, and metabolites biomarkers
Where local regulations permit, blood samples will be drawn for exploratory RNA, proteins and 
metabolites biomarker analysis at the time points specified in the schedule of study assessments 
(Table 5‒1).
Where local regulation permit, lesional and nonlesional skin biopsies for exploratory RNA, 
proteins, and metabolites biomarker  analysis will be taken at the time points specified in the 
schedule of study assessments (Table 5‒1).
Collection of these samples will enable evaluation of biomarkers relative to disease biology and 
progression, drug treatment and inflammatory and immune response processes. 
Instructions pertaining to sample collection, processing, storage, labeling, and shipping are 
provided in the laboratory manual for this study. The nature and format of these tentative 
analyses will be determined at a later stage.
The samples will be stored at the secure long-term storage facility selected by UCB for up to 
20 years.
11
ASSESSMENT OF IMMUNOLOGICAL VARIABLES
11.1
Assessment of immunogenicity
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.
11.2
Assessment of immunological variables
Blood samples for measurement of immunological variables 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. 


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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.
12
ASSESSMENT OF SAFETY
12.1
Adverse events
12.1.1
Definition of adverse event
An adverse event (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 CRF 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.
12.1.2
Adverse events of special interest
An AE of special interest (AESI) is any AE that a regulatory authority has mandated be reported 
on an expedited basis, regardless of the seriousness, expectedness, or relatedness of the AE to the 
administration of a UCB product/compound.
Potential Hy’s Law, defined as ≥3xULN ALT or AST with coexisting ≥2xULN total bilirubin in 
the absence of ≥2xULN ALP, with no alternative explanation for the biochemical abnormality, 
must ALWAYS be reported to UCB as an AESI (ie, without waiting for any additional etiologic 
investigations to have been concluded). Follow-up information should then be reported if an 
alternative etiology is identified during investigation and monitoring of the subject.
12.1.3
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 12.6.1), cytopenias, hypersensitivities, suicide 
ideation or behavior (assessed using the C-SSRS), depression-and anxiety (assessed using the 


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HADS, see Section 9.4 ), major cardiovascular events and liver function test changes/enzyme 
elevations (ALT, AST, and bilirubin; see Section 12.5.1), and malignancies and inflammatory 
bowel diseases.
12.1.4
Procedures for reporting and recording adverse events
The subject will be given the opportunity to report AEs spontaneously. A general prompt will 
also be given at each study visit to detect AEs. For example:
“Did you notice anything unusual about your health (since your last visit)?”
In addition, the Investigator should review any self-assessment procedures (eg, diary cards) 
employed in the study.
12.1.5
Description of adverse events
When recording an AE, the Investigator should use the overall diagnosis or syndrome using 
standard medical terminology, rather than recording individual symptoms or signs. The CRF and 
source documents should be consistent. Any discrepancies between the subject’s own words on 
his/her own records (eg, diary card) and the corresponding medical terminology should be 
clarified in the source documentation.
When recording the severity of an AE in the 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 Adverse Event CRF (including judgment of severity and relationship to IMP) 
are described in the CRF Completion Guidelines.
12.1.6
Follow up of adverse events
An AE should be followed until it has resolved, has a stable sequelae, the Investigator
determines that it is no longer clinically significant, or the subject is lost to follow up. 
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.
12.1.7
Rule for repetition of an adverse event
An increase in the intensity of an AE should lead to the repetition of the AE being reported with:

The outcome date of the first AE that is not related to the natural course of the disease being 
the same as the start date of the repeated AE, and the outcome of “worsening”

The AE verbatim term being the same for the first and repeated AE, so that the repeated AE 
can be easily identified as the worsening of the first one
12.1.8
Pregnancy
If an Investigator is notified that a subject has become pregnant after the first intake of any IMP, 
the Investigator must immediately notify UCB’s 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 


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as soon as pregnancy is known (by positive pregnancy test), and the following should be 
completed:

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 for 
a medical indication 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.
12.1.9
Suspected transmission of an infectious agent via a medicinal 
product
For the purposes of reporting, any suspected transmission of an infectious agent via a medicinal 
product should be considered as an SAE; such cases must be reported immediately, recorded in 
the AE module of the CRF, 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.


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12.1.10
Overdose of investigational medicinal product
Excessive dosing (beyond that prescribed in the protocol and including overdose) should be 
recorded in the eCRF. Any SAE or nonserious AE associated with excessive dosing must be 
followed as any other SAE or nonserious AE. These events are only considered AEs or SAEs if 
there are associated clinical signs and symptoms or if the act of taking the excess medicine itself 
is an AE or SAE (eg, suicide attempt).
12.1.11
Safety signal detection
Selected data from this study will be reviewed periodically to detect as early as possible any 
safety concern(s) related to the IMP so that Investigators, clinical study subjects, regulatory 
authorities, and IRBs/IECs will be informed appropriately and as early as possible.
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 (CV) Adjudication Committee will also periodically review and 
monitor the safety data from this study and advise UCB. Details are provided in the CV 
Adjudication Committee Charter.
12.2
Serious adverse events
12.2.1
Definition of serious adverse event
Once it is determined that a subject experienced an AE, the seriousness of the AE must be 
determined. An SAE must meet 1 or more of the following criteria:

Death

Life-threatening
(Life-threatening does not include a reaction that might have caused death had it occurred in 
a more severe form.)

Significant or persistent disability/incapacity

Congenital anomaly/birth defect (including that occurring in a fetus)

Important medical event that, based upon appropriate medical judgment, may jeopardize the 
patient or subject and may require medical or surgical intervention to prevent 1 of the other 
outcomes listed in the definition of serious
(Important medical events may include but are not limited to, potential Hy’s Law (see 
Section 12.1.2), allergic bronchospasm requiring intensive treatment in an emergency room 
or at home, blood dyscrasias that do not result in inpatient hospitalization, or the 
development of drug dependency or drug abuse.)

Initial inpatient hospitalization or prolongation of hospitalization
(A patient admitted to a hospital, even if he/she is released on the same day, meets the 
criteria for the initial inpatient hospitalization. An emergency room visit that results in 
admission to the hospital would also qualify for the initial inpatient hospitalization criteria. 
However, emergency room visits that do not result in admission to the hospital would not 
qualify for this criteria and, instead, should be evaluated for 1 of the other criteria in the 
definition of serious [eg, life-threatening adverse experience, important medical event].


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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.
12.2.2
Procedures for reporting serious adverse events
If an SAE is reported, UCB must be informed within 24 hours of receipt of this information by 
the site (see contact information for SAE reporting listed in the Serious Adverse Event Reporting 
section at the front of the protocol). The Investigator must forward to UCB (or its representative) 
a duly completed “Investigator SAE Report Form for Development Drug” (SAE Report Form) 
provided by UCB, even if the data are incomplete, or if it is obvious that more data will be 
needed in order to draw any conclusions. Information recorded on this form will be entered into 
the global safety database.
An Investigator SAE Report Form will be provided to the Investigator. The Investigator SAE 
Report Form must be completed in English. 
It is important for the Investigator, when completing the SAE Report Form, to include the 
assessment as to a causal relationship between the SAE and the IMP administration. This insight 
from the Investigator is very important for UCB to consider in assessing the safety of the IMP 
and in determining whether the SAE requires reporting to the regulatory authorities in an 
expedited manner.
Additional information (eg, autopsy or laboratory reports) received by the Investigator must be 
provided within 24 hours. All documents in the local language must be accompanied by a 
translation in English, or the relevant information included in the same document must be 
summarized in the Investigator SAE Report Form.
The Investigator is specifically requested to collect and report to UCB (or its representative) any 
SAEs (even if the Investigator is certain that they are in no way associated with the IMP), up to 
30 days from the end of the study for each subject, and to also inform participating subjects of 
the need to inform the Investigator of any SAE within this period. Serious AEs that the 
Investigator thinks may be associated with the IMP must be reported to UCB regardless of the 
time between the event and the end of the study.
Upon receipt of the SAE Report Form, UCB will perform an assessment of expectedness of the 
reported SAE. The assessment of the expectedness of the SAE is based on the IB.
12.2.3
Follow up of serious adverse events
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. 


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Information on SAEs obtained after clinical database lock will be captured through the Drug 
Safety database without limitation of time.
12.3
Immediate reporting of adverse events
The following AEs must be reported immediately:

SAE: AE that the Investigator classifies as serious by the above definitions regardless of 
causality

Suspected transmission of an infectious agent via a medicinal product

AEs of special interest as defined in Section 12.1.2
12.4
Anticipated serious adverse events
The following list of Anticipated SAEs has been identified, as these events are anticipated to 
occur in the population studied in this protocol at some frequency that is independent of drug 
exposure. This original list will remain in effect for the duration of the protocol. Note that listed 
events will not be regarded as anticipated SAEs if they are life threatening or if they result in the 
death of the study subject.
This list does not change the Investigator’s obligation to report all SAEs (including Anticipated 
SAEs) as detailed in Section 12.2.2.
Table 12‒1: Anticipated serious adverse events for the population of subjects 
with moderate to severe chronic plaque psoriasis
MedDRA® system order class
MedDRA preferred term
Skin and subcutaneous tissue disorders
Any psoriatic condition HLT
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
HLT=high level term; MedDRA=Medical Dictionary for Regulatory Activities
Note: Exception: Listed events will not be regarded as anticipated SAEs if they are life threatening or if they result 
in the death of the study subject.
12.5
Laboratory measurements
Clinical laboratory assessments consist of serum chemistry, hematology, and urinalysis. A 
centralized laboratory will be used to supply all laboratory test supplies and analyze all blood 
and urine samples for hematology, biochemistry and urinalysis measurements. Any unscheduled 
laboratory testing should also be collected using the central laboratory. Testing to rule out 
hepatitis B, hepatitis C, and HIV (see Exclusion Criterion #7, Section 6.2) will be performed at 
Screening in addition to those measurements listed in Table 12‒2. 
Specific details regarding the handling and processing of serum chemistry, hematology, and 
urinalysis samples are provided in the study laboratory manuals.


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Table 12‒2: 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
Platelet count
ALT
RBC count
GGT
WBC count
Total bilirubin
LDH
Total cholesterol
Serum pregnancy testinga
Serum FSHb (Screening)
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea 
nitrogen; CRP=C-reactive protein; GGT=gamma glutamyltransferase; FSH=follicle stimulating hormone; 
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 consist of serum testing at the Screening and SFU Visits. The pregnancy test will be urine 
at all other visits and will be performed locally. If the subject is entering the extension study, a urine pregnancy 
test will be performed at SFU.
b The FSH test should only be performed on postmenopausal females who have been postmenopausal for ≥1 year 
and last menstrual cycle occurred <2 years ago.
Assessments of immunological variables are described in Section 11. Assessments of PK and PD 
variables are described in Section 10.
12.5.1
Evaluation of PDILI
The PDILI IMP discontinuation criteria for this study are provided in Section 6.3.1, with the 
accompanying required follow-up investigation and monitoring detailed below. All PDILI events 
must be reported as an AE and reported to the study site and sponsor within 24 hours of learning 
of their occurrence. Any PDILI event that meets the criterion for potential Hy’s Law must be 
reported as an AESI (see Section 12.1.2), and, if applicable, also reported as an SAE (see 
Section 12.2.1). 


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Evaluation of PDILI consists of the diagnostic testing and continued monitoring included in 
Table 12‒3 (specific tests dependent on laboratory results and corresponding symptoms) and 
consultation with a local hepatologist (if applicable; discussed in Section 12.5.1.1). The local 
hepatologist is the expert usually consulted by the treating physician for assessment and 
management of potential hepatic disease. This would usually be a hepatologist, but may be a 
gastroenterologist. Additional investigation and monitoring may be required and adapted based 
on the diagnosis after the cause of the liver injury/abnormality is confirmed (details in 
Section 12.5.1.5). 
The results of all monitoring, including laboratory testing and other testing, should be made 
available to the study site and Sponsor.
All initial tests resulting in abnormal hepatic laboratory values need to be repeated, but 
appropriate medical action must not be delayed waiting for the repeat result.
If tests are done locally for more rapid results, a concurrent sample should also be sent to the 
central laboratory whenever possible. Medical care decisions are to be made initially using the 
most rapidly available results and a conservative approach must be taken if the results from the 2 
laboratory tests are significantly different. Data from the local and central laboratory are to be 
recorded on the applicable CRF pages.
When IMP is discontinued, all concomitant medications and herbal supplements that are not 
medically necessary should also be discontinued. In these cases, the investigator should also 
consider dose reduction for medically necessary concomitant medication and consider changing 
any medically required concomitant medication known to be hepatotoxic to a suitable 
alternative.
Rechallenge with a substance potentially causing drug-induced liver injury is dangerous, may be 
fatal, and must not occur.
Table 12‒3 summarizes the approach to investigate PDILI.


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Table 12‒3: Required investigations and follow up for PDILI
Laboratory value
Immediate
Follow up
ALT or 
AST
Total 
bilirubin
Symptomsa of 
hepatitis of 
hypersensitivity
Consultation 
requirements
Actions
Testing
Evaluation
≥3xULN
≥2xULNb
NA
Hepatology consultc
Medical Monitor must 
be notified within 
24 hours (eg, by 
laboratory alert) and 
subject discussed with 
Medical Monitor 
ASAP.
Immediate, 
permanent IMP 
discontinuation.
Essential: Must have 
repeat liver 
chemistry values 
and additional 
testing completed 
ASAP (see 
Section 12.5.1.4); 
recommended to 
occur at the site with 
HCP.
Monitoring of liver 
chemistry values at least 
twice per week until 
values normalize, 
stabilize, or return to 
within baseline values.d
≥3xULN
NA
Yes
≥5xULN
NA
NA
Need for hepatology 
consult to be 
discussed.( required if 
ALT or AST 
≥8xULN)
Medical Monitor must 
be notified within 
24 hours (eg, by 
laboratory alert) and 
subject discussed with 
Medical Monitor 
ASAP.
Immediate, 
permanent IMP 
discontinuation


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Table 12‒3: Required investigations and follow up for PDILI
Laboratory value
Immediate
Follow up
ALT or 
AST
Total 
bilirubin
Symptomsa of 
hepatitis of 
hypersensitivity
Consultation 
requirements
Actions
Testing
Evaluation
≥3xULN 
(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 12.5.1.2).
IMP discontinuation 
required if any of the 
following occur:
Subject cannot 
comply with 
monitoring 
schedule. 
Liver chemistry 
values continue to 
increase 
Liver chemistry 
values remain 
≥3xULN (and 
≥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 12.5.1.4).
Monitoring of liver 
chemistry values at least 
twice per week for 2 
weeks.d

Immediate IMP 
discontinuation 
required if liver 
chemistry values 
continue to increase.
After 2 weeks of 
monitoring liver 
chemistry values:

Discontinue IMP if 
levels remain 
≥3xULN (and ≥2x 
baseline) without 
evidence of 
resolutiond
Continue to monitor until 
values normalize, 
stabilize, or return to 
within baseline values.d


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Table 12‒3: Required investigations and follow up for PDILI
Laboratory value
Immediate
Follow up
ALT or 
AST
Total 
bilirubin
Symptomsa of 
hepatitis of 
hypersensitivity
Consultation 
requirements
Actions
Testing
Evaluation
ALT=alanine aminotransferase; ASAP=as soon as possible; AST=aspartate aminotransferase; HCP=healthcare practitioner; IMP=investigational medicinal 
product; NA=not applicable; PDILI=potential drug-induced liver injury; ULN=upper limit of normal
a Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or tenderness; hypersensitivity symptoms include eosinophilia (>5%), 
rash, and fever (without clear alternative cause).
b If the subject also has ≥2xULN ALP, the possibility of an indication of biliary obstruction should be discussed with the Medical Monitor.
c Details provided in Section 12.5.1.1. The local hepatologist is the expert usually consulted by the treating physician for assessment and management of 
potential hepatic disease. This would usually be a hepatologist, but may be a gastroenterologist.
d Unless an alternative monitoring schedule is agreed by the investigator and UCB responsible physician. Determination of stabilization is at the discretion of the 
investigator in consultation with the hepatologist (as applicable) and UCB responsible physician, as needed.


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12.5.1.1
Consultation with Medical Monitor and local hepatologist
Potential drug-induced liver injury events require notification of the Medical Monitor within 
24 hours (eg, by laboratory alert), and the subject must be discussed with the Medical Monitor as 
soon as possible. If required, the subject must also be discussed with the local hepatologist. The 
local hepatologist is the expert usually consulted by the treating physician for assessment and 
management of potential hepatic disease. This would usually be a hepatologist, but may be a 
gastroenterologist. If determined necessary, this discussion should be followed by a full 
hepatology assessment (see Section 12.5.1.4) and SAE report (if applicable).
12.5.1.2
Immediate action: determination of IMP discontinuation
All PDILI events require immediate action, testing, and monitoring. 
The immediate action is dependent on the laboratory values and symptoms of hepatitis or 
hypersensitivity and ranges from continuation of IMP (followed by immediate investigation) to 
immediate and permanent discontinuation (see Section 6.3.1 and Table 12‒3 for details).
When IMP is discontinued, all concomitant medications and herbal supplements that are not 
medically necessary should also be discontinued. The investigator should also consider dose 
reduction for medically necessary concomitant medication and consider changing any medically 
required concomitant medication known to be hepatotoxic to a suitable alternative.
12.5.1.3
IMP restart/rechallenge
Rechallenge with a substance potentially causing drug-induced liver injury is dangerous, may be 
fatal, and must not occur.
12.5.1.4
Testing: identification/exclusion of alternative etiology
The measurements and additional information required for the assessment of PDILI events when 
there is a reasonable possibility that they may have been caused by the IMP are included but not 
limited to those listed in Table 12‒4 (laboratory measurements) and Table 12‒5 (additional 
information). Results of the laboratory measurements and information collected are to be 
submitted to the sponsor on the corresponding CRF. If the medical history of the subject 
indicates a requirement for other assessments not included below, these additional assessments 
should be completed and submitted, as applicable.
All blood samples should be stored, if possible. If tests are done locally for more rapid results, a 
concurrent sample must also be sent to the central laboratory.
The following measurements are to be assessed:


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Table 12‒4: PDILI laboratory measurements
Virology-
related
Hepatitis A IgM antibody
HBsAg
Hepatitis E IgM antibody
HBcAb-IgM
Hepatitis C RNA
Cytomegalovirus IgM antibody
Epstein-Barr viral capsid antigen IgM antibody (if unavailable, obtain 
heterophile antibody or monospot testing)
Immunology
Anti-nuclear antibody (qualitative and quantitative)
Anti-smooth muscle antibody (qualitative and quantitative)
Type 1 anti-liver kidney microsomal antibodies (qualitative and/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/INR
b
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  such as amphetamines, benzodiazepines, opioids, marijuana, cocaine, phencyclidine, 
and tricyclic antidepressants. Additional tests may be performed based on the investigator’s medical judgment and 
patient’s history.
b Measured only for subjects with ALT >8xULN, elevations in total bilirubin, and symptoms of hepatitis or 
hypersensitivity. Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or 
tenderness; hypersensitivity symptoms include eosinophilia (>5%), rash, and fever (without clear alternative 
cause).


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The following additional information is to be collected:
Table 12‒5: PDILI information to be collected
New or updated information
Concomitant prescription and over-the-counter medications (eg, acetaminophen, herbal remedies, 
vitamins); dosages and dates should be included.
Pertinent medical history, including the following:

History of liver disease (eg, autoimmune hepatitis, nonalcoholic steatohepatitis or other “fatty 
liver disease”)

Adverse reactions to drugs

Allergies

Relevant family history or inheritable disorders (eg, Gilbert’s syndrome, alpha-1 antitrypsin 
deficiency)

Recent travel 
Progression of malignancy involving the liver (Note: Metastatic disease to the liver, by itself, should not 
be used as an explanation for significant AST and/or ALT elevations.)
The appearance or worsening of clinical symptoms of hepatitis or hypersensitivity (eg, fatigue, nausea, 
vomiting, right upper quadrant pain or tenderness, decreased appetite, abdominal pain, jaundice, fever, or 
rash)
Recent clinically significant hypotension or hypoxemia with compromised cardiopulmonary function
Alcohol and illicit drug use
Results of liver imaging or liver biopsy, if done
Results of any specialist or hepatology consult, if done
Any postmortem/pathology reports
ALT=alanine aminotransferase; AST=aspartate aminotransferase; PDILI=potential drug-induced liver injury
12.5.1.5
Follow-up evaluation
Potential drug-induced liver injury events require follow-up monitoring as described in 
Table 12‒3. Monitoring should continue until liver chemistry values normalize, stabilize, or 
return to baseline. Determination of stabilization is at the discretion of the investigator in 
consultation with the hepatologist (as applicable) and UCB responsible physician, as needed.
12.6
Other safety measurements
12.6.1
Assessment and management of TB and TB risk factors
All subjects will be assessed for tuberculosis (TB) at Screening and at the timepoints specified in 
the Schedule of Assessments (Table 5‒1) through physical examination for signs and symptoms 
of TB, chest x-ray (Section 12.6.1.2), laboratory testing (Section 12.6.1.1), and subject
questionnaire (Section 12.6.1.3). 
At Screening, all subjects will have an IGRA test (QuantiFERON TB GOLD is recommended), a 
chest x-ray (unless already performed within 3 months of Screening) and examination for signs 


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and symptoms of TB. In addition, each subject will complete a TB questionnaire with questions 
directed at symptoms of TB and potential exposure to TB. 
Exclusion criteria at Screening
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 
Screening

Time spent in a healthcare delivery setting or institution where individuals infected with 
TB are housed and where the risk of transmission of infection is high
c.
Latent TB infection 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 
randomized to study medication. The retest must be done during the protocol-defined 
Screening window (up to 4 weeks).
Note: If available, respiratory or other specimens must also be smear and culture 
negative for TB (Centers for Disease Control [CDC] diagnosis of LTB infection)
http://www.cdc.gov/TB/topic /testing/default.htm)
d. Current or history of nontuberculous mycobacterial (NTMB) infection despite prior or 
current therapy.
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 gastrointestinal 
system, bone/joints, lymph glands and meninges etc. However, in immune compromised patients 
and/or patients treated with TNF inhibitors, extra-pulmonary manifestations of TB is common 
compared to normal population.


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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.
LTBI 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 randomized to study medication. If LTBI or active TB is identified, 
subject must undergo appropriate study specified withdrawal procedures. The retest must be 
done during the protocol-defined Screening window (up to 4 weeks). 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 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 LTBI, active TB, or NTMB then, per UCB TB working instructions, 
TB test conversion (confirmed) should be classified adequately, either as due to LTBI, 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 Drug Safety function.
Latent TB
In case the evaluation by the appropriate specialist indicates a new LTBI 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 36/EWD Visit, 
complete all Early Withdrawal Visit assessments, and complete a SFU Visit (20 weeks after the 
last dose of study medication).
Active TB or nontuberculosis mycobacterium 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. 
12.6.1.1
Tuberculosis assessment by IGRA
During conduct of the study, the TB assessment by IGRA (QuantiFERON TB GOLD is 
recommended) will be performed at Screening and should be repeated at Week 36/Early 


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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, subject must undergo appropriate study-specified withdrawal procedures. The retest 
during Screening must be done during the protocol-defined Screening window (up to 4 weeks).
12.6.1.2
Chest x-ray for tuberculosis
A plain posteroanterior chest x-ray must be performed in the Screening Period unless one has 
been performed within 3 months prior to the Screening Visit. The chest x-ray (or, if done, 
Computed Axial Tomography [CAT] of the Chest) must be clear of signs of TB infection 
(previous or current) before first study medication administration. All chest imaging (particularly 
x-rays) should be available for review by the Investigator before randomization of the subject. 
The chest x-ray should be repeated only if the TB test was confirmed positive or any further 
evidence is suggestive of potential lung TB infection (eg, exposure). Radiographic findings 
suggestive of inactive TB or active TB may include but are not limited to: apical fibrosis, pleural 
thickening, pulmonary nodules, fibrotic scars, calcified granulomas, upper lobe infiltrates, 
cavitations and pleural effusions, calcified lung nodules, calcified hilar lymph nodes, and 
pericardial calcification.
The chest imaging must be negative for any old or recent TB infection as determined by a 
qualified radiologist and/or pulmonary physician. Any new clinically significant findings post 
Baseline on chest x-ray must be documented in the source documents and the eCRF as an AE.
12.6.1.3
Tuberculosis questionnaire 
The questionnaire “Evaluation of signs and symptoms of tuberculosis” should be used as a 
source document. The questionnaire will assist with the identification of subjects who may 
require therapy for TB. A subject who answers “Yes” to the question “Has the subject been in 
close contact with an individual with active TB, or an individual who has recently been treated 
for TB?” at Screening is excluded. A “Yes” response to any of the other questions within the 
questionnaire at Screening should trigger further careful assessment to determine if subject has 
LTB or active TB (see Exclusion Criterion 13, Section 6.2). A “Yes” response to any of the 
questions during the study should trigger further assessments to determine if the subject has 
either LTB or active TB infection. 
Subjects with a latent or active TB infection must be withdrawn from the study.
12.6.1.4
Tuberculosis management
LTB infection and active TB identified during study
During the study, subjects who develop evidence of LTB infection or active TB must 
immediately stop further administration of study medication and will be referred to an 
appropriate TB specialist (pulmonologist or infectious disease specialist) for further evaluation. 
Evidence of LTB infection is defined as subject’s IGRA test converts to positive or 
indeterminate (and confirmed indeterminate on repeat), or the subject’s questionnaire or history 
and physical indicates that TB infection or exposure may have occurred. Evidence of active TB 
includes, in addition to the aforementioned tests, signs and symptoms of organ involvement. In 
either situation, the subject should be carefully assessed by a TB specialist for active TB. 


