Clinical trial NCT03766685
Conditions: Chronic Plaque Psoriasis Moderate to Severe Chronic Plaque Psoriasis
Keywords: Bimekizumab PSO Psoriasis Auto-Injector
Sponsor: UCB Biopharma SRL
Start date: 2018-12-20; Completion date: 2020-09-08
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the ability of subjects with moderate to severe chronic plaque psoriasis (PSO) to safely and effectively self-inject bimekizumab at study start and 8 weeks after training in self-injection technique using a prefilled safety syringe or an auto-injector.

Detailed description:

Arms: arm 1: Subjects will receive assigned bimekizumab dose regimen using a prefilled safety syringe (SS). arm 2: Subjects will receive assigned bimekizumab dose regimen using an auto-injector (AI).
Interventions: intervention 1: Bimekizumab
Intervention descriptions: intervention 1: Subjects will receive bimekizumab at pre-specified time-points.

Protocol documents:
Prot_000.pdf: 
UCB 
28 Oct 2019 
Clinical Study Protocol 
Bimekizumab 
DV0002 
Confidential 
Page 1 of 115 
PROTOCOL DV0002 AMENDMENT 1 
(NORTH AMERICAN SUBSTUDY TO PS0014) 
A MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO 
EVALUATE THE SAFE AND EFFECTIVE USE OF THE 
PREFILLED SAFETY SYRINGES OR THE AUTO-INJECTOR 
FOR THE SUBCUTANEOUS SELF-INJECTION OF 
BIMEKIZUMAB SOLUTION BY SUBJECTS WITH MODERATE 
TO SEVERE CHRONIC PLAQUE PSORIASIS 
PHASE 3 
IND Number: 128707 
Sponsor: 
UCB Biopharma SPRL 
Allée de la Recherche 60 
1070 Brussels 
BELGIUM 
Protocol/Amendment number 
Date 
Type of amendment 
Final protocol 
26 Jul 2018 
Not applicable 
Protocol amendment 1 
28 Oct 2019 
Not applicable 
Confidential Material 
Confidential 
This document is the property of UCB and may not – in full or in part – be passed on, 
reproduced, published, or otherwise used without the express permission of UCB. 
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Clinical Study Protocol 
Bimekizumab 
DV0002 
 
 
 
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STUDY CONTACT INFORMATION 
Sponsor 
UCB Biopharma SPRL 
Allée de la Recherche 60 
1070 Brussels 
BELGIUM 
Sponsor Study Physician 
Name: 
Address: 
UCB Biosciences Inc. 
208 Bath Road 
Slough SL1 3WE, UK 
Phone: 
Clinical Project Manager 
Name: 
Address: 
UCB Biosciences Inc. 
8010 Arco Corporate Drive,
 
Raleigh, NC 27617, USA 
Phone: 
Clinical Trial Biostatistician 
Name: 
Address: 
UCB Biosciences Inc. 
8010 Arco Corporate Drive,
 
Raleigh, NC 27617, USA 
Phone: 
Clinical Monitoring Contract Research Organization 
Name: 
PAREXEL International (IRL) Limited-Ireland 
Address: 
Ireland Limited at 70 Sir John Rogerson’s Quay, Dublin 2, 
Ireland 
Phone: 
 
Fax: 
 
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
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Clinical Study Protocol 
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SERIOUS ADVERSE EVENT AND PRODUCT QUALITY COMPLAINTS 
REPORTING 
Serious adverse event reporting (24h) 
Email: 
 
Fax: 
 
Product Quality Complaints Reporting (24h) 
Email: 
 
PPD
PPD
PPD
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Clinical Study Protocol 
Bimekizumab 
DV0002 
 
 
 
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Page 4 of 115 
TABLE OF CONTENTS 
TABLE OF CONTENTS ........................................................................................................... 4 
LIST OF TABLES ..................................................................................................................... 8 
LIST OF FIGURES ................................................................................................................... 8 
LIST OF ABBREVIATIONS .................................................................................................... 9 
1 
SUMMARY ..................................................................................................................... 11 
2 
INTRODUCTION ........................................................................................................... 13 
3 
STUDY OBJECTIVES .................................................................................................... 13 
3.1 
Primary objective ......................................................................................................... 13 
3.2 
Secondary objective ..................................................................................................... 13 
3.3 
Other objectives ........................................................................................................... 14 
4 
STUDY VARIABLES ..................................................................................................... 14 
4.1 
Outcome variables ....................................................................................................... 14 
4.1.1 
Primary outcome variable .................................................................................... 14 
4.1.2 
Secondary outcome variable ................................................................................ 14 
4.1.3 
Other variables ..................................................................................................... 15 
4.1.3.1 
Outcome variables ..................................................................................... 15 
4.1.3.2 
Pharmacokinetic variable .......................................................................... 15 
4.1.3.3 
Safety variable ........................................................................................... 15 
5 
STUDY DESIGN ............................................................................................................. 15 
5.1 
Study description ......................................................................................................... 15 
5.1.1 
Study duration per subject ................................................................................... 19 
5.1.2 
Planned number of subjects and sites .................................................................. 19 
5.1.3 
Anticipated regions and countries ....................................................................... 19 
5.2 
Schedule of study assessments..................................................................................... 19 
5.3 
Schematic diagram ....................................................................................................... 32 
5.4 
Rationale for study design and selection of dose ......................................................... 32 
6 
SELECTION AND WITHDRAWAL OF SUBJECTS ................................................... 33 
6.1 
Inclusion criteria .......................................................................................................... 33 
6.2 
Exclusion criteria ......................................................................................................... 33 
6.3 
Withdrawal criteria ...................................................................................................... 33 
7 
INVESTIGATIONAL MEDICINAL PRODUCT AND INVESTIGATIONAL DEVICE34 
7.1 
Description of investigational devices ......................................................................... 34 
7.1.1 
Bimekizumab-SS-1mL ........................................................................................ 34 
7.1.1.1 
Instruction for use of bimekizumab-SS-1mL ............................................ 34 
7.1.2 
Bimekizumab-AI-1mL ........................................................................................ 35 
7.1.2.1 
Instruction for use of bimekizumab-AI-1mL ............................................ 35 
7.1.3 
Bimekizumab-SS-2mL ........................................................................................ 36 
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7.1.3.1 
Instruction for use of bimekizumab-SS-2mL ............................................ 36 
7.1.4 
Bimekizumab-AI-2mL ........................................................................................ 36 
7.1.4.1 
Instruction for use of bimekizumab-AI-2mL ............................................ 37 
7.2 
Treatment to be administered....................................................................................... 37 
7.3 
Packaging ..................................................................................................................... 38 
7.4 
Labeling ....................................................................................................................... 38 
7.5 
Handling and storage requirements ............................................................................. 39 
7.6 
Drug and device accountability ................................................................................... 39 
7.7 
Procedures for monitoring subject compliance ............................................................ 39 
7.8 
Concomitant medications/treatments ........................................................................... 39 
7.8.1 
Permitted concomitant treatments (medications and therapies) .......................... 40 
7.8.2 
Prohibited concomitant treatments (medications and therapies) ......................... 40 
7.9 
Blinding........................................................................................................................ 40 
7.10 
Randomization and numbering of subjects .................................................................. 40 
8 
STUDY PROCEDURES BY VISIT ............................................................................... 40 
8.1 
Treatment Period for the 1mL Device Cohort ............................................................. 41 
8.1.1 
Visit 1 (Baseline) ................................................................................................. 41 
8.1.2 
Visit 2 (Week 4) ................................................................................................... 43 
8.1.3 
Visit 3 (Week 8) ................................................................................................... 43 
8.1.4 
Visit 3a (Week 9; safety follow-up telephone call) ............................................. 44 
8.1.5 
Visit 4 (Week 12) ................................................................................................. 44 
8.1.6 
Visit 5 (Week 16) ................................................................................................. 45 
8.2 
Treatment Period for 2mL Device Cohort ................................................................... 45 
8.2.1 
Visit 1 (Baseline) ................................................................................................. 46 
8.2.2 
Visit 2 (Baseline + 4 weeks) ................................................................................ 46 
8.2.3 
Visit 3 (Baseline + 8 weeks) ................................................................................ 46 
8.2.4 
Visit 3a (Baseline + 9 weeks; safety follow-up telephone call) .......................... 47 
8.2.5 
Visit 4 (Baseline + 12 weeks) .............................................................................. 47 
8.2.6 
Visit 5 (Baseline + 16 weeks) .............................................................................. 47 
9 
ASSESSMENT OF SELF-INJECTION .......................................................................... 48 
9.1 
Assessment of self-injection experience by SIAQ ....................................................... 48 
9.2 
Assessment of injection site pain ................................................................................. 48 
9.3 
Evaluation of post-use structural and mechanical integrity of self-injection 
investigational devices ................................................................................................. 49 
10 ASSESSMENT OF PHARMACOKINETIC VARIABLES ........................................... 49 
11 ASSESSMENT OF SAFETY .......................................................................................... 50 
11.1 
Adverse events (investigational device) ...................................................................... 50 
11.1.1 
Definitions (investigational device) ..................................................................... 50 
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11.1.1.1 
Adverse device effect (investigational device).......................................... 50 
11.1.1.2 
Serious adverse device effects ................................................................... 51 
11.1.1.3 
Device deficiency (investigational device) ............................................... 52 
11.1.2 
Procedures for reporting and recording adverse device effects and 
device deficiencies ............................................................................................... 52 
11.1.2.1 
Reporting of adverse device effects .......................................................... 52 
11.1.2.2 
Reporting of device deficiencies ............................................................... 52 
11.1.2.3 
Reporting of serious adverse device effects including device deficiencies 
with risk of serious adverse event ............................................................. 53 
11.1.2.4 
Rule for repetition of an adverse device effect, serious adverse device 
effect, and/or device deficiency ................................................................. 54 
11.1.3 
Follow up of adverse device effects and serious adverse device effects ............. 54 
11.2 
Pregnancy ..................................................................................................................... 54 
11.3 
Suspected transmission of an infectious agent............................................................. 54 
11.4 
Overdose of investigational medicinal product ........................................................... 54 
11.5 
Safety signal detection ................................................................................................. 55 
11.6 
Other safety measurements .......................................................................................... 55 
11.6.1 
Vital signs measurement ...................................................................................... 55 
12 EFFICACY ASSESSMENTS FOR PS0014 ................................................................... 55 
13 STUDY MANAGEMENT AND ADMINISTRATION ................................................. 55 
13.1 
Adherence to protocol .................................................................................................. 55 
13.2 
Monitoring ................................................................................................................... 55 
13.2.1 
Definition of source data ..................................................................................... 56 
13.2.2 
Source data verification ....................................................................................... 56 
13.3 
Data handling ............................................................................................................... 56 
13.3.1 
Case Report form completion .............................................................................. 56 
13.3.2 
Database entry and reconciliation ........................................................................ 57 
13.3.3 
Subject Screening and Enrollment log/Subject Identification Code list.............. 57 
13.4 
Termination of the study .............................................................................................. 57 
13.5 
Archiving and data retention ........................................................................................ 58 
13.6 
Audit and inspection .................................................................................................... 58 
13.7 
Good Clinical Practice ................................................................................................. 58 
14 STATISTICS ................................................................................................................... 58 
14.1 
Definition of analysis sets ............................................................................................ 59 
14.2 
General statistical considerations ................................................................................. 59 
14.3 
Planned analyses of outcome variables ........................................................................ 59 
14.3.1 
Analysis of the primary outcome variable ........................................................... 60 
14.3.2 
Analysis of the secondary outcome variable ....................................................... 60 
14.3.3 
Analysis of other outcome variables .................................................................... 60 
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14.4 
Planned pharmacokinetic analyses .............................................................................. 60 
14.5 
Planned safety analyses................................................................................................ 61 
14.6 
Planned efficacy analyses ............................................................................................ 61 
14.7 
Handling of protocol deviations................................................................................... 61 
14.8 
Handling of dropouts or missing data .......................................................................... 61 
14.9 
Planned interim analysis and data monitoring ............................................................. 61 
14.10 Determination of sample size ....................................................................................... 61 
15 ETHICS AND REGULATORY REQUIREMENTS ...................................................... 62 
15.1 
Informed consent ......................................................................................................... 62 
15.2 
Subject identification cards .......................................................................................... 63 
15.3 
Institutional Review Boards ......................................................................................... 63 
15.4 
Subject privacy............................................................................................................. 64 
15.5 
Protocol amendments ................................................................................................... 64 
16 FINANCE, INSURANCE, AND PUBLICATION ......................................................... 64 
17 REFERENCES ................................................................................................................ 64 
18 APPENDICES ................................................................................................................. 65 
18.1 
Protocol Amendment 1 ................................................................................................ 65 
19 DECLARATION AND SIGNATURE OF INVESTIGATOR ..................................... 114 
20 SPONSOR DECLARATION ........................................................................................ 115 
 
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Clinical Study Protocol 
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LIST OF TABLES 
Table 5-1: 
Bimekizumab administration schedule visits in DV0002 substudy 1mL 
device cohort .................................................................................................... 16 
Table 5-2: 
Bimekizumab administration schedule visits in DV0002 substudy 2mL 
device cohort .................................................................................................... 18 
Table 5-3: 
Schedule of assessments for the PS0014 study and DV0002 substudy 
(1mL device cohort) ......................................................................................... 21 
Table 5-4: 
Schedule of assessments for the PS0014 study (2mL device cohort) .............. 26 
Table 5-5: 
Schedule of assessments for the DV0002 substudy (2mL device cohort) ....... 29 
Table 10-1: 
DV0002 substudy 2mL device cohort PK sample collection time points ....... 50 
 
LIST OF FIGURES 
Figure 5‒1: 
Schematic diagram for the 1mL device cohort ................................................ 32 
Figure 5‒2: 
Schematic diagram for the 2mL device cohort ................................................ 32 
Figure 7-1: 
Bimekizumab-SS-1mL .................................................................................... 34 
Figure 7-2: 
Bimekizumab-AI-1mL ..................................................................................... 35 
Figure 7-3: 
Bimekizumab-SS-2mL .................................................................................... 36 
Figure 7-4: 
Bimekizumab-AI-2mL ..................................................................................... 37 
 
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LIST OF ABBREVIATIONS 
ADE 
adverse device effect 
AE 
adverse event 
bimekizumab-AI-1mL 
1mL bimekizumab auto-injector  
bimekizumab-AI-2mL 
2mL bimekizumab auto-injector 
bimekizumab-SS-1mL 
1mL bimekizumab safety syringe 
bimekizumab-SS-2mL 
2mL bimekizumab safety syringe 
BMI 
body mass index 
BP 
blood pressure 
BSA 
body surface area 
CDMS 
clinical data management system 
CI 
confidence interval 
CRO 
contract research organization 
ECG 
electrocardiogram 
eCRF 
electronic Case Report form 
eC-SSRS 
electronic Columbia Suicide Severity Rating Scale 
FAS 
Full Analysis Set(s) 
FAS-a 
Full Analysis Set for the bimekizumab-AI-1mL 
FAS-s 
Full Analysis Set for the bimekizumab-SS-1mL 
GCP 
Good Clinical Practice 
ICF 
Informed Consent form 
ICH 
International Council for Harmonisation 
IFU 
instructions for use 
IGA 
Investigator’s Global Assessment 
IL 
interleukin 
IMP 
investigational medicinal product 
IRB 
Institutional Review Board 
IRT 
interactive response technology 
PASI 
Psoriasis Area Severity Index 
PFS 
prefilled syringe 
PHQ-9 
Patient Health Questionnaire 9 
PK 
pharmacokinetic(s) 
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PKS 
Pharmacokinetic Set 
PKS-PPS-a 
Pharmacokinetic Set for the bimekizumab-AI-1mL 
PKS-PPS-s 
Pharmacokinetic Set for the bimekizumab-SS-1mL 
PS 
Patient Safety 
PSO 
psoriasis 
Q4W 
every 4 weeks 
Q8W 
every 8 weeks 
RNS 
rigid needle shield 
SADE 
serious adverse device effect 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
sc 
subcutaneous 
SFU 
safety follow-up 
SIAQ 
Self-injection Assessment Questionnaire 
SOP 
Standard Operating Procedure 
SS 
Safety Set(s) 
SS-a 
Safety Set for the bimekizumab-AI-1mL  
Safety Set for the bimekizumab-AI-2mL 
SS-s 
Safety Set for the bimekizumab-SS-1mL 
Safety Set for the bimekizumab-SS-2mL 
TB 
tuberculosis 
USADE 
unanticipated serious adverse device effect 
VAS 
visual analog scale 
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1 
SUMMARY 
DV0002 is a multicenter, open-label, randomized substudy in adult subjects with moderate to 
severe chronic plaque psoriasis (PSO) to evaluate the safe and effective use of 4 single-use 
disposable self-injection investigational devices for the subcutaneous (sc) administration of 
bimekizumab solution (the investigational medicinal product [IMP]). The 4 self-injection devices 
to be tested are the 1mL bimekizumab safety syringe (bimekizumab-SS-1mL), the 
1mL bimekizumab auto injector (bimekizumab-AI-1mL), the 2mL bimekizumab safety syringe 
(bimekizumab-SS-2mL), and the 2mL bimekizumab auto injector (bimekizumab-AI-2ml). 
DV0002 is a substudy of PS0014, which is a multicenter, open-label, long-term safety study for 
subjects with moderate to severe chronic plaque PSO who complete 1 of the Phase 3 feeder 
studies (PS0008, PS0009, or PS0013). The PS0014 study will evaluate the long-term safety, 
tolerability, and efficacy of bimekizumab in subjects with PSO, and study personnel qualified in 
sc injection technique will administer bimekizumab to subjects in a 1mL True North prefilled 
syringe (referred to throughout this protocol as the 1mL PFS). In the DV0002 substudy, subjects 
will self-administer bimekizumab at DV0002 Baseline and at DV0002 Week 8. 
During the Treatment Period of DV0002, subjects will receive either bimekizumab 320mg every 
8 weeks (Q8W) or bimekizumab 320mg every 4 weeks (Q4W), based on their assigned dosing at 
Baseline of PS0014. The same interactive response technology (IRT) will be used for both 
studies (DV0002 and PS0014). The dose regimen will remain stable for the entire Treatment 
Period of DV0002.  
In the DV0002 substudy, subjects will be assigned to 1 of the 4 self-injection devices and will 
self-administer bimekizumab only at DV0002 Baseline and at DV0002 Week 8 after training, 
regardless of their assigned dosing regimen. Bimekizumab will be administered by study 
personnel at DV0002 Week 4 and DV0002 Week 12 for subjects in the Q4W dosing arm and at 
DV0002 Week 16 for both dosing arms. A safety follow-up (SFU) telephone call will occur 
1 week after the last self-administration (at DV0002 Week 9). After Week 16 in the DV0002 
substudy, subjects will continue in PS0014. 
The primary objective of the DV0002 substudy is to evaluate, for each device, the ability of 
subjects with moderate to severe chronic plaque PSO to safely and effectively self-inject 
bimekizumab 8 weeks after training in the self-injection technique. The primary outcome 
variable is the percentage of subjects able to self-administer safe and effective injections using 
the bimekizumab-SS-1mL, bimekizumab-AI-1mL, bimekizumab-SS-2mL, or 
bimekizumab-AI-2mL device 8 weeks after training in self-injection technique (DV0002 
Week 8).  
Safe and effective self-injection will be evaluated by the study personnel and is defined as: 
 Complete dose delivery: Subject self-injects the complete dose of bimekizumab as confirmed 
by a visual inspection of the device, which shows that the IMP is delivered completely (ie, 
container is empty), and 
 No adverse device effects (ADEs) that would preclude continued use of the device for 
self-injection (ie, no serious ADEs [SADEs] and/or ADEs leading to withdrawal from the 
DV0002 substudy) 
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The secondary study objectives and other study objectives are provided in Section 3.2 and 
Section 3.3, respectively. Of note, one of the other study objectives is to assess trough 
pharmacokinetic (PK) levels associated with self-injection using the investigational device, 
injection by study personnel, injection site (abdomen or thigh), and body mass index (BMI) 
category (by tertile). The secondary outcome variable, other outcome variables, and the other 
safety variable are listed in Section 4.1.2, Section 4.1.3.1, and Section 4.1.3.3, respectively.  
The DV0002 substudy consists of 2 cohorts. The 1mL device cohort will evaluate 2 different 
self-injection investigational devices: the bimekizumab-SS-1mL and the bimekizumab-AI-1mL. 
The 2mL device cohort will also evaluate 2 different self-injection investigational devices: the 
bimekizumab-SS-2mL and the bimekizumab-AI-2ml. The data for each cohort will be analyzed 
and reported separately. 
1mL Device Cohort 
Subjects who enroll in the 1mL device cohort of DV0002 will begin the DV0002 substudy and 
the PS0014 study at the same time, and as such, the Baseline visit and all subsequent study visits 
(up to Week 16) will be the same. 
To compensate for subjects who have different study treatments between the feeder studies and 
DV0002, the 1mL device cohort of the DV0002 substudy is planned to enroll approximately 
200 subjects (100 subjects per device arm) to ensure that approximately 50 subjects per device 
arm are evaluable for steady state trough PK level analyses. Within each device arm, subjects 
will be divided into tertiles by BMI; there will be approximately 33 subjects per tertile, which is 
expected to yield approximately 16 to 17 subjects per tertile who are evaluable for steady state 
trough PK level analyses.  
In the DV0002 substudy 1mL device cohort, the 320mg bimekizumab dose will be administered 
as two 160mg injections with either 2 bimekizumab-SS-1mL devices or 2 bimekizumab-AI-1mL 
devices. Each self-injection will be evaluated by study personnel for safety and effectiveness 
using the above criteria. The endpoint of safe and effective self-injection will be met only if both 
self-injections are determined to be safe and effective.  
2mL Device Cohort 
Subjects who participated in the 1mL device cohort are not eligible to participate in the 
2mL device cohort. To allow flexible enrollment, subjects may be randomized in the 2mL device 
cohort at the PS0014 Week 24, Week 28, or Week 32 visit for subjects receiving bimekizumab 
Q4W or the PS0014 Week 24 or Week 32 visit for subjects receiving bimekizumab Q8W.  
For evaluation of the 2mL device, it is planned to enroll approximately 100 subjects; each device 
arm (bimekizumab-SS-2mL or bimekizumab-AI-2mL) will consist of approximately 50 subjects.  
In the DV0002 substudy, for the 2ml devices, the 320mg bimekizumab dose will be 
self-administered as 1 injection with either 1 bimekizumab-SS-2mL or 1 bimekizumab-AI-2mL 
device. Each self-injection will be evaluated for safety and effectiveness by study personnel 
using the above criteria. The endpoint of safe and effective self-injection will be met if the single 
self-injection is determined to be safe and effective. 
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2 
INTRODUCTION 
Psoriasis is a common, chronic inflammatory disease characterized by a series of linked cellular 
changes in the skin. Bimekizumab (UCB4940; the IMP) is an engineered, humanized full length 
monoclonal antibody of immunoglobulin G1 subclass that selectively and potently inhibits the 
activity of interleukin (IL)-17A and IL-17F in vitro. Interleukin-17A and IL-17F are key 
proinflammatory cytokines believed to play important roles in autoimmune and inflammatory 
diseases. Bimekizumab is being developed for the treatment of patients with inflammatory 
diseases such as psoriatic arthritis, PSO, and axial spondyloarthritis. 
It is important for patients who may use bimekizumab for the treatment of moderate to severe 
chronic plaque PSO to have options for the self-injection of bimekizumab that fit their needs and 
preferences. Whilst some patients may prefer to manually regulate various tasks comprising the 
self-injection process (eg, needle visibility, skin penetration by needle, speed of self-injection), 
others may prefer a more automated process (eg, do not wish to see the needle, desire an 
automatic injection). UCB therefore intends to provide patients with different options to 
self-inject bimekizumab. 
The DV0002 study is a substudy of the PS0014 study. PS0014 will evaluate the long-term safety, 
tolerability, and efficacy of bimekizumab in subjects with moderate to severe chronic plaque 
PSO; study personnel will administer bimekizumab in a 1mL PFS. The DV0002 substudy will 
evaluate 4 self-injection investigational devices: the bimekizumab-SS-1mL, the 
bimekizumab-AI-1mL, the bimekizumab-SS-2mL, and the bimekizumab-AI-2ml. Full 
descriptions of the 4 devices are provided in Section 7.1.1, Section 7.1.2, Section 7.1.3 and 
Section 7.1.4, respectively. 
The proposed substudy is planned to demonstrate that adult subjects with moderate to severe 
chronic plaque PSO can safely and effectively self-inject bimekizumab using the bimekizumab-
SS-1mL, bimikizumab-AI-1mL, bimekizumab-SS-2mL, or bimekizumab-AI-2mL device. 
For subjects in the 1mL device cohort, subjects will be randomly assigned in a 1:1 ratio to 
perform self-injection using either the bimekizumab-SS-1mL or the bimekizumab-AI-1mL. 
Subjects who participated in the 1mL device cohort of DV0002 are not eligible to enroll in the 
2mL device cohort. 
Once the 1mL device cohort has finished enrolling, the 2mL device cohort will start enrolling. 
Subjects in this cohort will be randomly assigned in a 1:1 ratio to perform self-injection using 
either the bimekizumab-SS-2mL or bimekizumab-AI-2mL device. 
3 
STUDY OBJECTIVES 
3.1 
Primary objective 
The primary objective of the study is to evaluate, for each device, the ability of subjects with 
moderate to severe chronic plaque PSO to safely and effectively self-inject bimekizumab 
8 weeks after training in the self-injection technique. 
3.2 
Secondary objective 
The secondary objective of the study is to evaluate, for each device, the ability of subjects with 
moderate to severe chronic plaque PSO to safely and effectively self-inject bimekizumab 
immediately after training in self-injection technique using the devices. 
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3.3 
Other objectives 
Other objectives of the study are to evaluate the following: 
 Subject experience of self-injection using the investigational devices as assessed by the pain 
visual analog scale (VAS) and the Self-injection Assessment Questionnaire (SIAQ). 
 Trough PK (trough bimekizumab) levels associated with self-injection using the 
investigational devices, injection by study personnel, injection site (abdomen or thigh), and 
BMI category (by tertile). 
 The structural and mechanical integrity of the investigational devices after completion of 
self-injection. 
 The overall safety and tolerability of self-injections using the investigational devices. 
4 
STUDY VARIABLES 
4.1 
Outcome variables 
4.1.1 
Primary outcome variable 
The primary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the bimekizumab-SS-1mL, bimekizumab-AI-1mL, 
bimekizumab-SS-2mL, or bimekizumab-AI-2mL, 8 weeks after training in self-injection 
technique. Safe and effective self-injection will be evaluated by the study personnel and is 
defined as: 
 Complete dose delivery: Subject self-injects the complete dose of bimekizumab as confirmed 
by a visual inspection of the device which shows that the IMP is delivered completely 
(ie, container is empty), and 
 No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs 
and/or ADEs leading to withdrawal from the DV0002 substudy). 
In the DV0002 substudy, for the 1mL devices, the 320mg bimekizumab dose will be 
administered as two 160mg injections with either 2 bimekizumab-SS-1mL devices or 
2 bimekizumab-AI-1mL devices. Each self-injection will be evaluated for safety and 
effectiveness by study personnel using the above criteria. The endpoint of safe and effective 
self-injection will be met only if both self-injections are determined to be safe and effective. 
For the 2ml devices, the 320mg bimekizumab dose will be administered as 1 injection with either 
1 bimekizumab-SS-2mL or 1 bimekizumab-AI-2mL device. Each self-injection will be evaluated 
for safety and effectiveness by study personnel using the above criteria. The endpoint of safe and 
effective self-injection will be met if the single self-injection is determined to be safe and 
effective. 
4.1.2 
Secondary outcome variable 
The secondary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the bimekizumab-SS-1mL, bimekizumab-AI-1mL, 
bimekizumab-SS-2mL, or 1 bimekizumab-AI-2mL at DV0002 Baseline (the first self-injection 
visit, immediately after training in self-injection technique). Safe and effective self-injection will 
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be evaluated by study personnel and is defined as for the primary outcome variable (see 
Section 4.1.1). 
4.1.3 
Other variables 
4.1.3.1 
Outcome variables 
The other outcome variables are: 
 Responses to pre-injection SIAQ (versions 2.0 and 2.1) at DV0002 Baseline. 
Whenever SIAQ is assessed, version 2.0 of the SIAQ will be used to assess 
bimekizumab-SS-1mL and bimekizumab-SS-2mL and version 2.1 of the SIAQ will be used 
to assess bimekizumab-AI-1mL and bimekizumab-AI-2mL (see Section 9.1). 
 Responses to post-injection SIAQ (versions 2.0 and 2.1) by visit following self-injection 
using the assigned device at DV0002 Baseline and Week 8. 
 Injection site pain (using a VAS; 100mm) by visit after self-injection using the assigned 
device at DV0002 Baseline and Week 8. 
 Percentage of used devices identified as having structural or mechanical integrity issues after 
completion of self-injection. This is based on a visual examination of the device that shows 
clear evidence of damage and/or compromised structural or mechanical integrity.  
4.1.3.2 
Pharmacokinetic variable 
The PK variable is trough PK (bimekizumab) levels associated with self-injection using the 
investigational device, injection by study personnel, injection site (abdomen or thigh), and BMI 
category (by tertile). Trough levels will be assessed at DV0002 Baseline, Week 4, Week 8, and 
Week 12 for subjects who receive bimekizumab Q4W and trough levels will be assessed at 
DV0002 Baseline, Week 8, and Week 16 for subjects who receive bimekizumab Q8W. 
4.1.3.3 
Safety variable 
The other safety variable is the occurrence of ADEs. Additional safety and tolerability variables 
will be collected as described in the PS0014 study protocol. 
5 
STUDY DESIGN 
5.1 
Study description 
DV0002 is a Phase 3 open-label, randomized, noncomparator, North America-only substudy to 
PS0014. PS0014 will evaluate the long-term safety, tolerability, and efficacy of bimekizumab in 
subjects with moderate to severe chronic plaque PSO, and study personnel will administer 
bimekizumab to subjects in a 1mL PFS. In the DV0002 substudy, the safe and effective use of 
the bimekizumab-SS-1mL, bimekizumab-AI-1mL, bimekizumab-SS-2mL, or the 
bimekizumab-AI-2mL for the sc self-injection of bimekizumab solution by subjects with PSO 
will be evaluated.  
Subjects from selected sites in the PS0014 feeder studies PS0008, PS0009, and PS0013 will be 
eligible for the DV0002 substudy. At DV0002 Baseline, each subject will be provided with 
training in self-injection and will receive the instructions for use (IFU) and any other applicable 
training materials.  
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1mL Device Cohort 
For the 1mL device cohort, subjects in the DV0002 substudy will perform self-injections at 
Baseline (corresponding to the Baseline Visit of PS0014) with a subsequent self-injection at 
Week 8 (corresponding to Week 8 of PS0014).  
During the 16-week Treatment Period of DV0002, subjects will receive either bimekizumab 
320mg Q8W or bimekizumab 320mg Q4W, based on their assigned dosing at Baseline 
(Table 5-1). Baseline for DV0002 and Baseline for PS0014 will occur at the same time, and the 
same interactive response technology (IRT) will be used for both studies. The 320mg 
bimekizumab dose will be administered as two 160mg injections, and both injections will be 
either self-administered using the investigational device (at Baseline and Week 8) or 
administered by study personnel using the 1mL PFS (at Week 4 and Week 12 for subjects in the 
Q4W dosing arm and at Week 16 for both dosing arms). This dose regimen will remain stable for 
the entire 16-week Treatment Period of DV0002, as per PS0014 design. The DV0002 substudy 
will evaluate 2 self-injection investigational devices: the bimekizumab-SS-1mL and the 
bimekizumab-AI-1mL.  
Eligible subjects (PS0014 entry criteria and Section 6 DV0002 entry criteria) will be randomly 
assigned in a 1:1 ratio to perform self-injection using either the bimekizumab-SS-1mL or the 
bimekizumab-AI-1mL (see Section 7.10). Regardless of the assigned dose regimen, subjects will 
perform self-injection with the assigned device only at Baseline (corresponding to the Baseline 
Visit of PS0014) and at Week 8 (corresponding to Week 8 of PS0014). 
Table 5-1: 
Bimekizumab administration schedule visits in DV0002 substudy 
1mL device cohort 
Dose Regimen 
Baseline 
Week 4 
Week 8 
Week 12 
Week 16 
320mg Q8W 
S 
NA 
S 
NA 
SP 
320mg Q4W 
S 
SP 
S 
SP 
SP 
bimekizumab-AI-1mL=1mL bimekizumab auto-injector; bimekizumab-SS-1mL=1mL bimekizumab safety 
syringe; NA=not applicable; Q4W=every 4 weeks; Q8W=every 8 weeks; S=subject performing self-injection 
using the investigational device; SP=study personnel performing injection using the 1mL pre-filled syringe  
Note: For S injections, the 320mg bimekizumab dose will be administered as two 160mg injections (using 
2 bimekizumab-SS-1mL or 2 bimekizumab-AI-1mL). For SP injections, the 320mg bimekizumab dose will be 
administered as two 160mg injections (using prefilled syringes). Both injections will be administered in the 
same manner (eg, both self-administered injections or both study personnel-administered injections), but each 
injection will be administered at a separate injection site and rotation between injection sites should be 
observed. 
Note: For the 1mL device cohort, visits in the DV0002 substudy correlate with the same visit in the PS0014 study 
(ie, the DV0002 Baseline Visit is the PS0014 Baseline Visit). Dose regimen will be assigned at Baseline, and 
the same interactive response technology will be used for both studies. 
The bimekizumab administration schedule optimizes the collection of PK trough level data 
within the constraints of a short treatment period and a Q4W and Q8W dosing regimen. At 
Weeks 4, 12, and 16, subjects on the Q4W dosing regimen will be injected by study personnel 
with 2 injections each of 160mg bimekizumab using a 1mL PFS (ie, the same device as that used 
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in PS0014). For these subjects, the Q4W administration schedule will provide PK trough data 
associated with injection by: 
 Study personnel using the 1mL PFS from PK samples collected (before self-injection) at 
Baseline and Week 8 (ie, PK data from 2 timepoints) 
 Subject self-injection using the assigned device from PK samples collected (before 
injection by study personnel) at Week 4 and Week 12 (ie, PK data from 2 timepoints) 
At Baseline and Week 8, subjects on the Q8W dosing regimen will self-inject 2 injections each 
of 160 mg bimekizumab using the assigned device (ie, bimekizumab-SS-1mL or the 
bimekizumab-AI-1mL). For these subjects, the Q8W administration schedule will provide PK 
trough data associated with injection by: 
 Study personnel using the 1mL PFS from PK samples collected (before self-injection) at 
Baseline (ie, PK data from 1 timepoint) 
 Subject self-injection using the assigned device from PK samples collected (before 
self-injection) at Week 8 and (before injection by study personnel) at Week 16 (ie, PK 
data from two timepoints) 
In addition to self-injections, DV0002 substudy-specific assessments (eg, study personnel 
evaluation, SIAQ responses, VAS for injection site pain, and PK analyses; see Section 5.2) will 
be performed from Baseline through Week 16 (inclusive). An SFU telephone call will occur 
1 week after the last self-administration (at Week 9).  
After Week 16 in the DV0002 substudy, subjects will continue in PS0014 (the next visit after 
DV0002 completion will be the Week 20 Visit in PS0014). Studies DV0002 and PS0014 will 
share a common database/electronic Case Report form (eCRF) system (including common 
adverse event [AE] reporting) and a common IRT. 
Subjects who are withdrawn from DV0002 but continue their PS0014 study participation will be 
required to perform an SFU telephone call 1 week after their final DV0002 dosing visit (see 
Section 6.3). Subjects who are withdrawn from bimekizumab treatment (PS0014 study) during 
the course of DV0002 will also be required to follow the PS0014 withdrawal procedures. 
2mL Device Cohort 
To allow flexible enrollment, subjects may be randomized in the 2mL device cohort at the 
PS0014 Week 24, Week 28, or Week 32 visit for subjects receiving bimekizumab Q4W or the 
PS0014 Week 24 or Week 32 visit for subjects receiving bimekizumab Q8W.  
For the 2mL device cohort, subjects will perform self-injections at DV0002 Baseline with a 
subsequent self-injection 8 weeks after training. The 2mL device cohort will evaluate 
2 self-injection devices: the bimekizumab-SS-2mL and the bimekizumab-AI-2mL. 
During the Treatment Period of DV0002, subjects will receive either bimekizumab 320mg Q8W 
or bimekizumab 320mg Q4W, based on their assigned dosing at Baseline of PS0014 (Table 5-3). 
In the 2mL device cohort, Baseline for DV0002 will occur at the PS0014 Week 24, Week 28, or 
Week 32 visit for subjects receiving bimekizumab Q4W or the PS0014 Week 24 or Week 32 
visit for subjects receiving bimekizumab Q8W. The same IRT will be used for both studies. The 
320mg bimekizumab dose will either be self-administered as 1 injection using the assigned 
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investigational device (at DV0002 Baseline and Week 8) or administered as 2 injections by study 
personnel using the 1mL PFS (at DV0002 Week 4 and Week 12 for subjects in the Q4W dosing 
arm and at DV0002 Week 16 for both dosing arms). This dose regimen will remain stable for the 
entire 16-week Treatment Period of DV0002, per the PS0014 design.  
Eligible subjects (PS0014 entry criteria and Section 6 DV0002 entry criteria) who have not 
participated in the 1mL device cohort, will be randomly assigned in a 1:1 ratio to perform 
self-injection using either the bimekizumab-SS-2mL or the bimekizumab-AI-2mL (see 
Section 7.10). Regardless of the assigned dose regimen, subjects will perform self-injection with 
the assigned devices only at DV0002 Baseline and at DV0002 Week 8.  
Table 5-2: 
Bimekizumab administration schedule visits in DV0002 substudy 
2mL device cohort 
Dose Regimen 
DV0002 Visits 
Baseline 
Week 4 
Week 8 
Week 12 
Week 16 
320mg Q8W 
S 
NA 
S 
NA 
SP 
320mg Q4W 
S 
SP 
S 
SP 
SP 
bimekizumab-AI-2mL=2mL bimekizumab auto-injector; bimekizumab-SS-2mL=2mL bimekizumab safety 
syringe; IRT = interactive response technology; NA=not applicable; Q4W=every 4 weeks; Q8W=every 
8 weeks; S=subject performing self-injection using the investigational device; SP=study personnel performing 
injection using the 1mL prefilled syringe 
Note: For S injections, the 320mg bimekizumab dose will be administered as a single injection (using the 
bimekizumab-SS-2mL or bimekizumab-AI-2mL devices). For SP injections, the 320mg bimekizumab dose will 
be administered as two 160mg injections (using 2 prefilled syringes). The injections will be administered in the 
same manner (eg, both self-administered injections or both SP-administered injections), but each injection will 
be administered at a separate injection site and rotation between injection sites should be observed. 
Note: For the 2mL device cohort, Baseline for DV0002 will occur at PS0014 Week 24, Week 28, or Week 32 for 
subjects receiving bimekizumab Q4W or at PS0014 Week 24 or Week 32 for subjects receiving bimekizumab 
Q8W. Dose regimen will be assigned at Baseline of the PS0014 study, and the same IRT will be used for both 
the PS0014 and DV0002 studies. 
 
The bimekizumab administration schedule optimizes the collection of PK trough data within the 
constraints of a short treatment period and a Q4W and Q8W dosing regimen. At Weeks 4, 12, 
and 16, subjects on the Q4W dosing regimen will be injected by study personnel with 
2 injections each of 160 mg bimekizumab using a 1mL PFS (ie, the same device as that used in 
PS0014). For these subjects, the Q4W administration schedule will provide PK trough data 
associated with injection by: 
 Study personnel using the 1mL PFS from PK samples collected (before self-injection) at 
DV0002 Baseline and Week 8 (ie, PK data from 2 timepoints) 
 Subject self-injection using the assigned device from PK samples collected (before 
injection by study personnel) at Week 4 and Week 12 (ie, PK data from 2 timepoints) 
At DV0002 Baseline and Week 8, subjects on the Q8W dosing regimen will self-inject 1 
injection using the assigned 2mL device (bimekizumab-SS-2mL or the 1 bimekizumab-AI-2mL). 
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For these subjects, the Q8W administration schedule will provide PK trough data associated with 
injection by: 
 Study personnel using the 1mL PFS from PK samples collected (before self-injection) at 
DV0002 Baseline (ie, PK data from 1 timepoint) 
 Subject self-injection using the assigned device from PK samples collected (before 
self-injection) at DV0002 Week 8 and (before injection by study personnel) at DV0002 
Week 16 (ie, PK data from 2 timepoints) 
In addition to self-injections, DV0002 substudy-specific assessments (eg, study personnel 
evaluation, SIAQ responses, VAS for injection site pain, and PK analyses; see Section 5.2) will 
be performed from DV0002 Baseline through Week 16 (inclusive). An SFU telephone call will 
occur 1 week after the last self-administration (at DV0002 Week 9).  
After Week 16 in the DV0002 substudy, subjects will continue in PS0014. Studies DV0002 and 
PS0014 will share a common database/eCRF system (including common AE reporting) and a 
common IRT. 
Subjects who are withdrawn from DV0002 but continue their PS0014 study participation will be 
required to perform an SFU telephone call 1 week after their final DV0002 dosing visit (see 
Section 6.3). Subjects who are withdrawn from bimekizumab treatment (PS0014 study) during 
the course of DV0002 will also be required to follow the PS0014 withdrawal procedures. 
5.1.1 
Study duration per subject 
The maximum DV0002 substudy duration will be 16 weeks for each subject. Subjects will then 
continue to receive treatment in PS0014 for the duration of the PS0014 study. 
The end of the DV0002 substudy is defined as the date on which the last subject completes 
his/her Week 16 Visit or withdraws from the study. 
5.1.2 
Planned number of subjects and sites 
For evaluation of the 1mL device, it is planned to enroll approximately 200 subjects; each device 
arm (bimekizumab-SS-1mL, bimekizumab-AI-1mL) will consist of approximately 100 subjects.  
Once the 1mL device cohort has finished enrolling, the 2mL device cohort will start enrolling. 
For evaluation of the 2mL device, it is planned to enroll approximately 100 subjects; each device 
arm (bimekizumab-SS-2mL or bimekizumab-AI-2mL) will consist of approximately 50 subjects.  
It is anticipated that this study will involve up to 80 sites in North America. 
5.1.3 
Anticipated regions and countries 
This substudy will be conducted in North America. 
5.2 
Schedule of study assessments 
The schedule of assessments in presented in Table 5-3 for the 1mL device cohort. For subjects in 
the 1mL device cohort, Baseline for DV0002 corresponds to Baseline in PS0014, and the 
subsequent study visits are the same in both studies. Table 5-3 includes assessments performed 
specifically in the DV0002 substudy and assessments performed as part of the PS0014 study, 
inclusive. Assessments specific to the DV0002 substudy are labeled for clarity. 
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For subjects in the 2mL device cohort, Baseline for DV0002 can correspond to the PS0014 
Week 24, Week 28, or Week 32 visits for subjects receiving bimekizumab Q4W and to the 
PS0014 Week 24 or Week 32 visits for subjects receiving bimekizumab Q8W. The schedule of 
assessments for the PS0014 Week 24 through Week 48 visits is presented in Table 5-4. The 
additional assessments to be performed for the DV0002 substudy in the 2mL device cohort 
specifically are presented in Table 5-5.  
 
