Conditions: Healthy Study Participants
Keywords: UCB4940 BKZ bimekizumab Bioequivalence Auto-injector Healthy study participants
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 121
Healthy volunteers: yes

Brief summary:
The purpose of the study is to compare the pharmacokinetics (PK), safety and tolerability of a single subcutaneous (sc) dose of bimekizumab (BKZ) when administered using bimekizumab-autoinjector (AI)-2mL presentation versus bimekizumab-AI-2x1mL presentation in healthy study participants.

Detailed description:

Arms:
arm 1: Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-2mL presentation (test). arm 2: Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-1x2mL presentation (reference).

Interventions: intervention 1: bimekizumab
Intervention descriptions: intervention 1: Study participants will receive a single dose of bimekizumab (BKZ) administered subcutaneously in the Treatment Period.

Protocol document:
Prot_000.pdf: 
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21 Mar 2022 
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UP0119 
 
 
 
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AN OPEN-LABEL, RANDOMIZED, PARALLEL-GROUP, 
SINGLE-DOSE BIOEQUIVALENCE STUDY OF BIMEKIZUMAB 
GIVEN AS 1X2ML OR 2X1ML SUBCUTANEOUS INJECTION 
USING AN AUTOINJECTOR IN HEALTHY STUDY 
PARTICIPANTS 
 
PROTOCOL UP0119 AMENDMENT 1 
PHASE 1 
 
SHORT TITLE: 
A bioequivalence study of bimekizumab administered as 1x2mL or 2x1mL subcutaneously in 
healthy study participants. 
Sponsor: 
UCB Biopharma SRL 
Allée de la Recherche 60 
1070 Brussels 
BELGIUM 
Regulatory agency identifying number(s): 
Eudra CT Number: 
2021-005334-41 
IND Number  
128707 
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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PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE 
Document History 
Document 
Date 
Type of amendment 
Amendment1 
21 Mar 2022 
Substantial 
Original Protocol 
23 Nov 2021 
Not applicable 
Amendment 1 (21 Mar 2022) 
Overall Rationale for the Amendment 
This amendment addresses recommendations from the Standing Committee on Vaccination for the 
provision of COVID-19 documentation at Screening for study participants in Germany. 
Corrected section headings and implemented terminology to align with changes in adverse 
device effect language that have been implement in the protocol template. Additional changes 
include clarification of body weights for pairing of study participants, clarification of exclusion 
criteria, clarification of footnotes in the Schedule of activities, and clarification of names of 
central laboratories. 
Section # and name 
Description of change 
Brief rationale 
1.1 Synopsis,  
4.1 Overall design, 
and  
6.3 Measures to minimize bias: 
randomization and blinding 
Clarified that body weights in 
each pair should differ by ≤10kg 
and that ideally the participant’s 
body weight at admission 
(Day -1) should be used for 
pairing 
Clarification 
1.3 Schedule of activities 
Corrected footnote j to clarify 
the HBc-Ab sample included 
both IgG and IgM  
Correction 
2.3.1 Risk assessment for 
coronavirus disease 2019  
And 
5.3.4 Other restrictions 
Added requirement for 
documentation of COVID-19 
vaccination at Screening for 
study participants in Germany 
Addition 
5.2 Exclusion criteria 
Renumbered criterion 23 as 23a, 
clarified alcohol equivalent 
volume, removed examples 
Clarification 
8.3.7 Medical device – adverse 
device effects and device 
presentation deficiencies 
and  
11 References 
Corrected publication year of 
ISO 14155 to reflected updated 
version 
Correction 
8.3.7 Medical device – adverse 
device effects and device 
presentation deficiencies 
and subsections 
Corrected section headings and 
terminology to align with 
changes in adverse device effect 
language in template 
Correction 
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8.4 Safety signal detection 
Added terminology to align with 
changes in adverse device effect 
language in template 
Addition  
Section 10.2 Appendix 2: 
Clinical laboratory tests 
Clarified names of central 
laboratories performing 
laboratory tests 
Clarification 
Section 10.7 Appendix 7: 
Medical device presentation 
ADEs and Device Deficiencies: 
– definition and procedures for 
recording, evaluating, follow up, 
and reporting  
and subsections 
Corrected section headings and 
terminology and deleted 
subsections to align with 
changes in adverse device effect 
language in template 
Correction 
 
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SERIOUS ADVERSE EVENT REPORTING 
 
Serious adverse event reporting (24h) 
Fax 
Europe and Rest of the World: +32 2 386 24 21 
Email 
Global: DS_ICT@ucb.com 
 
SAFETY REPORTING OF ADVERSE EVENTS (SERIOUS AND 
NONSERIOUS) AND DEVICE DEFICIENCIES 
Safety reporting of adverse events (24h) 
Email 
Global: DS_ICT@ucb.com 
Fax 
+32 2 386 24 21 
 
Reporting of device deficiencies (24h) 
Email 
Global: qactscomplaints@ucb.com 
 
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TABLE OF CONTENTS 
1 
PROTOCOL SUMMARY ................................................................................................. 9 
1.1 
Synopsis ......................................................................................................................... 9 
1.2 
Schema ......................................................................................................................... 12 
1.3 
Schedule of activities ................................................................................................... 13 
2 
INTRODUCTION ........................................................................................................... 20 
2.1 
Study rationale ............................................................................................................. 20 
2.2 
Background .................................................................................................................. 21 
2.3 
Benefit/risk assessment ................................................................................................ 22 
2.3.1 
Risk assessment for coronavirus disease 2019 .................................................... 22 
3 
OBJECTIVES AND ENDPOINTS ................................................................................. 25 
4 
STUDY DESIGN ............................................................................................................. 26 
4.1 
Overall design .............................................................................................................. 26 
4.2 
Scientific rationale for study design ............................................................................ 26 
4.3 
Justification for dose .................................................................................................... 27 
4.4 
End of study definition................................................................................................. 27 
5 
STUDY POPULATION .................................................................................................. 27 
5.1 
Inclusion criteria .......................................................................................................... 27 
5.2 
Exclusion criteria ......................................................................................................... 28 
5.3 
Lifestyle restrictions..................................................................................................... 31 
5.3.1 
Meals and dietary restrictions .............................................................................. 31 
5.3.2 
Caffeine, alcohol, and tobacco ............................................................................. 31 
5.3.3 
Activity ................................................................................................................ 31 
5.3.4 
Other restrictions ................................................................................................. 31 
5.4 
Screen failures .............................................................................................................. 32 
5.5 
Rescreening .................................................................................................................. 32 
6 
STUDY TREATMENTS/INVESTIGATIONAL DEVICE ............................................ 32 
6.1 
Treatments administered .............................................................................................. 33 
6.1.1 
Medical devices ................................................................................................... 33 
6.1.1.1 
Bimekizumab-AI-1mL .............................................................................. 33 
6.1.1.2 
Bimekizumab-AI-2mL .............................................................................. 34 
6.2 
Preparation, handling, storage, and accountability requirements ................................ 34 
6.2.1 
Retention samples ................................................................................................ 35 
6.3 
Measures to minimize bias: randomization and blinding ............................................ 35 
6.4 
Treatment compliance .................................................................................................. 36 
6.5 
Concomitant medication(s)/treatment(s) ..................................................................... 36 
6.5.1 
Permitted concomitant treatments (medications and therapies) .......................... 36 
6.5.2 
Prohibited concomitant treatments (medications and therapies) ......................... 37 
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6.6 
Dose modification ........................................................................................................ 37 
6.7 
Treatment after the end of the study ............................................................................ 37 
7 
DISCONTINUATION OF STUDY MEDICATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ........................................................................ 37 
7.1 
Discontinuation of IMP................................................................................................ 37 
7.1.1 
Criteria for study hold due to adverse events ...................................................... 37 
7.2 
Study participant withdrawal from the study ............................................................... 37 
7.3 
Lost to follow up .......................................................................................................... 38 
8 
STUDY ASSESSMENTS AND PROCEDURES ........................................................... 39 
8.1 
Efficacy assessments .................................................................................................... 39 
8.2 
Safety assessments ....................................................................................................... 39 
8.2.1 
Physical examination ........................................................................................... 39 
8.2.2 
Body weight and height ....................................................................................... 40 
8.2.3 
Vital signs ............................................................................................................ 40 
8.2.4 
Electrocardiograms .............................................................................................. 40 
8.2.5 
Clinical safety laboratory assessments ................................................................ 40 
8.2.6 
Tuberculosis test .................................................................................................. 41 
8.3 
Adverse events and serious adverse events ................................................................. 41 
8.3.1 
Time period and frequency for collecting AE and SAE information .................. 41 
8.3.2 
Method of detecting AEs and SAEs .................................................................... 42 
8.3.3 
Follow-up of AEs and SAEs ................................................................................ 42 
8.3.4 
Regulatory reporting requirements for SAEs ...................................................... 42 
8.3.5 
Pregnancy ............................................................................................................ 42 
8.3.6 
Adverse events of special interest ........................................................................ 43 
8.3.6.1 
Other safety topics of interest .................................................................... 43 
8.3.7 
Medical device– adverse device effects and device presentation deficiencies .... 43 
8.3.7.1 
Time period for detecting medical device presentation deficiencies ........ 43 
8.3.7.2 
Follow-up of device deficiencies............................................................... 44 
8.3.7.3 
Prompt reporting of device deficiencies to the Sponsor ............................ 44 
8.3.7.4 
Regulatory reporting requirements for device deficiencies....................... 44 
8.4 
Safety signal detection ................................................................................................. 44 
8.5 
Treatment of overdose ................................................................................................. 44 
8.6 
Pharmacokinetics ......................................................................................................... 44 
8.7 
Genetics........................................................................................................................ 45 
8.8 
Pharmacodynamics ...................................................................................................... 45 
8.9 
Biomarkers ................................................................................................................... 46 
8.10 
Immunogenicity assessments ....................................................................................... 46 
8.11 
Medical resource utilization and health economics ..................................................... 46 
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9 
STATISTICAL CONSIDERATIONS ............................................................................. 46 
9.1 
Definition of analysis sets ............................................................................................ 46 
9.2 
General statistical considerations ................................................................................. 47 
9.3 
Planned efficacy/outcome analyses ............................................................................. 47 
9.4 
Planned outcome analyses ........................................................................................... 47 
9.4.1 
Primary endpoint analyses ................................................................................... 47 
9.4.2 
Secondary endpoint analyses ............................................................................... 47 
9.5 
Planned safety and other analyses................................................................................ 47 
9.5.1 
Safety analyses ..................................................................................................... 47 
9.5.2 
Immunogenicity analyses .................................................................................... 48 
9.5.3 
Other analyses ...................................................................................................... 48 
9.5.3.1 
Study participant disposition and characteristics ...................................... 48 
9.6 
Handling of protocol deviations................................................................................... 48 
9.7 
Handling of dropouts or missing data .......................................................................... 49 
9.8 
Planned interim analysis and data monitoring ............................................................. 49 
9.9 
Determination of sample size ....................................................................................... 49 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS... 50 
10.1 
Appendix 1: Regulatory, ethical, and study oversight considerations ......................... 50 
10.1.1 
Regulatory and ethical considerations ................................................................. 50 
10.1.2 
Financial disclosure ............................................................................................. 50 
10.1.3 
Informed consent process .................................................................................... 51 
10.1.4 
Data protection ..................................................................................................... 51 
10.1.5 
Committees structure ........................................................................................... 51 
10.1.6 
Data quality assurance ......................................................................................... 52 
10.1.6.1 
Case Report form completion .................................................................... 52 
10.1.6.2 
Apps ........................................................................................................... 53 
10.1.7 
Data collection and source documents ................................................................ 53 
10.1.8 
Study and site closure .......................................................................................... 53 
10.1.9 
Publication policy ................................................................................................ 54 
10.2 
Appendix 2: Clinical laboratory tests .......................................................................... 55 
10.3 
Appendix 3: Adverse events – definitions and procedures for recording, evaluating, 
follow up, and reporting ............................................................................................... 57 
10.3.1 
Definition of AE .................................................................................................. 57 
10.3.2 
Definition of SAE ................................................................................................ 58 
10.3.3 
Recording and follow up of AE and/or SAE ....................................................... 59 
10.4 
Appendix 4: Contraceptive guidance and collection of pregnancy information ......... 62 
10.5 
Appendix 5: Genetics ................................................................................................... 65 
10.6 
Appendix 6: Liver safety – suggested actions and follow-up assessments ................. 66 
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10.7 
Appendix 7: Medical device presentation ADEs and Device Deficiencies: – definition 
and procedures for recording, evaluating, follow up, and reporting ............................ 68 
10.7.1 
Definitions of a medical device presentation incident ......................................... 68 
10.7.2 
Definition of ADE ............................................................................................... 68 
10.7.3 
Definition of device deficiency ........................................................................... 68 
10.7.4 
Recording and follow up of ADE and device deficiencies .................................. 69 
10.8 
Appendix 8: Rapid alert procedures ............................................................................ 71 
10.9 
Appendix 9: Country-specific requirements ................................................................ 72 
10.10 Appendix 10: Abbreviations and trademarks .............................................................. 73 
10.11 Appendix 11: Sample size estimation parameters ....................................................... 76 
10.12 Appendix 12: Protocol amendment history ................................................................. 77 
11 REFERENCES ................................................................................................................ 77 
12 SPONSOR DECLARATION .......................................................................................... 78 
 
LIST OF TABLES 
Table 1-1: 
Schedule of study assessments overview ......................................................... 13 
Table 1-2: 
Study assessments from dosing Day 1 to Day 3, 48h after IMP 
administration .................................................................................................. 17 
Table 1-3: 
Study assessments from Day 4 to 10 after IMP administration ....................... 18 
Table 1-4: 
Study assessments from Day 13 to 140 after IMP administration ................... 19 
Table 3-1: 
Objectives and estimands/endpoints ................................................................ 25 
Table 6-1: 
UP0119 treatments administered ..................................................................... 33 
Table 10-1: 
Protocol-required safety laboratory assessments ............................................. 55 
Table 10-2: 
Highly effective contraceptive methods a ........................................................ 63 
Table 10-3: 
Phase I liver chemistry stopping criteria and follow-up assessments .............. 66 
 
LIST OF FIGURES 
Figure 1-1: 
Study schematic ............................................................................................... 12 
Figure 6-1: 
Bimekizumab-AI-1mL ..................................................................................... 34 
Figure 6-2: 
Bimekizumab-AI-2mL ..................................................................................... 34 
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1 
PROTOCOL SUMMARY 
1.1 
Synopsis 
Protocol title: 
An open-label, randomized, parallel-group, single-dose bioequivalence study of bimekizumab 
given as 1x2mL or 2x1mL subcutaneous injection using an autoinjector in healthy study 
participants. 
Short Title: 
A bioequivalence study of bimekizumab administered as 1x2mL or 2x1mL subcutaneously in 
healthy study participants. 
Rationale: 
The bimekizumab 320mg dose was assessed in Phase 3 psoriasis [PSO] studies and was 
approved in the European Union (EU) on 20 Aug 2021 for the treatment of moderate to severe 
PSO. Currently, the dose is administered as 2x1mL subcutaneous (sc) injections of 160mg. To 
provide additional options to healthcare professionals and patients, it is considered of benefit by 
UCB to develop bimekizumab 320mg device presentations (ie, functional secondary packaging) 
where the dose can be delivered as a single 2mL sc injection. The primary objective of this study 
is, therefore, to compare the pharmacokinetics (PK) of bimekizumab 320mg when administered 
sc using a 2mL auto-injector (AI; bimekizumab-AI-2mL, test) versus 2x1mL auto-injector 
(bimekizumab-AI-1mL, reference) to support the development of the 2mL AI device 
presentation. 
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Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
• 
To compare the PK of a single sc dose of BKZ when 
administered using the bimekizumab-AI-2mL 
presentation (test) versus the bimekizumab-AI-
2x1mL presentation (reference) in healthy study 
participants 
• 
AUC, AUC(0-t), Cmax 
Secondary 
• 
To assess the safety and tolerability of a single sc 
dose of BKZ when administered using the 
bimekizumab-AI-2x1mL or bimekizumab-AI-2mL 
presentation in healthy study participants 
• 
TEAEs and treatment-emergent SAEs 
• 
To assess additional PK parameters of a single sc 
dose of BKZ when administered using the 
bimekizumab-AI-2x1mL or bimekizumab-AI-2mL 
presentation in healthy study participants 
• 
t½, tmax 
Other/exploratory 
• 
To assess additional PK parameters of a single sc 
dose of BKZ when administered using the 
bimekizumab-AI-2x1mL or bimekizumab-AI-2mL 
presentation in healthy study participants 
• 
%AUCex, CL/F, Vz/F 
• 
To assess immunogenicity of a single sc dose of 
BKZ when administered using the bimekizumab-AI-
2x1mL or bimekizumab-AI-2mL presentation in 
healthy study participants 
• 
Incidence of BKZ antidrug antibodies 
• 
To assess additional safety and tolerability of a 
single sc dose of BKZ when administered using the 
bimekizumab-AI-2x1mL or bimekizumab-AI-2mL 
presentation in healthy study participants 
• 
Vital signs (pulse rate, BP, and 
tympanic body temperature) 
• 
Safety laboratory data (hematology 
[including coagulation/hemostasis 
tests], clinical chemistry, and 
urinalysis) 
• 
12-lead ECG assessments 
AI=autoinjector; AUC=area under the plasma concentration-time curve from time zero to infinity; 
%AUCex=percentage of the AUC extrapolated from Clast; AUC(0-t)=area under the plasma concentration-time 
curve from time zero to the last quantifiable concentration; BKZ=bimekizumab; BP=blood pressure; 
CL/F=apparent total body clearance; Clast=last observed quantifiable plasma drug concentration; 
Cmax=maximum observed plasma drug concentration; ECG=electrocardiogram; PK=pharmacokinetic; 
SAE=serious adverse event; sc=subcutaneous; TEAE=treatment-emergent adverse event; t½=apparent terminal 
half-life; tmax=time of occurrence of Cmax 
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Overall Design 
This is a Phase 1, open label, randomized, parallel-group, single dose, 2-arm bioequivalence 
(BE) study to compare the PK of bimekizumab 320mg when administered as either a 1x2mL or 
2x1mL sc injection in healthy male and female study participants using an AI presentation. The 
2 arms will be: 
1. Bimekizumab-AI-2mL (test) 
2. 2xBimekizumab-AI-1mL (reference) 
Number of Participants 
Assuming a dropout rate and nonevaluable study participants of approximately 10%, 60 study 
participants per group for a total of approximately 120 study participants are to be enrolled in the 
study. Study participants who withdraw from the study may be replaced at the discretion of the 
Investigator and Sponsor. Any replacement must match the gender and weight (≤10kg difference 
between the 2 participants) of the remaining participant being replaced and receive the same 
treatment as the participant being withdrawn from treatment. 
Treatment Groups and Duration 
Each study participant will receive a single-dose administration of bimekizumab 320mg 
administered sc either using a single 2mL AI (bimekizumab-AI-2mL, test) or two 1mL AIs 
(bimekizumab-AI-1mL, reference). The duration of the study will be approximately 168 days, 
including 27 days of Screening, admission on Day -1, an inhouse Treatment Period from Day 1 
to Day 3, Outpatient Visits until Day 112, and a Safety Follow-Up (SFU) Visit on Day 140. 
Randomization will occur on Day 1 prior to dosing. 
 