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Subjects diagnosed with active TB or LTB infection should be withdrawn from the study and 
receive appropriate TB or prophylaxis therapy. 
Any presumptive diagnosis or diagnosis of a TB infection is a reportable event. Confirmed active 
TB must be reported as an SAE. The Investigator is to complete and submit the TB follow up 
form provided.
The subject should be transferred to the care of his/her physician and managed according to the 
best available standard of care. Subjects identified as having converted to active TB during the 
study must be withdrawn and scheduled to return for the Week 36/EWD Visit as soon as possible 
but no later than the next scheduled study visit and complete all Week 36/EWD Visit 
assessments. 
The subject should be encouraged to complete a SFU Visit (20 weeks after the last dose of study 
medication).
If infection with NTMB is identified during the study, the same procedure as for active TB 
acquired during the study must be followed.
12.6.2
Pregnancy testing
Pregnancy testing will consist of serum testing at the Screening and SFU Visits. The pregnancy 
test will be urine at all other visits. If the subject is entering the extension study, a urine 
pregnancy test will be performed at SFU.
The Screening Visit serum pregnancy testing results must be negative and received and reviewed 
prior to randomization. A negative urine pregnancy test result should be obtained immediately 
prior to each administration of study drug and at all subsequent post-dosing visits. Pregnancy 
tests should be administered to all female subjects of childbearing potential, regardless of their 
use of birth control.
12.6.3
Vital signs
Vital signs will be collected at every visit and will include systolic and diastolic BP, pulse rate, 
and body temperature (oral or otic). Subjects should be sitting for 5 minutes before and during 
vital signs assessments. 
Vital signs are to be measured prior to blood sampling, and prior to dosing, where applicable. 
12.6.4
12-lead electrocardiograms
Standard 12-lead ECG will be recorded after 10 minutes of rest in the supine or semirecumbent 
position. The following ECG variables will be recorded: heart rate, PR interval, QRS duration, 
QT interval, Fridericia’s  QTc interval (QTcF), and the Investigator’s interpretation of the ECG
profile. 
12.6.5
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 visits specified in 
Table 5‒1. Findings considered clinically significant changes since the physical examination at 
the Screening Visit will be recorded as AEs.


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12.6.6
Height and body weight
Height will be measured at Screening only.
Body weight will be measured at the visits specified in Table 5‒1.
12.6.7
Assessment of suicidal ideation and behavior
Suicidal ideation and behavior will be assessed by trained study personnel using the C-SSRS.  
This scale will be used to assess suicidal ideation and behavior that may occur during the study. 
The visits at which the C-SSRS assessments will be performed are specified in the schedule of 
study assessments (Table 5‒1). 
The C-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 
C-SSRS defines 5 subtypes of suicidal ideation and behavior in addition to self-injurious 
behavior with no suicidal intent. The C-SSRS takes approximately 3 to 10 minutes to complete.
Refer to Section 6.3 for C-SSRS-related withdrawal criteria.
12.7
Other study measurements
12.7.1
Demographic information
Demographic information will be collected in all subjects and include age, gender, race and 
ethnicity. Information on demographics will be collected according to local rules and regulations. 
Demographic information will be recorded in the eCRF.
12.7.2
Medical History
A complete medical history will be collected as part of the Screening assessment and include all 
clinically relevant past or coexisting medical conditions and surgeries. Findings will be recorded 
in the eCRF. 
12.7.3
Psoriasis History
A detailed history of each subject’s psoriasis history will be collected and include the date of 
onset and past treatments for psoriasis. 
12.7.4
Data Monitoring Committee
The DMC membership includes experienced clinicians and a statistician, all of whom have 
expertise in clinical studies. 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 PS0016. 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 (CV) Adjudication Committee will also periodically review the safety data 
from this study. Details will be described in a separate charter document.


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13
STUDY MANAGEMENT AND ADMINISTRATION 
13.1
Adherence to protocol
The Investigator should not deviate from the protocol. However, the Investigator should take any 
measure necessary in deviation from or not defined by the protocol in order to protect clinical 
study subjects from any immediate hazard to their health and safety. In this case, this action 
should be taken immediately, without prior notification of the regulatory authority, IRB/IEC, or 
Sponsor.
After implementation of such measure, the Investigator must notify the CPM of the Sponsor
within 24 hours and follow any local regulatory requirements.
13.2
Monitoring
The CRO will monitor the study using their own monitoring Standard Operating Procedures
(SOPs), in line with ICH GCP guidelines and applicable regulatory requirements, and to ensure 
that study initiation, conduct, and closure are adequate.
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 CRFs 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.
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 quality of life questionnaires, for example. Source documents should be kept in a
secure, limited access area.
Sponsor or designee will review to ensure that computerized source documents produced by the 
site are compliant with 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 


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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 PASI records, must be saved and stored as instructed by the 
Sponsor or designee. 
13.2.2
Source data verification
Source data verification ensures accuracy and credibility of the data obtained. During monitoring 
visits, reported data are reviewed with regard to being accurate, complete, and verifiable from 
source documents (eg, subject files, recordings from automated instruments, tracings [ECG], 
x-ray films, laboratory notes). All data reported on the eCRF should be supported by source 
documents, unless otherwise specified in Section 13.2.1.
13.3
Data handling
13.3.1
Case Report Form completion
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.
Serious adverse event reporting will be done using the SAE Form (see Section 12.2.2) while also 
entering the event in the appropriate eCRF section. The safety database and the clinical database 
will be reconciled during the study and discrepancies will be corrected as needed.
The Investigator should maintain a list of personnel authorized to enter data into the eCRF. 
Access to the EDC will be given after training has been received. A training certificate will be 
provided and filed.
Detailed instructions on the use of the EDC will be provided in the eCRF Completion 
Guidelines.
Corrections made after the Investigator’s review and approval (by means of a 
password/electronic signature) will be re-approved by the Investigator. Any change or correction 
to the eCRF after saving must be accompanied by a reason for the change.
13.3.2
Database entry and reconciliation
Case Report Forms/external electronic data will be entered/loaded into a validated electronic 
database using a clinical data management system (CDMS). Computerized data cleaning checks 
will be used in addition to manual review to check for discrepancies and to ensure consistency of 
the data. This study is performed using 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 Screening and Enrollment log/Subject Identification Code list
The subject’s screening and enrollment will be recorded in the Subject Screening and Enrollment 
Log.
The Investigator will keep a Subject Identification Code list. This list remains with the 
Investigator and is used for unambiguous identification of each subject.


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The subject’s consent and enrollment in the study must be recorded in the subject’s medical 
record. These data should identify the study and document the dates of the subject’s 
participation.
13.4
Termination of the study
UCB reserves the right to temporarily suspend or prematurely discontinue this study either at a 
single site, multiple sites, or at all sites at any time for reasons including, but not limited to, 
safety or ethical issues, inaccurate or incomplete data recording, noncompliance, or 
unsatisfactory enrollment with respect to quality or quantity.
If the study is prematurely terminated or suspended, UCB (or its representative) will inform the 
Investigators/institutions and the regulatory authority(ies) of the termination or suspension and 
the reason(s) for the termination or suspension, in accordance with applicable regulatory 
requirement(s). The IRB/IEC should also be informed and provided with reason(s) for the 
termination or suspension by the Sponsor or by the Investigator/institution, as specified by the 
applicable regulatory requirement(s). In addition, arrangements will be made for the return of all 
unused IMP and other material in accordance with UCB procedures for the study.
13.5
Archiving and data retention
The Investigator will maintain adequate records for the study, including eCRFs, medical records, 
laboratory results, Informed Consent documents, drug dispensing and disposition records, safety 
reports, information regarding participants who discontinued, and other pertinent data.
All essential documents are to be retained by the Investigator until at least 2 years after the last 
approval of a marketing application in an ICH region and until there are no pending or 
contemplated marketing applications in an ICH region, or at least 2 years have elapsed since the 
formal discontinuation of clinical development of the IMP. These documents should be retained 
for a longer period, however, if required by the applicable regulatory requirement(s) or by an 
agreement with UCB (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).


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13.7
Good Clinical Practice
Noncompliance with the protocol, ICH-GCP, or local regulatory requirements by the 
Investigator, institution, institution staff, or designees of the Sponsor will lead to prompt action 
by UCB to secure compliance. Continued noncompliance may result in the termination of the 
site’s involvement in the study.
14
STATISTICS
A description of statistical methods 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.
The Randomized Set (RS) will consist of all randomized subjects. 
The Safety Set (SS) will consist of all subjects who received at least 1 dose of the study 
medication.
The Full Analysis Set (FAS) will consist of all randomized subjects who received at least 1 dose 
of the study medication and have a valid measurement of the primary efficacy variable 
post-Baseline.
The Per-Protocol Set (PPS) will consist of all randomized subjects who receive at least 1 dose of 
the study medication and have a valid measurement of the primary efficacy variable 
post-Baseline without important protocol deviations affecting the measurement.
The Pharmacokinetics Per-Protocol Set (PK-PPS) will consist of all randomized subjects who 
received at least 1 dose of the study medication and provided at least 1 quantifiable plasma 
concentration post-dose. 
The Pharmacodynamics Per-Protocol Set (PD-PPS) will consist of all randomized subjects who 
received at least 1 dose of the study medication and provided at least 1 PD measurement post-
dose without important protocol deviations affecting the measurement.
14.2
General statistical considerations
Summary statistics will consist of frequency tables for categorical variables. For continuous 
variables, summary statistics will consist of the number of available observations, arithmetic 
mean, standard deviation, median, minimum, and maximum unless stated otherwise.
All statistical tests will be performed based on a 2-sided significance level of 5% unless stated 
otherwise.
14.3
Planned efficacy analyses
14.3.1
Analysis of the primary efficacy variable
The primary efficacy variable will be analyzed for all subjects in the FAS.
The absolute and percentage (%) change from baseline in PASI will be listed and summarized by 
treatment group at each post-Baseline assessment. 


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Spaghetti plots of change from Baseline in PASI will be plotted for each subject over time by 
treatment group.
The analysis of the primary efficacy variable may be repeated on the PPS (if appropriate). 
14.3.2
Other efficacy analyses
14.3.2.1
Analysis of the secondary efficacy variables
The secondary efficacy variables will be analyzed for all subjects in the FAS.
Subjects who achieve a PASI25, PASI50, PASI75, PASI90, and PASI100 response will be 
summarized and plotted by treatment group for each visit.
The 95% CIs for the PASI25/50/75/90/100 response rates will be included in the summaries and 
plots.
The IGA will be summarized using a frequency table by treatment group for each visit.
14.3.2.2
Analysis of the other efficacy variables
All other efficacy variables will be analyzed for all subjects in the FAS.
All categorical variables will be summarized using frequency tables by treatment group for each 
visit.
All continuous variables will be summarized using descriptive statistics by treatment group for 
each visit.
The change in IGA category from Baseline will be presented in shift tables at Week 8, Week 16,
and Week 28.  
14.3.2.3
PKPD analysis
A pooled PKPD analysis will be performed by combining data from this study and PS0010. The 
methodology for the PKPD analysis will be described in the data analysis plan (DAP). The 
results of the analysis will be reported in a PKPD report and added as an appendix to the CSR.
14.3.3
Planned safety and other analyses
14.3.3.1
Safety analyses
All 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 adverse events (TEAEs) will be summarized descriptively by 
treatment group, primary system organ class, high level term, and preferred term. Additional 
tables will summarize TEAEs by intensity and relationship to study drug, TEAEs leading to 
withdrawal from the study, treatment-emergent SAEs, and deaths.
Treatment-emergent adverse events will be defined as events that have a start date on or 
following the first administration of study treatment up until the final administration of study 
treatment +140 days (covering the 20-week SFU Period). To allow for a fair comparison across 
all subjects, exposure at risk for defining treatment-emergence during the 28-week treatment 
period will be cut off at the Week 16 Visit (for subjects who complete through the Week 16 
Visit) or at 20 weeks (140 days) after the last administration of study treatment (for subjects who 
discontinue prior to the Week 16 Visit).


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Laboratory values, urinary values, ECGs, vital signs, and extent of exposure will be presented 
descriptively by treatment group.
14.4
Handling of protocol deviations
Important protocol deviations are deviations from the protocol which potentially could have a 
meaningful impact on study conduct, or on the primary efficacy, key safety, or PK/PD outcomes 
for an individual subject. The criteria for identifying important protocol deviations will be 
defined within the appropriate protocol-specific document. Important protocol deviations will be 
reviewed as part of the ongoing data cleaning process and all important deviations will be 
identified and documented prior to unblinding to confirm exclusion from analysis sets.
14.5
Handling of dropouts or missing data
For the primary efficacy analysis, missing data will be imputed using NRI. That is, subjects with 
missing data at Week 28 or who discontinue study treatment prior to Week 28 will be counted as 
non-responders for the analysis. Imputations (such as LOCF) will be considered for missing 
PASI scores for summary statistics and changes from baseline. More details will be included in 
the SAP.  Sensitivity analyses may be performed and will be detailed in the SAP.
14.6
Planned interim analysis and data monitoring
No formal interim analysis will be performed; however, regular data cuts will be performed, and 
data may be evaluated. Data will also be made available, as requested, to the DMC overseeing 
the study.
14.7
Determination of sample size
No formal statistical sample size estimation has been performed due to the exploratory nature of 
this study. This clinical study is not powered for any conclusive statistical analysis of PK, safety 
or immunological variables. The sample size has been determined based on the number of 
subjects required in the current study to provide reliable PKPD model parameter estimates when 
the data was combined with PS0010. Reliable estimates of PKPD parameters are defined as 
number of subjects required to achieve a relative standard error of ≤30% for fixed effects 
parameters and ≤50% for all random effects parameters. 
In order to determine the sample size required for the PKPD model, MCMC simulations were 
performed. Five hundred trials were simulated with the proposed design, and including 
240 subjects from PS0010. The simulated data was re-estimated using the same model. The 
simulations re-estimations indicated that reliable estimates will be possible with a total N=45 
(30 subjects in Treatment arm A vs. 15 subjects in Treatment arm B).
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 


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designee). Each subject will have the opportunity to discuss the study and its alternatives with 
the Investigator.
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
Institutional Review Boards and Independent Ethics 
Committees
The study will be conducted under the auspices of an IRB/IEC, as defined in local regulations, 
ICH-GCP, and in accordance with the ethical principles that have their origin in the Declaration 
of Helsinki.
The Investigator/UCB will ensure that an appropriately constituted IRB/IEC that complies with 
the requirements of the current ICH-GCP version or applicable country-specific regulations will 
be responsible for the initial and continuing review and approval of the clinical study. Prior to 
initiation of the study, the Investigator/UCB will forward copies of the protocol, Informed 
Consent Form, IB, Investigator’s curriculum vitae (if applicable), advertisement (if applicable), 
and all other subject-related documents to be used for the study to the IRB/IEC for its review and 
approval.
Before initiating a study, the Investigator will have written and dated full approval from the 
responsible IRB/IEC for the protocol.
The Investigator will also promptly report to the IRB/IEC all changes in the study, all 
unanticipated problems involving risks to human subjects or others, and any protocol deviations, 
to eliminate immediate hazards to subjects.


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The Investigator will not make any changes in the study or study conduct without IRB/IEC 
approval, except where necessary to eliminate apparent immediate hazards to the subjects. For 
minor changes to a previously approved protocol during the period covered by the original 
approval, it may be possible for the Investigator to obtain an expedited review by the IRB/IEC as 
allowed.
As part of the IRB/IEC requirements for continuing review of approved studies, the Investigator
will be responsible for submitting periodic progress reports to the IRB/IEC (based on IRB/IEC 
requirements), at intervals appropriate to the degree of subject risk involved, but no less than 
once per year. The Investigator should provide a final report to the IRB/IEC following study 
completion.
UCB (or its representative) will communicate safety information to the appropriate regulatory 
authorities and all active Investigators in accordance with applicable regulatory requirements. 
The appropriate IRB/IEC will also be informed by the Investigator or the Sponsor, as specified 
by the applicable regulatory requirements in each concerned country. Where applicable, 
Investigators are to provide the Sponsor (or its representative) with evidence of such IRB/IEC 
notification.
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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Christophers E, Barker JN, Griffiths CE, Daudén E, Milligan G, Molta C, et al. The risk of 
psoriatic arthritis remains constant following initial diagnosis of psoriasis among patients seen in 
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Dauden E, Griffiths CE, Ortonne JP, Kragballe K, Molta CT, Robertson D, et al. Improvements 
in patient-reported outcomes in moderate-to-severe psoriasis patients receiving continuous or 
paused etanercept treatment over 54 weeks: the CRYSTEL study. J Eur Acad Dermatol 
Venereol. 2009;23(12):1374-82.
Dowlatshahi EA, Wakkee M, Arends LR, Nijsten T. The prevalence and odds of depressive 
symptoms and clinical depression in psoriasis patients: a systematic review and meta-analysis. 
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Feldman SR. A quantitative definition of severe psoriasis for use in clinical trials. J Dermatolog 
Treat. 2004;15(1):27-9.
Food and Drug Administration. Guidance for Industry. Drug-induced liver injury: premarketing 
clinical evaluation. US Dept of Health and Human Services, Center for Drug Evaluation and 
Research, Center for Biologics Evaluation and Research, 07/2009.
Gelfand JM, Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB. Risk of myocardial 
infarction in patients with psoriasis. JAMA. 2006;296:1735-41. 
Gisondi P, Tessari G, Conti A, Piaserico S, Schianchi S, Peserico A, et al. Prevalence of 
metabolic syndrome in patients with psoriasis: a hospital-based case-control study. Br J 
Dermatol. 2007;157:68-73.
Gottlieb AB. Psoriasis: Emerging therapeutic strategies. Nat Rev Drug Discov. 2005;4:19-34.
Icen M, Crowson CS, McEvoy MT, Dann FJ, Gabriel SE, Maradit Kremers H. Trends in 
incidence of adult-onset psoriasis over three decades: a population-based study. J Am Acad 
Dermatol. 2009;60:394-401.
Krueger G, Ellis CN. Psoriasis–recent advances in understanding its pathogenesis and treatment. 
J Am Acad Dermatol. 2005;53(1 Suppl 1):S94-100.
Krueger G, Koo J, Lebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on 
quality of Life. Results of a 1998 National Psoriasis Foundation patient-membership survey. 
Arch Dermatol. 2001;137:280-4. 
Kurd SK, Smith N, VanVoorhees A, Troxel AB, Badmaev V, Seykora JT, et al. Oral curcumin 
in the treatment of moderate to severe psoriasis vulgaris: a prospective clinical trial. J Am Acad 
Dermatol. 2008;58:625-31.
Kurd SK, Gelfand JM. The prevalence of previously diagnosed and undiagnosed psoriasis in US 
adults: results from NHANES 2003-2004. J Am Acad Dermatol. 2009;60:218-24.


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Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K, et al. Secukinumab in 
plaque psoriasis – results of two phase 3 trials. N Engl J Medicine. 2014;24:326-38.
Langley RG, Feldman SR, Han C, Schenkel B, Szapary P, Hsu MC, et al. Ustekinumab 
significantly improves symptoms of anxiety, depression, and skin-related quality of life in 
patients with moderate-to-severe psoriasis: Results from a randomized, doubleblind, 
placebo-controlled phase III trial. J Am Acad Dermatol. 2010;63(3):457-65.
Langley RG, Krueger GG, Griffiths CEM. Psoriasis: epidemiology, clinical features, and quality 
of life. Ann Rheum Dis. 2005;64(Suppl II):ii18–ii23.
Mallinckrodt CH, Lin Q, Lipkovich I, Molenberghs G. A structured approach to choosing 
estimands and estimators in longitudinal clinical trials. Pharm Stat. 2012;11:456-61.
Mantel N, Haenszel W. Statistical aspects of the Analysis of Data From Retrospective Studies of 
Disease. J Nat Cancer Inst. 1959;22:719-48.
Maruish, M. E. (Ed.). User’s manual for the SF-36v2 Health Survey (3rd ed.). Lincoln, RI: 
QualityMetric Incorporated. 2011.
Mukhtar R, Choi J, Koo JY. Quality of life issues in psoriasis. Dermatol Clin. 2004;22:389-95. 
Mundt JC, Greist JH, Gelenberg AJ, Katzelnick DJ, Jefferson JW, Modell JG. Feasibility and 
Validation of a Computer-Automated Columbia-Suicide severity Rating Scale Using Interactive 
Voice Response Technology. J Psychiatr Res. 2010;44(16):1224-8.
Nam JM. A simple approximation for calculating sample sizes for detecting linear trend in 
proportions. Biometrics. 1987;43(3):701-5.
Ortonne JP. Redefining clinical response in psoriasis: targeting the pathological basis of disease. 
J Drugs Dermatol. 2004;3:13-20.
Parisi R, Symmons DP, Griffiths CE, Ashcroft DM, Identification and Management of Psoriasis 
and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: A 
systematic review of incidence and prevalence. J Invest Dermatol. 2013;133:377–385.
Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, et al. The 
Columbia-Suicide Severity Rating Scale: Initial Validity and Internal Consistency Findings From 
Three Multisite Studies With Adolescents and Adults. Am J Psychiatry. 2011;168(12):1266-77.
Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United 
States. J Am Acad Dermatol. 2014;70:512-6. 
Raychaudhuri SP, Gross J. A comparative study of pediatric onset psoriasis with adult onset 
psoriasis. Pediatric Dermatology. 2000; 17(3):174–178.
Snaith RP, Zigmond AS. The hospital anxiety and depression scale, with the irritability-
depression-anxiety scale and the Leeds situational anxiety scale manual. 1994.
Yeung H, Takeshita J, Mehta NN, Kimmel SE, Ogdie A, Margolis DJ, et al. Psoriasis severity 
and the prevalence of major medical comorbidity: a population-based study. JAMA Dermatol. 
2013;149:1173-9.


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18
APPENDICES
18.1
Protocol Amendment 1
Rationale for the amendment
The purpose of this amendment is the following:

To revise the references to an “open-label extension study.” Because of changes to the study 
design, the extension study is no longer planned to be an “open-label” study 

Clarify that subjects who have not achieved a PASI25 response prior to Week 20 will not be 
eligible to enter the extension study

Clarify that subjects eligible for the extension study must have the assessments for SFU 
conducted prior to entering the extension study

Clarify that Week 20 is the earliest a subject can enter the extension study. 

Extend the timing of the SFU Visit to 20 weeks after the last dose of study medication

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

Removed the blood sample for anti-bimekizumab antibodies at Baseline

Clarify that the paper, not the electronic, version of the C-SSRS will be used

Clarify that a urine pregnancy test will be performed at SFU for those subjects entering the 
extension study

Clarify that lesional and nonlesional biopsies to be obtained at Baseline and Week 8, and 
lesional biopsies only at Week 16 and Week 28

Clarify the exclusion criterion regarding laboratory values

Added FSH test for postmenopausal females who have been postmenopausal for ≥1 year and 
last menstrual cycle occurred <2 years ago

Clarify that subjects with any pustular PSO (ie, localized or generalized) are ineligible for 
study participation and that development of any form of pustular PSO (ie, localized or 
generalized) during the study will result in withdrawal from the study

Clarify that subjects with a diagnosis of Crohn’s disease or ulcerative colitis are allowed as 
long as they have no active symptomatic disease at Screening or Baseline

Clarify the HADS thresholds for study eligibility in the Exclusion Criteria and for 
withdrawal of a subject in the Withdrawal Criteria

Provide more detail in the Withdrawal Criterion regarding subjects that develop illnesses that 
would interfere with study participation

Provide more detail in the Withdrawal Criteria regarding the withdrawal of subjects due to 
adverse events and clinical laboratory values

Clarify the exclusion criterion prior to Baseline for etanercept


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
Clarify the adverse events for special monitoring

Provide additional detail and a reference for recording the severity of AEs

Remove the requirement to test for alcohol in the PDILI urine toxicology screen

Clarify the assessment of ECGs

Added a DMC

Clarify and correct text regarding the analyses sets, analyses of safety, and handling of 
dropouts and missing data
Modifications and changes
Global changes
The following changes were made throughout the protocol:

Section 2 Introduction was revised with updated information.

The timing of the Safety Follow-Up Visit was changed from 17 weeks after the last dose of 
study medication to 20 weeks after the last dose of study medication, ie, from Week 33 to 
Week 36.

The maximum study duration was changed from 37 weeks to 40 weeks.

The List of Abbreviations was revised.

The term “photochemotherapy” was changed to “chemophototherapy” throughout for 
consistency.

The references to an “open-label extension study” were changed to “extension study.”

The eC-SSRS was changed to the C-SSRS.