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Table 5-3: 
Schedule of assessments for the PS0014 study and DV0002 substudy (1mL device cohort) 
Visit a 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(DV0002 SFU) 
Visit 4 
Visit 5 
Baseline/Feeder 
Study Final Visit 
Week 4 
Week 8 
Week 9 
Week 12 
Week 16 
Informed consent for DV0002 and 
PS0014 assessments 
X 
 
 
 
 
 
Inclusion/exclusion  
X 
 
 
 
 
 
Physical exam b, c 
X 
 
 
 
X 
 
Body weight 
X 
 
 
 
 
 
Vital signs d 
X 
X 
X 
 
 
X 
Hematology and chemistry 
X 
X 
X 
 
 
X 
Urinalysis 
X 
X 
X 
 
 
X 
Urine drug screen 
X 
 
 
 
 
 
ECG 
X 
 
 
 
 
 
Pregnancy testing e 
X 
X 
X 
 
X 
X 
TB questionnaire  
X 
 
 
 
X 
 
Blood sample for bimekizumab 
plasma concentrations f (DV0002-
specific for Weeks 4, 8, and 12) 
X 
X g 
X  
 
X g 
X h 
Blood sample for anti-bimekizumab 
antibodies f 
X 
 
 
 
 
X 
PASI  
X 
X 
X 
 
X 
X 
Percentage of BSA 
X 
X 
X 
 
X 
X 
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Table 5-3: 
Schedule of assessments for the PS0014 study and DV0002 substudy (1mL device cohort) 
Visit a 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(DV0002 SFU) 
Visit 4 
Visit 5 
Baseline/Feeder 
Study Final Visit 
Week 4 
Week 8 
Week 9 
Week 12 
Week 16 
IGA  
X 
X 
X 
 
X 
X 
DLQI 
X 
 
 
 
 
 
PHQ-9 
X 
X 
X 
 
 
X 
eC-SSRS 
X 
X 
X 
 
 
X 
mNAPSI i 
X 
 
 
 
 
 
Scalp IGA j 
X 
 
 
 
 
 
pp-IGA k 
X 
 
 
 
 
 
EQ-5D-3L 
X 
 
 
 
 
 
SF-36 
X 
 
 
 
 
 
PGA of PSO 
X 
 
 
 
 
 
PASE 
X 
 
 
 
 
 
PGADA l 
X 
 
 
 
 
 
WPAI-SHP v2.0 
X 
 
 
 
 
 
Concomitant medication 
(DV0002-specific for Week 9) 
X 
X 
X 
X 
X 
X 
Adverse events m (DV0002-specific 
for Week 9) 
X 
X 
X 
X 
X 
X 
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Table 5-3: 
Schedule of assessments for the PS0014 study and DV0002 substudy (1mL device cohort) 
Visit a 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(DV0002 SFU) 
Visit 4 
Visit 5 
Baseline/Feeder 
Study Final Visit 
Week 4 
Week 8 
Week 9 
Week 12 
Week 16 
Random assignment to device 
(DV0002-specific) 
X 
 
 
 
 
 
IRT contact 
X 
X 
X 
 
X 
X 
Subject training for VAS and SIAQ 
Questionnaire (DV0002-specific) 
X 
 
 
 
 
 
Pre-injection SIAQ Questionnaire n 
(DV0002-specific) 
X 
 
 
 
 
 
Subject training for self-injection 
(DV0002-specific) 
X 
 
 
 
 
 
Bimekizumab administration by study 
personnel using the PFS o 
 
X g 
 
 
X g 
X 
Subject self-injection of bimekizumab 
using the assigned deviceo, p 
(DV0002-specific) 
X 
 
X 
 
 
 
Study personnel evaluation of 
self-injection (DV0002-specific) 
X 
 
X 
 
 
 
Study personnel evaluation of 
post-use device for 
structural/mechanical integrity 
(DV0002-specific) 
X 
 
X 
 
 
 
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Table 5-3: 
Schedule of assessments for the PS0014 study and DV0002 substudy (1mL device cohort) 
Visit a 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(DV0002 SFU) 
Visit 4 
Visit 5 
Baseline/Feeder 
Study Final Visit 
Week 4 
Week 8 
Week 9 
Week 12 
Week 16 
VAS for injection site pain 
(DV0002-specific) 
X 
 
X 
 
 
 
Post-injection SIAQ Questionnaire n 
(DV0002-specific) 
X 
 
X 
 
 
 
Drug and device accountability 
(DV0002-specific) 
X 
Xg 
X 
 
Xg 
X 
bimekizumab-AI-1mL=1mL bimekizumab auto-injector; bimekizumab-SS-1mL=1mL bimekizumab safety syringe; BSA=body surface area; 
DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide Severity Rating Scale; EQ-5D-3L=Euro-Quality 
of Life 5-Dimensions 3-level; IGA=Investigator’s Global Assessment; IRT=interactive response technology; mNAPSI=modified Nail Psoriasis Severity 
Index; PASE=Psoriatic Arthritis Screening and Evaluation; PASI=Psoriasis Area Severity Index; PGA=Patient Global Assessment; PGADA=Patient’s 
Global Assessment of Disease Activity; PHQ-9=Patient Health Questionnaire 9; pp-IGA=palmoplantar Investigator’s Global Assessment; PSO=psoriasis; 
Q4W=every 4 weeks; Q8W=every 8 weeks; SF-36=Short Form 36-item Health Survey; SFU=safety follow-up; SIAQ=Self-injection Assessment 
Questionnaire; TB=tuberculosis; VAS=visual analog scale; WPAI-SHP=Work Productivity and Activity Impairment Questionnaire-specific health problem 
a Visit windows of ±7 days from the first dose at all visits except Visit 3a (SFU telephone call). The SFU telephone call window is 7 days from the last dose in 
the DV0002 substudy, ±3 days. 
b Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
c The physical exam will include examination of the following systems: eyes, hair, and skin; respiratory; cardiovascular; and gastrointestinal. 
d Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where 
applicable. 
e Pregnancy testing will consist of urine pregnancy tests at all visits. Pregnancy test results must be negative prior to administering investigational medicinal 
product. 
f All blood samples will be taken prior to dosing. 
g This will only be done for subjects who receive bimekizumab Q4W. 
h This will only be done for subjects who receive bimekizumab Q8W. 
i The mNAPSI will be assessed only in subjects with nail involvement at Baseline in the feeder studies. 
j The scalp IGA will only be assessed for those subjects with scalp involvement (scalp IGA score >0) at Baseline in the feeder studies. 
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Table 5-3: 
Schedule of assessments for the PS0014 study and DV0002 substudy (1mL device cohort) 
Visit a 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(DV0002 SFU) 
Visit 4 
Visit 5 
Baseline/Feeder 
Study Final Visit 
Week 4 
Week 8 
Week 9 
Week 12 
Week 16 
k The pp-IGA will only be assessed in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline in the feeder studies. 
l The PGADA is assessed only for subjects with psoriatic arthritis at Baseline in the feeder studies. 
m Adverse events not related to the investigational devices will be reported in PS0014 and adverse device effects and device deficiencies will be reported in 
DV0002. A single safety database will be used for both studies. 
n Version 2.0 of the SIAQ will be used to assess bimekizumab-SS-1mL, while version 2.1 will be used to assess bimekizumab-AI-1mL (see Section 9.1). 
o The dosing window is ±7 days relative to the scheduled dosing visit. 
p The 320mg bimekizumab dose will be administered as two 160mg injections (using 2 bimekizumab-SS-1mL devices or 2 bimekizumab-AI-1mL devices). 
 
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Table 5-4: 
Schedule of assessments for the PS0014 study (2mL device cohort) 
Week 
Procedures 
Week 24a 
Week 28a 
Week 32a 
Week 36 
Week 40 
Week 44 Week 48 
Physical examb,c 
X 
 
 
X 
 
 
X 
Body weight 
 
 
 
 
 
 
X 
Vital signsd 
X 
 
X 
 
X 
 
X 
Hematology and chemistry 
X 
 
X 
 
X 
 
X 
Urinalysis 
X 
 
X 
 
X 
 
X 
ECG 
 
 
 
 
 
 
X 
Pregnancy testinge 
X 
X 
X 
X 
X 
X 
X 
IGRA TB test 
 
 
 
 
 
 
X 
TB questionnaire 
X 
 
 
X 
 
 
X 
Blood sample for bimekizumab plasma 
concentrationsf 
X 
 
 
 
X 
 
X 
Blood sample for anti-bimekizumab antibodiesf 
X 
 
 
 
X 
 
X 
PASI  
X 
X 
X 
X 
X 
X 
X 
Percentage of BSA 
X 
X 
X 
X 
X 
X 
X 
IGA  
X 
X 
X 
X 
X 
X 
X 
DLQI 
X 
 
 
 
 
 
X 
PHQ-9 
X 
 
X 
 
X 
 
X 
eC-SSRS 
X 
 
X 
 
X 
 
X 
mNAPSIg 
X 
 
 
 
 
 
X 
Scalp IGAh 
X 
 
 
 
 
 
X 
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Table 5-4: 
Schedule of assessments for the PS0014 study (2mL device cohort) 
Week 
Procedures 
Week 24a 
Week 28a 
Week 32a 
Week 36 
Week 40 
Week 44 Week 48 
pp-IGAi 
X 
 
 
 
 
 
X 
EQ-5D-3L 
X 
 
 
 
 
 
X 
SF-36 
X 
 
 
 
 
 
X 
PGA of PSO 
X 
 
 
 
 
 
X 
PASEj 
 
 
 
 
 
 
X 
PGADAj 
X 
 
 
 
 
 
X 
WPAI-SHP V2.0 
X 
 
 
 
 
 
X 
TSQM-9 
 
 
 
 
 
 
X 
Concomitant medication 
X 
X 
X 
X 
X 
X 
X 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
IRT 
X 
X 
X 
X 
X 
X 
X 
Bimekizumab administrationk,l  
X 
X 
X 
X 
X 
X 
X 
Subject training on home self-injectionm 
 
 
 
 
X 
X 
 
BSA=body surface area; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide Severity Rating Scale; EQ-5D-3L=Euro-
Quality of Life 5-Dimensions 3-level; IGA=Investigator’s Global Assessment; IGRA=interferon-gamma release assay; IMP=investigational medicinal product; 
IRT=interactive response technology; mNAPSI=modified Nail Psoriasis Severity Index; PASE=Psoriatic Arthritis Screening and Evaluation; PASI=Psoriasis Area Severity 
Index; PGA=Patient Global Assessment; PGADA=Patient’s Global Assessment of Disease Activity; PHQ-9=Patient Health Questionnaire-9; pp-IGA=palmoplantar 
Investigator’s Global Assessment; PsA=psoriatic arthritis; PSO=psoriasis; Q4W=every 4 weeks; Q8W=every 8 weeks; SF-36=Short Form 36-item Health Survey; 
TB=tuberculosis; TSQM-9=Treatment Satisfaction Questionnaire for Medication; WPAI-SHP=Work Productivity and Activity Impairment Questionnaire-specific health 
problem  
Note: Starting at Week 48 of the PS0014 Treatment Period, subjects may self-inject IMP at home; self-injection training will be provided to the 
subject/caregivers by qualified site personnel (refer to PS0014 protocol). 
a For the 2mL device cohort, Baseline of DV0002 can occur at PS0014 Week 24, Week 28, or Week 32 for subjects receiving bimekizumab Q4W and at 
PS0014 Week 24 or Week 32 for subjects receiving bimekizumab Q8W. 
b Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
c The physical examination will be performed as per the PS0014 protocol Section 9.3.5. 
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Table 5-4: 
Schedule of assessments for the PS0014 study (2mL device cohort) 
Week 
Procedures 
Week 24a 
Week 28a 
Week 32a 
Week 36 
Week 40 
Week 44 Week 48 
d Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where 
applicable. 
e Urine pregnancy testing will be performed at all visits. Pregnancy test results must be negative prior to administering IMP. 
f All blood samples taken prior to dosing. 
g The mNAPSI will be assessed only in subjects with nail involvement at Baseline in the feeder studies. 
h The scalp IGA will only be assessed for those subjects with scalp involvement (scalp IGA score >0) at Baseline in the feeder studies. 
i The pp-IGA will only be assessed in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline in the feeder studies 
j The PGADA and the PASE are assessed only for subjects with PsA at Baseline in the feeder studies. 
k The dosing window is ±7 days relative to the scheduled dosing visit. 
l Only subjects receiving IMP Q4W are dosed on Week 28, Week 36, and Week 44. 
m Subject training on at-home self-injection is to be performed as described in the PS0014 protocol Section 7.2. Starting at Week 48 of the PS0014 Treatment 
Period, subjects may self-inject IMP at home. 
 
 
 
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Table 5-5: 
Schedule of assessments for the DV0002 substudy (2mL device cohort) 
Visita 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(Device SFU) 
Visit 4 
Visit 5 
Baselineb 
Baseline + 
4 weeks 
Baseline + 
8 weeks 
Baseline + 
9 weeks 
Baseline + 
12 weeks 
Baseline + 
16 weeks 
Informed consent for DV0002  
X 
 
 
 
 
 
Random assignment to device 
(DV0002-specific) 
X 
 
 
 
 
 
IRT contact 
X 
X 
X 
 
X 
X 
Blood sample for bimekizumab 
plasma concentrationsc (DV0002-
specific for Weeks 4, 8, and 12) 
X 
Xd 
X 
 
Xd 
Xe 
Subject training for VAS and SIAQ 
Questionnaire (DV0002-specific) 
X 
 
 
 
 
 
Pre-injection SIAQ Questionnairef 
(DV0002-specific) 
X 
 
 
 
 
 
Subject training for self-injection 
(DV0002-specific) 
X 
 
 
 
 
 
Bimekizumab administration by study 
personnel using the PFSg 
 
Xd 
 
 
Xd 
X 
Subject self-injection of bimekizumab 
using the assigned deviceg,h 
(DV0002-specific) 
X 
 
X 
 
 
 
Study personnel evaluation of 
self-injection (DV0002-specific) 
X 
 
X 
 
 
 
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Table 5-5: 
Schedule of assessments for the DV0002 substudy (2mL device cohort) 
Visita 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(Device SFU) 
Visit 4 
Visit 5 
Baselineb 
Baseline + 
4 weeks 
Baseline + 
8 weeks 
Baseline + 
9 weeks 
Baseline + 
12 weeks 
Baseline + 
16 weeks 
VAS for injection site pain 
(DV0002-specific) 
X 
 
X 
 
 
 
Post-injection SIAQ Questionnairef 
(DV0002-specific) 
X 
 
X 
 
 
 
Study personnel evaluation of 
post-use device for 
structural/mechanical integrity 
(DV0002-specific) 
X 
 
X 
 
 
 
Drug and device accountability 
(DV0002-specific) 
X 
Xd 
X 
 
Xd 
X 
Concomitant medication 
 
 
 
X 
 
 
Adverse Eventsi 
 
 
 
X 
 
 
IRT=interactive response technology; Q4W=every 4 weeks; Q8W=every 8 weeks; SFU=safety follow-up; SIAQ=Self-injection Assessment Questionnaire; 
VAS=visual analog scale  
a Visit windows of ±7 days from the first dose at all visits except Visit 3a (SFU telephone call). The SFU telephone call window is 7 days from the last dose in 
the DV0002 substudy, ±3 days. 
b For subjects in the 2mL device cohort, Baseline for DV0002 corresponds to PS0014 Week 24, Week 28, or Week 32 for subjects receiving bimekizumab 
Q4W and to PS0014 Week 24 or Week 32 for subjects receiving bimekizumab Q8W. Refer to Table 5-4 for PS0014 study assessments.  
c All blood samples will be taken prior to dosing. For detail on PK sampling in the 2mL device cohort, refer to Table 10-1 in Section 10. 
d This will only be done for subjects who receive bimekizumab Q4W. 
e This will only be done for subjects who receive bimekizumab Q8W. 
f Version 2.0 of the SIAQ will be used to assess bimekizumab-SS-2mL, while version 2.1 will be used to assess bimekizumab-AI-2mL (see Section 9.1). 
g The dosing window is ±7 days relative to the scheduled dosing visit. 
h The 320mg bimekizumab dose will be administered as 1 injection using the bimekizumab-SS-2mL device or bimekizumab-AI-2mL device. 
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Table 5-5: 
Schedule of assessments for the DV0002 substudy (2mL device cohort) 
Visita 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(Device SFU) 
Visit 4 
Visit 5 
Baselineb 
Baseline + 
4 weeks 
Baseline + 
8 weeks 
Baseline + 
9 weeks 
Baseline + 
12 weeks 
Baseline + 
16 weeks 
i Adverse events not related to the devices will be reported in PS0014 and adverse device effects and device deficiencies will be reported in DV0002. A single 
safety database will be used for both studies. 
 
 
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5.3 
Schematic diagram 
The study schematic diagram for DV0002 1 mL device cohort is presented in Figure 5‒1, and the 
2mL device cohort is presented in Figure 5‒2. 
Figure 5‒1: Schematic diagram for the 1mL device cohort 
 
BL=Baseline; Q4W=every 4 weeks; Q8W=every 8 weeks; self-inject=self-injection; SFU=safety follow-up; 
Wk=week 
Note: Phase 3 feeder studies include PS0008, PS0009, and PS0013. 
Note: Subjects will receive 320mg bimekizumab either Q4W or Q8W. Bimekizumab will be self-administered only 
at Baseline and at Week 8 (study personnel will administer bimekizumab at other visits, as applicable). 
Note: For the 1mL device cohort, subjects will begin the DV0002 substudy and the PS0014 study at the same time; 
therefore, Baseline for DV0002 corresponds to Baseline for PS0014. 
 
Figure 5‒2: Schematic diagram for the 2mL device cohort 
 
BL=Baseline; Q4W=every 4 weeks; Q8W=every 8 weeks; self-inject=self-injection; SFU=safety follow-up; 
WK=week 
Note: Subjects will receive 320mg bimekizumab either Q4W or Q8W. Bimekizumab will be self-administered only 
at DV0002 Baseline and 8 weeks after training (study personnel will administer bimekizumab at other visits). 
a For the 2mL device cohort, subjects will not begin the DV0002 substudy and the PS0014 study at the same time. 
Baseline for DV0002 corresponds to the PS0014 Week 24, Week 28, or Week 32 visit for subjects receiving 
bimekizumab Q4W and to the PS0014 Week 24 or Week 32 visit for subjects receiving bimekizumab Q8W. 
5.4 
Rationale for study design and selection of dose 
DV0002 is a Phase 3, randomized, multicenter, open-label study for subjects with moderate to 
severe chronic plaque PSO who will self-inject bimekizumab. DV0002 is a substudy of PS0014; 
PS0014 is a multicenter, open-label, long-term study to evaluate the safety, tolerability, and 
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efficacy of bimekizumab in subjects with moderate to severe chronic plaque PSO who complete 
1 of the Phase 3 feeder studies (PS0008, PS0009, or PS0013).  
It is expected that most individuals who will use commercial bimekizumab for the treatment of 
moderate to severe chronic plaque PSO will self-inject bimekizumab and also that these 
individuals will prefer to have options for the self-administration of their medication. DV0002 
will therefore evaluate the safe and effective use of 4 different self-injection investigational 
devices in 2 cohorts: the 1mL device cohort and the 2mL device cohort. The 1mL device cohort 
will evaluate the bimekizumab-SS-1mL and bimekizumab-AI-1mL investigational devices. The 
2mL device cohort will evaluate the bimekizumab-SS-2mL and bimekizumab-AI-2mL 
investigational devices. In addition, DV0002 will assess trough PK levels associated with 
self-injection using the investigational device, injection by study personnel using the 1mL PFS, 
injection site (abdomen or thigh), and BMI category (by tertile). 
6 
SELECTION AND WITHDRAWAL OF SUBJECTS 
6.1 
Inclusion criteria 
To be eligible for DV0002, subjects must meet all of the following additional criteria: 
1. An Institutional Review Board (IRB) approved written Informed Consent form (ICF) for 
DV0002 is signed and dated by the subject.  
2. Subject fulfills all inclusion criteria for the PS0014 study. 
3. Subject is considered reliable and capable of adhering to the DV0002 protocol (eg, able to 
understand and complete questionnaires, able to use investigational device according to the 
IFU, and able to adhere to the visit schedule) according to the judgment of the Investigator.  
4. Subject is willing to self-inject. 
6.2 
Exclusion criteria 
Subjects are not permitted to enroll in DV0002 if any of the PS0014 study exclusion criteria are 
met. Subjects who participated in the 1mL device cohort of DV0002 are not eligible to enroll in 
the 2mL device cohort. 
6.3 
Withdrawal criteria 
Since DV0002 is a substudy of PS0014, all DV0002 withdrawal criteria are captured in the 
PS0014 protocol. There are no additional DV0002-specific withdrawal criteria beyond those that 
are described in PS0014. Subjects are free to withdraw from DV0002 at any time, without 
prejudice to their continued care. Subjects who withdraw from DV0002 but remain eligible for 
PS0014 (ie, subjects who have a medical condition or personal preference that precludes further 
self-injection) may continue in PS0014. These subjects must perform an SFU telephone call 
1 week after their final DV0002 dosing visit.  
Subjects who are withdrawn from bimekizumab treatment (PS0014 study) during DV0002 will 
also be required to follow the PS0014 withdrawal procedures. 
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7 
INVESTIGATIONAL MEDICINAL PRODUCT AND 
INVESTIGATIONAL DEVICE 
In the DV0002 substudy, the term IMP refers to the bimekizumab drug product. The term 
investigational device refers to 4 different self-injection investigational devices 
(bimekizumab-SS-1mL, bimekizumab-AI-1mL, bimekizumab-SS-2mL, and 
bimekizumab-AI-2mL) that are comprised of drug product (IMP) associated with a functional 
secondary packaging. 
7.1 
Description of investigational devices 
At DV0002 Baseline, each subject will be provided with self-injection training and IFU for the 
appropriate device.  
7.1.1 
Bimekizumab-SS-1mL 
The bimekizumab-SS-1mL, shown in Figure 7-1, consists of the naked PFS (primary packaging 
containing bimekizumab drug product for all Phase 3 studies) and a customized
safety syringe for sc bimekizumab administration. 
The naked PFS is a glass, 1mL long, primary container with small round flange and a 27G 
half-inch staked needle containing 1mL of bimekizumab. The
safety syringe is a 
single-use platform device with a passive needle stick safety mechanism. To enhance the device 
usability,
 
 
Figure 7-1: Bimekizumab-SS-1mL 
 
bimekizumab-SS-1mL=1mL bimekizumab safety syringe; SnS=Safe’n’Sound 
7.1.1.1 
Instruction for use of bimekizumab-SS-1mL 
The bimekizumab-SS-1mL is used to administer an sc injection in either the right or left lateral 
abdominal wall or the right or left outer thigh without massage. Each injection should be 
administered at a separate injection site, and rotation between the injection sites should be 
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observed. Treatment of the injection site with an anesthetic cream prior to dosing is not 
permitted. 
During the study (at Baseline and Week 8), 2 bimekizumab-SS-1mL devices will be used to 
administer 160mg injections of bimekizumab (320mg total). To use the bimekizumab-SS-1mL, 
the overcap is removed and the plunger rod is fully depressed, which empties the syringe 
contents through the needle. When the plunger rod reaches its final position the needle safety 
retraction mechanism is activated, which retracts the sleeve, syringe, and plunger rod and holds 
the needle safely within the body molding.  
Additional instructions for device use, including the injection angle, are provided in the IFU. 
7.1.2 
Bimekizumab-AI-1mL 
The bimekizumab-AI-1mL, shown in Figure 7-2, consists of the naked PFS (primary packaging 
containing bimekizumab drug product used for all Phase 3 studies and in the 
bimekizumab-SS-1mL) and a customized auto-injector. The PFS volume will be administered 
from the same primary container, a 1mL long glass syringe, with a small round flange and a 27G 
half-inch stacked needle. The bimekizumab-AI-1mL is a single dose, disposable, nonsterile 
combination product. To enhance the device usability, UCB customized the auto-injector by 
adding a ring-pull cap and an external envelope. 
Figure 7-2: Bimekizumab-AI-1mL 
 
bimekizumab-AI-1mL=1mL bimekizumab auto-injector 
7.1.2.1 
Instruction for use of bimekizumab-AI-1mL 
The bimekizumab-AI-1mL is used to administer an sc injection in either the right or left lateral 
abdominal wall or the right or left outer thigh without massage. Each injection should be 
administered at a separate injection site, and rotation between the injection sites should be 
observed. Treatment of the injection site with an anesthetic cream prior to dosing is not 
permitted. 
During the study (at Baseline and Week 8), 2 bimekizumab-AI-1mL devices will be used to 
administer 160mg injections of bimekizumab (320mg total). To use the bimekizumab-AI-1mL, 
the ring-pull cap is removed and the device is depressed on the injection site. The auto-injector 
provides needle insertion, dose delivery, and needle protection through an extending and locking 
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shroud. Needle protection is performed by a shroud that will deploy should the auto-injector lose 
contact with the skin during an injection.  
Additional instructions for device use, including the injection angle, are provided in the IFU. 
7.1.3 
Bimekizumab-SS-2mL 
The bimekizumab-SS-2mL, shown in Figure 7-3, consists of the primary container (a glass 
syringe filled with 2mL of bimekizumab drug product) and a safety syringe. 
The bimekizumab-SS-2mL is a single-use syringe with a passive safety feature. 
Figure 7-3: Bimekizumab-SS-2mL 
7.1.3.1 
Instruction for use of bimekizumab-SS-2mL 
The bimekizumab-SS-2mL is used to administer a sc injection in either the right or left lateral 
abdominal wall or the right or left outer thigh without massage. Treatment of the injection site 
with an anesthetic cream prior to dosing is not permitted. 
During the study (at DV0002 Baseline and Week 8), 1 bimekizumab-SS-2mL device will be 
used to administer a 320mg injection of bimekizumab. To use the bimekizumab-SS-2mL, the 
rigid needle shield (RNS) is removed, and the plunger rod is fully depressed, which empties the 
syringe contents through the needle. When the plunger rod reaches its final position the needle 
safety retraction mechanism is activated, which retracts the sleeve, syringe, and plunger rod and 
holds the needle safely within the body molding.  
Additional instructions for device use, including the injection angle, are provided in the IFU. 
7.1.4 
Bimekizumab-AI-2mL 
The bimekizumab-AI-2mL, shown in Figure 7-4, consists of the primary container (a glass 
syringe filled with 2mL of bimekizumab drug product) and an auto injector. The 
bimekizumab-AI-2mL is a single use auto injector with a passive needle stick safety mechanism. 
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Figure 7-4: Bimekizumab-AI-2mL 
 
bimekizumab-AI-2mL=2mL bimekizumab auto-injector 
7.1.4.1 
Instruction for use of bimekizumab-AI-2mL 
The bimekizumab-AI-2mL is used to administer a sc injection in either the right or left lateral 
abdominal wall or the right or left outer thigh without massage. Treatment of the injection site 
with an anesthetic cream prior to dosing is not permitted. 
During the study (at DV0002 Baseline and Week 8), 1 bimekizumab-AI-2mL device will be 
used to administer a 320mg injection of bimekizumab. To use the bimekizumab-AI-2mL, the cap 
is removed, and the device is depressed on the injection site. The auto injector provides needle 
insertion, dose delivery, and needle protection through an extending and locking shroud. Needle 
protection is performed by a shroud that will deploy should the auto-injector lose contact with 
the skin during an injection.  
Additional instructions for device use, including the injection angle, are provided in the IFU. 
7.2 
Treatment to be administered 
The IMP used in this study is bimekizumab. Bimekizumab will be supplied at a concentration of 
160mg/mL (55mM sodium acetate, 220mM glycine, 0.04% polysorbate 80 at pH 5.0) for sc 
injection. 
1mL Device Cohort 
For the 1mL device cohort, IMP will be supplied in 2 investigational devices: 
bimekizumab-SS-1mL or the bimekizumab-AI-1mL. 
The IMP will be administered according to the schedule shown in Table 5-1. Subjects will be 
assigned to the use of 1 device and will receive the following doses of IMP based on their 
established dosing regimen in PS0014: 
 320mg bimekizumab, Q8W or 
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 320mg bimekizumab, Q4W. 
Regardless of the assigned dose regimen, subjects will perform self-injection with the assigned 
device only at Baseline and at Week 8. For the 1mL device cohort, the 320mg bimekizumab dose 
will be administered as two 160mg injections with either 2 bimekizumab-SS-1mL or 
2 bimekizumab-AI-1mL devices. At all visits except Baseline and Week 8, the 
320mg bimekizumab dose will be administered as two 160mg injections in a 1mL PFS by study 
personnel (ie, the same administration manner and device used in PS0014).  
The investigational devices will be used as described in the IFU. Subjects will be observed onsite 
for 30 minutes after self-injection with bimekizumab for any AEs. Subjects will be asked to 
contact the designated site personnel in case any AEs occur outside of the site visits. Of note, 
reported AEs related to IMP will be assessed within PS0014 and reported ADEs and device 
deficiencies will be assessed within DV0002. 
2mL Device Cohort 
For the 2mL device Cohort, IMP will be supplied in 2 investigational devices: 
bimekizumab-SS-2mL or bimekizumab-AI-2mL. 
The IMP will be administered according to the schedule shown in Table 5-2. Subjects will be 
assigned to the use of 1 device and will receive the following doses of IMP based on their dosing 
regimen in PS0014: 
 320mg bimekizumab, Q8W or 
 320mg bimekizumab, Q4W. 
Regardless of the assigned dose regimen, subjects will perform self-injection with the assigned 
device only at DV0002 Baseline and 8 weeks after training with the investigational device. For 
the 2mL device cohort, 320mg bimekizumab dose will be administered as 1 injection with either 
the bimekizumab-SS-2mL device or the bimekizumab-AI-2mL device. For subjects who receive 
bimekizumab Q4W, the bimekizumab dose at Week 4 will be administered as 
two 160mg injections in a 1mL PFS by study personnel (ie, the same administration manner used 
in PS0014).  
The devices will be used as described in the IFU. Subjects will be observed onsite for 30 minutes 
after self-injection with bimekizumab for any AEs. Subjects will be asked to contact the 
designated site personnel in case any AEs occur outside of the site visits. Of note, reported AEs 
related to IMP will be assessed within PS0014 and reported ADEs and device deficiencies will 
be assessed within DV0002. 
7.3 
Packaging 
The site will receive uniquely-numbered investigational devices (bimekizumab-SS-1mL, 
bimekizumab-AI-1mL, bimekizumab-SS-2mL, and bimekizumab-AI-2mL) for use in the 
DV0002 substudy. 
7.4 
Labeling 
Clinical drug and investigational device supplies will be labeled in accordance with the current 
International Council for Harmonisation (ICH) guidelines on Good Clinical Practice (GCP) and 
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Good Manufacturing Practice and will include any locally required statements. If necessary, 
labels will be translated into the local language.  
7.5 
Handling and storage requirements 
The investigational devices that house IMP must be securely stored at 2ºC to 8ºC (ie, in a 
refrigerator), that is either in a locked room or in the pharmacy. Appropriate storage conditions 
must be ensured by controlling refrigerator temperature by using either an automated 
temperature monitoring and recording system or a minimum/maximum thermometer and 
completing a daily temperature log in accordance with local requirements. If an out-of-range 
temperature is noted, the Sponsor or designee must be notified so that a determination can be 
made whether the product should be used or not.  
The Investigator or hospital pharmacist is responsible for the appropriate storage and 
accountability of the investigational device at the site, as well as, for the documentation of 
appropriate storage and accountability. Refer to the IMP Handling Manual for additional 
information on handling and storage requirements. 
7.6 
Drug and device accountability 
The Investigator will receive numbered treatments that will be assigned to eligible subjects by an 
IRT at Baseline. All IMP administrations will be observed by the Investigator or his/her 
appropriately trained designee. 
Appropriate accountability forms that reflect the receipt and use of the IMP and the 
investigational devices will be supplied to the investigational site. Details of any loss of the 
self-injection investigational devices due to breakage or wastage, non-use, destruction at the 
study site, or return to the Sponsor or designee must also be recorded on these forms. All 
supplies and pharmacy documentation must be made available throughout the study for UCB (or 
designee) to review. 
The Investigator (or designee) is responsible for retaining all used, unused, and partially used 
IMP and investigational devices until returned to UCB. Used or partially used devices are to be 
stored at room temperature in a secured area and may only be destroyed following UCB’s 
instruction. Devices with noted deficiencies are to be returned to UCB immediately. The 
Investigator may assign some of the Investigator’s duties for drug accountability at the study site 
to an appropriate pharmacist/designee.  
The IMP and investigational devices 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, IMP administration (either self-administration or 
study personnel-administration) will be performed in the clinic and observed by the Investigator 
or his/her designee. Subject compliance will be reported in the PS0014 study. 
7.8 
Concomitant medications/treatments 
Any specifications given in PS0014 regarding permitted and prohibited concomitant medications 
must be followed. 
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7.8.1 
Permitted concomitant treatments (medications and therapies) 
Unless otherwise specified in PS0014, subjects are permitted to continue their prescribed 
medical therapy for the disease in accordance with the instructions of their treating physician. 
Concomitant medications and therapies, including over-the-counter products and supplements, 
must be recorded in the subject’s notes (source documentation) and provided on the eCRF. This 
record should include the name of the drug, the dose, the route and date(s) of administration, and 
the indication for use. 
7.8.2 
Prohibited concomitant treatments (medications and therapies) 
In addition to the prohibited treatments described in PS0014, subjects are not permitted to use 
topical analgesics at the injection site at Baseline or Week 8 in the DV0002 substudy. 
7.9 
Blinding 
This is an open-label substudy. 
7.10 
Randomization and numbering of subjects 
The same unique 5-digit identification number used in the feeder study will be used in PS0014 
and in substudy DV0002. This subject number will be used to identify the subject throughout 
PS0014 and DV0002 and to maintain subject confidentiality. At study visits, an IRT will assign 
the applicable subject kits of IMP. Further instructions will be provided in the IRT manual. 
The IRT will generate individual assignments for the self-injection investigational devices. 
Eligible subjects will be assigned to the investigational devices based on a predetermined 
production randomization and/or packaging schedule provided by UCB (or designee). In the 
1mL device cohort, all eligible subjects will be randomly assigned to perform self-injection using 
either the bimekizumab-SS-1mL or the bimekizumab-AI-1mL at a 1:1 ratio. The IRT will 
allocate kit numbers to the subject based on the subject number during the study. 
Once the 1mL device cohort has finished enrolling, the 2mL device cohort will start enrolling. 
Eligible subjects in the 2mL device cohort will be randomly assigned to perform self-injection 
using either the bimekizumab-SS-2mL or bimekizumab-AI-2mL device at a 1:1 ratio. The IRT 
will allocate kit numbers to the subject based on the subject number during the study.  
Subject numbers and kit numbers will be tracked via the IRT. 
8 
STUDY PROCEDURES BY VISIT 
A general overview of the study assessments for the DV0002 substudy 1mL device cohort is 
provided in Table 5-3. Although Table 5-3 contains assessments for both DV0002 and PS0014, it 
also indicates which assessments are specific to the DV0002 substudy. The lists of procedures at 
each study visit for the 1mL device cohort are described in Section 8.1. 
For subjects in the 2mL device cohort, Baseline for DV0002 can correspond to the PS0014 
Week 24, Week 28, or Week 32 visits for subjects receiving bimekizumab Q4W or to the 
PS0014 Week 14 or Week 32 visits for subjects receiving bimekizumab Q8W. For the 
2mL device cohort, the schedule of assessments for PS0014 is presented in Table 5-4. The 
additional assessments to be performed for the DV0002 substudy specifically are presented in 
Table 5-5 and the list of procedures at each study visit is described in Section 8.2.  
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Of note, DV0002 and PS0014 will share a common database/eCRF system (including common 
AE reporting) and a common IRT. 
The following visit windows are permitted: 
 As in PS0014, a 7-day visit window on either side of the scheduled dosing is permitted; 
however, the Investigator should try to keep the subjects on the original dosing schedule. 
Changes to the dosing schedule outside of the 7-day window must be discussed with the 
Medical Monitor. 
 The SFU telephone call should occur within 7 days after the last dose in the DV0002 
substudy, ±3 days. 
8.1 
Treatment Period for the 1mL Device Cohort 
The DV0002 substudy will include all PS0014 study assessments from Baseline to Week 16 
(inclusive). For subjects in the 1mL device cohort, Baseline for DV0002 corresponds to Baseline 
in PS0014. 
8.1.1 
Visit 1 (Baseline) 
The following procedures/assessments will be performed: 
 Obtain written informed consent (may be obtained prior to Visit 1). 
 Verification of inclusion/exclusion criteria.  
 Physical examination (including evaluation for signs and symptoms of tuberculosis [TB] and 
risk of exposure to TB). 
 Body weight. 
 Vital signs (sitting systolic blood pressure [BP], diastolic BP, pulse rate, and body 
temperature). 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and chemistry.  
 Urinalysis. 
 Urine drug screen. 
 Urine pregnancy test. 
 Bimekizumab plasma concentration.  
 Anti-bimekizumab antibodies. 
 Electrocardiogram (ECG). 
 TB questionnaire. 
 Psoriasis Area Severity Index (PASI). 
 Percentage of body surface area (BSA). 
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 Investigator’s Global Assessment (IGA). 
 Dermatology Life Quality Index. 
 Patient Health Questionnaire 9 (PHQ-9). 
 Electronic Columbia Suicide Severity Rating Scale (eC-SSRS). 
 Modified Nail Psoriasis Severity Index for subjects with nail involvement at Baseline in the 
feeder study. 
 Scalp IGA for subjects with scalp involvement at Baseline in the feeder study. 
 Palmoplantar Investigator’s Global Assessment for subjects with palmoplantar involvement 
at Baseline in the feeder study. 
 Euro-Quality of Life 5-Dimensions 3-level. 
 Short Form 36-item Health Survey. 
 Patient Global Assessment of PSO. 
 Psoriatic Arthritis Screening and Evaluation. 
 Patient Global Assessment of Disease Activity (only for subjects with psoriatic arthritis). 
 Work Productivity and Activity Impairment Questionnaire-specific health problem v2.0. 
 Concomitant medication. 
 Recording of AEs.  
 IRT contact. 
 Random assignment to self-injection investigational device (DV0002-specific). 
 Subject training for VAS and SIAQ Questionnaire (DV0002-specific). 
 Complete the pre-injection SIAQ Questionnaire (version 2.0 for bimekizumab-SS-1mL and 
version 2.1 for bimekizumab-AI-1mL) (DV0002-specific). 
 Subject training for self-injection (DV0002-specific). 
 Subject self-injection of bimekizumab (DV0002-specific). 
 Study personnel evaluation of self-injection (DV0002-specific). 
 Study personnel evaluation of post-use device for structural/mechanical integrity (DV0002-
specific) 
 Complete the VAS for injection site pain (DV0002-specific). 
 Complete the post-injection SIAQ Questionnaire (version 2.0 for bimekizumab-SS-1mL and 
version 2.1 for bimekizumab-AI-1mL) (DV0002-specific). 
 Drug and device accountability (DV0002-specific). 
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8.1.2 
Visit 2 (Week 4) 
The following procedures/assessments will be performed: 
 Vital signs (sitting systolic BP, diastolic BP, pulse rate, and body temperature). 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and chemistry.  
 Urinalysis. 
 Urine pregnancy test. 
 Bimekizumab plasma concentration (for subjects with bimekizumab Q4W dosing) 
(DV0002-specific). 
 PASI. 
 Percentage of BSA. 
 IGA. 
 PHQ-9. 
 eC-SSRS. 
 Concomitant medication. 
 Recording of AEs. 
 IRT contact. 
 Study personnel administration of bimekizumab using a 1mL PFS (for subjects with 
bimekizumab Q4W dosing). 
 Drug and device accountability (DV0002-specific). 
8.1.3 
Visit 3 (Week 8) 
The following procedures/assessments will be performed: 
 Vital signs (sitting systolic BP, diastolic BP, pulse rate, and body temperature). 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and chemistry.  
 Urinalysis. 
 Urine pregnancy test. 
 Bimekizumab plasma concentration (DV0002-specific).  
 PASI. 
 Percentage of BSA. 
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 IGA. 
 PHQ-9. 
 eC-SSRS. 
 Concomitant medication. 
 Recording of AEs. 
 IRT contact. 
 Subject self-injection of bimekizumab (DV0002-specific). 
 Study personnel evaluation of self-injection (DV0002-specific). 
 Study personnel evaluation of post-use device for structural/mechanical integrity (DV0002-
specific). 
 Complete the VAS for injection site pain (DV0002-specific). 
 Complete the post-injection SIAQ Questionnaire (version 2.0 for bimekizumab-SS-1mL and 
version 2.1 for bimekizumab-AI-1mL) (DV0002-specific). 
 Drug and device accountability (DV0002-specific). 
8.1.4 
Visit 3a (Week 9; safety follow-up telephone call) 
Visit 3a (Week 9) will occur in the DV0002 substudy, but not in the PS0014 study. The 
following procedures/assessments will be performed: 
 Concomitant medication (DV0002-specific). 
 Recording of AEs and ADEs (DV0002-specific). 
8.1.5 
Visit 4 (Week 12) 
The following procedures/assessments will be performed: 
 Physical examination (including evaluation for signs and symptoms of TB and risk of 
exposure to TB). 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Urine pregnancy test. 
 Bimekizumab plasma concentration (for subjects with bimekizumab Q4W dosing) 
(DV0002-specific). 
 TB questionnaire. 
 PASI. 
 Percentage of BSA. 
 IGA. 
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 Concomitant medication. 
 Recording of AEs. 
 IRT contact. 
 Study personnel administration of bimekizumab using a 1mL PFS (for subjects with 
bimekizumab Q4W dosing). 
 Drug and device accountability (DV0002-specific). 
8.1.6 
Visit 5 (Week 16) 
The following procedures/assessments will be performed: 
 Vital signs (sitting systolic BP, diastolic BP, pulse rate, and body temperature). 
 Collection of blood and urine samples for the following clinical laboratory tests should be 
obtained prior to dosing: 
 Hematology and chemistry. 
 Urinalysis. 
 Urine pregnancy test. 
 Bimekizumab plasma concentration for subjects on bimekizumab Q8W dosing. 
 Anti-bimekizumab antibody plasma concentration for subjects on Q4W and Q8W dosing. 
 PASI. 
 Percentage of BSA. 
 IGA. 
 PHQ-9. 
 eC-SSRS. 
 Concomitant medication. 
 Recording of AEs. 
 IRT contact. 
 Study personnel administration of bimekizumab using a 1mL PFS. 
 Drug and device accountability (DV0002-specific). 
8.2 
Treatment Period for 2mL Device Cohort 
For the 2mL device cohort, DV0002 Visit 1 (Baseline) will occur at PS0014 Week 24, Week 28, 
or Week 32 for subjects receiving bimekizumab Q4W or Week 24 or Week 32 for subjects 
receiving bimekizumab Q8W.  
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8.2.1 
Visit 1 (Baseline) 
For DV0002 Visit 1 (Baseline) study assessments, refer to Table 5-4 and perform the 
assessments for the week that the subject starts the DV0002 substudy (PS0014 Week 24, 
Week 28, or Week 32 for bimekizumab Q4W or Week 24 or Week 32 for bimekizumab Q8W). 
In addition to the PS0014 study assessments, the following assessments will be performed at the 
Baseline visit of DV0002 (Table 5-5): 
 Informed consent for DV0002.  
 Random assignment to device (DV0002-specific). 
 IRT contact. 
 Blood sample for bimekizumab plasma concentrations. 
 Subject training for VAS and SIAQ Questionnaire (version 2.0 for bimekizumab-SS-2mL 
and version 2.1 for bimekizumab-AI-2mL) (DV0002-specific). 
 Complete the pre-injection SIAQ Questionnaire (DV0002-specific). 
 Subject training for self-injection (DV0002-specific). 
 Subject self-injection of bimekizumab using the assigned device (DV0002-specific). 
 Study personnel evaluation of self-injection (DV0002-specific).  
 Complete the VAS for injection site pain (DV0002-specific). 
 Complete the post-injection SIAQ Questionnaire (version 2.0 for bimekizumab-SS-2mL and 
version 2.1 for bimekizumab-AI-2mL) (DV0002-specific).  
 Study personnel evaluation of device for structural/mechanical integrity (DV0002-specific). 
 Drug and device accountability (DV0002-specific). 
8.2.2 
Visit 2 (Baseline + 4 weeks) 
For PS0014 study assessments, refer to Table 5-4. In addition, perform the following DV0002 
substudy assessments:  
 IRT contact 
 Blood sample for bimekizumab plasma concentrations (DV0002-specific)—only done for 
subjects who receive bimekizumab Q4W 
 Bimekizumab administration by study personnel using the PFS—only done for subjects who 
receive bimekizumab Q4W. 
 Drug and device accountability (DV0002-specific)—only done for subjects who receive 
bimekizumab Q4W. 
8.2.3 
Visit 3 (Baseline + 8 weeks) 
For PS0014 study assessments, refer to Table 5-4. In addition, perform the following DV0002 
substudy assessments:  
 IRT contact. 
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 Blood sample for bimekizumab plasma concentrations (DV0002-specific). 
 Subject self-injection of bimekizumab using the assigned device (DV0002-specific). 
 Study personnel evaluation of self-injection (DV0002-specific).  
 Complete the VAS for injection site pain (DV0002-specific). 
 Complete the post-injection SIAQ Questionnaire (version 2.0 for bimekizumab-SS-2mL and 
version 2.1 for bimekizumab-AI-2mL) (DV0002-specific).  
 Study personnel evaluation of device for structural/mechanical integrity (DV0002-specific). 
 Drug and device accountability (DV0002-specific). 
8.2.4 
Visit 3a (Baseline + 9 weeks; safety follow-up telephone call)  
Visit 3a (Week 9) will occur in the DV0002 substudy but not in the PS0014 study. The following 
procedures/assessments will be performed:   
 Concomitant medications. 
 Adverse events. 
8.2.5 
Visit 4 (Baseline + 12 weeks) 
For PS0014 study assessments, refer to Table 5-4. In addition, perform the following DV0002 
substudy assessments:  
 IRT contact. 
 Blood sample for bimekizumab plasma concentrations (DV0002-specific)—only done for 
subjects who receive bimekizumab Q4W. 
 Bimekizumab administration by study personnel using the PFS—only done for subjects who 
receive bimekizumab Q4W. 
 Drug and device accountability (DV0002-specific). 
8.2.6 
Visit 5 (Baseline + 16 weeks) 
For PS0014 study assessments, refer to Table 5-4. In addition, perform the following DV0002 
substudy assessments:  
 IRT contact. 
 Blood sample for bimekizumab plasma concentrations (DV0002-specific)—only done for 
subjects who receive bimekizumab Q8W. 
 Bimekizumab administration by study personnel using the PFS. (If this visit coincides with 
Week 48 of PS0014, subjects will have the option to self-inject; refer to the PS0014 
protocol.) 
 Drug and device accountability (DV0002-specific). 
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9 
ASSESSMENT OF SELF-INJECTION 
Evaluation of dose delivery and safe self-injection will be performed as described for the primary 
outcome variable (Section 4.1.1). 
9.1 
Assessment of self-injection experience by SIAQ 
The SIAQ will be used to assess the subject’s self-injection experience. 
The SIAQ was developed by UCB to assess the perceived advantages and the potential 
limitations of self-injection of an sc medication (Keininger and Coteur, 2011). The pre-injection 
SIAQ is composed of 7 items grouped into 3 domains (feelings about injection, self-confidence, 
and satisfaction with the current mode of administration). The post-injection SIAQ is composed 
of 21 items grouped into 6 domains (feelings about injection, self-image, self-confidence, 
injection site reactions, ease of use, and satisfaction with self-injection). The pre-injection SIAQ 
will be completed at Visit 1, and the post-injection SIAQ will be completed within 30 minutes 
after self-injection (ie, at Visit 1 and Visit 3). For the 1mL device cohort, the SIAQ will be 
completed within 30 minutes of completing the second injection. For the 2mL device cohort, the 
SIAQ will be completed within 30 minutes of completing the single injection. 
Version 2.0 and version 2.1 of the SIAQ are identical, except for Question 11. In version 2.0 of 
the SIAQ, Question 11 discusses the use of a plunger, while in version 2.1 of the SIAQ, 
Question 11 discusses depression of the device. Version 2.0 will therefore be used to assess 
bimekizumab-SS-1mL and bimekizumab-SS-2mL, while version 2.1 will be used to assess 
bimekizumab-AI-1mL and bimekizumab-AI-2mL. 
9.2 
Assessment of injection site pain 
A VAS will be used to assess overall injection pain due to self-injection at DV0002 Baseline and 
at 8 weeks after training. Subjects will be required to indicate their injection pain by placing a 
mark on a 100mm line from 0 (no pain) to 100 (worst possible pain).  
1mL Device Cohort 
In the 1mL device cohort of the DV0002 substudy, the 320mg bimekizumab dose will be 
administered as two 160mg sc injections with either 2 bimekizumab-SS-1mL or 2 bimekizumab-
AI-1mL devices. To evaluate injection pain for both self-injections, the VAS will be assessed 
immediately (within 15 minutes) after completion of the second self-injection. The subject will 
complete the VAS prior to completion of the post-injection SIAQ (refer to Section 9.1 for 
details). 
2mL Device Cohort 
In the 2mL device cohort, the 320mg bimekizumab dose will be administered as 1 sc injection 
with either the bimekizumab-SS-2mL or bimekizumab-AI-2mL device. To evaluate injection 
pain for the self-injection, the VAS will be assessed immediately (within 15 minutes) after 
completion of the self-injection. The subject will complete the VAS prior to completion of the 
post-injection SIAQ (refer to Section 9.1 for details). 
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9.3 
Evaluation of post-use structural and mechanical integrity of 
self-injection investigational devices 
The visual inspection of the used devices will check for structural/mechanical integrity and 
damage (ie, clear evidence of damage/compromised structural integrity and not any superficial, 
cosmetic imperfections). All evaluations will be performed by appropriately trained site staff. 
Any device with structural/mechanical integrity issues will be returned to UCB for further 
evaluation. Superficial, cosmetic imperfections which have no impact on structural or 
mechanical integrity are to be ignored. 
Used devices that functioned as intended and which had no post-use structural or mechanical 
integrity issues (as determined by the post-use site evaluation) will also be returned to UCB for 
further evaluation.  
10 
ASSESSMENT OF PHARMACOKINETIC VARIABLES 
1mL Device Cohort 
Blood samples for measurement of trough bimekizumab PK (Section 4.1.3.2) will be collected at 
the time points specified in the schedule of study assessments (Table 5-3). 
At dosing visits, blood samples will be drawn prior to dosing (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. 
2mL Device Cohort 
For subjects who participate in the 2mL device cohort, blood samples for measurement of trough 
bimekizumab PK levels (Section 4.1.3.2 ) will be collected at the timepoints specified in 
Table 10-1. 
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Table 10-1: DV0002 substudy 2mL device cohort PK sample collection time 
points 
 
 
DV0002 Visits 
Dose 
Regimen 
PS0014 Week 
that subject starts 
DV0002 
Visit 1 
(Baseline)/ 
Week 0 
Visit 2/ 
Week 4 
Visit 3/ 
Week 8 
Visit 4/ 
Week 12 
Visit 5/ 
Week 16 
320mg Q4W 
Week 24 
Xa 
X 
X 
X 
Xa 
Week 28 
X 
X 
X 
Xa 
NA 
Week 32 
X 
X 
Xa 
X 
Xa 
320mg Q8W 
Week 24 
Xa 
NA 
X 
NA 
Xa 
Week 32 
X 
NA 
Xa 
NA 
Xa 
NA=not applicable; PK=pharmacokinetics; Q4W=every 4 weeks; Q8W=every 8 weeks 
Note: For the 2mL device cohort, the DV0002 Baseline visit will be PS0014 Week 24, Week 28, or Week 32 for 
subjects receiving bimekizumab 320mg Q4W or PS0014 Week 24 or Week 32 for subjects receiving 
bimekizumab 320mg Q8W. 
a PK sample taken per the PS0014 schedule. 
 