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1.2 
Schema 
Figure 1-1: Study schematic 
 
AI=autoinjector 
 
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1.3 
Schedule of activities 
Table 1-1: 
Schedule of study assessments overview 
Assessments 
Screening 
Inhouse Treatment Period 
Outpatient Visits 
Early 
Withdrawala/ 
SafetyFollow-Up/ 
Visits 
Day -28 
to Day -2 
Day -1 
Day 1 
Day 1 
postdose 
to Day 3 
postdose 
Days 4 to 
10 
Days 13, 
16, 19, 
22, 25, 
and 28 
(±1 days) 
Days 56, 
84, 112 
(±3 days) 
Day 140 
(±3 day) 
Admission 
Pre-
dose 
0 h 
Ambulatory (A)/inhouse (I) visit 
A 
I 
A 
A 
A 
A 
Written informed consent 
X 
 
 
 
 
 
 
 
 
Verification of inclusion/exclusion 
and withdrawal criteria 
X 
X 
X 
 
 
 
 
 
 
Demographic data and lifestyle 
X 
 
 
 
 
 
 
 
 
Medical/procedures history 
X 
 
 
 
 
 
 
 
 
Urine drug and alcohol screen  
X 
X 
 
 
 
 
 
 
 
TB test 
(QuantiFERON®-TB GOLD PLUS)b 
X 
 
 
 
 
 
 
 
 
TB questionnairea 
X 
 
 
 
 
 
 
 
 
Smoking habits/Fagerström test 
X 
 
 
 
 
 
 
 
 
Randomizationc 
 
 
X 
 
 
 
 
 
 
Pre-visit COVID-19 questioningd 
 
X 
 
 
 
 
X 
X 
X 
IMP administratione 
 
 
 
X 
 
 
 
 
 
Physical examinationf 
X 
X 
 
 
Xf 
Xf 
Xf 
Xf 
X 
Vital signsg, h 
X 
X 
X 
 
X 
Xg 
Xg 
X 
X 
Body weight 
X 
X 
 
 
 
 
 
 
X 
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Table 1-1: 
Schedule of study assessments overview 
Assessments 
Screening 
Inhouse Treatment Period 
Outpatient Visits 
Early 
Withdrawala/ 
SafetyFollow-Up/ 
Visits 
Day -28 
to Day -2 
Day -1 
Day 1 
Day 1 
postdose 
to Day 3 
postdose 
Days 4 to 
10 
Days 13, 
16, 19, 
22, 25, 
and 28 
(±1 days) 
Days 56, 
84, 112 
(±3 days) 
Day 140 
(±3 day) 
Admission 
Pre-
dose 
0 h 
Height 
X 
 
 
 
 
 
 
 
 
12-lead ECGh 
X 
X 
X 
 
X 
X 
X 
X 
X 
Prior and concomitant medication 
X 
X 
X 
 
X 
X 
X 
X 
X 
Concomitant medical procedures 
X 
X 
X 
 
X 
X 
X 
X 
X 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Device presentation deficiencies 
 
 
 
Xi 
 
 
 
 
 
Serology j 
X 
 
 
 
 
 
 
 
 
SARS-CoV-2 RT-PCRk 
 
X 
 
 
 
 
 
 
 
Hematologyl  
X 
X 
 
 
X 
X 
X 
X 
X 
Clinical chemistryl 
X 
X 
 
 
X 
X 
X 
X 
X 
Coagulation/hemostasisl 
X 
X 
 
 
X 
X 
X 
X 
X 
Urinalysis (dipstick) m 
X 
X 
 
 
X 
X 
X 
X 
X 
Blood samples for BKZ plasma 
concentrationsn 
 
 
X 
 
X 
X 
X 
X 
X 
Blood samples for ADAbso  
 
 
X 
 
 
 
X 
X 
X 
Pregnancy testp 
X 
X 
 
 
 
 
X 
X 
X 
Follicle-stimulating hormone testp 
X 
 
 
 
 
 
 
 
 
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Table 1-1: 
Schedule of study assessments overview 
Assessments 
Screening 
Inhouse Treatment Period 
Outpatient Visits 
Early 
Withdrawala/ 
SafetyFollow-Up/ 
Visits 
Day -28 
to Day -2 
Day -1 
Day 1 
Day 1 
postdose 
to Day 3 
postdose 
Days 4 to 
10 
Days 13, 
16, 19, 
22, 25, 
and 28 
(±1 days) 
Days 56, 
84, 112 
(±3 days) 
Day 140 
(±3 day) 
Admission 
Pre-
dose 
0 h 
A=ambulatory; Ab=antibody; ADAb=antidrug-antibody; AE=adverse event; BKZ=bimekizumab; BP=blood pressure; COVID-19=coronavirus disease 2019; 
ECG=electrocardiogram; FSH=follicle stimulating hormone; h=hour; HBc-Ab=hepatitis B core antibody; HBsAg=hepatitis B surface antigen; HCV-Ab=hepatitis C virus 
antibody; HIV=human immunodeficiency virus; HIV1/2-Ab=HIV1/2 antibody; HIV1-Ag=HIV1 antigen; I=inhouse; IgG=immunoglobulin G; IgM=immunoglobulin M; 
IMP=investigational medicinal product; PK=pharmacokinetic(s); RT-PCR=real-time reverse transcriptase polymerase chain reaction; SARS-CoV-2=severe acute respiratory 
syndrome coronavirus 2; sc=subcutaneous; SFU=Safety Follow-Up; SOP=Standard Operating Procedure; TB=tuberculosis 
Note: At the Investigator’s discretion, an Unscheduled Visit may be completed at any time during the study but prior to the SFU Visit, if deemed necessary for the study 
participant’s safety and well-being. The same assessments as performed on the SFU Visit, or alternatively as advised by the Investigator, should be performed if a study 
participant is attending an Unscheduled Visit during the study. 
a If a study participant withdraws prior to completion of the study, an Early Withdrawal Visit will be conducted at the time of withdrawal and the same assessments planned for 
the SFU Visit will be performed. 
b Refer to UCB g-q-100573 Tuberculosis Detection Procedure Guideline for details regarding TB infection status, detection procedures, and the related exclusion criteria. 
c Randomization will occur prior to dosing on Day 1, provided all information for eligibility is known. The study identification card will be given to the study participant 
following IMP administration. 
d Within 24 hours of the indicated visit study participants will be asked to record signs and symptoms of COVID-19 or any contact with persons having confirmed SARS-CoV-
2 infection. In case of signs/symptoms or contact, the visit will be cancelled and reason for cancellation will be appropriately documented documented in the eCRF. 
e Bimekizumab will be administered as a sc injection as detailed in Section 6.1 
f A full physical examination will be performed at the Screening Visit, Day -1, and the Early Withdrawal/SFU Visit. On all other days (Days 2, 3, 9, 25, 56, 84, and 112) a 
physical examination is planned, it will be performed symptom-driven, ie, in case of an AE. 
g Vital signs include BP, pulse rate, and tympanic body temperature. At outpatient visits without regular vital signs measurements, only tympanic body temperature will be 
collected. The number of readings to be collected will be determined by local SOPs at the sites. 
h During the inhouse treatment period, vital signs and ECGs should be measured/taken prior to blood sampling, where applicable, with the study participant resting in the 
supine position for at least 3 minutes. Vital signs and ECGs will be measured on Day 1 at predose, at 1.5h, 5h, and 11h postdose, on Day 2 at 24h postdose, and on Day 3 at 
48 hours postdose, then on Days 9, 25, 56, 84, 112, and 140. 
i As this is a single-dose study, device presentation deficiencies are only to be captured on Day 1 (ie, the day when IMP is administered during the inhouse treatment period). 
j Serology variables include HbsAg, HBc-Ab (both IgG and IgM), HCV-Ab, HIV1-Ab, HIV1-Ag, and HIV-2 Ab. 
k The frequency of SARS-CoV-2 RT-PCR will be assessed in compliance site-specific procedures and local regulations. 
l Blood sampling for hematology (including coagulation and hemostasis) and clinical chemistry will be performed at the Screening Visit, and Days -1, 2, 9, 25, 56, 84, 112, and 
the SFU Visit. 
m Urinalysis via dipstick will be performed at Screening, Day-1, Days 2, 9, 25, 56, 84, 112, and 140. 
n The PK sampling time points will be as follows: predose (within a maximum of 60 minutes prior to dosing), 1.5h, 5h, 24h, 48h postdose, and from Day 4 onwards at every 
visit (ie, Days 4 to 10, 13, 16, 19, 22, 25, 28, 56, 84, 112, and 140). 
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Table 1-1: 
Schedule of study assessments overview 
Assessments 
Screening 
Inhouse Treatment Period 
Outpatient Visits 
Early 
Withdrawala/ 
SafetyFollow-Up/ 
Visits 
Day -28 
to Day -2 
Day -1 
Day 1 
Day 1 
postdose 
to Day 3 
postdose 
Days 4 to 
10 
Days 13, 
16, 19, 
22, 25, 
and 28 
(±1 days) 
Days 56, 
84, 112 
(±3 days) 
Day 140 
(±3 day) 
Admission 
Pre-
dose 
0 h 
o  ADAb samples will be taken predose and on Days 13, 28, 56, 84, 112, and 140; blood samples will be processed as specified in the laboratory manual. If feasible, an 
additional blood sample for PK and ADAb analysis should be collected from participants who develop a hypersensitivity reaction. The sample should be obtained close to the 
time of the event using an unscheduled visit if needed. 
p Pregnancy tests will be performed at the Screening Visit, Day-1, Days 28, 56, 84, 112, and Day 140. Prior to dosing (at Screening and Day -1), the test should be performed in 
serum; post dosing the test may be performed in urine. The FSH test will be performed in postmenopausal women at the Screening Visit. Additional details are provided in 
Appendix 4 (Section 10.4). 
 
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Table 1-2: 
Study assessments from dosing Day 1 to Day 3, 48h after IMP administration 
Assessments 
Day 1 
Day 2 
Day 3 
Predose 
Dosing 0h 
1.5h 
3h 
5h 
11h 
24h 
48h 
Physical examination 
 
 
 
 
 
 
X 
X 
Vital signsa 
X 
 
X 
 
X 
X 
X 
X 
12-lead ECG 
X 
 
X 
 
X 
X 
X 
X 
Hematology 
 
 
 
 
 
 
X 
 
Clinical chemistry 
 
 
 
 
 
 
X 
 
Coagulation/hemostasis 
 
 
 
 
 
 
X 
 
Urinalysis (dipstick) 
 
 
 
 
 
 
X 
 
IMP administration 
 
X 
 
 
 
 
 
 
Blood samples for BKZ 
plasma concentrations 
X b 
 
X 
 
X 
 
X 
X 
Blood samples for ADAbs 
X 
 
 
 
 
 
 
 
Concomitant medication 
X 
 
X 
X 
X 
X 
X 
X 
Concomitant medical 
procedures 
X 
 
X 
X 
X 
X 
X 
X 
Adverse events 
X 
X  
X 
X 
X 
X 
X 
X 
Device presentation 
deficiencies 
 
Xc 
 
 
 
 
 
 
ADAb=antidrug antibody; BKZ=bimekizumab; ECG=electrocardiogram; h=hour; IMP=investigational medicinal product; SOP=standard operating procedure 
a The number of readings to be collected will be determined by local SOPs at the sites. 
b Within a maximum of 60 minutes prior to dosing. 
c As this is a single-dose study, device presentation deficiencies are only to be captured on Day 1 (ie, the day when IMP is administered during the inhouse treatment period). 
 
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Table 1-3: 
Study assessments from Day 4 to 10 after IMP administration 
Assessment 
Day 4 
Day 5 
Day 6 
Day 7 
Day 8 
Day 9 
Day 10 
Physical examination 
 
 
 
 
 
X 
 
Vital signsa 
Xa 
Xa 
Xa 
Xa 
Xa 
X 
Xa 
12-lead ECG  
 
 
 
 
 
X 
 
Hematology  
 
 
 
 
 
X 
 
Clinical chemistry 
 
 
 
 
 
X 
 
Coagulation/hemostasis 
 
 
 
 
 
X 
 
Urinalysis (dipstick) 
 
 
 
 
 
X 
 
Blood samples for BKZ plasma 
concentrations  
X 
X 
X 
X 
X 
X 
X 
Concomitant medication 
X 
X 
X 
X 
X 
X 
X 
Concomitant medical procedures 
X 
X 
X 
X 
X 
X 
X 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
BKZ=bimekizumab; ECG=electrocardiogram; IMP=investigational medicinal product; SOP=standard operating procedure 
a At outpatient visits without regular vital signs measurements, only tympanic body temperature will be collected. The number of readings to be collected will be determined by 
local SOPs at the sites. 
 
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Table 1-4: 
Study assessments from Day 13 to 140 after IMP administration 
Assessment 
Day 13 
Day 16 
Day 19 
Day 22 
Day 25 
Day 28 
Day 56 
Day 84 
Day 112 
Day 140 
Pre-visit COVID-19 questioninga 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Physical examination 
 
 
 
 
X 
 
X 
X 
X 
X 
Vital signsb 
Xb 
Xb 
Xb 
Xb 
X 
Xb 
X 
X 
X 
X 
Body weight 
 
 
 
 
 
 
 
 
 
X 
12-lead ECG  
 
 
 
 
X 
 
X 
X 
X 
X 
Hematology  
 
 
 
 
X 
 
X 
X 
X 
X 
Clinical chemistry 
 
 
 
 
X 
 
X 
X 
X 
X 
Coagulation/hemostasis 
 
 
 
 
X 
 
X 
X 
X 
X 
Urinalysis (dipstick) 
 
 
 
 
X 
 
X 
X 
X 
X 
Urine pregnancy test 
 
 
 
 
 
X 
X 
X 
X 
X 
Blood samples for BKZ plasma 
concentrations 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Blood samples for ADAbs 
X 
 
 
 
 
X 
X 
X 
X 
X 
Concomitant medication 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medical procedures 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ADAb=antidrug antibody; BKZ=bimekizumab; COVID-19=coronavirus disease 2019; ECG=electrocardiogram; eCRF=electronic Case Report form; IMP=investigational 
medicinal product; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2; SOP=standard operating procedure 
a Within 24 hours of the indicated visit study participants will be asked to record signs and symptoms of COVID-19 or any contact with persons having confirmed SARS-CoV-
2 infection. In case of signs/symptoms or contact, the visit will be cancelled and reason for cancellation will be appropriately documented in the eCRF. 
b At outpatient visits without regular vital signs measurements, only tympanic body temperature will be collected. The number of readings to be collected will be determined by 
local SOPs at the sites. 
 