Minor editorial revisions were made.
Specific changes
Change #1
Section 1 Summary
Approximately 90 subjects will be screened in order to have 45 subjects randomized in the study. 
There will be approximately 30 subjects in treatment arm A and 15 subjects in treatment arm B, 
respectively. For each subject, the study will last a maximum of 37 weeks and will consist of 
3 periods, a Screening Period (up to 4 weeks), a Treatment Period (28 weeks), and a Safety 
Follow-Up (SFU) Period (17 weeks after the last dose of study medication). After the 28-week 
Treatment Period, eligible subjects will be allowed to enroll in an open-label extension study. 
Has been changed to
Approximately 90 subjects will be screened in order to have 45 subjects randomized in the study. 
There will be approximately 30 subjects in treatment arm A and 15 subjects in treatment arm B, 


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respectively. For each subject, the study will last a maximum of 3740 weeks and will consist of 
3 periods, a Screening Period (up to 4 weeks), a Treatment Period (28 weeks), and a Safety 
Follow-Up (SFU) Period (2017 weeks after the last dose of study medication). Between 
Week 20 and the end ofAfter the 28-week Treatment Period, eligible subjects will be allowed 
to enroll in an open-label extension study. 
Change #2
Section 1 Summary
Study medication will be administered in the clinic at Baseline, Week 4, and Week 16. 
Additional nondosing study visits will occur at Week 2, Week 8, Week 12, Week 20, Week 24, 
and Week 28. At Week 16 through Week 28, subjects who relapse, defined as within 25% of 
their Baseline PASI value, will undergo the study assessments for that visit (ie, Week 16, 
Week 20, Week 24, or Week 28) before receiving their first open-label dose of bimekizumab at 
Week 20, Week 24, or Week 28. All subjects not enrolling in the open-label extension study will 
continue in PS0016 until the SFU Visit at Week 33. Subjects who are PASI25 responders will 
continue in the study until Week 33 and will then have the option to enter the open-label 
extension study.
Subjects who are PASI25 responders will continue in the study until Week 33 and will then have 
the option to enter the open-label extension study.
Subjects withdrawing early from the study will undergo the Early Withdrawal Visit assessments 
and will enter the SFU Period. Subjects who withdraw early from study treatment will be asked 
to return for study assessments 28 weeks after the first dose (ie, the Week 28 Visit) and for the 
SFU Visit.
Has been changed to
Study medication will be administered in the clinic at Baseline, Week 4, and Week 16. 
Additional nondosing study visits will occur at Week 2, Week 8, Week 12, Week 20, Week 24, 
and Week 28. FromAt Week 2016 through Week 28, subjects who were previously PASI25 
responders but subsequently relapse, (defined as returning to less than PASI25 response
25% of their Baseline PASI value,) will undergo the study assessments for that visit (ie, Week 
16, Week 20, Week 24, or Week 28) before receiving their first open-label dose of study 
treatment in the extension studybimekizumab at Week 20, Week 24, or Week 28. Subjects 
eligible for the extension study must have the assessments for SFU conducted prior to 
entering the extension study. Subjects who have not achieved a PASI25 response at any 
visit prior to Week 20 will not be eligible to enter the extension study. All subjects not 
enrolling in the open-label extension study will continue in PS0016 until the SFU Visit at 
Week 3336. Subjects who are PASI25 responders will continue in the study until Week 33 
and will then have the option to enter the open-label extension study.
Subjects who are PASI25 responders will continue in the study until Week 33 and will then 
have the option to enter the open-label extension study.
Subjects withdrawing early from the study will undergo the Early Withdrawal Visit 
assessments and will enter the SFU Period. Subjects who withdraw early from study 


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treatment will be asked to return for study assessments 28 weeks after the first dose (ie, the 
Week 28 Visit) and for the SFU Visit.
Change #3
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, an IL-17A 
inhibitor approved for treatment of moderate to severe psoriasis; and ixekizumab, an IL-17A 
inhibitor. 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, 
an IL-17A inhibitors approved for treatment of moderate to severe psoriasis; and ixekizumab, 
an IL-17A inhibitor. 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 #4
Section 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, PA0007 in 53 subjects with 
psoriatic arthritis. A fourth study in subjects with moderate to severe rheumatoid arthritis is 
ongoing (RA0123).
Has been changed to
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 


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to severe rheumatoid arthritis and in healthy subjects, respectively. A fourth study in 
subjects with moderate to severe rheumatoid arthritis is ongoing (RA0123).
Change #5
Section 2.2.1 Clinical
A fourth study of bimekizumab is ongoing. RA0123 is a Phase 2a, double-blind, randomized, 
placebo-controlled, multiple dose study to evaluate the safety, PK, PD, 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.
Has been changed to
Two additional studies of bimekizumab are ongoing A fourth study of bimekizumab is 
ongoing. RA0123 is a Phase 2a, double-blind, randomized, placebo-controlled, multiple dose 
study to evaluate the safety, PK, PD, 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.
Change #6
Section 4.1.3 Primary immunogenicity variable
The primary immunological variable is anti-bimekizumab antibody detection prior to and 
following study treatment. 
Has been changed to
The primary immunological variable is anti-bimekizumab antibody detection prior to and
following study treatment. 
Change #7
Section 4.4 Immunological variable 
The immunological variable is anti-bimekizumab antibody detection prior to and following study
treatment. 
Has been changed to
The immunological variable is anti-bimekizumab antibody detection prior to and following 
study treatment. 


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Change #8
Section 5.1.1 Study periods
This study will include 3 periods: a Screening Period (up to 4 weeks), a Treatment Period 
(28 weeks), and a SFU Period (17 weeks after the last dose of study medication). After the 
28-week Treatment Period, eligible subjects will be allowed to enroll in an open-label extension 
study.
Has been changed to
This study will include 3 periods: a Screening Period (up to 4 weeks), a Treatment Period 
(28 weeks), and a SFU Period (2017 weeks after the last dose of study medication).
AfterBetween Week 20 and the end of the 28-week Treatment Period, eligible subjects will be 
allowed to enroll in an open-label extension study
Change #9
Section 5.1.1, Study periods
There will be approximately 30 subjects in treatment arm A and 15 subjects in treatment arm B, 
respectively, and bimekizumab will be administered in the clinic at Baseline and Week 4, and at 
Baseline, Week 4, and Week 16, respectively. Additional nondosing study visits will occur at 
Week 2, Week 8, Week 12, Week 20, Week 24, and Week 28.
At Week 16 through Week 28, subjects who are not PASI25 responders may enroll in an OLE 
study after undergoing the assessments for that visit (ie, Week 16, Week 20, Week 24, or 
Week 28) before receiving their first open-label dose of bimekizumab at Week 20, Week 24, or 
Week 28. Subjects not electing to enroll in the OLE will continue in the study through Week 33. 
Subjects who are PASI25 responders will continue in the study until Week 33 and will then have 
the option to enter the open-label extension study.
Has been changed to
There will be approximately 30 subjects in treatment arm A and 15 subjects in treatment arm B., 
respectively, and. bBimekizumab will be administered in the clinic at Baseline and Week 4, and 
at Baseline, Week 4, and Week 16 for those in treatment arm A and treatment arm B,  
respectively. Additional nondosing study visits will occur at Week 2, Week 8, Week 12, 
Week 20, Week 24, and Week 28.
FromAt Week 2016 through Week 28, subjects who were previouslyare not PASI25 
responders but subsequently relapse, (defined as returning to a less than PASI25 response)
willmay enroll in an OLE extension study after undergoing the study assessments for that 
visit (ie, Week 16, Week 20, Week 24, or Week 28) before receiving their first open-label
dose of study treatmentbimekizumab in the extension study at Week 20, Week 24, or Week 
28. Subjects eligible for the extension study must have the assessments for SFU conducted 
prior to entering the extension study. Subjects who have not achieved a PASI25 response at 
any visit prior to Week 20 will not be eligible to enter the extension study. All subjects not
electing to enrolling in the extension studyOLE will continue in the study PS0016 until the 


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SFU Visit the study through at Week 3633. Subjects who are PASI25 responders will 
continue in the study until Week 33 and will then have the option to enter the open-label 
extension study.


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Change #10
Table 5-1:
Schedule of assessments
                                                
Visita/ Week
Protocol activity
Screeningb
Baseline 
Treatment Period
(Time after the first dose)
Wk 36 
EWD/
SFUc
Wk 2
Wk 4
Wk 8
Wk 12
Wk 16
Wk 20
Wk 24
Wk 28
Hematology/biochemistry/ 
urinalysis
X
X
X
X
X
X
X
X
X
X
X
Blood sample for bimekizumab 
plasma concentrationsm
X
X
X
X
X
X
X
X
X
X
Blood sample for anti-
bimekizumab antibodies m
X
X
X
X
X
X
X
X
X
Blood sample for cytokines, 
complement, candidate 
biomarker analysis, and flow 
cytometry m
X
X
X
X
X
Skin biopsyn
X (2)
X (2)
X (2)
X (2)
Has been changed to
Table 5-1:
Schedule of assessments
                                                
Visita/ Week
Protocol activity
Screeningb
Baseline 
Treatment Period
(Time after the first dose)
Wk 36 
EWD/
SFUc
Wk 2
Wk 4
Wk 8
Wk 12
Wk 16
Wk 20
Wk 24
Wk 28
Hematology/biochemistry/ 
urinalysis
X
Xg
X
X
X
X
X
X
X
X
X
Blood sample for bimekizumab 
plasma concentrationsm
X
X
X
X
X
X
X
X
X
X
Blood sample for anti-
X
X
X
X
X
X
X
X
X


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Table 5-1:
Schedule of assessments
                                                
Visita/ Week
Protocol activity
Screeningb
Baseline 
Treatment Period
(Time after the first dose)
Wk 36 
EWD/
SFUc
Wk 2
Wk 4
Wk 8
Wk 12
Wk 16
Wk 20
Wk 24
Wk 28
bimekizumab antibodies m
Blood sample for cytokines, 
complement, candidate 
biomarker analysis, and flow 
cytometry m
X
X
X
X
X
Skin biopsyn
X (2)
X (2)
X (21)
X (21)


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Change #11
Table 5-1 Schedule of assessments
The following footnote was added and subsequent footnotes letters were revised
accordingly.
g
The FSH test should only be performed on postmenopausal females who have been 
postmenopausal for ≥1 year and last menstrual cycle occurred <2 years ago.
Change #12
Table 5-1 Schedule of assessments
h
Pregnancy testing will be serum testing at Screening and SFU. The pregnancy test will be 
urine at all other visits.
Has been changed to
i
Pregnancy testing will be serum testing at Screening and SFU. The pregnancy test will be 
urine at all other visits. If the subject is entering the extension study, a urine pregnancy 
test will be performed at SFU.
Change #13
Table 5-1 Schedule of assessments
n
Lesional and nonlesional biopsies to be obtained.
Has been changed to
o
Lesional and nonlesional biopsies to be obtained at Baseline and Week 8. Lesional biopsies 
to be obtained at Week 16 and Week 28.


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Change #14
Figure 5-1 Schematic diagram of PS0016
OLE=open-label extension; PASI= Psoriasis Area and Severity Index; SFU=Safety Follow-Up
Subjects who are not PASI25 responders may enroll into the OLE after their Week 16 assessments, but will not 
receive a dose in the OLE until at least Week 20. Subjects who do not enroll into the OLE will continue in PS0016 
through Week 33.
Subjects who are PASI25 responders will continue in PS0016 until Week 33 and then have the opportunity to enroll 
into the OLE.
Has been changed to
OLE=open-label extension; PASI= Psoriasis Area and Severity Index; SFU=Safety Follow-Up
Subjects who are not PASI25 responders may enroll into the OLE after their Week 16 assessments, but will 
not receive a dose in the OLE until at least Week 20. Subjects who do not enroll into the OLE will continue in 
PS0016 through Week 33.
Subjects who are PASI25 responders will continue in PS0016 until Week 33 and then have the opportunity to 
enroll into the OLE. From  Week 20 through Week 28, subjects who were previously PASI25 responders but 


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subsequently relapse (defined as returning to less than PASI25 response) will undergo the study assessments 
for that visit (ie, Week 20, Week 24, or Week 28) before receiving their first dose of study treatment in the 
extension study at Week 20, Week 24, or Week 28. Subjects eligible for the extension study must have the 
assessments for SFU conducted prior to entering the extension study. Subjects who have not achieved a 
PASI25 response at any visit prior to Week 20 will not be eligible to enter the extension study. All subjects not 
enrolling in the extension study will continue in PS0016 until the SFU Visit at Week 36.
Change #15
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 legal representative.
Has been changed to
1a. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written 
Informed Consent Form is signed and dated by the subject or legal representative.
Change #16
Section 6.1 Inclusion criteria
2. Subject/legal representative is considered reliable and capable of adhering to the protocol 
(eg, able to understand and complete diaries), visit schedule, or medication intake according 
to the judgment of the Investigator.
Has been changed to
2a. Subject/legal representative is considered reliable and capable of adhering to the protocol 
(eg, able to understand and complete diaries), visit schedule, or medication intake according 
to the judgment of the Investigator.
Change #17
Section 6.2 Exclusion criteria
5. Subjects with erythrodermic, guttate, generalized pustular form of psoriasis, or drug-induced 
psoriasis.
Has been changed to
5a. Subjects with erythrodermic, guttate, generalized pustular form of psoriasis, or drug-induced 
psoriasis.
Change #18
Section 6.2 Exclusion criteria
20. Subject has >2x upper limit of normal (ULN) of any of the following: alanine 
aminotransferase (ALT), aspartate aminotransferase (AST), *alkaline phosphatase (ALP), or 


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>ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert’s syndrome). If subject has 
elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to 
identify possible undiagnosed Gilbert’s syndrome (ie, direct bilirubin <35%).
*An isolated elevation between 2x ULN and <3x ULN of ALP is acceptable in the absence 
of an identified exclusionary medical condition.
Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated 
once for confirmation during the Screening Period. Upon retesting, subjects whose ALT, 
AST, or ALP remain above the thresholds defined above, should not be randomized. 
For randomized subjects with a baseline result >ULN for ALT, AST, ALP, or total bilirubin, 
a baseline diagnosis and/or the cause of any clinically meaningful elevation must be 
understood and recorded in the Case Report form (CRF).
If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at screening, 
repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically 
relevant increase. In case of a clinically relevant increase, inclusion of the subject must be 
discussed with the Medical Monitor.
Has been changed to
20a. Subject has >2x upper limit of normal (ULN) of any of the following: alanine 
aminotransferase (ALT), aspartate aminotransferase (AST), *alkaline phosphatase (ALP), or 
>ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert’s syndrome). If subject has 
elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to 
identify possible undiagnosed Gilbert’s syndrome (ie, direct bilirubin <35%).
*An isolated elevation between 2x ULN and <3x ULN of ALP is acceptable in the 
absence of an identified exclusionary medical condition.
Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated 
once for confirmation during the Screening Period. Upon retesting, subjects whose ALT, 
AST, or ALP remain above the thresholds defined above, should not be randomized. 
For randomized subjects with a baseline result >ULN for ALT, AST, ALP, or total bilirubin, 
a baseline diagnosis and/or the cause of any clinically meaningful elevation must be 
understood and recorded in the Case Report form (CRF).
If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at screening, 
repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically 
relevant increase. In case of a clinically relevant increase, inclusion of the subject must be 
discussed with the Medical Monitor.
Change #19
Section 6.2 Exclusion criteria
25. Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic 
arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic lupus 
erythematosus. 


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Has been changed to
25a. Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic 
arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic lupus 
erythematosus. Subjects with a diagnosis of Crohn’s disease or ulcerative colitis are 
allowed as long as they have no active symptomatic disease at Screening or Baseline.
Change #20
Section 6.2 Exclusion criteria
29. Presence of significant uncontrolled neuropsychiatric disorder, active suicidal ideation, or 
positive suicide behavior using the “Baseline” version of the eC-SSRS and the HADS with 
either of the following criteria:

Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted 
attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by 
a positive response (“Yes”) to either question 4 or question 5 of the “Screening/Baseline” 
version of the eC-SSRS at Screening. 

HADS Depression score ≥10 and Anxiety score ≥15
Has been changed to
29a.Presence of significant uncontrolled neuropsychiatric disorder, active suicidal ideation, or 
positive suicide behavior using the “Baseline” version of the eC-SSRS and the HADS with 
either of the following criteria:

Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted 
attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by 
a positive response (“Yes”) to either Qquestion 4 or Qquestion 5 of the 
“Screening/Baseline” version of the eC-SSRS at Screening. 

HADS Depression score >10 orand Anxiety score ≥15
Change #21
Section 6.3 Withdrawal criteria
2. Subject develops an illness that would interfere with his/her continued participation.
Has been changed to
2a. 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 #22
Section 6.3 Withdrawal criteria
3. Subject develops erythrodermic, guttate, or generalized pustular form of psoriasis.
Has been changed to
3a. Subject develops erythrodermic, guttate, or generalized pustular form of psoriasis.
Change #23
Section 6.3 Withdrawal criteria
The following withdrawal criterion has been deleted
7. Subject develops total bilirubin >2xULN (except Gilbert’s); neutropenia <1.0x109/L; 
lymphopenia <0.5x109/L or other laboratory abnormalities consistent with rheumatology 
Common Terminology Criteria (CTC) Grade 3 or higher if clinically relevant.
Change #24
Section 6.3 Withdrawal criteria
8. 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.
9. 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
8a. Subject has active suicidal ideation as indicated by a positive response (“Yes”) to Qquestions 
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.
9a. Subjects with a HADS-D score ≥15 must be withdrawn. Any subject who hasdevelops 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.
Change #25
Section 6.3 Withdrawal criteria
The following withdrawal criteria have been added


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10. 
Subject experiences an AE as described below: 

Any Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 and above 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.
11. 
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 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 #26
Section 7.2 Treatments to be administered
In treatment arm A, bimekizumab will be administered at Baseline and Week 4, and placebo 
administered at Week 16. For treatment arm B, bimekizumab medication will be administered at 
Baseline, Week 4, and Week 16. The minimum of time between doses should be no less than 
24 days.
Has been changed to
In treatment arm A, bimekizumab will be administered at Baseline and Week 4, and placebo 
administered at Week 16. For treatment arm B, bimekizumab medication will be administered at 
Baseline, Week 4, and Week 16. The first dose of study treatment in the extension study will 
be at Week 20, Week 24, or Week 28. The minimum of time between doses should be no less 
than 24 days.


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Change #27
Section 7.8.2 Prohibited concomitant treatments (medications and therapies)
The following paragraph was removed
Subjects who use prohibited medications, with the exception of topicals, will be withdrawn 
from study treatment but followed until the SFU. 
Change #28
Table 7-1:Prohibited psoriasis medications
Drug
Exclusion criteria prior to 
Baseline Visit
Systemic retinoids
12 weeks 
Systemic treatment (non-biological):
systemic immunosuppressant agents (eg, methotrexate, 
cyclosporine, azathioprine, thioguanine)
systemic fumarate
systemic corticosteroids
phototherapy or photochemotherapy
8 weeks for methotrexate, 
azathioprine, and cyclosporine
4 weeks for everything other than 
methotrexate, azathioprine, and 
cyclosporine
Anti-TNFs:
infliximab (including biosimilar), golimumab
etanercept (including biosimilar)
certolizumab pegol
adalimumab (including biosimilar)
12 weeks for everything


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Has been changed to
Drug
Exclusion criteria prior to 
Baseline Visit
Systemic retinoids
12 weeks 
Systemic treatment (non-biological):
systemic immunosuppressant agents (eg, methotrexate, 
cyclosporine, azathioprine, thioguanine)
systemic fumarate
systemic corticosteroids
phototherapy or photochemophototherapy
8 weeks for methotrexate, 
azathioprine, and cyclosporine
4 weeks for everything other than 
methotrexate, azathioprine, and 
cyclosporine
Anti-TNFs:
infliximab (including biosimilar), golimumab
etanercept (including biosimilar)
certolizumab pegol
adalimumab (including biosimilar)
4 weeks for etanercept
12 weeks for everything other 
than etanercept
Change #29
Section 7.9 Blinding
Bimekizumab and placebo injections will be prepared and administered at the investigational 
sites by unblinded, dedicated study personnel. The unblinded personnel will not be involved in 
the study in any way other than assuring the medication is taken from the correct kit and 
administering the drug to the subjects.
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 blinded 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
Has been changed to
Bimekizumab and placebo injections will be prepared and administered at the investigational 
sites by unblinded, dedicated study personnel. The unblinded personnel will not be involved in 
the study in any way other than assuring the medication is taken from the correct kit and 
administering the drug to the subjects.
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 blinded nature of the 
study is maintained. 


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During the study, the Sponsor will provide blinded and unblinded site monitors for the purposes 
of verifying safety, efficacy, and study drug administration and documentation records. Blinded 
study monitors and study site personnel, blinded to treatment assignment, will not discuss or 
have access to any study drug-related information.
Change #30
Section 8.2 Baseline Visit

Obtain blood sample(s) for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

Cytokines, complement, candidate biomarker analysis, and flow cytometry 

RNA, proteins, and metabolites biomarkers
Has been changed to

Obtain blood sample(s) for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

Cytokines, complement, candidate biomarker analysis, and flow cytometry 

RNA, proteins, and metabolites biomarkers
Change #31
Section 8.6 Week 12 (+/-3 days)
The following procedures or assessments will be performed/recorded prior to administration of 
study drug:
Has been changed to
The following procedures or assessments will be performed/recorded prior to administration of 
study drug:
Change #32
Section 8.7 Week 16 (+/-3 days)
The following procedures or assessments will be performed/recorded:

Obtain skin biopsy (lesional and nonlesional)


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Has been changed to
The following procedures or assessments will be performed/recorded prior to administration of 
study drug:

Obtain skin biopsy (lesional and nonlesional)
Change #33
Section 8.10 Week 28 (+/-3 days)

Obtain skin biopsy (lesional and nonlesional)
Has been changed to

Obtain skin biopsy (lesional and nonlesional)
Change #34
Section 8.11 Week 33/Safety Follow-Up Visit (17 weeks after last dose)

Obtain blood sample(s) for:

TB test (interferon gamma release assay; IGRA; it is recommended that the 
QuantiFERON TB GOLD test be performed)

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

Cytokines, complement, candidate biomarker analysis, and flow cytometry 

RNA, proteins, and metabolites biomarkers

Serum pregnancy test for women of childbearing potential
Has been changed to
Section 8.11 Week 3336/Safety Follow-Up Visit (1720 weeks after last dose)

Obtain blood sample(s) for:

TB test (interferon gamma release assay; IGRA; it is recommended that the 
QuantiFERON TB GOLD test be performed)

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

Cytokines, complement, candidate biomarker analysis, and flow cytometry 

RNA, proteins, and metabolites biomarkers


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
Serum pregnancy test for women of childbearing potential. If the subject is entering the 
extension study, a urine pregnancy test will be performed. 
Change #35
Section 12.1.3 Adverse events for special monitoring
Adverse events for special monitoring for this study include: serious infections (including 
opportunistic infections and TB, see Section 12.6.1), cytopenias, hypersensitivities, suicide 
ideation or behavior (assessed using the eC-SSRS), depression-and anxiety (assessed using the 
HADS, see Section 9.4), major cardiac events and liver function test changes/enzyme elevations 
(ALT, AST, and bilirubin; see Section 12.5.1), 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 12.6.1), cytopenias, hypersensitivities, suicide 
ideation or behavior (assessed using the eC-SSRS), depression-and anxiety (assessed using the 
HADS, see Section 9.4), major cardiac cardiovascular events and liver function test 
changes/enzyme elevations (ALT, AST, and bilirubin; see Section 12.5.1), malignancies, and 
inflammatory bowel diseases.
Change #36
Section 12.1.5 Description of adverse events
Details for completion of the Adverse Event CRF (including judgment of relationship to IMP) 
are described in the CRF 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 Adverse Event CRF (including judgment of severity and relationship to IMP) 
are described in the CRF Completion Guidelines.
Change #37
Section 12.1.11 Safety signal detection
Selected data from this study will be reviewed periodically to detect as early as possible any 
safety concern(s) related to the IMP so that Investigators, clinical study subjects, regulatory 
authorities, and IRBs/IECs will be informed appropriately and as early as possible.
The Study Physician or medically qualified designee/equivalent will conduct an ongoing review 
of SAEs and perform ongoing SAE reconciliations in collaboration with the PS representative.


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As appropriate for the stage of development and accumulated experience with the IMP, 
medically qualified personnel at UCB may identify additional safety measures (eg, AEs, vital 
signs, laboratory or ECG results) for which data will be periodically reviewed during the course 
of the study.
Has been changed to
Selected data from this study will be reviewed periodically to detect as early as possible any 
safety concern(s) related to the IMP so that Investigators, clinical study subjects, regulatory 
authorities, and IRBs/IECs will be informed appropriately and as early as possible.
The Study Physician or medically qualified designee/equivalent will conduct an ongoing 
review of SAEs and perform ongoing SAE reconciliations in collaboration with the PS 
representative.
As appropriate for the stage of development and accumulated experience with the IMP, 
medically qualified personnel at UCB may identify additional safety measures (eg, AEs, 
vital signs, laboratory or ECG results) for which data will be periodically reviewed during 
the course of the study.
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 (CV) Adjudication Committee will also periodically 
review and monitor the safety data from this study and advise UCB. Details are provided in 
the CV Adjudication Committee Charter.
Change #38
Table 12-2 Laboratory measurements
Hematology
Chemistry
Urinalysis
Total cholesterol
Serum pregnancy testinga
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 consist of serum testing at the Screening and SFU Visits. The pregnancy test will be urine 
at all other visits and will be performed locally.
Has been changed to
Hematology
Chemistry
Urinalysis
Total cholesterol
Serum pregnancy testinga
Serum FSHb (Screening)
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea 
nitrogen; CRP=C-reactive protein; GGT=gamma glutamyltransferase; FSH=follicle stimulating hormone;


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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 consist of serum testing at the Screening and SFU Visits. The pregnancy test will be urine 
at all other visits and will be performed locally. If the subject is entering the extension study, a urine 
pregnancy test will be performed at SFU.
b The FSH test should only be performed on postmenopausal females who have been postmenopausal for ≥1 
year and last menstrual cycle occurred <2 years ago.
Change #39
Table 12-4 PDILI laboratory measurements
a
For detecting substances such as 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 such as 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.
Change #40
Section 12.6.1.1  Assessment and management of TB and TB risk factors
Once withdrawn from study treatment, subjects should return for the Week 12/WD 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 1236/EWD Visit, 
complete all Early Withdrawal Visit assessments, and complete a SFU Visit (1720 weeks after 
the last dose of study medication).
Change #41
Section 12.6.1.4 Tuberculosis management
The subject should be transferred to the care of his/her physician and managed according to the 
best available standard of care. Subjects identified as having converted to active TB during the 
study must be withdrawn and scheduled to return for the Week 12/WD Visit as soon as possible 
but no later than the next scheduled study visit and complete all Week 12/WD Visit assessments. 
Has been changed to
The subject should be transferred to the care of his/her physician and managed according to the 
best available standard of care. Subjects identified as having converted to active TB during the 
study must be withdrawn and scheduled to return for the Week 1236/EWD Visit as soon as 


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possible but no later than the next scheduled study visit and complete all Week 1236/EWD Visit 
assessments. 
Change #42
Section 12.6.2 Pregnancy testing
Pregnancy testing will consist of serum testing at the Screening and SFU Visits. The pregnancy 
test will be urine at all other visits.
Has been changed to
Pregnancy testing will consist of serum testing at the Screening and SFU Visits. The pregnancy 
test will be urine at all other visits. If the subject is entering the extension study, a urine 
pregnancy test will be performed at SFU.
Change #43
Section 12.6.4 12-lead electrocardiograms
Twelve-lead standard ECGs will be recorded at the visits specified in Table 5-1, and read by a 
central ECG laboratory. 
Full details of ECG recording will be provided in the ECG Manual. 
Has been changed to
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. 
Standard 12-lead ECG will be recorded after 10 minutes of rest in the supine or 
semirecumbent position. The following ECG variables will be recorded: heart rate, PR 
interval, QRS duration, QT interval, Fridericia’s  QTc interval (QTcF), and the 
Investigator’s interpretation of the ECG profile. 
Change #44
The following section was added
Section 12.7.4 Data Monitoring Committee
The DMC membership includes experienced clinicians and a statistician, all of whom have 
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 PS0010. 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.