At dosing visits, blood samples will be drawn prior to dosing (at the same time of the sampling 
for clinical laboratory tests). The time and date of collection will be recorded in the eCRF. 
Instructions pertaining to sample collection, processing, storage, labeling, and shipping are 
provided in the laboratory manual for this study. Detailed information on sample analysis will be 
provided in a bioanalytical report. 
11 
ASSESSMENT OF SAFETY 
11.1 
Adverse events (investigational device) 
All AEs (including serious adverse events [SAEs]) will be reported in a common database for 
PS0014 and DV0002, but only ADEs, SADEs, and device deficiencies will be summarized in the 
DV0002 substudy. Specifically, only those AEs related to the use of the investigational medical 
devices (based on the Investigator’s judgement) will be assessed. All AEs (including SAEs) 
which are not assessed to be related to the investigational devices will be summarized separately 
in the report for the main study, PS0014; please refer to the PS0014 protocol for information on 
reporting and recording AEs (including SAEs). 
11.1.1 
Definitions (investigational device) 
11.1.1.1 
Adverse device effect (investigational device) 
An ADE is an AE related to the use of an investigational device. An ADE must meet 1 or more 
of the following criteria: 
 Adverse event resulting from insufficiencies or inadequacies in the IFU, the deployment, the 
implantation, the installation, the operation, or any malfunction of the investigational medical 
device. 
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 Adverse event that is a result of a use error or intentional misuse of the investigational 
device. 
11.1.1.1.1 
Unanticipated adverse device effect  
An unanticipated ADE is an ADE which by its nature, incidence, severity, or outcome has not 
been previously identified.  
11.1.1.2 
Serious adverse device effects  
A SADE is an ADE that has resulted in any of the consequences characteristic of an SAE. 
An SAE (and therefore a SADE) 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, 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 these criteria and, instead, should be evaluated for 1 of the other criteria in the 
definition of serious [eg, life-threatening adverse experience, important medical event]. 
Hospitalizations for reasons not associated with the occurrence of an AE [eg, preplanned 
surgery or elective surgery for a pre-existing condition that has not worsened or manifested 
in an unusual or uncharacteristic manner] do not qualify for reporting. For example, if a 
subject has a condition recorded on his/her medical history and later has a preplanned surgery 
for this condition, it is not appropriate to record the surgery or hospitalization as an SAE, 
since there is no AE upon which to assess the serious criteria. Please note that, if the 
pre-existing condition has worsened or manifested in an unusual or uncharacteristic manner, 
this would then qualify as an AE and, if necessary, the seriousness of the event would need to 
be determined.) 
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11.1.1.2.1 
Anticipated and unanticipated serious adverse device effects 
An anticipated SADE is a SADE which by its nature, incidence, severity, or outcome has been 
identified in the risk analysis report (ISO 14155). 
An unanticipated serious adverse device effect (USADE) is a SADE which by its nature, 
incidence, severity, or outcome has not been identified in the current version of the risk analysis 
report. 
The Sponsor will determine if a SADE qualifies as an USADE. The Sponsor will also evaluate 
all SADEs to ensure that expedited reporting requirements are met according to UCB Standard 
Operating Procedures (SOPs) and applicable country-specific regulatory requirements for the 
investigational device. 
11.1.1.3 
Device deficiency (investigational device) 
A device deficiency is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. Device deficiencies include malfunctions, use 
errors, and inadequate labeling. 
11.1.2 
Procedures for reporting and recording adverse device effects and 
device deficiencies 
The subject will be given the opportunity to report ADEs, SADEs, and device deficiencies 
spontaneously. A general prompt will also be given at each study visit to detect AEs that qualify 
as ADEs, SADEs, and device deficiencies. Below is an example prompt: 
“Did you notice anything unusual about the injection?” 
11.1.2.1 
Reporting of adverse device effects 
All ADEs and SADEs will be captured on the eCRF. The eCRF will allow Investigators to 
specify whether an AE or SAE is device-related and will clarify which investigational device is 
associated with the ADE or SADE. 
An Investigator Adverse Device Effect and Device Deficiency form will be provided to the 
Investigator. The Investigator Adverse Device Effect and Device Deficiency form must be 
completed in English.  
The Investigator (or designee) shall report all SADEs and device deficiencies that might have led 
to an SAE (if suitable action had not been taken, if intervention had not been made, or if 
circumstances had been less fortunate) to UCB within 24 hours after knowledge of the event 
using the appropriate forms in the electronic data capture system. When required by national or 
local regulations, the Investigator shall also notify the IRB and regulatory agencies of all 
reportable events according to national regulations in acceptable timely conditions and may also 
be requested by the IRBs to provide annual reports. 
11.1.2.2 
Reporting of device deficiencies 
If a device deficiency related to the identity, quality, durability, reliability, safety, or performance 
of the investigational device is reported (even if the investigational device was not used), UCB 
must be informed within 1 business day (within 24 hours, as a rule) of receipt of this information 
by the site. The Investigator must forward to UCB (or designee) a duly completed Investigator 
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Adverse Device Effect and Device Deficiency form provided by UCB, even if the data are 
incomplete or if it is obvious that more data will be needed to draw any conclusions.  
An Investigator Adverse Device Effect and Device Deficiency form will be provided to the 
Investigator. The Investigator Adverse Device Effect and Device Deficiency form must be 
completed in English. 
It is important for the Investigator, when completing the Investigator Adverse Device Effect and 
Device Deficiency form, to include an assessment and documentation of whether the device 
deficiency could have led to an SAE if any of the following occurred: 
 Suitable action had not been taken, or 
 Intervention had not been made, or 
 Circumstances had been less fortunate. 
All defective devices must be returned to UCB according to standard procedures. 
11.1.2.3 
Reporting of serious adverse device effects including device 
deficiencies with risk of serious adverse event 
If a device deficiency that could have led to an SAE (if suitable action had not been taken, or 
intervention had not been made, or circumstances had been less fortunate) 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 designee) a duly completed “Investigator SAE Report 
Form for Investigational Medical Devices” provided by UCB, even if the data are incomplete, or 
if it is obvious that more data will be needed to draw any conclusions. Information recorded on 
this form will be entered into the global safety database. 
An Investigator SAE Report Form for Investigational Medical Devices will be provided to the 
Investigator. The Investigator SAE Report Form for Investigational Medical Devices must be 
completed in English.  
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 for Investigational Medical Devices. 
The Investigator is specifically requested to collect and report to UCB (or designee) any ADEs 
or SADEs up to completion of the follow-up visit/telephone call for each subject, and to also 
inform participating subjects of the need to inform the Investigator of any ADEs or SADEs 
within this period. Serious AEs that the Investigator thinks may be associated with the device 
must be reported to UCB regardless of the time between the event and the end of the study. 
Upon receipt of the Investigator SAE Report Form for Investigational Medical Devices, UCB 
will perform an assessment of whether the SADE is anticipated based on the current version of 
the risk analysis report. 
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11.1.2.4 
Rule for repetition of an adverse device effect, serious adverse 
device effect, and/or device deficiency 
An increase in the intensity of an ADE or SADE should lead to the repetition of the ADE or 
SADE being reported with: 
 The outcome date of the first ADE or SADE that is not related to the natural course of the 
disease being the same as the start date of the repeated ADE or SADE, and the outcome of 
“worsening.” 
 The ADE or SADE verbatim term being the same for the first and repeated ADE or SADE, 
so that the repeated ADE or SADE can be easily identified as the worsening of the first one. 
11.1.3 
Follow up of adverse device effects and serious adverse device 
effects 
All ADEs and SADEs should be followed until they have resolved, have stable sequelae, the 
Investigator determines that they are no longer clinically significant, or the subject is lost to 
follow up.  
If an ADE or SADE 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.  
Information on SADEs obtained after clinical database lock will be captured through the Patient 
Safety (PS) database without limitation of time. 
11.2 
Pregnancy 
All events of pregnancy or partner pregnancy will be followed and documented as described in 
the PS0014 protocol. 
11.3 
Suspected transmission of an infectious agent 
For the purposes of reporting, any suspected transmission of an infectious agent via medicinal 
products (device or IMP) should be considered as an SAE or SADE; such cases must be reported 
immediately, recorded in the Adverse Event module of the eCRF, and followed as any other 
SAE or SADE. Any organism, virus, or infectious particle (eg, prion protein transmitting 
transmissible spongiform encephalopathy), pathogenic or nonpathogenic, is considered an 
infectious agent. 
There is no evidence that there is a risk of transmission of an infectious agent with the 
investigational device. 
11.4 
Overdose of investigational medicinal product 
Excessive dosing (beyond that prescribed in the protocol and including overdose) should be 
recorded in the eCRF. Any SADE or nonserious ADE associated with excessive dosing must be 
followed as any other SADE or nonserious ADE. These events are only considered ADEs or 
SADEs if there are associated clinical signs and symptoms or if the act of taking the excess 
medicine itself is an ADE or SADE (eg, suicide attempt). 
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There is no evidence that there is a risk of overdose with the IMP when used with the 
investigational device. 
11.5 
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 or the investigational device so that Investigators, clinical 
study subjects, regulatory authorities, and IRBs will be informed appropriately and as early as 
possible. 
The Study Physician (or medically qualified designee/equivalent) will conduct an ongoing 
review of SADEs and will perform ongoing SADE reconciliations in collaboration with the PS 
representative. Serious AEs not related to a device will be reported in PS0014. 
As appropriate for the stage of development and accumulated experience with the IMP and the 
investigational device, medically qualified personnel at UCB may identify additional safety 
measures (ie, vital signs) for which data will be periodically reviewed during the study. 
11.6 
Other safety measurements 
11.6.1 
Vital signs measurement 
No vital sign assessments will be performed for the DV0002 substudy. The vital sign 
assessments presented in Table 5-3, Table 5-4, and Section 8 will be captured as part of the 
PS0014 study and are described in the PS0014 protocol. 
12 
EFFICACY ASSESSMENTS FOR PS0014 
No efficacy assessments will be performed for the DV0002 substudy. The efficacy assessments 
presented in Table 5-3, Table 5-4, and Section 8 will be captured as part of the PS0014 study and 
are described in the PS0014 protocol. 
13 
STUDY MANAGEMENT AND ADMINISTRATION 
13.1 
Adherence to protocol 
The Investigator should not deviate from the DV0002 protocol or the PS0014 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, or Sponsor. 
After implementation of such measure, the Investigator must notify the Clinical Project Manager 
of the Sponsor within 24 hours and follow any local regulatory requirements. 
13.2 
Monitoring 
UCB (or designee) will monitor the study to meet the Sponsor’s monitoring SOPs, ICH-GCP 
guidelines, and applicable regulatory requirements, and to ensure that study initiation, conduct, 
and closure are adequate. Monitoring of the study may be delegated by UCB to a contract 
research organization (CRO) or a contract monitor. 
The Investigator and his/her staff are expected to cooperate with UCB (or designee) and to be 
available during the monitoring visits to answer questions sufficiently and to provide any 
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missing information. The Investigator(s)/institution(s) will permit direct access to source 
data/documents for study-related monitoring, audits, IRB review, and regulatory inspection(s). 
The Investigator will allow UCB (or designee) to periodically review all eCRFs and 
corresponding source documents (eg, hospital and laboratory records for each study participant). 
Monitoring visits will provide UCB (or designee) with the opportunity to evaluate the progress 
of the study, verify the accuracy and completeness of eCRFs, ensure that all protocol 
requirements, applicable authorities’ regulations, and Investigator’s obligations are being 
fulfilled, and resolve any inconsistencies in the study records. 
13.2.1 
Definition of source data  
All source documents must be accurate, clear, unambiguous, permanent, and capable of being 
audited. They should be made using some permanent form of recording (ink, typing, printing, 
optical disc). They should not be obscured by correction fluid or have temporary attachments 
(such as removable self-stick notes).  
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. 
Source documents that are computer generated and stored electronically must be printed for 
review by the monitor (eg, ECG reports). Once printed, these copies should be signed and dated 
by the Investigator and become a permanent part of the subject’s source documents. The 
Investigator will facilitate the process for enabling the monitor to compare the content of the 
printout and the data stored in the computer to ensure all data are consistent. 
Electronic data records, such as Holter monitor records or electroencephalogram records, must 
be saved and stored as instructed by UCB (or designee). 
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 is performed using remote data capture; the same data capture is used for PS0014 and 
DV0002. The Investigator is responsible for prompt reporting of accurate, complete, and legible 
data in the eCRFs and in all required reports.  
Any change or correction to the eCRF after saving must be accompanied by a reason for the 
change. 
Corrections made after the Investigator’s review and approval (by means of a 
password/electronic signature) will be reapproved by the Investigator. 
The Investigator should maintain a list of personnel authorized to enter data into the eCRF.  
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Detailed instructions will be provided in the eCRF Completion Guidelines. 
13.3.2 
Database entry and reconciliation 
Case Report forms/external electronic data will be entered/loaded into a validated electronic 
database using a clinical data management system (CDMS). Computerized data cleaning checks 
will be used, in addition to manual review, to check for discrepancies and to ensure consistency 
of the data. The data are entered into the eCRFs once and are subsequently verified. 
An electronic audit trail system will be maintained within the CDMS to track all data changes in 
the database once the data have been saved initially into the system or electronically loaded. 
Regular backups of the electronic data will be performed. 
13.3.3 
Subject Screening and Enrollment log/Subject Identification Code list 
The subject’s screening and enrollment will be recorded in the Subject Screening and 
Enrollment log. 
The Investigator will keep a Subject Identification Code list. This list will remain with the 
Investigator and be used for unambiguous identification of each subject. 
The subject’s consent and enrollment in the study must be recorded in the subject’s medical 
record. These data should identify the study and document the dates of the subject’s 
participation. 
13.4 
Termination of the study 
UCB reserves the right to temporarily suspend or prematurely discontinue this study either at a 
single site, multiple sites, or at all sites at any time for reasons including, but not limited to, 
safety or ethical issues, inaccurate or incomplete data recording, noncompliance, or 
unsatisfactory enrollment with respect to quality or quantity. 
The study may also be temporarily suspended or prematurely terminated in either of the 
following situations: 
 Severe or serious injection site reaction (eg, bleeding, bruising, pain) that, in the opinion of 
the Investigator, the overseeing IRB, or the Sponsor, is likely to be seen in other enrolled 
subjects who have not yet been injected with bimekizumab. 
 Unexpected device malfunction leading to a failed or incomplete injection, or resulting in an 
SAE that, in the opinion of the Investigator, the overseeing IRB, or the Sponsor, is likely to 
be seen in other enrolled subjects who have not yet been injected with bimekizumab. 
If the study is prematurely terminated or suspended, UCB (or designee) 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 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. 
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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 or investigational device. These 
documents should be retained for a longer period; however, if required by the applicable 
regulatory requirement(s) or by an agreement with UCB (CPMP/ICH/135/95, 2002 
[Section 4.9.5]). The Investigator will contact UCB for authorization prior to the destruction of 
any study records or in the event of accidental loss or destruction of any study records. The 
Investigator will also notify UCB should he/she relocate or move the study-related files to a 
location other than that specified in the Sponsor’s trial master file. 
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 and the investigational device have been processed and reported in compliance with the 
planned arrangements, the protocol, investigational site, and IRB SOPs, ICH GCP, and 
applicable regulatory requirements. 
The Investigator will provide direct access to all study documents, source records, and source 
data. If an inspection by a regulatory authority is announced, the Investigator will immediately 
inform UCB (or designee). 
13.7 
Good Clinical Practice 
Noncompliance with the protocol, ICH-GCP, or local regulatory requirements by the 
Investigator, institution, institution staff, or designees of the Sponsor will lead to prompt action 
by UCB to secure compliance. Continued noncompliance may result in the termination of the 
site’s involvement in the study. 
14 
STATISTICS 
A description of statistical methods follows and will be described in more detail in the Statistical 
Analysis Plan (SAP). 
Once subjects in the 1mL device cohort complete DV0002, a final analysis for that cohort will be 
performed, and a clinical study report will be prepared. A separate final analysis will be 
performed for the 2mL device cohort. 
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14.1 
Definition of analysis sets 
1mL Device Cohort  
For the 1mL device cohort, 2 different Safety Sets (SS) will be generated (1 for each device 
type): the bimekizumab-SS-1mL Safety Set (SS-s) and the bimekizumab-AI-1mL Safety Set 
(SS-a). Each SS will consist of all subjects in the study who receive at least 1 dose of 
bimekizumab by the indicated self-injection investigational device. Safety variables will be 
analyzed using the SS-s and SS-a. 
Two different Full Analysis Sets (FASs) will be generated (1 for each device type): the 
bimekizumab-SS-1mL Full Analysis Set (FAS-s) and the bimekizumab-AI-1mL Full Analysis 
Set (FAS-a). Each FAS will consist of all subjects in the SS-s or SS-a who self-inject at least 
1 dose of bimekizumab using the given device and who have an assessment of self-injection. All 
self-injection related endpoints will be analyzed using the FAS-s and FAS-a. 
For the PK analyses, 2 different Pharmacokinetic Per Protocol Sets (PK-PPS) will be generated 
(1 for each device type): the bimekizumab-SS-1mL PK-PPS (PK-PPS-s) and the 
bimekizumab-AI-1mL PK-PPS (PK-PPS-a). Each PK-PPS will consist of all subjects who 
receive the same bimekizumab administration (frequency and dose) in the PS0014 feeder studies 
as in the DV0002 substudy and who have at least 1 evaluable PK assessment in the DV0002 
substudy without important protocol deviations that would affect the concentration. 
Pharmacokinetic variables will be analyzed using the PK-PPS-s and PK-PPS-a. 
All PK assessments after baseline assessments from feeder study will be considered for the 
requirement of at least 1 evaluable PK assessment.  
2mL Device Cohort  
For the 2mL device cohort, the same analysis sets will be generated. 
14.2 
General statistical considerations 
This is an estimation study design with no formal statistical hypothesis testing. The study will 
estimate the true population proportion and/or mean of self-injection related endpoints for each 
device separately. Summary statistics for continuous variables will include: number of available 
observations, mean, standard deviation, minimum, median, and maximum. For categorical 
variables, the number and proportion of subjects, along with the 90% confidence interval (CI) 
based on the Exact Binomial method, will be presented. 
The Baseline value is defined as the last nonmissing measurement prior to the first self-injection 
at DV0002 Visit 1 (Baseline). No imputation of missing data will be performed. All data 
recorded in the eCRF and questionnaires will be listed. 
14.3 
Planned analyses of outcome variables 
All statistical analyses will be descriptive in nature. No inferential statistical analyses are 
planned.  
All analyses will be performed separately for the 1mL device cohort and for the 2mL device 
cohort. Once subjects in the 1mL device cohort complete DV0002, a final analysis will be 
performed for that cohort, and a clinical study report will be prepared. A separate final analysis 
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will be performed for the 2mL device cohort once all data have been collected and will be 
reported separately from the initial clinical study report. 
14.3.1 
Analysis of the primary outcome variable 
The primary outcome variable is the percentage of all subjects able to self-administer safe and 
effective injections using the given device at DV0002 Week 8 (8 weeks after training). Safe and 
effective self-injection will be evaluated by the study personnel as defined in in Section 4.1.1. 
The number and percentage of subjects with safe and effective self-injections will be tabulated 
separately for each device overall and within each device by dosing regimen using the relevant 
FAS population (FAS-s or FAS-a). The 90% CIs based on the Exact Binomial method will be 
reported as well. 
14.3.2 
Analysis of the secondary outcome variable 
The secondary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the given device at DV0002 Baseline (first self-injection visit). Safe 
and effective self-injection will be evaluated by the study personnel as defined in Section 4.1.1. 
The secondary outcome variables will be analyzed in the same manner as the primary outcome 
variable (see Section 14.3.1). 
14.3.3 
Analysis of other outcome variables 
The other outcome variables are defined in Section 4.1.3. These variables will be summarized 
using descriptive statistics and they will be tabulated separately for each device overall and 
within each device by dosing regimen using the relevant FAS population (FAS-s or FAS-a). 
14.4 
Planned pharmacokinetic analyses 
The statistical analyses of the PK data will be descriptive in nature and will be summarized using 
the relevant device-specific population (PK-PPS-s or PK-PPS-a). Data will be analyzed overall 
for each device by injection type (self-administered or study personnel-administered), by 
injection site (abdomen or thigh), and by BMI category. Three BMI categories will be defined 
based on tertiles derived from subjects’ Baseline BMI values within the device-specific 
population (PK-PPS-s or PK-PPS-a). 
To allow for an analysis of PK trough levels for bimekizumab administration via self-injection or 
via study personnel administration, pre-dose PK samples will be taken throughout the DV0002 
substudy. For the Q4W dose regimen, PK trough levels will be determined based on pre-dose PK 
sampling at DV0002 Baseline and Week 8 for the study personnel administration and at DV0002 
Week 4 and Week 12 for the self-administration trough levels, respectively. For the Q8W dose 
regimen, PK trough levels will be determined based on pre-dose PK sampling at DV0002 
Baseline for the study personnel administration and at 8 weeks after training (DV0002 Week 8) 
and DV0002 Week 16 for the self-administration trough levels, respectively. For the analysis of 
PK trough levels by injection site (abdomen or thigh) and by BMI category (by tertile), only 
self-administration PK trough levels will be used. 
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14.5 
Planned safety analyses 
The safety variable is the occurrence of ADEs; additional safety and tolerability variables will be 
collected in PS0014 (see Section 4.1.3.3). Analyses of safety data will be done separately for 
each device overall and within each device by dosing regimen using the relevant SS population 
(SS-s or SS-a). 
All ADE data will be listed and no statistical testing will be performed. Only treatment-emergent 
ADEs will be included in the summary tables. All ADEs will be coded and classified by system 
organ class, high level term, and preferred term according to the latest version of the Medical 
Dictionary for Regulatory Activities. Adverse device effects will be summarized by the 
frequency and percentage of subjects having 1 or more of the events in question. Additional 
planned summaries include overall ADEs and SADEs. 
14.6 
Planned efficacy analyses 
No efficacy analyses are planned for the DV0002 substudy. 
14.7 
Handling of protocol deviations 
Only subjects who had no important protocol deviations affecting the primary outcome variable, 
as confirmed during ongoing data cleaning meetings prior to database lock, will be included in 
the FAS-s or FAS-a. Important protocol deviations are deviations from the protocol which could 
potentially have a meaningful impact on the primary objective of the study. The criteria for 
identifying important protocol deviations and the classification of important protocol deviations 
will be defined within the project Data Cleaning Plan. To the extent feasible, the rules for 
identifying protocol deviations will be defined without review of the data and without 
consideration of the frequency of occurrence of such deviations. Whenever possible, criteria for 
identifying important protocol deviations will be implemented algorithmically to ensure 
consistency in the classification of important protocol deviations across all subjects. 
14.8 
Handling of dropouts or missing data 
There will be no special procedures for handling missing data. All imputation of missing or 
partial dates for safety assessments will be detailed in the SAP. 
14.9 
Planned interim analysis and data monitoring 
No interim analysis is planned for the DV0002 study. No Data Monitoring Committee will be 
established for this study.  
The subjects of DV0002 are ongoing subjects of PS0014. Data cut off for the 1mL final analysis 
will be last subject last Week 16 visit in DV0002 in the 1mL device cohort. Data cut off for the 
2mL final analysis will be last subject last Week 16 visit in DV0002 in the 2mL device cohort. 
Data cut off rules will be applied for ongoing ADEs and ongoing concomitant medication. 
14.10 
Determination of sample size 
This study will not be powered with respect to any endpoint and sample size is based on practical 
considerations.  
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1mL Device Cohort  
For the 1mL device cohort, to maintain blinding in the PS0014 feeder studies, DV0002 will 
recruit subjects who were administered bimekizumab 320mg (Q4W or Q8W) and subjects who 
were administered placebo or ustekinumab in the PS0014 feeder studies. A total of 100 subjects 
(50 subjects per device arm) are planned for PK trough level analyses, but these analyses can 
only be performed on subjects who do not change their bimekizumab dose or dosing regimen 
(ie, 320mg bimekizumab Q4W or Q8W) between the PS0014 feeder studies and in the DV0002 
substudy. The DV0002 substudy will therefore enroll approximately 200 subjects (to compensate 
for subjects with bimekizumab dose changes) to ensure that 100 subjects are available for PK 
trough analysis.  
Subjects who enroll in the DV0002 substudy 1mL device cohort will be randomly assigned to 
the bimekizumab-SS-1mL or the bimekizumab-AI-1mL device arms (each device arm will 
consist of approximately 100 subjects). Within each device arm, subjects will be divided into 
tertiles by BMI; there will be approximately 33 subjects per tertile, which is expected to yield 
approximately 16 to 17 subjects per tertile who are evaluable for steady state trough PK level 
analyses. 
2mL Device Cohort  
Once the 1mL device cohort has finished enrolling, the 2mL device cohort will start enrolling. 
Subjects who participated in the 1mL device cohort of DV0002 are not eligible to enroll in the 
2mL device cohort. For evaluation of the 2mL device, it is planned to enroll approximately 
100 subjects. All 100 subjects will have been on a consistent bimekizumab dose regimen for at 
least 16 weeks, and thus all will be evaluable for the PK trough level analyses. 
Subjects who enroll in the DV0002 substudy 2mL device cohort will be randomly assigned to 
the bimekizumab-SS-2mL or the bimekizumab-AI-2mL device arms (each device arm will 
consist of approximately 50 subjects). Within each device arm, subjects will be divided into 
tertiles by BMI; there will be approximately 16 to 17 subjects per tertile who are evaluable for 
steady state trough PK level analyses. 
15 
ETHICS AND REGULATORY REQUIREMENTS 
15.1 
Informed consent 
Subject’s informed consent must be obtained and documented in accordance with local 
regulations, ICH-GCP requirements, and the ethical principles that have their origin in the 
principles of the Declaration of Helsinki. 
Prior to obtaining informed consent, information should be given in a language and at a level of 
complexity understandable to the subject in both oral and written form by the Investigator (or 
designee). Each subject will have the opportunity to discuss the study and its alternatives with 
the Investigator. 
Prior to participation in the study, the ICF should be signed and personally dated by the subject, 
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 ICF. As part of the consent process, each subject must consent to direct access 
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to his/her medical records for study-related monitoring, auditing, IRB review, and regulatory 
inspection. 
If the ICF is amended during the study, the Investigator (or the Sponsor, if applicable) must 
follow all applicable regulatory requirements pertaining to the approval of the amended ICF by 
the IRB and use of the amended form. 
All studies conducted at centers in the US must include the use of a Health Insurance Portability 
and Accountability Act Authorization form. 
The subject may withdraw his/her consent to participate in the study at any time. A subject is 
considered as enrolled in the study when he/she has signed the ICF. 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 ICF, the subject or legal representative will be provided with a subject 
identification card in the language of the subject. The Investigator will fill in the subject 
identifying information and medical emergency contact information. The Investigator will 
instruct the subject to keep the card with him/her at all times. 
15.3 
Institutional Review Boards  
The study will be conducted under the auspices of an IRB, 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, that complies with the 
requirements of the current ICH-GCP version or applicable country-specific regulations, will be 
responsible for the initial and continuing review and approval of the clinical study. Prior to 
initiation of the study, the Investigator/UCB will forward copies of the protocol, ICF, 
Investigator’s Brochure, Investigator’s curriculum vitae (if applicable), advertisement (if 
applicable), and all other subject-related documents to be used for the study to the IRB for its 
review and approval. 
Before initiating a study, the Investigator will have written and dated full approval from the 
responsible IRB for the protocol. 
The Investigator will also promptly report to the IRB all changes in the study, all unanticipated 
problems involving risks to human subjects or others, and any protocol deviations, to eliminate 
immediate hazards to subjects. 
The Investigator will not make any changes in the study or study conduct without IRB 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 as allowed. 
As part of the IRB requirements for continuing review of approved studies, the Investigator will 
be responsible for submitting periodic progress reports to the IRB (based on IRB 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 following study completion. 
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UCB (or designee) will communicate safety information to the appropriate regulatory authorities 
and all active Investigators in accordance with applicable regulatory requirements. The 
appropriate IRB 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 designee) with evidence of such IRB 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 Visit 1. 
The Investigator agrees that representatives of UCB, its designee, representatives of the relevant 
IRB, 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, 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 
CPMP/ICH/135/95 Note for guidance on Good Clinical Practice (EMEA) Jul 2002. 
Keininger D, Coteur G. Assessment of self-injection experience in patients with rheumatoid 
arthritis: psychometric validation of the Self-Injection Assessment Questionnaire (SIAQ). 
Health and Quality of Life Outcomes. 2011;9:2. 
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18 
APPENDICES 
18.1 
Protocol Amendment 1 
Rationale for the amendment 
This protocol has been amended to add the evaluation of the 2mL self-injection devices 
developed by UCB: a 2mL bimekizumab safety syringe (bimekizumab‑SS‑2mL) and a 
2mL bimekizumab auto‑injector (bimekizumab‑AI‑2mL).  
Modifications and changes 
Global changes: 
The following changes were made throughout the protocol:  
 The DV0002 study number was added before the study visit where it was necessary to 
distinguish it from the PS0014 study visits. 
 The list of abbreviations was updated accordingly. 
 Minor spelling, editorial, and formatting changes were made throughout the document.  
Specific changes: 
Change #1  
Section 1 Summary 
DV0002 is a multicenter, open-label, randomized substudy in adult subjects with moderate to 
severe chronic plaque psoriasis (PSO) to evaluate the safe and effective use of 2 single-use 
disposable self-injecting investigational devices for the subcutaneous (sc) administration of 
bimekizumab solution (the investigational medicinal product [IMP]). It is expected that 
individuals with PSO will prefer to have options for the self-administration of bimekizumab. 
DV0002 will therefore evaluate 2 different self-injection investigational devices: the 1mL 
bimekizumab safety syringe (bimekizumab-SS-1mL) and the 1mL bimekizumab auto-injector 
(bimekizumab-AI-1mL). 
DV0002 is a substudy of PS0014, which is a multicenter, open-label, long-term safety study for 
subjects with moderate to severe chronic plaque PSO who complete 1 of the Phase 3 feeder 
studies (PS0008, PS0009, or PS0013). The PS0014 study will evaluate the long-term safety, 
tolerability, and efficacy of bimekizumab in subjects with PSO, and study personnel qualified in 
sc injection technique will administer bimekizumab to subjects in a 1mL True North prefilled 
syringe (referred to throughout this protocol as the 1mL PFS). Subjects will begin the DV0002 
substudy and the PS0014 study at the same time. The DV0002 substudy will include all PS0014 
study assessments from Baseline to Week 16 (inclusive). However, subjects in the DV0002 
substudy will self-administer bimekizumab at Baseline and at Week 8. Subjects will be randomly 
assigned to either the bimekizumab-SS-1mL or the bimekizumab-AI-1mL device arm.  
During the 16-week Treatment Period of DV0002, subjects will receive either bimekizumab 
320mg every 8 weeks (Q8W) or bimekizumab 320mg every 4 weeks (Q4W), based on their 
assigned dosing at Baseline. This dose regimen will remain stable for the entire 16-week 
Treatment Period of DV0002. In the DV0002 substudy, subjects will be assigned to 1 of the 
2 self-injection investigational devices and will self-administer bimekizumab only at Baseline 
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and at Week 8, regardless of their assigned dosing regimen. For subjects in the bimekizumab 
Q4W dosing arm, bimekizumab will be administered by study personnel at Week 4 and 
Week 12; for all subjects, bimekizumab will be administered by study personnel at Week 16. A 
safety follow-up (SFU) telephone call will occur 1 week after the last self-administration (at 
Week 9). After Week 16 in the DV0002 substudy, subjects will continue in PS0014 (the next 
visit after DV0002 completion will be the Week 20 Visit in PS0014). 
To compensate for subjects who have different study treatments between the feeder studies and 
DV0002, DV0002 is planned to enroll approximately 200 subjects (100 subjects per device arm) 
to ensure that approximately 50 subjects per device arm are evaluable for steady state trough 
pharmacokinetic (PK) level analyses. Within each device arm, subjects will be divided into 
tertiles by body mass index (BMI); there will be approximately 33 subjects per tertile, which is 
expected to yield approximately 16 to 17 subjects per tertile who are evaluable for steady state 
trough PK level analyses.  
The primary objective of the DV0002 substudy is to evaluate for each device the ability of 
subjects with moderate to severe chronic plaque PSO to safely and effectively self-inject 
bimekizumab 8 weeks after training in the self-injection technique using the 
bimekizumab-SS-1mL or the bimekizumab-AI-1mL. The primary outcome variable is the 
percentage of subjects able to self-administer safe and effective injections using the 
bimekizumab-SS-1mL or the bimekizumab-AI-1mL, respectively, at Week 8.  
Safe and effective self-injection will be evaluated by the study personnel and is defined as: 
 Complete dose delivery: Subject self-injects the complete dose of bimekizumab as confirmed 
by a visual inspection of the bimekizumab-SS-1mL or the bimekizumab-AI-1mL, which 
shows that the IMP is delivered completely (ie, container is empty), and 
 No adverse device effects (ADEs) that would preclude continued use of the device for 
self-injection (ie, no serious ADEs [SADEs] and/or ADEs leading to withdrawal from the 
DV0002 substudy) 
In the DV0002 substudy, the 320mg bimekizumab dose will be administered as two 160mg 
injections with either 2 bimekizumab-SS-1mL devices or 2 bimekizumab-AI-1mL devices. Each 
self-injection will be evaluated by study personnel for safety and effectiveness using the above 
criteria. The endpoint of safe and effective self-injection will be met only if both self-injections 
are determined to be safe and effective. 
The secondary study objectives and other study objectives are provided in Section 3.2 and 
Section 3.3, respectively. Of note, one of the other study objectives is to assess trough PK levels 
associated with self-injection using the test device, injection by study personnel using the 1mL 
PFS, injection site (abdomen or thigh), and BMI category (by tertile). The secondary outcome 
variable, other outcome variables, and the other safety variable are listed in Section 4.1.2, 
Section 4.1.3, and Section 4.1.3.3, respectively.  
Has been changed to: 
DV0002 is a multicenter, open-label, randomized substudy in adult subjects with moderate to 
severe chronic plaque psoriasis (PSO) to evaluate the safe and effective use of 24 single-use 
disposable self-injection investigational devices for the subcutaneous (sc) administration of 
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bimekizumab solution (the investigational medicinal product [IMP]). It is expected that 
individuals with PSO will prefer to have options for the self-administration of bimekizumab. 
DV0002 will therefore evaluate 2 different self-injection investigational devices: the 1mL 
bimekizumab safety syringe (bimekizumab-SS-1mL) and the 1mL bimekizumab auto-injector 
(bimekizumab-AI-1mL). The 4 self-injection devices to be tested are the 1mL bimekizumab 
safety syringe (bimekizumab-SS-1mL), the 1mL bimekizumab auto injector 
(bimekizumab-AI-1mL), the 2mL bimekizumab safety syringe (bimekizumab-SS-2mL), 
and the 2mL bimekizumab auto injector (bimekizumab-AI-2ml). 
DV0002 is a substudy of PS0014, which is a multicenter, open-label, long-term safety study for 
subjects with moderate to severe chronic plaque PSO who complete 1 of the Phase 3 feeder 
studies (PS0008, PS0009, or PS0013). The PS0014 study will evaluate the long-term safety, 
tolerability, and efficacy of bimekizumab in subjects with PSO, and study personnel qualified in 
sc injection technique will administer bimekizumab to subjects in a 1mL True North prefilled 
syringe (referred to throughout this protocol as the 1mL PFS). Subjects will begin the DV0002 
substudy and the PS0014 study at the same time. The DV0002 substudy will include all PS0014 
study assessments from Baseline to Week 16 (inclusive). However, subjects In the DV0002 
substudy, subjects will self-administer bimekizumab at DV0002 Baseline and at DV0002 
Week 8. Subjects will be randomly assigned to either the bimekizumab-SS-1mL or the 
bimekizumab-AI-1mL device arm. 
During the 16-week Treatment Period of DV0002, subjects will receive either bimekizumab 
320mg every 8 weeks (Q8W) or bimekizumab 320mg every 4 weeks (Q4W), based on their 
assigned dosing at Baseline of PS0014. The same interactive response technology (IRT) will 
be used for both studies (DV0002 and PS0014). The dose regimen will remain stable for the 
entire Treatment Period of DV0002.  
In the DV0002 substudy, subjects will be assigned to 1 of the 24 self-injection investigational 
devices and will self-administer bimekizumab only at DV0002 Baseline and at DV0002 Week 8 
after training, regardless of their assigned dosing regimen. For subjects in the bimekizumab 
Q4W dosing arm, bimekizumab will be administered by study personnel at Week 4 and 
Week 12; for all subjects, bimekizumab will be administered by study personnel at Week 16. 
Bimekizumab will be administered by study personnel at DV0002 Week 4 and DV0002 
Week 12 for subjects in the Q4W dosing arm and at DV0002 Week 16 for both dosing 
arms. A safety follow-up (SFU) telephone call will occur 1 week after the last 
self-administration (at DV0002 Week 9). After Week 16 in the DV0002 substudy, subjects will 
continue in PS0014 (the next visit after DV0002 completion will be the Week 20 Visit in 
PS0014). 
To compensate for subjects who have different study treatments between the feeder studies and 
DV0002, DV0002 is planned to enroll approximately 200 subjects (100 subjects per device arm) 
to ensure that approximately 50 subjects per device arm are evaluable for steady state trough 
pharmacokinetic (PK) level analyses. Within each device arm, subjects will be divided into 
tertiles by body mass index (BMI); there will be approximately 33 subjects per tertile, which is 
expected to yield approximately 16 to 17 subjects per tertile who are evaluable for steady state 
trough PK level analyses.  
The primary objective of the DV0002 substudy is to evaluate, for each device, the ability of 
subjects with moderate to severe chronic plaque PSO to safely and effectively self-inject 
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bimekizumab 8 weeks after training in the self-injection technique. The primary outcome 
variable is the percentage of subjects able to self-administer safe and effective injections using 
the bimekizumab-SS-1mL, bimekizumab-AI-1mL, bimekizumab-SS-2mL, or 
bimekizumab-AI-2mL device 8 weeks after training in self-injection technique (DV0002 at 
Week 8).  
Safe and effective self-injection will be evaluated by the study personnel and is defined as: 
 Complete dose delivery: Subject self-injects the complete dose of bimekizumab as confirmed 
by a visual inspection of the bimekizumab-SS-1mL or the bimekizumab-AI-1mL device, 
which shows that the IMP is delivered completely (ie, container is empty), and 
 No adverse device effects (ADEs) that would preclude continued use of the device for 
self-injection (ie, no serious ADEs [SADEs] and/or ADEs leading to withdrawal from the 
DV0002 substudy) 
In the DV0002 substudy, the 320mg bimekizumab dose will be administered as two 160mg 
injections with either 2 bimekizumab-SS-1mL devices or 2 bimekizumab-AI-1mL devices. Each 
self-injection will be evaluated by study personnel for safety and effectiveness using the above 
criteria. The endpoint of safe and effective self-injection will be met only if both self-injections 
are determined to be safe and effective. 
The secondary study objectives and other study objectives are provided in Section 3.2 and 
Section 3.3, respectively. Of note, one of the other study objectives is to assess trough 
pharmacokinetic (PK) levels associated with self-injection using the test investigational 
device, injection by study personnel, injection site (abdomen or thigh), and body mass index 
(BMI) category (by tertile). The secondary outcome variable, other outcome variables, and the 
other safety variable are listed in Section 4.1.2, Section 4.1.34.1.3.1, and Section 4.1.3.3, 
respectively.  
The DV0002 substudy consists of 2 cohorts. The 1mL device cohort will evaluate 2 different 
self-injection investigational devices: the bimekizumab-SS-1mL and the 
bimekizumab-AI-1mL. The 2mL device cohort will also evaluate 2 different self-injection 
investigational devices: the bimekizumab-SS-2mL and the bimekizumab-AI-2ml. The data 
for each cohort will be analyzed and reported separately. 
1mL Device Cohort 
Subjects who enroll in the 1mL device cohort of DV0002 will begin the DV0002 substudy 
and the PS0014 study at the same time, and as such, the Baseline visit and all subsequent 
study visits (up to Week 16) will be the same. 
To compensate for subjects who have different study treatments between the feeder studies 
and DV0002, the 1mL cohort of the DV0002 substudy is planned to enroll approximately 
200 subjects (100 subjects per device arm) to ensure that approximately 50 subjects per 
device arm are evaluable for steady state trough PK level analyses. Within each device 
arm, subjects will be divided into tertiles by BMI; there will be approximately 33 subjects 
per tertile, which is expected to yield approximately 16 to 17 subjects per tertile who are 
evaluable for steady state trough PK level analyses.  
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In the DV0002 substudy 1mL device cohort, the 320mg bimekizumab dose will be 
administered as two 160mg injections with either 2 bimekizumab-SS-1mL devices or 
2 bimekizumab-AI-1mL devices. Each self-injection will be evaluated by study personnel 
for safety and effectiveness using the above criteria. The endpoint of safe and effective 
self-injection will be met only if both self-injections are determined to be safe and effective.  
2mL Device Cohort 
Subjects who participated in the 1mL device cohort are not eligible to participate in the 
2mL device cohort. To allow flexible enrollment, subjects may be randomized in the 2mL 
device cohort at the PS0014 Week 24, Week 28, or Week 32 visit for subjects receiving 
bimekizumab Q4W or the PS0014 Week 24 or Week 32 visit for subjects receiving 
bimekizumab Q8W.  
For evaluation of the 2mL device, it is planned to enroll approximately 100 subjects; each 
device arm (bimekizumab-SS-2mL or bimekizumab-AI-2mL) will consist of approximately 
50 subjects.  
In the DV0002 substudy, for the 2ml devices, the 320mg bimekizumab dose will be 
self-administered as 1 injection with either 1 bimekizumab-SS-2mL or 1 
bimekizumab-AI-2mL device. Each self-injection will be evaluated for safety and 
effectiveness by study personnel using the above criteria. The endpoint of safe and effective 
self-injection will be met if the single self-injection is determined to be safe and effective. 
Change #2  
Section 2 Introduction, paragraph 3 and 4 
The DV0002 study is a substudy of the PS0014 study. PS0014 will evaluate the long-term safety, 
tolerability, and efficacy of bimekizumab in subjects with moderate to severe chronic plaque 
PSO; study personnel will administer bimekizumab in a 1mL PFS. The DV0002 substudy will 
evaluate 2 self-injection investigational devices: the 1mL bimekizumab-SS-1mL and the 1mL 
bimekizumab-AI-1mL. Full descriptions of the 2 devices are provided in Section 7.1.1 and 
Section 7.1.2, respectively. 
The proposed study is planned to demonstrate that adult subjects with moderate to severe chronic 
plaque PSO can safely and effectively self-inject bimekizumab using the bimekizumab-SS-1mL 
or the bimekizumab-AI-1mL. 
Has been changed to: 
The DV0002 study is a substudy of the PS0014 study. PS0014 will evaluate the long-term safety, 
tolerability, and efficacy of bimekizumab in subjects with moderate to severe chronic plaque 
PSO; study personnel will administer bimekizumab in a 1mL PFS. The DV0002 substudy will 
evaluate 24 self-injection investigational devices: the 1mL bimekizumab-SS-1mL and, the 1mL 
bimekizumab-AI-1mL, the bimekizumab-SS-2mL, and the bimekizumab-AI-2ml. Full 
descriptions of the 24 devices are provided in Section 7.1.1, Section 7.1.2, Section 7.1.3 and 
Section 7.1.4, respectively. 
The proposed studysubstudy is planned to demonstrate that adult subjects with moderate to 
severe chronic plaque PSO can safely and effectively self-inject bimekizumab using the 
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bimekizumab-SS-1mL or the, bimikizumab-AI-1mL, bimekizumab-SS-2mL, or 
bimekizumab-AI-2mL device. 
For subjects in the 1mL device cohort, subjects will be randomly assigned in a 1:1 ratio to 
perform self-injection using either the bimekizumab-SS-1mL or the bimekizumab-AI-1mL. 
Subjects who participated in the 1mL device cohort of DV0002 are not eligible to enroll in 
the 2mL device cohort. 
Once the 1mL device cohort has finished enrolling, the 2mL device cohort will start 
enrolling. Subjects in this cohort will be randomly assigned in a 1:1 ratio to perform 
self-injection using either the bimekizumab-SS-2mL or bimekizumab-AI-2mL device. 
Change #3  
Section 3.1 
Primary objective 
The primary objective of the study is to evaluate for each device the ability of subjects with 
moderate to severe chronic plaque PSO to safely and effectively self-inject bimekizumab 
8 weeks after training in the self-injection technique using the bimekizumab-SS-1mL or the 
bimekizumab-AI-1mL. 
Has been changed to: 
The primary objective of the study is to evaluate, for each device, the ability of subjects with 
moderate to severe chronic plaque PSO to safely and effectively self-inject bimekizumab 8 
weeks after training in the self-injection technique using the bimekizumab-SS-1mL or the 
bimekizumab-AI-1mL. 
Change #4  
Section 3.2 
Secondary objective 
The secondary objective of the study is to evaluate the ability of subjects with moderate to severe 
chronic plaque PSO to safely and effectively self-inject bimekizumab immediately after training 
in self-injection technique using the bimekizumab-SS-1mL or the bimekizumab-AI-1mL. 
Has been changed to: 
The secondary objective of the study is to evaluate, for each device, the ability of subjects with 
moderate to severe chronic plaque PSO to safely and effectively self-inject bimekizumab 
immediately after training in self-injection technique using the bimekizumab-SS-1mL or the 
bimekizumab-AI-1mL devices. 
Change #5  
Section 3.3 
Other objectives 
Other objectives of the study are to evaluate the following: 
 Subject experience of self-injection as assessed by the pain visual analog scale (VAS) and the 
Self-injection Assessment Questionnaire (SIAQ). 
 Trough PK (trough bimekizumab) levels associated with self-injection using the test device, 
injection by study personnel using the 1mL PFS, injection site (abdomen or thigh), and BMI 
category (by tertile). 
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 The structural and mechanical integrity of the bimekizumab-SS-1mL and the 
bimekizumab-AI-1mL after completion of self-injection. 
 The overall safety and tolerability of self-injections. 
Has been changed to: 
Other objectives of the study are to evaluate the following: 
 Subject experience of self-injection using the investigational devices as assessed by the pain 
visual analog scale (VAS) and the Self injection Assessment Questionnaire (SIAQ). 
 Trough PK (trough bimekizumab) levels associated with self-injection using the test 
deviceinvestigational devices, injection by study personnel using the 1mL PFS, injection 
site (abdomen or thigh), and BMI category (by tertile). 
 The structural and mechanical integrity of the bimekizumab-SS-1mL and the 
bimekizumab-AI-1mLinvestigational devices after completion of self-injection. 
 The overall safety and tolerability of self-injections using the investigational devices. 
Change #6  
Section 4.1.1 Primary outcome variable 
The primary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the bimekizumab-SS-1mL or the bimekizumab-AI-1mL, respectively, 
at Week 8. Safe and effective self-injection will be evaluated by the study personnel and is 
defined as: 
 Complete dose delivery: Subject self-injects the complete dose of bimekizumab as confirmed 
by a visual inspection of the bimekizumab-SS-1mL or the bimekizumab-AI-1mL which 
shows that the IMP is delivered completely (ie, container is empty), and 
 No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs 
and/or ADEs leading to withdrawal from the DV0002 substudy). 
In the DV0002 substudy, the 320mg bimekizumab dose will be administered as two 160mg 
injections with either 2 bimekizumab-SS-1mL devices or 2 bimekizumab-AI-1mL devices. Each 
self-injection will be evaluated for safety and effectiveness by study personnel using the above 
criteria. The endpoint of safe and effective self-injection will be met only if both self-injections 
are determined to be safe and effective. 
Has been changed to: 
The primary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the bimekizumab-SS-1mL or the, bimekizumab-AI-1mL, respectively, 
at Week bimekizumab-SS-2mL, or bimekizumab-AI-2mL, 8 weeks after training in self-
injection technique. Safe and effective self-injection will be evaluated by the study personnel 
and is defined as: 
 Complete dose delivery: Subject self-injects the complete dose of bimekizumab as confirmed 
by a visual inspection of the bimekizumab-SS-1mL or the bimekizumab-AI-1mLdevice 
which shows that the IMP is delivered completely (ie, container is empty), and 
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 No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs 
and/or ADEs leading to withdrawal from the DV0002 substudy). 
In the DV0002 substudy, for the 1mL devices, the 320mg bimekizumab dose will be 
administered as two 160mg injections with either 2 bimekizumab-SS-1mL devices or 2 
bimekizumab-AI-1mL devices. Each self-injection will be evaluated for safety and effectiveness 
by study personnel using the above criteria. The endpoint of safe and effective self-injection will 
be met only if both self-injections are determined to be safe and effective. 
For the 2ml devices, the 320mg bimekizumab dose will be administered as 1 injection with 
either 1 bimekizumab-SS-2mL or 1 bimekizumab-AI-2mL device. Each self-injection will 
be evaluated for safety and effectiveness by study personnel using the above criteria. The 
endpoint of safe and effective self-injection will be met if the single self-injection is 
determined to be safe and effective. 
Change #7  
Section 4.1.2 Secondary outcome variable 
The secondary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the bimekizumab-SS-1mL or the bimekizumab-AI-1mL at Baseline 
(the first self-injection visit, immediately after training in self-injection technique). Safe and 
effective self-injection will be evaluated by study personnel and is defined as for the primary 
outcome variable (see Section 4.1.1). 
Has been changed to:  
The secondary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the bimekizumab-SS-1mL, or the bimekizumab-AI-1mL, 
bimekizumab-SS-2mL, or 1 bimekizumab-AI-2mL at DV0002 Baseline (the first 
self-injection visit, immediately after training in self-injection technique). Safe and effective 
self-injection will be evaluated by study personnel and is defined as for the primary outcome 
variable (see Section 4.1.1). 
Change #8  
Section 4.1.3.1 
Outcome variables 
The other outcome variables are: 
 Responses to pre-injection SIAQ (versions 2.0 and 2.1) at Baseline. 
Whenever SIAQ is assessed, version 2.0 of the SIAQ will be used to assess 
bimekizumab-SS-1mL and version 2.1 of the SIAQ will be used to assess 
bimekizumab-AI-1mL (see Section 9.1). 
 Responses to post-injection SIAQ (versions 2.0 and 2.1) by visit following self-injection 
using the assigned device at Baseline and Week 8. 
 Injection site pain (using a VAS; 100mm) by visit after self-injection at Baseline and 
Week 8. 
 Percentage of used bimekizumab-SS-1mL and bimekizumab-AI-1mL identified as having 
structural or mechanical integrity issues after completion of self-injection. This is based on a 
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visual examination of the device that shows clear evidence of damage and/or compromised 
structural or mechanical integrity.  
Has been changed to: 
The other outcome variables are: 
 Responses to pre-injection SIAQ (versions 2.0 and 2.1) at DV0002 Baseline. 
Whenever SIAQ is assessed, version 2.0 of the SIAQ will be used to assess 
bimekizumab-SS-1mL and bimekizumab-SS-2mL and version 2.1 of the SIAQ will be used 
to assess bimekizumab-AI-1mL and bimekizumab-AI-2mL (see Section 9.1). 
 Responses to post-injection SIAQ (versions 2.0 and 2.1) by visit following self-injection 
using the assigned device at DV0002 Baseline and Week 8. 
 Injection site pain (using a VAS; 100mm) by visit after self-injection at using the assigned 
device at DV0002 Baseline and Week 8. 
 Percentage of used bimekizumab-SS-1mL and bimekizumab-AI-1mL devices identified as 
having structural or mechanical integrity issues after completion of self-injection. This is 
based on a visual examination of the device that shows clear evidence of damage and/or 
compromised structural or mechanical integrity.  
Change #9  
Section 4.1.3.2 
Pharmacokinetic variable 
The PK variable is trough PK (bimekizumab) levels associated with self-injection using the test 
device, injection by study personnel using the 1mL PFS, injection site (abdomen or thigh), and 
BMI category (by tertile). Trough levels will be assessed at Baseline, Week 4, Week 8, and 
Week 12 for subjects who receive bimekizumab Q4W and trough levels will be assessed at 
Baseline, Week 8, and Week 16 for subjects who receive bimekizumab Q8W. 
Has been changed to:  
The PK variable is trough PK (bimekizumab) levels associated with self-injection using the 
testinvestigational device, injection by study personnel using the 1mL PFS, injection site 
(abdomen or thigh), and BMI category (by tertile). Trough levels will be assessed at DV0002 
Baseline, Week 4, Week 8, and Week 12 for subjects who receive bimekizumab Q4W and 
trough levels will be assessed at DV0002 Baseline, Week 8, and Week 16 for subjects who 
receive bimekizumab Q8W. 
Change #10  
Section 5.1 
Study description, paragraph 1 through the paragraph immediately 
following Table 5-1 
DV0002 is a Phase 3 open-label, randomized, noncomparator, North America-only substudy to 
PS0014. PS0014 will evaluate the long-term safety, tolerability, and efficacy of bimekizumab in 
subjects with moderate to severe chronic plaque PSO, and study personnel will administer 
bimekizumab to subjects in a 1mL PFS. In the DV0002 substudy, the safe and effective use of 
the bimekizumab-SS-1mL or the bimekizumab-AI-1mL for the sc self-injection of bimekizumab 
solution by subjects with PSO will be evaluated.  
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Subjects from selected sites in the PS0014 feeder studies PS0008, PS0009, and PS0013 will be 
eligible for the DV0002 substudy. The DV0002 substudy will maintain all study assessments of 
the main PS0014 study from Baseline to Week 16 (inclusive). However, only subjects in the 
DV0002 substudy will self-administer bimekizumab. At DV0002 Baseline, each subject will be 
provided with training in self-injection and will receive the instructions for use (IFU) and any 
other applicable training materials. Subjects in the DV0002 substudy will perform self-injections 
at Baseline (corresponding to the Baseline Visit of PS0014) with a subsequent self-injection at 
Week 8 (corresponding to Week 8 of PS0014).  
During the 16-week Treatment Period of DV0002, subjects will receive either bimekizumab 
320mg Q8W or bimekizumab 320mg Q4W, based on their assigned dosing at Baseline 
(Table 5-1). Baseline for DV0002 and Baseline for PS0014 will occur at the same time, and the 
same interactive response technology (IRT) will be used for both studies. The 320mg 
bimekizumab dose will be administered as two 160mg injections, and both injections will be 
either self-administered using the test device (at Baseline and Week 8) or administered by study 
personnel using the 1mL PFS (at Week 4 and Week 12 for subjects in the Q4W dosing arm and 
at Week 16 for both dosing arms). This dose regimen will remain stable for the entire 16-week 
Treatment Period of DV0002, as per PS0014 design. The DV0002 substudy will evaluate 2 
self-injection investigational devices: the bimekizumab-SS-1mL and the bimekizumab-AI-1mL.  
Eligible subjects will be randomly assigned in a 1:1 ratio to perform self-injection using either 
the bimekizumab-SS-1mL or the bimekizumab-AI-1mL (see Section 7.10). Regardless of the 
assigned dose regimen, subjects will perform self-injection with the assigned device only at 
Baseline (corresponding to the Baseline Visit of PS0014) and at Week 8 (corresponding to 
Week 8 of PS0014). 
Table 5-1: 
Bimekizumab administration schedule 
Dose Regimen 
Baseline 
Week 4 
Week 8 
Week 12 
Week 16 
320mg Q8W 
S 
NA 
S 
NA 
SP 
320mg Q4W 
S 
SP 
S 
SP 
SP 
bimekizumab-AI-1mL=1mL bimekizumab auto-injector; bimekizumab-SS-1mL=1mL bimekizumab safety 
syringe; NA=not applicable; Q4W=every 4 weeks; Q8W=every 8 weeks; S=subject performing self-injection 
using the test device; SP=study personnel performing injection using the 1mL pre-filled syringe  
Note: For S injections, the 320mg bimekizumab dose will be administered as two 160mg injections (using 
2 bimekizumab-SS-1mL or 2 bimekizumab-AI-1mL). For SP injections, the 320mg bimekizumab dose will be 
administered as two 160mg injections (using prefilled syringes). Both injections will be administered in the 
same manner (eg, both self-administered injections or both study personnel-administered injections), but each 
injection will be administered at a separate injection site and rotation between injection sites should be 
observed. 
Note: Visits in the DV0002 substudy correlate with the same visit in the PS0014 study (ie, the DV0002 Baseline 
Visit is the PS0014 Baseline Visit). Dose regimen will be assigned at Baseline, and the same interactive 
response technology will be used for both studies 
The bimekizumab administration schedule optimizes the collection of PK trough data within the 
constraints of a short treatment period and a Q4W and Q8W dosing regimen. At Weeks 4 and 12, 
subjects on the Q4W dosing regimen will be injected by study personnel with two injections 
each of 160 mg bimekizumab using a 1mL PFS (i.e., the same device as that used in PS0014). 
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For these subjects, the Q4W administration schedule will provide PK trough data associated with 
injection by:  
Has been changed to:  
DV0002 is a Phase 3 open-label, randomized, noncomparator, North America-only substudy to 
PS0014. PS0014 will evaluate the long-term safety, tolerability, and efficacy of bimekizumab in 
subjects with moderate to severe chronic plaque PSO, and study personnel will administer 
bimekizumab to subjects in a 1mL PFS. In the DV0002 substudy, the safe and effective use of 
the bimekizumab-SS-1mL, bimekizumab-AI-1mL, bimekizumab-SS-2mL, or the 
bimekizumab-AI-2mL for the sc self-injection of bimekizumab solution by subjects with PSO 
will be evaluated.  
Subjects from selected sites in the PS0014 feeder studies PS0008, PS0009, and PS0013 will be 
eligible for the DV0002 substudy. The DV0002 substudy will maintain all study assessments of 
the main PS0014 study from Baseline to Week 16 (inclusive). However, only subjects in the 
DV0002 substudy will self-administer bimekizumab. At DV0002 Baseline, each subject will be 
provided with training in self-injection and will receive the instructions for use (IFU) and any 
other applicable training materials.  
1mL Device Cohort 
For the 1mL device cohort, subjects in the DV0002 substudy will perform self-injections at 
Baseline (corresponding to the Baseline Visit of PS0014) with a subsequent self-injection at 
Week 8 (corresponding to Week 8 of PS0014).  
During the 16-week Treatment Period of DV0002, subjects will receive either bimekizumab 
320mg Q8W or bimekizumab 320mg Q4W, based on their assigned dosing at Baseline 
(Table 5-1). Baseline for DV0002 and Baseline for PS0014 will occur at the same time, and the 
same interactive response technology (IRT) will be used for both studies. The 320mg 
bimekizumab dose will be administered as two 160mg injections, and both injections will be 
either self-administered using the testinvestigational device (at Baseline and Week 8) or 
administered by study personnel using the 1mL PFS (at Week 4 and Week 12 for subjects in the 
Q4W dosing arm and at Week 16 for both dosing arms). This dose regimen will remain stable for 
the entire 16-week Treatment Period of DV0002, as per PS0014 design. The DV0002 substudy 
will evaluate 2 self-injection investigational devices: the bimekizumab-SS-1mL and the 
bimekizumab-AI-1mL.  
Eligible subjects (PS0014 entry criteria and Section 6 DV0002 entry criteria) will be 
randomly assigned in a 1:1 ratio to perform self-injection using either the bimekizumab-SS-1mL 
or the bimekizumab-AI-1mL (see Section 7.10). Regardless of the assigned dose regimen, 
subjects will perform self-injection with the assigned device only at Baseline (corresponding to 
the Baseline Visit of PS0014) and at Week 8 (corresponding to Week 8 of PS0014). 
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Table 5-1: 
Bimekizumab administration schedule visits in DV0002 substudy 1mL 
device cohort 
Dose Regimen 
Baseline 
Week 4 
Week 8 
Week 12 
Week 16 
320mg Q8W 
S 
NA 
S 
NA 
SP 
320mg Q4W 
S 
SP 
S 
SP 
SP 
bimekizumab-AI-1mL=1mL bimekizumab auto-injector; bimekizumab-SS-1mL=1mL bimekizumab safety 
syringe; NA=not applicable; Q4W=every 4 weeks; Q8W=every 8 weeks; S=subject performing self-injection 
using the test investigational device; SP=study personnel performing injection using the 1mL pre-filled syringe  
Note: For S injections, the 320mg bimekizumab dose will be administered as two 160mg injections (using 
2 bimekizumab-SS-1mL or 2 bimekizumab-AI-1mL). For SP injections, the 320mg bimekizumab dose will be 
administered as two 160mg injections (using prefilled syringes). Both injections will be administered in the 
same manner (eg, both self-administered injections or both study personnel-administered injections), but each 
injection will be administered at a separate injection site and rotation between injection sites should be 
observed. 
Note: For the 1mL cohort, visits in the DV0002 substudy correlate with the same visit in the PS0014 study (ie, 
the DV0002 Baseline Visit is the PS0014 Baseline Visit). Dose regimen will be assigned at Baseline, and the 
same interactive response technology will be used for both studies. 
The bimekizumab administration schedule optimizes the collection of PK trough data within the 
constraints of a short treatment period and a Q4W and Q8W dosing regimen. At Weeks 4, and 
12, and 16, subjects on the Q4W dosing regimen will be injected by study personnel with two 
2 injections each of 160mg bimekizumab using a 1mL PFS (i.e.ie, the same device as that used 
in PS0014). For these subjects, the Q4W administration schedule will provide PK trough data 
associated with injection by:  
Change #11 
Section 5.1 
Study description, Addition of 2mL device cohort 
The following text was added at the end of Section 5.1 and appears before Section 5.1.1: 
2mL Device Cohort 
To allow flexible enrollment, subjects may be randomized in the 2mL device cohort at the 
PS0014 Week 24, Week 28, or Week 32 visit for subjects receiving bimekizumab Q4W or 
the PS0014 Week 24 or Week 32 visit for subjects receiving bimekizumab Q8W.  
For the 2mL device cohort, subjects will perform self-injections at DV0002 Baseline with a 
subsequent self-injection 8 weeks after training. The 2mL device cohort will evaluate 
2 self-injection devices: the bimekizumab-SS-2mL and the bimekizumab-AI-2mL. 
During the Treatment Period of DV0002, subjects will receive either bimekizumab 320mg 
Q8W or bimekizumab 320mg Q4W, based on their assigned dosing at Baseline of 
PS0014 (Table 5-3). In the 2mL device cohort, Baseline for DV0002 will occur at the 
PS0014 Week 24, Week 28, or Week 32 visit for subjects receiving bimekizumab Q4W or 
the PS0014 Week 24 or Week 32 visit for subjects receiving bimekizumab Q8W. The same 
IRT will be used for both studies. The 320mg bimekizumab dose will either be self-
administered as 1 injection using the assigned investigational device (at DV0002 Baseline 
and Week 8) or administered as 2 injections by study personnel using the 1mL PFS (at 
DV0002 Week 4 and Week 12 for subjects in the Q4W dosing arm and at DV0002 Week 16 
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for both dosing arms). This dose regimen will remain stable for the entire 16-week 
Treatment Period of DV0002, per the PS0014 design.  
Eligible subjects (PS0014 entry criteria and Section 6 DV0002 entry criteria) who have not 
participated in the 1mL device cohort, will be randomly assigned in a 1:1 ratio to perform 
self-injection using either the bimekizumab-SS-2mL or the bimekizumab-AI-2mL (see 
Section 7.10). Regardless of the assigned dose regimen, subjects will perform self-injection 
with the assigned devices only at DV0002 Baseline and at DV0002 Week 8.  
Table 5-2: 
Bimekizumab administration schedule visits in DV0002 substudy 
2mL device cohort 
Dose Regimen 
DV0002 Visits 
Baseline 
Week 4 
Week 8 
Week 12 
Week 16 
320mg Q8W 
S 
NA 
S 
NA 
SP 
320mg Q4W 
S 
SP 
S 
SP 
SP 
bimekizumab-AI-2mL=2mL bimekizumab auto-injector; bimekizumab-SS-2mL=2mL bimekizumab safety 
syringe; IRT = interactive response technology; NA=not applicable; Q4W=every 4 weeks; Q8W=every 
8 weeks; S=subject performing self-injection using the investigational device; SP=study personnel 
performing injection using the 1mL prefilled syringe 
Note: For S injections, the 320mg bimekizumab dose will be administered as a single injection (using the 
bimekizumab-SS-2mL or bimekizumab-AI-2mL devices). For SP injections, the 320mg bimekizumab 
dose will be administered as two 160mg injections (using 2 prefilled syringes). The injections will be 
administered in the same manner (eg, both self-administered injections or both SP-administered 
injections), but each injection will be administered at a separate injection site and rotation between 
injection sites should be observed. 
Note: For the 2mL device cohort, Baseline for DV0002 will occur at PS0014 Week 24, Week 28, or Week 32 
for subjects receiving bimekizumab Q4W or at PS0014 Week 24 or Week 32 for subjects receiving 
bimekizumab Q8W. Dose regimen will be assigned at Baseline of the PS0014 study, and the same IRT 
will be used for both the PS0014 and DV0002 studies. 
 