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2 
INTRODUCTION 
Bimekizumab is a humanized, full-length monoclonal antibody (mAb) of immunoglobulin G1 
(IgG1) subclass with 2 identical antigen binding regions that selectively binds with high affinity 
to interleukin (IL)-17A, IL-17F, and IL-17AF cytokines. This property makes bimekizumab 
distinctly different from the other IL-17-targeting agents, like secukinumab and ixekizumab 
(selective anti-IL-17A cytokine targeting mAb) or brodalumab (anti-IL-17 receptor targeting 
mAb). Bimekizumab-SS-1ml and bimekizumab-AI-1ml device presentations were approved in 
the EU on 20 Aug 2021 and the United Kingdom on 25 Aug 2021 for the treatment of moderate 
to severe PSO. 
Antibodies targeting IL-17A cytokines have demonstrated efficacy in study participants with 
psoriatic arthritis (PsA), axial spondyloarthritis (axSpA), and hidradenitis suppurativa (HS) and 
parallel development programs in these inflammatory diseases are ongoing. 
As of the current Investigator’s Brochure (IB) clinical cutoff date of 23 Oct 2021, the following 
studies with bimekizumab have been completed: 
• First-in-human study UP0008 
• Bioavailability studies RA0124 and UP0031 
• Phase 1 studies PA0007, UP0042, UP0033, UP0034, and UP0074 
• Phase 2 studies PS0018 (open-label extension [OLE] of PS0016), and HS0001 
• Phase 2a studies RA0123, UC0011 (discontinued study), PS0016, and AS0013 
• Phase 2b studies PS0010, PS0011 (OLE of PS0010), PA0008, PA0009, and AS0008 
• Phase 3 studies PS0008, PS0009, PS0013, DV0002, and DV0006 
The ongoing and planned studies with bimekizumab, as well as additional information on the 
clinical and nonclinical data for bimekizumab are available in the current version of the IB. 
2.1 
Study rationale 
The bimekizumab 320mg dose was assessed in Phase 3 psoriasis [PSO] studies and was 
approved in the EU on 20 Aug 2021 for the treatment of moderate to severe PSO. Currently, the 
dose is administered as 2x1mL sc injections of 160mg. To provide additional options to 
healthcare professionals and patients, it is considered of benefit by UCB to develop 
bimekizumab 320mg device presentations (ie, functional secondary packaging) where the dose 
can be delivered as a single 2mL sc injection. The primary objective of this study is, therefore, to 
compare the PK of bimekizumab 320mg when administered sc using a 2mL AI (bimekizumab-
AI-2mL, test) versus 2x1mL AI (bimekizumab-AI-1mL, reference) to support the development 
of the 2mL AI device presentations. 
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2.2 
Background 
UCB is currently developing 4 self-injection, single-use, device presentations, including two 
1mL presentations (bimekizumab-SS-1mL and bimekizumab-AI-1mL) and two 2mL 
presentations (bimekizumab-SS-2mL and bimekizumab-AI-2mL), to provide study participants 
with multiple needle-safe self-injection options. The bimekizumab-SS-1mL and the 
bimekizumab-SS-2mL device presentations provide study participants with control over the 
self-injection process (eg, needle visibility, skin penetration by needle, control speed of 
self-injection) while the bimekizumab-AI-1mL and the bimekizumab-AI-2mL device 
presentations provide study participants with a more automated self-injection. 
Clinical use substudies demonstrated that study participants with moderate to severe chronic 
PSO (DV0002 and DV0006) could self-inject bimekizumab across all 4 device presentations 
(bimekizumab-SS-1mL, bimekizumab-AI-1mL, bimekizumab-SS-2mL, and bimekizumab-AI-
2mL) in a safe and effective manner. The bimekizumab-SS-1mL and bimekizumab-AI-1mL 
presentations were approved in the EU on 20 Aug 2021 for the treatment of moderate to severe 
PSO. 
UP0033 (EudraCT number: 2017-004403-48) was a single-dose healthy participant study that 
investigated the PK of bimekizumab-SS-1mL (test 1; P5 drug substance) or bimekizumab-AI-
1mL (test 2; P5 drug substance) in comparison to the PK of bimekizumab 320mg when 
administered sc with the bimekizumab-True North (TN; reference; P4 drug substance). 
Bioequivalence was demonstrated across device presentations and an acceptable safety profile 
was demonstrated. 
UP0068 (UP0068-EudraCT number: 2019-002378-30) was a single-dose healthy participant BE 
study that investigated the PK of bimekizumab 320mg when administered sc using the 
bimekizumab-SS-2mL presentation (test 1) versus the bimekizumab-SS-1mL presentation 
(reference 1) or the bimekizumab-AI-2mL presentation (test 2) versus the bimekizumab-AI-1mL 
presentation (reference 2). This study was closed prematurely, prior to enrollment of all study 
participants, due to coronavirus disease 2019 (COVID-19) and several lock-downs that delayed 
recruitment. BE was demonstrated for the 2mL SS but the sponsor was not able to conclude that 
BE was demonstrated for the 2mL AI device. 
UP0119 is an open-label, randomized, parallel-group, single-dose BE study of bimekizumab 
given as 1x2ml or 2x1ml sc injection in healthy study participants using the 
bimekizumab-AI-2mL presentation (test) versus the bimekizumab-AI-2x1mL presentation 
(reference). 
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2.3 
Benefit/risk assessment 
Participation in this study does not have any therapeutic benefit for the healthy study 
participants. Healthy study participants will benefit from complete health check-ups and regular 
routine blood tests throughout the course of the study. Nonetheless, the participation of healthy 
study participants in the study is of importance to the patients and the development of the 
bimekizumab-AI-2mL for administration of bimekizumab. Currently, bimekizumab 320mg is 
administered as 2x1mL sc injections; therefore, UCB considers it a beneficial option for 
healthcare professionals and patients to administer bimekizumab 320mg as a single 1x2mL sc 
injection. 
Healthy study participants who participate in this study may be exposed to the: 
• Risks of the study procedures 
• Known and unknown risks related to the exposure to the IMP 
Procedure-related risks 
The use of an indwelling cannula for blood sampling may be accompanied by mild bruising and 
in rare cases, by transient inflammation of the wall of the vein. After initial irritation, the 
presence of an indwelling cannula is usually painless and hardly noticeable. The same applies to 
vein puncturing for further blood sampling. In very rare cases, a nerve might be injured while 
inserting the cannula. This could be followed by paresthesia, reduced sensitivity, and/or pain. 
The total volume of blood drawn during the entire study per study participant is estimated at 
approximately 450mL. No health-related risk to healthy study participants is expected from this 
blood withdrawal. 
Drug-related risks and safety measures 
Bimekizumab has a generally favorable clinical safety profile, and the drug is not associated with 
serious adverse events (SAEs) that would suggest a high risk to study participants in this study. 
The main safety concerns associated with bimekizumab include an increase in the risk for 
infection, in particular nonserious upper respiratory tract infections. Other types of nonserious 
infections (gastrointestinal, ear infection, conjunctivitis, bronchitis, mucocutaneous fungal 
infections) have also been commonly reported. The risk to study participants in this study will be 
minimized by the enrollment of healthy adult study participants who will be exposed to 
bimekizumab 320mg, dosed only once, by the implementation of conservative eligibility criteria, 
and that all study participants will be screened for chronic infections, including tuberculosis 
(TB). 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of bimekizumab may be found in the current IB. 
2.3.1 
Risk assessment for coronavirus disease 2019 
Bimekizumab is a humanized, full-length IgG monoclonal antibody, with high affinity for both 
human IL-17A and IL-17F. While the risk related to severe acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2) or COVID-19 is not yet fully researched, a safety concern cannot 
be excluded based on bimekizumab being an immunomodulatory antibody and dual inhibitor of 
2 cytokines. Interleukin-17 is a family of pleiotropic pro-inflammatory cytokines released by 
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activated T cells in the epithelial mucosal barrier upon stimulation with IL-23, which is mainly 
secreted by activated dendritic cells, macrophages, or monocytes. Interleukin-17 is often 
associated with allergic responses and autoimmune diseases, such as psoriasis. Interleukin-17A 
and IL-17F are the best characterized members of the IL-17 family, and IL-17A and IL-17F 
seem to be differently expressed in different tissues. Interleukin-17 is pivotal in innate and 
adaptive immune reaction to bacterial and viral infection, but has controversial effects. Studies 
suggest that the infectious dose may act as a determining factor regarding the protective or 
pathologic role of IL-17 during viral infection and was associated with the exacerbated 
pathology following viral infections, such as Epstein Barr Virus in mice (Ohta et al, 2013). There 
is growing evidence that inhibition of IL-17 might be beneficial in patients with COVID-19 to 
reduce the cytokine storm that causes the acute respiratory distress syndrome and vascular 
destruction, and studies are currently being conducted with other IL-17 inhibitors to investigate a 
potential beneficial effect. 
Based on these assumptions, the study is feasible in the appropriate population of healthy study 
participants. The risk of the study participants to be exposed to SARS-CoV-2 or to suffer from 
COVID-19 will be acceptable in comparison to the general population. However, the risk of 
exposure to infected people cannot be completely excluded as the participants may need to share 
public spaces and communal areas with other members of the public (eg, commute to the site) 
and have additional human contact (eg, with site staff and other participants of the clinical 
study). 
Measures to mitigate the additional risks caused by COVID-19 are: 
• This study will start enrolling only when the Sponsor and contract research organization 
(CRO) in collaboration deem it is safe to start the study. 
• Current national laws and local recommendations for prevention of pandemic will be strictly 
adhered to. 
• In Germany, at the time of Screening, study participants must provide documentation of 
COVID-19 vaccination corresponding to the recommendation of the Standing Committee on 
Vaccination. 
• Study participants will be closely monitored for any signs and symptoms of COVID-19, 
including fever, dry cough, dyspnea, sore throat, and fatigue throughout the study. Once 
clinical signs of infection are reported by participants, the Investigator needs to determine 
whether samples can be collected and safety data can be recorded on site. If not, AEs and 
concomitant medications will be obtained via phone calls. Tympanic body temperature 
measurements during inhouse stay and outpatient visits will be implemented. 
• The Investigator will not dose participants upon identification of any signs of COVID-19 
infection within the previous 14 days. 
• Confirmation of COVID-19 by laboratory assessment will be conducted with approved tests: 
a SARS-CoV-2 real-time reverse transcriptase polymerase chain reaction (RT-PCR) will be 
conducted on admission and participants with a negative test will be randomized. 
• The probability of virus transmission will be controlled as much as possible by: 
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− Advice for study participants to adhere to local requirements for social distancing and to 
minimize potential exposure to and/or transmission of the virus that causes COVID-19. 
− All participants within 24 hours of the indicated visit will be questioned (as per the 
schedule of activities) for assessing COVID-19 symptoms and signs and will be asked 
not to attend the site in case of suspected infection. In addition, participants will be asked 
for any contact with a person who has tested positive for SARS-CoV-2. If applicable, 
participants will be referred to the local health care system for further follow up and 
treatment. 
− Physical distancing and person-to-person contact restrictions will be applied during site 
admission and inhouse confinement. 
− Personal protective equipment will be used by study participants (eg, surgical face mask, 
gloves) and staff (for example but not limited to masks, gloves, protectors, medical suits) 
as guided by local requirements. 
Logistical improvements of the site and structural measures of the study site building were 
implemented to further improve physical distancing. 
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3 
OBJECTIVES AND ENDPOINTS 
Table 3-1: 
Objectives and estimands/endpoints 
Objectives 
Endpoints 
Primary 
• 
To compare the PK of a single sc dose of BKZ when 
administered using the bimekizumab-AI-2mL 
presentation (test) versus the bimekizumab-AI-
2x1mL presentation (reference) in healthy study 
participants 
• 
AUC, AUC(0-t), Cmax 
Secondary 
• 
To assess the safety and tolerability of a single sc 
dose of BKZ when administered using the 
bimekizumab-AI-2x1mL or bimekizumab-AI-2mL 
presentation in healthy study participants 
• 
TEAEs and treatment-emergent SAEs 
• 
To assess additional PK parameters of a single sc 
dose of BKZ when administered using the 
bimekizumab-AI-2x1mL or bimekizumab-AI-2mL 
presentation in healthy study participants 
• 
t½, tmax 
Other/exploratory 
• 
To assess additional PK parameters of a single sc 
dose of BKZ when administered using the 
bimekizumab-AI-2x1mL or bimekizumab-AI-2mL 
presentation in healthy study participants 
• 
%AUCex, CL/F, Vz/F 
• 
To assess immunogenicity of a single sc dose of 
BKZ when administered using the bimekizumab-AI-
2x1mL or bimekizumab-AI-2mL presentation in 
healthy study participants 
• 
Incidence of BKZ antidrug antibodies 
• 
To assess additional safety and tolerability of a 
single sc dose of BKZ when administered using the 
bimekizumab-AI-2x1mL or bimekizumab-AI-2mL 
presentation in healthy study participants 
• 
Vital signs (pulse rate, BP, and 
tympanic body temperature) 
• 
Safety laboratory data (hematology 
[including coagulation/hemostasis 
tests], clinical chemistry, and 
urinalysis) 
• 
12-lead ECG assessments 
AI=autoinjector; AUC=area under the plasma concentration-time curve from time zero to infinity; 
%AUCex=percentage of the AUC extrapolated from Clast; AUC(0-t)=area under the plasma concentration-time 
curve from time zero to the last quantifiable concentration; BKZ=bimekizumab; BP=blood pressure; 
CL/F=apparent total body clearance; Clast=last observed quantifiable plasma drug concentration; 
Cmax=maximum observed plasma drug concentration; ECG=electrocardiogram; PK=pharmacokinetic; 
SAE=serious adverse event ;sc=subcutaneous; TEAE=treatment-emergent adverse event; t½=apparent terminal 
half-life; tmax=time of occurrence of Cmax 
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4 
STUDY DESIGN 
4.1 
Overall design 
This is a Phase 1, open label, randomized, parallel-group, single dose, 2-arm BE study to 
compare the PK of bimekizumab 320mg when administered as either a 1x2mL or 2x1mL sc 
injection in healthy male and female study participants using an AI presentation. The 2 arms will 
be: 
1. Bimekizumab-AI-2mL (test) 
2. 2xBimekizumab-AI-1mL (reference) 
The aim of this study is to demonstrate the BE of bimekizumab administered as either 1x2mL or 
2x1mL sc injections using the bimekizumab-AI presentation in healthy study participants. 
Approximately 120 healthy male and female study participants will participate at a maximum of 
2 centers in the study (approximately 60 study participants in each of 2 arms). Enrollment 
between the 2 sites will be balanced, with an approximate 1:1 ratio. Each study participant will 
receive a single dose administration of bimekizumab 320mg, as either 1x2mL or 2x1mL sc 
injections. 
Each eligible study participants will be matched with another participant for gender and body 
weight prior to randomization. The intention is that the body weights in each pair should differ 
by ≤10kg. Ideally, the participant’s body weight at admission (Day -1) should be used for 
pairing. One participant within each pair will be randomly allocated to receive 1 of the 2 
treatments; the other participant will be allocated to the other treatment. 
The duration of the study will be approximately 168 days, including 27 days of Screening, 
admission on Day -1, an inhouse Treatment Period from Day 1 to Day 3, Outpatients Visits until 
Day 112, and a SFU Visit on Day 140. Randomization will occur on Day 1 prior to dosing. 
4.2 
Scientific rationale for study design 
The study design for UP0119 is based on the recommendation of the guideline on the 
investigation of BE and the feedback received from the European Medicine Agency (EMA) in 
the Scientific Advice procedure EMEA/H/SA/3306/1/FU/1/2017/III (Sep 2017) on the 1mL 
device presentations and from FDA on the 1mL and 2mL device presentations (Aug 2017, 
Mar 2018, and Nov 2019). The parallel design was chosen with regard to the long half-life of 
bimekizumab of approximately 28 days. 
UCB is currently developing 4 self-injection, single-use, device presentations, including two 
1mL presentations (bimekizumab-SS-1mL and bimekizumab-AI-1mL) and two 2mL 