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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 (CV) Adjudication Committee will also periodically review the safety data 
from this study. Details will be described in a separate charter document.
Change #45
Section 13.2.1 Definition of source data
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, PtGADA) will be completed by each subject 
utilizing electronic data capture.
Has been changed to
Electronic data records, such as PASIHolter monitor recordsor electroencephalogram 
records, must be saved and stored as instructed by the Sponsor or designee. 
Patient Reported Outcome (PRO) measures (eg, PtGADA) will be completed by each 
subject utilizing electronic data capture.
Change #46
Section 13.3.1 Case Report Form completion
The second paragraph was removed
This study will use an electronic device to capture patient reported outcomes (see 
Section 13.2.1).
Change #47
Section 14.1 Definition of analysis sets
The Full Analysis Set (FAS) will consist of all randomized subjects who received at least 1 dose 
of the study medication and have a valid measurement of the primary efficacy variable at 
Baseline.
The Pharmacokinetics Per-Protocol Set (PK-PPS) will consist of all randomized subjects who 
took at least 1 dose of the study medication and provided at least 1 quantifiable plasma 
concentration post-dose. 
The Pharmacodynamics Per-Protocol Set (PD-PPS) will consist of all randomized subjects who 
took at least 1 dose of the study medication and provided at least 1 PD measurement post-dose 
without important protocol deviations affecting the measurement. 
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The Full Analysis Set (FAS) will consist of all randomized subjects who received at least 1 dose 
of the study medication and have a valid measurement of the primary efficacy variable 
atpost-Baseline.
The Per-Protocol Set (PPS) will consist of all randomized subjects who receive at least 
1 dose of the study medication and have a valid measurement of the primary efficacy 
variable post-Baseline without important protocol deviations affecting the measurement.
The Pharmacokinetics Per-Protocol Set (PK-PPS) will consist of all randomized subjects who 
tookreceived at least 1 dose of the study medication and provided at least 1 quantifiable plasma 
concentration post-dose. 
The Pharmacodynamics Per-Protocol Set (PD-PPS) will consist of all randomized subjects who 
tookreceived at least 1 dose of the study medication and provided at least 1 PD measurement 
post-dose without important protocol deviations affecting the measurement. 
Change #48
Section 14.1 Definition of analysis sets
The analysis of the primary efficacy variable may be repeated on the PD-PPS (if appropriate). 
Has been changed to
The analysis of the primary efficacy variable may be repeated on the PD-PPS (if appropriate). 
Change #49
Section 14.3.3.1 Safety analyses
Treatment-emergent adverse events will be defined as events that have a start date on or 
following the first administration of study treatment through the final administration of study 
treatment +119 days (covering the 17-week SFU Period). To allow for a fair comparison across 
all subjects, exposure at risk for defining treatment-emergence during the 28-week treatment 
period will be cut off at the Week 16 Visit (for subjects who complete through the Week 16 
Visit) or at 17 weeks (119 days) after the last administration of study treatment (for subjects who 
discontinue prior to the Week 16 Visit).
Has been changed to
Treatment-emergent adverse events will be defined as events that have a start date on or 
following the first administration of study treatment up untilthrough the final administration of 
study treatment +119140 days (covering the 1720-week SFU Period). To allow for a fair 
comparison across all subjects, exposure at risk for defining treatment-emergence during the 28-
week treatment period will be cut off at the Week 16 Visit (for subjects who complete through 
the Week 16 Visit) or at 1720 weeks (119140 days) after the last administration of study 
treatment (for subjects who discontinue prior to the Week 16 Visit).


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Change #50
Section 14.5 Handling of dropouts or missing data
For the primary efficacy analysis, missing data will be imputed using NRI. That is, subjects with 
missing data at Week 28 or who discontinue study treatment prior to Week 28 will be counted as 
non-responders for the analysis. Sensitivity analyses may be performed and will be detailed in 
the SAP.
Has been changed to
For the primary efficacy analysis, missing data will be imputed using NRI. That is, subjects with 
missing data at Week 28 or who discontinue study treatment prior to Week 28 will be counted as 
non-responders for the analysis. Imputations (such as LOCF) will be considered for missing 
PASI scores for summary statistics and changes from baseline. More details will be 
included in the SAP.  Sensitivity analyses may be performed and will be detailed in the SAP.
Change #51
Section 14.6 Planned interim analysis and data monitoring
No formal interim analysis will be performed; however, regular data cuts will be performed, and 
data may be evaluated
Has been changed to
No formal interim analysis will be performed; however, regular data cuts will be performed, and 
data may be evaluated. Data will also be made available, as requested, to the DMC 
overseeing the study.
Change #52
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.
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.


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Change #53
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 #54
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 03 Mar 
2016.
18.2
Protocol Amendment 2
Rationale for the amendment
The purpose of this amendment is to revise the following: 

Serious adverse event reporting contact information included the wrong fax number for 
Canada and this was corrected

The PtGADA assessment was removed from the protocol, as this assessment is not relevant 
for the study population of patients with psoriasis

The PASI25 assessment was added to the study.


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Specific changes
Change #1 Serious adverse event reporting
Serious adverse event reporting (24h)
Fax
Europe and Rest of the World: 
USA:
or
Canada:
Email
Global:
 
Has been changed to
Serious adverse event reporting (24h)
Fax
Europe and Rest of the World: 
USA and Canada:
or
Canada:
Email
Global:
 
Change #2 List of Abbreviations
The table row with PtGADA and its definition was deleted
Change #3 Section 4.3.1 Other efficacy variables
Original text:

Absolute and % change from Baseline in PASI with time (Week 2 to Week 36)

PASI50, PASI75, PASI90, and PASI100 response at Weeks 2, 4, 8, 12, 20, 24, 28, and 36

IGA response (Clear or Almost Clear with at least 2-category improvement from Baseline) at
Weeks 2, 4, 8, 12, 20, 24, 28, and 36

Change from Baseline in IGA score 

Absolute and percent change from Baseline in the BSA affected by psoriasis 

Change from Baseline in the Patient’s Global Assessment of Disease Activity (PtGADA) for 
the arthritis visual analog scale (VAS)
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD


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
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) HADS-A and 
HADS-D scores

Percentage of subjects with scores below 8 in HADS-A and HADS-D (subjects with normal 
scores)
Has been changed to:

Absolute and % change from Baseline in PASI with time (Week 2 to Week 36)

PASI50, PASI75, PASI90, and PASI100 response at Weeks 2, 4, 8, 12, 20, 24, 28, and 36

PASI25 and PASI50 response (Week 2 to Week 36)

IGA response (Clear or Almost Clear with at least 2-category improvement from Baseline) at 
Weeks 2, 4, 8, 12, 20, 24, 28, and 36

Change from Baseline in IGA score 

Absolute and percent cChange from Baseline in the BSA affected by psoriasis 

Change from Baseline in the Patient’s Global Assessment of Disease Activity (PtGADA) for
the arthritis visual analog scale (VAS)

Change from Baseline in Hospital Anxiety and Depression Scale (HADS) HADS-A and 
HADS-D scores

Percentage of subjects with scores below 8 in HADS-A and HADS-D (subjects with normal 
scores)
Change #4 Table 5-1 Schedule of assessments
The table row for the PtGADA assessment was deleted. 
The footnote with PtGADA abbreviation definition was deleted.
Change #5 Section 7.6 Drug Accountability
Original text:
In order to maintain the blind, all study drug documentation (eg, shipping receipts, drug 
accountability logs, IXRS randomization materials) must be maintained and accessed by 
unblinded, trained site personnel only. Designated, unblinded site personnel must be 
appropriately trained and licensed (per country guidelines) to administer injections. 
Blinded study staff may be delegated the responsibility to receive, inventory, and destroy the 
used kits. The packaging identifies each kit by a unique number that does not correlate to the 
contents and therefore, does not unblind study site staff. Unblinded study staff will be 
responsible for preparation (breaking tamper proof sticker on kit, etc) of the clinical trial 
material, including recording the administration information on source document.


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Has been changed to: 
In order to maintain the blind, all study drug documentation (eg, shipping receipts, drug 
accountability logs, IXRS randomization materials) must be maintained and accessed by 
unblinded, trained site personnel only. Designated, unblinded site personnel must be 
appropriately trained and licensed (per country guidelines) to administer injections. 
Blinded study staff may be delegated the responsibility to receive, inventory, and destroy the 
used kits. The packaging identifies each kit by a unique number that does not correlate to the 
contents and therefore, does not unblind study site staff. Unblinded study staff will be 
responsible for preparation (breaking tamper proof sticker on kit, etc) of the clinical trial 
material, including recording the administration information on source document.
Change #6 Section 8.2 Baseline Visit
PtGADA assessment was deleted.
Change #7 Section 8.11 Week 36/Safety Follow-Up Visit (20 weeks after the last dose)
PtGADA assessment was deleted.
Change #8 Section 9 Assessment of Efficacy
The subsection discussing the PtGADA (Section 9.5 Patient’s Global Assessment of Disease 
Activity for the arthritis VAS) was deleted.
In addition the following change was made to Section 9.1 Psoriasis Area and Severity Index:
Original text:
The PASI50, PASI75, PASI90, and PASI100 responses are based on at least 50%, 75%, 90%, 
and 100% improvement in the PASI score.
Has been changed to:
The PASI25, PASI50, PASI75, PASI90, and PASI100 responses are based on at least 25%,
50%, 75%, 90%, and 100% improvement in the PASI score.
Change #9 Section 14.3.2.1 Analysis of the secondary efficacy variables
Original text:
Subjects who achieve a PASI50, PASI75, PASI90, and PASI100 response will be summarized 
and plotted by treatment group for each visit.
The 95% CIs for the PASI50/75/90/100 response rates will be included in the summaries and 
plots.


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Has been changed to: 
Subjects who achieve a PASI25, PASI50, PASI75, PASI90, and PASI100 response will be 
summarized and plotted by treatment group for each visit.
The 95% CIs for the PASI25/50/75/90/100 response rates will be included in the summaries and 
plots.
18.3
Protocol Amendment 3
Rationale for the amendment
The purpose of this amendment is the following:

Add an exclusion criterion to exclude subjects that had been admitted to a mental hospital or 
other institution by an order of the court

Clarify wording in the RNA, proteins, and metabolite variables section

Add a Baseline blood sample for anti-bimekizumab antibodies

Specify the study stopping rules

Delete Section 4.3.4 header: Non-hereditary pharmacogenomics variables. This section had 
no content and the header was included in error.
Specific changes
Change #1
Section 4.1.3 Primary immunogenicity variable
The primary immunological variable is anti-bimekizumab antibody detection following study 
treatment.
Has been changed to
The primary immunological variable is anti-bimekizumab antibody detection prior to and
following study treatment.
Change #2
The section header Section 4.3.4 Non-hereditary pharmacogenomic variables was deleted.
Change #3
Section 4.3.4 RNA, proteins, and metabolite variables
Where local regulations permit, blood and tissue biopsy samples will be collected at specific 
time points and stored for up to 20 years to allow for potential exploratory analyses of RNA, 


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proteins, and metabolites biomarkers relevant to psoriasis and the inflammatory and immune 
response processes.
Has been changed to
Blood and tissue biopsy samples will be collected at specific time points and stored for up to 20 
years to allow for potential exploratory analyses of RNA, proteins, and metabolites biomarkers 
relevant to psoriasis and the inflammatory and immune response processes.
Change #4
Table 5-1 Schedule of assessments
An “X” has been added to the Baseline column for the “Blood sample for anti-bimekizumab 
antibodies” assessment.
Change #5
Table 5-1 Schedule of assessments, footnote n
All blood samples taken prior to dosing. PK sampling for bimekizumab: sample at each visit; to 
be collected predose at the dosing visits (ie, BaselineWeeks 4 and 16). Samples for detection of 
anti-bimekizumab antibodies will be collected at Week 4, and each visit thereafter.
Has been changed to
All blood samples taken prior to dosing. 
Change #6
Section 6.2 Exclusion criteria
The following exclusion criterion was added
32. Subjects who have been admitted to a mental hospital or other institution by an order of the 
court
Change #7
Section 6.4 Study stopping rules has been added
6.4
Study stopping rules
During the study, planned dosing and procedures may be discontinued or suspended for all 
subjects in any part of the study and appropriate follow up procedures established. Where it is 
possible to do so without threatening the safety of subjects, such discontinuation/suspension 
should be discussed with the UCB Study Physician prior to its implementation.
Possible reasons for discontinuation or suspension of the study include (but are not limited to):


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
A pattern of AEs occurs that contraindicates the further dosing of enrolled/additional 
subjects, including (but not limited to):

More than 1 subject meets any individual Withdrawal Criteria 4, 8a, 9a, 10 or 11 (as 
provided in Section 6.3), regardless of whether they met the same or different criteria.

Once a second subject meets any of those criteria, referral to the DMC may not be 
delayed while awaiting the outcome of either case.
If the above criteria are reached, the DMC will meet as soon as possible to determine 
whether discontinuation or suspension of the study should occur, and to determine what 
investigations, analyses, procedural amendments, or other actions should occur, before 
making any recommendation regarding the possibility of recommencing the study. Further 
details on the role of the DMC are provided in Section 12.1.11 and Section 12.7.4. 

If the Sponsor or its designees judges it necessary for medical, safety, regulatory, or any 
other reasons consistent with applicable laws, regulations, and GCP.
Change #8
Section 8.2 Baseline Visit
The following procedures or assessments will be performed/recorded prior to administration of 
study drug:

Confirm inclusion/exclusion criteria 

Ensure no significant changes in medical procedure history and concomitant disease, 
including psoriasis disease history

Vital signs (blood pressure, pulse rate, and temperature)

Body weight

Record 12-lead ECG 

TB questionnaire

C-SSRS

HADS

PASI

IGA

BSA

Obtain blood sample(s) for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Cytokines, complement, candidate biomarker analysis, and flow cytometry 


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
RNA, proteins, and metabolites biomarkers

Obtain urine sample for:

Standard safety laboratory tests 

Urine pregnancy test for women of childbearing potential. (Note: A negative result must 
be received prior to administration of study medication.)

Obtain skin biopsy (lesional and nonlesional)

Concomitant medications

Record AEs

Contact the IXRS

Study medication administration (after all other visit assessments completed)
Has been changed to
The following procedures or assessments will be performed/recorded prior to administration of 
study drug:

Confirm inclusion/exclusion criteria 

Ensure no significant changes in medical procedure history and concomitant disease, 
including psoriasis disease history

Vital signs (blood pressure, pulse rate, and temperature)

Body weight

Record 12-lead ECG 

TB questionnaire

C-SSRS

HADS

PASI

IGA

BSA

Obtain blood sample(s) for:

Standard safety laboratory tests (hematology and biochemistry)

Bimekizumab plasma concentration

Anti-bimekizumab antibodies

Cytokines, complement, candidate biomarker analysis, and flow cytometry 

RNA, proteins, and metabolites biomarkers

Obtain urine sample for:


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
Standard safety laboratory tests 

Urine pregnancy test for women of childbearing potential. (Note: A negative result must 
be received prior to administration of study medication.)

Obtain skin biopsy (lesional and nonlesional)

Concomitant medications

Record AEs

Contact the IXRS

Study medication administration (after all other visit assessments completed)


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19
DECLARATION AND SIGNATURE OF INVESTIGATOR
I confirm that I have carefully read and understood this protocol and agree to conduct this 
clinical study as outlined in this protocol, according to current Good Clinical Practice and local 
laws and requirements.
I will ensure that all subinvestigators and other staff members read and understand all aspects of 
this protocol.
I have received and read all study-related information provided to me.
The objectives and content of this protocol as well as the results deriving from it will be treated 
confidentially, and will not be made available to third parties without prior authorization by 
UCB.
All rights of publication of the results reside with UCB, unless other agreements were made in a 
separate contract.
Investigator:
Printed name
Date/Signature


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20
SPONSOR DECLARATION
I confirm that I have carefully read and understand this protocol and agree to conduct this 
clinical study as outlined in this protocol and according to current Good Clinical Practice.


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ELECTRONIC SIGNATURES 
 
Signed by 
Meaning of Signature 
Server Approval Date 
(dd-mon-yyyy 
(HH:mm)) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PS0016 Protocol Amendment 3
Clinical Approval
26-Sep-2016 13:35 GMT+02
Clinical Approval
26-Sep-2016 17:45 GMT+02
PPD
PPD

SAP_003.pdf: 
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STATISTICAL ANALYSIS PLAN AMENDMENT 1
Study: PS0016
Product: Bimekizumab (UCB4940)
A MULTICENTER, RANDOMIZED, SUBJECT-BLIND, INVESTIGATOR-BLIND STUDY 
TO EVALUATE THE TIME COURSE OF PHARMACODYNAMIC RESPONSE, SAFETY 
AND PHARMACOKINETICS OF BIMEKIZUMAB IN ADULT SUBJECTS WITH 
MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
SAP/Amendment Number
Date
Final SAP
23 February 2017
SAP Amendment 1
30 November 2017
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 ...........................................................................................................11
2
PROTOCOL SUMMARY...............................................................................................11
2.1 Study objectives...............................................................................................................11
2.1.1
Primary objective.................................................................................................11
2.1.2
Secondary objectives ...........................................................................................11
2.1.3
Other objectives...................................................................................................11
2.2 Study variables.................................................................................................................12
2.2.1
Primary variables.................................................................................................12
2.2.1.1
Primary efficacy variable ..........................................................................12
2.2.1.2
Primary pharmacokinetic variable.............................................................12
2.2.1.3
Primary immunogenicity variable.............................................................12
2.2.1.4
Primary safety variable..............................................................................12
2.2.2
Secondary variables.............................................................................................12
2.2.3
Other variables.....................................................................................................12
2.2.3.1
Other efficacy variables.............................................................................12
2.2.3.2
Other pharmacodynamic variable..............................................................13
2.2.3.3
Other safety variables................................................................................13
2.2.4
Ribonucleic acid, proteins, and metabolite variables ..........................................13
2.2.5
Immunological variable.......................................................................................13
2.3 Study design and conduct ................................................................................................13
2.4 Determination of sample size...........................................................................................14
3
DATA ANALYSIS CONSIDERATIONS......................................................................15
3.1 General presentation of summaries and analyses ............................................................15
3.2 General study level definitions ........................................................................................16
3.2.1
Analysis timepoints .............................................................................................16
3.2.1.1
Relative day...............................................................................................16
3.2.1.2
Study periods.............................................................................................17
3.3 Definition of Baseline values...........................................................................................17
3.4 Protocol deviations...........................................................................................................17
3.5 Analysis sets.....................................................................................................................18
3.5.1
Enrolled Set .........................................................................................................18
3.5.2
Randomized Set...................................................................................................18
3.5.3
Safety Set.............................................................................................................18
3.5.4
Full Analysis Set..................................................................................................18
3.5.5
Per-Protocol Set...................................................................................................18
3.5.6
Pharmacokinetics Per-Protocol Set......................................................................19


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3.5.7
Pharmacodynamics Per-Protocol Set...................................................................19
3.6 Treatment assignment and treatment groups ...................................................................19
3.7 Center pooling strategy....................................................................................................19
3.8 Coding dictionaries ..........................................................................................................19
3.9 Changes to protocol-defined analyses..............................................................................20
4
STATISTICAL/ANALYTICAL ISSUES.......................................................................20
4.1 Adjustments for covariates...............................................................................................20
4.2 Handling of dropouts or missing data..............................................................................20
4.2.1
Efficacy data ........................................................................................................20
4.2.1.1
Psoriasis Area and Severity Index.............................................................20
4.2.1.2
Body surface area ......................................................................................21
4.2.1.3
Investigator’s Global Assessment .............................................................21
4.2.1.4
Hospital Anxiety and Depression Scale ....................................................21
4.2.2
Safety laboratory data..........................................................................................21
4.2.3
Bimekizumab concentration data.........................................................................21
4.2.4
Dates and times....................................................................................................21
4.3 Handling of repeated and unscheduled measurements ....................................................23
4.4 Handling of measurements obtained at the early withdrawal visit..................................24
4.5 Interim analyses and data monitoring..............................................................................24
4.5.1
Data monitoring committee .................................................................................24
4.5.2
Interim analysis....................................................................................................25
4.6 Multicenter studies...........................................................................................................25
4.7 Multiple comparisons/multiplicity...................................................................................25
4.8 Use of an efficacy subset of subjects ...............................................................................25
4.9 Active-control studies intended to show equivalence......................................................25
4.10 Examination of subgroups ...............................................................................................25
5
STUDY POPULATION CHARACTERISTICS.............................................................25
5.1 Subject disposition...........................................................................................................25
5.2 Protocol deviations...........................................................................................................26
6
DEMOGRAPHICS AND OTHER BASELINE CHARACTERISTICS ........................27
6.1 Derivation of variables.....................................................................................................27
6.1.1
Calculation of body mass index...........................................................................27
6.1.2
Classification of age categories ...........................................................................27
6.1.3
Duration of disease ..............................................................................................27
6.2 Demographics ..................................................................................................................28
6.3 Other Baseline characteristics..........................................................................................28
6.4 Medical history and concomitant diseases.......................................................................28
6.5 Past, prior, and concomitant medications ........................................................................29


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6.5.1
Past medication definition ...................................................................................29
6.5.2
Prior medication definition..................................................................................29
6.5.3
Concomitant medication definition .....................................................................29
6.5.4
Classification of concomitant medications..........................................................30
7
MEASUREMENTS OF TREATMENT COMPLIANCE...............................................30
8
EFFICACY ANALYSES ................................................................................................30
8.1 Statistical analysis of the primary efficacy variable ........................................................30
8.1.1
Derivations of primary efficacy variable.............................................................31
8.1.2
Primary analysis of the primary efficacy variable...............................................32
8.2 Statistical analysis of the secondary efficacy variables ...................................................32
8.2.1
Psoriasis Area and Severity Index response variables at Week 16......................33
8.2.2
Investigator’s Global Assessment Response at Week 16....................................33
8.3 Analysis of other efficacy variables.................................................................................34
8.3.1
Psoriasis Area and Severity Index .......................................................................35
8.3.2
Investigator’s Global Assessment........................................................................35
8.3.3
Body surface area ................................................................................................36
8.3.4
Hospital Anxiety and Depression Scale ..............................................................36
9
PHARMACOKINETICS AND PHARMACODYNAMICS..........................................36
9.1 Pharmacokinetics .............................................................................................................36
9.2 Pharmacodynamics ..........................................................................................................37
9.3 Pharmacokinetic/pharmacodynamic analyses .................................................................37
10
IMMUNOLOGICAL ANALYSES.................................................................................38
11
SAFETY ANALYSES.....................................................................................................39
11.1 Extent of exposure ...........................................................................................................39
11.1.1
Drug administration.............................................................................................39
11.1.2
Number of injections received.............................................................................39
11.1.3
Subject time at risk ..............................................................................................39
11.2 Adverse events.................................................................................................................40
11.2.1
Definitions and classification of adverse events..................................................40
11.2.2
Calculation of exposure adjusted incidence and event rates................................40
11.2.3
Presentation of adverse events.............................................................................41
11.3 Clinical laboratory evaluations ........................................................................................44
11.4 Vital signs, physical findings, and other observations related to safety..........................46
11.4.1
Vital signs ............................................................................................................46
11.4.2
Body weight.........................................................................................................47
11.4.3
Electrocardiograms..............................................................................................47
11.4.4
Other safety variables ..........................................................................................47
11.4.4.1
Physical examination.................................................................................47


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11.4.4.2
Chest x-ray and TB questionnaire.............................................................48
11.4.4.3
C-SSRS......................................................................................................48
12
OTHER ANALYSES ......................................................................................................48
13
REFERENCES ................................................................................................................49
14
APPENDICES .................................................................................................................50
14.1 Treatment group assignment for the TFLs.......................................................................50
14.2 Hospital Anxiety and Depression Scale...........................................................................51
14.3 Flow cytometry variables.................................................................................................52
14.4 Classification of markedly abnormal laboratory values based on CTCAE grades..........53
14.5 Treatment-emergent abnormal liver values .....................................................................54
14.6 Adverse events of special monitoring..............................................................................54
14.6.1
Major cardiovascular events................................................................................55
14.6.2
Serious infections, including opportunistic infections and tuberculosis .............55
14.6.2.1
Serious infections ......................................................................................55
14.6.2.2
Fungal infections .......................................................................................55
14.6.2.3
Opportunistic infections ............................................................................55
14.6.3
Malignancies including lymphoma......................................................................56
14.6.4
Cytopenias ...........................................................................................................57
14.6.5
Neuropsychiatric events.......................................................................................57
14.6.6
Inflammatory bowel disease................................................................................57
14.6.7
Anaphylactic reaction ..........................................................................................57
14.6.7.1
Anaphylactic reaction algorithm ...............................................................58
14.6.8
Hepatic events and drug-induced liver injury......................................................61
14.7 Treatment-emergent markedly abnormal vital signs values ............................................61
15
AMENDMENTS TO THE SAP......................................................................................62
15.1 Rationale for the amendment...........................................................................................62
15.2 List of changes .................................................................................................................62
STATISTICAL ANALYSIS PLAN SIGNATURE PAGE.....................................................67


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LIST OF ABBREVIATIONS
ACP
above cut point
ADA
anti-drug (bimekizumab) antibody
ADAE
analysis data adverse events
ADaM
analysis data model
AE(s)
adverse event(s)
AESM
adverse events of special monitoring
ALC
absolute lymphocyte count
ALP
alkaline phosphatase
ALQ
above the limit of quantification
ALT
alanine aminotransferase
ANC
absolute neutrophil count
anti-HBc
hepatitis B core antibody
anti-HBs
hepatitis B surface antibody
AST
aspartate aminotransferase
BCP
below cut point
BKZ
bimekizumab
BLQ
below the limit of quantification
BMI
body mass index
BSA
body surface area
BUN
blood urea nitrogen
CCR
chemokine receptor
CD
cluster of differentiation
CI
confidence interval
CP
confirmed positive


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CRF
case report form
CRO
Contract Research Organization
CRP
C-reactive protein
CSR
clinical study report
C-SSRS
Columbia Suicide Severity Rating Scale
CTCAE
Common Terminology Criteria for Adverse Events
CV
coefficient of variation
CXCR
CXC chemokine receptor
DAP
data analysis plan
DC
dendritic cell
DEM
data evaluation meeting
DMC
Data Monitoring Committee
EAER
exposure adjusted event rate
EAIR
exposure adjusted incidence rate
ECG
electrocardiogram
ES
Enrolled Set
EudraCT
European Union Drug Regulating Authorities 
Clinical Trials
EWD
early withdrawal visit
FAS
Full Analysis Set
FDA
Food and Drug Administration
FSH
follicle stimulating hormone
geoCV
geometric coefficient of variation
GGT
gamma glutamyltransferase
HADS
Hospital Anxiety and Depression Scale