The bimekizumab administration schedule optimizes the collection of PK trough data 
within the constraints of a short treatment period and a Q4W and Q8W dosing regimen. At 
Weeks 4, 12, and 16, subjects on the Q4W dosing regimen will be injected by study 
personnel with 2 injections each of 160 mg bimekizumab using a 1mL PFS (ie, the same 
device as that used in PS0014). For these subjects, the Q4W administration schedule will 
provide PK trough data associated with injection by: 
 Study personnel using the 1mL PFS from PK samples collected (before self-injection) 
at DV0002 Baseline and Week 8 (ie, PK data from 2 timepoints) 
 Subject self-injection using the assigned device from PK samples collected (before 
injection by study personnel) at Week 4 and Week 12 (ie, PK data from 2 
timepoints) 
At DV0002 Baseline and Week 8, subjects on the Q8W dosing regimen will self-inject 1 
injection using the assigned 2mL device (bimekizumab-SS-2mL or the 1 bimekizumab-AI-
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2mL). For these subjects, the Q8W administration schedule will provide PK trough data 
associated with injection by: 
 Study personnel using the 1mL PFS from PK samples collected (before self-injection) 
at DV0002 Baseline (ie, PK data from 1 timepoint) 
 Subject self-injection using the assigned device from PK samples collected (before 
self-injection) at DV0002 Week 8 and (before injection by study personnel) at 
DV0002 Week 16 (ie, PK data from 2 timepoints) 
In addition to self-injections, DV0002 substudy-specific assessments (eg, study personnel 
evaluation, SIAQ responses, VAS for injection site pain, and PK analyses; see Section 5.2) 
will be performed from DV0002 Baseline through Week 16 (inclusive). An SFU telephone 
call will occur 1 week after the last self-administration (at DV0002 Week 9).  
After Week 16 in the DV0002 substudy, subjects will continue in PS0014. Studies DV0002 
and PS0014 will share a common database/eCRF system (including common AE reporting) 
and a common IRT. 
Subjects who are withdrawn from DV0002 but continue their PS0014 study participation 
will be required to perform an SFU telephone call 1 week after their final DV0002 dosing 
visit (see Section 6.3). Subjects who are withdrawn from bimekizumab treatment (PS0014 
study) during the course of DV0002 will also be required to follow the PS0014 withdrawal 
procedures. 
Change #12  
Section 5.1.2 Planned number of subjects and sites 
It is planned to enroll approximately 200 subjects; each device arm will consist of approximately 
100 subjects. It is anticipated that this study will involve up to 80 sites in North America. 
Has been changed to: 
For evaluation of the 1mL device, it is planned to enroll approximately 200 subjects; each 
device arm (bimekizumab-SS-1mL, bimekizumab-AI-1mL) will consist of approximately 
100 subjects.  
Once the 1mL device cohort has finished enrolling, the 2mL device cohort will start 
enrolling. For evaluation of the 2mL device, it is planned to enroll approximately 
100 subjects; each device arm (bimekizumab-SS-2mL or bimekizumab-AI-2mL) will 
consist of approximately 50 subjects.  
It is anticipated that this study will involve up to 80 sites in North America. 
Change #13  
Section 5.2 
Schedule of study assessments 
The schedule of assessments in presented in Table 5-2 and includes assessments performed 
specifically in the DV0002 substudy and assessments performed as part of the PS0014 study. 
Assessments specific to the DV0002 substudy are labeled for clarity.  
 
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Table 5-2: 
Schedule of study assessments 
Visit a 
Week 
 
 
Procedures 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(Device SFU) 
Visit 4 
Visit 5 
Baseline/Feeder 
Study Final Visit 
Week 4 
Week 8 
Week 9 
Week 12 
Week 16 
Informed consent for DV0002 and 
PS0014 assessments 
X 
 
 
 
 
 
Inclusion/exclusion  
X 
 
 
 
 
 
Physical exam b, c 
X 
 
 
 
X 
 
Body weight 
X 
 
 
 
 
 
Vital signs d 
X 
X 
X 
 
 
X 
Hematology and chemistry 
X 
X 
X 
 
 
X 
Urinalysis 
X 
X 
X 
 
 
X 
Urine drug screen 
X 
 
 
 
 
 
ECG 
X 
 
 
 
 
 
Pregnancy testing e 
X 
X 
X 
 
X 
X 
TB questionnaire  
X 
 
 
 
X 
 
Blood sample for bimekizumab 
plasma concentrations f (DV0002-
specific for Weeks 4, 8, and 12) 
X 
X g 
X  
 
X g 
X h 
Blood sample for anti-bimekizumab 
antibodies f 
X 
 
 
 
 
X 
PASI  
X 
X 
X 
 
X 
X 
Percentage of BSA 
X 
X 
X 
 
X 
X 
IGA  
X 
X 
X 
 
X 
X 
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Table 5-2: 
Schedule of study assessments 
Visit a 
Week 
 
 
Procedures 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(Device SFU) 
Visit 4 
Visit 5 
Baseline/Feeder 
Study Final Visit 
Week 4 
Week 8 
Week 9 
Week 12 
Week 16 
DLQI 
X 
 
 
 
 
 
PHQ-9 
X 
X 
X 
 
 
X 
eC-SSRS 
X 
X 
X 
 
 
X 
mNAPSI i 
X 
 
 
 
 
 
Scalp IGA j 
X 
 
 
 
 
 
pp-IGA k 
X 
 
 
 
 
 
EQ-5D-3L 
X 
 
 
 
 
 
SF-36 
X 
 
 
 
 
 
PGA of PSO 
X 
 
 
 
 
 
PASE 
X 
 
 
 
 
 
PGADA l 
X 
 
 
 
 
 
WPAI-SHP v2.0 
X 
 
 
 
 
 
Concomitant medication 
(DV0002-specific for Week 9) 
X 
X 
X 
X 
X 
X 
Adverse events m (DV0002-specific 
for Week 9) 
X 
X 
X 
X 
X 
X 
Random assignment to device 
(DV0002-specific) 
X 
 
 
 
 
 
IRT contact 
X 
X 
X 
 
X 
X 
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Table 5-2: 
Schedule of study assessments 
Visit a 
Week 
 
 
Procedures 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(Device SFU) 
Visit 4 
Visit 5 
Baseline/Feeder 
Study Final Visit 
Week 4 
Week 8 
Week 9 
Week 12 
Week 16 
Subject training for VAS and SIAQ 
Questionnaire (DV0002-specific) 
X 
 
 
 
 
 
Pre-injection SIAQ Questionnaire n 
(DV0002-specific) 
X 
 
 
 
 
 
Subject training for self-injection 
(DV0002-specific) 
X 
 
 
 
 
 
Bimekizumab administration by study 
personnel using the PFS o 
 
X g 
 
 
X g 
X 
Subject self-injection of bimekizumab 
using the assigned device p 
(DV0002-specific) 
X 
 
X 
 
 
 
Study personnel evaluation of 
self-injection (DV0002-specific) 
X 
 
X 
 
 
 
Study personnel evaluation of 
post-use device for 
structural/mechanical integrity 
(DV0002-specific) 
X 
 
X 
 
 
 
VAS for injection site pain 
(DV0002-specific) 
X 
 
X 
 
 
 
Post-injection SIAQ Questionnaire n 
(DV0002-specific) 
X 
 
X 
 
 
 
Drug and device accountability 
(DV0002-specific) 
X 
X 
X 
 
X 
X 
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Table 5-2: 
Schedule of study assessments 
Visit a 
Week 
 
 
Procedures 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(Device SFU) 
Visit 4 
Visit 5 
Baseline/Feeder 
Study Final Visit 
Week 4 
Week 8 
Week 9 
Week 12 
Week 16 
bimekizumab-AI-1mL=1mL bimekizumab auto-injector; bimekizumab-SS-1mL=1mL bimekizumab safety syringe; BSA=body surface area; 
DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide Severity Rating Scale; EQ-5D-3L=Euro-Quality 
of Life 5-Dimensions 3-level; IGA=Investigator’s Global Assessment; IGRA=interferon-gamma release assay; IRT=interactive response technology; 
mNAPSI=modified Nail Psoriasis Severity Index; PASE=Psoriatic Arthritis Screening and Evaluation; PASI=Psoriasis Area Severity Index; PGA=Patient 
Global Assessment; PGADA=Patient’s Global Assessment of Disease Activity; PHQ-9=Patient Health Questionnaire 9; pp-IGA=palmoplantar 
Investigator’s Global Assessment; PSO=psoriasis; Q4W=every 4 weeks; Q8W=every 8 weeks; SF-36=Short Form 36-item Health Survey; SFU=safety 
follow-up; SIAQ=Self-injection Assessment Questionnaire; TB=tuberculosis; VAS=visual analog scale; WPAI-SHP=Work Productivity and Activity 
Impairment Questionnaire-specific health problem 
a Visit windows of ±7 days from the first dose at all visits except Visit 3a (SFU telephone call). The SFU telephone call window is 7 days from the last dose in 
the DV0002 substudy, ±3 days. 
b Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
c The physical exam will include examination of the following systems: eyes, hair, and skin; respiratory; cardiovascular; and gastrointestinal. 
d Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where 
applicable. 
e Pregnancy testing will consist of urine pregnancy tests at all visits. Pregnancy test results must be negative prior to administering investigational medicinal 
product. 
f All blood samples will be taken prior to dosing. 
g This will only be done for subjects who receive bimekizumab Q4W. 
h This will only be done for subjects who receive bimekizumab Q8W. 
i The mNAPSI will be assessed only in subjects with nail involvement at Baseline in the feeder studies. 
j The scalp IGA will only be assessed for those subjects with scalp involvement (scalp IGA score >0) at Baseline in the feeder studies. 
k The pp-IGA will only be assessed in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline in the feeder studies. 
l The PGADA is assessed only for subjects with psoriatic arthritis at Baseline in the feeder studies. 
m Adverse events not related to the investigational devices will be reported in PS0014 and adverse device effects and device deficiencies will be reported in 
DV0002. A single safety database will be used for both studies. 
n Version 2.0 of the SIAQ will be used to assess bimekizumab-SS-1mL, while version 2.1 will be used to assess bimekizumab-AI-1mL (see Section 9.1). 
o The dosing window is ±7 days relative to the scheduled dosing visit. 
p The 320mg bimekizumab dose will be administered as two 160mg injections (using 2 bimekizumab-SS-1mL devices or 2 bimekizumab-AI-1mL devices). 
 
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Has been changed to:  
The schedule of assessments in presented in Table 5-2 Table 5-3 for the 1mL device cohort. 
For subjects in the 1mL device cohort, Baseline for DV0002 corresponds to Baseline in 
PS0014, and the subsequent study visits are the same in both studies. Table 5-2 Table 5-3 
includes assessments performed specifically in the DV0002 substudy and assessments performed 
as part of the PS0014 study, inclusive. Assessments specific to the DV0002 substudy are labeled 
for clarity. 
For subjects in the 2mL device cohort, Baseline for DV0002 can correspond to the PS0014 
Week 24, Week 28, or Week 32 visits for subjects receiving bimekizumab Q4W and to the 
PS0014 Week 24 or Week 32 visits for subjects receiving bimekizumab Q8W. The schedule 
of assessments for the PS0014 Week 24 through Week 48 visits is presented in Table 5-4. 
The additional assessments to be performed for the DV0002 substudy in the 2mL device 
cohort specifically are presented in Table 5-5.  
 
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Table 5-3: 
Schedule of study assessments for the PS0014 study and DV0002 substudy (1mL device cohort) 
Visit a 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(DV0002 SFU) 
Visit 4 
Visit 5 
Baseline/Feeder 
Study Final Visit 
Week 4 
Week 8 
Week 9 
Week 12 
Week 16 
Informed consent for DV0002 and 
PS0014 assessments 
X 
 
 
 
 
 
Inclusion/exclusion  
X 
 
 
 
 
 
Physical exam b, c 
X 
 
 
 
X 
 
Body weight 
X 
 
 
 
 
 
Vital signs d 
X 
X 
X 
 
 
X 
Hematology and chemistry 
X 
X 
X 
 
 
X 
Urinalysis 
X 
X 
X 
 
 
X 
Urine drug screen 
X 
 
 
 
 
 
ECG 
X 
 
 
 
 
 
Pregnancy testing e 
X 
X 
X 
 
X 
X 
TB questionnaire  
X 
 
 
 
X 
 
Blood sample for bimekizumab 
plasma concentrations f (DV0002-
specific for Weeks 4, 8, and 12) 
X 
X g 
X  
 
X g 
X h 
Blood sample for anti-bimekizumab 
antibodies f 
X 
 
 
 
 
X 
PASI  
X 
X 
X 
 
X 
X 
Percentage of BSA 
X 
X 
X 
 
X 
X 
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Table 5-3: 
Schedule of study assessments for the PS0014 study and DV0002 substudy (1mL device cohort) 
Visit a 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(DV0002 SFU) 
Visit 4 
Visit 5 
Baseline/Feeder 
Study Final Visit 
Week 4 
Week 8 
Week 9 
Week 12 
Week 16 
IGA  
X 
X 
X 
 
X 
X 
DLQI 
X 
 
 
 
 
 
PHQ-9 
X 
X 
X 
 
 
X 
eC-SSRS 
X 
X 
X 
 
 
X 
mNAPSI i 
X 
 
 
 
 
 
Scalp IGA j 
X 
 
 
 
 
 
pp-IGA k 
X 
 
 
 
 
 
EQ-5D-3L 
X 
 
 
 
 
 
SF-36 
X 
 
 
 
 
 
PGA of PSO 
X 
 
 
 
 
 
PASE 
X 
 
 
 
 
 
PGADA l 
X 
 
 
 
 
 
WPAI-SHP v2.0 
X 
 
 
 
 
 
Concomitant medication 
(DV0002-specific for Week 9) 
X 
X 
X 
X 
X 
X 
Adverse events m (DV0002-specific 
for Week 9) 
X 
X 
X 
X 
X 
X 
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Table 5-3: 
Schedule of study assessments for the PS0014 study and DV0002 substudy (1mL device cohort) 
Visit a 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(DV0002 SFU) 
Visit 4 
Visit 5 
Baseline/Feeder 
Study Final Visit 
Week 4 
Week 8 
Week 9 
Week 12 
Week 16 
Random assignment to device 
(DV0002-specific) 
X 
 
 
 
 
 
IRT contact 
X 
X 
X 
 
X 
X 
Subject training for VAS and SIAQ 
Questionnaire (DV0002-specific) 
X 
 
 
 
 
 
Pre-injection SIAQ Questionnaire n 
(DV0002-specific) 
X 
 
 
 
 
 
Subject training for self-injection 
(DV0002-specific) 
X 
 
 
 
 
 
Bimekizumab administration by study 
personnel using the PFS o 
 
X g 
 
 
X g 
X 
Subject self-injection of bimekizumab 
using the assigned deviceo, p 
(DV0002-specific) 
X 
 
X 
 
 
 
Study personnel evaluation of 
self-injection (DV0002-specific) 
X 
 
X 
 
 
 
Study personnel evaluation of 
post-use device for 
structural/mechanical integrity 
(DV0002-specific) 
X 
 
X 
 
 
 
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Table 5-3: 
Schedule of study assessments for the PS0014 study and DV0002 substudy (1mL device cohort) 
Visit a 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(DV0002 SFU) 
Visit 4 
Visit 5 
Baseline/Feeder 
Study Final Visit 
Week 4 
Week 8 
Week 9 
Week 12 
Week 16 
VAS for injection site pain 
(DV0002-specific) 
X 
 
X 
 
 
 
Post-injection SIAQ Questionnaire n 
(DV0002-specific) 
X 
 
X 
 
 
 
Drug and device accountability 
(DV0002-specific) 
X 
Xg 
X 
 
Xg 
X 
bimekizumab-AI-1mL=1mL bimekizumab auto-injector; bimekizumab-SS-1mL=1mL bimekizumab safety syringe; BSA=body surface area; 
DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide Severity Rating Scale; EQ-5D-3L=Euro-Quality 
of Life 5-Dimensions 3-level; IGA=Investigator’s Global Assessment; IGRA=interferon-gamma release assay; IRT=interactive response technology; 
mNAPSI=modified Nail Psoriasis Severity Index; PASE=Psoriatic Arthritis Screening and Evaluation; PASI=Psoriasis Area Severity Index; PGA=Patient 
Global Assessment; PGADA=Patient’s Global Assessment of Disease Activity; PHQ-9=Patient Health Questionnaire 9; pp-IGA=palmoplantar 
Investigator’s Global Assessment; PSO=psoriasis; Q4W=every 4 weeks; Q8W=every 8 weeks; SF-36=Short Form 36-item Health Survey; SFU=safety 
follow-up; SIAQ=Self-injection Assessment Questionnaire; TB=tuberculosis; VAS=visual analog scale; WPAI-SHP=Work Productivity and Activity 
Impairment Questionnaire-specific health problem 
a Visit windows of ±7 days from the first dose at all visits except Visit 3a (SFU telephone call). The SFU telephone call window is 7 days from the last dose in 
the DV0002 substudy, ±3 days. 
b Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
c The physical exam will include examination of the following systems: eyes, hair, and skin; respiratory; cardiovascular; and gastrointestinal. 
d Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to dosing, where 
applicable. 
e Pregnancy testing will consist of urine pregnancy tests at all visits. Pregnancy test results must be negative prior to administering investigational medicinal 
product. 
f All blood samples will be taken prior to dosing. 
g This will only be done for subjects who receive bimekizumab Q4W. 
h This will only be done for subjects who receive bimekizumab Q8W. 
i The mNAPSI will be assessed only in subjects with nail involvement at Baseline in the feeder studies. 
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Table 5-3: 
Schedule of study assessments for the PS0014 study and DV0002 substudy (1mL device cohort) 
Visit a 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(DV0002 SFU) 
Visit 4 
Visit 5 
Baseline/Feeder 
Study Final Visit 
Week 4 
Week 8 
Week 9 
Week 12 
Week 16 
j The scalp IGA will only be assessed for those subjects with scalp involvement (scalp IGA score >0) at Baseline in the feeder studies. 
k The pp-IGA will only be assessed in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline in the feeder studies. 
l The PGADA is assessed only for subjects with psoriatic arthritis at Baseline in the feeder studies. 
m Adverse events not related to the investigational devices will be reported in PS0014 and adverse device effects and device deficiencies will be reported in 
DV0002. A single safety database will be used for both studies. 
n Version 2.0 of the SIAQ will be used to assess bimekizumab-SS-1mL, while version 2.1 will be used to assess bimekizumab-AI-1mL (see Section 9.1). 
o The dosing window is ±7 days relative to the scheduled dosing visit. 
p The 320mg bimekizumab dose will be administered as two 160mg injections (using 2 bimekizumab-SS-1mL devices or 2 bimekizumab-AI-1mL devices). 
 