presentations (bimekizumab-SS-2mL and bimekizumab-AI-2mL), to provide study participants 
with multiple needle-safe self-injection options. The bimekizumab-SS-1mL and the 
bimekizumab-SS-2mL device presentations provide study participants with control over the 
self-injection process (eg, needle visibility, skin penetration by needle, control speed of 
self-injection) while the bimekizumab-AI-1mL and the bimekizumab-AI-2mL device 
presentations provide study participants with a more automated self-injection. The aim of this 
study is to demonstrate the BE of bimekizumab administered as either 1x2mL or 2x1mL sc 
injections using the bimekizumab AI in healthy study participants. 
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4.3 
Justification for dose 
The dose selected in this study was the dose used in the pivotal Phase 3 studies in PSO and is the 
approved dose in EU for the treatment of moderate to severe PSO. 
4.4 
End of study definition 
A study participant is considered to have completed the study if he/she has completed all phases 
of the study including the Day 140 SFU Visit or the last scheduled procedure shown in the 
schedule of activities (Section 1.3). 
The end of the study is defined as the date of the last scheduled procedure shown in the schedule 
of activities for the last study participant in the study. 
5 
STUDY POPULATION 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
5.1 
Inclusion criteria 
Study participants are eligible to be included in the study only if all of the following criteria 
apply: 
Age 
1. Study participant must be ≥18 years and ≤65 years of age inclusive, at the time of signing the 
informed consent. 
Type of study participant 
2. Study participants who are overtly healthy as determined by medical evaluation including 
medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and 
laboratory tests, during the Screening Period and on admission. 
3. Study participant has a body temperature between 35.0°C and 37.5°C, inclusive, at Screening 
and on admission. 
Weight 
4. Body weight minimum of 50kg for male and 45kg for female study participants and a 
maximum of 100kg for all study participants, and body mass index (BMI) within the range 
18 to 32kg/m2 (inclusive) at the Screening Visit. 
Sex 
5. Male or female. Contraception guidelines (as per the standard UCB contraceptive guideline) 
will be applicable. 
− A male study participant must agree to use contraception as detailed in Appendix 4 
(Section 10.4) of this protocol during the inhouse treatment period and for at least 
20 weeks after the administration of study treatment, and refrain from donating sperm 
during this period. 
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− A female study participant is eligible to participate if she is not pregnant (see 
Appendix 4; Section 10.4), not breastfeeding, and at least one of the following conditions 
applies: 
◦ 
Not a woman of childbearing potential (WOCBP) as defined in Appendix 4 
OR 
◦ 
A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 during the 
inhouse treatment period and for a period of 20 weeks after the administration of 
IMP. 
Informed consent 
6. An Independent Ethics Committee (IEC)-approved written Informed Consent Form (ICF) is 
signed and dated by the study participant prior to the initiation of any study-specific 
assessment at the Screening Visit, as described in Appendix 1 (Section 10.1.3). 
5.2 
Exclusion criteria 
Study participants are excluded from the study if any of the following criteria apply: 
Medical conditions 
1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (including 
inflammatory bowel disease), endocrinological, hematological, or neurological disorders 
constituting a risk when taking the study intervention; or interfering with the interpretation of 
data. 
2. Study participant has any medical or psychiatric condition that, in the opinion of the 
Investigator, could jeopardize or would compromise the study participant’s ability to 
participate in this study. 
3. Study participant has a current history of alcohol or drug use disorder, as defined in 
Diagnostic and Statistical Manual of Mental Disorders (DSM) V, within the previous 1 year 
prior to the Screening Visit. 
4. Study participant has a known hypersensitivity to any components of the bimekizumab 
(and/or an investigational device) as stated in this protocol. 
5. Study participant has cardiovascular or cerebrovascular disease, including hypertension, 
angina, ischemic heart disease, transient ischemic attacks, stroke, peripheral arterial disease 
sufficient to cause symptoms, and/or requires therapy to maintain stable status. 
6. Study participant has an active infection or history of infections as follows: 
− Any active infection (except common cold) within 14 days prior to Screening Visit 
− A serious infection, defined as requiring hospitalization or iv anti-infectives within 
2 months prior to the Screening Visit 
− A history of opportunistic, recurrent, or chronic infections that, in the opinion of the 
Investigator, might cause this study to be detrimental to the study participant. 
Opportunistic infections are infections caused by uncommon pathogens (eg, 
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pneumocystis jirovicii, cryptococcosis) or unusually severe infections caused by common 
pathogens (eg, cytomegalovirus, herpes zoster). 
7. Study participant has a history of a positive TB test or evidence of possible TB or latent TB 
infection at Screening Visit. Refer to g-q-100573 Tuberculosis Detection Procedure 
Guideline for details regarding TB infection status, detection procedures, and the related 
exclusion criteria. 
Prior/Concomitant therapy 
8. Study participants receiving any live (includes attenuated) vaccination within the 8 weeks 
prior to the Screening Visit (eg, inactivated influenza and pneumococcal vaccines are 
allowed, but nasal influenza vaccination is not permitted). Live vaccines are not allowed 
during the study or for 20 weeks after the last dose of the investigational medicinal product 
(IMP). 
9. Past or intended use of prescription medication within 14 days or 5 half-lives prior to dosing. 
Specific medications listed in Section 6.5.1 may be allowed. 
10. Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) 
within 3 months or 5 half-lives (whichever is longer) prior to dosing. 
Prior/Concurrent clinical study experience 
11. Study participant has previously participated in this study or a study participant has 
previously been assigned to bimekuzimab treatment in any other study. 
12. Exposure to 3 or more new chemical entities within 12 months prior to dosing. 
13. Current enrollment or past participation within the last 30 days before signing the ICF in any 
other clinical study involving an investigational study intervention or any other type of 
medical research. 
Diagnostic assessments 
14. Study participant has concurrent acute or chronic viral hepatitis B or C or human 
immunodeficiency virus (HIV) infection. Study participants who have evidence of, or tested 
positive for hepatitis B or hepatitis C are excluded. A positive test for the hepatitis B virus 
(HBV) is defined as: 
− Positive for hepatitis B surface antigen (HBsAg+); or 
− Positive for anti-hepatitis B core antibody (HBc-Ab+) (IgM) 
A positive test for the hepatitis C virus (HCV) is defined as: 
− Positive for hepatitis C antibody (anti-HCV-Ab), and 
− Positive via a confirmatory test for HCV (for example, HCV polymerase chain reaction) 
15. Study participant has any of the following hematology values at Screening Visit and Day -1: 
− For women, hemoglobin <10.5g/dL; for men, <13.0g/dL 
− Absolute neutrophil count <1.5x109/L 
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16. Study participant has alanine transaminase (ALT), aspartate aminotransferase (AST), or 
alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN). 
17. Study participant has total bilirubin >1.0xULN (isolated bilirubin <1.5xULN is acceptable if 
bilirubin is fractionated and direct bilirubin <35%). 
18. Study participant has current or chronic history of liver disease or known hepatic or biliary 
abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 
19. Study participant has 12-lead ECG with changes considered to be clinically significant (eg, 
QT interval corrected using Fridericia’s formula >450ms, bundle branch block, or evidence 
of myocardial ischemia) at Screening Visit or on Day -1. 
20. Study participant has abnormal blood pressure (BP) at the Screening Visit and on Day -1 as 
follows: mean systolic BP ≥140mmHg; mean diastolic BP ≥90mmHg. Study participants 
with a BP within this range but who, in the opinion of the Investigator, have a high risk for 
cardiovascular accident based on, eg, family anamneses, smoking, BMI, or lipid spectrum 
can be excluded. 
Other exclusions 
21. Study participant has made a blood donation of a blood loss of more than 400mL of blood or 
blood products within 90 days prior to admission (Day -1) or plans to donate blood during 
the study. 
22. Female study participant who is pregnant, or plans to become pregnant during the study, or 
lactating, or sexually active with childbearing potential who is not using a medically accepted 
birth control method (see Appendix 4). 
23a. 
Study participant has an alcohol consumption of more than 21 units (males) or 14 units 
(females) of alcohol per week (1 unit of alcohol is equivalent to 12.5mL ethanol at room 
temperature). 
24. Study participant tests positive for alcohol or drugs (urine test) at Screening or Day -1. 
25. Study participant smokes >10 cigarettes per day or has a score of >4 on the Fagerström Test 
for Nicotine Dependence. 
26. Study participant has a high consumption of xanthine-containing products (≥ 300mg of 
xanthine-equivalent per day) [1 cup of coffee ≈ 100mg of caffeine; 1 cup of tea ≈ 30mg of 
caffeine; 1 glass of cola ≈ 20mg of caffeine]. 
27. Study participant is not willing to avoid heavy physical exertion 48 hours before each 
assessment visit. 
28. Vulnerable study participants (eg, participants kept in detention, protected adults under 
guardianship or trusteeship, and soldiers or participants committed to an institution by 
governmental or juridical order), employees of the Sponsor or the contract research 
organization (CRO) with direct involvement in the proposed study or other studies under the 
direction of the Investigator or the CRO, as well as family members of the employees or the 
Investigator. 
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29. Study participant has a positive test result for severe acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2) in real-time reverse transcriptase polymerase chain 
reaction (RT-PCR) on the admission sample. 
30. Study participant has clinical signs and symptoms consistent with COVID-19, eg fever, dry 
cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test 
within the previous 14 days prior to Screening or on admission. 
31. Study participant who had severe course of COVID-19 (ie, hospitalization, extracorporal 
membrane oxygenation, mechanically ventilated). 
32. Study participant has active neoplastic disease or history of neoplastic disease within 5 years 
of Screening Visit (except for basal or squamous cell carcinoma of the skin or carcinoma in 
situ that has been definitively treated with standard of care). 
5.3 
Lifestyle restrictions 
5.3.1 
Meals and dietary restrictions 
No specific dietary restrictions are required. 
5.3.2 
Caffeine, alcohol, and tobacco 
Study participants should refrain from consuming alcohol, caffeine, and tobacco during the 
inhouse treatment period. 
5.3.3 
Activity 
Study participants should abstain from strenuous exercise for at least 48 hours before each blood 
collection for clinical laboratory tests. Study participants may engage in light recreational 
activities during the study. 
5.3.4 
Other restrictions 
During a pandemic or other exceptional circumstance (eg, hurricanes) regulatory authorities 
accompanied by local or global regulations may implement safety measures and guidelines. In 
such situation site personnel and study participants may need to adhere and implement these 
safety measures. 
Due to the exceptional circumstance of the evolving COVID-19 pandemic, study participants are 
advised to adhere to local requirements while ambulatory, to minimize potential exposure to 
and/or transmission of the virus that causes COVID-19. 
In Germany, at the time of Screening, study participants must provide documentation of COVID-19 
vaccination corresponding to the recommendation of the Standing Committee on Vaccination. 
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5.4 
Screen failures 
Screen failures are defined as study participants who consent to participate in the clinical study 
but are not subsequently randomly assigned to study treatment. A minimal set of screen failure 
information is required to ensure transparent reporting of screen failure study participants to 
meet the Consolidated Standards of Reporting Trials publishing requirements and to respond to 
queries from regulatory authorities. Minimal information includes demography, screen failure 
details, eligibility criteria, and any SAE. 
Individuals who do not meet the criteria for participation in this study (screen failures) may be 
rescreened (Section 5.5). 
Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated 
once for confirmation. This includes rescreening. 
5.5 
Rescreening 
Per investigator discretion, study participants may be rescreened once under conditions such as 
the following: 
• Study participant falls outside the Screening Period 
• If a study participant does not meet the inclusion criteria at Screening or on Day -1 due to an 
out-of-range laboratory result or a minor illness, he/she can be rescreened once at the 
discretion of the Investigator. Provided all inclusion criteria are met at the second screening, 
the study participant can be included. 
Study participants may be included if the repeat values for the laboratory screening criteria are 
within normal ranges and/or if repeat values show normalization of the out-of-range safety 
laboratory values, and/or after the study participant makes a complete recovery from the mild or 
moderate illness and if all other screening criteria are met. 
Rescreened study participants are assigned a new study participant number from the number 
assigned at the initial screening. 
6 
STUDY TREATMENTS/INVESTIGATIONAL DEVICE 
In this study, the term IMP refers to the bimekizumab drug product. The term device 
presentation refers to 2 different injection device presentations (bimekizumab-AI-1mL and 
bimekizumab-AI-2mL) that are comprised of drug product (IMP) associated with a functional 
secondary packaging. 
Bimekizumab will be supplied by UCB Clinical Trial Supply Operations or designee as a clear to 
opalescent, colorless to slightly yellow-brown, sterile, preservative-free solution, suitable for 
injection by sc administration, in either a 1mL prefilled syringe (PFS) or a 2mL PFS at a nominal 
concentration of 160mg/mL (55mM sodium acetate, 220mM glycine, 0.04% polysorbate 80 at 
pH 5.0) for sc administration. 
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6.1 
Treatments administered 
The treatments to be administered are presented in Table 6-1. 
Table 6-1: 
UP0119 treatments administered 
Study Treatment Name 
Bimekizumab-AI-2mL 
Bimekizumab-AI-1mL 
Drug product: 
2mL PFS 
1mL PFS 
All treatments: a nominal formulation of 160mg/mL in 55mM 
sodium acetate, 220mM glycine and 0.04% (w/v) polysorbate 80 at 
pH5.0 
Total dose: 
320mg 
320mg 
Duration of treatment: 
Single dose 
Single dose 
Number of injections: 
1x320mg 
2x160mg 
Route of administration: 
sc 
sc 
Site of injection: 
Thigh (left or right) 
Thigh (1 in left and 1 in right) 
Device: 
2mL AI 
1mL AI 
AI=auto-injector; PFS=prefilled syringe; sc=subcutaneous 
The IMP will be given in the thigh without massage. For bimekizumab-AI-1mL, the injection 
should continue until a second click is heard (to give an injection time of up to 15 seconds). For 
the administration of the 2x1mL, each sc injection should be given in a separate thigh (but at the 
same relative site of the thigh) with a maximum time of 60 seconds between injections. The 
exact timing of the injection(s) should be recorded in the electronic Case Report Form (eCRF). 
For bimekizumab-AI-2mL, the injection will take approximately up to 20 seconds until the 
second click is heard. After the second click, continue to hold down the AI for an additional 
5 seconds to ensure the full dose is delivered. 
Further details on how to proceed in the event of malfunction of any of the devices will be 
provided in the IMP handling manual. 
6.1.1 
Medical devices 
All medical device presentation deficiencies, including malfunction use error, and inadequate 
labelling, shall be documented and reported by the Investigator throughout the study 
(see Section 8.3.7) and appropriately managed by the Sponsor. 
6.1.1.1 
Bimekizumab-AI-1mL 
The bimekizumab-AI-1mL is a single-use AI with a passive needle-safety mechanism. The 
bimekizumab-AI-1mL consists of a 1mL glass PFS containing bimekizumab drug product within 
a customized Ypsomed Ypsomate device. This device presentation was approved in the EU on 
20 Aug 2021. 
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Figure 6-1: Bimekizumab-AI-1mL 
 