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HADS-A
HADS-Anxiety
HADS-D
HADS-Depression
HBsAg
hepatitis B surface antigen
HCV-Ab
hepatitis C virus antibody
HIV1-Ab
human immunodeficiency virus 1 antibody
HIV2-Ab
human immunodeficiency virus 2 antibody
HLT
high level term
HLGT
high level group term
ICH
International Council for Harmonisation
IGA
Investigator’s Global Assessment
IL
interleukin
IMP
investigational medicinal product
LCL
lower confidence limit
LDH
lactate dehydrogenase
LLOQ
lower limit of quantification
LLT
lower level term
LOCF
last observation carried forward
MACE
major adverse cardiovascular event
MCH
mean corpuscular hemoglobin
MCHC
mean corpuscular hemoglobin concentration
MCMC
Markov chain Monte Carlo
MCV
mean corpuscular volume
MedDRA
Medical Dictionary for Regulatory Activities
n
number of subjects


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NCP
not confirmed positive
NK
natural killer
NRI
nonresponder imputation
NSAIDs
non-steroidal anti-inflammatory drugs
PASI
Psoriasis Area and Severity Index
PBO
placebo
PCS
potentially clinically significant
PD
pharmacodynamic
PD-PPS
Pharmacodynamic Per-Protocol Set
PK
pharmacokinetic
PK-PPS
Pharmacokinetic Per-Protocol Set
PPS
Per-Protocol Set
PT
preferred term
QTcF
QT corrected for heart rate using Fridericia’s 
formula
RBC
red blood cell
RNA
ribonucleic acid
RS
Randomized Set
SAEs
serious adverse events
SAP
Statistical Analysis Plan
sc
subcutaneous
SD
standard deviation
SDTM
Study Data Tabulation Model
SFU
safety follow-up
SMQ
standardized MedDRA query


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SOC
system organ class
SS
Safety Set
TB
tuberculosis
TBNK
T cell, B cell and NK cell assay
Tc
T cytotoxic
TEAE(s)
treatment-emergent adverse event(s)
TEMA
treatment-emergent markedly abnormal
TFLs
tables, figures and listings
Th
T helper
UCL
upper confidence limit
ULN
upper limit of normal
WBC
white blood cell
WHODD
World Health Organization Drug Dictionary


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1
INTRODUCTION
The purpose of this statistical analysis plan (SAP) is to provide all information that is necessary 
to perform the required statistical analysis of study PS0016. It also defines the summary tables, 
figures and listings (TFLs) to be included in the final clinical study report (CSR) according to the 
protocol.
This SAP Amendment 1 is based on, and assumes familiarity, with the following documents:

Final protocol, dated 06 June 2016

Protocol amendment 1, dated 04 August 2016

Protocol amendment 2, dated 06 September 2016

Protocol amendment 3, dated 23 September 2016

Statistical analysis plan, dated 23 February 2017
Unless specified in the sections below, the study will be analyzed as described in the most recent 
version of the protocol. If a future protocol amendment necessitates a substantial change to the 
statistical analysis of the study data, this SAP amendment will be updated accordingly. In 
addition, if analysis definitions have to be modified or updated prior to database lock, a further 
SAP amendment will be required. If, after database lock, additional analyses are required to 
supplement the planned analyses described in this SAP amendment, these changes will be 
described in the CSR together with the associated rationale.
The content of this SAP amendment is compatible with the International Council for
Harmonisation (ICH)/Food and Drug Administration (FDA) E9 Guidance documents.
UCB is the Sponsor and PAREXEL is the Contract Research Organization (CRO) for this study.
2
PROTOCOL SUMMARY
2.1
Study objectives
2.1.1
Primary objective
The primary objective of this study is to evaluate the time-course of Psoriasis Area and Severity 
Index (PASI) over a 28-week period following the administration of bimekizumab given at 
Baseline and Week 4 to subjects with moderate to severe chronic plaque psoriasis.
2.1.2
Secondary objectives
The secondary objectives of the study are to:

To evaluate the time-course of PASI over a 28-week period following the administration of 
bimekizumab given at Baseline and Weeks 4 and 16 in subjects with moderate to severe 
chronic plaque psoriasis

Assess the pharmacokinetics (PK) and immunogenicity of bimekizumab

Assess the safety and tolerability of bimekizumab
2.1.3
Other objectives
The other objectives of the study are to:


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
Assess the effect of bimekizumab on gene and protein expression, and explore the 
relationship between genomic, genetic, and proteomic biomarkers and disease biology, drug 
treatment and inflammatory/immune responses
2.2
Study variables
2.2.1
Primary variables
2.2.1.1
Primary efficacy variable
The primary endpoint of this study is change from Baseline in PASI at Week 28.
2.2.1.2
Primary pharmacokinetic variable
The primary PK variable is plasma concentration of bimekizumab.
2.2.1.3
Primary immunogenicity variable
The primary immunological variable is anti-drug (bimekizumab) antibody (ADA) detection prior 
to and following study treatment.
2.2.1.4
Primary safety variable
The primary safety variable is incidence of adverse events (AEs).
2.2.2
Secondary variables
The secondary efficacy variables are:

PASI75, PASI90 and PASI100 response at Week 16

Investigator’s Global Assessment (IGA) response (Clear or Almost Clear with at least a 
2-category improvement from Baseline) at Week 16
2.2.3
Other variables
2.2.3.1
Other efficacy variables
The other efficacy variables are listed below and will be evaluated at all scheduled visits in 
accordance with the schedule of assessments in Table 5-1 of the clinical study protocol. This 
excludes the primary and secondary variables as previously specified in Section 2.2.1 and 
Section 2.2.2.

Absolute and percentage change from Baseline in PASI with time (Week 2 to Week 36)

PASI75, PASI90 and PASI100 response at Weeks 2, 4, 8, 12, 20, 24, 28 and 36

PASI25 and PASI50 response (Week 2 to Week 36)

IGA response (Clear or Almost Clear with at least 2-category improvement from Baseline) at 
Weeks 2, 4, 8, 12, 20, 24, 28 and 36

Change from Baseline in IGA score with time (Week 2 to Week 36)

Change from Baseline in the body surface area (BSA) affected by psoriasis with time 
(Week 2 to Week 36)

Change from Baseline in Hospital Anxiety and Depression Scale (HADS) HADS-Anxiety 
(HADS-A) and HADS-Depression (HADS-D) scores with time (Week 4 to Week 36)


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
Percentage of subjects with scores below 8 in HADS-A and HADS-D (subjects with normal 
scores) at each post-Baseline visit (Week 4 to Week 36)
2.2.3.2
Other pharmacodynamic variable
The pharmacodynamic (PD) variable is to determine the blood or blood derivative (eg, plasma) 
concentrations of cytokines of relevance to interleukin (IL)-17A/F signaling pathway and 
psoriasis biology, including but not limited to serum complement concentrations, mononuclear 
cell subtypes (flow cytometry), cytokines and other candidate biomarkers.
Only the results for the flow cytometry will be included in the TFLs. The results arising from the 
analysis of other PD variables will be reported separately, if applicable. These are not described 
further in this SAP.
2.2.3.3
Other safety variables
Other safety variables to be assessed are:

Change from Baseline in clinical laboratory variables (chemistry, hematology and urinalysis)

Change from Baseline in vital signs

Change from Baseline in physical examination

Electrocardiogram (ECG) results
2.2.4
Ribonucleic acid, proteins, and metabolite variables
Blood and tissue biopsy samples will be collected at specified timepoints and stored for up to 20 
years to allow for potential exploratory analyses of ribonucleic acid (RNA), proteins and 
metabolites biomarkers relevant to psoriasis and the inflammatory and immune response process.
The nature and format of these tentative analyses will be determined at a later stage.
These results will not form part of the TFLs and therefore are not discussed further in this SAP.
2.2.5
Immunological variable
The immunological variable is ADA detection following study treatment.
2.3
Study design and conduct
This is a Phase 2a, multicenter, randomized, subject-blind and investigator-blind study to 
evaluate the PD, PK, and safety of bimekizumab administered via subcutaneous (sc) injection to 
subjects with psoriasis. To be eligible to participate in this study, subjects must be adults with a 
diagnosis of moderate to severe chronic plaque psoriasis (Baseline PASI ≥12 and BSA affected 
by psoriasis ≥10% and IGA score ≥3 [on a 5-point scale]) who are candidates for systemic 
psoriasis therapy and/or phototherapy and/or chemophototherapy.
This study will include 3 periods: a Screening Period (up to 4 weeks), a Treatment Period 
(28 weeks), and a Safety Follow-Up (SFU) Period (20 weeks after the last dose of study 
medication). Between Week 20 and the end of the 28-week Treatment Period, eligible subjects 
will be allowed to enroll in an extension study.


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Screening Period
The Screening Period will last up to a total of 4 weeks in the event that applicable laboratory 
screening tests require retesting if the initial results are in error, borderline, or indeterminate. 
During this time, laboratory data (hematology, urine, and biochemistry tests) will be obtained, 
the doses of non-steroidal anti-inflammatory drugs (NSAIDs) (if used to treat psoriatic arthritis), 
will be verified as stable. 
Treatment Period
During the Treatment Period, subjects will be randomized 2:1 to receive one of the following 
blinded study treatment regimens:

Treatment arm A: Bimekizumab 320mg administered sc at Baseline and Week 4, and 
placebo administered at Week 16

Treatment arm B: Bimekizumab 320mg administered sc at Baseline and Weeks 4 and 16
There will be approximately 30 subjects in treatment arm A and 15 subjects in treatment arm B. 
Bimekizumab will be administered in the clinic at Baseline and Week 4, and at Baseline, 
Week 4, and Week 16 for those in treatment arm A and treatment arm B, respectively. 
Additional nondosing study visits will occur at Week 2, Week 8, Week 12, Week 20, Week 24, 
and Week 28.
From Week 20 through Week 28, subjects who were previously PASI25 responders (defined as 
described in Section 8.3.1) but subsequently relapse (defined as returning to a less than PASI25 
response) will undergo the study assessments for that visit (ie, Week 20, Week 24, or Week 28) 
before receiving their first dose of study treatment in the extension study at Week 20, Week 24, 
or Week 28. Subjects eligible for the extension study must have the assessments for SFU (for 
PS0016) conducted prior to entering the extension study. Subjects may also enter the extension 
study after the SFU Visit at Week 36. Subjects who have not achieved a PASI25 response at any 
visit prior to Week 20 will not be eligible to enter the extension study. All subjects not enrolling 
in the extension study will continue in PS0016 until the SFU Visit at Week 36.
Subjects withdrawing early from the study will undergo the Early Withdrawal Visit (EWD)
assessments (ie, the same assessments as for Week 36) and will enter the SFU Period,
completing study participation with the SFU Visit 20 weeks after the last dose of investigational 
medicinal product (IMP).
Safety Follow-Up Period 
All subjects not continuing in the extension study, including those withdrawn from study 
treatment, will have a SFU Visit 20 weeks after their last dose of IMP (ie, bimekizumab or 
placebo).
2.4
Determination of sample size
No formal statistical sample size estimation has been performed due to the exploratory nature of 
this study. This clinical study is not powered for any conclusive statistical analysis of efficacy, 
PK, safety or immunological variables. The sample size has been determined based on the 
number of subjects required in the current study to provide reliable PK/PD model parameter 
estimates when the data is combined with PS0010. Reliable estimates of PK/PD parameters are 


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defined as number of subjects required to achieve a relative standard error of ≤30% for fixed 
effects parameters and ≤50% for all random effects parameters.
In order to determine the sample size required for the PK/PD model, Markov chain Monte Carlo 
(MCMC) simulations were performed. Five hundred trials were simulated with the proposed 
design, and including 240 subjects from PS0010. The simulated data were re-estimated using the 
same model. These simulations indicated that reliable estimates will be possible with a total 
number of 45 subjects (30 subjects in Treatment arm A and 15 subjects in Treatment arm B).
3
DATA ANALYSIS CONSIDERATIONS
3.1
General presentation of summaries and analyses
Statistical evaluation will be performed by PAREXEL. The datasets will follow the UCB 
analysis data model (ADaM) data specifications.
All analyses will be performed using SAS version 9.3 or higher (SAS Institute, Cary, North 
Carolina, United States). Continuous variables will be summarized by treatment group, visit and 
timepoint (where applicable) including number of subjects (n), mean, standard deviation (SD), 
median, minimum, maximum and confidence intervals (CI) where stated in the SAP. Categorical 
variables will be summarized by treatment, visit and timepoint (where applicable) with 
frequency counts and percentages. Coefficient of variation (CV), geometric mean and 95% CI 
for the geometric mean will also be presented in the descriptive statistics for the PK 
concentration data. In all outputs the confidence limits will be restricted to the possible values 
that the variable can take.
When reporting relative frequencies or other percentage values, the following rules apply:

For values where all subjects fulfill certain criteria, the percentage value will be displayed as 
100

For values where the absolute frequency is zero, there will be no percentage displayed at all

All other percentage displays will use 1 decimal place
Percentages displayed based on continuous data (eg, percentage changes from baseline) will be 
displayed to 1 decimal place. Unless otherwise stated, the denominator for the percentages will 
be based on the number of subjects in the respective analysis set and treatment group.
When reporting descriptive statistics, the following rules will apply in general (with the 
exception of PK concentration data, for which additional rules are stated below):

n will be an integer

Mean (arithmetic and geometric), SD and median will use 1 decimal place more than the 
original data

Coefficient of variation (CV) will be reported as a percentage to 1 decimal place

Minimum and maximum will be reported using the same number of decimal places as the 
original value


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
If no subjects have data at a given timepoint, for example, then only n=0 will be presented. If 
n<3, then only the n, minimum and maximum will be presented. If n=3, then only n, median, 
minimum and maximum will be presented. The other descriptive statistics will be left blank.
When reporting individual values and descriptive statistics for PK concentration data, the 
following rules will apply with regard to rounding and precision:

Individual values for PK concentration data will be reported to the same level of precision as 
received from the bioanalytical laboratory

Descriptive statistics for PK concentration data will be reported to the same level of precision 
as the individual data for the minimum and maximum, and to 1 additional significant figure 
for the mean (arithmetic and geometric), median, SD and 95% CI for the geometric mean 

Geometric CV (geoCV) will be reported as a percentage to 1 decimal place
All tabulations will be performed by treatment group, visit and timepoint (where applicable). In 
the TFLs the treatment groups will be displayed as follows where BKZ refers to bimekizumab 
and PBO refers to placebo:

BKZ 320mg + PBO

BKZ 320mg 
Data listings containing all documented data and all derived data will be generated.
3.2
General study level definitions
3.2.1
Analysis timepoints
3.2.1.1
Relative day
Relative day for an event will be derived with the date of the first sc injection of IMP as 
reference.
Relative days for an event of measurement occurring before the date of first sc injection are 
calculated as follows:
	
  = 
  −  	 	 
[1]
The relative day for an event or measurement occurring on or after the reference date to the date 
of the last injection is calculated as follows:
	
  = (
  −  	 	) + 1 
[2]
For events or measurements occurring after the date of the last injection, relative day will be 
prefixed with ‘+’ in the data listings and will be calculated as follows:
	
  = 
  −   	
[3]
There is no relative Day 0. Relative day is not calculated for partial dates in cases where relative 
day is shown in a subject data listing. In such cases, relative day should be presented as ‘-‘ in the 
subject data listings.


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3.2.1.2
Study periods
For each subject, the study will last a maximum of up to 40 weeks. This includes the following 
study period durations:

Screening Period: up to 4 weeks

Treatment Period: 28 weeks

Safety Follow-Up Period: a SFU Visit is planned 20 weeks after the last dose of study 
medication
The end of the study is defined as the date of the last visit of the last subject in the study.
Additional analysis periods for classification of concomitant medications and AEs are provided 
in Section 6.5.4 and Section 11.2.1 respectively.
3.3
Definition of Baseline values
Baseline will be the last available value prior to the first injection of IMP. Scheduled or 
unscheduled measurements can be used as the Baseline value. Measurement-specific Baseline 
timepoints (based on the planned timepoints in the protocol) are presented in Table 3‒1.
Table 3‒1:
Definition of Baseline
Category
Measurement
Definition of Baseline
Efficacy
PASI
IGA
BSA
HADS
Baseline Visit, or if missing the 
Screening results.
Pharmacodynamic
Mononuclear cell subtypes (flow 
cytometry)
Baseline Visit
Safety
Laboratory results (including 
hematology, biochemistry and 
urinalysis)
Vital signs
ECG
Body weight
C-SSRS
Baseline visit, or if missing the 
Screening results.
For the C-SSRS the ‘Baseline’
version of the questionnaire will 
be completed at Screening and 
the ‘Since Last Visit’ version will 
be completed at all subsequent 
visits.
Immunological
ADA
Baseline Visit
ADA=anti-bimekizumab antibody; BSA=body surface area; C-SSRS=Columbia Suicide Severity Rating Scale; 
ECG=electrocardiogram; HADS=Hospital Anxiety and Depression Scale; IGA=Investigator’s Global Assessment; 
PASI=Psoriasis Area and Severity Index.
If a measurement is repeated at Baseline and is obtained prior to receiving the first dose of IMP, 
then the last available measurement will be used as the Baseline value.
3.4
Protocol deviations
Important protocol deviations are deviations from the protocol which potentially could have a 
meaningful impact on study conduct or on the primary efficacy, key safety, or PK/PD outcomes 


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for an individual subject. The criteria for identifying such protocol deviations will be defined 
within the protocol deviation specifications document which is part of the data cleaning plan. 
Important protocol deviations will include the following categories:

Inclusion/exclusion criteria deviations

Administration of prohibited concomitant medications

Deviations relating to withdrawal criteria

Visit schedule deviations

Study drug administration deviations (including incorrect treatment received)

Missing data
Important protocol deviations will be reviewed as part of the ongoing data cleaning process and 
data evaluation. 
After all data have been verified/coded/entered into the database, the final data evaluation 
meeting (DEM) will be performed. The purpose of this DEM will be to review all protocol 
deviations, define the analysis sets and check the quality of the data prior to unblinding. The 
review will also help decide how to manage problems in the subjects’ data (eg, missing values 
and withdrawals). 
After the pre-analysis review, resolution of all issues, and documentation of all decisions, the 
database will be locked.
3.5
Analysis sets
3.5.1
Enrolled Set
The Enrolled Set (ES) will consist of all subjects who have given informed consent (ie, all 
screened subjects). This will therefore include screening failures.
3.5.2
Randomized Set
The Randomized Set (RS) will consist of all randomized subjects.
3.5.3
Safety Set
The Safety Set (SS) will consist of all subjects who received at least 1 dose of the study 
medication.
3.5.4
Full Analysis Set
The Full Analysis Set (FAS) will consist of all randomized subjects who received at least 1 dose 
of the study medication and have a valid measurement of the primary efficacy variable at 
Baseline.
3.5.5
Per-Protocol Set
The Per-Protocol Set (PPS) will consist of all randomized subjects who received at least 1 dose 
of the study medication and have a valid measurement of the primary efficacy variable 
post-Baseline without important protocol deviations affecting the measurement.
The analyses of the efficacy variables will be repeated for the PPS where stated in the SAP. If 
the FAS and PPS are the same, any outputs based on the PPS will not be presented.


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3.5.6
Pharmacokinetics Per-Protocol Set
The Pharmacokinetics Per-Protocol Set (PK-PPS) will consist of all randomized subjects who 
received at least 1 dose of the study medication and provided at least 1 quantifiable plasma 
concentration post-dose.
3.5.7
Pharmacodynamics Per-Protocol Set
The Pharmacodynamics Per-Protocol Set (PD-PPS) will consist of all randomized subjects who
received at least 1 dose of the study medication and provided at least 1 PD measurement 
post-dose without important protocol deviations affecting the measurement.
3.6
Treatment assignment and treatment groups
Treatment assignment for the SS, PK-PPS and PD-PPS will be according to the actual treatment 
received. Analyses of efficacy data (based on the FAS) will be conducted according to the 
randomized treatment.
Subjects receiving the incorrect treatment at a particular visit will be excluded from the PPS as 
this would be considered as an important protocol deviation. Subjects may be excluded from the 
analysis at a particular visit (or visits) only, following discussion at the DEM.
Listings and summaries will be presented by treatment group and overall where applicable
(Table 14‒1).
The following order will be used in the TFLs:

Not randomized

BKZ 320mg + PBO (Treatment arm A)

BKZ 320mg (Treatment arm B)

All subjects
In the case of dosing administration errors during the Treatment Period, all statistical analyses of 
safety, PK and PD data will be conducted according to the actual treatment received with the 
following rules:

Subjects randomized to Treatment arm A who received bimekizumab at Week 16 will be 
summarized together with subjects in Treatment arm B

Subjects randomized to Treatment arm B who received placebo at Week 16 will be 
summarized together with subjects in Treatment arm A
Any other dosing errors will be discussed at the DEM and the decision regarding the inclusion 
into the relevant analyses will be documented as part of the DEM minutes.
3.7
Center pooling strategy
The data from different sites will be pooled for all analyses. There will be no stratification by site 
or country performed.
3.8
Coding dictionaries
Adverse events and medical history will be coded using the Medical Dictionary for Regulatory 
Activities (MedDRA®), Version 19.0. 


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Medications will be coded according to the World Health Organization Drug Dictionary 
(WHODD [September 2015]). Medical procedures will not be coded
3.9
Changes to protocol-defined analyses
In the clinical study protocol the definition of the FAS included all subjects with a valid 
measurement of the primary efficacy variable post-Baseline. However, this was adjusted to all 
subjects with a valid Baseline measurement for the primary efficacy variable in the SAP in order 
to comply with program standards and FDA requirements (ie, inclusion into the FAS is no longer 
dependent on availability of post-Baseline data).
According to the final clinical study protocol spaghetti plots of change from Baseline in PASI 
would be plotted for each subject over time. However as the PASI response is based on 
percentage change, it was deemed more appropriate to present the individual plots based on 
percentage change from Baseline.
The protocol stated that exposure at risk for defining treatment-emergence for
treatment-emergent adverse events (TEAEs) would be cut off at the Week 16 visit (for subjects
who complete through the Week 16 visit) or at 20 weeks (140 days) after the last administration 
of study treatment (for subjects that discontinue prior to the Week 16 visit). This was further 
stated to be done in order to provide a fair comparison across all subjects when comparing the 
incidence of TEAEs. In this SAP amendment it has been clarified that the definition of a TEAE 
is any AE with onset following the first administration of study medication until the final 
administration of study medication + 140 days (regardless of study discontinuation). In order to 
allow for direct comparison of the treatment groups with respect to incidence of TEAEs, prior to 
the point at which subjects are eligible to enter the extension study, it would be necessary to use 
a cut off at Week 20 (ie, the first point at which a subject may enter the extension study). This 
has also been clarified in the SAP amendment accordingly.
4
STATISTICAL/ANALYTICAL ISSUES
4.1
Adjustments for covariates
There will be no adjustment for covariates.
4.2
Handling of dropouts or missing data
Missing data will be handled as described in the sections below for efficacy, safety and PK 
results. No other imputations will be performed. 
4.2.1
Efficacy data
4.2.1.1
Psoriasis Area and Severity Index
Missing data for the individual items of the PASI score will be imputed as described in 
Section 8.1.1 in order to calculate the PASI score at each visit.
The primary efficacy variable is change from Baseline in PASI at Week 28. Missing data at this 
visit may be attributable to either premature discontinuation or subjects entering the extension 
study at Week 20 or Week 24. In both scenarios, missing data will be imputed using last 
observation carried forward (LOCF) where the last observed overall PASI score will be used to 
impute the missing data for all visits after the point of withdrawal or transition to the extension 
study. Missing data at other visits will also be imputed using LOCF (ie, if a subject has missing 


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at Week 12, for example, this will be imputed with the PASI score obtained at Week 8). In 
addition, PASI summaries will also be presented using observed cases.
There will be no imputation of missing individual item scores for the PASI; the LOCF 
imputation will apply to the overall PASI score only.
For the binary response variables (PASI25, PASI50, PASI75, PASI90 and PASI100), missing 
data will be imputed using nonresponder imputation (NRI), ie, subjects with missing data at a 
specific visit will be considered as nonresponders for the analysis. This will include visits after 
the point of withdrawal or after the point of transition to the extension study, if applicable. This 
will also be presented using observed cases.
4.2.1.2
Body surface area
For missing BSA, the missing data will be imputed using LOCF as described in Section 4.2.1.1
for the PASI score. This will also be presented using observed cases.
4.2.1.3
Investigator’s Global Assessment
There will be no imputation of missing individual data for the IGA score. For the responder 
analysis, missing data will be imputed using NRI, ie, subjects with missing data at a specific visit 
will be considered as nonresponders for the analysis. This will include visits after the point of 
withdrawal or after the point of transition to the extension study, if applicable. In addition, IGA
summaries will also be presented using observed cases.
4.2.1.4
Hospital Anxiety and Depression Scale
Missing data for the individual items of the HADS will be imputed as described in Section 14.2
in order to calculate the HADS-A and HADS-D scores at each visit. No other imputation will be 
performed.
4.2.2
Safety laboratory data
Measurements below the limit of quantification (BLQ) will be imputed with half of the lower 
limit of quantification (LLOQ) for the purpose of calculating change from Baseline and for 
descriptive statistics. Measurements above the limit of quantification (ALQ), if applicable, will 
be imputed to the upper quantification limit.
These rules will be applied to all numeric safety laboratory data including clinical chemistry, 
hematology and urinalysis variables. 
4.2.3
Bimekizumab concentration data
Measurements that are BLQ will be imputed with LLOQ/2 for the purpose of calculating the 
geometric mean and its 95% CI, the geoCV, the arithmetic mean, and SD for summaries and 
figures.
For the individual figures, any concentrations that are BLQ will be imputed with LLOQ/2, with 
the exception of predose BLQ measurements on Day 1 (Baseline Visit), which will be imputed 
with zero for linear scale plots.
Additional rules for PK data summaries are provided in Section 9.1.
4.2.4
Dates and times
Partial dates may be imputed for the following reasons:


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
Classification of AEs as treatment-emergent

Classification of medications as past, prior or concomitant
Imputed dates will not be shown in the listings; all dates will be displayed as reported in the 
database.
The following rules will be applied for partial start dates:

If only the month and year are specified and the month and year of first dosing is not the 
same as the month and year of the start date then use the 1st of the month, or the date of 
screening if this is later (if the latter imputation results in an end date that is earlier than the 
start date, then use the 1st of the month). If time is missing this will be imputed as 00:00 h;

If only the month and year are specified and the month and year of first dosing is the same as 
the month and year of the start date, then use the date of first dosing. If this results in an 
imputed start date that is after the specified end date, then use the 1st of the month, or the date 
of screening if this is later (if the latter imputation results in an end date that is earlier than 
the start date, then use the 1st of the month). If the imputed date is the date of first dosing then 
time will be imputed with the time of the first injection (ie, event will be regarded as 
treatment-emergent);

If only the year is specified, and the year of dosing is not the same as the year of the start date 
then use January 01 of the year of the start date. If time is missing this will be imputed as 
00:00 h;

If only the year is specified, and the year of dosing is the same as the year of the start date, 
then use the date of first dosing in the given year. If this results in an imputed start date that 
is after the specified end date, then use January 01 of the year of start date, or the date of 
screening if this is later (if the latter imputation results in an end date that is earlier than the 
start date, then use January 01). If the imputed date is the date of first dosing then time will 
be imputed with the time of the first injection (ie, event will be regarded as treatment-
emergent);

If the start date is completely unknown, then use the date of first dosing. If this results in an 
imputed start date that is after the specified end date, then use January 01 of the year of the 
end date, or the date of screening if this is later (if the latter imputation results in an end date 
that is earlier than the start date, then use January 01). If the imputed date is the date of first 
dosing then time will be imputed as the start time of the first injection (ie, event will be 
regarded as treatment-emergent).
The following rules will be applied for partial stop dates:

If only the month and year are specified, then use the last day of the month;

If only the year is specified, then use December 31 of the known year;

If the stop date is completely unknown, do not impute the stop date
Missing or partially missing date and/or times will be imputed as described in Table 4‒1 for the 
calculation of duration of each AE. Adverse event duration is computed in and reported in day 
and time format: xx d hh:mm.