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Table 5-4: 
Schedule of assessments for the PS0014 study (2mL device cohort) 
Week 
Procedures 
Week 24a 
Week 28a 
Week 32a 
Week 36 
Week 40 
Week 44 Week 48 
Physical examb,c 
X 
 
 
X 
 
 
X 
Body weight 
 
 
 
 
 
 
X 
Vital signsd 
X 
 
X 
 
X 
 
X 
Hematology and chemistry 
X 
 
X 
 
X 
 
X 
Urinalysis 
X 
 
X 
 
X 
 
X 
ECG 
 
 
 
 
 
 
X 
Pregnancy testinge 
X 
X 
X 
X 
X 
X 
X 
IGRA TB test 
 
 
 
 
 
 
X 
TB questionnaire 
X 
 
 
X 
 
 
X 
Blood sample for bimekizumab plasma 
concentrationsf 
X 
 
 
 
X 
 
X 
Blood sample for anti-bimekizumab antibodiesf 
X 
 
 
 
X 
 
X 
PASI  
X 
X 
X 
X 
X 
X 
X 
Percentage of BSA 
X 
X 
X 
X 
X 
X 
X 
IGA  
X 
X 
X 
X 
X 
X 
X 
DLQI 
X 
 
 
 
 
 
X 
PHQ-9 
X 
 
X 
 
X 
 
X 
eC-SSRS 
X 
 
X 
 
X 
 
X 
mNAPSIg 
X 
 
 
 
 
 
X 
Scalp IGAh 
X 
 
 
 
 
 
X 
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Table 5-4: 
Schedule of assessments for the PS0014 study (2mL device cohort) 
Week 
Procedures 
Week 24a 
Week 28a 
Week 32a 
Week 36 
Week 40 
Week 44 Week 48 
pp-IGAi 
X 
 
 
 
 
 
X 
EQ-5D-3L 
X 
 
 
 
 
 
X 
SF-36 
X 
 
 
 
 
 
X 
PGA of PSO 
X 
 
 
 
 
 
X 
PASEj 
 
 
 
 
 
 
X 
PGADAj 
X 
 
 
 
 
 
X 
WPAI-SHP V2.0 
X 
 
 
 
 
 
X 
TSQM-9 
 
 
 
 
 
 
X 
Concomitant medication 
X 
X 
X 
X 
X 
X 
X 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
IRT 
X 
X 
X 
X 
X 
X 
X 
Bimekizumab administrationk,l  
X 
X 
X 
X 
X 
X 
X 
Subject training on home self-injectionm 
 
 
 
 
X 
X 
 
BSA=body surface area; DLQI=Dermatology Life Quality Index; ECG=electrocardiogram; eC-SSRS=electronic Columbia Suicide Severity Rating Scale; 
EQ-5D-3L=Euro-Quality of Life 5-Dimensions 3-level; IGA=Investigator’s Global Assessment; IGRA=interferon-gamma release assay; IMP=investigational 
medicinal product; IRT=interactive response technology; mNAPSI=modified Nail Psoriasis Severity Index; PASE=Psoriatic Arthritis Screening and Evaluation; 
PASI=Psoriasis Area Severity Index; PGA=Patient Global Assessment; PGADA=Patient’s Global Assessment of Disease Activity; PHQ-9=Patient Health 
Questionnaire-9; pp-IGA=palmoplantar Investigator’s Global Assessment; PsA=psoriatic arthritis; PSO=psoriasis; Q4W=every 4 weeks; Q8W=every 8 weeks; 
SF-36=Short Form 36-item Health Survey; TB=tuberculosis; TSQM-9=Treatment Satisfaction Questionnaire for Medication; WPAI-SHP=Work Productivity and 
Activity Impairment Questionnaire-specific health problem  
Note: Starting at Week 48 of the PS0014 Treatment Period, subjects may self-inject IMP at home; self-injection training will be provided to the 
subject/caregivers by qualified site personnel (refer to PS0014 protocol). 
a For the 2mL device cohort, Baseline of DV0002 can occur at PS0014 Week 24, Week 28, or Week 32 for subjects receiving bimekizumab Q4W and 
at PS0014 Week 24 or Week 32 for subjects receiving bimekizumab Q8W. 
b Includes evaluation of signs and symptoms of active TB and risk for exposure to TB. 
c The physical examination will be performed as per the PS0014 protocol Section 9.3.5. 
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Table 5-4: 
Schedule of assessments for the PS0014 study (2mL device cohort) 
Week 
Procedures 
Week 24a 
Week 28a 
Week 32a 
Week 36 
Week 40 
Week 44 Week 48 
d Vital signs (sitting systolic and diastolic blood pressure, pulse rate, and temperature) are to be measured prior to blood sampling, and prior to 
dosing, where applicable. 
e Urine pregnancy testing will be performed at all visits. Pregnancy test results must be negative prior to administering IMP. 
f All blood samples taken prior to dosing. 
g The mNAPSI will be assessed only in subjects with nail involvement at Baseline in the feeder studies. 
h The scalp IGA will only be assessed for those subjects with scalp involvement (scalp IGA score >0) at Baseline in the feeder studies. 
i The pp-IGA will only be assessed in subjects with palmoplantar involvement (pp-IGA score >0) at Baseline in the feeder studies 
j The PGADA and the PASE are assessed only for subjects with PsA at Baseline in the feeder studies. 
k The dosing window is ±7 days relative to the scheduled dosing visit. 
l Only subjects receiving IMP Q4W are dosed on Week 28, Week 36, and Week 44. 
m Subject training on at-home self-injection is to be performed as described in the PS0014 protocol Section 7.2. Starting at Week 48 of the PS0014 
Treatment Period, subjects may self-inject IMP at home. 
 
 
 
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Table 5-5: 
Schedule of assessments for the DV0002 substudy (2mL device cohort) 
Visit a 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(Device SFU) 
Visit 4 
Visit 5 
Baselineb 
Baseline + 
4 weeks 
Baseline + 
8 weeks 
Baseline + 
9 weeks 
Baseline + 
12 weeks 
Baseline + 
16 weeks 
Informed consent for DV0002  
X 
 
 
 
 
 
Random assignment to device 
(DV0002-specific) 
X 
 
 
 
 
 
IRT contact 
X 
X 
X 
 
X 
X 
Blood sample for bimekizumab 
plasma concentrationsc (DV0002-
specific for Weeks 4, 8, and 12) 
X 
Xd 
X 
 
Xd 
Xe 
Subject training for VAS and SIAQ 
Questionnaire (DV0002-specific) 
X 
 
 
 
 
 
Pre-injection SIAQ Questionnairef 
(DV0002-specific) 
X 
 
 
 
 
 
Subject training for self-injection 
(DV0002-specific) 
X 
 
 
 
 
 
Bimekizumab administration by 
study personnel using the PFSg 
 
Xd 
 
 
Xd 
X 
Subject self-injection of 
bimekizumab using the assigned 
deviceg,h (DV0002-specific) 
X 
 
X 
 
 
 
Study personnel evaluation of 
self-injection (DV0002-specific) 
X 
 
X 
 
 
 
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Table 5-5: 
Schedule of assessments for the DV0002 substudy (2mL device cohort) 
Visit a 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(Device SFU) 
Visit 4 
Visit 5 
Baselineb 
Baseline + 
4 weeks 
Baseline + 
8 weeks 
Baseline + 
9 weeks 
Baseline + 
12 weeks 
Baseline + 
16 weeks 
VAS for injection site pain 
(DV0002-specific) 
X 
 
X 
 
 
 
Post-injection SIAQ Questionnairef 
(DV0002-specific) 
X 
 
X 
 
 
 
Study personnel evaluation of 
post-use device for 
structural/mechanical integrity 
(DV0002-specific) 
X 
 
X 
 
 
 
Drug and device accountability 
(DV0002-specific) 
X 
Xd 
X 
 
Xd 
X 
Concomitant medication 
 
 
 
X 
 
 
Adverse Eventsi 
 
 
 
X 
 
 
IRT=interactive response technology; Q4W=every 4 weeks; Q8W=every 8 weeks; SFU=safety follow-up; SIAQ=Self-injection Assessment 
Questionnaire; VAS=visual analog scale  
a Visit windows of ±7 days from the first dose at all visits except Visit 3a (SFU telephone call). The SFU telephone call window is 7 days from the last 
dose in the DV0002 substudy, ±3 days. 
b For subjects in the 2mL device cohort, Baseline for DV0002 corresponds to PS0014 Week 24, Week 28, or Week 32 for subjects receiving 
bimekizumab Q4W and to PS0014 Week 24 or Week 32 for subjects receiving bimekizumab Q8W. Refer to Table 5-4 for PS0014 study 
assessments.  
c All blood samples will be taken prior to dosing. For detail on PK sampling in the 2mL device cohort, refer to Table 10-1 in Section 10. 
d This will only be done for subjects who receive bimekizumab Q4W. 
e This will only be done for subjects who receive bimekizumab Q8W. 
f Version 2.0 of the SIAQ will be used to assess bimekizumab-SS-2mL, while version 2.1 will be used to assess bimekizumab-AI-2mL (see 
Section 9.1). 
g The dosing window is ±7 days relative to the scheduled dosing visit. 
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Table 5-5: 
Schedule of assessments for the DV0002 substudy (2mL device cohort) 
Visit a 
Week 
 
 
Procedures 
DV0002 Treatment Period 
Visit 1 
Visit 2 
Visit 3 
Visit 3a 
Telephone Call 
(Device SFU) 
Visit 4 
Visit 5 
Baselineb 
Baseline + 
4 weeks 
Baseline + 
8 weeks 
Baseline + 
9 weeks 
Baseline + 
12 weeks 
Baseline + 
16 weeks 
h The 320mg bimekizumab dose will be administered as 1 injection using the bimekizumab-SS-2mL device or bimekizumab-AI-2mL device. 
i Adverse events not related to the devices will be reported in PS0014 and adverse device effects and device deficiencies will be reported in DV0002. 
A single safety database will be used for both studies. 
 
 
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Change #14  
Section 5.3 
Schematic diagram 
The study schematic diagram for DV0002 is presented in Figure 5-1. 
Figure 5-1: Schematic diagram 
 
BL=Baseline; Q4W=every 4 weeks; Q8W=every 8 weeks; self-inject=self-injection; SFU=safety follow-up; 
Wk=week 
Note: Phase 3 feeder studies include PS0008, PS0009, and PS0013. 
Note: Subjects will receive 320mg bimekizumab either Q4W or Q8W. Bimekizumab will be self-administered only 
at Baseline and at Week 8 (study personnel will administer bimekizumab at other visits). 
Has been changed to:  
The study schematic diagram for DV0002 1 mL device cohort is presented in Figure 5-1, and 
the 2mL device cohort is presented in Figure 5-2. 
Figure 5-1: 
Schematic diagram for the 1mL device cohort 
 
BL=Baseline; Q4W=every 4 weeks; Q8W=every 8 weeks; self-inject=self-injection; SFU=safety follow-up; 
Wk=week 
Note: Phase 3 feeder studies include PS0008, PS0009, and PS0013. 
Note: Subjects will receive 320mg bimekizumab either Q4W or Q8W. Bimekizumab will be self-administered only 
at Baseline and at Week 8 (study personnel will administer bimekizumab at other visits, as applicable). 
Note: For the 1mL device cohort, subjects will begin the DV0002 substudy and the PS0014 study at the same 
time; therefore, Baseline for DV0002 corresponds to Baseline for PS0014. 
 
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Figure 5-2: Schematic diagram for the 2mL device cohort 
 
BL=Baseline; Q4W=every 4 weeks; Q8W=every 8 weeks; self-inject=self-injection; SFU=safety follow-up; 
WK=week 
Note: Subjects will receive 320mg bimekizumab either Q4W or Q8W. Bimekizumab will be self-administered 
only at DV0002 Baseline and 8 weeks after training (study personnel will administer bimekizumab at other 
visits). 
a For the 2mL device cohort, subjects will not begin the DV0002 substudy and the PS0014 study at the same 
time. Baseline for DV0002 corresponds to the PS0014 Week 24, Week 28, or Week 32 visit for subjects 
receiving bimekizumab Q4W and to the PS0014 Week 24 or Week 32 visit for subjects receiving 
bimekizumab Q8W. 
Change #15 
Section 5.4 
Rationale for study design and selection of dose, paragraph 2 
It is expected that most individuals who will use commercial bimekizumab for the treatment of 
moderate to severe chronic plaque PSO will self-inject bimekizumab and also that these 
individuals will prefer to have options for the self-administration of their medication. DV0002 
will therefore evaluate the safe and effective use of 2 different self-injection investigational 
devices: bimekizumab-SS-1mL and bimekizumab-AI-1mL. In addition, DV0002 will assess 
trough PK levels associated with self-injection using the test device, injection by study personnel 
using the 1mL PFS, injection site (abdomen or thigh), and BMI category (by tertile). 
Has been changed to: 
It is expected that most individuals who will use commercial bimekizumab for the treatment of 
moderate to severe chronic plaque PSO will self-inject bimekizumab and also that these 
individuals will prefer to have options for the self-administration of their medication. DV0002 
will therefore evaluate the safe and effective use of 24 different self-injection investigational 
devices in 2 cohorts: the 1mL device cohort and the 2mL device cohort. The 1mL device 
cohort will evaluate the bimekizumab-SS-1mL and bimekizumab-AI-1mL. investigational 
devices. The 2mL device cohort will evaluate the bimekizumab-SS-2mL and bimekizumab-
AI-2mL investigational devices. In addition, DV0002 will assess trough PK levels associated 
with self-injection using the testinvestigational device, injection by study personnel using the 
1mL PFS, injection site (abdomen or thigh), and BMI category (by tertile). 
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Change #16 
Section 6.2 
Exclusion Criteria 
Subjects are not permitted to enroll in DV0002 if any of the PS0014 study exclusion criteria are 
met. 
Has been changed to:  
Subjects are not permitted to enroll in DV0002 if any of the PS0014 study exclusion criteria are 
met. Subjects who participated in the 1mL device cohort of DV0002 are not eligible to 
enroll in the 2mL device cohort. 
Change #17  
Section 7 Investigational Medicinal Product and Device Presentation 
In the DV0002 substudy, the term IMP refers to the bimekizumab drug product. The term 
investigational device refers to 2 different self-injection investigational devices 
(bimekizumab-SS-1mL and bimekizumab-AI-1mL) that are comprised of drug product (IMP) 
associated with a functional secondary packaging. 
Has been changed to:  
In the DV0006 substudy, the term IMP refers to the bimekizumab drug product. The term 
investigational device refers to 24 different self-injection investigational devices (bimekizumab-
SS-1mL and, bimekizumab-AI-1mL, bimekizumab-SS-2mL, and bimekizumab-AI-2mL) that 
are comprised of drug product (IMP) associated with a functional secondary packaging. 
Change #18  
New Section 7.1.3Bimekizumab-SS-2mL and Section 7.1.4 Bimekizumab-AI-2mL 
7.1.3 Bimekizumab-SS-2mL 
The bimekizumab-SS-2mL, shown in Figure 7-3, consists of the primary container (a glass 
syringe filled with 2mL of bimekuzmab drug product) and a safety syringe. 
The bimekizumab-SS-2mL is a single-use syringe with a passive safety feature. 
Figure 7-3: Bimekizumab-SS-2mL 
CCI
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7.1.3.1 
Instruction for use of bimekizumab-SS-2mL 
The bimekizumab-SS-2mL is used to administer a sc injection in either the right or left 
lateral abdominal wall or the right or left outer thigh without massage. Treatment of the 
injection site with an anesthetic cream prior to dosing is not permitted. 
During the study (at DV0002 Baseline and Week 8), 1 bimekizumab-SS-2mL device will be 
used to administer a 320mg injection of bimekizumab. To use the bimekizumab-SS-2mL, 
the rigid needle shield (RNS) is removed, and the plunger rod is fully depressed, which 
empties the syringe contents through the needle. When the plunger rod reaches its final 
position the needle safety retraction mechanism is activated, which retracts the sleeve, 
syringe, and plunger rod and holds the needle safely within the body molding.  
Additional instructions for device use, including the injection angle, are provided in the 
IFU. 
7.1.4 Bimekizumab-AI-2mL 
The bimekizumab-AI-2mL, shown in Figure 7-4, consists of the primary container (a glass 
syringe filled with 2mL of bimekizumab drug product) and an auto injector. The 
bimekizumab-AI-2mL is a single use auto injector with a passive needle stick safety 
mechanism. 
Figure 7-4: Bimekizumab-AI-2mL 
 
bimekizumab-AI-2mL=2mL bimekizumab auto-injector 
7.1.4.1 
Instruction for use of bimekizumab-AI-2mL 
The bimekizumab-AI-2mL is used to administer a sc injection in either the right or left 
lateral abdominal wall or the right or left outer thigh without massage. Treatment of the 
injection site with an anesthetic cream prior to dosing is not permitted. 
During the study (at DV0002 Baseline and Week 8), 1 bimekizumab-AI-2mL device will be 
used to administer a 320mg injection of bimekizumab. To use the bimekizumab-AI-2mL, 
the cap is removed, and the device is depressed on the injection site. The auto injector 
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provides needle insertion, dose delivery, and needle protection through an extending and 
locking shroud. Needle protection is performed by a shroud that will deploy should the 
auto-injector lose contact with the skin during an injection.  
Additional instructions for device use, including the injection angle, are provided in the 
IFU. 
Change #19  
Section 7.2 
Treatment to be administered 
The IMP used in this study is bimekizumab. Bimekizumab will be supplied at a concentration of 
160mg/mL (55mM sodium acetate, 220mM glycine, 0.04% polysorbate 80 at pH 5.0) for sc 
injection in the bimekizumab-SS-1mL or the bimekizumab-AI-1mL. 
The IMP will be administered according to the schedule shown in Table 5-1. Subjects will be 
assigned to the use of 1 device and will receive the following doses of IMP based on their 
established dosing regimen in PS0014: 
 320mg bimekizumab, Q8W or 
 320mg bimekizumab, Q4W. 
Regardless of the assigned dose regimen, subjects will perform self-injection with the assigned 
device only at Baseline and at Week 8. The 320mg bimekizumab dose will be administered as 
two 160mg injections with either 2 bimekizumab-SS-1mL or 2 bimekizumab-AI-1mL devices. 
At all visits except Baseline and Week 8, the 320mg bimekizumab dose will be administered as 
two 160mg injections in a 1mL PFS by study personnel (ie, the same administration manner and 
device used in PS0014).  
The investigational devices will be used as described in the IFU. Subjects will be observed onsite 
for 30 minutes after self-injection with bimekizumab for any AEs. Subjects will be asked to 
contact the designated site personnel in case any AEs occur outside of the site visits. Of note, 
reported AEs related to IMP will be assessed within PS0014 and reported ADEs and device 
deficiencies will be assessed within DV0002. 
Has been changed to: 
The IMP used in this study is bimekizumab. Bimekizumab will be supplied at a concentration of 
160mg/mL (55mM sodium acetate, 220mM glycine, 0.04% polysorbate 80 at pH 5.0) for sc 
injection in the bimekizumab-SS-1mL or the bimekizumab-AI-1mL. 
1mL Device Cohort 
For the 1mL device cohort, IMP will be slupplied in 2 investigational devices: 
bimekizumab-SS-1mL or the bimekizumab-AI-1mL. 
The IMP will be administered according to the schedule shown in Table 5-1. Subjects will be 
assigned to the use of 1 device and will receive the following doses of IMP based on their 
established dosing regimen in PS0014: 
 320mg bimekizumab, Q8W or 
 320mg bimekizumab, Q4W. 
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Regardless of the assigned dose regimen, subjects will perform self-injection with the assigned 
device only at Baseline and at Week 8. For the 1mL device cohort, the 320mg bimekizumab 
dose will be administered as two 160mg injections with either 2 bimekizumab-SS-1mL or 2 
bimekizumab-AI-1mL devices. At all visits except Baseline and Week 8, the 320mg 
bimekizumab dose will be administered as two 160mg injections in a 1mL PFS by study 
personnel (ie, the same administration manner and device used in PS0014).  
The investigational devices will be used as described in the IFU. Subjects will be observed onsite 
for 30 minutes after self-injection with bimekizumab for any AEs. Subjects will be asked to 
contact the designated site personnel in case any AEs occur outside of the site visits. Of note, 
reported AEs related to IMP will be assessed within PS0014 and reported ADEs and device 
deficiencies will be assessed within DV0002. 
2mL Device Cohort 
For the 2mL device Cohort, IMP will be supplied in 2 investigational devices: 
bimekizumab-SS-2mL or bimekizumab-AI-2mL. 
The IMP will be administered according to the schedule shown in Table 5-2. Subjects will 
be assigned to the use of 1 device and will receive the following doses of IMP based on their 
dosing regimen in PS0014: 
 320mg bimekizumab, Q8W or 
 320mg bimekizumab, Q4W. 
Regardless of the assigned dose regimen, subjects will perform self-injection with the 
assigned device only at DV0002 Baseline and 8 weeks after training with the investigational 
device. For the 2mL device cohort, 320mg bimekizumab dose will be administered as 1 
injection with either the bimekizumab-SS-2mL device or the bimekizumab-AI-2mL device. 
For subjects who receive bimekizumab Q4W, the bimekizumab dose at Week 4 will be 
administered as two 160mg injections in a 1mL PFS by study personnel (ie, the same 
administration manner used in PS0014).  
The devices will be used as described in the IFU. Subjects will be observed onsite for 
30 minutes after self-injection with bimekizumab for any AEs. Subjects will be asked to 
contact the designated site personnel in case any AEs occur outside of the site visits. Of 
note, reported AEs related to IMP will be assessed within PS0014 and reported ADEs and 
device deficiencies will be assessed within DV0002. 
Change #20 
Section 7.3 
Packaging 
The site will receive uniquely-numbered investigational devices (bimekizumab-SS-1mL and 
bimekizumab-AI-1mL) for use in the DV0002 substudy. 
Has been changed to: 
The site will receive uniquely-numbered investigational devices (bimekizumab-SS-1mL, and 
bimekizumab-AI-1mL, bimekizumab-SS-2mL, and bimekizumab-AI-2mL) for use in the 
DV0002 substudy. 
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Change #21  
Section 7.5 
Handling and storage requirements, paragraph 1 
The investigational device that houses the naked PFS including IMP must be securely stored at 
2ºC to 8ºC (ie, in a refrigerator), that is either in a locked room or in the pharmacy. Appropriate 
storage conditions must be ensured by controlling refrigerator temperature by using either an 
automated temperature monitoring and recording system or a minimum/maximum thermometer 
and completing a daily temperature log in accordance with local requirements. If an out-of-range 
temperature is noted, the Sponsor or designee must be notified so that a determination can be 
made whether the product should be used or not.  
Has been changed to: 
The investigational devices that houses the naked PFS including IMP must be securely stored at 
2ºC to 8ºC (ie, in a refrigerator), that is either in a locked room or in the pharmacy. Appropriate 
storage conditions must be ensured by controlling refrigerator temperature by using either an 
automated temperature monitoring and recording system or a minimum/maximum thermometer 
and completing a daily temperature log in accordance with local requirements. If an out-of-range 
temperature is noted, the Sponsor or designee must be notified so that a determination can be 
made whether the product should be used or not. 
Change #22  
Section 7.7 
Procedures for monitoring subject compliance 
During the Treatment Period of this study, IMP administration (either self-administration or 
study personnel-administration) will be performed in the clinic and observed by the Investigator 
or his/her designee; monitoring subject compliance is therefore not applicable. 
Has been changed to: 
During the Treatment Period of this study, IMP administration (either self-administration or 
study personnel-administration) will be performed in the clinic and observed by the Investigator 
or his/her designee; monitoring subject compliance is therefore not applicable. Subject 
compliance will be reported in the PS0014 study. 
Change #23  
Section 7.10 Randomization and numbering of subjects, paragraphs 2 and 3 
The IRT will generate individual assignments for the self-injection investigational devices. 
Eligible subjects will be assigned to the investigational devices based on a predetermined 
production randomization and/or packaging schedule provided by UCB (or designee). All 
eligible subjects will be randomly assigned to perform self-injection using either the 
bimekizumab-SS-1mL or the bimekizumab-AI-1mL at a 1:1 ratio. The IRT will allocate kit 
numbers to the subject based on the subject number during the study. 
Subject numbers and kit numbers will be tracked via the IRT. 
Has been changed to:  
The IRT will generate individual assignments for the self-injection investigational devices. 
Eligible subjects will be assigned to the investigational devices based on a predetermined 
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production randomization and/or packaging schedule provided by UCB (or designee). In the 
1mL device cohort, all eligible subjects will be randomly assigned to perform self-injection 
using either the bimekizumab-SS-1mL or the bimekizumab-AI-1mL at a 1:1 ratio. The IRT will 
allocate kit numbers to the subject based on the subject number during the study. 
Once the 1mL device cohort has finished enrolling, the 2mL device cohort will start 
enrolling. Eligible subjects in the 2mL cohort will be randomly assigned to perform 
self-injection using either the bimekizumab-SS-2mL or bimekizumab-AI-2mL device at a 
1:1 ratio. The IRT will allocate kit numbers to the subject based on the subject number 
during the study.  
Subject numbers and kit numbers will be tracked via the IRT. 
Change #24  
Section 8 Study Procedures by Visit, paragraph 1 
A general overview of the study assessments is provided in Table 5-2. Although Table 5-2 
contains assessments for both DV0002 and PS0014, it also indicates which assessments are 
specific to the DV0002 substudy. Of note, DV0002 and PS0014 will share a common 
database/eCRF system (including common AE reporting) and a common IRT. The list of 
procedures at each study visit is described in the following sections. 
Has been changed to: 
A general overview of the study assessments for the DV0002 substudy 1mL device cohort is 
provided in Table 5-2 Table 5-3. Although Table 5-2Table 5-3 contains assessments for both 
DV0002 and PS0014, it also indicates which assessments are specific to the DV0002 substudy. 
Of note, DV0002 and PS0014 will share a common database/eCRF system (including common 
AE reporting) and a common IRT. The lists of procedures at each study visit isfor the 1mL 
device cohort are described in Section 8.1the following sections. 
For subjects in the 2mL device cohort, Baseline for DV0002 can correspond to the PS0014 
Week 24, Week 28, or Week 32 visits for subjects receiving bimekizumab Q4W or to the 
PS0014 Week 14 or Week 32 visits for subjects receiving bimekizumab Q8W. For the 2mL 
device cohort, the schedule of assessments for PS0014 is presented in Table 5-4. The 
additional assessments to be performed for the DV0002 substudy specifically are presented 
in Table 5-5 and the list of procedures at each study visit is described in Section 8.2.  
Of note, DV0002 and PS0014 will share a common database/eCRF system (including 
common AE reporting) and a common IRT. 
Change #25  
Section 8.1 
Treatment Period 
8.1 Treatment Period 
The DV0002 substudy will include all PS0014 study assessments from Baseline to Week 16 
(inclusive). 
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Has been changed to: 
8.1 Treatment Period for the 1mL Device Cohort 
The DV0002 substudy will include all PS0014 study assessments from Baseline to Week 16 
(inclusive). For subjects in the 1mL device cohort, Baseline for DV0002 corresponds to 
Baseline in PS0014. 
Change #26  
Section 8.1.1 Visit 1 (Baseline), first bullet 
The following procedures/assessments will be performed: 
 Obtain written informed consent for DV0002 and PS0014 (may be obtained prior to Visit 1). 
Has been changed to: 
The following procedures/assessments will be performed: 
 Obtain written informed consent for DV0002 and PS0014 (may be obtained prior to Visit 1). 
Change #27  
New Section 8.2 Treatment Period for 2mL Device Presentation Cohort and new 
subsections 8.2.1 through 8.2.6 added as follows:  
8.2 Treatment Period for 2mL Device Cohort 
For the 2mL device cohort, DV0002 Visit 1 (Baseline) will occur at PS0014 Week 24, Week 
28, or Week 32 for subjects receiving bimekizumab Q4W or Week 24 or Week 32 for 
subjects receiving bimekizumab Q8W.  
8.2.1 Visit 1 (Baseline) 
For DV0002 Visit 1 (Baseline) study assessments, refer to Table 5-4 and perform the 
assessments for the week that the subject starts the DV0002 substudy (PS0014 Week 24, 
Week 28, or Week 32 for bimekizumab Q4W or Week 24 or Week 32 for bimekizumab 
Q8W). In addition to the PS0014 study assessments, the following assessments will be 
performed at the Baseline visit of DV0002 (Table 5-5): 
 Informed consent for DV0002.  
 Random assignment to device (DV0002-specific). 
 IRT contact. 
 Blood sample for bimekizumab plasma concentrations. 
 Subject training for VAS and SIAQ Questionnaire (version 2.0 for 
bimekizumab-SS-2mL and version 2.1 for bimekizumab-AI-2mL) (DV0002-specific). 
 Complete the pre-injection SIAQ Questionnaire (DV0002-specific). 
 Subject training for self-injection (DV0002-specific). 
 Subject self-injection of bimekizumab using the assigned device (DV0002-specific). 
 Study personnel evaluation of self-injection (DV0002-specific).  
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 Complete the VAS for injection site pain (DV0002-specific). 
 Complete the post-injection SIAQ Questionnaire (version 2.0 for bimekizumab-SS-2mL 
and version 2.1 for bimekizumab-AI-2mL) (DV0002-specific).  
 Study personnel evaluation of device for structural/mechanical integrity 
(DV0002-specific). 
 Drug and device accountability (DV0002-specific). 
8.2.2 Visit 2 (Baseline + 4 weeks) 
For PS0014 study assessments, refer to Table 5-4. In addition, perform the following 
DV0002 substudy assessments:  
 IRT contact. 
 Blood sample for bimekizumab plasma concentrations (DV0002-specific)—only done 
for subjects who receive bimekizumab Q4W. 
 Bimekizumab administration by study personnel using the PFS—only done for subjects 
who receive bimekizumab Q4W. 
 Drug and device accountability (DV0002-specific)—only done for subjects who receive 
bimekizumab Q4W. 
8.2.3 Visit 3 (Baseline + 8 weeks) 
For PS0014 study assessments, refer to Table 5-4. In addition, perform the following 
DV0002 substudy assessments:  
 IRT contact. 
 Blood sample for bimekizumab plasma concentrations (DV0002-specific). 
 Subject self-injection of bimekizumab using the assigned device (DV0002-specific). 
 Study personnel evaluation of self-injection (DV0002-specific).  
 Complete the VAS for injection site pain (DV0002-specific). 
 Complete the post-injection SIAQ Questionnaire (version 2.0 for bimekizumab-SS-2mL 
and version 2.1 for bimekizumab-AI-2mL) (DV0002-specific).  
 Study personnel evaluation of device for structural/mechanical integrity 
(DV0002-specific). 
 Drug and device accountability (DV0002-specific). 
8.2.4 Visit 3a (Baseline + 9 weeks; safety follow-up telephone call)  
Visit 3a (Week 9) will occur in the DV0002 substudy but not in the PS0014 study. The 
following procedures/assessments will be performed:   
 Concomitant medications. 
 Adverse events. 
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8.2.5 Visit 4 (Baseline + 12 weeks) 
For PS0014 study assessments, refer to Table 5-4. In addition, perform the following 
DV0002 substudy assessments:  
 IRT contact. 
 Blood sample for bimekizumab plasma concentrations (DV0002-specific)—only done 
for subjects who receive bimekizumab Q4W. 
 Bimekizumab administration by study personnel using the PFS—only done for subjects 
who receive bimekizumab Q4W. 
 Drug and device accountability (DV0002-specific). 
8.2.6 Visit 5 (Baseline + 16 weeks) 
For PS0014 study assessments, refer to Table 5-4. In addition, perform the following 
DV0002 substudy assessments:  
 IRT contact. 
 Blood sample for bimekizumab plasma concentrations (DV0002-specific)—only done 
for subjects who receive bimekizumab Q8W. 
 Bimekizumab administration by study personnel using the PFS. (If this visit coincides 
with Week 48 of PS0014, subjects will have the option to self-inject; refer to the PS0014 
protocol.) 
 Drug and device accountability (DV0002-specific). 
Change #28  
Section 9.1 
Assessment of self-injection experience by SIAQ, paragraph 2 and 3 
The SIAQ was developed by UCB to assess the perceived advantages and the potential 
limitations of self-injection of an sc medication (Keininger and Coteur, 2011). The pre-injection 
SIAQ is composed of 7 items grouped into 3 domains (feelings about injection, self-confidence, 
and satisfaction with the current mode of administration). The post-injection SIAQ is composed 
of 21 items grouped into 6 domains (feelings about injection, self-image, self-confidence, 
injection site reactions, ease of use, and satisfaction with self-injection). The pre-injection SIAQ 
will be completed at Visit 1, and the post-injection SIAQ will be completed within 30 minutes 
after each self-injection (ie, at Visit 1 and Visit 3).  
Version 2.0 and version 2.1 of the SIAQ are identical, except for Question 11. In version 2.0 of 
the SIAQ, Question 11 discusses the use of a plunger, while in version 2.1 of the SIAQ, Question 
11 discusses depression of the device. Version 2.0 will therefore be used to assess 
bimekizumab-SS-1mL, while version 2.1 will be used to assess bimekizumab-AI-1mL. 
Has been changed to: 
The SIAQ was developed by UCB to assess the perceived advantages and the potential 
limitations of self-injection of an sc medication (Keininger and Coteur, 2011). The pre-injection 
SIAQ is composed of 7 items grouped into 3 domains (feelings about injection, self-confidence, 
and satisfaction with the current mode of administration). The post-injection SIAQ is composed 
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of 21 items grouped into 6 domains (feelings about injection, self-image, self-confidence, 
injection site reactions, ease of use, and satisfaction with self-injection). The pre-injection SIAQ 
will be completed at Visit 1, and the post-injection SIAQ will be completed within 30 minutes 
after each self-injection (ie, at Visit 1 and Visit 3). For the 1mL device cohort, the SIAQ will 
be completed within 30 minutes of completing the second injection. For the 2mL device 
cohort, the SIAQ will be completed within 30 minutes of completing the single injection. 
Version 2.0 and version 2.1 of the SIAQ are identical, except for Question 11. In version 2.0 of 
the SIAQ, Question 11 discusses the use of a plunger, while in version 2.1 of the SIAQ, Question 
11 discusses depression of the device. Version 2.0 will therefore be used to assess 
bimekizumab-SS-1mL and bimekizumab-SS-2mL, while version 2.1 will be used to assess 
bimekizumab-AI-1mL and bimekizumab-AI-2mL. 
Change #29  
Section 9.2 
Assessment of injection site pain 
A VAS will be used to assess overall injection pain due to self-injection at Baseline and at 
Week 8. Subjects will be required to indicate their injection pain by placing a mark on a 100mm 
line from 0 (no pain) to 100 (worst possible pain). In the DV0002 substudy, the 320mg 
bimekizumab dose will be administered as two 160mg sc injections with either 
2 bimekizumab-SS-1mL or 2 bimekizumab-AI-1mL devices. To evaluate injection pain for both 
self-injections, the VAS will be assessed immediately (within 15 minutes) after completion of 
the second self-injection. The subject will complete the VAS prior to completion of the 
post-injection SIAQ (refer to Section 9.1 for details). 
Has been changed to: 
A VAS will be used to assess overall injection pain due to self-injection at DV0002 Baseline and 
at Week 8 weeks after training. Subjects will be required to indicate their injection pain by 
placing a mark on a 100mm line from 0 (no pain) to 100 (worst possible pain). 
1mL Device Cohort 
In the 1mL device cohort of the DV0002 substudy, the 320mg bimekizumab dose will be 
administered as two 160mg sc injections with either 2 bimekizumab-SS-1mL or 2 bimekizumab-
AI-1mL devices. To evaluate injection pain for both self-injections, the VAS will be assessed 
immediately (within 15 minutes) after completion of the second self-injection. The subject will 
complete the VAS prior to completion of the post injection SIAQ (refer to Section 9.1 for 
details). 
2mL Device Cohort 
In the 2mL device cohort, the 320mg bimekizumab dose will be administered as 1 sc 
injection with either the bimekizumab-SS-2mL or bimekizumab-AI-2mL device. To 
evaluate injection pain for the self-injection, the VAS will be assessed immediately (within 
15 minutes) after completion of the self-injection. The subject will complete the VAS prior 
to completion of the post-injection SIAQ (refer to Section 9.1 for details). 
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Change #30  
Section 9.3 Evaluation of post-use structural and mechanical integrity of self-injection 
device presentations 
The visual inspection of the used bimekizumab-SS-1mL and bimekizumab-AI-1mL devices will 
check for structural/mechanical integrity and damage (ie, clear evidence of 
damage/compromised structural integrity and not any superficial, cosmetic imperfections). All 
evaluations will be performed by appropriately trained site staff. Any device with 
structural/mechanical integrity issues will be returned to UCB for further evaluation. Superficial, 
cosmetic imperfections which have no impact on structural or mechanical integrity are to be 
ignored. 
Has been changed to: 
The visual inspection of the used bimekizumab-SS-1mL and bimekizumab-AI-1mL devices will 
check for structural/mechanical integrity and damage (ie, clear evidence of 
damage/compromised structural integrity and not any superficial, cosmetic imperfections). All 
evaluations will be performed by appropriately trained site staff. Any device with 
structural/mechanical integrity issues will be returned to UCB for further evaluation. Superficial, 
cosmetic imperfections which have no impact on structural or mechanical integrity are to be 
ignored. 
Used devices that functioned as intended and which had no post-use structural or 
mechanical integrity issues (as determined by the post-use site evaluation) will also be 
returned to UCB for further evaluation. 
Change #31  
Section 10 
Assessment of Pharmacokinetic Variables 
Blood samples for measurement of trough bimekizumab PK (Section 4.1.3) will be collected at 
the time points specified in the schedule of study assessments (Table 5-2). 
At dosing visits, blood samples will be drawn prior to dosing (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. 
Has been changed to: 
1mL Device Cohort 
Blood samples for measurement of trough bimekizumab PK (Section 4.1.3.2) will be collected at 
the time points specified in the schedule of study assessments (Table 5-23). 
At dosing visits, blood samples will be drawn prior to dosing (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. 
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2mL Device Cohort 
For subjects who participate in the 2mL device cohort, blood samples for measurement of 
trough bimekizumab PK levels (Section 4.1.3.2) will be collected at the timepoints specified 
in Table 10-1. 
Table 10-1: DV0002 substudy 2mL device cohort PK sample collection time 
points 
 
 
DV0002 Visits 
Dose 
Regimen 
PS0014 Week 
that subject starts 
DV0002 
Visit 1 
(Baseline)/ 
Week 0 
Visit 2/ 
Week 4 
Visit 3/ 
Week 8 
Visit 4/ 
Week 12 
Visit 5/ 
Week 16 
320mg Q4W 
Week 24 
Xa 
X 
X 
X 
Xa 
Week 28 
X 
X 
X 
Xa 
NA 
Week 32 
X 
X 
Xa 
X 
Xa 
320mg Q8W 
Week 24 
Xa 
NA 
X 
NA 
Xa 
Week 32 
X 
NA 
Xa 
NA 
Xa 
NA=not applicable; PK=pharmacokinetics; Q4W=every 4 weeks; Q8W=every 8 weeks 
Note: For the 2mL device cohort, the DV0002 Baseline visit will be PS0014 Week 24, Week 28, or Week 32 
for subjects receiving bimekizumab 320mg Q4W or PS0014 Week 24 or Week 32 for subjects receiving 
bimekizumab 320mg Q8W. 
a PK sample taken per the PS0014 schedule. 
 