AI=auto-injector 
6.1.1.2 
Bimekizumab-AI-2mL 
The bimekizumab-AI-2mL is a single-use AI with a passive needle-safety mechanism. The 
bimekizumab-AI-2mL consists of a 2.25mL glass PFS containing bimekizumab drug product 
within an Ypsomed Ypsomate device. 
Figure 6-2: Bimekizumab-AI-2mL 
 
AI=auto-injector 
6.2 
Preparation, handling, storage, and accountability requirements 
The Investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study treatment received and any discrepancies are reported and 
resolved before use of the study treatment. 
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Only study participants enrolled in the study may receive study treatment and only authorized 
site staff may supply or administer study treatment. All study treatments must be stored in a 
secure, environmentally controlled, and monitored (manual or automated) area in accordance 
with the labeled storage conditions with access limited to the Investigator and authorized site 
staff. 
The Investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study treatment accountability, reconciliation, and record maintenance 
(ie, receipt, reconciliation, and final disposition records). 
In case an out-of-range temperature is noted, it must be immediately reported as per instructions 
contained in the IMP Handling Manual. 
Appropriate accountability forms that reflect the receipt and use of the IMP and the 
investigational device presentations including IMP will be supplied to the investigational site. 
Details of any loss of the IMP and/or injection investigational device presentations 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 device presentations until returned or destroyed. The Investigator may 
assign some of the Investigator’s duties for drug accountability at the study site to an appropriate 
pharmacist/designee. 
The device presentations should be stored with a proper study participant identification number 
until the study has been completed. UCB will then instruct the Investigator to destroy them. Used 
device presentations can be stored at room temperature, preferably placed in the original 
packaging. Further details are provided in the IMP Handling Manual. 
The IMP and investigational device presentations intended for the study cannot be used for any 
other purpose than that described in this protocol. 
6.2.1 
Retention samples 
As UP0119 is a BE study, retention samples are required to be kept at sites per FDA 
requirement. All information related to storage and quantity needed on site will be provided in 
the IMP Handling Manual. 
6.3 
Measures to minimize bias: randomization and blinding 
This is an open-label study. 
A PAREXEL Biostatistician (or designee) will write the randomization plan, program and will 
provide a dummy output of the randomization lists for review and approval in order to ensure 
compliance to study requirements. 
Study participant treatment assignment will be random throughout the study. Study participants 
will be randomized in a 1:1 ratio to each treatment group as described in Section 4.1. 
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Copies of each site’s randomization list will be sent to the respective site before the start of the 
study to the following recipients: 
• ClinBase TM setup designer 
• Sponsor Drug Safety staff for SAE reporting 
• Bioanalytical staff 
• Site pharmacist and Pharmaceutical Services staff (for dispensing IMP) 
Pharmacokinetic concentration data will not be available to the study team until after the last 
scheduled procedure for the last study participant in the study, so the decision to replace 
participants who dropped out or are missing PK visits can be made in an unbiased manner. 
At the Screening Visit, each study participant will be assigned a unique 5-digit number from a 
range of numbers supplied by UCB. Once the Investigator determines that the study participant 
is eligible for the study, the study participant will be paired to another eligible study participant, 
matching by gender and bodyweight (≤10kg difference between the 2 participants) and manually 
assigned to the next 2 available randomization numbers by the Investigator or designee prior to 
dosing on Day 1. Ideally, the participant’s body weight at admission (Day -1) should be used for 
pairing. Allocating in pairs will improve the precision of the comparison between treatments. 
Each specific randomization number will identify the pair a study participant belongs to and is 
tied to the treatment allocation on the randomization schedule, which can then be dispensed by 
the site pharmacist. This randomization number will also be recorded in the eCRF (ie, ClinBase; 
see Section 10.1.6). 
Participants who withdraw from the study may be replaced at the discretion of the Investigator 
and Sponsor. Any replacement must match the gender and weight (≤10kg difference between the 
2 participants) of the remaining participant being replaced and receive the same treatment as the 
participant being withdrawn from treatment. 
6.4 
Treatment compliance 
All IMP will be administered by the Investigator or his/her appropriately trained designee. 
6.5 
Concomitant medication(s)/treatment(s) 
6.5.1 
Permitted concomitant treatments (medications and therapies) 
The following concomitant medications are permitted during the study: 
• Acetaminophen/paracetamol (maximum 2g/day) 
• Oral contraceptives 
• Hormonal postmenopausal treatment 
• Herbal remedy or food supplements (eg, vitamins) within the recommended daily dose limits 
• Short-term intake of over-the-counter/non-prescription drugs is allowed if judged by the 
Investigator to have no potential for drug-drug interactions with the IMP 
Non-live vaccines (eg, inactivated influenza and pneumococcal vaccines or non-live COVID 
vaccines) are allowed up to 2 weeks prior to randomization and 2 weeks after dosing, at 
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minimum. Investigators can contact the UCB Study Physician or medically qualified 
designee/equivalent for further guidance. 
6.5.2 
Prohibited concomitant treatments (medications and therapies) 
With the exception of those medications listed in Section 6.5.1 and medications necessary for the 
treatment of treatment-emergent adverse events (TEAEs) per Investigator discretion, no 
prescription or nonprescription medicines are allowed within 14 days (3 months for biologic 
agents) or 5 half-lives of the respective medication (whichever is longer), prior to randomization 
and until the SFU Visit (Day 140). 
6.6 
Dose modification 
Not applicable. 
6.7 
Treatment after the end of the study 
Not applicable. 
7 
DISCONTINUATION OF STUDY MEDICATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 
Discontinuation of IMP 
Not applicable; eligible study participants are randomized to receive a single-dose administration 
of bimekizumab 320mg in UP0119. 
7.1.1 
Criteria for study hold due to adverse events 
During the study, planned dosing and procedures must be discontinued or suspended for all 
remaining study participants who are yet to be dosed in the study and appropriate follow-up 
procedures established for (but not limited to) any of the following reasons: 
• A pattern of adverse events (AEs), considered as related to the study drug, occurs that in the 
opinion of the Investigator and/or Sponsor Study Physician contraindicates the further dosing 
of additional study participants. 
• If the Sponsor or its designee judges it necessary for medical, safety, regulatory, or any other 
reasons consistent with applicable laws, regulations, and Good Clinical Practice (GCP). 
Where it is possible to do so without threatening the safety of study participants, such 
discontinuation/suspension should be discussed with the UCB Study Physician prior to its 
implementation. 
Study and site closure information is provided in Section 10.1.8. 
7.2 
Study participant withdrawal from the study 
Study participants are free to withdraw from the study at any time, without prejudice to their 
continued care and without having to provide any reason. 
A study participant may withdraw from the study at any time at his/her own request, or may be 
withdrawn at any time at the discretion of the Investigator for safety, behavioral, compliance, or 
administrative reasons. 
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If the study participant withdraws consent for disclosure of future information, the Sponsor may 
retain and continue to use any data collected before such a withdrawal of consent. 
If a study participant withdraws from the study, he/she may request destruction of any samples 
taken and not tested, and the Investigator must document this in the site study records. 
Upon study discontinuation, an Early WithdrawalVisit will be conducted at the time of 
withdrawal and the same assessments planned for the SFU Visit per the Schedule of activities 
(Section 1.3) will be performed. 
Study participants should be discontinued from the study if any of the following events occur: 
1. Study participant develops an illness that would interfere with his/her continued participation 
as per the Investigator’s judgment. 
2. Study participant is noncompliant with the study procedures in the opinion of the 
Investigator. 
3. Study participant takes prohibited concomitant medications as defined in this protocol. 
4. Study participant withdraws his/her consent. 
5. There is confirmation of a pregnancy during the study, as evidenced by a positive pregnancy 
test. Study participants should attend the SFU Visit following withdrawal. 
6. The Sponsor or a regulatory agency requests withdrawal of the study participant. 
7. Participation in any other study during the duration of this study. 
Study participants must be withdrawn by the Investigator based on discussion with the Sponsor 
under the following circumstances: 
• Any confirmed COVID-19 case that warrants discontinuation in the judgment of the 
Investigator or Sponsor to protect the safety of the study participant, other participants, or 
study site staff. 
Investigators should contact the Medical Monitor, whenever possible, to discuss the withdrawal 
of a study participant in advance. Study participants will be encouraged to return for an SFU 
Visit following premature discontinuation from the study. 
7.3 
Lost to follow up 
A study participant will be considered lost to follow up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
The following actions must be taken if a study participant fails to return to the clinic for a 
required study visit: 
• The site must attempt to contact the study participant and reschedule the missed visit as soon 
as possible and counsel the study participant on the importance of maintaining the assigned 
visit schedule and ascertain whether or not the study participant wishes to and/or should 
continue in the study. 
• Before a study participant is deemed lost to follow up, the Investigator or designee must 
make a reasonable effort to regain contact with the study participant (at least 1 phone call and 
1 written message to the study participant), and document his/her effort (date and summary 
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of the phone call and copy of the written message in the source documents), to complete the 
final evaluation. All results of these evaluations and observations, together with a narrative 
description of the reason(s) for removing the study participant, must be recorded in the 
source documents. The eCRF must document the primary reason for withdrawal or 
discontinuation. 
Should the study participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study with a primary reason of lost to follow up documented in the eCRF. 
8 
STUDY ASSESSMENTS AND PROCEDURES 
Study procedures and their timing are summarized in the schedule of activities (Section 1.3). 
Protocol waivers or exemptions are not allowed. 
Adherence to the study design requirements, including those specified in the schedule of 
activities (Section 1.3), is essential and required for study conduct. 
All screening evaluations must be completed and reviewed to confirm that potential study 
participants meet all eligibility criteria. The Investigator will maintain a screening log to record 
details of all study participants screened and to confirm eligibility or record reasons for screening 
failure, as applicable. 
Procedures conducted as part of the study participant’s routine clinical management (eg, blood 
count) and obtained before signing of the ICF may be utilized for screening or baseline purposes 
provided the procedures met the protocol-specified criteria and were performed within the time 
frame defined in the schedule of activities. 
The maximum amount of blood collected from each study participant over the duration of the 
study, including any extra assessments that may be required, will not exceed 450mL. Repeat or 
unscheduled samples may be taken for safety reasons or for technical issues with the samples. 
8.1 
Efficacy assessments 
Not applicable. 
8.2 
Safety assessments 
Planned time points for all safety assessments are provided in the schedule of activities 
(Section 1.3). 
8.2.1 
Physical examination 
Physical examinations will be performed as per Section 1.3. The physical examination will 
include general appearance; ear, nose, and throat; eyes, hair, and skin; respiratory; 
cardiovascular; gastrointestinal; musculoskeletal; hepatic; neurological (including limb reflexes); 
and mental status. Findings considered as clinically significant changes since the physical 
examination at the Screening Visit will be recorded as AEs. 
A full physical examination will be performed at the Screening Visit, Day -1, and the 
EarlyWithdrawal/SFU Visit. On all other days a physical examination is planned, it will be 
performed symptom-driven (ie, in case of an AE). 
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8.2.2 
Body weight and height 
Body weight will be measured with the study participant wearing no shoes and light clothing 
(weight should be recorded to one decimal place) according to the schedule of activities in 
Section 1.3. Height will only be measured at the Screening Visit. 
8.2.3 
Vital signs 
Vital signs (BP [systolic and diastolic], pulse rate, and tympanic body temperature) will be 
recorded before taking PK samples and with the study participant resting in the supine position 
for at least 3 minutes in a quiet setting without distractions (eg, television, cell phones). At 
outpatient visits without regular vital signs measurements, only tympanic body temperature will 
be collected. The number of readings to be collected will be determined by local standard 
operating procedures (SOPs) at the sites. 
8.2.4 
Electrocardiograms 
Single 12-lead ECG will be obtained as outlined in the schedule of activities (see Section 1.3) 
using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, 
and QTc intervals. 
All ECG recordings should be taken before taking PK samples and with the study participant 
resting in the supine position for at least 3 minutes. 
8.2.5 
Clinical safety laboratory assessments 
See Appendix 2 (Section 10.2) for the list of clinical laboratory tests to be performed and the 
schedule of activities (Section 1.3) for the timing and frequency. 
Laboratory data will be electronically captured by ClinBase, a software tool that ensures quality 
assurance and enables comprehensive capture of all relevant medical information gathered 
during the study (Section 10.1.6). The Investigator can assess the data in ClinBase and sign off 
on them electronically. 
All laboratory tests with values considered clinically significantly abnormal during participation 
in the study should be repeated until the values return to normal or baseline or are no longer 
considered clinically significant by the Investigator or Medical Monitor. If such values do not 
return to normal/baseline within a period of time judged reasonable by the Investigator, the 
etiology should be identified and the Sponsor notified. 
All protocol-required laboratory assessments, as defined in Appendix 2 (Section 10.2), must be 
conducted in accordance with the laboratory manual and the schedule of activities (Section 1.3). 
If laboratory values from non-protocol specified laboratory assessments performed at the 
institution’s local laboratory require a change in study participant management or are considered 
clinically significant by the Investigator (eg, SAE or AE), then the results are to be captured in 
ClinBase. 
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8.2.6 
Tuberculosis test 
Refer to g-q-100573, UCB Tuberculosis Detection Procedure Guideline for details regarding TB 
infection status, detection procedures, and the related exclusion criteria. 
A QuantiFERON®-TB PLUS GOLD test and a TB questionnaire will be performed at the 
Screening Visit to identify those study participants who have had TB or may have active or latent 
TB. Results of this test will be reported as positive, negative, or indeterminate. Study participants 
with a positive test result will not be included in the study. If the result is reported as 
indeterminate, then the test can be repeated once. If the repeat test result is reported as 
indeterminate, then the study participant will not be included in the study. 
8.3 
Adverse events and serious adverse events 
The definitions of device-related safety events (adverse device effects [ADEs]) can be found in 
Appendix 7. Device deficiencies are addressed in Appendix 7 (Section 10.7). 
Adverse events will be reported by the study participant (or, when appropriate, by a caregiver, 
surrogate, or the study participant’s legally authorized representative). 
The Investigator and any designees are responsible for detecting, documenting, and recording 
events that meet the definition of an AE or SAE and remain responsible for following up AEs 
that are serious, considered related to the study treatment or study procedures, or that caused the 
study participant to discontinue the study (see Section 7). 
Confirmed and suspected cases of SARS-CoV-2 infection will be recorded as AEs (or SAE, as 
required). 
8.3.1 
Time period and frequency for collecting AE and SAE information 
All AEs and SAEs will be collected from the signing of the ICF and at the time points specified 
in the schedule of activities (Section 1.3). 
In order to ensure complete safety data collection, all AEs occurring during the study (ie, after 
the signing of the ICF), including any pretreatment and posttreatment periods required by the 
protocol, must be reported in the CRF even if no study medication was taken but specific study 
procedures were conducted. This includes all AEs not present prior to the initial visit and all AEs 
that recurred or worsened after the initial visit. 
All SAEs will be recorded and reported to the Sponsor or designee within 24 hours, as indicated 
in Appendix 4 (Section 10.4). The Investigator will submit any updated SAE data to the Sponsor 
within 24 hours of it being available. 
The Investigator is specifically requested to collect and report to UCB (or its representative) any 
SAEs (even if the Investigator is certain that they are in no way associated with the IMP), up to 
30 days from the end of the study for each study participant, and to also inform study participants 
of the need to inform the Investigator of any SAE within this period. Serious AEs that the 
Investigator thinks may be associated with the IMP must be reported to UCB regardless of the 
time between the event and the end of the study. 
The method of recording, evaluating, and assessing causality of AE and SAE and the procedures 
for completing and transmitting SAE reports are provided in Appendix 3 (Section 10.3). 
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8.3.2 
Method of detecting AEs and SAEs 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
non-leading verbal questioning of the study participant is the preferred method to inquire about 
AE occurrences. 
8.3.3 
Follow-up of AEs and SAEs 
After the initial AE/SAE report, the Investigator is required to proactively follow each study 
participant at subsequent visits/contacts. All SAEs, [and non-serious AEs of special interest (as 
defined in Section 8.3.6), will be followed until resolution, stabilization, the Investigator 
determines that it is no longer clinically significant, the event is otherwise explained, or the study 
participant is lost to follow up (as defined in Section 7.3). Further information on follow-up 
procedures is given in Appendix 3 (Section 10.3). 
8.3.4 
Regulatory reporting requirements for SAEs 
Prompt notification by the Investigator to the Sponsor of a SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of study participants and the safety of a 
study treatment under clinical investigation are met. 
The Sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study treatment under clinical investigation. The 
Sponsor will comply with country-specific regulatory requirements relating to safety reporting to 
the regulatory authority, IEC, and Investigators. 
Investigator safety reports must be prepared for suspected unexpected serious adverse reactions 
according to local regulatory requirements and Sponsor policy and forwarded to Investigators as 
necessary. 
An Investigator who receives an Investigator safety report describing a SAE or other specific 
safety information (eg, summary or listing of SAEs) from the Sponsor will review and then file it 
along with the IB and will notify the IEC, if appropriate according to local requirements. 
8.3.5 
Pregnancy 
Details of all pregnancies in female study participants and, if indicated, female partners of male 
study participants will be collected after the start of the inhouse treatment period and for at least 
20 weeks after the administration of IMP (anticipated 5 half-lives). 
If a pregnancy is reported, the Investigator must immediately inform the Sponsor within 24 hours 
of learning of the pregnancy and should follow the procedures outlined in Appendix 4 
(Section 10.4). 
The study participant should be withdrawn from the study as soon as pregnancy is known (by 
positive pregnancy test), and the following should be completed: 
• The study participant should return for an early discontinuation visit. 
• A SFU Visit should be scheduled 20 weeks after the date of administration of the study 
participant’s IMP. 
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, and ectopic pregnancy) are considered SAEs. 
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8.3.6 
Adverse events of special interest 
An AE of special interest is any AE that a regulatory authority has mandated be reported on an 
expedited basis, regardless of the seriousness, expectedness, or relatedness of the AE to the 
administration of a UCB product/compound. 
For bimekizumab, the following event requires immediate reporting (within 24 hours, regardless 
of seriousness) to UCB: 
• Hy’s Law 
− Potential Hy’s Law, defined as ≥3xULN ALT or AST with coexisting ≥2xULN total 
bilirubin in the absence of ≥2xULN ALP, with no alternative explanation for the 
biochemical abnormality (ie, without waiting for any additional etiologic investigations 
to have been concluded). Follow-up information should be reported if an alternative 
etiology is identified during investigation and monitoring of the study participant. 
8.3.6.1 
Other safety topics of interest 
Prespecified safety topics of interest for the study are: infections (serious, opportunistic, fungal 
and TB), neutropenia, hypersensitivity, suicidal ideation and behavior, major cardiovascular 
events, liver function test changes/enzyme elevations, malignancies, and inflammatory bowel 
diseases (with gastroenterology referral, as appropriate). 
This is based on findings from the IMP clinical program to date, potential risks generally 
associated with biologic immunomodulators, or findings from other medicines with a related 
mechanism of action. There are no specific AE reporting requirements for these topics; however, 
special monitoring, additional data collection activities, and/or enhanced signal detection 
activities (within UCB) are in place. 
8.3.7 
Medical device– adverse device effects and device presentation 
deficiencies 
Medical device presentations are being provided for use in this study. In order to fulfill 
regulatory reporting obligations worldwide, the Investigator is responsible for the detection and 
documentation of events meeting the definitions of device deficiency that occur during the study 
with such device presentations. 
Adverse events will be reported according to the ISO 14155:2020, while recognizing and 
following requirements including reporting timelines specified in other specific laws, 
regulations, directives, standards and/or guidelines as appropriate and as required by the 
countries in which the clinical investigation is conducted. 
The definition of a device deficiency can be found in Appendix 7 (Section 10.7). 
8.3.7.1 
Time period for detecting medical device presentation deficiencies 
Device deficiencies or malfunctions of the device presentation that result in reportable events 
will be detected, documented, and reported on the date of IMP administration when the medical 
device presentation is used. 
The method of documenting Medical Device Deficiency is provided in Appendix 7. 
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8.3.7.2 
Follow-up of device deficiencies 
Follow-up applies to all study participants, including those who discontinue the study. 
The Investigator is responsible for ensuring that follow up includes any supplemental 
investigations as indicated to elucidate the nature and/or causality of the deficiency. 
New or updated information will be recorded on the originally completed form with all changes 
signed and dated by the Investigator. 
8.3.7.3 
Prompt reporting of device deficiencies to the Sponsor 
Device deficiencies will be reported to the Sponsor within 24 hours after the Investigator 
determines that the event meets the protocol definition of a medical device deficiency. 
The Adverse Event and Device Deficiency Report Form will be sent electronically to the 
Sponsor. The Sponsor will be the contact for the receipt of medical device deficiency reports. 
8.3.7.4 
Regulatory reporting requirements for device deficiencies 
The Investigator will promptly report all device deficiencies occurring with any medical device 
presentation used in the study in order for the Sponsor to fulfill the legal responsibility to notify 
appropriate regulatory authorities and other entities about certain safety information relating to 
medical device presentations being used in clinical studies. 
The Investigator, or responsible person according to local requirements (eg, the head of the 
medical institution), will comply with the applicable local regulatory requirements relating to the 
reporting of device deficiencies to the IEC. 
8.4 
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 and/or device presentation so that Investigators, clinical 
study participants, regulatory authorities, and IECs will be informed appropriately and as early as 
possible. 
The UCB Study Physician or medically qualified designee/equivalent will conduct an ongoing 
review of SAEs and perform ongoing SAE reconciliations in collaboration with the Patient 