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Table 4‒1:
Calculation rules for duration of adverse events
Data availability
Onset 
date/time
Outcome 
date/time
Calculation rules
Complete data
D1/T1
D2/T2
Duration = [(D2 – D1)*24 + (T2 – T1)]/24 d
End time missing
D1/T1
D2/--
End time is substituted by time 23:59h (=23.98 in 
decimal format)
Duration = <[(D2 – D1)*24 + (23.98 – T1)]/24 d
Start time missing
D1/--
D2/T2
Onset time is substituted by time 00:00h.
Duration = <[(D2 – D1)*24 + T2]/24 d
Start and end time 
missing
D1/--
D2/--
Duration = <D2 – D1 + 1
Start day and time 
missing
--/--
D2/T2
Duration = <[(D2 – D0)*24 + (T2 – T0)]/24 d
For a subject in the SS, D0 and T0 are the date and 
time of first administration of IMP and for screen 
failures, D0 is the date of the screening visit and T0 = 
00:00h
End day and time 
missing
D1/T1
--/--
If the stop date is missing, duration will not be 
calculated.
Start and end date 
missing
--/--
--/--
If the stop date is missing, duration will not be 
calculated.
IMP=investigational medicinal product; SS=Safety Set.
4.3
Handling of repeated and unscheduled measurements
All repeated and unscheduled measurements will be presented in the listings, where applicable. 
The following general rules will apply to all repeated and unscheduled measurements:

For repeated or unscheduled measurements obtained prior to the first dose of IMP, the latest 
value (which may be scheduled or unscheduled) will be used in the calculation of descriptive 
statistics at each visit (ie, Screening and/or Baseline);

For repeated or unscheduled measurements obtained at the designated Baseline visit, the 
latest value (which may be scheduled or unscheduled) will be defined as the Baseline 
provided that this occurred prior to the first dose of IMP;

For repeated or unscheduled measurements obtained at any timepoint after the first dose of 
IMP, the first value will be used in the calculation of changes from Baseline and for the 
descriptive statistics (ie, in summaries by timepoint). Unscheduled and repeated 
measurements will not be included in the summaries by timepoint, for all timepoints after the 
first dose of IMP;

Data from unscheduled visits may be used for tables that present abnormalities (where stated 
in the SAP amendment).


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4.4
Handling of measurements obtained at the early withdrawal 
visit
Subjects who withdraw from the study prematurely will be encouraged to return for the EWD
and the SFU Visit, the latter at 20 weeks following the final dose of IMP. The following rules 
will apply with regard to the inclusion of the results obtained at the EWD in the descriptive 
summaries:

Any efficacy, PK, PD, immunological and safety measurements conducted at the EWD
should be included in the summaries for the respective scheduled visit, if the EWD occurs at 
the time of the next scheduled visit (within the tolerance window specified in the protocol). 
For example, if the EWD occurs on Day 28, the results would be summarized together with 
the Week 4 results.

If the EWD does not correspond to the day of a scheduled visit, the efficacy, safety and other 
relevant assessments of the EWD should be mapped to the nearest scheduled visit, relative to 
the Baseline visit date, following the last scheduled visit where assessments are available.

If the date of the EWD is equidistant between 2 scheduled visits at which no scheduled 
assessments were performed, the assessments from the EWD will be mapped to the earliest 
of these visits.
For example, vital sign assessments are performed at Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28 
and 36. If a subject discontinues on Day 37, and the previous vital sign assessment was done at 
Week 4 (Day 28), the nearest scheduled assessment (following the last visit at which assessments 
were available) would be Week 8 (Day 56). Therefore, the EWD assessment should be 
re-assigned to the Week 8 visit. 
However, if a subject discontinues at Day 37, and the previous vital sign assessment was done at 
Week 2 (Day 14), the EWD assessments would be re-assigned to the Week 4 (Day 28) visit, 
which would be the nearest scheduled visit relative to the Baseline visit date.
Different domains (eg, vital signs, ECG, safety laboratory tests, PASI, IGA) from the same EWD
may be re-assigned to different study visits depending on the study schedule of assessments, ie, 
measurements obtained at the EWD can only be mapped to a scheduled visit at which the 
respective assessment was intended to be measured. Assessments from the EWD that are mapped 
to scheduled visits will be flagged in the data listings.
4.5
Interim analyses and data monitoring
4.5.1
Data monitoring committee
An independent data monitoring committee (DMC) will be convened to periodically review and 
monitor safety data and to advise UCB accordingly. A separate cardiovascular adjudication 
committee and neuropsychiatric adjudication committee will also review the relevant data for 
assessment of cardiovascular and potential suicide events respectively, and will provide 
additional advice to UCB.
The detailed role, scope, responsibilities and complete procedures as well as the identity of the 
DMC members will be described in a separate DMC Charter. The DMC procedures will ensure 
that data remain blind to the study team and Investigators at all times during the conduct of the 


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study. The details regarding the outputs to be produced and the analyses to be performed for the 
DMC review will be provided in a separate DMC SAP.
A separate Charter will be written for each of the cardiovascular and neuropsychiatric 
adjudication committees.
4.5.2
Interim analysis
No formal interim analysis will be performed; however interim data cuts will be performed and 
evaluated. Please refer to the interim SAP for details on the timings and deliverables of these 
data cuts.
4.6
Multicenter studies
Individual center results will not be displayed.
4.7
Multiple comparisons/multiplicity
Not applicable.
4.8
Use of an efficacy subset of subjects
Not applicable.
4.9
Active-control studies intended to show equivalence
Not applicable.
4.10
Examination of subgroups
Not applicable.
5
STUDY POPULATION CHARACTERISTICS
5.1
Subject disposition
The number and percentage of subjects who were randomized into the study, subjects who 
completed (which includes those who entered the extension study at Week 36) or prematurely 
discontinued the study, as well as the reason for discontinuation will be presented by treatment 
group and for all subjects, based on the RS. The tabulation will also include the number and 
percentage of subjects who achieved a PASI25 response (for at least one post-Baseline visit), the 
number and percentage of subjects who relapsed, and the number and percentage of subjects 
entering the extension study prior to Week 36.
The number and percentage of subjects who discontinued due to AEs will be separately 
summarized by treatment group and for all subjects, based on the RS.
The number and percentage of subjects included into each of the analysis sets will be 
summarized by treatment group and for all subjects based on all subjects screened. Percentages 
will be based on the RS for the purpose of this summary.
Finally, screen failure reasons will be summarized, based on all subjects screened. A listing of 
subjects who did not meet study eligibility criteria (including glossary) will also be presented.
A subject who completed the study is defined as follows:


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
All subjects not enrolling in the extension study will be regarded as completers if they 
continue in the current study (PS0016) until Week 28 (ie, and completed the Week 28 visit).

From Week 20 through Week 28, subjects who were previously PASI25 responders but 
subsequently relapse will undergo the study assessments for that visit (ie, Week 20, Week 24 
or Week 28) before receiving the first dose of IMP in the extension study. Subjects may also 
enter the extension study after the SFU Visit at Week 36. All subjects eligible for the 
extension study must have the assessment for SFU conducted prior to entering the extension 
study. 
Thus, a subject entering the extension study is regarded as completing PS0016 if they have 
completed the last visit (ie, Week 20, Week 24 or Week 28) up to the point of entering the 
extension study.
In addition, the following listings will be presented by treatment group:

Subject disposition (all subjects screened [ES])

Study discontinuation (RS)

Visit dates (SS)

Subject analysis sets (all subjects screened [ES])
The listing of subject disposition will include the date of informed consent, date of 
randomization, date and time of first and last dose of IMP (in PS0016), date of premature 
termination (and primary reason) and date of final contact. The listing will also flag any subjects 
who entered the extension study, including the visit at which this occurred (ie, Week 20, 
Week 24, Week 28 or Week 36). If applicable, the date and reason for premature unblinding will 
also be included.
The listing of study discontinuation will include the reason for discontinuation and the total days 
on IMP.
The number of days on IMP will be calculated as follows:
.    !" = (    	
 −  	  	
 ) + 1 
[4]
5.2
Protocol deviations
Important protocol deviations will be identified and classified by the deviation types listed in the 
protocol deviation specification document. A listing of all important protocol deviations will be 
presented for all subjects in the RS and will include the deviation type and description. The 
number and percentage of subjects with important protocol deviations will be summarized by 
treatment group and for all subjects for each deviation type, based on the RS.


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6
DEMOGRAPHICS AND OTHER BASELINE 
CHARACTERISTICS
6.1
Derivation of variables
6.1.1
Calculation of body mass index
The BMI in kg/m2 is calculated based on the height (in m) and the weight (in kg) using the 
following formula:
#! = $	%ℎ/((	%ℎ)) 
[5]
The BMI will be reported to 1 decimal place.
6.1.2
Classification of age categories
Age will be classified into categories based on requirements for European Union Drug 
Regulating Authorities Clinical Trials (EudraCT) and clinicaltrials.gov reporting.
For the EudraCT reporting, the categories will include:

18 to <65 years

65 to <85 years

≥85 years
For the clinicaltrials.gov reporting, the categories will include:

≤18 years

19 to <65 years

≥65 years
6.1.3
Duration of disease
The duration of disease will be calculated as follows and will be presented in years to 1 decimal 
place:
*	 = [(  ,	% −  	%	)/365.25] 
[6]
In the event that the date of diagnosis is incomplete, it will be imputed to the most recent feasible 
date:

If only the day is missing, it will be imputed to the last day of the known month

If the day and month are missing, it will be imputed to December 31 in the known year

If the date of diagnosis is completely missing, the duration of disease will not be calculated


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6.2
Demographics
A by-subject listing of Baseline demographic characteristics will be presented by treatment 
group. This will include the year of birth (if available), age (in years), sex, race, ethnicity, height 
(in cm), weight at Screening (in kg) and BMI for all subjects screened. The age will be directly 
entered into the study database and will not be re-calculated for the statistical analysis.
All Baseline demographic characteristics (with the exception of year of birth) will be 
summarized by treatment group and for all subjects based on the SS. The summary of age will 
include descriptive statistics and categorical summaries, the latter based on requirements for 
EudraCT and clinicaltrials.gov reporting. 
The tabulation will be repeated for the FAS, only if the SS differs from the FAS.
Childbearing potential will be listed for the SS.
6.3
Other Baseline characteristics
The following Baseline characteristics will be presented in a by-subject listing for the SS:

*Duration of disease (including date of diagnosis)

*Percentage BSA involvement

*PASI total score

IGA score

*HADS-A and HADS-D scores

Previous use (ie, those therapies classified as past medications) of biologic therapy (Yes/No)
Baseline for each variable (where applicable) is defined in Table 3‒1.
The Baseline characteristics listed above will be summarized using descriptive statistics (for 
continuous variables only*). The IGA score will be summarized including the number and 
percentage of subjects with each specific IGA score. The previous use of biologic therapy
(Yes/No) will be summarized using number and percentage of subjects. Previous use of biologic 
therapies will be listed as part of the past medications for psoriasis (Section 6.5.1) and will be 
confirmed at the DEM.
The tabulation will be presented by treatment group and for all subjects based on the FAS.
6.4
Medical history and concomitant diseases
Medical history will be listed for the RS and summarized for the SS by treatment group and
overall, MedDRA system organ class (SOC) and preferred term (PT). The reported term will be 
included in the listing. The summary will include the number and percentage of subjects, and 
will be sorted alphabetically by SOC and by descending incidence of PT within each SOC, based 
on the ‘All Subjects’ column. A glossary of all medical history conditions will be presented for 
the RS including the SOC, PT and reported term.
Procedure history will be listed separately by treatment group for the procedure reported term 
based on the RS.
Concomitant medical procedures performed during the study will be listed for the RS.


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6.5
Past, prior, and concomitant medications
Past, prior and concomitant medications will be listed for the RS by treatment group and subject 
and summarized for the SS by WHODD Anatomical Main Group (Level 1), Pharmacological
Subgroup (Level 3) and PT. Tabulations will be presented by treatment group and for all 
subjects, with separate tabulations for prior (excluding past psoriasis medications) and 
concomitant categories. Concomitant medications will further be classified into ‘Treatment 
Period’ and ‘Post-Treatment Period’ medications as described in Section 6.5.4.
Past medications for the treatment of psoriasis (based on the information recorded on the 
psoriasis treatment history page of the case report form [CRF]) will be listed and tabulated 
separately. The listing will include the treatment name, treatment type (non-biologic systemic 
agent, biologic agent, phototherapy or photochemotherapy, topical prescription or 
non-prescription therapy, other) and reason for discontinuation. All other past medications will 
be summarized together with the prior medications.
All tabulations (excluding past psoriasis medications) will be sorted alphabetically by Level 1 
term, alphabetical Level 3 term within Level 1 and decreasing frequency of PT in the ‘All 
Subjects’ column. For past psoriasis medications the tabulations will be presented by treatment 
type as these medications will not be coded.
A glossary of all past, prior and concomitant medications will be presented for the RS including 
the Anatomical Main Group (Level 1), Pharmacological Subgroup (Level 3), PT and reported 
term.
6.5.1
Past medication definition
Past medications will include any medications that started and stopped prior to the first 
administration of IMP. Past medications are therefore a subset of prior medications and include 
any prior medication with a stop date prior to the date of first administration of IMP. Any 
medications recorded on the psoriasis treatment history page of the CRF will be considered as 
past medications.
6.5.2
Prior medication definition
Prior medications include any medications that started prior to the date of administration of the 
first dose of IMP. This includes medications that started prior to dosing and continued after.
6.5.3
Concomitant medication definition
Concomitant medications are medications taken at least 1 day in common with the study 
Treatment Period.
Any medication that started prior to dosing and continued after dosing will therefore be classified 
as both prior and concomitant. Such medications will therefore be counted in tabulations for both 
prior and concomitant categories.
Any medications with missing dates and/or times will be handled as described in Section 4.2.4 in 
order to classify them as prior or concomitant.


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6.5.4
Classification of concomitant medications
In order to allow for a comparative period across all subjects for incidence of concomitant 
medication usage, prior to the point at which subjects are eligible to enter the extension study, 
concomitant medications will be classified as follows:

Treatment Period medications: all concomitant medications taken at least once from the 
time of the first administration of IMP up until the Week 20 visit. Any medications taken on 
the date of the Week 20 visit will be included (ie, the cut off will be assumed to be at 
23:59 hours on the date of Week 20). Such medications will be designated as ‘Treatment 
Period’ medications in the tabulations. This will include medications that start prior to the 
Week 20 visit and are ongoing. Any subjects that withdraw prior to Week 20 will have 
Treatment Period medications cut off at 140 days relative to the first dose (ie, equivalent to 
20 weeks).

Post-Treatment Period medications: all concomitant medications with a start date/time 
after the Week 20 visit will be designated as ‘Post-Treatment Period’ medications in the 
tabulations. Thus, Post-Treatment Period medications will include only those medications for 
subjects not entering the extension study at all or those medications for subjects who enter 
the extension study at a later visit. For subjects that withdraw prior to Week 20, 
Post-Treatment Period medications are classified as those starting after 140 days relative to 
the first dose (ie, equivalent to 20 weeks).
7
MEASUREMENTS OF TREATMENT COMPLIANCE
Overall compliance will be examined in terms of completed injections, where 1 dose consists of 
2 sc injections. 
This will be calculated as follows and will be presented to 1 decimal place in the listings:
2
 34	 (%) =
[1007(8 *39  34  		/8 *39  74  		)]
[7]
The total number of expected injections will be derived relative to the date of premature 
discontinuation for subjects who do not complete the treatment period. For a subject completing 
the treatment as per protocol, the total number of expected injections is 6 (ie, 2 injections at each 
of Baseline, Week 4 and Week 16).
The calculated overall compliance will be listed by treatment group and subject, and summarized 
by treatment group, based on the SS. The summary will include both descriptive statistics for 
overall compliance (n, mean, SD, median, minimum and maximum) and the number and 
percentage of subjects based on the following classifications:

Compliance ≤75.0%

Compliance >75.0%
All data regarding IMP administration will be listed as described in Section 11.1.
8
EFFICACY ANALYSES
8.1
Statistical analysis of the primary efficacy variable
The primary efficacy variable is the change from Baseline in PASI at Week 28.


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8.1.1
Derivations of primary efficacy variable
The PASI is the most commonly used assessment for grading the severity of psoriasis in clinical 
studies and quantifies the severity and extent of the disease and weighs these with the percentage 
of BSA involvement. The body is divided into four regions comprising the head (h), upper 
extremities (ue), trunk (t), and lower extremities (le). In each of these regions, the total surface 
area-of-involvement (A) is graded on a scale of 0 to 6 (0 for no involvement up to 6 for 90% -
100% involvement). The body regions and associated BSA are presented in Table 8‒1.
Table 8‒1:
Body regions for calculation of percent BSA for PASI
Body region
Details of region
BSA
Area-of-
involvement of 
body region (A) a
Head (h)
Face, back of head
10%
0 to 6
Upper limbs (ue)
Left, right, upper lower, flexor surface, 
extensor surface
20%
0 to 6
Trunk (t)
Front, back, groin
30%
0 to 6
Lower limbs (le)
Left, right, upper lower, flexor surface, 
extensor surface, including buttocks
40%
0 to 6
Total
100%
A=area-of-involvement score; 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.
.
Scoring of psoriatic plaques for the PASI is based on 3 criteria: redness (R), thickness (T), and 
scaliness (S). Severity is rated for each index (R, T, S) on a scale of 0 to 4 (0=none, 1=slight, 
2=moderate, 3=marked, and 4=very marked). 
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
(R, T and S) for each region by the weighted area-of-involvement score (A) for that respective 
region, and then summing the 4 resulting quantities as follows:
PASI = 0.17[(ℎ+ 8ℎ+ ,ℎ)7:ℎ] + 0.27[(* + 8* + ,*)7:*] + 
  0.37[( + 8 + ,)7:] +  0.47[( + 8 + ,)7:]
[8]
The following rules will be applied in the calculation of the PASI score in case of missing 
data:

If 1 or 2 severity measurements are missing for a certain region (eg, head), the average of the 
remaining measurements within that region will be utilized to substitute the missing values

If the area of affected skin and/or all severity measurements for 1 or 2 regions are missing, 
then the missing (R+T+S)×A for a region will be substituted by the average of the available 
(R+T+S)×A across the remaining regions

If the PASI assessment has more missing data than indicated above, at a given visit, then the 
PASI will be set to missing for that visit


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The highest potential PASI score is 72 for severe disease; the lowest score is 0 which indicates 
no psoriatic lesions are present. The PASI scores are considered as a continuous variable and will 
be calculated and presented to 1 decimal place in the listings. The percentage improvement in 
PASI score from Baseline will be calculated as follows:
Percentage improvement from Baseline = 1007[(#	 ":, −"#	 ":,)/
#	 ":,]   [9]
Thus, for subjects with an improvement in the PASI score, the percentage will be positive. For 
subjects with a worsening in the PASI score, the percentage will be negative.
8.1.2
Primary analysis of the primary efficacy variable
The individual scores for the PASI for each body region (redness, thickness and scaliness
severity scores and area-of-involvement score [A]), and the derived total PASI score (from 0 to 
72) will be listed for each subject and visit. The listing will include the change from Baseline and 
percentage change from Baseline for the total score only.
Descriptive statistics (including 95% CI) will be presented by treatment group and visit for 
absolute values, changes from Baseline and percentage change from Baseline (based on the total 
PASI score only). For the purpose of the tabulations the lower and upper 95% confidence limits 
will be truncated as follows:

For the absolute values the lower 95% confidence limit will be truncated at 0 and the upper 
95% confidence limit will be truncated at 72

For the changes from Baseline the lower 95% confidence limit will be truncated at -72 and 
the upper 95% confidence limit will be truncated at +72

For the percentage change from Baseline the upper 95% confidence limit will be truncated at 
+100%, there will be no truncation of the lower 95% confidence limit
The following figures will be presented:

Combined individual (spaghetti) plots displaying percentage change from Baseline in PASI 
score versus time (visit) by treatment group (all subjects will be overlaid on the same plot 
with separate plots for each treatment group)

Mean (with 95% CI) percentage change from Baseline in PASI score versus time (visit) by 
treatment group (both treatment groups will be overlaid on the same plot)
All tabulations and both individual and mean figures will be presented using the FAS and 
repeated for the PPS (if it differs from the FAS). All listings will be presented using the SS.
For subjects that discontinue the study or those that enter the extension study, missing data will 
be imputed using LOCF as described in Section 4.2.1.1 for the tabulations and mean figures.
Separate tables and mean figures will also be created based on the observed cases only. Missing 
data will not be imputed for the listings or the individual figures.
8.2
Statistical analysis of the secondary efficacy variables
The secondary efficacy variables are:

PASI75, PASI90 and PASI100 response at Week 16


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
IGA response (Clear or Almost Clear with at least a 2 category improvement from Baseline) 
at Week 16
The analysis of the secondary efficacy variables will be based on the FAS for all tabulations and 
figures. Listings will be based on the SS.
8.2.1
Psoriasis Area and Severity Index response variables at Week 16
The PASI75, PASI90, and PASI100 responses are based on at least 75%, 90%, and 100% 
improvement from Baseline in the PASI score. Thus, the following will apply:

If the percentage improvement is ≥75% then the subject is a PASI75 responder

If the percentage improvement is ≥90% then the subject is a PASI90 responder (and is a 
PASI75 responder also)

If the percentage improvement is 100% then the subject is a PASI100 responder (and is a 
PASI75 and PASI90 responder also)
The number and percentage of subjects achieving a PASI75, PASI90, and PASI100 response at 
Week 16 will be tabulated by treatment group. The 95% CI for the percentage of responders will 
be calculated using a Wilson approximation and included in the tabulation. For the purpose of 
the tabulation the lower and upper 95% confidence limits for the percentage of responders will 
be truncated at 0 and 100% respectively.
Missing data will be imputed using NRI as described in Section 4.2.1.1. Subjects with missing 
data at Week 16 will be regarded as nonresponders for the PASI75, PASI90, and PASI100
variables. This will also be presented using observed cases. Missing data will not be imputed for 
the listing.
The individual PASI scores will be listed as described in Section 8.1.2. Subjects achieving a 
PASI75, PASI90 and PASI100 response at each visit will be flagged in the listing.
8.2.2
Investigator’s Global Assessment Response at Week 16
A static IGA for psoriasis will be used to assess disease severity in all subjects during the study. 
The Investigator will assess the severity of psoriasis using a 5-point scale (Table 8‒2). 


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Table 8‒2:
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
A clinical response with regard to the IGA is defined as clear (0) or almost clear (1) with at least 
a 2-category improvement from Baseline.
The results of the IGA will be listed by subject and visit. Subjects achieving a clinical response 
at Week 16 will be flagged in the listing. 
The number and percentage of subjects achieving an IGA response at Week 16 will be 
summarized by treatment group. The 95% CI for the percentage of responders will be included, 
calculated using a Wilson approximation. For the purpose of the tabulation the lower and upper 
95% confidence limits for the percentage of responders will be truncated at 0 and 100% 
respectively.
Missing data will be imputed using NRI as described in Section 4.2.1.3. Subjects with missing 
data at Week 16 will be regarded as nonresponders for the analysis. Missing data will not be 
imputed for the listing.
8.3
Analysis of other efficacy variables

Absolute and percentage change from Baseline in PASI with time (Week 2 to Week 36)

PASI75, PASI90 and PASI100 response at Weeks 2, 4, 8, 12, 20, 24, 28 and 36

PASI25 and PASI50 response (Week 2 to Week 36)

IGA response (Clear or Almost Clear with at least 2-category improvement from Baseline) at 
Weeks 2, 4, 8, 12, 20, 24, 28 and 36

Change from Baseline in IGA score with time (Week 2 to Week 36)

Change from Baseline in the BSA affected by psoriasis with time (Week 2 to Week 36)

Change from Baseline in HADS-A and HADS-D scores with time (Week 4 to Week 36)

Percentage of subjects with scores below 8 in HADS-A and HADS-D (subjects with normal 
scores) at each post-Baseline visit (Week 4 to Week 36)
Tabulations and figures will be based on the FAS and listings will be based on the SS.