At dosing visits, blood samples will be drawn prior to dosing (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. 
Change #32  
Section 11.1 Adverse events (investigational device) 
All AEs (including serious adverse events [SAEs]) will be reported in a common database for 
PS0014 and DV0002, but only ADEs, SADEs, and device deficiencies will be summarized in the 
DV0002 substudy. Specifically, only those AEs related to the use of the investigational medical 
devices bimekizumab-SS-1mL or bimekizumab-AI-1mL (based on the Investigator’s judgement) 
will be assessed. All AEs (including SAEs) which are not assessed to be related to the 
investigational devices will be summarized separately in the report for the main study, PS0014; 
please refer to the PS0014 protocol for information on reporting and recording AEs (including 
SAEs). 
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Has been changed to:  
All AEs (including serious adverse events [SAEs]) will be reported in a common database for 
PS0014 and DV0002, but only ADEs, SADEs, and device deficiencies will be summarized in the 
DV0002 substudy. Specifically, only those AEs related to the use of the investigational medical 
devices bimekizumab-SS-1mL or bimekizumab-AI-1mL (based on the Investigator’s judgement) 
will be assessed. All AEs (including SAEs) which are not assessed to be related to the 
investigational devices will be summarized separately in the report for the main study, PS0014; 
please refer to the PS0014 protocol for information on reporting and recording AEs (including 
SAEs). 
Change #33  
Section 13.3.1  
Case Report form completion, paragraph 1 
This study is performed using remote data capture. The Investigator is responsible for prompt 
reporting of accurate, complete, and legible data in the eCRFs and in all required reports.  
Has been changed to:  
This study is performed using remote data capture; the same data capture is used for PS0014 
and DV0002. The Investigator is responsible for prompt reporting of accurate, complete, and 
legible data in the eCRFs and in all required reports.  
Change #34  
Section 14 
Statistics 
A description of statistical methods follows and will be described in more detail in the Statistical 
Analysis Plan (SAP). 
Has been changed to: 
A description of statistical methods follows and will be described in more detail in the Statistical 
Analysis Plan (SAP). 
Once subjects in the 1mL device cohort complete DV0002, a final analysis for that cohort 
will be performed, and a clinical study report will be prepared. A separate final analysis 
will be performed for the 2mL device cohort. 
Change #35  
Section 14.1 Definition of analysis sets 
Two different Safety Sets (SS) will be generated (1 for each device type): the 
bimekizumab-SS-1mL Safety Set (SS-s) and the bimekizumab-AI-1mL Safety Set (SS-a). Each 
SS will consist of all subjects in the study who receive at least 1 dose of bimekizumab by the 
indicated self-injection investigational device. Safety variables will be analyzed using the SS-s 
and SS-a. 
Two different Full Analysis Sets (FASs) will be generated (1 for each device type): the 
bimekizumab-SS-1mL Full Analysis Set (FAS-s) and the bimekizumab-AI-1mL Full Analysis 
Set (FAS-a). Each FAS will consist of all subjects in the SS-s or SS-a who self-inject at least 
1 dose of bimekizumab using the given device and who have an assessment of self-injection. All 
self-injection related endpoints will be analyzed using the FAS-s and FAS-a. 
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Two different Pharmacokinetic Sets (PKS) will be generated (1 for each device type): the 
bimekizumab-SS-1mL PKS (PKS-s) and the bimekizumab-AI-1mL PKS (PKS-a). Each PKS 
will consist of all subjects who receive the same bimekizumab administration (frequency and 
dose) in the PS0014 feeder studies as in the DV0002 substudy and who have at least 1 evaluable 
PK assessment in the DV0002 substudy. Pharmacokinetic variables will be analyzed using the 
PKS-s and PKS-a. 
Has been changed to: 
1mL Device Cohort 
For the 1mL device cohort, 2 Two different Safety Sets (SS) will be generated (1 for each 
device type): the bimekizumab-SS-1mL Safety Set (SS-s) and the bimekizumab-AI-1mL Safety 
Set (SS-a). Each SS will consist of all subjects in the study who receive at least 1 dose of 
bimekizumab by the indicated self-injection investigational device. Safety variables will be 
analyzed using the SS-s and SS-a. 
Two different Full Analysis Sets (FASs) will be generated (1 for each device type): the 
bimekizumab-SS-1mL Full Analysis Set (FAS-s) and the bimekizumab-AI-1mL Full Analysis 
Set (FAS-a). Each FAS will consist of all subjects in the SS-s or SS-a who self-inject at least 
1 dose of bimekizumab using the given device and who have an assessment of self-injection. All 
self-injection related endpoints will be analyzed using the FAS-s and FAS-a. 
TwoFor the PK analyses, 2 different Pharmacokinetic Per Protocol Sets (PKSPK-PPS) will be 
generated (1 for each device type): the bimekizumab-SS-1mL PKS (PKSPK-PPS (PK-PPS-s) 
and the bimekizumab-AI-1mL PKS (PKS PK-PPS (PK-PPS-a). Each PKSPK-PPS will consist 
of all subjects who receive the same bimekizumab administration (frequency and dose) in the 
PS0014 feeder studies as in the DV0002 substudy and who have at least 1 evaluable PK 
assessment in the DV0002 substudy without important protocol deviations that would affect 
the concentration. Pharmacokinetic variables will be analyzed using the PKS PK-PPS-s and 
PKSPK-PPS-a. 
All PK assessments after baseline assessments from feeder study will be considered for the 
requirement of at least 1 evaluable PK assessment.  
2mL Device Cohort  
For the 2mL device cohort, the same analysis sets will be generated. 
Change #36  
Section 14.3 Planned analyses of outcome variables 
All statistical analyses will be descriptive in nature. No inferential statistical analyses are 
planned.  
Has been changed to: 
All statistical analyses will be descriptive in nature. No inferential statistical analyses are 
planned.  
All analyses will be performed separately for the 1mL device cohort and for the 2mL 
device cohort. Once subjects in the 1mL device cohort complete DV0002, a final analysis 
will be performed for that cohort, and a clinical study report will be prepared. A separate 
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final analysis will be performed for the 2mL device cohort once all data have been collected 
and will be reported separately from the initial clinical study report. 
Change #37 
Section 14.3.1  
Analysis of the primary outcome variable, paragraph 1 
The primary outcome variable is the percentage of all subjects able to self-administer safe and 
effective injections using the given device presentation at Week 8. Safe and effective self-
injection will be evaluated by the study personnel as defined in in Section 4.1.1. 
Has been changed to: 
The primary outcome variable is the percentage of all subjects able to self-administer safe and 
effective injections using the given device presentation at DV0002 Week 8 (8 weeks after 
training). Safe and effective self-injection will be evaluated by the study personnel as defined in 
in Section 4.1.1. 
Change #38 
Section 14.4 Planned pharmacokinetic analyses 
The statistical analyses of the PK data will be descriptive in nature and will be summarized using 
the relevant device-specific population (PKS-s or PKS-a). Data will be analyzed overall for each 
device by injection type (self-administered or study personnel-administered), by injection site 
(abdomen or thigh), and by BMI category. Three BMI categories will be defined based on 
tertiles derived from subjects’ Baseline BMI values. 
To allow for an analysis of PK trough levels for bimekizumab administration via self-injection or 
via study personnel administration, pre-dose PK samples will be taken throughout the DV0002 
substudy. For the Q4W dose regimen, PK trough levels will be determined based on pre-dose PK 
sampling at Baseline and Week 8 for the study personnel administration and at Week 4 and 
Week 12 for the self-administration trough levels, respectively. For the Q8W dose regimen, PK 
trough levels will be determined based on pre-dose PK sampling at Baseline for the study 
personnel administration and at Week 8 and Week 16 for the self-administration trough levels, 
respectively. For the analysis of PK trough levels by injection site (abdomen or thigh) and by 
BMI category (by tertile), only self-administration PK trough levels will be used. 
Has been changed to: 
The statistical analyses of the PK data will be descriptive in nature and will be summarized using 
the relevant device-specific population (PKSPK-PPS-s or PKSPK-PPS-a). Data will be 
analyzed overall for each device by injection type (self-administered or study 
personnel-administered), by injection site (abdomen or thigh), and by BMI category. Three BMI 
categories will be defined based on tertiles derived from subjects’ Baseline BMI values within 
the device-specific population (PK-PPS-s or PK-PPS-a). 
To allow for an analysis of PK trough levels for bimekizumab administration via self-injection or 
via study personnel administration, pre-dose PK samples will be taken throughout the DV0002 
substudy. For the Q4W dose regimen, PK trough levels will be determined based on pre-dose PK 
sampling at DV0002 Baseline and Week 8 for the study personnel administration and at DV0002 
Week 4 and Week 12 for the self-administration trough levels, respectively. For the Q8W dose 
regimen, PK trough levels will be determined based on pre-dose PK sampling at DV0002 
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Baseline for the study personnel administration and at 8 weeks after training (DV0002 Week 8) 
and DV0002 Week 16 for the self-administration trough levels, respectively. For the analysis of 
PK trough levels by injection site (abdomen or thigh) and by BMI category (by tertile), only 
self-administration PK trough levels will be used. 
Change #39 
Section 14.9 Planned interim analysis and data monitoring 
The final DV0002 substudy analysis and clinical study report will be prepared once all data have 
been collected. No Data Monitoring Committee will be established for this study. 
Has been changed to:  
The final DV0002 substudy No interim analysis and clinical is planned for the DV0002 study 
report will be prepared once all data have been collected. No Data Monitoring Committee will be 
established for this study. 
The subjects of DV0002 are ongoing subjects of PS0014. Data cut off for the 1mL final 
analysis will be last subject last Week 16 visit in DV0002 in the 1mL device cohort. Data cut 
off for the 2mL final analysis will be last subject last Week 16 visit in DV0002 in the 2mL 
device cohort. Data cut off rules will be applied for ongoing ADEs and ongoing 
concomitant medication. 
Change #40 
Section 14.10 Determination of sample size 
This study will not be powered with respect to any endpoint and sample size is based on practical 
considerations. In order to maintain blinding in the PS0014 feeder studies, DV0002 will recruit 
subjects who were administered bimekizumab 320mg (Q4W or Q8W) and subjects who were 
administered placebo or ustekinumab in the PS0014 feeder studies. A total of 100 subjects 
(50 subjects per device arm) are planned for PK trough level analyses, but these analyses can 
only be performed on subjects who do not change their bimekizumab dose or dosing regimen 
(ie, 320mg bimekizumab Q4W or Q8W) between the PS0014 feeder studies and in the DV0002 
substudy. The DV0002 substudy will therefore enroll approximately 200 subjects (to compensate 
for subjects with bimekizumab dose changes) to ensure that 100 subjects are available for PK 
trough analysis. 
Subjects who enroll in the DV0002 substudy will be randomly assigned to the 
bimekizumab-SS-1mL or the bimekizumab-AI-1mL device arms (each device arm will consist 
of approximately 100 subjects). Within each device arm, subjects will be divided into tertiles by 
BMI; there will be approximately 33 subjects per tertile, which is expected to yield 
approximately 16 to 17 subjects per tertile who are evaluable for steady state trough PK level 
analyses. 
Has been changed to: 
This study will not be powered with respect to any endpoint and sample size is based on practical 
considerations.  
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1mL Device Cohort  
For the 1mL device cohort, In order to maintain blinding in the PS0014 feeder studies, DV0002 
will recruit subjects who were administered bimekizumab 320mg (Q4W or Q8W) and subjects 
who were administered placebo or ustekinumab in the PS0014 feeder studies. A total of 100 
subjects (50 subjects per device arm) are planned for PK trough level analyses, but these 
analyses can only be performed on subjects who do not change their bimekizumab dose or 
dosing regimen (ie, 320mg bimekizumab Q4W or Q8W) between the PS0014 feeder studies and 
in the DV0002 substudy. The DV0002 substudy will therefore enroll approximately 200 subjects 
(to compensate for subjects with bimekizumab dose changes) to ensure that 100 subjects are 
available for PK trough analysis.  
Subjects who enroll in the DV0002 substudy 1mL device cohort will be randomly assigned to 
the bimekizumab-SS-1mL or the bimekizumab-AI-1mL device arms (each device arm will 
consist of approximately 100 subjects). Within each device arm, subjects will be divided into 
tertiles by BMI; there will be approximately 33 subjects per tertile, which is expected to yield 
approximately 16 to 17 subjects per tertile who are evaluable for steady state trough PK level 
analyses. 
2mL Device Cohort  
Once the 1mL device cohort has finished enrolling, the 2mL device cohort will start 
enrolling. Subjects who participated in the 1mL device cohort of DV0002 are not eligible to 
enroll in the 2mL device cohort. For evaluation of the 2mL device, it is planned to enroll 
approximately 100 subjects. All 100 subjects will have been on a consistent bimekizumab 
dose regimen for at least 16 weeks, and thus all will be evaluable for the PK trough level 
analyses. 
Subjects who enroll in the DV0002 substudy 2mL device cohort will be randomly assigned 
to the bimekizumab-SS-2mL or the bimekizumab-AI-2mL device arms (each device arm 
will consist of approximately 50 subjects). Within each device arm, subjects will be divided 
into tertiles by BMI; there will be approximately 16 to 17 subjects per tertile who are 
evaluable for steady state trough PK level analyses. 
 
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19 
DECLARATION AND SIGNATURE OF INVESTIGATOR 
I confirm that I have carefully read and understood this protocol and agree to conduct this 
clinical study as outlined in this protocol, according to current Good Clinical Practice and local 
laws and requirements. 
I will ensure that all subinvestigators and other staff members read and understand all aspects of 
this protocol. 
I have received and read all study-related information provided to me. 
The objectives and content of this protocol as well as the results deriving from it will be treated 
confidentially and will not be made available to third parties without prior authorization by UCB. 
All rights of publication of the results reside with UCB, unless other agreements were made in a 
separate contract. 
Investigator: 
 
 
  
Printed name 
 Date/Signature 
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20 
SPONSOR DECLARATION 
I confirm that I have carefully read and understand this protocol and agree to conduct this 
clinical study as outlined in this protocol and according to current Good Clinical Practice. 
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Approval Signatures
Name:
dv0002-protocol-amendment-1
Version:
1. 0
Document Number:
CLIN-000142795
Title:
DV0002-Protocol Amendment 1
Approved Date:
31 Oct 2019
Document Approvals
Approval
Verdict: Approved
Name: 
Capacity: Medical
Date of Signature: 30-Oct-2019 20:36:26 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 30-Oct-2019 21:31:24 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 31-Oct-2019 00:07:44 GMT+0000
PPD
PPD
PPD
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SAP_001.pdf: 
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Statistical Analysis Plan 
Bimekizumab 
DV0002 
Confidential 
Page 1 of 58 
STATISTICAL ANALYSIS PLAN 
AMENDMENT 3 
Study: DV0002  
Product: Bimekizumab 
NORTH AMERICAN SUBSTUDY TO PS0014 
A MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE SAFE 
AND EFFECTIVE USE OF THE PREFILLED SAFETY SYRINGES OR THE AUTO-
INJECTOR FOR THE SUBCUTANEOUS SELF-INJECTION OF BIMEKIZUMAB 
SOLUTION BY SUBJECTS WITH MODERATE TO SEVERE CRONIC PLAQUE 
PSORIASIS 
SAP 
Date 
Final SAP 
01 Feb 19 
SAP Amendment 1 03 Dec 19 
SAP Amendment 2 16 Jul 20 
SAP Amendment 3 07 Oct 20 
   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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Statistical Analysis Plan 
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TABLE OF CONTENTS 
LIST OF ABBREVIATIONS .................................................................................................... 5 
1 
INTRODUCTION ............................................................................................................. 8 
2 
PROTOCOL SUMMARY ................................................................................................. 8 
2.1 
Study objectives ............................................................................................................. 8 
2.1.1 
Primary objective ................................................................................................... 8 
2.1.2 
Secondary objective ............................................................................................... 8 
2.1.3 
Other objectives ..................................................................................................... 8 
2.2 
Study variables ............................................................................................................... 8 
2.2.1 
Primary outcome variable ...................................................................................... 8 
2.2.2 
Secondary outcome variable .................................................................................. 9 
2.2.3 
Other variables ....................................................................................................... 9 
2.2.3.1 
Outcome variables ....................................................................................... 9 
2.2.3.2 
Pharmacokinetic variable .......................................................................... 10 
2.2.3.3 
Safety variable ........................................................................................... 10 
2.3 
Study design and conduct ............................................................................................ 10 
2.3.1 
Study description ................................................................................................. 10 
2.3.2 
Treatment Period ................................................................................................. 11 
2.3.3 
Safety Follow-Up ................................................................................................. 11 
2.3.4 
Withdrawal .......................................................................................................... 11 
2.3.5 
Study duration per subject ................................................................................... 11 
2.3.6 
Planned number of subjects ................................................................................. 12 
2.4 
Determination of sample size ....................................................................................... 12 
3 
DATA ANALYSIS CONSIDERATIONS ...................................................................... 13 
3.1 
General presentation of summaries and analyses ........................................................ 13 
3.2 
Analysis Time Points ................................................................................................... 14 
3.3 
Definition of Baseline values ....................................................................................... 14 
3.4 
Relative Day................................................................................................................. 14 
3.5 
Protocol deviations....................................................................................................... 14 
3.6 
Analysis sets................................................................................................................. 15 
3.6.1 
1mL Device Cohort ............................................................................................. 15 
3.6.1.1 
Enrolled Set ............................................................................................... 15 
3.6.1.2 
Safety Set ................................................................................................... 15 
3.6.1.3 
Full Analysis Set ....................................................................................... 15 
3.6.1.4 
Pharmacokinetic Per Protocol Set ............................................................. 15 
3.6.2 
2mL Device Cohort ............................................................................................. 15 
3.6.2.1 
Enrolled Set ............................................................................................... 15 
3.6.2.2 
Safety Set ................................................................................................... 15 
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3.6.2.3 
Full Analysis Set ....................................................................................... 15 
3.6.2.4 
Pharmacokinetic Per Protocol Set ............................................................. 16 
3.7 
Treatment assignment, treatment and device groups ................................................... 16 
3.8 
Center pooling strategy ................................................................................................ 17 
3.9 
Coding dictionaries ...................................................................................................... 17 
3.10 
Changes to protocol-defined analyses ......................................................................... 17 
3.10.1 
Changes related to COVID-19 ............................................................................. 17 
4 
STATISTICAL/ANALYTICAL ISSUES ....................................................................... 17 
4.1 
Adjustments for covariates .......................................................................................... 17 
4.2 
Handling of dropouts or missing data .......................................................................... 17 
4.3 
Interim analyses and data monitoring .......................................................................... 18 
4.4 
Multicenter studies ....................................................................................................... 19 
4.5 
Multiple comparisons/multiplicity ............................................................................... 19 
4.6 
Use of an efficacy subset of subjects ........................................................................... 19 
4.7 
Active-control studies intended to show equivalence .................................................. 19 
4.8 
Examination of subgroups ........................................................................................... 19 
5 
STUDY POPULATION CHARACTERISTICS ............................................................. 19 
5.1 
Subject disposition ....................................................................................................... 19 
5.2 
Protocol deviations....................................................................................................... 20 
5.3 
COVID-19 Impact ....................................................................................................... 20 
6 
DEMOGRAPHICS AND OTHER BASELINE CHARACTERISTICS ........................ 20 
6.1 
Demographics .............................................................................................................. 20 
6.2 
Other Baseline characteristics ...................................................................................... 21 
6.3 
Medical history and concomitant diseases ................................................................... 22 
6.4 
Prior and concomitant medications .............................................................................. 22 
7 
MEASUREMENTS OF TREATMENT COMPLIANCE ............................................... 22 
8 
EFFICACY ANALYSES ................................................................................................ 22 
9 
PHARMACOKINETICS AND PHARMACODYNAMICS .......................................... 22 
9.1 
Pharmacokinetics ......................................................................................................... 22 
9.2 
Pharmacodynamics ...................................................................................................... 23 
10 SAFETY ANALYSES ..................................................................................................... 23 
10.1 
Extent of exposure ....................................................................................................... 23 
10.2 
Adverse events ............................................................................................................. 23 
10.2.1 
Adverse device effects ......................................................................................... 24 
10.2.2 
Injection site reaction ........................................................................................... 24 
10.3 
Clinical laboratory evaluations .................................................................................... 25 
10.4 
Vital signs, physical findings, and other observations related to safety ...................... 25 
11 OTHER ANALYSES ...................................................................................................... 25 
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Statistical Analysis Plan 
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11.1 
Primary outcome .......................................................................................................... 25 
11.2 
Secondary outcome ...................................................................................................... 26 
11.3 
Other outcomes ............................................................................................................ 26 
11.3.1 
Pre-injection SIAQ (versions 2.0 and 2.1) ........................................................... 26 
11.3.2 
Post-injection SIAQ (versions 2.0 and 2.1) ......................................................... 26 
11.3.3 
Injection site pain ................................................................................................. 27 
11.3.4 
Structural and mechanical integrity of the devices .............................................. 27 
12 REFERENCES ................................................................................................................ 28 
13 APPENDICES ................................................................................................................. 29 
13.1 
SAP Amendment 1 ...................................................................................................... 29 
13.2 
SAP Amendment 2 ...................................................................................................... 50 
13.3 
SAP Amendment 3 ...................................................................................................... 54 
STATISTICAL ANALYSIS PLAN SIGNATURE PAGE ..................................................... 58 
 
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Statistical Analysis Plan 
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LIST OF ABBREVIATIONS 
 
ADE 
adverse device effect 
AE 
adverse event 
bimekizumab-AI-1mL 
1mL bimekizumab auto-injector 
bimekizumab-AI-2mL 
2mL bimekizumab auto-injector 
bimekizumab-SS-1mL 
1mL bimekizumab safety syringe 
bimekizumab-SS-2mL 
2mL bimekizumab safety syringe 
BKZ 
bimekizumab 
BMI 
body mass index 
COVID-19 
Coronavirus Disease 2019 
ES 
Enrolled Set 
FAS 
Full Analysis Set 
FAS-a 
Full Analysis Set for the bimekizumab-AI-1mL 
Full Analysis Set for the bimekizumab AI 2mL 
FAS-s 
Full Analysis Set for the bimekizumab-SS-1mL 
Full Analysis Set for the bimekizumab SS 2mL 
HLT 
higher level term 
IFU 
instructions for use 
IMP 
investigational medicinal product 
LLOQ 
lower level of quantification 
MedDRA 
Medical Dictionary for Regulatory Activities 
PFS 
prefilled syringe 
PK 
pharmacokinetic(s) 
PK-PPS 
Pharmacokinetic Per Protocol Set 
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Statistical Analysis Plan 
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PK-PPS-a 
Pharmacokinetic Per Protocol Set for the bimekizumab-AI-
1mL 
Pharmacokinetic Per Protocol Set for the bimekizumab-AI-
2mL 
PK-PPS-s 
Pharmacokinetic Per Protocol Set for the bimekizumab-SS-
1mL 
Pharmacokinetic Per Protocol Set for the bimekizumab-SS-
2mL 
PEOT 
Premature End of Treatment  
PSO 
psoriasis 
PT  
preferred term 
Q4W  
every 4 weeks 
Q8W  
every 8 weeks 
SADE 
serious adverse device effect 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
sc 
subcutaneously 
SIAQ 
Self-Injection Assessment Questionnaire 
SD 
standard deviation 
SFU 
Safety Follow-Up 
SOC 
System Organ Class 
SS 
Safety Set 
SS-a 
Safety Set for the bimekizumab-AI-1mL 
Safety Set for the bimekizumab AI 2mL 
SS-s 
Safety Set for the bimekizumab-SS-1mL 
Safety Set for the bimekizumab SS 2mL 
TEADE 
treatment-emergent adverse device effect 
TEAE 
treatment-emergent adverse event 
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Statistical Analysis Plan 
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VAS 
visual analog scale 
WHO 
World Health Organization 
 
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Statistical Analysis Plan 
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1 
INTRODUCTION 
This statistical analysis plan (SAP) defines the scope of the statistical analyses and provides a 
detailed description of the statistical methodology for subject data obtained in this substudy of 
PS0014. The SAP is based on the following study document:  
• Final Protocol DV0002, 26 Jul 2018.  
• Protocol amendment 1, 28 Oct 2019. 
All references to study protocol hereafter refer to this version of the protocol. 
All analyses will be performed separately for the 1mL device cohort and for the 2mL device 
cohort. Once subjects in the 1mL device cohort complete DV0002, a final analysis will be 
performed for that cohort, and a clinical study report will be prepared. A separate final analysis 
will be performed for the 2mL device cohort once all data have been collected and will be 
reported separately from the initial clinical study report. 
2 
PROTOCOL SUMMARY 
2.1 
Study objectives 
2.1.1 
Primary objective 
The primary objective of the study is to evaluate for each device the ability of subjects with 
moderate to severe chronic plaque psoriasis (PSO) to safely and effectively self-inject 
bimekizumab 8 weeks after training in the self-injection technique.  
2.1.2 
Secondary objective 
The secondary objective of the study is to evaluate, for each device, the ability of subjects with 
moderate to severe chronic plaque PSO to safely and effectively self-inject bimekizumab 
immediately after training in the self-injection technique. 
2.1.3 
Other objectives 
Other objectives of the study are to evaluate the following: 
• Subject experience of self-injection using the investigational devices as assessed by the pain 
visual analog scale (VAS) and the Self-injection Assessment Questionnaire (SIAQ). 
• Trough pharmacokinetic (PK) (trough bimekizumab) levels associated with self-injection 
using the investigational devices, injection by study personnel, injection site (abdomen or 
thigh), and body mass index (BMI) category (by tertile). 
• The structural and mechanical integrity of the investigational devices after completion of 
self-injection. 
• The overall safety and tolerability of self-injections using the investigational devices. 
2.2 
Study variables 
2.2.1 
Primary outcome variable 
The primary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the 1mL bimekizumab safety syringe (bimekizumab-SS-1mL), 1mL 
bimekizumab auto-injector (bimekizumab-AI-1mL), 2mL bimekizumab safety syringe 
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Statistical Analysis Plan 
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(bimekizumab SS 2mL), or 2mL bimekizumab auto-injector (bimekizumab-AI-2mL), 8 weeks 
after training in self-injection technique. Safe and effective self-injection will be evaluated by the 
study personnel and is 
defined as: 
• Complete dose delivery: Subject self-injects the complete dose of bimekizumab as confirmed 
by a visual inspection of the device which shows that the investigational medicinal product 
(IMP) is delivered completely (ie, container is empty), and 
• No adverse device effects (ADEs) that would preclude continued use of the device for self-
injection (ie, no serious adverse device effects (SADEs) and/or ADEs leading to withdrawal 
from the DV0002 substudy).  
In the DV0002 substudy, for the 1mL devices the 320mg bimekizumab dose will be 
administered as two 160mg injections with either 2 bimekizumab-SS-1mL devices or 2 
bimekizumab-AI-1mL devices. Each self-injection will be evaluated for safety and effectiveness 
by study personnel using the above criteria. The endpoint of safe and effective self-injection will 
be met only if both self-injections are determined to be safe and effective. 
For the 2ml devices, the 320mg bimekizumab dose will be administered as 1 injection with either 
1 bimekizumab-SS-2mL or 1 bimekizumab-AI-2mL device. Each self-injection will be evaluated 
for safety and effectiveness by study personnel using the above criteria. The endpoint of safe and 
effective self-injection will be met if the single self-injection is determined to be safe and 
effective. 
2.2.2 
Secondary outcome variable 
The secondary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the bimekizumab-SS-1mL, bimekizumab-AI-1mL bimekizumab SS 
2mL, or 1 bimekizumab-AI-2mL at DV0002 Baseline (the first self-injection visit, immediately 
after training in self-injection technique). Safe and effective self-injection will be evaluated by 
study personnel and is defined as for the primary outcome variable (see Section 2.2.1). 
2.2.3 
Other variables 
2.2.3.1 
Outcome variables 
The other outcome variables are: 
• Responses to pre-injection SIAQ (versions 2.0 and 2.1) at DV0002 Baseline. 
Whenever SIAQ is assessed, version 2.0 of the SIAQ will be used to assess bimekizumab-
SS-1mL and bimekizumab-SS-2mL and version 2.1 of the SIAQ will be used to assess 
bimekizumab-AI-1mL and bimekizumab AI 2mL. 
• Responses to post-injection SIAQ (versions 2.0 for bimekizumab-SS-1ml and 2.1 for 
bimekizumab-1ml-AI) by visit following self-injection using the assigned device at DV0002 
Baseline and Week 8. 
• Injection site pain (using a VAS; 100mm) by visit after self-injection using the assigned 
device at DV0002 Baseline and Week 8. 
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• Percentage of used devices identified as having structural or mechanical integrity issues after 
completion of self-injection. This is based on a visual examination of the device that shows 
clear evidence of damage and/or compromised structural or mechanical integrity. 
2.2.3.2 
Pharmacokinetic variable 
The PK variable is trough PK (bimekizumab) levels associated with self-injection using the 
investigational device, injection by study personnel, injection site (abdomen or thigh), and BMI 
category (by tertile). Trough levels will be assessed at DV0002 Baseline, Week 4, Week 8, and 
Week 12 for subjects who receive bimekizumab Q4W and trough levels will be assessed at 
DV0002 Baseline, Week 8, and Week 16 for subjects who receive bimekizumab Q8W. 
2.2.3.3 
Safety variable 
The other safety variable is the occurrence of ADEs. An ADE is an adverse event (AE) related to 
the use of an investigational device. An ADE must meet 1 or more of the following criteria: 
• Adverse event resulting from insufficiencies or inadequacies in the instructions for use (IFU), 
the deployment, the implantation, the installation, the operation, or any malfunction of the 
investigational medical device. 
• Adverse event that is a result of a use error or intentional misuse of the investigational 
device. 
Additional safety and tolerability variables will be collected as described in the PS0014 study 
protocol. 
2.3 
Study design and conduct 
2.3.1 
Study description 
DV0002 is a Phase 3 open-label, randomized, noncomparator, North America-only substudy to 
PS0014. PS0014 will evaluate the long-term safety, tolerability, and efficacy of bimekizumab in 
subjects with moderate to severe chronic plaque PSO; study personnel will administer 
bimekizumab to subjects in a 1mL PFS. 
In the DV0002 substudy, the safe and effective use of the bimekizumab-SS-1mL, bimekizumab-
AI-1mL, bimekizumab-SS-2mL, or the bimekizumab-AI-2mL for the sc self-injection of 
bimekizumab by subjects with PSO will be evaluated.  
Subjects from selected sites in the PS0014 feeder studies PS0008, PS0009, and PS0013 will be 
eligible for the DV0002 substudy. At DV0002 Baseline, each subject will be provided with 
training in self-injection and will receive the IFU and any other applicable training materials. 
For the 1mL device cohort, subjects in the DV0002 substudy will perform self-injections at 
DV0002 Baseline (corresponding to the Baseline Visit of PS0014) with a subsequent self-
injection at DV0002 Week 8 (corresponding to Week 8 of PS0014). 
To allow flexible enrollment, subjects may be randomized in the 2mL device cohort at the 
PS0014 Week 24, Week 28, or Week 32 visit for subjects receiving bimekizumab Q4W or the 
PS0014 Week 24 or Week 32 visit for subjects receiving bimekizumab Q8W.  
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For the 2mL device cohort, subjects will perform self-injections at DV0002 Baseline with a 
subsequent self-injection 8 weeks after training. The 2mL device cohort will evaluate 2 self-
injection devices: the bimekizumab SS 2mL and the bimekizumab AI 2mL. 
2.3.2 
Treatment Period 
During the 16-week Treatment Period of DV0002, subjects will receive either bimekizumab 
320mg Q8W or bimekizumab 320mg Q4W, based on their assigned dose at PS0014 Baseline. 
Baseline for DV0002 and Baseline for PS0014 will occur at the same time for the 1mL device 
cohort. In the 2mL device cohort, Baseline for DV0002 will occur at the PS0014 Week 24, Week 
28, or Week 32 visit for subjects receiving bimekizumab Q4W or the PS0014 Week 24 or Week 
32 visit for subjects receiving bimekizumab Q8W. 
Eligible subjects (PS0014 entry criteria and DV0002 entry criteria) will be randomly assigned in 
a 1:1 ratio to perform self-injection using either the bimekizumab-SS-1mL or the bimekizumab-
AI-1mL for the 1mL device cohort or using either the bimekizumab-SS-2mL or the 
bimekizumab-AI-2mL for the 2mL device cohort. Regardless of the assigned dose regimen, 
subjects will perform self-injection with the assigned device only at DV0002 Baseline and at 
DV0002 Week 8. For subjects in the bimekizumab 320mg Q4W dosing arm, injections will be 
administered by study personnel using the investigational device at Week 4 and Week 12; for 
subjects in both dosing arms, injections will be administered by study personnel using the 
investigational device at Week 16.  
First treatment for the 1ml device cohort in PS0014 will be the timepoint of first bimekizumab 
injection in DV0002. First treatment in DV0002 will be the timepoint of first self-injection in 
DV0002. 
After Week 16 in the DV0002 substudy, subjects will continue in PS0014. 
2.3.3 
Safety Follow-Up 
A device Safety Follow-up (SFU) telephone call will occur 1 week after the last self-
administration (at DV0002 Week 9).  
Subjects who are withdrawn from DV0002 but continue their PS0014 study participation will be 
required to perform an SFU telephone call 1 week after their final DV0002 dosing visit. 
2.3.4 
Withdrawal 
Subjects who are withdrawn from bimekizumab treatment (PS0014 study) during the course of 
DV0002 will also be required to follow the PS0014 withdrawal procedures that means subjects 
will undergo the Premature End of Treatment (PEOT) Visit assessments and will enter the SFU 
Period. 
2.3.5 
Study duration per subject 
The maximum DV0002 substudy duration will be 16 weeks for each subject. Subjects will then 
continue to receive treatment in PS0014 for the duration of the PS0014 study.  
The end of the DV0002 substudy is defined as the date on which the last subject completes 
his/her DV0002 Week 16 Visit or withdraws from the study. 
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2.3.6 
Planned number of subjects 
For evaluation of the 1mL device, it is planned to enroll approximately 200 subjects; each device 
arm (bimekizumab-SS-1mL, bimekizumab-AI-1mL) will consist of approximately 100 subjects.  
Once the 1mL device cohort has finished enrolling, the 2mL device cohort will start enrolling. 
For evaluation of the 2mL device, it is planned to enroll approximately 100 subjects; each device 
arm (bimekizumab SS 2mL or bimekizumab-AI-2mL) will consist of approximately 50 subjects. 
It is anticipated that this study will involve up to 80 sites in North America. 
2.4 
Determination of sample size 
This study will not be powered with respect to any endpoint and sample size is based on practical 
considerations. 
1mL Device Cohort 
For the 1mL device cohort, to maintain blinding in the PS0014 feeder studies, DV0002 will 
recruit subjects who were administered bimekizumab 320mg (Q4W or Q8W) and subjects who 
were administered placebo or ustekinumab in the PS0014 feeder studies. A total of 100 subjects 
(50 subjects per device arm) are planned for PK trough level analyses, but these analyses can 
only be performed on subjects who do not change their bimekizumab dose or dosing regimen (ie, 
320mg bimekizumab Q4W or Q8W) between the PS0014 feeder studies and the DV0002 
substudy. The DV0002 substudy will therefore enroll approximately 200 subjects (to compensate 
for subjects with bimekizumab dose changes) to ensure that 100 subjects are available for PK 
trough analysis. 
Subjects who enroll in the DV0002 substudy 1mL device cohort will be randomly assigned to 
the bimekizumab SS 1mL or the bimekizumab AI 1mL device arms (each device arm will 
consist of approximately 100 subjects). Within each device arm, subjects will be divided into 
tertiles by BMI; there will be approximately 33 subjects per tertile, which is expected to yield 
approximately 16 to 17 subjects per tertile who are evaluable for steady state trough PK level 
analyses. 
Subjects are evaluable for steady state trough PK level analyses, if they enter PS0014 on the 
same drug and dose as completing the feeder study and if they receive the drug at least 16-20 
weeks before PS0014. The second condition is automatically fulfilled. Each subject in the feeder 
study will receive more than 20 weeks of the same treatment in the maintenance phase except 
escape subjects from PS0013 which are excluded from DV0002 enrollment.  
2mL Device Cohort 
Once the 1mL device cohort has finished enrolling, the 2mL device cohort will start enrolling. 
Subjects who participated in the 1mL device cohort of DV0002 are not eligible to enroll in the 
2mL device cohort. For evaluation of the 2mL device, it is planned to enroll approximately 
100 subjects. Subjects are evaluable for steady state trough PK level analysis if they receive the 
same bimekizumab administration (frequency and dose) from beginning of PS0014 through to 
the end of the sub-study. It is expected that most subjects will be evaluable for the PK trough 
level analyses.  
Subjects who enroll in the DV0002 substudy 2mL device cohort will be randomly assigned to 
the bimekizumab-SS-2mL or the bimekizumab-AI-2mL device arms (each device arm will 
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consist of approximately 50 subjects). Within each device arm, subjects will be divided into 
tertiles by BMI; there will be approximately 16 to 17 subjects per tertile who are evaluable for 
steady state trough PK level analyses. 
3 
DATA ANALYSIS CONSIDERATIONS 
3.1 
General presentation of summaries and analyses 
Statistical analysis and generation of tables, figures, subject data listings, and statistical output 
will be performed using SAS Version 9.3 or higher. All tables and listings will use Courier New 
font size 9. 
Descriptive statistics will be displayed to provide an overview of the study results. For 
continuous variables, descriptive statistics will include number of subjects with available 
measurements (n), mean, standard deviation (SD), median, minimum, and maximum. 
For categorical variables, the number and proportion of subjects, will be presented. In addition, 
for the primary, secondary and other variables the 90% confidence interval (CI) based on the 
Exact Binomial, will also be presented. Unless otherwise noted, the denominator for percentages 
should be based on the number of subjects included in the respective analysis set. Subjects with 
missing data can generally be accounted for using either of the following approaches: 
• For summaries of demographics and Baseline characteristics: summarize percentages based 
on all subjects in the analysis set and include a “Missing” category (corresponding to subjects 
with missing data for the variable being summarized) as the last row in the list of categories 
being summarized.  
• For summaries of outcome and safety variables, unless otherwise specified: percentages will 
be summarized based only on those subjects with observed data for the variable being 
summarized. As the denominator may be different from the number of subjects in the 
analysis set being considered, the denominator should be displayed in the table. The general 
format for displaying this will be “n/NSub (%).” 
Percentages will be presented to 1 decimal place. If the percentage is 100 or 0, no decimal will 
be presented. Typically, the % sign should be presented in the column header, but not with each 
individual value. 
For bimekizumab PK concentrations, summary statistics will include geometric mean, geometric 
coefficient of variation (CV), 95% confidence intervals for geometric mean, arithmetic mean, 
SD, median, minimum, and maximum. All summaries of PK variables will be based on the 
observed values. No imputation will be used. 
Decimal places for descriptive statistics will always apply the following rules: 
• “n” will be an integer 
• Mean, SD, and median will use one additional decimal place compared to the original data 
• CV [%] will be presented with one decimal place 
• Minimum and maximum will have the same number of decimal places as the original value. 
Derived variables in general will display the mean, SD, and median to 1 more decimal place than 
the variables used in the derivation. If the number of decimal places reported in the raw data is 
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varied, then use either the maximum raw number of reported decimal places or 3, whichever is 
the lowest, as a guide for the descriptive statistics. 
A complete set of data listings containing all documented data as well as calculated data will be 
generated 
3.2 
Analysis Time Points 
If the early withdrawal visit occurs at a scheduled visit as outlined in the schedule of 
assessments, then no mapping is necessary, and any early withdrawal assessments should 
correspond to that scheduled visit. Premature study withdrawal visit assessments that occur on a 
date after a scheduled visit will be assigned to the next scheduled site visit per the protocol 
following the last visit where assessments were available. 
3.3 
Definition of Baseline values 
The Baseline value is defined as the last non-missing measurement prior to the first self-injection 
at Visit 1 (Baseline). 
If a scheduled Baseline assessment is taken on the same day as the first administration of study 
medication, then the assessment will be assumed to have been performed prior to study 
medication. 
3.4 
Relative Day 
The relative day will be included in different listings and will be calculated as follows: 
• If the start (stop) date occurred on or after the first dose in DV0002, but prior to the drug stop 
date, relative day is calculated as start (stop) date minus first dose date + 1 
• If the start (stop) date occurred after the last dose of bimekizumab, the relative day to the 
most recent dose is calculated as start (stop) date minus most recent dose date. The relative 
day in this situation should be preceded by a ‘+’ 
• If the start (stop) date occurred before the first dose in DV0002, the relative day is calculated 
as start (stop) date minus first dose date. The relative day in this situation should be preceded 
by a ‘-‘. 
Relative day will only be computed for fully completed dates and will be missing for partial 
dates. 
3.5 
Protocol deviations 
Important protocol deviations are deviations from the protocol which could potentially have a 
meaningful impact on the primary objective of the study. The criteria for identifying important 
protocol deviations and the classification of important protocol deviations will be defined within 
the project Data Cleaning Plan. 
WHO declared a global COVID-19 pandemic on 11 March 2020.  All subjects were recruited 
into this study during the pandemic and therefore the impact of COVID-19 on the study will be 
assessed. Deviations related to the Coronavirus Disease 2019 (COVID-19) global pandemic are 
unavoidable deviations from the protocol due to confirmed COVID-19 infection, suspected 
COVID-19 infection, general circumstances around COVID-19 without infection or any other 
deviation from the protocol due to COVID-19. COVID-19 protocol deviations will be reviewed 
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as part of the ongoing data cleaning process. Any COVID-19 impact protocol deviations that are 
determined to be important or not-important will be included in this summary. A by-subject 
listing of COVID-19 related protocol deviations will be provided. 
3.6 
Analysis sets 
3.6.1 
1mL Device Cohort 
3.6.1.1 
Enrolled Set 
The Enrolled Set (ES) will consist of all subjects who have given informed consent for DV0002. 
3.6.1.2 
Safety Set 
Two different Safety Sets (SS) will be generated (1 for each device type): the bimekizumab-SS-
1mL Safety Set (SS-s) and the bimekizumab-AI-1mL Safety Set (SS-a). Each SS will consist of 
all subjects in the study who receive at least 1 dose of bimekizumab by the indicated self-
injection investigational device. Safety variables will be analyzed using the SS-s and SS-a. 
3.6.1.3 
Full Analysis Set 
Two different Full Analysis Sets (FASs) will be generated (1 for each device type): FAS-s and 
FAS-a. Each FAS will consist of all subjects in the SS-s or SS-a who self-inject at least 1 dose of 
bimekizumab using the given device and who have an assessment of self-injection. All self-
injection related endpoints will be analyzed using the FAS-s and FAS-a. 
3.6.1.4 
Pharmacokinetic Per Protocol Set 
Two different Pharmacokinetic Per Protocol Sets (PK-PPS) will be generated (1 for each device 
type): the bimekizumab-SS-1mL PK-PPS (PK-PPS-s) and the bimekizumab-AI-1mL PK-PPS 
(PK-PPS-a). Each PK-PPS will consist of all subjects who receive the same bimekizumab 
administration (frequency and dose) in the PS0014 feeder studies as in the DV0002 substudy and 
who have at least 1 evaluable PK assessment in the DV0002 substudy without important protocol 
deviations that would affect the concentration. Pharmacokinetic variables will be analyzed using 
the PK-PPS-s and PK-PPS-a. 
All PK assessments after baseline assessments from feeder study will be considered for the 
requirement of at least one evaluable PK assessment.  
3.6.2 
2mL Device Cohort 
3.6.2.1 
Enrolled Set 
The Enrolled Set (ES) will consist of all subjects who have given informed consent for DV0002. 
3.6.2.2 
Safety Set 
Two different Safety Sets (SS) will be generated (1 for each device type): the bimekizumab-SS-
2mL Safety Set (SS-s) and the bimekizumab-AI-2mL Safety Set (SS-a). Each SS will consist of 
all subjects in the study who receive at least 1 dose of bimekizumab by the indicated self-
injection investigational device. Safety variables will be analyzed using the SS-s and SS-a. 
3.6.2.3 
Full Analysis Set 
Two different Full Analysis Sets (FASs) will be generated (1 for each device type): FAS-s and 
FAS-a. Each FAS will consist of all subjects in the SS-s or SS-a who self-inject at least 1 dose of 
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bimekizumab using the given device and who have an assessment of self-injection. All self-
injection related endpoints will be analyzed using the FAS-s and FAS-a. 
3.6.2.4 
Pharmacokinetic Per Protocol Set 
Two different Pharmacokinetic Per Protocol Sets (PK-PPS) will be generated (1 for each device 
type): the bimekizumab-SS-2mL PK-PPS (PK-PPS-s) and the bimekizumab-AI-2mL PK-PPS 
(PK-PPS-a). Each PK-PPS will consist of all subjects who receive the same bimekizumab 
administration (frequency and dose) from beginning of PS0014 through to the end of the sub-
study and who have at least 1 evaluable PK assessment in the DV0002 substudy without 
important protocol deviations that would affect the concentration. Pharmacokinetic variables will 
be analyzed using the PK-PPS-s and PK-PPS-a. 
All PK assessments after DV0002 baseline assessments (Week 24, Week 28 or Week 32 from 
PS0014 study) will be considered for the requirement of at least one evaluable PK assessment. 
3.7 
Treatment assignment, treatment and device groups 
This is an open-label study and as such all subjects will be summarized according to the 
treatment that was provided. The treatment group will be allocated in PS0014 and the device 
group will be allocated in DV0002.  
PS0014 treatment groups 
This refers to the study treatment assigned to the subject at the beginning of PS0014 and does not 
account for the treatment received in the relevant Feeder Study. The allocation of treatments in 
PS0014 is done by an algorithm considering the subjects’ feeder study (PS0008, PS0009, or 
PS0013) and PASI90 response at PS0014 study entry.  The PS0014 treatment groups are as 
follows: 
• Bimekizumab 320mg Q8W 
• Bimekizumab 320mg Q4W. 
DV0002 device groups 
This refers to the study device assigned to the subject at the beginning of DV0002. The DV0002 
1mL device groups are as follows: 
• Bimekizumab-SS-1mL 
• Bimekizumab-AI-1mL. 
The DV0002 2mL device groups are as follows: 
• Bimekizumab-SS-2mL 
• Bimekizumab-AI-2mL. 
The outcome variables will be summarized by PS0014 treatment and DV0002 device group. The 
different DV0002 device groups are reflected in the use of the corresponding analysis set SS-s, 
SS-a, FAS-s, FAS-a, PK-PPS-s and PK-PPS-a. For simplification “treatment group” and “device 
group” will be used in the outputs.  
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3.8 
Center pooling strategy 
No pooling of centers is planned for this study. 
3.9 
Coding dictionaries 
All ADEs will be coded and classified by system organ class (SOC), high level term (HLT), and 
preferred term (PT) according version 19.0 of the Medical Dictionary for Regulatory Activities 
(MedDRA®). 
All medications other than the study drug will be classified by World Health Organization 
(WHO) Anatomical Therapeutic Chemical (ATC) classification, presenting Anatomical Main 
Group (ATC Level 1), Pharmacological Subgroup (ATC Level 3), and preferred term (PT), using 
version SEP/2015 of the World Health Organization Drug Dictionary (WHO-DD), according to 
UCB standard operating procedures (SOP). 
Previous and ongoing medical history will be classified by version 19.0 of MedDRA® SOC and 
PT. 
3.10 
Changes to protocol-defined analyses 
Subjects who had important protocol deviations affecting the primary outcome variable, as 
confirmed during ongoing data cleaning meetings prior to database lock, will be not excluded 
from the FAS-s or FAS-a. 
3.10.1 
Changes related to COVID-19 
COVID-19 protocol deviations have been defined in Section 3.5 and the presentation of COVID-
19 protocol deviations is described in Section 5.3.  
4 
STATISTICAL/ANALYTICAL ISSUES 
4.1 
Adjustments for covariates 
Not applicable. 
4.2 
Handling of dropouts or missing data 
For analyses of ADEs and concomitant medication usage, a complete date must be established in 
order to correctly identify the ADE or medication as occurring during treatment or not. To 
calculate the duration of disease, a complete date of onset of plaque psoriasis is needed. For 
purposes of imputing missing components of partially-reported start and stop dates for ADEs,  
for medication use, and date of onset of plaque psoriasis, the algorithms listed below will be 
followed. Start and stop dates of ADEs or concomitant medication will be displayed as reported 
in the subject data listings (i.e., no imputed values will be displayed in data listings). 
Partial ADE and concomitant medication start dates will be imputed as follows: 
Imputation of Partial Start Dates 
• If only the month and year are specified and the month and year of first dose is not the same 
as the month and year of the start date, then use the 1st of the month 
• If only the month and year are specified and the month and year of first dose is the same as 
the month and year of the start date, then use the date of first dose 
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• If only the year is specified, and the year of first dose is not the same as the year of the start 
date, then use the 1st of January of the year of the start date 
• If only the year is specified, and the year of first dose is the same as the year of the start date, 
then use the date of first dose 
• If the start date is completely unknown and the stop date is unknown or not prior to the date 
of first dose, then use the date of first dose. 
Imputation of Partial Stop Dates 
• If only the month and year are specified, then use the last day of the month 
• If only the year is specified, then use December 31st of that year 
• If the stop date is completely unknown, do not impute the stop date. 
If the (imputed) stop date is prior to the imputed start date: 
• If only the month and year are specified and the month and year of first dose is the same as 
the month and year of the start date and the stop date is before the date of first dose, then set 
the start date to the 1st of that month. 
• If only the year is specified, and the year of first dose is the same as the year of the start date, 
and the stop date is before the date of first dose, then use the 1st of January of the year of the 
start date 
Partial start dates for onset date of plaque psoriasis will be imputed as follows:  
• If only the month and year are specified, then use the last day of the month. 
• If only the year is specified, then use the 31st of December of the year. 
• If the start date is completely unknown, do not impute the start date. 
In the event of ambiguity or incomplete data which makes it impossible to determine whether a 
medication was concomitant or an adverse event was treatment emergent, the medication will be 
considered as concomitant or the adverse event will be considered treatment emergent. 
If the intensity of an ADE is unknown, it will be considered as severe.  
There will be no special procedures for handling missing data for any other data points. 
4.3 
Interim analyses and data monitoring 
No interim analysis is planned for this study. No Data Monitoring Committee will be established 
for this study.  
The subjects of DV0002 are ongoing subjects of PS0014. Data cut off for the 1mL final analysis 
will be last subject last Week 16 visit in DV0002 in the 1mL device cohort. Data cut off for the 
2mL final analysis will be last subject last Week 16 visit in DV0002 in the 2mL device cohort. 
Data cut off rules will be applied for ongoing adverse device events and ongoing concomitant 
medication.  
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4.4 
Multicenter studies 
Individual center results will not be directly presented. Centers are only located in North 
America (United States and Canada).  
4.5 
Multiple comparisons/multiplicity 
Not applicable. 
4.6 
Use of an efficacy subset of subjects 
Not applicable. 
4.7 
Active-control studies intended to show equivalence 
Not applicable. 
4.8 
Examination of subgroups 
Not applicable. 
5 
STUDY POPULATION CHARACTERISTICS 
5.1 
Subject disposition 
All subject disposition tables will use the PS0014 treatment groups BKZ 320mg Q8W and BKZ 
320mg Q4W and an overall treatment group category (BKZ Total).  
The disposition of subjects including the number of subjects in ES and all device-specific 
analysis sets (SS-s, FAS-s, PKS-s or SS-a, FAS-a, PKS-a) will be summarized. This summary 
will be based on ES and will present subjects overall and by site in North America.  
The disposition of ES will present all bimekizumab treated subjects by PS0014 treatment group 
and broken out by DV0002 device group. 
The number and percentage of subjects who entered the substudy, completed, discontinued with 
the reasons for discontinuation of the substudy will be presented. This summary will be based on 
the ES and will present all bimekizumab treated subjects by PS0014 treatment group and broken 
out by DV0002 device group. 
Subjects will be counted as completer if they completed the DV0002 Week 16 visit.  
The following listings for subject disposition will be produced based on the ES and presented by 
PS0014 treatment group/ DV0002 device group: 
• A listing of subjects who did not meet study eligibility criteria  
• A listing of subject disposition  
• A listing of study discontinuation  
• A listing of visit dates  
• A listing of subjects excluded from analysis sets. 
• A listing of subject analysis sets 
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5.2 
Protocol deviations 
A summary of number and percentage of subjects with an important protocol deviation 
(including a summary of subjects excluded from any analysis set due to important protocol 
deviations) by treatment group will be provided for the SS-a and SS-s. 
A by-subject listing of important protocol deviations will be provided. 
5.3 
COVID-19 Impact 
For study participants impacted by the COVID-19 global pandemic, data were collected on a 
separate eCRF. This form was collected for study visits that were affected by COVID-19, and it 
collected how the visits were impacted by the pandemic (e.g., performed out of window, done by 
telephone instead of on-site, not done, etc).     
Based on how the visit was affected by the global pandemic, all visits will have a variable 
indicating how the visit was performed:  
• Visit not done at all 
• Visit done by video call 
• Visit done by telephone 
• Visit done at different time point than planned / out of window 
Additionally, for visits that are affected by COVID-19, all assessments that are missing will be 
flagged as missing due to COVID-19. Further, the specific reason of missing data will be 
captured as the following flags: 
•  Confirmed COVID-19 infection  
• Suspected COVID-19 infection  
• General circumstances around COVID-19 without infection 
• Other 
A summary of number and percentage of subjects with COVID-19 related protocol deviations 
and COVID-19 related device protocol deviations by treatment group and visit will be provided 
for the SS-a and SS-s. This summary on COVID-19 related protocol deviations will also be 
repeated by country. 
A by-site, subject and visit listing of COVID-19 related protocol deviations along with a listing 
of COVID-19 related device protocol deviations will be provided. 
6 
DEMOGRAPHICS AND OTHER BASELINE 
CHARACTERISTICS 
All summaries detailed in this section will be performed on the SS-a and SS-s and by PS0014 
treatment group. 
6.1 
Demographics 
Demographic variables will be summarized by PS0014 treatment group and all bimekizumab 
treated subjects. 
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The following continuous variables will be summarized using descriptive statistics (number of 
subjects, mean, SD, minimum, median and maximum). 
• Age at the time of feeder study entry (years) 
• Height (cm) 
• DV0002 Baseline Weight (kg): will be derived from the weight from the last visit of the 
feeder study for 1mL device cohort and 2mL cohort subjects. 
• DV0002 Baseline BMI (kg/m2)  
• BMI (kg/m2) will be calculated as: 
 