Safety representative. 
As appropriate for the stage of development and accumulated experience with the IMP, 
medically qualified personnel at UCB may identify additional safety measures (eg, AEs, vital 
signs, laboratory, or ECG results) for which data will be periodically reviewed during the course 
of the study. 
8.5 
Treatment of overdose 
For this study, any dose of bimekizumab greater than a single-dose administration of 320mg will 
be considered an overdose. Overdose events are only considered AEs or SAEs if there are 
associated clinical signs and symptoms. 
8.6 
Pharmacokinetics 
Whole blood samples will be collected for measurement of plasma concentrations of 
bimekizumab as specified in the schedule of activities (Section 1.3). Instructions for the 
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collection and handling of biological samples will be provided by the Sponsor. The actual date 
and time (24-hour clock time) of each sample will be recorded. The overall blood volume to be 
drawn from each study participant participating in the study will not exceed 450mL, ie, the 
amount of a blood donation. 
Samples will be used to evaluate the PK of bimekizumab. 
Genetic analyses will not be performed on these blood samples. Study participant confidentiality 
will be maintained. At visits during which blood samples for the determination of multiple 
aspects of bimekizumab will be taken, one sample of sufficient volume can be used. 
All PK samples should be drawn from study participants after the ECG has been recorded and 
the vital signs, including BP, have been measured. The following PK parameters will be derived 
from the plasma concentrations of bimekizumab: 
• Area under the plasma concentration-time curve from time zero to infinity (AUC) 
• Area under the plasma concentration-time curve from time zero to the last quantifiable 
concentration (AUC[0-t]) 
• Maximum observed plasma drug concentration (Cmax) 
• Time of occurrence of Cmax (tmax) 
• Apparent terminal half-life (t½) 
• Apparent total body clearance (CL/F) after sc administration , calculated as dose/AUC 
• Apparent volume of distribution (Vz/F), calculated as CL/λz 
• Percentage of the AUC extrapolated from the last observed quantifiable plasma drug 
concentration (Clast) (%AUCex) 
All PK data analyses will be performed under the supervision of the Quantitative Clinical 
Pharmacology Department, UCB using validated software (Phoenix 64, Pharsight, a Certara 
Company, USA). 
Any changes in the timing or addition of time points for any planned study assessments must be 
documented and approved by the relevant study team member and then archived in the Sponsor 
and site study files, but will not constitute a protocol amendment. The IEC will be informed of 
any safety issues that require alteration of the safety monitoring scheme or amendment of the 
ICF. 
Pharmacokinetic samples for concentration measurement of bimekizumab may be stored for a 
maximum of 5 years (or according to local regulations) following the last study participant’s last 
visit at a facility selected by the Sponsor. 
8.7 
Genetics 
Genetics are not evaluated in this study. 
8.8 
Pharmacodynamics 
Pharmacodynamic parameters are not evaluated in this study. 
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8.9 
Biomarkers 
Biomarkers are not evaluated in this study. 
8.10 
Immunogenicity assessments 
Antibodies to bimekizumab will be evaluated in plasma samples collected from all study 
participants according to the schedule of activities (Section 1.3). If feasible, additional blood 
samples for PK and anti-drug antibody (ADAb) analysis should be collected from participants 
who develop a hypersensitivity reaction. This sample should be obtained close to the time of the 
event using an unscheduled visit if needed. Additionally, plasma samples should also be 
collected at the final visit from study participants who were withdrawn from the study. These 
samples will be tested by the Sponsor or Sponsor’s designee. 
Plasma samples will be screened for antibodies binding to bimekizumab and the titer of 
confirmed positive samples will be reported. Other analyses may be performed to verify the 
stability of antibodies to bimekizumab and/or further characterize the immunogenicity of 
bimekizumab. 
The detection and characterization of antibodies to bimekizumab will be performed using a 
validated assay method by or under the supervision of the Sponsor. Anti-drug-antibodies will be 
measured using a three-tiered assay approach: screening assay, confirmatory assay, and titration 
assay. Samples may be stored for a maximum of 5 years (or according to local regulations) 
following the last study participant’s last visit for the study at a facility selected by the Sponsor 
to enable further analysis of immune responses to bimekizumab. 
8.11 
Medical resource utilization and health economics 
Not applicable. 
9 
STATISTICAL CONSIDERATIONS 
A description of statistical methods follows and will be described in more detail in the Statistical 
Analysis Plan (SAP). 
9.1 
Definition of analysis sets 
All study participants will consist of all study participants who signed the ICF. 
The Randomized Set will consist of all randomized study participants. Note: This set will only be 
produced if it differs from the Safety Set. 
The Safety Set will consist of all study participants who are randomized and receive full or 
partial IMP according to the treatment the participants actually received. The Safety Set will be 
used for summaries of demographics, medical history, prior and concomitant medications, IMP 
exposure, and general safety outcomes such as AEs, laboratory parameters, vital signs, and 
ECGs. 
The Pharmacokinetic Set (PKS) will be a subset of the Safety Set, consisting of those study 
participants that received at least 1 total dose of IMP and have at least 1 observable PK 
measurement. All participants in the PKS will be included in the listings. Study participants with 
no protocol deviations to impact observed concentrations will be included in summary tables and 
figures of concentration-time profiles and PK parameters. 
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9.2 
General statistical considerations 
All analyses will be performed using Statistical Analysis System® (SAS®) version 9.4 or later 
(SAS Institute, Cary, NC, USA). 
For continuous variables, summary statistics will include number of study participants, mean, 
median, standard deviation (SD), minimum, and maximum. Categorical endpoints will be 
summarized using number of study participants, frequency, and percentages. Missing data will 
not be imputed. 
If not otherwise stated, Baseline will be the last assessment prior to dosing. Measurement of 
specific Baseline values will be described in the SAP. 
9.3 
Planned efficacy/outcome analyses 
As efficacy is not evaluated in this study, there is no primary efficacy endpoint. 
9.4 
Planned outcome analyses 
9.4.1 
Primary endpoint analyses 
The PK analyses will be performed on the PKS. 
Following loge-transformation, the primary PK parameters (Cmax, area under the plasma 
concentration-time curve from time zero to the last quantifiable concentration [AUC(0-t)], and 
AUC) will each be evaluated according to an analysis of variance (ANOVA) model with a fixed 
effect term for pair and treatment. The estimate of the ratio of geometric mean for the AI-2mL 
(test) versus 2xbimekizumab-AI-1mL (reference) treatment along with the associated 90% 
confidence intervals (CIs) for the ratio will be calculated. Bioequivalence will be concluded if 
the 90% CIs for the ratio of the comparison is fully included in the acceptance range from 0.8 to 
1.25 for AUC, AUC(0-t), and Cmax. 
Two sensitivity analyses will add 1) the main effect of center and 2) both main effect of center 
and center-by-treatment interaction. Further sensitivity analyses may also be performed on the 
PK parameters. 
9.4.2 
Secondary endpoint analyses 
Additionally, a similar ANOVA will be also performed on loge-transformed t½ to compare 
elimination characteristics between treatment groups. The point estimate and the 90% CI for the 
median treatment differences for tmax will be computed according to the Hodges Lehmann’s 
method. 
9.5 
Planned safety and other analyses 
9.5.1 
Safety analyses 
All safety parameters will be listed by study participant and treatment group using the Safety Set. 
The incidence of TEAEs will be determined by treatment group, where applicable. Absolute and 
relative frequencies for a given TEAE by preferred term as per the Medical Dictionary for 
Regulatory Activities (MedDRA®, version 19.0) will be determined within each treatment group 
and system organ class. Additional tables will summarize TEAEs by maximum event intensity 
and causal relationship with IMP per treatment group and overall. The actions taken for each 
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TEAE, the time of onset of the TEAE after dosing, and the duration of each AE will be listed. 
The TEAEs leading to discontinuation and SAEs will also be summarized. 
For continuous laboratory variables, values and changes from Baseline will be summarized at 
each time point. For categorized values according to the reference range, shift tables from 
Baseline to each postdose time point will be presented for selected variables. Values outside the 
reference range will be flagged in the data listings. The reference ranges will be reported. 
Normal versus abnormal findings for the various ECG parameters and overall ECG will be 
analyzed as required, focusing on the identification of outliers and of any trends for changes 
following administration of IMP with respect to QT/QTc. Descriptive statistics will be presented 
for ECG value and changes from Baseline over time. 
Descriptive statistics will be reported for all vital sign measurements (including systolic and 
diastolic BP, pulse rate, and tympanic body temperature). Measured values and changes from 
Baseline will be summarized for all study participants by time point. 
Abnormal findings in the physical examination will be presented in listings only. 
9.5.2 
Immunogenicity analyses 
Bimekizumab ADAb levels will be listed per participant and summarized using summary tables 
and figures. The number (and percentage) of study participants with first occurrence of 
treatment-induced ADAb positivity will also be summarized at each postdose visit. 
9.5.3 
Other analyses 
9.5.3.1 
Study participant disposition and characteristics 
The number of study participants who were enrolled and randomized into the study, in each 
analysis set, and who completed or prematurely discontinued the study, as well as the reason for 
discontinuation, will be presented by treatment and overall using frequency counts and 
percentages. In addition, listings will be provided for study discontinuation, study participant 
disposition, and participant analysis sets. 
Study participant characteristics will include a summary and listing of the following: 
• Demographics (including sex, age, race, ethnicity, height, weight, BMI, and lifestyle) 
• Medical history 
• Prior and concomitant medications 
Concomitant medical procedures will only be listed. 
9.6 
Handling of protocol deviations 
No protocol deviation is permitted, either in retrospect or prospect. 
Important protocol deviations are identified as part of the data cleaning process in the Data 
Cleaning Plan (DCP). The objective of the data cleaning meeting will be to review and update (if 
necessary) the important protocol deviations in the DCP and discuss exclusion of study 
participants from analysis populations. 
Furthermore, overall trends in protocol deviations will be discussed at the Data Evaluation 
Meeting. Through this data cleaning and evaluation process, all decisions regarding important 
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protocol deviations and exclusions from analysis populations will be made. Protocol deviations 
(eg, missing assessments or visits) related to COVID-19 may be listed separately. 
Accepted deviations from theoretical time points will be described in the appropriate documents 
and included in the trial master file (TMF). 
After resolution of all issues, and documentation of all decisions, the database will be locked. 
9.7 
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, as well as handling values below the limit of quantification 
in the PK data, will be detailed in the SAP. 
9.8 
Planned interim analysis and data monitoring 
No formal interim analysis is planned for this study. 
9.9 
Determination of sample size 
This is a BE study to compare the PK of bimekizumab-AI-2mL (test) versus bimekizumab-AI-
1mL (reference). 
The sample size estimation was based upon variability observed in studies UP0033 and UP0068. 
These were the 2 most recent studies which included the AI device with a single administration 
of bimekizumab in healthy study participants. The respective inter-participant variabilities 
(coefficient of variation [CV%]) observed in these studies were up to 32%, 33% (AUC) and 
31%, 25% (Cmax). The geometric mean ratios for all primary PK parameters were between 0.97 
and 1.02 (UP0033) and between 1.03 and 1.15 (UP0068). The individual study CV% and 
geometric mean ratios are presented in Appendix 11 (Section 10.11). 
Assuming a geometric mean ratio of 1.08 (or 0.93) and inter-participant variability (CV%) of 
32%, 54 study participants per group are required to assess BE with 80% power assuming that 
BE will be declared if the 90% CI for the geometric mean ratio is contained entirely within the 
acceptance range (0.8, 1.25). 
Sample size estimation was performed using SAS software (version 9.4). 
Assuming a dropout rate and non-evaluable study participants of approximately 10%, 60 study 
participants per group for a total of approximately 120 study participants are to be enrolled in the 
study. 
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10 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
10.1 
Appendix 1: Regulatory, ethical, and study oversight 
considerations 
10.1.1 
Regulatory and ethical considerations 
The study will be conducted under the auspices of an IEC, as defined in local regulations, 
International Council for Harmonisation (ICH)-GCP (ICH E6[R2]), and in accordance with the 
ethical principles that have their origin in the Declaration of Helsinki (1996). 
The Investigator/UCB will ensure that an appropriately constituted IEC that complies with the 
requirements of the current ICH-GCP version or applicable country-specific regulations will be 
responsible for the initial and continuing review and approval of the clinical study. Prior to 
initiation of the study, the Investigator/UCB will forward copies of the protocol, ICF, IB, 
Investigator’s curriculum vitae (if applicable), advertisement (if applicable), and all other study 
participant-related documents to be used for the study to the IEC for its review and approval. 
Before initiating a study, the Investigator will have written and dated full approval from the 
responsible IEC for the protocol. 
The Investigator will also promptly report to the IEC all changes in the study, all unanticipated 
problems involving risks to study participants or others, and any protocol deviations, to eliminate 
immediate hazards to study participants. 
The Investigator will not make any changes in the study or study conduct without IEC approval, 
except where necessary to eliminate apparent immediate hazards to the study participants. 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 IEC as 
allowed. 
As part of the IEC requirements for continuing review of approved studies, the Investigator will 
be responsible for submitting periodic progress reports to the IEC (based on IEC requirements), 
at intervals appropriate to the degree of study participant risk involved, but no less than once per 
year. The Investigator should provide a final report to the IEC following study completion. 
UCB (or its representative) will communicate safety information to the appropriate regulatory 
authorities and all active Investigators in accordance with applicable regulatory requirements. 
The appropriate IEC will also be informed by the Investigator or the Sponsor, as specified by the 
applicable regulatory requirements in each concerned country. Where applicable, Investigators 
are to provide the Sponsor (or its representative) with evidence of any such IEC notification. 
10.1.2 
Financial disclosure 
Insurance coverage will be handled according to local requirements. 
Finance and insurance are addressed in the Investigator and/or CRO agreements, as applicable. 
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10.1.3 
Informed consent process 
Study participant’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 study participant in both oral and written form by the 
Investigator (or designee). Each study participant will have the opportunity to discuss the study 
and its alternatives with the Investigator. 
Prior to participation in the study, an IEC-approved, written ICF should be signed and personally 
dated by the study participant and by the person who conducted the informed consent discussion 
(Investigator or designee) prior to the initiation of any study-specific assessment at the Screening 
Visit. The study participant must receive a copy of the signed and dated ICF. As part of the 
consent process, each study participant must consent to direct access to his/her medical records 
for study-related monitoring, auditing, IEC 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 IEC and use of the amended form. 
The study participant may withdraw his/her consent to participate in the study at any time. A 
study participant 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 study 
participant, without having obtained his/her written consent to participate in the study. 
10.1.4 
Data protection 
UCB staff (or designee) will affirm and uphold the study participant’s confidentiality. 
Throughout this study, all data forwarded to UCB (or designee) will be identified by the study 
participant’s randomization number. 
The Investigator agrees that representatives of UCB, its designee, representatives of the relevant 
IEC, or representatives of regulatory authorities will be allowed to review that portion of the 
study participant’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 participant’s study participation, and autopsy reports for 
deaths occurring during the study). 
The study participant must be informed that his/her personal study-related data will be used by 
the Sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the study participant. 
The study participant must be informed that his/her medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the Sponsor, by 
appropriate IEC members, and by inspectors from regulatory authorities. 
10.1.5 
Committees structure 
Not applicable. 
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10.1.6 
Data quality assurance 
The Sponsor will supervise study initiation visits to verify the qualifications of the Investigators, 
inspect the facilities, and inform the Investigators of responsibilities and procedures for ensuring 
adequate and correct documentation. 
The Investigators must prepare and maintain adequate and accurate records of all observations 
and other data pertinent to the clinical study for each study participant. Frequent communication 
between the clinical unit and the Sponsor is essential to ensure that the safety of the study is 
monitored adequately. The Investigators will make all appropriate safety assessments on an 
ongoing basis. 
All aspects of the study will be carefully monitored with respect to GCP and SOPs for 
compliance with applicable government regulations. The Study Monitor will be an authorized 
individual designated by the Sponsor. The Study Monitor will have access to all records 
necessary to ensure the integrity of the data and will periodically review the progress of the study 
with the Investigators. Remote monitoring visits may be conducted during the COVID-19 
pandemic or under other exceptional circumstances as deemed appropriate to ensure study 
participants’ safety. 
The Investigator must permit study-related monitoring, audits, IEC review, and regulatory 
agency inspections and provide direct access to source data documents. 
The Sponsor or designee is responsible for the data management of this study including quality 
checking of the data. 
Study Monitors will perform ongoing source data verification to confirm that data entered into 
ClinBase by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of participants are being protected; and that the study is 
being conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP, and all applicable regulatory requirements. 
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/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 TMF. 
10.1.6.1 
Case Report form completion 
The Investigator is responsible for prompt reporting of accurate, complete, and legible data in 
ClinBase and in all required reports. 
Any change or correction to ClinBase after saving must be accompanied by a reason for the 
change. 
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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 ClinBase. 
10.1.6.2 
Apps 
Not applicable. 
10.1.7 
Data collection and source documents 
PAREXEL will use ClinBase to collect medical data during this study. 
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, quality of life 
questionnaires, or video, 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 study participant’s source documents. 
If source documents have been captured by ClinBase, they need to be electronically 
signed/stamped to indicate review by the Investigator/designee/delegate. 
The Investigator/designee 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. 
10.1.8 
Study and site closure 
The Sponsor designee reserves the right to close the study site or terminate the study at any time 
for any reason at the sole discretion of the Sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
The Investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the Sponsor or Investigator may include but are 
not limited to: 
• Failure of the Investigator to comply with the protocol, the requirements of the IEC or local 
health authorities, the Sponsor’s procedures, or GCP guidelines 
• Inadequate recruitment of study participants by the Investigator 
• Discontinuation of further IMP development 
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• A required adaptation of the maximum insurance sum is not possible (ie, the risk/benefit 
estimation changes, leading to insufficient insurance coverage while the maximum insurance 
sum is not adapted) 
• The positive evaluation or approval is withdrawn by the IEC or local health authority 
The criteria for study holds due to AEs are provided in Section 7.1.1. 
10.1.9 
Publication policy 
The results of this study may be published or presented at scientific meetings. If this is foreseen, 
the Investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. 
This allows the Sponsor to protect proprietary information and to provide comments. 
The Sponsor will comply with the requirements for publication of study results. In accordance 
with standard editorial and ethical practice, the Sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data. In this case, a 
coordinating Investigator will be designated by mutual agreement. 
Authorship will be determined by mutual agreement and in line with International Committee of 
Medical Journal Editors authorship requirements. 
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10.2 
Appendix 2: Clinical laboratory tests 
The tests detailed in Table 10-1 below will be performed. The following central laboratories will 
be used: 
• For the site in Germany: at SGS Analytics Germany GmbH (safety laboratory assessments) 
and Parexel International (urinalysis/urine drug screen and SARS-CoV-2 RT-PCR). 
• For the site in the US: at Parexel International (urine drug screen, in-house pregnancy) and 
GenX Laboratories, Inc. (safety laboratory assessments and everything else required). 
Protocol-specific requirements for inclusion or exclusion of study participants are detailed in 
Section 5.1 and Section 5.2 of this protocol. 
Additional tests may be performed at any time during the study as determined necessary by the 
Investigator or required by local regulations. 
Table 10-1: Protocol-required safety laboratory assessments 
Laboratory measurements 
Variables 
Serology 
HbsAg, HBc-Ab (both IgG and IgM), HCV-Ab, HIV1-Ab, 
HIV1-Ag, HIV-2 Ab, SARS-CoV-2 RT-PCRa 
Hematology 
Complete blood count, ie, hemoglobin, hematocrit, RBC, 
WBC, WBC with differential, platelet count 
Coagulation/hemostasis 
Prothrombin time, aPTT 
Clinical chemistry 
Albumin, ALP, ALT, AST, GGT, creatine kinase, LDH, total 
bilirubin, BUN, creatinine, glucose, total cholesterol, LDL 
cholesterol, HDL cholesterol, triglycerides, electrolytes 
(sodium, potassium, chloride, total calcium), and total 
protein, FSH 
Urine (dipstick) b 
pH, protein, glucose, ketone, urobilinogen, bilirubin, blood, 
specific gravity, nitrite, and leukocytes 
Urine alcohol test/drug screen 
Ethanol will be measured using a urine alcohol test. 
Urine drug screen includes 
amphetamines/methamphetamines, barbiturates, 
benzodiazepines, tetrahydrocannabinol, cocaine, tricyclic 
antidepressants, phencyclidine, and morphine/opiates 
Pregnancy 
Prior to dosing, a serum pregnancy test (hCG) will be 
performed; post dosing the test may be performed in urine. 
The FSH test will be performed in postmenopausal women at 
the Screening Visit. 
ALP=alkaline phosphatase; ALT=alanine aminotransferase; aPTT=activated partial thromboplastin time; 
AST=aspartate aminotransferase; BUN=blood urea nitrogen; FSH=follicle stimulating hormone; 
GGT=gamma glutamyltransferase; HBc-Ab=hepatitis B core antibody; HbsAg=hepatitis B surface antigen; 
hCG=human chorionic gonadotropin; HCV-Ab=hepatitis C virus antibody; HDL=high density lipoprotein; 
HIV=human immunodeficiency virus; HIV1/2-Ab=HIV1/2 antibody; HIV1-Ag=HIV1 antigen; LDH=lactate 
dehydrogenase; LDL=low density lipoprotein; RBC=red blood cell; WBC=white blood cell 
a Sample will be obtained per local requirements. 
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b Upon a positive urine test for leukocytes, blood, nitrite, or protein, the Investigator may require further urine 
analysis, such as flow cytometry. Results of additional urine analyses will be included in the database. If the flow 
cytometry examination shows a different result than the urine dipsticks, the urine will be investigated by fully 
automated digital imaging where leukocytes, erythrocytes, and casts (cellular, granular, hyaline) in urine will be 
analyzed. 
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10.3 
Appendix 3: Adverse events – definitions and procedures for 
recording, evaluating, follow up, and reporting 
10.3.1 
Definition of AE 
AE Definition 
• 
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally 
associated with the use of IMP, whether or not considered related to the IMP. 
• 
NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the 
use of IMP. 
 