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8.3.1
Psoriasis Area and Severity Index
The absolute values and percentage change (improvement) from Baseline in the PASI score will 
be summarized as described in Section 8.1.2.
The PASI25 and PASI50 responses are based on at least 25% and 50% improvement from 
Baseline in the PASI score. Thus, the following will apply:

If the percentage improvement is ≥25% then the subject is a PASI25 responder

If the percentage improvement is ≥50% then the subject is a PASI50 responder (and is a 
PASI25 responder also)
The definitions of PASI75, PASI90 and PASI100 response are provided in Section 8.2.1. 
Subjects meeting the definition for PASI75, PASI90 and PASI100 response are also considered 
as PASI25 and PASI50 responders at the respective visit.
The number and percentage of subjects achieving a PASI25, PASI50, PASI75, PASI90 and 
PASI100 response will be tabulated by treatment group and visit. The 95% CI for the percentage 
of responders will be calculated using a Wilson approximation and included in the tabulation. In 
addition, the percentage of responders (including 95% CI) will be plotted at each post-Baseline 
visit for each response variable. Separate plots will be presented for each of PASI25, PASI50, 
PASI75, PASI90 and PASI100 with both treatment groups overlaid on the same plot
Missing data will be imputed using NRI as described in Section 4.2.1.1. Subjects with missing 
data will be regarded as nonresponders for each of the response variables. Missing data will not 
be imputed for the listing.
The tables and figures for PASI response variables will also be repeated using observed cases
and will include a category for missing data; subjects who enroll in the extension study or those 
who discontinue will be counted in the missing category for this tabulation where applicable. For 
this tabulation based on observed cases the denominator for the percentage of responders and 
nonresponders will be the number of subjects with nonmissing data at the visit.
The individual PASI scores will be listed as described in Section 8.1.2. Subjects achieving a 
PASI25 and PASI50 response at each visit will be flagged in the listing.
8.3.2
Investigator’s Global Assessment 
The IGA results will be listed by subject and visit as described in Section 8.2.2. Subjects 
achieving a clinical response (clear [0] or almost clear [1] with at least a 2-category improvement 
from Baseline) at each visit (Weeks 2, 4, 8, 12, 20, 24, 28 and 36) will be flagged in the listing as 
responders.
The number and percentage of responders at each post-Baseline visit (Weeks 2, 4, 8, 12, 20, 24, 
28 and 36) will be summarized by treatment group as described in Section 8.2.2. The 95% CI for 
the percentage of responders will be included, calculated using a Wilson approximation. The 
percentage of responders (with 95% CI) will also be plotted over time.
Missing data for the IGA response at a specific visit will be imputed using NRI as described in 
Section 4.2.1.3. Subjects with missing data will be regarded as nonresponders for the analysis. 
Missing data will not be imputed for the listing. The table and figure will also be repeated using 
observed cases and will include a category for missing data; subjects who enroll in the extension 


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study or those who discontinue will be counted in the missing category for this tabulation where 
applicable. For this tabulation based on observed cases the denominator for the percentage of 
responders and nonresponders will be the number of subjects with nonmissing data at the visit.
In addition to the IGA responder tabulations, shift tables will be presented including the change 
in IGA individual scores at Week 8, Week 16 and Week 24, compared to the Baseline score. In 
addition, a frequency table will be presented showing the number and percentage of subjects 
with each specific IGA score at each visit. Both tabulations will include a category for missing 
data. The denominator for the percentages will be the number of subjects in the FAS, for each 
treatment group. 
8.3.3
Body surface area
The percentage BSA (0 to 100%) affected by psoriasis will be listed by subject and visit 
including the percentage change from Baseline. Descriptive statistics will be presented by 
treatment group and visit for both absolute values and percentage changes from Baseline.
For subjects that discontinue the study or those that enter the extension study, missing data will 
be imputed using LOCF for the tabulations as described in Section 4.2.1.2. Missing data will not 
be imputed for the listing.
Tabulations (absolute values and percentage change from Baseline) will also be repeated using 
observed cases.
8.3.4
Hospital Anxiety and Depression Scale
The HADS scores for anxiety (HADS-A) and depression (HADS-D) each range from 0 to 21 
with higher scores indicating worse state. A score below 8 is considered to be normal whereas a 
score of 15 and above is considered severe (Snaith and Zigmond, 1994). The individual items, 
associated item scores and calculation rules for the anxiety and depression domains are provided 
in Section 14.2.
The results of the HADS will be listed by subject and visit including the individual item 
responses and the derived domain scores for anxiety (HADS-A) and depression (HADS-D). 
Changes from Baseline will be calculated based on the domain scores only, and will be included 
in the listing.
Descriptive statistics will be presented by treatment group and visit for both absolute values and 
changes from Baseline, separately for each domain (HADS-A and HADS-D). The number and 
percentage of subjects with scores <8 for the HADS-A and HADS-D will be summarized by 
treatment group at each visit. The percentages will be based on the number of available 
observations at each visit; the number of subjects with missing data (including subjects who 
enroll in the extension study) will be included in the tabulation.
There will be no imputation of missing data for the HADS scores, either for the descriptive 
statistics or frequency tables.
9
PHARMACOKINETICS AND PHARMACODYNAMICS 
9.1
Pharmacokinetics
There will be no calculation of PK parameters for this study.  The analysis of PK data for this 
study will focus on the concentrations of bimekizumab only.


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The actual blood sampling times for bimekizumab concentrations will be obtained relative to the 
start time of the first injection and will be reported in weeks to 1 decimal place. Individual blood 
sampling times and concentrations of bimekizumab will be listed by treatment group for the SS 
and will include the actual sampling time in weeks relative to the first dose.
Individual concentrations will be summarized by treatment group at each scheduled visit based 
on the PK-PPS, using n, mean, median, SD, minimum, maximum, geometric mean, 95% CI for 
the geometric mean and geoCV (assuming log-normally distributed data).
Individual concentration versus time (week) profiles will be presented graphically in linear and 
semi-logarithmic scale with all subjects overlaid on the same plot (spaghetti plots) and separate 
plots for each treatment group. Geometric mean profiles of bimekizumab will also be presented 
on both linear and semi-logarithmic scale respectively with and without the corresponding lower 
and upper limit of the 95% CI for linear and semi-logarithmic plots respectively. Both treatment 
groups will be overlaid on the same plot. All figures will include the LLOQ on the 
semi-logarithmic plots.
The following rules will apply for PK data listings and summaries:

Values below the LLOQ will be reported as BLQ

Descriptive statistics of concentrations will be calculated if at most ⅓ of the individual data 
points are missing or are not quantifiable (<LLOQ). Values that are BLQ will be replaced by 
the numerical values of the LLOQ/2 in this instance. However, if n≤3 or more than ⅓ of the 
individual data points are missing or are not quantifiable, then only n, minimum and 
maximum will be presented. The other descriptive statistics will be left blank.

The 95% CI for the geometric mean should be left blank if the SD (or equivalently, the 
geoCV) is 0

The geoCV will be calculated using the following formula where SD is the standard 
deviation from the log-transformed data
%<= = [1007>(?@A −1)]
[10]
Additional rules for handling values that are BLQ are described in Section 4.2.3.
9.2
Pharmacodynamics
The results of the PD assessments (flow cytometry variables) will be listed by treatment group 
and subject (based on the SS) including changes from Baseline. 
Absolute values and changes from Baseline will be summarized (including 95% CI) by treatment 
group based on the PD-PPS. 
Figures of mean and mean changes from Baseline (including 95% CI) will be presented with 
separate plots for each variable and both treatment groups overlaid on the same plot.
The list of flow cytometry variables to be measured is provided in Section 14.3.
9.3
Pharmacokinetic/pharmacodynamic analyses
A pooled PKPD analysis will be performed by combining the data from this study (PS0016) with 
the data from PS0010. The methodology for the PK/PD analysis will be described in a separate 


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data analysis plan (DAP). The results of the analysis will be reported in a separate PK/PD report 
and added as an appendix to the CSR.
10
IMMUNOLOGICAL ANALYSES
The results for the ADA measurements will be listed by treatment group and timepoint based on 
the SS, including the Screening assay, confirmatory assay and titre (if applicable). 
A cut point will be determined by the bioanalytical laboratory that will be used to determine the 
status of ADA as above the cut point (ACP) or below the cut point (BCP). For any ADA levels 
that are ACP, a further confirmatory assay will be performed, the results of which will be 
determined as either ‘confirmed positive’ (CP) or ‘not confirmed positive’ (NCP). For samples 
that are CP, a further titre assay will be performed and the ADA titre will be reported. 
The following definitions will be applied:

An ADA status of positive will be concluded for any subject with an ADA level that is ACP 
and CP at any timepoint 

An ADA status of negative will be concluded for any subject with an ADA level that is either 
BCP or ACP and NCP at any timepoint

A subject will be classified as having ADA positivity at Baseline if the Day 1, predose result 
is ACP and CP

A subject will be classified as having treatment-induced ADA positivity when meeting one 
of the following criteria:

The Baseline result is either BCP or ACP and NCP, and at least one post-Baseline 
timepoint is ACP and CP

The Baseline result is positive (ACP and CP) and at least one post-Baseline measurement 
shows a pre-defined fold increase in titre from the Baseline value (the fold increase from 
Baseline required to meet this criteria will be defined with the development of the assay 
and will be included in the TFLs)

A subject will be classified as overall positive if at least one post-Baseline measurement is 
ACP and CP (this includes subject who have negative results at Baseline)

A subject will be classified as overall negative if at all post-Baseline visits the ADA status is 
negative (this includes subjects who have positive [ACP and CP] results at Baseline)
The ADA status (positive/negative) will be summarized as a categorical endpoint (number and 
percentage of subjects) by treatment group for all timepoints and overall, based on the SS. 
In addition, the first occurrence of treatment-induced ADA positivity (based on the definitions 
above) will be summarized (number and percentage of subjects) by treatment group at each 
post-Baseline visit, based on the SS. This tabulation will count the number of subjects at each 
post-Baseline visit who fulfill at least one of the above defined criteria for treatment-induced 
positivity; subjects will be counted in the numerator based on the earliest visit at which one of 
these criteria is fulfilled. At other visits, subjects will be counted in the denominator (assuming a 
measurement is available). For all tabulations, percentages will be based on the number of 
observations at each visit.


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A separate listing will be presented (based on the SS) showing the bimekizumab concentrations 
and ADA measurements in the same output in adjacent columns. The listing will include the 
bimekizumab concentration, ADA status (ACP or BCP) and confirmatory assay results if 
applicable (NCP or CP), together with the titre for results that are CP. In addition, the time since 
the previous administration of IMP will be reported (in days).
Finally, individual subject plots will be presented displaying the PASI total score, ADA titre and 
bimekizumab concentrations overlaid on the same figure. The figure will also show the timing 
and dose of each administration of bimekizumab (or placebo) received during the study. The 
ADA data will be plotted using a semi-logarithmic scale.
The rules for handling values that are BLQ in the bimekizumab concentration data are described 
in Section 4.2.3. For the ADA data, any negative results for which there are no titres available at 
a specific visit will be substituted with 0.001 for the purpose of the figure.
11
SAFETY ANALYSES
All analysis of safety variables will be performed using the SS, unless otherwise stated.
11.1
Extent of exposure
11.1.1
Drug administration
All drug administration details (including date, time of injection, location, side of body and 
volume delivered) will be listed. The IMP will be given as 2 sc injections at each planned dosing 
visit (Baseline, Week 4 and Week 16).
11.1.2
Number of injections received
The number of injections received will be summarized by treatment group using descriptive 
statistics, based on the SS. There are anticipated to be 2 injections per dosing visit, ie, a total of 6 
injections for subjects that completed the treatment as planned.
11.1.3
Subject time at risk
The subject time at risk represents the time a subject was at risk for having an AE and will be 
used to calculate the exposure adjusted incidence rate (EAIR) and exposure adjusted event rate 
(EAER) as described in Section 11.2.
The subject time at risk (days) will be calculated as follows:
8	3  	B = (    −  	 ) + 140 
[11]
In cases where the last clinical contact or last visit occurs prior to completion of the SFU period, 
the subject time at risk is calculated as follows:
8	3  	B = (   < −  	 ) + 1 
[12]
This will apply for the following:

For subjects entering the extension study the date of last contact (in PS0016) refers to the
date of the visit at which they enter the extension study (ie, Week 20, 24, 28 or 36)

For subjects that discontinue prematurely (ie, and no SFU data are available), the date of 
final contact refers to the date of the latest contact with the subject during the study after 


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which no further information or data are available. This will be reported on the study 
termination page of the CRF.

For subjects that have died during the study the date of last contact refers to the date of death
Subject-years at risk is defined as the subject time at risk divided by 365.25. The days at risk and 
subject-years at risk will be listed together with the drug administration information
(Section 11.1.1).
11.2
Adverse events
11.2.1
Definitions and classification of adverse events
All AEs will be recorded in the CRF from informed consent until study completion or 
termination. 
Adverse events with start date prior to the first administration of IMP are defined as 
pre-treatment AEs. A TEAE is defined as any AE with a start date/time at the time of or after the 
first administration of IMP up until the last received dose of IMP + 140 days (which covers the 
20 week SFU Period). Adverse events occurring after this date will not be classified as TEAEs 
and will therefore be excluded from the summary tables.
Where dates are missing or partially missing, AEs will be assumed to be treatment-emergent, 
unless there is clear evidence to suggest that the AE started prior to dosing. Handling of missing 
dates/times for classification of AEs as TEAEs is described in Section 4.2.4.
In order to allow for a comparative period across all subjects, prior to the point at which subjects 
are eligible to enter the extension study, TEAEs will be classified as follows:

Treatment Period TEAEs: all TEAEs with onset at the time of or after the first 
administration of IMP up until the Week 20 visit. Any TEAEs that occur on the date of the 
Week 20 visit will be included (ie, the cut off will be assumed to be at 23:59 hours on the 
date of Week 20). Such TEAEs will be designated as ‘Treatment Period’ TEAEs in the 
tabulations. Any subjects that withdraw prior to Week 20 will have Treatment Period TEAEs 
cut off at 140 days relative to the first dose (ie, equivalent to 20 weeks).

Post-Treatment Period TEAEs: all TEAEs with onset after the Week 20 visit up until the 
last dose of IMP + 140 days will be designated as ‘Post-Treatment’ TEAEs in the 
tabulations. Thus, any tabulation including Post-Treatment TEAEs will include only those 
TEAEs for subjects not entering the extension study at all or those TEAEs for subjects who 
enter the extension study at a later visit. For subjects that withdraw prior to Week 20, 
Post-Treatment Period TEAEs are classified as those starting after 140 days relative to the 
first dose (ie, equivalent to 20 weeks).
For the EAIR and EAER tabulations the above classifications will not be applicable, as these 
summaries are, by definition, adjusted for the individual exposure at risk for each subject.
All AEs will be coded and categorized by intensity (mild/moderate/severe) and relationship to 
IMP (related/not related).
11.2.2
Calculation of exposure adjusted incidence and event rates
The EAIR is defined as the number of subjects (n) with a specific TEAE adjusted for the 
exposure and will be scaled to 100 subject-years:


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: = 100 ×
D
∑
FGHI,K
L
KMN
[13]
In the above equation, N is the total number of subjects at risk (in each treatment group) and 
8OPQ,R is the time at risk for subject 	, expressed in years. Subject time at risk represents the time 
a subject was at risk for having a TEAE calculated as follows:

For subjects experiencing the specific TEAE the time at risk (8OPQ,R) is calculated from the 
time of the first dose to the onset of the TEAE. If a subject has multiple events, the time at 
risk is calculated relative to the first occurrence of the TEAE being considered.  

For subjects who do not experience the specific TEAE the total time at risk (8OPQ,R) is 
calculated as described in Section 11.1.3.
Exact Poisson 95% CIs (lower confidence limit [LCL], upper confidence limit [UCL]) for the 
EAIR will be calculated using the relationship between the Poisson and the chi-square 
distribution (Fay and Feuer, 1997):
< =
SAT,U
A
A
)
,   V< =
SA(TWN),NXU
A
A
)
[14]
where  is the number of subjects with the specific TEAE for the incidence rate of interest and is 
the basis for the number of the degrees of freedom for the chi-square quantile. The LCL and 
UCL calculated above will be scaled to the number of subject-years by dividing these by the total 
exposure at risk for each treatment group (∑
8OPQ,R
Y
RZ[
).
The EAER is defined as the total number of TEAEs (including repeat occurrences in individual 
subjects) divided by the total time at risk scaled to 100 subject-years:
: = 100 ×
D\G
∑
F]K^_,K
L
KMN
[15]
where `O is the total number of TEAEs and 8aRbc,R is the time at risk for subject 	, expressed in 
years (calculated as described in Section 11.1.3).
No confidence intervals will be computed for EAER.
11.2.3
Presentation of adverse events
An overview of the number and percentage of subjects who experience TEAEs will be presented 
by treatment group (including All Subjects), based on the SS. This tabulation will include the 
number and percentage of subjects with any TEAEs, serious TEAEs, related TEAEs, 
discontinuation due to TEAEs, severe TEAEs, AEs leading to death and TEAEs leading to death; 
event counts will also be included. The tabulation will be repeated for Treatment Period TEAEs 
and Overall TEAEs.
In addition, the following summaries will be presented by treatment group (including All 
Subjects), SOC, high level term (HLT) and PT, based on the SS:

Incidence of TEAEs during Treatment Period

Incidence of TEAEs Overall

Incidence of serious TEAEs during Treatment Period

Incidence of serious TEAEs Overall


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
Incidence of non-serious TEAEs during Treatment Period

Incidence of non-serious TEAEs Overall

Incidence of TEAEs during Treatment Period by relationship

Incidence of TEAEs Overall by relationship

Incidence of TEAEs during Treatment Period by maximum relationship

Incidence of TEAEs Overall by maximum relationship

Incidence of TEAEs during Treatment Period by maximum intensity

Incidence of TEAEs Overall by maximum intensity

Incidence of fatal TEAEs during Treatment Period by relationship

Incidence of fatal TEAEs Overall by relationship

Incidence of non-serious TEAEs during Treatment Period by relationship

Incidence of non-serious TEAEs Overall by relationship

Incidence of serious TEAEs during Treatment Period by relationship

Incidence of serious TEAEs Overall by relationship

Incidence of non-serious TEAEs during Treatment Period above threshold of 5% of subjects

Incidence of non-serious TEAEs Overall above threshold of 5% of subjects

Incidence of non-serious TEAEs during Treatment Period above threshold of 5% of subjects 
by relationship

Incidence of non-serious TEAEs Overall above threshold of 5% of subjects by relationship

Incidence of TEAEs during Treatment Period by SOC and PT (including the number and 
percentage of subjects and individual subject numbers/reported terms for each PT stratified 
by intensity, relationship and seriousness)

Incidence of TEAEs (including all TEAEs during Treatment and Post-Treatment Periods) by 
SOC, HLT and PT and including the EAIR and EAER calculated as described in 
Section 11.2.2

Incidence of TEAEs (including all TEAEs during Treatment and Post-Treatment Periods) by 
SOC, HLT and PT and including the EAIR and EAER, stratified by overall ADA status 
(positive/negative)
In addition, separate AE summaries by treatment group, SOC, HLT and PT (including all TEAEs 
during Treatment and Post-Treatment Periods combined) will be included for the following AEs 
of special monitoring (AESM):

Major cardiovascular events 

Serious infections, including opportunistic infections and tuberculosis (TB)

Malignancies including lymphoma


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
Cytopenias

Neuropsychiatric events (in particular, depression and suicide)

Inflammatory bowel disease

Anaphylactic reaction (hypersensitivity and anaphylactic reactions)

Hepatic events and drug-induced liver injury
All summary tables (including those for AESM) will contain the number and percentage of 
subjects and the number of events where applicable. A subject who has multiple events in the 
same SOC, HLT and PT will be counted only once in the subject counts but all events will be 
included. In addition, for all tabulations of AESM, the EAER and EAIR will be reported.
The criteria for identifying AESM and additional criteria for reporting AESM are provided in 
Section 14.6.
In summaries including relationship to IMP, the following relationship categories will be 
included:

Related

Not related
Subjects who experience the same event multiple times will be included in the most related 
category for tabulations by maximum relationship. Events with missing relationship will be 
considered as ‘Related’ for summary purposes but shown as missing in the data listings.
In summaries including intensity, the following categories will be summarized:

Mild

Moderate

Severe
Subjects who experience the same event multiple times will be included in the most severe 
category for tabulations by maximum intensity. Events with missing intensity will be considered 
as severe for summary purposes. All data will be presented as recorded in the database for the 
listings.
Adverse event summaries will be ordered by alphabetical SOC, alphabetical HLT within SOC 
and decreasing frequency of PT in the ‘BKZ 320mg’ (Treatment arm B) column for tables 
including event counts. For tables including only number and percentage of subjects, summaries 
will be ordered by alphabetical SOC, alphabetical HLT within SOC and decreasing incidence of 
PT within HLT and SOC in the ‘BKZ 320mg’ (Treatment arm B) column.
Listings will be presented by treatment group and subject for all AEs, serious adverse events 
(SAEs), AEs leading to death and AEs leading to discontinuation. Listings will include the onset 
date/time and outcome date/time of the event (including relative days), the AE duration 
(derived), days since first dose of IMP, days since most recent dose of IMP, pattern of event, 
intensity, relationship, action taken and outcome. In addition the listing will flag AEs that led to 
discontinuation, TEAEs (including classification as ‘Treatment Period’ and ‘Post Treatment’ 
TEAEs), AESM, AEs of special interest (as reported on the CRF) and SAEs.


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All AE listings will be based on all subjects screened (ES). A glossary of all TEAE terms will be 
provided including the SOC, HLT, PT and reported term.
11.3
Clinical laboratory evaluations
Laboratory data (clinical chemistry, hematology, and urinalysis) and changes from Baseline (if 
applicable) for numeric variables will be listed by treatment group and visit. Any laboratory 
variables with values that are BLQ or ALQ will be handled as described in Section 4.2.2 for 
calculation of changes from Baseline and for summary tables. Values outside the reference range 
for the numeric variables will be flagged in the listings and in addition, will be listed separately. 
The reference ranges will also be reported in the listings.
Clinical chemistry and hematology variables will be summarized by treatment group (including 
All Subjects) at each visit, for both absolute values and changes from Baseline.
Laboratory variables will be grouped according to the laboratory function panel and categorized 
as normal, high or low, if applicable, based on the reference range supplied by the analytical 
laboratory. For selected variables that are identified in Table 11-1, the change in category from 
Baseline will be presented in shift tables at all post-Baseline visits.
The number and percentage of subjects with treatment-emergent markedly abnormal (TEMA)
laboratory results (to match the TEAE definition stated in Section 11.1.3) will be tabulated by 
treatment group and visit. Markedly abnormal laboratory values will be defined as those 
categorized as Grade 3 and above based on the ranges defined as per the Common Terminology 
Criteria for Adverse Events (CTCAE) Version 4.03 (2016). These are provided in Table 14‒4.
The tabulation will include a category for the incidence of TEMA results over all visits which 
will also count unscheduled measurements.
In addition, for absolute neutrophil count (ANC), all grade 2 CTCAE abnormalities (<1.5 – 1.0
x109/L) will be listed separately, with results from all visits for any subject that has any grade 2 
abnormality.
Laboratory measurements meeting the criteria for TEMA will be listed separately for 
hematology and chemistry. The listings will include all measurements for any variable with at 
least one TEMA result for each subject.
Any additional laboratory variables not included in the outputs described previously will be 
listed separately. These will include the following:

Serology 

Pregnancy tests (serum and urine)

Follicle stimulating hormone (FSH) (only for postmenopausal women)
The results of the Quantiferon TB Gold test will be listed separately.
Subjects with treatment-emergent liver function test abnormalities at any post-Baseline visit will 
be summarized (number and percentage of subjects) by treatment group. The criteria for this 
tabulation are presented in Section 14.5.


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Table 11‒1: Clinical laboratory measurements
Category
Panel
Variable
Serology
Serology
HIV1-Ab, HIV2-Ab, HBsAg,
anti-HBc, anti-HBs, anti-HCV-
Ab, TB
Hematology
Red blood cell
RBC counta, hemoglobin, 
hematocrit
Red blood cell indices
MCH, MCHC, MCV
Platelet
Platelets
White blood cell
WBC counta
White blood cell differential
Absolute counts: ANCa,
basophils, eosinophils, ALC, 
monocytes, atypical lymphocytes
(if indicated)
Percentages: 
neutrophils/leukocytes, 
basophils/leukocytes, 
eosinophils/leukocytes, 
lymphocytes/leukocytes, 
monocytes/leukocytes.
Chemistry
Electrolytes
Sodium, chloride, potassium, 
calcium, magnesium
Kidney function
BUN, creatinine
Liver function
ASTa, ALTa, GGTa, ALPa, LDHa, 
total bilirubin (direct bilirubin, 
indirect bilirubin, if indicated)
Lipids
Total cholesterola
Metabolic function
Glucose
Hormones
FSHb
Fertility
Pregnancy testc
Other
CRP
Urinalysis
Dipstick
pH, protein, blood, leukocyte 
esterase, nitrite, glucose


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Table 11‒1: Clinical laboratory measurements
Category
Panel
Variable
Urine sediment (if indicated)
WBC, RBC, epithelial cells 
(squamous, transitional and renal 
tubular), hyaline casts, WBC 
casts, RBC casts, waxy casts, 
granular casts, calcium oxalate 
crystals, uric acid crystals, 
triphosphate crystals, yeast, 
bacteria, amorphous urates,
amorphous phosphates 
ALC=absolute lymphocyte count; ALP=alkaline phosphatase; ALT=alanine aminotransferase; ANC=absolute 
neutrophil count; AST=aspartate aminotransferase; BUN=blood urea nitrogen; CRP=C-reactive protein; 
FSH=follicle stimulating hormone; GGT=gamma glutamyltransferase; anti-HBc= hepatitis B core antibody; 
anti-HBs=hepatitis B surface antibody; HbsAg=hepatitis B surface antigen; HCV-Ab=hepatitis C virus antibody; 
HIV1-Ab=human immunodeficiency virus 1 antibody; HIV2-Ab= human immunodeficiency virus 1 antibody; 
LDH=lactate dehydrogenase; MCH=mean cell hemoglobin; MCHC=mean cell hemoglobin concentration; 
MCV=mean cell volume; RBC=red blood cell; TB=tuberculosis; WBC=white blood cell.
a Shift tables will be presented for these variables.
b FSH performed on postmenopausal females who have been postmenopausal for >=1year and last menstrual cycle 
occurred <2 years ago.
c Pregnancy testing will consist of serum testing at the Screening and SFU visits. The pregnancy test will be urine at 
all other visits and will be performed locally. If the subject is entering the extension study, a urine pregnancy test 
will be performed at SFU.
11.4
Vital signs, physical findings, and other observations related to 
safety
11.4.1
Vital signs
The following vital signs measurements will be obtained:

Pulse rate

Systolic and diastolic blood pressure

Temperature (oral or otic)
A by-subject listing of all vital sign measurements and changes from Baseline will be presented 
by treatment group and visit. The listing will include a flag for measurements identified as 
TEMA/potentially clinically significant (PCS) as calculated by the criteria outlined in Table 14‒
6. 
Descriptive statistics will be reported for all vital sign measurements. Measured values and 
changes from Baseline will be summarized by vital signs variable and visit for each treatment 
group. 
The number and percentage of subjects with TEMA/PCS vital sign values (to match the TEAE 
definition stated in Section 11.1.3) will be summarized by treatment group (including All 
Subjects) and variable at each visit and overall (ie, across all post-Baseline visits).