𝐵𝑀𝐼= Weight (kg)
(Height (m))2 
 
The following categorical variables will be summarized using frequency counts and percentages. 
• Age group (≤18, 19-<65, ≥65 years)  
• DV0002 Baseline Body Weight (≤100kg, >100kg) 
• BMI (<25 kg/m2, 25 to <30 kg/m2, ≥30 kg/m2) 
• BMI tertiles (≤t1 kg/m2, >t1 kg/m2 to ≤ t2 kg/m2, >t2 kg/m2) based on the respective PK-
PPS populations (PK-PPS-s, PK-PPS-s) 
• Gender 
• Race 
• Ethnicity 
• Country 
By-subject listings of demographics will be provided. 
6.2 
Other Baseline characteristics 
Baseline characteristics will be summarized by treatment group and overall. 
Generally, the following continuous variables will be summarized using descriptive statistics 
(number of subjects, mean, SD, minimum, median and maximum). 
• Duration of disease (years) 
Duration of disease (years) will be calculated as: 
 
Disease Duration
=
(Date of randomization in DV0002 −Date of onset of Plaque Psoriasis1)
365.25
 
 
1If the date of onset of plaque psoriasis is partial, it should be imputed to the most recent feasible 
date (ie, last day of the month if only day is missing, or the last day of the year if day and month 
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are missing). Note that if the date of randomization is missing then the duration of disease will be 
derived using the date of screening.  
The following categorical variables will be summarized using frequency counts and percentages. 
• Duration of disease (<median, ≥median). 
6.3 
Medical history and concomitant diseases 
Previous and ongoing medical history collected at the start of the feeder study will be based on 
SS-s and SS-a and summarized by treatment groups, system organ class (SOC) and preferred 
term (PT) using MedDRA®. Medical history and psoriasis history will be included in the 
summary tables and listings for medical history. Medical procedures are not coded.  
Previous and ongoing medical history along with the updated medical history collected at the end 
of the feeder studies will be presented in a by-subject listing for SS-s and SS-a, respectively. 
6.4 
Prior and concomitant medications 
Concomitant medication details are collected at each visit of DV0002. Concomitant medications 
are medications taken at least one day in common with the DV0002 study medication dosing 
period (DV0002 Baseline to DV0002 Week 16). 
All concomitant medication will be listed for SS-s and SS-a, respectively.  
Concomitant medication which started before DV0002 Week 16 and were ongoing at the data 
cut off will be included with the status remaining as ongoing. Concomitant medication which 
were ongoing at DV0002 Week 16 but with an end date before the data cut off will be included 
with their end date as recorded.  
For 2 ml phase analysis, concomitant medications include those started on or before the later of 
the final contact date or (the last injection date + 7 days). 
7 
MEASUREMENTS OF TREATMENT COMPLIANCE 
During the Treatment Period of this study, IMP administration (either self-administration or 
study personnel-administration) will be performed in the clinic and observed by the Investigator 
or his/her designee; monitoring subject compliance is therefore not applicable. 
8 
EFFICACY ANALYSES 
No efficacy summaries are planned for the DV0002 substudy. 
9 
PHARMACOKINETICS AND PHARMACODYNAMICS  
9.1 
Pharmacokinetics 
The statistical analyses of the PK data will be descriptive in nature and will be summarized using 
the relevant device-specific population (PK-PPS-s or PK-PPS-a). Data will be analyzed overall 
for each device by injection type (self-administered or study personnel-administered), by 
injection site (abdomen or thigh), and by BMI category. The BMI categories will be defined into 
three tertiles within each device arm PK-PPS analysis set and device cohort and derived from 
subjects’ DV0002 Baseline BMI values. 
To allow for an analysis of PK trough levels for bimekizumab administration via self-injection or 
via study personnel administration, pre-dose PK samples will be taken throughout the DV0002 
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substudy. For the Q4W dose regimen, PK trough levels will be determined based on pre-dose PK 
sampling at DV0002 Baseline and DV0002 Week 8 for the study personnel administration and at 
DV0002 Week 4 and DV0002 Week 12 for the self-administration trough levels, respectively. 
For the Q8W dose regimen, PK trough levels will be determined based on pre-dose PK sampling 
at DV0002 Baseline for the study personnel administration and at DV0002 Week 8 and DV0002 
Week 16 for the self-administration trough levels, respectively. For the 1ml device cohort, 
DV0002 Baseline PK samples are the PK samples from the last visit of the feeder studies.  
For the analysis of PK trough levels by injection site (abdomen or thigh) and by BMI category 
(by tertiles), self-administration PK trough levels and study personnel administration PK trough 
levels will be used. 
PK samples for self-administration where the injection was done by site personnel or caregiver 
will be listed but not be used for summary statistics. PK samples for personnel administration 
where the injection was done by the subject will be listed but not be used for summary statistics. 
Only pre-dose (trough) concentrations will be included while summarizing tables and figures. If 
the dosing for a visit is +/- 7 days out of window then the plasma concentration from that visit 
and all subsequent visits will be excluded from the PK summary. PK samples collected after 
dosing will be excluded from summary statistics.  
PK summaries will be based on observed values. No imputation will be used. However, if 
plasma concentration measurements are below the level of quantification, then for calculation of 
the derived statistics the result will be set to ½ of the lower level of quantification (LLOQ). 
Descriptive statistics including geometric mean, geometric coefficient of variation, and 
geometric mean 95% CI if applicable will be calculated if at least 2/3 of the values of interest are 
above the LLOQ. If this is not the case, only median, minimum, and maximum will be presented. 
Boxplots of plasma concentration will be presented by visit and by treatment group. 
All PK results will be listed.  
In addition, the PK results from all subjects not in PK-PPS-s or PK-PPS-a will be listed based on 
the SS-a and SS-s.  
9.2 
Pharmacodynamics 
Not applicable. 
10 
SAFETY ANALYSES 
All safety analysis will be performed for SS-a and SS-s and by treatment group. 
10.1 
Extent of exposure 
Extent of exposure is not relevant for the DV0002 substudy. Occurrence of Adverse device 
effects in this substudy will not be affected by the duration of medication exposure.  
10.2 
Adverse events 
All AEs (including serious adverse events [SAEs]) will be reported in a common database for 
PS0014 and DV0002, but only adverse device effects (ADEs), serious adverse device effects 
(SADEs), and device deficiencies will be summarized in the DV0002 substudy. Specifically, 
only those AEs related to the use of the investigational medical devices bimekizumab-SS-
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1mL,bimekizumab-AI-1mL, bimekizumab-SS-2 mL or bimekizumab-AI-2 mL (based on the 
Investigator’s judgement) will be assessed. All AEs (including SAEs) which are not assessed to 
be related to the investigational devices will be summarized separately in the report for the main 
study PS0014. An exception are AEs that are indicated as injection site reactions during self-
injection. These will be listed in DV0002 as well as in PS0014. 
10.2.1 
Adverse device effects 
Adverse events are recorded at the AE CRF page at the time when they occur. If an adverse 
event is related to the device by assessment of the investigator it is counted as an Adverse device 
event. For DV0002 only ADE will be considered which started during the DV0002 study period. 
And ADEs started in the 1 ml phase will be included for 1 ml phase analysis, and those started in 
the 2 ml phase will be included for the 2 ml phase analysis. For 2 ml phase analysis, adverse 
device effects include those that started on or before the later of the final contact date or (the last 
injection date + 7 days). 
All ADE data will be listed and no statistical testing will be performed. Only treatment-emergent 
ADEs will be included in the summary tables. Treatment-emergent ADEs (TEADEs) will be 
defined as events that have a start date on or following the first self-administration of study 
treatment in DV0002 through the final self-administration of study treatment + 7 days. The 
device SFU will occur 1 week after the last self-administration. 
All ADEs will be coded and classified by system organ class, high level term, and preferred 
term. Adverse device effects will be summarized by the frequency and percentage of subjects 
having 1 or more of the events in question. Additional planned summaries include overall ADEs 
and SADEs. All summaries are presented by PS0014 treatment  
• Incidence of TEADEs – Overview 
• Incidence of TEADEs by SOC, HLT, and PT 
• Incidence of serious TEADEs by SOC, HLT, and PT 
• Incidence of TEADEs leading to death 
• Incidence of TEADEs leading to discontinuation 
• Incidence of non-TEADEs (only listed and not summarized in a table) 
For definition of serious, unanticipated and serious unanticipated ADEs see protocol of DV0002.  
Adverse device effects which started before DV0002 Week 16 and were ongoing at the data cut 
off will be included with the status remaining as ongoing. Adverse device effects which were 
ongoing at DV0002 Week 16 but with an end date before the data cut off will be included with 
their end date as recorded.  
10.2.2 
Injection site reaction 
Injection site reactions are recorded at the AE CRF page at the time when they occur. All AEs 
will be coded and classified by system organ class, high level term, and preferred term. An AE 
with High Level Terms of “Administration site reactions NEC” and “Injection site reactions” 
will be evaluated as injection site reaction. 
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All injection site reactions for self-injection with a start date on or following the first self-
administration of study treatment through the final self-administration of study treatment + 7 
days will be listed. 
10.3 
Clinical laboratory evaluations 
All clinical laboratory evaluations including hematology, chemistry and urinalysis will be 
collected in PS0014. 
10.4 
Vital signs, physical findings, and other observations related to 
safety 
eCRF data of vital signs, Electrocardiograms, physical examination and pregnancy test results 
will be collected in PS0014.  
11 
OTHER ANALYSES 
This section contains a detailed description of the analysis of the primary, secondary and other 
outcome variables. All statistical analyses will be descriptive in nature. No inferential statistical 
analyses are planned. The analysis is done on FAS-s and FAS-a, respectively. 
11.1 
Primary outcome 
The primary outcome variable is the percentage of all subjects able to self-administer safe and 
effective injections using the given device at DV0002 Week 8. Safe and effective self-injection 
will be 
evaluated by the study personnel as defined below: 
• Complete dose delivery: Subject self-injects the complete dose of bimekizumab as confirmed 
by a visual inspection of the investigational device which shows that the IMP is delivered 
completely (ie, container is empty), and 
• No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs 
and/or ADEs leading to withdrawal from the DV0002 substudy). 
All data to assess the primary outcome is collected on the subject self-injection of bimekizumab 
CRF page for DV0002 Week 8. For the number of subjects with safe and effective self-injections 
simply the cases which indicated “yes” for the question “Did the subject self-inject the complete 
dose of Bimekizumab” and “no” for the question “Where there any AEs related to use of the 
investigational device for self-injection” at Week 8 are counted.   
For subjects in the 1mL device cohort, two self-injections will be performed at DV0002 Week 8 
and the questions will be answered twice. If the answers are different between both self-
injections in one visit, then the worst case of both answers will be used for analysis at this visit. 
Subjects with only one self-injection at one visit will be counted as non-responder. Assessments 
where the self-injection was not performed by the subject will be not included in any summary 
statistics. 
The number and percentage of subjects with safe and effective self-injections will be tabulated 
separately for each device overall and within each device by dosing regimen. The 90% CIs based 
on the Exact Binomial method will be reported as well. 
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11.2 
Secondary outcome 
The secondary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the given device at DV0002 Baseline (first self-injection visit). Safe 
and effective self-injection will be evaluated by the study personnel. The secondary outcome 
variables will be analyzed in the same manner as the primary outcome variable.  
All data to assess the secondary outcome is collected on Subject self-injection of Bimekizumab 
CRF page for DV0002 Baseline. 
11.3 
Other outcomes 
The other outcome variables will be summarized using descriptive statistics and they will be 
tabulated separately for each device overall based and within each device by PS0014 treatment. 
Assessments where the self-injection was not performed by the subject will be not included in 
any summary statistics. 
11.3.1 
Pre-injection SIAQ (versions 2.0 and 2.1) 
The pre-injection SIAQ (versions 2.0 and 2.1) will be completed at DV0002 Baseline. Version 
2.0 of the SIAQ will be used to assess bimekizumab-SS-1mL and bimekizumab-SS-2mL and 
version 2.1 of the SIAQ will be used to assess bimekizumab-AI-1mL and bimekizumab-AI-2mL. 
There are no differences in Version 2.0 to Version 2.1 in pre-injection SIAQ.    
The pre-injection SIAQ consists of 7 items each with a scale of 1 to 5. There are three individual 
subscales (feelings about injections [FL, 3 items], self-confidence [CO, 3 items] and satisfaction 
with current mode of administration [SA, 1 item]). Each subscale score will be calculated using 
the average of the individual transformed item scores. The item score will be transformed using 
the following rule: 
𝑇𝑟𝑎𝑛𝑠𝑓𝑜𝑟𝑚𝑒𝑑 𝐼𝑡𝑒𝑚 𝑆𝑐𝑜𝑟𝑒= ((𝑟𝑎𝑤 𝑖𝑡𝑒𝑚 𝑠𝑐𝑜𝑟𝑒) −1) ×  2.5 
In the case of missing values, no domain score will be calculated if more than 50% of the items 
within the domain are missing. 
Higher individual scores of the pre-injection SIAQ indicate more confidence, higher satisfaction 
and less concerns with self-injections. 
Summary statistics for all individual items and each subscale will be produced for Baseline.  
11.3.2 
Post-injection SIAQ (versions 2.0 and 2.1) 
The post-injection SIAQ (versions 2.0 and 2.1) will be completed at DV0002 Baseline and 
DV0002 Week 8. Version 2.0 of the SIAQ will be used to assess bimekizumab-SS-1mL and 
bimekizumab-SS-2mL and version 2.1 of the SIAQ will be used to assess bimekizumab-AI-1mL 
and bimekizumab-AI-2mL. Version 2.0 and version 2.1 of the SIAQ are identical, except for 
Question 11 due to different handling of the devices. 
The post-injection SIAQ consists of 21 items on 6 individual subscales (FL [3 items], self-image 
[IM, 1 item], CO [3 items], Injection-site reactions [RE, 2 items], ease of use [EU, 5 items) and 
satisfaction with self-injection [SA, 7 items]). The items of the individual subscale EU have a 
score range of 1 to 6, the other individual subscales have a score range of 1 to 5. Each subscale 
score will be calculated using the average of the individual transformed item scores. The item 
scores for the EU subscale will be transformed using the following rule: 
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𝑇𝑟𝑎𝑛𝑠𝑓𝑜𝑟𝑚𝑒𝑑 𝐼𝑡𝑒𝑚 𝑆𝑐𝑜𝑟𝑒= ((𝑟𝑎𝑤 𝑖𝑡𝑒𝑚 𝑠𝑐𝑜𝑟𝑒) −1) ×  2 
The item scores for the other subscales will be transformed using the following rule: 
𝑇𝑟𝑎𝑛𝑠𝑓𝑜𝑟𝑚𝑒𝑑 𝐼𝑡𝑒𝑚 𝑆𝑐𝑜𝑟𝑒= ((𝑟𝑎𝑤 𝑖𝑡𝑒𝑚 𝑠𝑐𝑜𝑟𝑒) −1) ×  2.5 
In the case of missing values, no domain score will be calculated if more than 50% of the items 
within the domain are missing. 
Higher individual scores of the post-injection SIAQ indicate more confidence, higher satisfaction 
and less concerns with self-injections. 
Summary statistics for all individual items and each subscale will be produced for DV0002 
Baseline and DV0002 Week 8.  
11.3.3 
Injection site pain  
The visual analog scale of injection site pain indicates the level of pain during the injection. It 
ranges from 0-100 mm with higher values indicating more severe pain and 0 for no pain.   
Summary statistics of actual values and change from DV0002 Baseline values will be used to 
summarize injection site pain by visit after self-injection. 
11.3.4 
Structural and mechanical integrity of the devices 
The structural and mechanical integrity of the device after completion of self-injection will be 
assessed by the investigate after each injection in the “subject self-injection of bimekizumab” 
CRF page. The assessment will be done using the questions for structural integrity and function 
compromise. The structural integrity is based on a visual examination of the device that shows 
clear evidence of damage, compromised structural integrity not superficial and/or cosmetic 
imperfections. The functional compromise will be based on a visual examination of the device 
that shows clear evidence of damage and/or device dose not function normally. Both questions 
will be separately summarized.  
Two injections will be performed at each self-injection visit. At each injection the device could 
be replaced. Percentages will be based on the total number of devices used. 
Frequency tables will be produced to show the number and percentage of devices with:  
 
• used bimekizumab-SS-1mL, bimekizumab-AI-1mL, bimekizumab-SS-2mL and 
bimekizumab-AI-2mL syringes identified as having structural integrity issues after 
completion of self-injection. 
• used bimekizumab-SS-1mL, bimekizumab-AI-1mL, bimekizumab-SS-2mL and 
bimekizumab-AI-2mL syringes identified as functionally compromised. 
The 90% CIs based on the Exact Binomial method will be reported as well. 
 
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12 
REFERENCES 
Coteur G (2005) SIAQ©v2 User Manual (2nd Ed). UCB, Braine L’Alleud, Belgium. 
 
 
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13 
APPENDICES 
13.1 
SAP Amendment 1 
Rationale for the amendment 
This protocol has been amended to add the evaluation of the 2mL self-injection devices 
developed by UCB: a 2mL bimekizumab safety syringe (bimekizumab‑SS‑2mL) and a 2mL 
bimekizumab auto‑injector (bimekizumab‑AI‑2mL).  
Modifications and changes 
Global changes: 
The following changes were made throughout the SAP: 
• The DV0002 study number was added before the study visit where it was necessary to 
distinguish it from the PS0014 study visits. 
• The list of abbreviations was updated accordingly. 
• Minor spelling, editorial, and formatting changes were made throughout the document.  
Specific changes 
In addition to the global changes, the following specific changes have been made (formats as 
missing spaces or redundant spaces are not listed, typos): 
Change #1 
The following abbreviation has been added: 
bimekizumab-AI-2mL 
2mL bimekizumab auto-injector 
bimekizumab-SS-2mL 
2mL bimekizumab safety syringe 
The following abbreviation has been updated: 
FAS-a 
Full Analysis Set for the bimekizumab-AI-1mL 
Full Analysis Set for the bimekizumab-AI-2mL 
FAS-s 
Full Analysis Set for the bimekizumab-SS-1mL 
Full Analysis Set for the bimekizumab-SS-2mL 
PK-PPS-a 
Pharmacokinetic Per Protocol Set for the bimekizumab-AI-1mL 
Pharmacokinetic Per Protocol Set for the bimekizumab-AI-2mL 
PK-PPS-s 
Pharmacokinetic Per Protocol Set for the bimekizumab-SS-1mL 
Pharmacokinetic Per Protocol Set for the bimekizumab-SS-2mL 
SS-a 
Safety Set for the bimekizumab-AI-1mL 
Safety Set for the bimekizumab AI 2mL 
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SS-s 
Safety Set for the bimekizumab-SS-1mL 
Safety Set for the bimekizumab SS 2mL 
Change #2 
Section 1 Introduction 
The SAP is based on the following study document: Protocol DV0002, 26 Jul 2018. All 
references to study protocol hereafter refer to this version of the protocol. 
Has been changed to: 
The SAP is based on the following study document:  
• Final Protocol DV0002, 26 Jul 2018.  
• Protocol amendment 1, 28 Oct 2019. 
All references to study protocol hereafter refer to this version of the protocol. 
All analyses will be performed separately for the 1mL device cohort and for the 2mL 
device cohort. Once subjects in the 1mL device cohort complete DV0002, a final analysis 
will be performed for that cohort, and a clinical study report will be prepared. A separate 
final analysis will be performed for the 2mL device cohort once all data have been collected 
and will be reported separately from the initial clinical study report. 
Change #3  
Section 2.1.1 Primary objective 
The primary objective of the study is to evaluate for each device the ability of subjects with 
moderate to severe chronic plaque PSO to safely and effectively self-inject bimekizumab 
8 weeks after training in the self-injection technique using the bimekizumab-SS-1mL or the 
bimekizumab-AI-1mL. 
Has been changed to: 
The primary objective of the study is to evaluate, for each device, the ability of subjects with 
moderate to severe chronic plaque PSO to safely and effectively self-inject bimekizumab 8 
weeks after training in the self-injection technique using the bimekizumab-SS-1mL or the 
bimekizumab-AI-1mL. 
Change #4  
Section 2.1.2 Secondary objective 
The secondary objective of the study is to evaluate the ability of subjects with moderate to severe 
chronic plaque PSO to safely and effectively self-inject bimekizumab immediately after training 
in self-injection technique using the bimekizumab-SS-1mL or the bimekizumab-AI-1mL. 
Has been changed to: 
The secondary objective of the study is to evaluate, for each device, the ability of subjects with 
moderate to severe chronic plaque PSO to safely and effectively self-inject bimekizumab 
immediately after training in self-injection technique using the bimekizumab-SS-1mL or the 
bimekizumab-AI-1mL devices. 
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Change #5  
Section 2.1.3 Other objectives 
Other objectives of the study are to evaluate the following: 
• Subject experience of self-injection as assessed by the pain visual analog scale (VAS) and the 
Self-injection Assessment Questionnaire (SIAQ). 
• Trough PK (trough bimekizumab) levels associated with self-injection using the test device, 
injection by study personnel using the 1mL PFS, injection site (abdomen or thigh), and BMI 
category (by tertile). 
• The structural and mechanical integrity of the bimekizumab-SS-1mL and the 
bimekizumab-AI-1mL after completion of self-injection. 
• The overall safety and tolerability of self-injections. 
Has been changed to: 
Other objectives of the study are to evaluate the following: 
• Subject experience of self-injection using the investigational devices as assessed by the pain 
visual analog scale (VAS) and the Self injection Assessment Questionnaire (SIAQ). 
• Trough PK (trough bimekizumab) levels associated with self-injection using the test device 
investigational devices, injection by study personnel using the 1mL PFS, injection site 
(abdomen or thigh), and BMI category (by tertile). 
• The structural and mechanical integrity of the bimekizumab-SS-1mL and the 
bimekizumab-AI-1mLinvestigational devices after completion of self-injection. 
• The overall safety and tolerability of self-injections using the investigational devices. 
Change #6  
Section 2.2.1 Primary outcome variable 
The primary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the bimekizumab-SS-1mL or the bimekizumab-AI-1mL, respectively, 
at Week 8. Safe and effective self-injection will be evaluated by the study personnel and is 
defined as: 
• Complete dose delivery: Subject self-injects the complete dose of bimekizumab as confirmed 
by a visual inspection of the bimekizumab-SS-1mL or the bimekizumab-AI-1mL which 
shows that the IMP is delivered completely (ie, container is empty), and 
• No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs 
and/or ADEs leading to withdrawal from the DV0002 substudy). 
In the DV0002 substudy, the 320mg bimekizumab dose will be administered as two 160mg 
injections with either 2 bimekizumab-SS-1mL devices or 2 bimekizumab-AI-1mL devices. Each 
self-injection will be evaluated for safety and effectiveness by study personnel using the above 
criteria. The endpoint of safe and effective self-injection will be met only if both self-injections 
are determined to be safe and effective. 
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Has been changed to: 
The primary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the bimekizumab-SS-1mL or the, bimekizumab-AI-1mL, respectively, 
at Week bimekizumab-SS-2mL, or bimekizumab-AI-2mL, 8 weeks after training in self-
injection technique. Safe and effective self-injection will be evaluated by the study personnel 
and is defined as: 
• Complete dose delivery: Subject self-injects the complete dose of bimekizumab as confirmed 
by a visual inspection of the bimekizumab-SS-1mL or the bimekizumab-AI-1mLdevice 
which shows that the IMP is delivered completely (ie, container is empty), and 
• No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs 
and/or ADEs leading to withdrawal from the DV0002 substudy). 
In the DV0002 substudy, for the 1mL devices, the 320mg bimekizumab dose will be 
administered as two 160mg injections with either 2 bimekizumab-SS-1mL devices or 2 
bimekizumab-AI-1mL devices. Each self-injection will be evaluated for safety and effectiveness 
by study personnel using the above criteria. The endpoint of safe and effective self-injection will 
be met only if both self-injections are determined to be safe and effective. 
For the 2ml devices, the 320mg bimekizumab dose will be administered as 1 injection with 
either 1 bimekizumab-SS-2mL or 1 bimekizumab-AI-2mL device. Each self-injection will 
be evaluated for safety and effectiveness by study personnel using the above criteria. The 
endpoint of safe and effective self-injection will be met if the single self-injection is 
determined to be safe and effective. 
Change #7  
Section 2.2.2 Secondary outcome variable 
The secondary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the bimekizumab-SS-1mL or the bimekizumab-AI-1mL at Baseline 
(the first self-injection visit, immediately after training in self-injection technique). Safe and 
effective self-injection will be evaluated by study personnel and is defined as for the primary 
outcome variable (see Section 2.2.1). 
Has been changed to:  
The secondary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the bimekizumab-SS-1mL, or the bimekizumab-AI-1mL, 
bimekizumab-SS-2mL, or 1 bimekizumab-AI-2mL at DV0002 Baseline (the first 
self-injection visit, immediately after training in self-injection technique). Safe and effective 
self-injection will be evaluated by study personnel and is defined as for the primary outcome 
variable (see Section 2.2.1). 
Change #8  
Section 2.2.3.1 
Outcome variables 
The other outcome variables are: 
• Responses to pre-injection SIAQ (versions 2.0 and 2.1) at Baseline. 
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Whenever SIAQ is assessed, version 2.0 of the SIAQ will be used to assess 
bimekizumab-SS-1mL and version 2.1 of the SIAQ will be used to assess 
bimekizumab-AI-1mL (see Section 11.3.1 and Section 11.3.2). 
• Responses to post-injection SIAQ (versions 2.0 and 2.1) by visit following self-injection 
using the assigned device at Baseline and Week 8. 
• Injection site pain (using a VAS; 100mm) by visit after self-injection at Baseline and 
Week 8. 
• Percentage of used bimekizumab-SS-1mL and bimekizumab-AI-1mL identified as having 
structural or mechanical integrity issues after completion of self-injection. This is based on a 
visual examination of the device that shows clear evidence of damage and/or compromised 
structural or mechanical integrity.  
Has been changed to: 
The other outcome variables are: 
• Responses to pre-injection SIAQ (versions 2.0 and 2.1) at DV0002 Baseline. 
Whenever SIAQ is assessed, version 2.0 of the SIAQ will be used to assess 
bimekizumab-SS-1mL and bimekizumab-SS-2mL and version 2.1 of the SIAQ will be used 
to assess bimekizumab-AI-1mL and bimekizumab-AI-2mL (see Section 11.3.1 and 
Section 11.3.2). 
• Responses to post-injection SIAQ (versions 2.0 and 2.1) by visit following self-injection 
using the assigned device at DV0002 Baseline and Week 8. 
• Injection site pain (using a VAS; 100mm) by visit after self-injection at using the assigned 
device at DV0002 Baseline and Week 8. 
• Percentage of used bimekizumab-SS-1mL and bimekizumab-AI-1mL devices identified as 
having structural or mechanical integrity issues after completion of self-injection. This is 
based on a visual examination of the device that shows clear evidence of damage and/or 
compromised structural or mechanical integrity.  
Change #9  
Section 2.2.3.2 
Pharmacokinetic variable 
The PK variable is trough PK (bimekizumab) levels associated with self-injection using the test 
device, injection by study personnel using the 1mL PFS, injection site (abdomen or thigh), and 
BMI category (by tertile). Trough levels will be assessed at Baseline, Week 4, Week 8, and 
Week 12 for subjects who receive bimekizumab Q4W and trough levels will be assessed at 
Baseline, Week 8, and Week 16 for subjects who receive bimekizumab Q8W. 
Has been changed to:  
The PK variable is trough PK (bimekizumab) levels associated with self-injection using the test 
investigational device, injection by study personnel using the 1mL PFS, injection site (abdomen 
or thigh), and BMI category (by tertile). Trough levels will be assessed at DV0002 Baseline, 
Week 4, Week 8, and Week 12 for subjects who receive bimekizumab Q4W and trough levels 
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will be assessed at DV0002 Baseline, Week 8, and Week 16 for subjects who receive 
bimekizumab Q8W. 
Change #10  
Section 2.3.1 Study description 
DV0002 is a Phase 3 open-label, randomized, noncomparator, North America-only substudy to 
PS0014. PS0014 will evaluate the long-term safety, tolerability, and efficacy of bimekizumab in 
subjects with moderate to severe chronic plaque PSO; study personnel will administer 
bimekizumab to subjects in a 1mL PFS. The DV0002 substudy will evaluate 2 self-injection 
investigational devices: the 1mL bimekizumab-SS-1mL and the 1mL bimekizumab-AI-1mL. 
In the DV0002 substudy, the safe and effective use of the bimekizumab-SS-1mL or the 
bimekizumab-AI-1mL for the sc self-injection of bimekizumab by subjects with PSO will be 
evaluated.  
Subjects from selected sites in the PS0014 feeder studies PS0008, PS0009, and PS0013 will be 
eligible for the DV0002 substudy. The DV0002 substudy will maintain all study assessments of 
the main PS0014 study from Baseline to Week 16 (inclusive). However, only subjects in the 
DV0002 substudy will self-administer bimekizumab. At DV0002 Baseline, each subject will be 
provided with training in self-injection and will receive the IFU and any other applicable training 
materials. Subjects in the DV0002 substudy will perform self-injections at Baseline 
(corresponding to the Baseline Visit of PS0014) with a subsequent self-injection at Week 8 
(corresponding to Week 8 of PS0014). 
Has been changed to:  
DV0002 is a Phase 3 open-label, randomized, noncomparator, North America-only substudy to 
PS0014. PS0014 will evaluate the long-term safety, tolerability, and efficacy of bimekizumab in 
subjects with moderate to severe chronic plaque PSO; study personnel will administer 
bimekizumab to subjects in a 1mL PFS. The DV0002 substudy will evaluate 2 self-injection 
investigational devices: the 1mL bimekizumab-SS-1mL and the 1mL bimekizumab-AI-1mL. 
In the DV0002 substudy, the safe and effective use of the bimekizumab-SS-1mL or the, 
bimekizumab-AI-1mL, bimekizumab-SS-2mL, or the bimekizumab-AI-2mL for the sc self-
injection of bimekizumab by subjects with PSO will be evaluated.  
Subjects from selected sites in the PS0014 feeder studies PS0008, PS0009, and PS0013 will be 
eligible for the DV0002 substudy. The DV0002 substudy will maintain all study assessments of 
the main PS0014 study from Baseline to Week 16 (inclusive). However, only subjects in the 
DV0002 substudy will self-administer bimekizumab. At DV0002 Baseline, each subject will be 
provided with training in self-injection and will receive the IFU and any other applicable training 
materials. 
For the 1mL device cohort, subjectsSubjects in the DV0002 substudy will perform self-
injections at DV0002 Baseline (corresponding to the Baseline Visit of PS0014) with a 
subsequent self-injection at DV0002 Week 8 (corresponding to Week 8 of PS0014). 
To allow flexible enrollment, subjects may be randomized in the 2mL device cohort at the 
PS0014 Week 24, Week 28, or Week 32 visit for subjects receiving bimekizumab Q4W or 
the PS0014 Week 24 or Week 32 visit for subjects receiving bimekizumab Q8W.  
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For the 2mL device cohort, subjects will perform self-injections at DV0002 Baseline with a 
subsequent self-injection 8 weeks after training. The 2mL device cohort will evaluate 2 self-
injection devices: the bimekizumab SS 2mL and the bimekizumab AI 2mL. 
Change #11  
Section 2.3.2 Treatment Period 
During the 16-week Treatment Period of DV0002, subjects will receive either bimekizumab 
320mg Q8W or bimekizumab 320mg Q4W, based on their assigned dose at Baseline. Baseline 
for DV0002 and Baseline for PS0014 will occur at the same time.  
Eligible subjects will be randomly assigned in a 1:1 ratio to perform self-injection using either 
the bimekizumab-SS-1mL or the bimekizumab-AI-1mL. Regardless of the assigned dose 
regimen, subjects will perform self-injection with the assigned device only at Baseline 
(corresponding to the Baseline Visit of PS0014) and at Week 8 (corresponding to Week 8 of 
PS0014). For subjects in the bimekizumab 320mg Q4W dosing arm, injections will be 
administered by study personnel using the 1mL PFS at Week 4 and Week 12; for subjects in both 
dosing arms, injections will be administered by study personnel using the 1mL PFS at Week 16. 
After Week 16 in the DV0002 substudy, subjects will continue in PS0014 (the next visit after 
DV0002 completion will be the Week 20 Visit in PS0014). 
Has been changed to:  
During the 16-week Treatment Period of DV0002, subjects will receive either bimekizumab 
320mg Q8W or bimekizumab 320mg Q4W, based on their assigned dose at PS0014 Baseline. 
Baseline for DV0002 and Baseline for PS0014 will occur at the same time for the 1mL device 
cohort. In the 2mL device cohort, Baseline for DV0002 will occur at the PS0014 Week 24, 
Week 28, or Week 32 visit for subjects receiving bimekizumab Q4W or the PS0014 Week 
24 or Week 32 visit for subjects receiving bimekizumab Q8W. 
Eligible subjects (PS0014 entry criteria and DV0002 entry criteria) will be randomly assigned 
in a 1:1 ratio to perform self-injection using either the bimekizumab-SS-1mL or the 
bimekizumab-AI-1mL for the 1mL device cohort or using either the bimekizumab-SS-2mL 
or the bimekizumab-AI-2mL for the 2mL device cohort. Regardless of the assigned dose 
regimen, subjects will perform self-injection with the assigned device only at DV0002 Baseline 
(corresponding to the Baseline Visit of PS0014) and at DV0002 Week 8 (corresponding to Week 
8 of PS0014). For subjects in the bimekizumab 320mg Q4W dosing arm, injections will be 
administered by study personnel using the 1mL PFSinvestigational device at Week 4 and Week 
12; for subjects in both dosing arms, injections will be administered by study personnel using the 
investigational device 1mL PFSat Week 16. After Week 16 in the DV0002 substudy, subjects 
will continue in PS0014 (the next visit after DV0002 completion will be the Week 20 Visit in 
PS0014). 
First treatment for the 1ml device cohort in PS0014 will be the timepoint of first 
bimekizumab injection in DV0002. First treatment in DV0002 will be the timepoint of first 
self-injection in DV0002. 
After Week 16 in the DV0002 substudy, subjects will continue in PS0014 (the next visit 
after DV0002 completion will be the Week 20 Visit in PS0014). 
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Change #12  
Section 2.3.6 Planned number of subjects 
It is planned to enroll approximately 200 subjects; each device arm will consist of approximately 
100 subjects. It is anticipated that this study will involve up to 80 sites in North America. 
Has been changed to:  
For evaluation of the 1mL device, it It is planned to enroll approximately 200 subjects; each 
device arm (bimekizumab-SS-1mL, bimekizumab-AI-1mL) will consist of approximately 100 
subjects.  
Once the 1mL device cohort has finished enrolling, the 2mL device cohort will start 
enrolling. For evaluation of the 2mL device, it is planned to enroll approximately 100 
subjects; each device arm (bimekizumab SS 2mL or bimekizumab-AI-2mL) will consist of 
approximately 50 subjects. 
It is anticipated that this study will involve up to 80 sites in North America. 
Change #13  
Section 2.4 
Determination of sample size 
This study will not be powered with respect to any endpoint and sample size is based on practical 
considerations. In order to maintain blinding in the PS0014 feeder studies, DV0002 will recruit 
subjects who were administered bimekizumab 320mg (Q4W or Q8W) and subjects who were 
administered placebo or ustekinumab in the PS0014 feeder studies. A total of 100 subjects (50 
subjects per device arm) are planned for PK trough level analyses, but these analyses can only be 
performed on subjects who do not change their bimekizumab dose or dosing regimen (ie, 320mg 
bimekizumab Q4W or Q8W) between the PS0014 feeder studies and the DV0002 substudy. The 
DV0002 substudy will therefore enroll approximately 200 subjects (to compensate for subjects 
with bimekizumab dose changes) to ensure that 100 subjects are available for PK trough 
analysis. 
Each device arm will consist of approximately 100 subjects. Within each device arm, subjects 
will be divided into tertiles by BMI; there will be approximately 33 subjects per tertile, which is 
expected to yield approximately 16 to 17 subjects per tertile who are evaluable for steady state 
trough PK level analyses. 
Subjects are evaluable for steady state trough PK level analyses, if they enter PS0014 on the 
same drug and dose as completing the feeder study and if they receive the drug at least 16-20 
weeks before PS0014. The second condition is automatically fulfilled. Each subject in the feeder 
study will receive more than 20 week the same treatment in the maintenance phase except escape 
subjects from PS0013 which are excluded from DV0002 enrollment. 
Has been changed to:  
This study will not be powered with respect to any endpoint and sample size is based on practical 
considerations. For the 1mL device cohort, In order to maintain blinding in the PS0014 feeder 
studies, DV0002 will recruit subjects who were administered bimekizumab 320mg (Q4W or 
Q8W) and subjects who were administered placebo or ustekinumab in the PS0014 feeder studies. 
A total of 100 subjects (50 subjects per device arm) are planned for PK trough level analyses, but 
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these analyses can only be performed on subjects who do not change their bimekizumab dose or 
dosing regimen (ie, 320mg bimekizumab Q4W or Q8W) between the PS0014 feeder studies and 
the DV0002 substudy. The DV0002 substudy will therefore enroll approximately 200 subjects 
(to compensate for subjects with bimekizumab dose changes) to ensure that 100 subjects are 
available for PK trough analysis. 
Subjects who enroll in the DV0002 substudy 1mL device cohort will be randomly assigned 
to the bimekizumab SS 1mL or the bimekizumab AI 1mL device arms (each device arm 
will consist of approximately 100 subjects)Each device arm will consist of approximately 100 
subjects. Within each device arm, subjects will be divided into tertiles by BMI; there will be 
approximately 33 subjects per tertile, which is expected to yield approximately 16 to 17 subjects 
per tertile who are evaluable for steady state trough PK level analyses. 
Subjects are evaluable for steady state trough PK level analyses, if they enter PS0014 on the 
same drug and dose as completing the feeder study and if they receive the drug at least 16-20 
weeks before PS0014. The second condition is automatically fulfilled. Each subject in the feeder 
study will receive more than 20 week the same treatment in the maintenance phase except escape 
subjects from PS0013 which are excluded from DV0002 enrollment.  
Once the 1mL device cohort has finished enrolling, the 2mL device cohort will start 
enrolling. Subjects who participated in the 1mL device cohort of DV0002 are not eligible to 
enroll in the 2mL device cohort. For evaluation of the 2mL device, it is planned to enroll 
approximately 100 subjects. All 100 subjects will have been on a consistent bimekizumab 
dose regimen for at least 16 weeks, and thus all will be evaluable for the PK trough level 
analyses. 
Subjects who enroll in the DV0002 substudy 2mL device cohort will be randomly assigned 
to the bimekizumab SS 2mL or the bimekizumab AI 2mL device arms (each device arm 
will consist of approximately 50 subjects). Within each device arm, subjects will be divided 
into tertiles by BMI; there will be approximately 16 to 17 subjects per tertile who are 
evaluable for steady state trough PK level analyses. 
Change #14  
Section 3.5.1 1mL Device Cohort 
3.5.1 Enrolled Set 
3.5.2 Safety Set 
3.5.3 Full Analysis Set 
3.5.4 Pharmacokinetic Per Protocol Set 
Two different Pharmacokinetic Per Protocol Sets (PK-PPS) will be generated (1 for each device 
type): the bimekizumab-SS-1mL PK-PPS (PK-PPS-s) and the bimekizumab-AI-1mL PK-PPS 
(PK-PPS-a). Each PK-PPS will consist of all subjects who receive the same bimekizumab 
administration (frequency and dose) in the PS0014 feeder studies as in the DV0002 substudy and 
who have at least 1 evaluable PK assessment in the DV0002 substudy without important protocol 
deviations that would affect the concentration. Pharmacokinetic variables will be analyzed using 
the PK-PPS-s and PK-PPS-a. 
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Has been changed to:  
3.5.13.5.1.1 
Enrolled Set 
3.5.13.5.1.2 
Safety Set 
3.5.13.5.1.3 
Full Analysis Set 
3.5.13.5.1.4 
Pharmacokinetic Per Protocol Set 
Two different Pharmacokinetic Per Protocol Sets (PK-PPS) will be generated (1 for each device 
type): the bimekizumab-SS-1mL PK-PPS (PK-PPS-s) and the bimekizumab-AI-1mL PK-PPS 
(PK-PPS-a). Each PK-PPS will consist of all subjects who receive the same bimekizumab 
administration (frequency and dose) in the PS0014 feeder studies as in the DV0002 substudy and 
who have at least 1 evaluable PK assessment in the DV0002 substudy without important protocol 
deviations that would affect the concentration. Pharmacokinetic variables will be analyzed using 
the PK-PPS-s and PK-PPS-a. 
All PK assessments after baseline assessments from feeder study will be considered for the 
requirement of at least one evaluable PK assessment. 
Change #15  
The following sections has been added:  
3.5.2 2mL Device Cohort 
3.5.2.1 Enrolled Set 
The Enrolled Set (ES) will consist of all subjects who have given informed consent for 
DV0002. 
3.5.2.2 Safety Set 
Two different Safety Sets (SS) will be generated (1 for each device type): the bimekizumab-
SS-2mL Safety Set (SS-s) and the bimekizumab-AI-2mL Safety Set (SS-a). Each SS will 
consist of all subjects in the study who receive at least 1 dose of bimekizumab by the 
indicated self-injection investigational device. Safety variables will be analyzed using the 
SS-s and SS-a. 
3.5.2.3 Full Analysis Set 
Two different Full Analysis Sets (FASs) will be generated (1 for each device type): FAS-s 
and FAS-a. Each FAS will consist of all subjects in the SS-s or SS-a who self-inject at least 
1 dose of bimekizumab using the given device and who have an assessment of self-injection. 
All self-injection related endpoints will be analyzed using the FAS-s and FAS-a. 
3.5.2.4 Pharmacokinetic Per Protocol Set 
Two different Pharmacokinetic Per Protocol Sets (PK-PPS) will be generated (1 for each 
device type): the bimekizumab-SS-2mL PK-PPS (PK-PPS-s) and the bimekizumab-AI-
2mL PK-PPS (PK-PPS-a). Each PK-PPS will consist of all subjects who receive the same 
bimekizumab administration (frequency and dose) in the PS0014 feeder studies as in the 
DV0002 substudy and who have at least 1 evaluable PK assessment in the DV0002 
substudy without important protocol deviations that would affect the concentration. 
Pharmacokinetic variables will be analyzed using the PK-PPS-s and PK-PPS-a. 
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All PK assessments after baseline assessments from feeder study will be considered for the 
requirement of at least one evaluable PK assessment. 
Change #16  
Section 3.6 
Treatment assignment, treatment and device groups 
The PS0014 treatment groups are as follows: 
• 
Bimekizumab 320mg Q4W 
• 
Bimekizumab 320mg Q8W. 
DV0002 device groups 
This refers to the study device assigned to the subject at the beginning of DV0002. The DV0002 
device groups are as follows: 
• 
Bimekizumab-SS-1mL 
• 
Bimekizumab-AI-1mL. 
Has been changed to:  
The PS0014 treatment groups are as follows: 
• 
Bimekizumab 320mg Q4WQ8W 
• 
Bimekizumab 320mg Q8WQ4W. 
DV0002 device groups 
This refers to the study device assigned to the subject at the beginning of DV0002. The DV0002 
1mL device groups are as follows: 
• 
Bimekizumab-SS-1mL 
• 
Bimekizumab-AI-1mL. 
The DV0002 2mL device groups are as follows: 
• 
Bimekizumab-SS-2mL 
• 
Bimekizumab-AI-2mL. 
Change #17  
Section 3.9 
Changes to protocol-defined analyses 
The following part has been removed:  
The analysis sets to be used for the PK data have been amended from the PK Analysis set to the 
PK Per Protocol Analysis set (PK-PPS) throughout which will allow the exclusion of subjects 
with important protocol deviations related to PK from the primary analysis. 
Change #18  
Section 4.2 
Handling of dropouts or missing data 
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If the intensity of an ADE is unknown, it will be considered as severe. If the relationship to study 
drug is missing, it is considered as related.   
Has been changed to:  
If the intensity of an ADE is unknown, it will be considered as severe. If the relationship to study 
drug is missing, it is considered as related.   
Change #19  
Section 4.3 
Interim analyses and data monitoring 
The following part has been added: 
The subjects of DV0002 are ongoing subjects of PS0014. Data cut off for the 1mL final 
analysis will be last subject last Week 16 visit in DV0002 in the 1mL device cohort. Data cut 
off for the 2mL final analysis will be last subject last Week 16 visit in DV0002 in the 2mL 
device cohort. Data cut off rules will be applied for ongoing adverse device events and 
ongoing concomitant medication.  
Change #20  
Section 5.1 
Subject disposition 
All subject disposition tables will use the PS0014 treatment groups BKZ 320mg Q4W and BKZ 
320mg Q8W and an overall treatment group category (BKZ Total).  
[…] 
The number and percentage of subjects who entered the substudy, completed, discontinued with 
the reasons for discontinuation of the substudy will be presented. This summary will be based on 
the ES and will present all bimekizumab treated subjects by PS0014 treatment group and broken 
out by DV0002 device group. 
Has been changed to:  
All subject disposition tables will use the PS0014 treatment groups BKZ 320mg Q4W Q8W and 
BKZ 320mg Q8W Q4W and an overall treatment group category (BKZ Total).  
[…] 
The number and percentage of subjects who entered the substudy, completed, discontinued with 
the reasons for discontinuation of the substudy will be presented. This summary will be based on 
the ES and will present all bimekizumab treated subjects by PS0014 treatment group and broken 
out by DV0002 device group. 
Subjects will be counted as completer if they completed the DV0002 Week 16 visit. 
Change #21  
Section 6.1. 
Demographics 
Demographic variables will be summarized by PS0014 treatment group and all bimekizumab 
treated subjects. 
The following continuous variables will be summarized using descriptive statistics (number of 
subjects, mean, SD, minimum, median and maximum). 
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• Age at the time of DV0002 study entry (years) 
• Height (cm) 
• Weight (kg) 
• BMI (kg/m2)  
• BMI (kg/m2) will be calculated as: 
 