Events Meeting the AE Definition 
• 
Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other 
safety assessments (eg, ECG, radiological scans, vital signs measurements), including those 
that worsen from baseline, considered clinically significant in the medical and scientific 
judgment of the Investigator (ie, not related to progression of underlying disease). 
• 
Exacerbation of a chronic or intermittent pre-existing condition including either an increase in 
frequency and/or intensity of the condition. 
• 
New conditions detected or diagnosed after IMP administration even though it may have been 
present before the start of the study. 
• 
Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• 
Signs, symptoms, or the clinical sequelae of a suspected overdose of either IMP or a 
concomitant medication. Overdose per se will not be reported as an AE/SAE unless it is an 
intentional overdose taken with possible suicidal/self-harming intent. Such overdoses should be 
reported regardless of sequelae. 
 
Events NOT Meeting the AE Definition 
• 
Any clinically significant abnormal laboratory findings or other abnormal safety assessments 
which are associated with the underlying disease, unless judged by the Investigator to be more 
severe than expected for the study participant’s condition. 
• 
The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the study participant’s 
condition. 
• 
Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that leads to the 
procedure is the AE. 
• 
Situations in which an untoward medical occurrence did not occur (social and/or convenience 
admission to a hospital). 
• 
Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or 
detected at the start of the study that do not worsen. 
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10.3.2 
Definition of SAE 
If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions 
are met (eg, hospitalization for signs/symptoms of the disease under study, death due to 
progression of disease). 
A SAE is defined as any untoward medical occurrence that, at any dose: 
a. Results in death 
b. Is life-threatening 
The term ‘life-threatening’ in the definition of ‘serious’ refers to an event in which the study participant 
was at risk of death at the time of the event. It does not refer to an event, which hypothetically might 
have caused death, if it were more severe. 
c. 
Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the study participant has been detained (usually involving at 
least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would 
not have been appropriate in the physician’s office or outpatient setting. Complications that occur 
during hospitalization are AEs. If a complication prolongs hospitalization or fulfills any other serious 
criteria, the event is serious. When in doubt as to whether “hospitalization” occurred or was necessary, 
the AE should be considered serious. 
Hospitalization for elective treatment of a pre-existing condition that did not worsen from Baseline is 
not considered an AE. 
d. Results in persistent disability/incapacity 
• 
The term disability means a substantial disruption of a person’s ability to conduct normal life 
functions. 
• 
This definition is not intended to include experiences of relatively minor medical significance 
such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental trauma 
(eg, sprained ankle) which may interfere with or prevent everyday life functions but do not 
constitute a substantial disruption. 
e. 
Is a congenital anomaly/birth defect 
f. 
Is an important medical events: 
• 
Medical or scientific judgment should be exercised in deciding whether SAE reporting is 
appropriate in other situations such as important medical events that may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the study participant or 
may require medical or surgical intervention to prevent one of the other outcomes listed in the 
above definition. These events should usually be considered serious. 
• 
Examples of such events include, but are not limited to, potential Hy’s law, invasive or 
malignant cancers, intensive treatment in an emergency room or at home for allergic 
bronchospasm, blood dyscrasias, or convulsions that do not result in hospitalization, or 
development of drug dependency or drug abuse. 
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10.3.3 
Recording and follow up of AE and/or SAE 
AE and SAE Recording 
• 
When an AE/SAE occurs, it is the responsibility of the Investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostics reports) related 
to the event. 
• 
The Investigator will then record all relevant AE/SAE information in the eCRF. 
• 
It is not acceptable for the Investigator to send photocopies of the study participant’s medical 
records to UCB in lieu of completion of the UCB AE/SAE eCRF page. 
• 
There may be instances when copies of medical records for certain cases are requested by 
UCB. In this case, all study participant identifiers, with the exception of the study participant 
number, will be redacted on the copies of the medical records before submission to UCB. 
• 
The Investigator will attempt to establish a diagnosis of the event based on signs, symptoms, 
and/or other clinical information. Whenever possible, the diagnosis (not the individual 
signs/symptoms) will be documented as the AE/SAE. 
Assessment of Intensity 
The Investigator will make an assessment of intensity for each AE and SAE reported during the study 
and assign it to 1 of the following categories: 
• 
Mild: An event that is easily tolerated by the study participant, causing minimal discomfort and 
not interfering with everyday activities. 
• 
Moderate: An event that causes sufficient discomfort and interferes with normal everyday 
activities. 
• 
Severe: An event that prevents normal everyday activities. An AE that is assessed as severe 
should not be confused with a SAE. Severe is a category utilized for rating the intensity of an 
event; and both AEs and SAEs can be assessed as severe. 
• 
An event is defined as ‘serious’ when it meets at least 1 of the predefined outcomes as 
described in the definition of an SAE, NOT when it is rated as severe (eg, a severe AE may be 
either serious or not serious, depending on whether these criteria are also met). 
The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 
should be used as a supportive standardization instrument to evaluate AEs and SAEs but the final 
intensity grading by the Investigator must be mild, moderate, or severe. 
 
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Assessment of Causality 
• 
The Investigator is obligated to assess the relationship between IMP and each occurrence of 
each AE/SAE. 
• 
A “reasonable possibility” of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled out. 
• 
The Investigator will use clinical judgment to determine the relationship. 
• 
Alternative causes, such as underlying disease(s), concomitant therapy, and other risk factors, 
as well as the temporal relationship of the event to IMP administration will be considered and 
investigated. 
• 
The Investigator will also consult the IB and/or Product Information, for marketed products, in 
his/her assessment. 
• 
For each AE/SAE, the Investigator must document in the medical notes that he/she has 
reviewed the AE/SAE and has provided an assessment of causality. 
• 
There may be situations in which an SAE has occurred and the Investigator has minimal 
information to include in the initial report to UCB. However, it is very important that the 
Investigator always make an assessment of causality for every event before the initial 
transmission of the SAE data to UCB. 
• 
The Investigator may change his/her opinion of causality in light of follow-up information and 
send a SAE follow-up report with the updated causality assessment. 
• 
The causality assessment is one of the criteria used when determining regulatory reporting 
requirements. 
 
Follow-up of AEs and SAEs 
• 
The Investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by UCB to elucidate 
the nature and/or causality of the AE or SAE as fully as possible. This may include additional 
laboratory tests or investigations, histopathological examinations, or consultation with other 
health care professionals. 
• 
An AE should be followed until it has resolved, has a stable sequelae, the Investigator 
determines that it is no longer clinically significant, or the study participant is lost to follow up. 
This follow-up requirement applies to AEs, SAEs, and AEs of special interest. 
• 
If a study participant dies during participation in the study or during a recognized follow-up 
period, the Investigator will provide UCB with a copy of any post-mortem findings including 
histopathology. 
• 
New or updated information will be recorded in the originally completed eCRF. 
• 
The Investigator will submit any updated SAE data to the UCB within 24 hours of receipt of 
the information. 
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Reporting of SAEs 
SAE Reporting to UCB via an Electronic Data Collection Tool 
• 
The primary mechanism for reporting an SAE to UCB will be the electronic data collection 
tool. 
• 
If the electronic system is unavailable for more than 24 hours, then the site will use the paper 
SAE data collection tool (see next section). 
• 
The site will enter the SAE data into the electronic system as soon as it becomes available. 
• 
After the study is completed at a given site, the electronic data collection tool will be taken off-
line to prevent the entry of new data or changes to existing data. 
• 
If a site receives a report of a new SAE from a study participant or receives updated data on a 
previously reported SAE after the electronic data collection tool has been taken off-line, then 
the site can report this information on a paper SAE form (see next bullet) or to the UCB Study 
Physician by telephone. 
• 
Contacts for SAE reporting can be found in SERIOUS ADVERSE EVENT REPORTING. 
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10.4 
Appendix 4: Contraceptive guidance and collection of 
pregnancy information 
Definitions 
Woman of Childbearing Potential (WOCBP) 
A woman is considered fertile following menarche and until becoming post-menopausal unless 
permanently sterile (see below). 
Women in the following categories are not considered WOCBP: 
1. Premenarchal 
2. Premenopausal female with 1 of the following: 
− Documented hysterectomy 
− Documented bilateral salpingectomy 
− Documented bilateral oophorectomy 
Note: Documentation can come from the site personnel’s review of the study participant’s 
medical records, medical examination, or medical history interview. 
3. Postmenopausal female 
− A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal 
range may be used to confirm a postmenopausal state in women not using hormonal 
contraception or hormonal replacement therapy (HRT). However, in the absence of 
12 months of amenorrhea, a single FSH measurement is insufficient. 
− Females on HRT and whose menopausal status is in doubt will be required to use one of 
the non-estrogen hormonal highly effective contraception methods if they wish to 
continue their HRT during the study. Otherwise, they must discontinue HRT to allow 
confirmation of postmenopausal status before study enrollment. 
Contraception Guidance 
Male study participants 
Male study participants with female partners of childbearing potential are eligible to participate 
if they agree to ONE of the following for a period of 20 weeks after their dose of IMP. 
• Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent 
on a long term and persistent basis) and agree to remain abstinent. 
• Agree to use a male condom plus partner use of a contraceptive method with a failure rate of 
<1% per year as described in Appendix 4 (Section 10.4) when having penile-vaginal 
intercourse with a woman of childbearing potential who is not currently pregnant. 
In addition, male study participants must refrain from donating sperm for the duration of the 
study and for at least 20 weeks after IMP administration. 
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Male study participants with a pregnant or breastfeeding partner must agree to remain abstinent 
from penile-vaginal intercourse or use a male condom during each episode of penile penetration 
during the protocol-defined time frame. 
Female study participants 
Female study participants of childbearing potential are eligible to participate if they agree to use 
a highly effective method of contraception consistently and correctly as described in Appendix 4 
(Section 10.4). 
Table 10-2: Highly effective contraceptive methods a 
Highly Effective Contraceptive Methods That Are User Dependentb 
Failure rate of <1% per year when used consistently and correctly. 
Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of 
ovulation  
• 
Oral 
• 
Intravaginal 
• 
Transdermal 
Progestogen-only hormonal contraception associated with inhibition of ovulation 
• 
Oral 
• 
Injectable 
Highly Effective Methods That Are User Independentb 
Implantable progestogen-only hormonal contraception associated with inhibition of ovulation 
• 
Intrauterine device (IUD) 
• 
Intrauterine hormone-releasing system (IUS) 
• 
Bilateral tubal occlusion 
Vasectomized partner 
A vasectomized partner is a highly effective contraception method provided that the partner is the sole 
male sexual partner of the woman of childbearing potential (WOCBP) and the absence of sperm has 
been confirmed. If not, an additional highly effective method of contraception should be used. 
Sexual abstinence 
Sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the IMP. The reliability of 
sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and 
usual lifestyle of the study participant. 
a In case of newly started contraception pills/IUDs, PI should consider the correct timing of starting/applying such 
methods in relation to the menstrual cycle and the manufacturing instruction as when these newly started methods 
would become effective. 
b Typical use failure rates may differ from those when used consistently and correctly. Use should be consistent 
with local regulations regarding the use of contraceptive methods for study participants participating in clinical 
studies. 
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Pregnancy testing 
• WOCBP should only be included after a confirmed menstrual period and a negative highly 
sensitive serum pregnancy test. 
• Additional pregnancy testing should be performed at monthly intervals during the treatment 
period, and at the SFU Visit at Day 140. 
• Pregnancy testing will be performed whenever a menstrual cycle is missed or when 
pregnancy is otherwise suspected. 
• Pregnancy testing, with a sensitivity of 25mIU/mL will be performed. 
Male participants with partners who become pregnant 
• The Investigator will attempt to collect pregnancy information on any male study 
participant’s female partner who becomes pregnant while the male study participant is in this 
study and for at least 20 weeks after IMP administration. 
• After obtaining the necessary signed informed consent from the pregnant female partner 
directly, the Investigator will record pregnancy information on the appropriate form and 
submit it to the Sponsor within 1 working day of learning of the partner’s pregnancy. The 
female partner will also be followed to determine the outcome of the pregnancy. Information 
on the status of the mother and child will be forwarded to the Sponsor. Generally, the follow 
up will be at least 12 months after the delivery date. Any termination of the pregnancy will 
be reported regardless of fetal status (presence or absence of anomalies) or indication for the 
procedure. 
Female participants who become pregnant 
• Any female participant who becomes pregnant while participating in the study will be 
withdrawn from the study. 
• The Investigator will collect pregnancy information on any female study participant who 
becomes pregnant while participating in this study. Information will be recorded on the 
appropriate form and submitted to the Sponsor within 24 hours of learning of a study 
participant’s pregnancy. The study participant will be followed to determine the outcome of 
the pregnancy. The Investigator will collect follow-up information on the study participant 
and the neonate and the information will be forwarded to the Sponsor. Generally, the follow 
up will be at least 12 months after the delivery date. Any termination of pregnancy will be 
reported, regardless of fetal status (presence or absence of anomalies) or indication for the 
procedure. 
• While pregnancy itself is not considered to be an AE or SAE, any pregnancy complication or 
elective termination of a pregnancy will be reported as an AE or SAE. A spontaneous 
abortion is always considered to be an SAE and will be reported as such. Any post-study 
pregnancy-related SAE considered reasonably related to the IMP by the Investigator will be 
reported to the Sponsor as described in Section 8.3.5. While the Investigator is not obligated 
to actively seek this information in former study participants, he or she may learn of an SAE 
through spontaneous reporting. 
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10.5 
Appendix 5: Genetics 
Not applicable. 
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10.6 
Appendix 6: Liver safety – suggested actions and follow-up 
assessments 
Study participants with potential drug-induced liver injury should not be withdrawn from the 
study until investigation and monitoring are complete. All results of these evaluations and 
observations, as well as the reason(s) for study participant withdrawal (if applicable), must be 
recorded in the source documents. 
A specific monitoring plan must be agreed between the UCB Study Physician and the 
Investigator for study participants who have ALT >5 ULN. The monitoring plan should include 
any necessary follow-up assessments (until resolution of the abnormal lab values). 
Phase 1 liver chemistry stopping criteria are designed to assure study participant safety and to 
evaluate liver event etiology (Table 10-3). 
Table 10-3: Phase I liver chemistry stopping criteria and follow-up 
assessments 
Liver Chemistry Stopping Criteria – Liver Stopping Event 
ALT-absolute 
ALT≥3xULN 
If ALT ≥3xULN AND bilirubin 2xULN (>35% direct bilirubin) OR 
international normalized ratio (INR) >1.5, report as a serious adverse event 
(SAE).a,b 
See additional actions and follow-up assessments listed below. 
Suggested Actions and Follow up Assessments 
Actions 
Follow Up Assessments 
• Report the event to the UCB within 24 hours 
• Complete the liver event eCRF, and complete 
an SAE data collection tool if the event also 
met the criteria for an SAE. 
• Perform liver chemistry follow-up assessments. 
• Monitor the study participant until liver 
chemistry test abnormalities resolve, stabilize, 
or return to Baseline (see MONITORING). 
MONITORING: 
If ALT 3xULN AND bilirubin 2xULN or INR 
>1.5: 
• Repeat liver chemistry tests (include ALT, 
AST, ALP, bilirubin) and perform liver event 
follow-up assessments within 24 hours. 
• Monitor study participant twice weekly until 
liver chemistry test abnormalities resolve, 
stabilize, or return to Baseline. 
• Viral hepatitis serologyc 
• Obtain INR and recheck with each 
liver chemistry assessment until the 
transaminases values show 
downward trend 
• Serum creatine phosphokinase and 
LDH 
• Fractionate bilirubin, if total 
bilirubin 2xULN 
• Obtain complete blood count with 
differential to assess eosinophilia 
• Record the appearance or worsening 
of clinical symptoms of liver injury, 
or hypersensitivity, on the AE eCRF 
• Record use of concomitant 
medications (including 
acetaminophen, herbal remedies, and 
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Table 10-3: Phase I liver chemistry stopping criteria and follow-up 
assessments 
Liver Chemistry Stopping Criteria – Liver Stopping Event 
• A specialist or hepatology consultation is 
recommended. 
If ALT ≥3xULN AND bilirubin <2xULN and INR 
≤1.5: 
• Repeat liver chemistry tests (include ALT, 
AST, ALP, bilirubin) and perform liver 
chemistry follow-up assessments within 24 to 
72 hours. 
• Monitor study participants weekly until liver 
chemistry abnormalities resolve, stabilize, or 
return to Baseline. 
other over-the-counter medications) 
on the concomitant medications 
eCRF 
• Record alcohol use on the liver event 
alcohol intake eCRF 
If ALT ≥3xULN AND bilirubin 
2xULN or INR >1.5: 
• Anti-nuclear antibody, anti-smooth 
muscle antibody, Type 1 anti-liver 
kidney microsomal antibodies, and 
quantitative total IgG or gamma 
globulins 
• Serum acetaminophen adduct high 
performance liquid chromatography 
(HPLC) assay (quantifies potential 
acetaminophen contribution to liver 
injury in study participants with 
definite or likely acetaminophen use 
in the preceding week [James, 
2009]) 
• Liver imaging (ultrasound, magnetic 
resonance, or computerized 
tomography) and/or liver biopsy to 
evaluate liver disease; complete liver 
imaging and/or liver biopsy eCRFs 
a Serum bilirubin fractionation should be performed if testing is available. If serum bilirubin fractionation testing is 
unavailable, record the absence/presence of detectable urinary bilirubin on dipstick, which is indicative of direct 
bilirubin elevations suggesting liver injury. 
b All events of ALT ≥3xULN and bilirubin ≥2xULN (>35% direct bilirubin) or ALT ≥3xULN and INR >1.5 may 
indicate severe liver injury (possible ‘Hy’s Law’) and must be reported as SAEs (excluding studies of hepatic 
impairment or cirrhosis). The INR measurement is not required and the stated threshold value will not apply to 
study participants receiving anticoagulants. 
c Hepatitis A immunoglobulin M (IgM) antibody; HbsAg and HbcAb; hepatitis C ribonucleic acid; cytomegalovirus 
IgM antibody; Epstein-Barr viral capsid antigen IgM antibody (or if unavailable, heterophile antibody or monospot 
testing); and hepatitis E IgM antibody. 
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10.7 
Appendix 7: Medical device presentation ADEs and Device 
Deficiencies: – definition and procedures for recording, 
evaluating, follow up, and reporting 
10.7.1 
Definitions of a medical device presentation incident 
The definitions and procedures detailed in this appendix are in accordance with ISO 14155. 
Both the Investigator and the sponsor will comply with all local medical device reporting 
requirements. 
The detection and documentation procedures described in this protocol apply to all Sponsor 
medical device presentations provided for use in the study. See Section 6.1.1 for the Sponsor 
medical device presentations. 
10.7.2 
Definition of ADE 
AE and ADE Definition 
• 
An ADE is defined as an adverse event related to the use of an investigational medical device. 
This definition includes any adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction of 
the investigational medical device as well as any event resulting from use error or from 
intentional misuse of the investigational medical device. 
10.7.3 
Definition of device deficiency 
Device deficiency definition 
• 
A device presentation 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. 
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10.7.4 
Recording and follow up of ADE and device deficiencies 
ADE and device deficiency recording 
• 
When an ADE /device deficiency occurs, it is the responsibility of the Investigator to review 
all documentation (e.g., hospital progress notes, laboratory reports, and diagnostics reports) 
related to the event. 
• 
The Investigator will then record all relevant ADE /device deficiency information in the 
participant’s medical records, in accordance with the Investigator’s normal clinical practice 
and on the appropriate form of the CRF. 
• 
It is not acceptable for the Investigator to send photocopies of the participant’s medical records 
to UCB in lieu of completion of the UCB ADE/ device deficiency CRF page. 
• 
There may be instances when copies of medical records for certain cases are requested by 
UCB. In this case, all participant identifiers, with the exception of the participant number, will 
be redacted on the copies of the medical records before submission to UCB. 
• 
The Investigator will attempt to establish a diagnosis of the event based on signs, symptoms, 
and/or other clinical information. Whenever possible, the diagnosis (not the individual 
signs/symptoms) will be documented as the ADE. 
• 
For device deficiencies, it is very important that the Investigator returns the device to the 
sponsor, and describes any corrective or remedial actions taken to prevent recurrence of the 
deficiency. 
o A remedial action is any action other than routine maintenance or servicing of a 
medical device where such action is necessary to prevent recurrence of a device 
deficiency. This includes any amendment to the device design to prevent recurrence. 
The Investigator should complete a Product Complaint Form for all reported device 
deficiencies. 
Assessment of intensity 
The Investigator will make an assessment of intensity for each ADE /device deficiency reported during 
the study and assign it to one of the following categories: 
• 
Mild: An event that is easily tolerated by the participant, causing minimal discomfort and not 
interfering with everyday activities. 
• 
Moderate: An event that causes sufficient discomfort and interferes with normal everyday 
activities. 
• 
Severe: An event that prevents normal everyday activities. An AE that is assessed as severe 
should not be confused with a SAE. Severe is a category utilized for rating the intensity of an 
event; and both AEs and SAEs can be assessed as severe. 
• 
An event is defined as ‘serious’ when it meets at least 1 of the predefined outcomes as 
described in the definition of an SAE, NOT when it is rated as severe. 
 