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11.4.2
Body weight
A by-subject listing of body weight will be presented, including changes from Baseline. No 
summary tabulations will be provided for this variable.
11.4.3
Electrocardiograms
Standard 12-lead ECG recordings will be obtained after 10 minutes of rest in the supine or 
semirecumbent position. The following ECG variables will be reported together with the 
Investigator’s interpretation of the ECG profile:

PR interval

QRS interval

QT interval

Heart rate

QT corrected for heart rate using Fridericia’s formula (QTcF)
The results of all ECG variables will be reported in the by-subject listings. The listing will also 
include the change from Baseline and will be presented by treatment group and visit.
Measured values and changes from Baseline will be summarized for each variable by treatment 
group and visit. 
The following cut-points in QTcF (raw data and change from Baseline) will be summarized 
categorically by treatment group (number and percentage of subjects) and visit. The denominator 
for the percentages will be the number of subjects with a non-missing measurement for the 
variable at the specific visit.
Raw QTcF data:

<450msec

≥450 msec to <480msec

≥480msec to <500msec

≥500msec
Change from Baseline QTcF:

<30msec

≥30msec to <60msec

≥60msec
Electrocardiogram findings will be listed separately.
11.4.4
Other safety variables
11.4.4.1
Physical examination
Subjects with abnormalities in the physical examination will be listed including details of the 
abnormality.


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11.4.4.2
Chest x-ray and TB questionnaire
The results of the chest x-ray and the TB questionnaire will be listed for each subject. For the 
former listing, the date of the procedure will be included together with the evaluation (normal, 
abnormal not clinically significant or abnormal clinically significant).
11.4.4.3
C-SSRS
The results of the C-SSRS will be listed for each subject and visit.
12
OTHER ANALYSES 
A listing of comments will be presented, if applicable.


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13
REFERENCES
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 03 Mar 
2016.
Fay MP, Feuer EJ. Confidence intervals for directly standardized rates: a method based on the 
gamma distribution. Statistics in Medicine 1997; Vol 16: 791-801.
Snaith RP, Zigmond AS. The hospital anxiety and depression scale, with the irritability-
depression-anxiety scale and the Leeds situational anxiety scale manual 1994.


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14
APPENDICES
14.1
Treatment group assignment for the TFLs
The treatment group labels and tabulation requirements for each data type are displayed in 
Table 14‒1.
Table 14‒1: Treatment group assignment for the TFLs
TFL group
BKZ 320mg + PBO
BKZ 320mg
All Subjects
Subject disposition
X
X
X
Protocol deviations
X
X
X
Demographics
X
X
X
Psoriasis history and 
Baseline characteristics
X
X
X
Medical history
X
X
X
Prior/concomitant 
medications
X
X
X
AEs
X
X
X
Safety data (including 
vital signs, ECGs and 
laboratory tests)
X
X
Pharmacodynamic data
X
X
Efficacy data
X
X
Pharmacokinetic data
X
X
ADA
X
X
ADA=anti-bimekizumab antibody; AE=adverse event; BKZ=bimekizumab; ECG=electrocardiogram; 
PBO=placebo.


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14.2
Hospital Anxiety and Depression Scale
The individual items and associated domains are indicated in Table 14‒2.
Table 14‒2: Hospital Anxiety and Depression Scale
Anxiety (HADS-A)
Depression (HADS-D)
I feel tense or wound up
I still enjoy the things I used to enjoy
I get a sort of frightened feeling as if something 
awful is about to happen
I can laugh and see the funny side of things
Worrying thoughts go through my mind
I feel cheerful
I can sit at ease and feel relaxed
I feel as if I am slowed down
I get a sort of frightened feeling like butterflies in 
the stomach
I have lost interest in my appearance
I feel restless as if I have to be on the move
I look forward with enjoyment to things
I get sudden feelings of panic
I can enjoy  a good book or radio or television 
program
The scores for each item range from 0 to 3, with higher scores indicating more severe anxiety or 
depression. The total score for each domain ranges from 0 to 21. A score of <8 for a given domain is 
considered as normal.
In case of missing data, the following rules will be applied:

If a maximum of 1 item is missing in a given domain, the missing item will be imputed with the mean 
score from the remaining completed items within the same domain

If more than 1 item is missing in a given domain, the domain subscore will not be calculated


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14.3
Flow cytometry variables
The individual variables to be reported are presented in Table 14‒3.
Table 14‒3: Flow cytometry variables
Cell Subset/Population
Phenotype
Reportable Units
TBNK Panel
Lymphocytes
CD45+
% of singlets 
Total T Cells
CD3+ 
% of Lymphocytes
T helper Cells
CD3+ CD4+
% of Lymphocytes
Cytotoxic T cells
CD3+ CD4+
% of Lymphocytes
B lymphocytes
CD3- CD19+
% of Lymphocytes
DC,Monocytes and NK cells
CD3- CD19-
% of Lymphocytes
NK cells
CD3- CD16+ CD56+
% of Lymphocytes
Activated T cells
CD69+
% of T cells
Activated Th
CD69+
% of T helper cells
Activated Tc
CD69+
% of Cytotoxic T cells
Activated B cells
CD69+
% of B cells
Activated NK cells
CD69+
% ok NK cells
Th Subset Panel
Lymphocytes
CD45+
% of singlets 
Total T Cells
CD3+ 
% of Lymphocytes
T helper Cells
CD3+ CD4+
% of Lymphocytes
Th1
CXCR3+
% of T helper Cells
Th2
CCR6-CCR4+
% of T helper Cells
Th17/22
CCR6+ CCR4+
% of T helper Cells
Th17
CCR6+CCR4+CCR10-
% of T helper Cells
Th22
CCR6+CCR4+CCR10+
% of T helper Cells
Activated Th1
CD69+
% of Th1
Activated Th2
CD69+
% of Th2
Activated Th17
CD69+
% of Th17
CCR=chemokine receptor; CD=cluster of differentiation; CXCR=CXC chemokine receptor; DC=dendritic cell; 
NK=natural killer; TBNK=T cell, B cell and NK cell assay ;Tc=T cytotoxic ;Th=T helper.


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14.4
Classification of markedly abnormal laboratory values based on 
CTCAE grades
The criteria for assessing laboratory values as markedly abnormal are presented in Table 14‒4.
Table 14‒4: Criteria for markedly abnormal laboratory tests
Category
Panel
Variable
Criteria (CTCAE 
Grade 3 and above)
Hematology
Red blood cell
Hemoglobin (Decrease)
<80 g/L
Hemoglobin (Increase)
>4 g/dL (>40 g/L) 
above ULN OR
>4 g/dL (>40 g/L) 
above baseline if 
baseline is >ULN
White blood cell
WBC count (Decrease)
<2.0 x 10^9/L
WBC count (Increase)
>100 x 10^9/L
White blood cell 
differential
ALC (Decrease)
<0.5 x 10^9/L
ALC (Increase)
>20 x 10^9/L
ANC
<1.0 x 10^9/L
Platelet
Platelet
<50 x 10^9/L
Chemistry
Liver function
ALT
>5.0 x ULN
ALP
>5.0 x ULN
AST
>5.0 x ULN
Total bilirubin
>3.0  x ULN
GGT
>5.0  x ULN
Kidney function
Creatinine
>3.0 x baseline value
OR
>3.0  x ULN
Electrolytes
Calcium (Decrease)
<1.75 mmol/L
Calcium (Increase)
>3.1 mmol/L
Magnesium (Decrease)
<0.4 mmol/L
Magnesium (Increase)
>1.23 mmol/L
Potassium (Decrease)
<3.0 mmol/L
Potassium (Increase)
>6.0 mmol/L
Sodium (Decrease)
<130 mmol/L
Sodium (Increase)
>155 mmol/L


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Category
Panel
Variable
Criteria (CTCAE 
Grade 3 and above)
Lipids
Total cholesterol
>10.34 mmol/L
ULN=upper limit of normal.
14.5
Treatment-emergent abnormal liver values
The criteria for identifying treatment-emergent liver function abnormalities are presented in 
Table 14‒5. Subjects will be counted in all applicable categories for the tabulations ie, a subject 
with ≥5 x ULN in AST will also be counted in the ≥3 x ULN in AST category, the ≥3 x ULN in 
AST or ALT category and the ≥5x ULN in AST or ALT category.
Table 14‒5: Definition of treatment-emergent liver function values
Criterion
≥3 x ULN increase for AST
≥5 x ULN increase for AST
≥10 x ULN increase for AST
≥20 x ULN increase for AST
≥3 x ULN increase for ALT
≥5 x ULN increase for ALT
≥10 x ULN increase for ALT
≥20 x ULN increase for ALT
≥3 x ULN increase for AST or ALT
≥5 x ULN increase for AST or ALT
≥10 x ULN increase for AST or ALT
≥20 x ULN increase for AST or ALT
≥1 x ULN increase for bilirubin
≥1.5 x ULN increase for bilirubin
≥1.5 x ULN increase for ALP
≥1 x ULN increase for bilirubin and 3 x ULN increase of either AST or ALT (at the same visit)
≥2 x ULN increase for bilirubin and 3 x ULN increase of either AST or ALT (at the same visit)
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of 
normal.
14.6
Adverse events of special monitoring
The following AESM are defined for bimekizumab and will be summarized separately as 
described in Section 11.2:

Major cardiovascular events 

Serious infections, including opportunistic infections and TB


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
Malignancies including lymphoma

Cytopenias

Neuropsychiatric events (in particular, depression and suicide)

Inflammatory bowel disease

Anaphylactic reaction (hypersensitivity and anaphylactic reactions)

Hepatic events and drug-induced liver injury
All AESM tabulations will be presented by treatment group, SOC, HLT and PT, based on the SS, 
and will include the EAIR and EAER.
14.6.1
Major cardiovascular events
Major adverse cardiovascular events (MACE) will be tabulated separately and will be identified 
using the following UCB-defined search criteria:

All serious TEAEs which code to a PT included in the search=Broad scope of the following 
standardized MedDRA queries (SMQ): 

Haemorrhagic central nervous system vascular disorders 

Ischaemic central nervous system vascular disorders

All serious TEAEs which code to a PT included in the HLT = ‘Ischaemic coronary artery 
disorders’ except events coding to PT = ‘Chest pain’ or PT = ‘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 the Primary SOC
14.6.2
Serious infections, including opportunistic infections and 
tuberculosis
14.6.2.1
Serious infections
Serious infections are based on MedDRA classification using the SOC = ‘Infections and 
Infestations’. Such events will be included in the tabulations of SAEs and no separate summary 
tabulations will be presented.
14.6.2.2
Fungal infections
Fungal infections will be summarized separately based on all TEAEs coding to the high level 
group term (HLGT) = ‘Fungal infectious disorders’.
14.6.2.3
Opportunistic infections
Opportunistic infections (including TB) will be summarized in a separate table including all 
TEAEs identified using search criteria defined by UCB.
Opportunistic infections are identified in 2 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’.


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
All 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:

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 needing case-by-case 
review. Information from the AE dataset to be included in the spreadsheet: Subject ID, 
AE verbatim term, SOC, HLT, Lower Level Term (LLT), PT, AE start date, AE end date, 
seriousness, severity, relationship to study medication, action taken. Additionally, a 
column will be included where the study physician can document their decision on the 
case.

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’.

Study programming team incorporates these decisions into the analysis data adverse 
events (ADAE) 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 an AE reported that has been confirmed by the study physician to be an 
opportunistic infection (based on case-by-case review) will be summarized as such in the 
stand-alone table, together with all of the events identified in Step 1 of this process.
The timing and frequency of Step 2 should be outlined and agreed to by the study team at the 
beginning of the study. 
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 timepoint 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.
14.6.3
Malignancies including lymphoma
Malignancies will be presented in 2 separate tables based on the following SMQs:

Malignant or unspecified tumours

Malignant tumours
Events included in the ‘Malignant tumours’ tabulation will be a subset of the events in the 
‘Malignant or unspecified tumours’ tabulation. The SMQ search should include all TEAEs 
which code to a PT included in the Scope=Narrow group within each SMQ.


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The output tables will include 2 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)’.
14.6.4
Cytopenias
Cytopenias will be tabulated separately based on the SMQ = ‘Haematopoietic cytopenias’. The 
SMQ search should include all TEAEs that code to a PT included in the Scope=Broad and/or 
Scope=Narrow groups within the SMQ.
14.6.5
Neuropsychiatric events
Neuropsychiatric events (in particular depression, anxiety and suicide ideation or behavior) will 
be tabulated separately based on the SMQ = ‘Depression and suicide/self-injury’. The SMQ 
search should include all TEAEs which code to a PT included in the Scope=Broad and/or 
Scope=Narrow groups within the SMQ.
14.6.6
Inflammatory bowel disease
Inflammatory bowel disease events will be tabulated separately, based on the HLT = ‘Colitis 
excl infective’.
14.6.7
Anaphylactic reaction
Anaphylactic reactions will be summarized together in a stand-alone table with the following 
incidence rows:

The first row within the body of the table will be labeled ‘Any hypersensitivity/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 by SOC, HLT and PT
(these will not be presented by subcategory).
Hypersensitivity reactions and anaphylactic reactions will be identified as follows:


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
Hypersensitivity reactions: all TEAEs with onset (start date/time) within 24 hours after any 
administration of IMP, which code to a PT which contains the term ‘hypersensitivity’ will be 
considered to be a hypersensitivity reaction and included in the summary table 

Anaphylactic reactions: An algorithmic approach will be used to identify TEAEs that are 
considered to be anaphylactic reactions. Preferred terms are separated into 4 distinct 
categories (A, B, C, D) prior to the algorithmic approach being applied.
All TEAEs with onset (start date/time) within 24 hours after any administration of IMP, and 
which fulfill any of the 3 criteria described in Section 14.6.7.1 will be included in the 
summary table.
Any TEAEs with missing start time will be assumed to have occurred at the time of or after 
dosing for this purpose, if the event date is on the same day as a dosing date.
14.6.7.1
Anaphylactic reaction algorithm
The SMQ = ‘anaphylactic reaction’ consists of 3 parts:

A narrow search containing PTs that represent core anaphylactic reaction terms. 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
1. Anaphylactic reaction
2. Anaphylactic shock
3. Anaphylactic transfusion reaction
4. Anaphylactoid reaction
5. Anaphylactoid shock
6. Circulatory collapse
7. Dialysis membrane reaction
8. Kounis syndrome
9. Shock
10. Shock symptom
11. Type I hypersensitivity

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
1. Acute respiratory failure
2. Asthma
3. Bronchial oedema


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4. Bronchospasm
5. Cardio-respiratory distress
6. Chest discomfort
7. Choking
8. Choking sensation
9. Circumoral oedema
10. Cough
11. Cyanosis
12. Dyspnoea
13. Hyperventilation
14. Irregular breathing
15. Laryngeal dyspnoea
16. Laryngeal oedema
17. Laryngospasm
18. Laryngotracheal oedema
19. Mouth swelling
20. Nasal obstruction
21. Oedema mouth
22. Oropharyngeal spasm
23. Oropharyngeal swelling
24. Respiratory arrest
25. Respiratory distress
26. Respiratory dyskinesia
27. Respiratory failure
28. Reversible airways obstruction
29. Sensation of foreign body
30. Sneezing
31. Stridor
32. Swollen tongue
33. Tachypnoea
34. Throat tightness
35. Tongue oedema
36. Tracheal obstruction


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37. Tracheal oedema
38. Upper airway obstruction
39. Wheezing

Category C
1. Allergic oedema
2. Angioedema
3. Erythema
4. Eye oedema
5. Eye pruritis
6. Eye swelling
7. Eyelid oedema
8. Face oedema
9. Flushing
10. Generalised erythema
11. Injection site urticaria
12. Lip oedema
13. Lip swelling
14. Nodular rash
15. Ocular hyperaemia
16. Oedema
17. Periorbital oedema
18. Pruritis
19. Pruritis allergic
20. Pruritis generalised
21. Rash
22. Rash erythematous
23. Rash generalized
24. Rash pruritic
25. Skin swelling
26. Swelling
27. Swelling face
28. Urticaria


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29. Urticaria papular

Category D
1. Blood pressure decreased
2. Blood pressure diastolic decreased
3. Blood pressure systolic decreased
4. Cardiac arrest
5. Cardio-respiratory arrest
6. Cardiovascular insufficiency
7. Diastolic hypertension
8. Hypotension

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 as anaphylactic reactions and summarized as such in 
the table.
14.6.8
Hepatic events and drug-induced liver injury
Hepatic events will include:

Events based on the SMQ = ‘Drug related hepatic disorders – comprehensive search’ 
(excluding sub-SMQs = ‘Liver neoplasms, benign [incl cysts and polyps]’ and ‘Liver 
neoplasms, malignant and unspecified’). All AEs should be included in the tabulation 
(included those considered both related and not related to the IMP) which code to a PT 
included in the Scope=Narrow group within each SMQ.

Hy’s Law cases will also be summarized separately in a table of liver function abnormalities 
as described in Section 11.3 (with adjudication for potential drug-induced liver injury cases).
14.7
Treatment-emergent markedly abnormal vital signs values
The criteria for identifying TEMA/PCS vital signs values are provided in Table 14‒6.
Table 14‒6: TEMA/PCS criteria for vital signs
Variable
Unit
Lowa
Higha
Systolic blood pressure
mmHg
Value ≤90 and ≥20
decrease from Baseline
Value ≥180 and ≥20 
increase from Baseline
Diastolic blood pressure
mmHg
Value ≤50 and ≥15
decrease from Baseline
Value ≥105 and ≥15
increase from Baseline
Note: the change in measurement (increase or decrease) will be calculated relative to the value obtained at Baseline.
a Both conditions must be satisfied for a measurement to be considered TEMA/PCS.


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15
AMENDMENTS TO THE SAP
15.1
Rationale for the amendment
Amendment 1 for this SAP was primarily created to add the extra tables and figures that were 
generated for Interim Analysis 3. In addition, the SAP focuses on the percentage change in PASI 
score from Baseline rather than the percentage improvement, to recognize the possibility that the 
change may be worsening.
15.2
List of changes
Change #1: Introduction, 2nd paragraph
This SAP Amendment 1 is based on, and assumes familiarity, with the following documents:

Final protocol, dated 06 June 2016

Protocol amendment 1, dated 04 August 2016

Protocol amendment 2, dated 06 September 2016

Protocol amendment 3, dated 23 September 2016
The following bullet has been added:

Statistical analysis plan, dated 23 February 2017
Change #2: Section 4.3
The following bullet has been added:-

Data from unscheduled visits may be used for tables that present abnormalities (where stated 
in the SAP amendment).
Change #3: Section 4.5.2
No formal interim analysis will be performed; however data cuts will be performed and 
evaluated.
Has been changed to:-
No formal interim analysis will be performed; however interim data cuts will be performed and 
evaluated.
Change #4: Section 8.1.1
Improvement from Baseline = 1007[(#	 ":, −"#	 ":,)/#	 ":,]   
[9]
Has been changed to:-
Percentage improvement from Baseline = 1007[("#	 ":, −#	 ":,)/
#	 ":,]   [9]
Change #5: Section 8.1.2, 4th paragraph


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All tabulations and both individual and mean figures will be presented using the FAS and 
repeated for the PPS.
Has been changed to:-
All tabulations and both individual and mean figures will be presented using the FAS and 
repeated for the PPS (only if the PPS differs from the FAS).
Change #6: Section 8.1.2, final paragraph
Tabulations (absolute values and percentage improvement from Baseline) will also be repeated 
using observed cases, based on the FAS only.
Has been changed to:-
Separate tables and mean figures will also be created based on the observed cases only.
Change #7: Section 8.2.1, 3rd paragraph
Missing data will be imputed using NRI as described in Section 4.2.1.1. Subjects with missing 
data at Week 16 will be regarded as nonresponders for the PASI75, PASI90, and PASI100 
variables. Missing data will not be imputed for the listing.
Has been changed to:-
Missing data will be imputed using NRI as described in Section 4.2.1.1. Subjects with missing 
data at Week 16 will be regarded as nonresponders for the PASI75, PASI90, and PASI100 
variables. This will also be presented using observed cases. Missing data will not be imputed for 
the listing.
Change #8: Section 8.3.1, 6th paragraph deleted
The tabulation will also be repeated using observed cases and will include a category for missing 
data;
Change #9: Section 8.3.1, 5th paragraph:
Has been added
The tables and figures for PASI response variables will also be repeated using observed cases 
and will include a category for missing data;
Change #10: Section 8.3.2, 2nd paragraph
This sentence has been added:-
The percentage of responders (with 95% CI) will also be plotted over time.
Change #11: Section 8.3.2, 3rd paragraph
The tabulation will also be repeated using observed cases


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Has been changed to:-
The table and figure will also be repeated using observed cases
Change #12: Section 11.2.3
In addition, the following summaries will be presented by treatment group, SOC, high level term 
(HLT) and PT, based on the SS:

Incidence of TEAEs during Treatment Period

Incidence of TEAEs during Post-Treatment Period

Incidence of serious TEAEs during Treatment Period

Incidence of serious TEAEs during Post-Treatment Period

Incidence of non-serious TEAEs during Treatment Period

Incidence of TEAEs during Treatment Period by relationship

Incidence of TEAEs during Treatment Period by maximum relationship

Incidence of TEAEs during Treatment Period by maximum intensity

Incidence of fatal TEAEs during Treatment Period by relationship

Incidence of non-serious TEAEs during Treatment Period by relationship

Incidence of serious TEAEs during Treatment Period by relationship

Incidence of non-serious TEAEs during Treatment Period above threshold of 5% of subjects

Incidence of non-serious TEAEs during Treatment Period above threshold of 5% of subjects 
by relationship

Incidence of TEAEs during Treatment Period by SOC and PT (including the number and 
percentage of subjects and individual subject numbers/reported terms for each PT stratified 
by intensity, relationship and seriousness)

Incidence of TEAEs (including all TEAEs during Treatment and Post-Treatment Periods) by 
SOC, HLT and PT and including the EAIR and EAER calculated as described in 
Section 11.2.2

Incidence of TEAEs (including all TEAEs during Treatment and Post-Treatment Periods) by 
SOC, HLT and PT and including the EAIR and EAER, stratified by overall ADA status 
(positive/negative)
Has been changed to:-
In addition, the following summaries will be presented by treatment group (including All 
Subjects), SOC, high level term (HLT) and PT, based on the SS:

Incidence of TEAEs during Treatment Period

Incidence of TEAEs Overall


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
Incidence of serious TEAEs during Treatment Period

Incidence of serious TEAEs Overall

Incidence of non-serious TEAEs during Treatment Period

Incidence of non-serious TEAEs Overall

Incidence of TEAEs during Treatment Period by relationship

Incidence of TEAEs Overall by relationship

Incidence of TEAEs during Treatment Period by maximum relationship

Incidence of TEAEs Overall by maximum relationship

Incidence of TEAEs during Treatment Period by maximum intensity

Incidence of TEAEs Overall by maximum intensity

Incidence of fatal TEAEs during Treatment Period by relationship

Incidence of fatal TEAEs Overall by relationship

Incidence of non-serious TEAEs during Treatment Period by relationship

Incidence of non-serious TEAEs Overall by relationship

Incidence of serious TEAEs during Treatment Period by relationship

Incidence of serious TEAEs Overall by relationship

Incidence of non-serious TEAEs during Treatment Period above threshold of 5% of subjects

Incidence of non-serious TEAEs Overall above threshold of 5% of subjects

Incidence of non-serious TEAEs during Treatment Period above threshold of 5% of subjects 
by relationship

Incidence of non-serious TEAEs Overall above threshold of 5% of subjects by relationship

Incidence of TEAEs during Treatment Period by SOC and PT (including the number and 
percentage of subjects and individual subject numbers/reported terms for each PT stratified 
by intensity, relationship and seriousness)

Incidence of TEAEs (including all TEAEs during Treatment and Post-Treatment Periods) by 
SOC, HLT and PT and including the EAIR and EAER calculated as described in 
Section 11.2.2
Change #13: Section 14.6.1

All serious TEAEs which code to a PT included in the Scope=Broad and/or Scope=Narrow 
groups of the following standardized MedDRA queries (SMQ): 
Has been changed to:-

All serious TEAEs which code to a PT included in the search=Broad scope of the following 
standardized MedDRA queries (SMQ):


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Change #14: Section 14.6.1

All serious TEAEs which code to a PT = ‘Cardiac failure congestive’
Has been changed to:-

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 the Primary SOC
Change #15: Section 14.6.4
Cytopenias will be tabulated separately based on the SMQ = ‘Haematopoietic cytopenias’. Only 
serious TEAEs will be included in the tabulation. 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.
Has been changed to:-
Cytopenias will be tabulated separately based on the SMQ = ‘Haematopoietic cytopenias’. The 
SMQ search should include all TEAEs that code to a PT included in the Scope=Broad and/or 
Scope=Narrow groups within the SMQ.
Change #16: Section 14.6.6
Inflammatory bowel disease events will be tabulated separately, based on the HLGT = ‘Colitis 
excl infective’.
Has been changed to:-
Inflammatory bowel disease events will be tabulated separately, based on the HLT = ‘Colitis 
excl infective’.


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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 SAP 
or amended SAP is released for execution.


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ELECTRONIC SIGNATURES 
 
Signed by 
Meaning of Signature 
Server Approval Date 
(dd-mon-yyyy 
(HH:mm)) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PS0016 Statistical Analysis Plan Amendment 1
Subject Matter Expert Approval
30-Nov-2017 10:40 GMT+0
Clinical Approval
18-Dec-2017 12:14 GMT+01
PPD
PPD