𝐵𝑀𝐼= Weight (kg)
(Height (m))2 
 
The following categorical variables will be summarized using frequency counts and percentages. 
• Age group (≤18, 19-<65, ≥65 years)  
• Body Weight (≤100kg, >100kg) 
• BMI (<25 kg/m2, 25 to <30 kg/m2, ≥30 kg/m2) 
• BMI tertiles (≤t1 kg/m2, >t1 kg/m2 to ≤ t2 kg/m2, >t2 kg/m2) based on the respective PK-
PPS populations (PK-PPS-s, PK-PPS-s) 
Has been changed to:  
Demographic variables will be summarized by PS0014 treatment group and all bimekizumab 
treated subjects. 
The following continuous variables will be summarized using descriptive statistics (number of 
subjects, mean, SD, minimum, median and maximum). 
• Age at the time of DV0002feeder study entry (years) 
• Height (cm) 
• DV0002 Baseline Weight (kg): will be derived from the weight from the last visit of the 
feeder study for 1mL device cohort subjects and will be derived from last weight prior 
to first treatment in DV0002 for 2mL cohort 
• DV0002 Baseline BMI (kg/m2)  
• BMI (kg/m2) will be calculated as: 
 
𝐵𝑀𝐼= Weight (kg)
(Height (m))2 
 
The following categorical variables will be summarized using frequency counts and percentages. 
• Age group (≤18, 19-<65, ≥65 years)  
• DV0002 Baseline Body Weight (≤100kg, >100kg) 
• BMI (<25 kg/m2, 25 to <30 kg/m2, ≥30 kg/m2) 
• BMI tertiles (≤t1 kg/m2, >t1 kg/m2 to ≤ t2 kg/m2, >t2 kg/m2) based on the respective PK-
PPS populations (PK-PPS-s, PK-PPS-s) 
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Change #22  
Section 6.2 
Other Baseline characteristics 
Disease Duration = (Date of randomization −Date of onset of Plaque Psoriasis1)
365.25
 
Has been changed to:  
Disease Duration =
(Date of randomization in DV0002 −Date of onset of Plaque Psoriasis1)
365.25
 
Change #23  
Section 6.3 
Medical history and concomitant diseases 
All medical conditions not yet occurred and reported in the feeder studies will be presented in a 
by-subject listing for SS-s and SS-a, respectively. 
Has been changed to:  
Previous and ongoing medical history from feeder study will be based on SS-s and SS-a and 
summarized by treatment groups, system organ class (SOC) and preferred term (PT) using 
MedDRA®. Medical history and psoriasis history will be included in the summary tables 
and listings for medical history. Medical procedures are not coded.  
Previous and ongoing medical history All medical conditions not yet occurred and reported in 
the feeder studies will be presented in a by-subject listing for SS-s and SS-a, respectively. 
Change #24  
Section 6.4 
Prior and concomitant medications 
Concomitant medication details are collected at each visit of DV0002. Concomitant medications 
are medications taken at least one day in common with the PS0014 study medication dosing 
period (Baseline to Visit 16). 
No imputation of start and stop dates will be done for concomitant medication. If a date is 
missing the medication is assumed to be concomitant. 
All concomitant medication will be listed for SS-s and SS-a, respectively. 
Has been changed to:  
Concomitant medication details are collected at each visit of DV0002. Concomitant medications 
are medications taken at least one day in common with the PS0014 DV0002 study medication 
dosing period (DV0002 Baseline to Visit DV0002 Week 16). 
No imputation of start and stop dates will be done for concomitant medication. If a date is 
missing the medication is assumed to be concomitant. 
All concomitant medication will be listed for SS-s and SS-a, respectively.  
Concomitant medication which started before DV0002 Week 16 and were ongoing at the 
data cut off will be included with the status remaining as ongoing. Concomitant medication 
which were ongoing at DV0002 Week 16 but with an end date before the data cut off will be 
included with their end date as recorded. 
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Change #25  
Section 9.1 
Pharmacokinetics 
The statistical analyses of the PK data will be descriptive in nature and will be summarized using 
the relevant device-specific population (PK-PPS-s or PK-PPS-a). Data will be analyzed overall 
for each device by injection type (self-administered or study personnel-administered), by 
injection site (abdomen or thigh), and by BMI category. The BMI categories will be defined into 
three tertiles within each device arm PK-PPS analysis set and derived from subjects’ Baseline 
BMI values. 
To allow for an analysis of PK trough levels for bimekizumab administration via self-injection or 
via study personnel administration, pre-dose PK samples will be taken throughout the DV0002 
substudy. For the Q4W dose regimen, PK trough levels will be determined based on pre-dose PK 
sampling at Baseline and Week 8 for the study personnel administration and at Week 4 and 
Week 12 for the self-administration trough levels, respectively. For the Q8W dose regimen, PK 
trough levels will be determined based on pre-dose PK sampling at Baseline for the study 
personnel administration and at Week 8 and Week 16 for the self-administration trough levels, 
respectively. For the analysis of PK trough levels by injection site (abdomen or thigh) and by 
BMI category (by tertile), only self-administration PK trough levels will be used. 
PK summaries will be based on observed values. No imputation will be used. However, if 
plasma concentration measurements are below the level of quantification, then for calculation of 
the derived statistics the result will be set to ½ of the lower level of quantification (LLOQ). 
Descriptive statistics including geometric mean, geometric coefficient of variation, and 
geometric mean 95% CI if applicable will be calculated if at least 2/3 of the values of interest are 
above the LLOQ. If this is not the case, only median, minimum, and maximum will be presented. 
Boxplots of plasma concentration will be presented by visit and by treatment group. 
Has been changed to:  
The statistical analyses of the PK data will be descriptive in nature and will be summarized using 
the relevant device-specific population (PK-PPS-s or PK-PPS-a). Data will be analyzed overall 
for each device by injection type (self-administered or study personnel-administered), by 
injection site (abdomen or thigh), and by BMI category. The BMI categories will be defined into 
three tertiles within each device arm PK-PPS analysis set and device cohort and derived from 
subjects’ DV0002 Baseline BMI values. 
To allow for an analysis of PK trough levels for bimekizumab administration via self-injection or 
via study personnel administration, pre-dose PK samples will be taken throughout the DV0002 
substudy. For the Q4W dose regimen, PK trough levels will be determined based on pre-dose PK 
sampling at DV0002 Baseline and DV0002 Week 8 for the study personnel administration and at 
DV0002 Week 4 and DV0002 Week 12 for the self-administration trough levels, respectively. 
For the Q8W dose regimen, PK trough levels will be determined based on pre-dose PK sampling 
at DV0002 Baseline for the study personnel administration and at DV0002 Week 8 and DV0002 
Week 16 for the self-administration trough levels, respectively. For the 1ml device cohort, 
DV0002 Baseline PK samples are the PK samples from the last visit of the feeder studies.  
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For the analysis of PK trough levels by injection site (abdomen or thigh) and by BMI category 
(by tertiles), only self-administration PK trough levels and study personnel administration PK 
trough levels will be used. 
In case the injection sites are different for both injections at one visit, or the injection site is 
the arm (not abdomen or thigh) the PK results will not be included for the summary by 
injection site.  
PK samples for self-administration where the injection was done by site personnel or 
caregiver will be listed but not be used for summary statistics. PK samples for personnel 
administration where the injection was done by the subject will be listed but not be used 
for summary statistics. 
Only pre-dose (trough) concentrations will be included while summarizing tables and 
figures. If the dosing for a visit is +/- 7 days out of window then the plasma concentration 
from that visit and all subsequent visits will be excluded from the PK summary. PK 
samples collected after dosing will be excluded from summary statistics.  
PK summaries will be based on observed values. No imputation will be used. However, if 
plasma concentration measurements are below the level of quantification, then for calculation of 
the derived statistics the result will be set to ½ of the lower level of quantification (LLOQ). 
Descriptive statistics including geometric mean, geometric coefficient of variation, and 
geometric mean 95% CI if applicable will be calculated if at least 2/3 of the values of interest are 
above the LLOQ. If this is not the case, only median, minimum, and maximum will be presented. 
Boxplots of plasma concentration will be presented by visit and by treatment group. 
All PK results will be listed.  
In addition, the PK results from all subjects not in PK-PPS-s or PK-PPS-a will be listed 
based on the SS-a and SS-s. 
Change #26  
Section 10.2 Adverse events 
10.1.1 Adverse device effects 
All AEs (including serious adverse events [SAEs]) will be reported in a common database for 
PS0014 and DV0002, but only adverse device effects (ADEs), serious adverse device effects 
(SADEs), and device deficiencies will be summarized in the DV0002 substudy. Specifically, 
only those AEs related to the use of the investigational medical devices bimekizumab-SS-1mL or 
bimekizumab-AI-1mL (based on the Investigator’s judgement) will be assessed. All AEs 
(including SAEs) which are not assessed to be related to the investigational devices will be 
summarized separately in the report for the main study PS0014. 
[…] 
• Incidence of TEADEs leading to discontinuation 
For definition of serious, unanticipated and serious unanticipated ADEs see protocol of DV0002.  
Has been changed to:  
10.1.1 Adverse device effects 
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All AEs (including serious adverse events [SAEs]) will be reported in a common database for 
PS0014 and DV0002, but only adverse device effects (ADEs), serious adverse device effects 
(SADEs), and device deficiencies will be summarized in the DV0002 substudy. Specifically, 
only those AEs related to the use of the investigational medical devices bimekizumab-SS-1mL or 
bimekizumab-AI-1mL (based on the Investigator’s judgement) will be assessed. All AEs 
(including SAEs) which are not assessed to be related to the investigational devices will be 
summarized separately in the report for the main study PS0014. An exception are AEs that are 
indicated as injection site reactions during self-injection. These will be listed in DV0002 as 
well as in PS0014. 
10.2.1 Adverse device effects 
[…] 
• Incidence of TEADEs leading to discontinuation 
• Incidence of non-TEADEs (only listed and not summarized in a table) 
For definition of serious, unanticipated and serious unanticipated ADEs see protocol of DV0002.  
Adverse device effects which started before DV0002 Week 16 and were ongoing at the data 
cut off will be included with the status remaining as ongoing. Adverse device effects which 
were ongoing at DV0002 Week 16 but with an end date before the data cut off will be 
included with their end date as recorded. 
10.2.2 Injection site reaction 
Injection site reactions are recorded at the AE CRF page at the time when they occur. All 
AEs will be coded and classified by system organ class, high level term, and preferred term. 
An AE with High Level Terms of “Administration site reactions NEC” and “Injection site 
reactions” will be evaluated as injection site reaction. 
All injection site reactions for self-injection with a start date on or following the first self-
administration of study treatment through the final self-administration of study treatment 
+ 7 days will be listed. 
Change #27  
Section 11.1 Primary outcome 
The primary outcome variable is the percentage of all subjects able to self-administer safe and 
effective injections using the given device at Week 8. Safe and effective self-injection will be 
evaluated by the study personnel as defined below: 
• Complete dose delivery: Subject self-injects the complete dose of bimekizumab as confirmed 
by a visual inspection of the bimekizumab-SS-1mL or the bimekizumab-AI-
1mLinvestigational device which shows that the IMP is delivered completely (ie, container is 
empty), and 
• No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs 
and/or ADEs leading to withdrawal from the DV0002 substudy). 
All data to assess the primary outcome is collected on the subject self-injection of bimekizumab 
CRF page for Week 8. For the number of subjects with safe and effective self-injections simply 
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the cases which indicated “yes” for the question “Did the subject self-inject the complete dose of 
Bimekizumab” and “no” for the question “Where there any AEs related to use of the 
investigational device for self-injection” at Week 8 are counted.   
Two self-injections will be performed at Week 8 and the questions will be answered twice. If the 
answers are different between both self-injections in one visit, then the worst case of both 
answers will be used for analysis at this visit.  
[…] 
Has been changed to:  
The primary outcome variable is the percentage of all subjects able to self-administer safe and 
effective injections using the given device at DV0002 Week 8. Safe and effective self-injection 
will be 
evaluated by the study personnel as defined below: 
• Complete dose delivery: Subject self-injects the complete dose of bimekizumab as confirmed 
by a visual inspection of the bimekizumab-SS-1mL or the bimekizumab-AI-
1mLinvestigational device which shows that the IMP is delivered completely (ie, container 
is empty), and 
• No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs 
and/or ADEs leading to withdrawal from the DV0002 substudy). 
All data to assess the primary outcome is collected on the subject self-injection of bimekizumab 
CRF page for DV0002 Week 8. For the number of subjects with safe and effective self-injections 
simply the cases which indicated “yes” for the question “Did the subject self-inject the complete 
dose of Bimekizumab” and “no” for the question “Where there any AEs related to use of the 
investigational device for self-injection” at DV0002 Week 8 are counted.   
For subjects in the 1mL device cohort, Ttwo self-injections will be performed at DV0002 
Week 8 and the questions will be answered twice. If the answers are different between both self-
injections in one visit, then the worst case of both answers will be used for analysis at this visit. 
Subjects with only one self-injection at one visit will be counted as non-responder. 
Assessments where the self-injection was not performed by the subject will be not included 
in any summary statistics. 
[…] 
Change #28  
Section 11.2 Secondary outcome 
The secondary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the given device at Baseline (first self-injection visit). Safe and 
effective self-injection will be evaluated by the study personnel. The secondary outcome 
variables will be analyzed in the same manner as the primary outcome variable. All data to 
assess the secondary outcome is collected on Subject self-injection of Bimekizumab CRF page 
for Baseline. 
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Has been changed to:  
The secondary outcome variable is the percentage of subjects able to self-administer safe and 
effective injections using the given device at DV0002 Baseline (first self-injection visit). Safe 
and effective self-injection will be evaluated by the study personnel. The secondary outcome 
variables will be analyzed in the same manner as the primary outcome variable. All data to 
assess the secondary outcome is collected on Subject self-injection of Bimekizumab CRF page 
for DV0002 Baseline. 
Change #29  
Section 11.3 Other outcomes 
The secondary outcome variables will be summarized using descriptive statistics and they will be 
tabulated separately for each device overall based and within each device by PS0014 treatment. 
Has been changed to:  
The secondary other outcome variables will be summarized using descriptive statistics and they 
will be tabulated separately for each device overall based and within each device by PS0014 
treatment. 
Assessments where the self-injection was not performed by the subject will be not included 
in any summary statistics. 
Change #30  
Section 11.3.1 Pre-injection SIAQ (versions 2.0 and 2.1) 
The pre-injection SIAQ (versions 2.0 and 2.1) will be performed at Baseline. Version 2.0 of the 
SIAQ will be used to assess bimekizumab-SS-1mL and version 2.1 of the SIAQ will be used to 
assess bimekizumab-AI-1mL. There are no differences in Version 2.0 to Version 2.1 in pre-
injection SIAQ.    
The pre-injection SIAQ consists of 7 items each with a scale of 1 to 5. There is an overall score 
(7 items) and three individual subscales (feelings about injections [FL, 3 items], self-confidence 
[CO, 3 items] and satisfaction with current mode of administration [SA, 1 item]). Each subscale 
and the overall score will be calculated using the average of the individual transformed item 
scores. The item score will be transformed using the following rule: 
𝑇𝑟𝑎𝑛𝑠𝑓𝑜𝑟𝑚𝑒𝑑 𝐼𝑡𝑒𝑚 𝑆𝑐𝑜𝑟𝑒= ((𝑟𝑎𝑤 𝑖𝑡𝑒𝑚 𝑠𝑐𝑜𝑟𝑒) −1) ×  2.5 
In the case of missing values, no domain score will be calculated if more than 50% of the items 
within the domain are missing. 
Higher individual or overall total scores of the pre- -injection indicate more confidence, higher 
satisfaction and less concerns with self-injections. 
Summary statistics for all individual items, each subscale and the total score will be produced for 
Baseline.  
Has been changed to:  
The pre-injection SIAQ (versions 2.0 and 2.1) will be completed performed at DV0002 
Baseline. Version 2.0 of the SIAQ will be used to assess bimekizumab-SS-1mL and 
bimekizumab-SS-2mL and version 2.1 of the SIAQ will be used to assess bimekizumab-AI-
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1mL and bimekizumab-AI-2mL. There are no differences in Version 2.0 to Version 2.1 in pre-
injection SIAQ.    
The pre-injection SIAQ consists of 7 items each with a scale of 1 to 5. There is an overall score 
(7 items) and There are three individual subscales (feelings about injections [FL, 3 items], self-
confidence [CO, 3 items] and satisfaction with current mode of administration [SA, 1 item]). 
Each subscale score and the overall score will be calculated using the average of the individual 
transformed item scores. The item score will be transformed using the following rule: 
Transformed Item Score= ((raw item score)-1)  × 2.5 
In the case of missing values, no domain score will be calculated if more than 50% of the items 
within the domain are missing. 
Higher individual or overall total scores of the pre- -injection SIAQ indicate more confidence, 
higher satisfaction and less concerns with self-injections. 
Summary statistics for all individual items and , each subscale and the total score will be 
produced for Baseline. 
Change #31 
Section 11.3.2 Post-injection SIAQ (versions 2.0 and 2.1) 
The post-injection SIAQ (versions 2.0 and 2.1) will be performed at Baseline. Version 2.0 of the 
SIAQ will be used to assess bimekizumab-SS-1mL and version 2.1 of the SIAQ will be used to 
assess bimekizumab-AI-1mL. Version 2.0 and version 2.1 of the SIAQ are identical, except for 
Question 11 due to different handling of the devices. 
The post-injection SIAQ consists of 21 items on 6 individual subscales (FL [3 items], self-image 
[IM, 1 item], CO [3 items], Injection-site reactions [RE, 2 items], ease of use [EU, 5 items) and 
satisfaction with self-injection [SA, 7 items]). The items of the individual subscale SA have a 
score range of 1 to 6, the other individual subscales have a score range of 1 to 5. Each subscale 
and the overall score will be calculated using the average of the individual transformed item 
scores. The item scores for the SA subscale will be transformed using the following rule: 
Transformed Item Score= ((raw item score)-1)  × 2 
The item scores for the other subscales and the overall score will be transformed using the 
following rule: 
Transformed Item Score= ((raw item score)-1)  × 2.5 
In the case of missing values, no domain score will be calculated if more than 50% of the items 
within the domain are missing. 
Higher individual or overall total scores of the post-injection indicate more confidence, higher 
satisfaction and less concerns with self-injections. 
Summary statistics for all individual items, each subscale and the total score will be produced for 
Baseline and week 8. 
Has been changed to:  
The post-injection SIAQ (versions 2.0 and 2.1) will be completed performed at DV0002 
Baseline and DV0002 Week 8. Version 2.0 of the SIAQ will be used to assess bimekizumab-
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SS-1mL and bimekizumab-SS-2mL and version 2.1 of the SIAQ will be used to assess 
bimekizumab-AI-1mL and bimekizumab-AI-2mL. Version 2.0 and version 2.1 of the SIAQ are 
identical, except for Question 11 due to different handling of the devices. 
The post-injection SIAQ consists of 21 items on 6 individual subscales (FL [3 items], self-image 
[IM, 1 item], CO [3 items], Injection-site reactions [RE, 2 items], ease of use [EU, 5 items) and 
satisfaction with self-injection [SA, 7 items]). The items of the individual subscale SA EU have 
a score range of 1 to 6, the other individual subscales have a score range of 1 to 5. Each subscale 
score and the overall score will be calculated using the average of the individual transformed 
item scores. The item scores for the SA EU subscale will be transformed using the following 
rule: 
Transformed Item Score= ((raw item score)-1)  × 2 
The item scores for the other subscales and the overall score will be transformed using the 
following rule: 
Transformed Item Score= ((raw item score)-1)  × 2.5 
In the case of missing values, no domain score will be calculated if more than 50% of the items 
within the domain are missing. 
Higher individual or overall total scores of the post-injection SIAQ indicate more confidence, 
higher satisfaction and less concerns with self-injections. 
Summary statistics for all individual items, and each subscale and the total score will be 
produced for DV0002 Baseline and DV0002 wWeek 8. 
Change #32 
Section 11.3.3 Injection site pain 
The visual analog scale of injection site pain indicates the level of pain during the injection. It 
reaches from 0-100 mm with higher values for more severe pain and 0 for no pain.   
Summary statistics of actual values and change from Baseline values will be used to summarize 
injection site pain by visit after self-injection. 
Has been changed to:  
The visual analog scale of injection site pain indicates the level of pain during the injection. It 
ranges reaches from 0-100 mm with higher values indicating for more severe pain and 0 for no 
pain.   
Summary statistics of actual values and change from DV0002 Baseline values will be used to 
summarize injection site pain by visit after self-injection. 
Change #33  
Section 11.3.4 Structural and mechanical integrity of the devices 
Frequency tables will be produced to show the number and percentage of devices with:  
• used bimekizumab-SS-1mL and bimekizumab-AI-1mL syringes identified as having 
structural integrity issues after completion of self-injection. 
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• used bimekizumab-SS-1mL and bimekizumab-AI-1mL syringes identified as functionally 
compromised. 
Has been changed to:  
Frequency tables will be produced to show the number and percentage of devices with:  
• used bimekizumab-SS-1mL, bimekizumab-AI-1mL, bimekizumab-SS-2mL and 
bimekizumab-AI-1mL2mL syringes identified as having structural integrity issues after 
completion of self-injection. 
• used bimekizumab-SS-1mL, bimekizumab-AI-1mL, bimekizumab-SS-2mL and 
bimekizumab-AI-1mL2mL syringes identified as functionally compromised. 
The 90% CIs based on the Exact Binomial method will be reported as well. 
 
13.2 
SAP Amendment 2 
Rationale for the amendment 
It was decided to add the analysis of the COVID-19 impact for the 2mL phase analysis. 
Modifications and changes 
Global changes: 
The following changes were made throughout the SAP: 
• The list of abbreviations was updated accordingly. 
• Minor spelling, editorial, and formatting changes were made throughout the document.  
Specific changes 
In addition to the global changes, the following specific changes have been made (formats as 
missing spaces or redundant spaces are not listed): 
Change #1 
The following sections has been added:  
3.2 Analysis Time Points 
If the early withdrawal visit occurs at a scheduled visit as outlined in the schedule of 
assessments, then no mapping is necessary, and any early withdrawal assessments should 
correspond to that scheduled visit. Premature study withdrawal visit assessments that 
occur on a date after a scheduled visit will be assigned to the next scheduled site visit per 
the protocol following the last visit where assessments were available. 
Change #2 
The following paragraphs have been added to section 3.5 
Protocol deviations:  
WHO declared a global COVID-19 pandemic on 11 March 2020.  All subjects were 
recruited into this study during the pandemic and therefore the impact of COVID-19 on 
the study will be assessed. Deviations related to the Coronavirus Disease 2019 (COVID-19) 
global pandemic are unavoidable deviations from the protocol due to confirmed COVID-19 
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infection, suspected COVID-19 infection, general circumstances around COVID-19 without 
infection or any other deviation from the protocol due to COVID-19. COVID-19 protocol 
deviations will be reviewed as part of the ongoing data cleaning process. Any COVID-19 
impact protocol deviations that are determined to be important or not-important will be 
included in this summary. A by-subject listing of COVID-19 related protocol deviations 
will be provided. 
Change #3 
The following sections has been added:  
3.10.1 Changes related to COVID-19 
COVID-19 protocol deviations have been defined in Section 3.5 and the presentation of 
COVID-19 protocol deviations is described in Section 5.3.  
Change #4 
Section 4.2 Handling of dropouts or missing data 
For analyses of ADEs and concomitant medication usage, a complete date must be established in 
order to correctly identify the ADE or medication as occurring during treatment or not. For 
purposes of imputing missing components of partially-reported start and stop dates for ADEs,  
for medication use, the algorithms listed below will be followed. Start and stop dates of ADEs or 
concomitant medication will be displayed as reported in the subject data listings (i.e., no imputed 
values will be displayed in data listings). 
Partial ADE and concomitant medication start dates will be imputed as follows: 
Imputation of Partial Start Dates 
• 
If only the month and year are specified and the month and year of first dose is not the 
same as the month and year of the start date, then use the 1st of the month 
• 
If only the month and year are specified and the month and year of first dose is the same 
as the month and year of the start date, then use the date of first dose 
• 
If only the year is specified, and the year of first dose is not the same as the year of the 
start date, then use the 1st of January of the year of the start date 
• 
If only the year is specified, and the year of first dose is the same as the year of the start 
date, then use the date of first dose 
• 
If the start date is completely unknown and the stop date is unknown or not prior to the 
date of first dose, then use the date of first dose. 
Imputation of Partial Stop Dates 
• 
If only the month and year are specified, then use the last day of the month 
• 
If only the year is specified, then use December 31st of that year 
• 
If the stop date is completely unknown, do not impute the stop date. 
Has been changed to:  
For analyses of ADEs and concomitant medication usage, a complete date must be established in 
order to correctly identify the ADE or medication as occurring during treatment or not. To 
calculate the duration of disease, a complete date of onset of plaque psoriasis is needed. For 
purposes of imputing missing components of partially-reported start and stop dates for ADEs,  
for medication use, and date of onset of plaque psoriasis, the algorithms listed below will be 
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followed. Start and stop dates of ADEs or concomitant medication will be displayed as reported 
in the subject data listings (i.e., no imputed values will be displayed in data listings). 
Partial ADE and concomitant medication start dates will be imputed as follows: 
Imputation of Partial Start Dates 
• If only the month and year are specified and the month and year of first dose is not the same 
as the month and year of the start date, then use the 1st of the month 
• If only the month and year are specified and the month and year of first dose is the same as 
the month and year of the start date, then use the date of first dose 
• If only the year is specified, and the year of first dose is not the same as the year of the start 
date, then use the 1st of January of the year of the start date 
• If only the year is specified, and the year of first dose is the same as the year of the start date, 
then use the date of first dose 
• If the start date is completely unknown and the stop date is unknown or not prior to the date 
of first dose, then use the date of first dose. 
Imputation of Partial Stop Dates 
• If only the month and year are specified, then use the last day of the month 
• If only the year is specified, then use December 31st of that year 
• If the stop date is completely unknown, do not impute the stop date. 
If the (imputed) stop date is prior to the imputed start date: 
• If only the month and year are specified and the month and year of first dose is the 
same as the month and year of the start date and the stop date is before the date of first 
dose, then set the start date to the 1st of that month. 
• If only the year is specified, and the year of first dose is the same as the year of the start 
date, and the stop date is before the date of first dose, then use the 1st of January of the 
year of the start date 
Partial start dates for onset date of plaque psoriasis will be imputed as follows:  
• If only the month and year are specified, then use the last day of the month. 
• If only the year is specified, then use the 31st of December of the year. 
• If the start date is completely unknown, do not impute the start date. 
Change #5 
The following section is added: 
Section 5.3 
 COVID-19 Impact 
For study participants impacted by the COVID-19 global pandemic, data was collected on 
a separate eCRF. This form was collected for study visits that were affected by COVID-19, 
and it collected how the visits were impacted by the pandemic (e.g., performed out of 
window, done by telephone instead of on-site, not done, etc).     
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Based on how the visit was affected by the global pandemic, all visits will have a variable 
indicating how the visit was performed:  
• Visit not done at all 
• Visit done by video call 
• Visit done by telephone 
• Visit done at different time point than planned / out of window 
Additionally, for visits that are affected by COVID-19, all assessments that are missing will 
be flagged as missing due to COVID-19. Further, the specific reason of missing data will be 
captured as the following flags: 
• Confirmed COVID-19 infection  
• Suspected COVID-19 infection  
• General circumstances around COVID-19 without infection 
• Other 
A summary of number and percentage of subjects with COVID-19 related protocol 
deviations and COVID-19 related device protocol deviations by treatment group and visit 
will be provided for the SS-a and SS-s. This summary on COVID-19 related protocol 
deviations will also be repeated by country. 
A by-site, subject and visit listing of COVID-19 related protocol deviations along with a 
listing of COVID-19 related device protocol deviations will be provided. 
Change #6 
The following text in section 13.2 has been removed: 
No imputation of start and stop dates will be done for concomitant medication. If a date is 
missing the medication is assumed to be concomitant. 
Change #7 
The following text in section 9.1 has been removed: 
In case the injection sites are different for both injections at one visit, or the injection site is the 
arm (not abdomen or thigh) the PK results will not be included for the summary by injection site.   
Change #8 
The following text has been added to section 10.2.1 Adverse device effects: 
Adverse events are recorded at the AE CRF page at the time when they occur. If an adverse 
event is related to the device by assessment of the investigator it is counted as an Adverse device 
event. For DV0002 only ADE will be considered which started during the DV0002 study 
period. And ADEs started in the 1 ml phase will be included for 1 ml phase analysis, and 
those started in the 2 ml phase will be included for the 2 ml phase analysis. 
 
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13.3 
SAP Amendment 3 
Rationale for the amendment 
It was decided to update the PK-PPS definition for the 2mL phase analysis. 
Modifications and changes 
Global changes: 
The following changes were made throughout the SAP: 
• Minor spelling, editorial, and formatting changes were made throughout the document.  
Specific changes 
In addition to the global changes, the following specific changes have been made (formats as 
missing spaces or redundant spaces are not listed): 
Change #1 
The section 2.4 
Determination of sample size: 
This study will not be powered with respect to any endpoint and sample size is based on practical 
considerations. For the 1mL device cohort, to maintain blinding in the PS0014 feeder studies, 
DV0002 will recruit subjects who were administered bimekizumab 320mg (Q4W or Q8W) and 
subjects who were administered placebo or ustekinumab in the PS0014 feeder studies. A total of 
100 subjects (50 subjects per device arm) are planned for PK trough level analyses, but these 
analyses can only be performed on subjects who do not change their bimekizumab dose or 
dosing regimen (ie, 320mg bimekizumab Q4W or Q8W) between the PS0014 feeder studies and 
the DV0002 substudy. The DV0002 substudy will therefore enroll approximately 200 subjects 
(to compensate for subjects with bimekizumab dose changes) to ensure that 100 subjects are 
available for PK trough analysis. 
Subjects who enroll in the DV0002 substudy 1mL device cohort will be randomly assigned to 
the bimekizumab SS 1mL or the bimekizumab AI 1mL device arms (each device arm will 
consist of approximately 100 subjects). Within each device arm, subjects will be divided into 
tertiles by BMI; there will be approximately 33 subjects per tertile, which is expected to yield 
approximately 16 to 17 subjects per tertile who are evaluable for steady state trough PK level 
analyses. 
Subjects are evaluable for steady state though PK level analyses, if they enter PS0014 on the 
same drug and dose as completing the feeder study and if they receive the drug at least 16-20 
weeks before PS0014. The second condition is automatically fulfilled. Each subject in the feeder 
study will receive more than 20 week the same treatment in the maintenance phase except escape 
subjects from PS0013 which are excluded from DV0002 enrollment.  
Once the 1mL device cohort has finished enrolling, the 2mL device cohort will start enrolling. 
Subjects who participated in the 1mL device cohort of DV0002 are not eligible to enroll in the 
2mL device cohort. For evaluation of the 2mL device, it is planned to enroll approximately 100 
subjects. All 100 subjects will have been on a consistent bimekizumab dose regimen for at least 
16 weeks, and thus all will be evaluable for the PK trough level analyses. 
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Subjects who enroll in the DV0002 substudy 2mL device cohort will be randomly assigned to 
the bimekizumab SS 2mL or the bimekizumab AI 2mL device arms (each device arm will 
consist of approximately 50 subjects). Within each device arm, subjects will be divided into 
tertiles by BMI; there will be approximately 16 to 17 subjects per tertile who are evaluable for 
steady state trough PK level analyses. 
Has been updated to: 
This study will not be powered with respect to any endpoint and sample size is based on practical 
considerations. 
1mL Device Cohort 
For the 1mL device cohort, to maintain blinding in the PS0014 feeder studies, DV0002 will 
recruit subjects who were administered bimekizumab 320mg (Q4W or Q8W) and subjects who 
were administered placebo or ustekinumab in the PS0014 feeder studies. A total of 100 subjects 
(50 subjects per device arm) are planned for PK trough level analyses, but these analyses can 
only be performed on subjects who do not change their bimekizumab dose or dosing regimen (ie, 
320mg bimekizumab Q4W or Q8W) between the PS0014 feeder studies and the DV0002 
substudy. The DV0002 substudy will therefore enroll approximately 200 subjects (to compensate 
for subjects with bimekizumab dose changes) to ensure that 100 subjects are available for PK 
trough analysis. 
Subjects who enroll in the DV0002 substudy 1mL device cohort will be randomly assigned to 
the bimekizumab SS 1mL or the bimekizumab AI 1mL device arms (each device arm will 
consist of approximately 100 subjects). Within each device arm, subjects will be divided into 
tertiles by BMI; there will be approximately 33 subjects per tertile, which is expected to yield 
approximately 16 to 17 subjects per tertile who are evaluable for steady state trough PK level 
analyses. 
Subjects are evaluable for steady state through PK level analyses, if they enter PS0014 on the 
same drug and dose as completing the feeder study and if they receive the drug at least 16-20 
weeks before PS0014. The second condition is automatically fulfilled. Each subject in the feeder 
study will receive more than 20 weeks of the same treatment in the maintenance phase except 
escape subjects from PS0013 which are excluded from DV0002 enrollment.  
2mL Device Cohort 
Once the 1mL device cohort has finished enrolling, the 2mL device cohort will start enrolling. 
Subjects who participated in the 1mL device cohort of DV0002 are not eligible to enroll in the 
2mL device cohort. For evaluation of the 2mL device, it is planned to enroll approximately 
100 subjects. Subjects are evaluable for steady state trough PK level analysis if they receive the 
same bimekizumab administration (frequency and dose) from PS0014 feeder study as in the 
DV0002 substudy beginning of PS0014 through to the end of the sub-study. It is expected 
that most subjects will be evaluable for the PK trough level analyses. All 100 subjects will 
have been on a consistent bimekizumab dose regimen for at least 16 weeks, and thus all will be 
evaluable for the PK trough level analyses. 
 Subjects who enroll in the DV0002 substudy 2mL device cohort will be randomly assigned to 
the bimekizumab-SS-2mL or the bimekizumab-AI-2mL device arms (each device arm will 
consist of approximately 50 subjects). Within each device arm, subjects will be divided into 
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tertiles by BMI; there will be approximately 16 to 17 subjects per tertile who are evaluable for 
steady state trough PK level analyses. 
Change #2 
3.6.2.4 Pharmacokinetic Per Protocol Set 
Two different Pharmacokinetic Per Protocol Sets (PK-PPS) will be generated (1 for each device 
type): the bimekizumab-SS-2mL PK-PPS (PK-PPS-s) and the bimekizumab-AI-2mL PK-PPS 
(PK-PPS-a). Each PK-PPS will consist of all subjects who receive the same bimekizumab 
administration (frequency and dose) in the PS0014 feeder studies as in the DV0002 substudy and 
who have at least 1 evaluable PK assessment in the DV0002 substudy without important protocol 
deviations that would affect the concentration. Pharmacokinetic variables will be analyzed using 
the PK-PPS-s and PK-PPS-a. 
All PK assessments after baseline assessments from feeder study will be considered for the 
requirement of at least one evaluable PK assessment.  
has been updated to:  
Two different Pharmacokinetic Per Protocol Sets (PK-PPS) will be generated (1 for each device 
type): the bimekizumab-SS-2mL PK-PPS (PK-PPS-s) and the bimekizumab-AI-2mL PK-PPS 
(PK-PPS-a). Each PK-PPS will consist of all subjects who receive the same bimekizumab 
administration (frequency and dose) in the PS0014 feeder studies from beginning of PS0014 
through to the end of DV0002 substudy as in the DV0002 substudy and who have at least 1 
evaluable PK assessment in the DV0002 substudy without important protocol deviations that 
would affect the concentration. Pharmacokinetic variables will be analyzed using the PK-PPS-s 
and PK-PPS-a. 
All PK assessments after baseline assessments from feeder study will be considered for the 
requirement of at least one evaluable PK assessment. 
All PK assessments after DV0002 baseline assessments (Week 24, Week 28 or Week 32 
from PS0014 study) will be considered for the requirement of at least one evaluable PK 
assessment. 
Change #3 
The section 6.3 Medical history and concomitant diseases 
Previous and ongoing medical history from feeder study will be based on SS-s and SS-a and 
summarized by treatment groups, system organ class (SOC) and preferred term (PT) using 
MedDRA®. Medical history and psoriasis history will be included in the summary tables and 
listings for medical history. Medical procedures are not coded. 
Previous and ongoing medical history will be presented in a by-subject listing for SS-s and SS-a, 
respectively. 
Has been updated to: 
6.3 Medical history and concomitant diseases 
Previous and ongoing medical history collected at the start of the from feeder study will be 
based on SS-s and SS-a and summarized by treatment groups, system organ class (SOC) and 
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preferred term (PT) using MedDRA®. Medical history and psoriasis history will be included in 
the summary tables and listings for medical history. Medical procedures are not coded.  
Previous and ongoing medical history along with the updated medical history collected at the 
end of the feeder studies will be presented in a by-subject listing for SS-s and SS-a, 
respectively. 
Change #4 
The following text is added to section 6.4 
Prior and concomitant medications: 
For 2 ml phase analysis, concomitant medications include those started on or before the 
later of the final contact date or (the last injection date + 7 days). 
Change #5 
Section 10.2.1 Adverse device effects: 
Adverse events are recorded at the AE CRF page at the time when they occur. If an adverse 
event is related to the device by assessment of the investigator it is counted as an Adverse device 
event. For DV0002 only ADE will be considered which started during the DV0002 study period. 
And ADEs started in the 1 ml phase will be included for 1 ml phase analysis, and those started in 
the 2 ml phase will be included for the 2 ml phase analysis.  
Has been updated to: 
Adverse events are recorded at the AE CRF page at the time when they occur. If an adverse 
event is related to the device by assessment of the investigator it is counted as an Adverse device 
event. For DV0002 only ADE will be considered which started during the DV0002 study period. 
And ADEs started in the 1 ml phase will be included for 1 ml phase analysis, and those started in 
the 2 ml phase will be included for the 2 ml phase analysis. For 2 ml phase analysis, adverse 
device effects include those started on or before the later of the final contact date or (the 
last injection date + 7 days). 
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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 
Statistical Analysis Plan (SAP) or amended SAP is released for execution. 
 
 
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Approval Signatures
Name:
dv0002-final-sap-amend-3
Version:
1. 0
Document Number:
CLIN-000162734
Title:
DV002 Final SAP Amendment 3
Approved Date:
12 Oct 2020
Document Approvals
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 10-Oct-2020 15:40:30 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 12-Oct-2020 17:11:22 GMT+0000
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