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Assessment of causality 
• 
The Investigator is obligated to assess the relationship between study intervention and each 
occurrence of each AE to assess if they are ADEs/ /device deficiency. 
• 
A “reasonable possibility” of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled out. 
• 
The Investigator will use clinical judgment to determine the relationship. 
• 
Alternative causes, such as underlying disease(s), concomitant therapy, and other risk factors, 
as well as the temporal relationship of the event to study intervention administration will be 
considered and investigated. 
• 
For each ADE /device deficiency, the Investigator must document in the medical notes that 
he/she has reviewed the ADE/ device deficiency and has provided an assessment of causality. 
• 
 
 
Follow-up of ADE /device deficiency 
• 
The Investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by UCB to elucidate 
the nature and/or causality of the ADE/ device deficiency as fully as possible. This may 
include additional laboratory tests or investigations, histopathological examinations, or 
consultation with other health care professionals. 
• 
New or updated information will be recorded in the originally completed CRF. 
• 
The Investigator will submit any updated ADE data to UCB within 24 hours of receipt of the 
information. 
 
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10.8 
Appendix 8: Rapid alert procedures 
Not applicable. 
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10.9 
Appendix 9: Country-specific requirements 
Not applicable. 
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10.10 
Appendix 10: Abbreviations and trademarks 
Ab 
antibody 
ADAb 
anti-drug antibody 
ADE 
adverse device effect 
AE 
adverse event 
AI 
auto-injector 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
ANOVA 
analysis of variance 
AST 
aspartate aminotransferase 
AUC 
area under the plasma concentration-time curve from time zero to 
infinity  
AUC(0-t)  
area under the plasma concentration-time curve from time zero to the 
last quantifiable concentration 
%AUCex 
percentage of the AUC extrapolated from Clast 
axSpA 
axial spondyloarthritis 
BE 
bioequivalence 
BMI 
body mass index 
BP 
blood pressure 
CI 
confidence interval 
CL/F 
apparent total body clearance  
Clast 
last observed quantifiable plasma drug concentration 
Cmax  
maximum observed plasma drug concentration 
COVID-19 
coronavirus disease 2019 
CRO 
contract research organization 
CV 
coefficient of variation 
DCP 
Data Cleaning Plan 
ECG 
electrocardiogram 
eCRF 
electronic Case Report Form 
EU 
European Union 
FSH 
follicle stimulating hormone 
GCP 
Good Clinical Practice 
HBc-Ab 
anti-hepatitis B core antibody 
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HbsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
HRT 
hormonal replacement therapy 
HS 
hidradenitis suppurativa 
IB 
Investigatorʼs Brochure 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation 
IEC 
Independent Ethics Committee 
IFU 
Instructions for Use 
Ig 
immunoglobulin 
IL 
interleukin 
IMP 
investigational medicinal product 
LDH 
lactate dehydrogenase 
mAb 
monoclonal antibody 
MedDRA® 
Medical Dictionary for Regulatory Activities 
PFS 
prefilled syringe 
PK 
pharmacokinetics 
PKS 
Pharmacokinetic Set 
PsA 
psoriatic arthritis 
PSO 
psoriasis 
QTcF 
QT interval corrected using Fridericia’s formula 
RT-PCR 
reverse transcriptase polymerase chain reaction  
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SAS® 
Statistical Analysis System 
sc 
subcutaneous 
SD 
standard deviation 
SFU 
Safety Follow-Up 
SOP 
standard operating procedure 
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SS 
safety syringe 
t½  
apparent terminal half-life 
TB 
tuberculosis 
TEAE 
treatment-emergent adverse event 
tmax 
time of occurrence of Cmax 
TMF 
trial master file 
TN 
True North 
ULN 
upper limit of normal 
Vz/F 
apparent volume of distribution 
WOCBP 
women of childbearing potential 
 
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10.11 
Appendix 11: Sample size estimation parameters 
Study 
Formulation Parameter 
CV% 
GeoMean 
ratio 
Comments 
UP0033 
n=63 
per arm 
SS 1mL 
AUC 
31.1 
97.8 
vs TN 1mL, CV% is from individual 
comparisons data 
Cmax 
28 
96.5 
vs TN 1mL, CV% is from individual 
comparisons data 
AI 1mL 
AUC 
29.9 
102 
vs TN 1mL, CV% is from individual 
comparisons data 
Cmax 
22.9 
98.25 
vs TN 1mL, CV% is from individual 
comparisons data 
TN 1mL 
AUC 
32.1 
 
 
Cmax 
30.5 
 
 
UP0068 
n=~18 
per arm 
SS 2mL 
AUC 
32.8 
103.4 
vs SS 2x1mL, Final Report, CV% is 
from individual comparison 
Cmax 
25.4 
104.0 
vs SS 2x1mL, Final Report, CV% is 
from individual comparison 
AI 2mL 
AUC 
28.6 
115.0 
vs AI 2x1mL, Final Report, CV% is 
from individual comparison 
Cmax 
24.7 
114.3 
vs AI 2x1mL, Final Report, CV% is 
from individual comparison 
AI=auto-injector; AUC=area under the plasma concentration-time curve from time zero to infinity; 
Cmax=maximum observed plasma drug concentration; CV=coefficient of variation; Geomean=geometric mean; 
SS=safety syringe; TN=True North 
 
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10.12 
Appendix 12: Protocol amendment history 
The Protocol Amendment Summary of Changes Table for the current amendment is located 
directly before the Table of Contents. 
11 
REFERENCES 
CPMP/ICH/135/95 Note for guidance on Good Clinical Practice (EMEA) Jul 2002. 
EMEA/H/SA/3306/1/FU/1/2017/III Sep 2017. 
Food and Drug Administration. Guidance for Industry. Drug-induced liver injury: premarketing 
clinical evaluation. US Dept of Health and Human Services, Center for Drug Evaluation and 
Research, Center for Biologics Evaluation and Research, 07/2009. 
ISO 14155:2020 Clinical Investigations of medical devices for human subjects – Good Clinical 
Practice. 
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on 
medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation 
(EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. 
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12 
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:
up0119-protocol-amend-1
Version:
2. 0
Document Number:
CLIN-000185658
Title:
UP0119 Protocol
Approved Date:
24 Mar 2022
Document Approvals
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 23-Mar-2022 15:28:16 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Medical
Date of Signature: 24-Mar-2022 07:24:15 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Management Approval
Date of Signature: 24-Mar-2022 08:53:17 GMT+0000
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SAP_001.pdf: 
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STATISTICAL ANALYSIS PLAN 
AMENDMENT 1 
 
Study: UP0119 
Product: Bimekizumab 
PHASE 1 
AN OPEN-LABEL, RANDOMIZED, PARALLEL-GROUP, 
SINGLE-DOSE BIOEQUIVALENCE STUDY OF BIMEKIZUMAB 
GIVEN AS 1X2ML OR 2X1ML SUBCUTANEOUS INJECTION 
USING AN AUTOINJECTOR IN HEALTHY STUDY 
PARTICIPANTS 
SHORT TITLE: 
A bioequivalence study of bimekizumab administered as 1x2mL or 2x1mL subcutaneously in 
healthy study participants 
 
Sponsor Name: UCB Biopharma SRL 
Legal Registered Address: Allée de la Recherche 60, 1070 Brussels, BELGIUM 
Regulatory Agency Identifier Number(s): 
Registry 
ID 
Eudra CT Number: 
2021-005334-41 
IND Number  
128707 
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Confidentiality Statement 
Confidential 
This document is the property of UCB and may not – in full or in part – be passed on, 
reproduced, published, or otherwise used without the express permission of UCB. 
 
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TABLE OF CONTENTS 
VERSION HISTORY ................................................................................................................ 6 
LIST OF ABBREVIATIONS .................................................................................................... 6 
1 
INTRODUCTION ........................................................................................................... 10 
1.1 
Objectives and Estimands/Endpoints ........................................................................... 10 
1.1.1 
Study objectives ................................................................................................... 10 
1.1.1.1 
Primary objective ...................................................................................... 10 
1.1.1.2 
Secondary objectives ................................................................................. 11 
1.1.1.3 
Other/Exploratory objectives .................................................................... 11 
1.1.2 
Study endpoints ................................................................................................... 11 
1.1.2.1 
Pharmacokinetic endpoints ........................................................................ 11 
1.1.2.2 
Safety endpoints ........................................................................................ 12 
1.1.2.3 
Immunogenicity endpoints ........................................................................ 12 
1.2 
Study Design ................................................................................................................ 13 
2 
STATISTICAL HYPOTHESES ...................................................................................... 15 
3 
SAMPLE SIZE DETERMINATION .............................................................................. 15 
4 
POPULATIONS FOR ANALYSIS ................................................................................. 15 
4.1 
All Study Participants Set ............................................................................................ 15 
4.2 
Randomized Set ........................................................................................................... 15 
4.3 
Safety Set ..................................................................................................................... 15 
4.4 
Pharmacokinetic Set..................................................................................................... 16 
5 
STATISTICAL ANALYSES .......................................................................................... 16 
5.1 
General Considerations ................................................................................................ 16 
5.1.1 
General study level definitions ............................................................................ 17 
5.1.1.1 
Analysis Time Points ................................................................................. 17 
5.1.1.2 
Handling of dropouts or missing data ....................................................... 18 
5.1.1.3 
Handling of repeated and unscheduled measurements .............................. 21 
5.1.1.4 
Protocol deviations .................................................................................... 21 
5.1.1.5 
Treatment assignment and treatment groups ............................................. 21 
5.1.1.6 
Coding dictionaries .................................................................................... 22 
5.1.1.7 
Multicenter studies .................................................................................... 22 
5.2 
Participant Dispositions ............................................................................................... 22 
5.3 
Efficacy Analyses ........................................................................................................ 23 
5.4 
Pharmacokinetics and Pharmacodynamics Analyses .................................................. 23 
5.4.1 
Pharmacokinetics ................................................................................................. 23 
5.4.1.1 
Descriptive analysis of Pharmacokinetics data ......................................... 24 
5.4.1.2 
Pharmacokinetics Parameters .................................................................... 25 
5.4.2 
Statistical analysis of bioequivalence .................................................................. 28 
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5.4.2.1 
Primary analysis ........................................................................................ 28 
5.4.2.2 
Secondary analysis .................................................................................... 29 
5.4.2.3 
Sensitivity analysis .................................................................................... 29 
5.5 
Immunogenicity Analyses ........................................................................................... 30 
5.5.1 
Anti-drug antibodies ............................................................................................ 30 
5.6 
Safety Analyses ............................................................................................................ 31 
5.6.1 
Extent of Exposure .............................................................................................. 31 
5.6.2 
Adverse Events .................................................................................................... 31 
5.6.3 
Additional Safety Assessments ............................................................................ 33 
5.6.3.1 
Clinical laboratory evaluations .................................................................. 33 
5.6.3.2 
Vital Signs ................................................................................................. 36 
5.6.3.3 
Electrocardiograms .................................................................................... 36 
5.6.3.4 
Physical examinations ............................................................................... 37 
5.7 
Other Analyses ............................................................................................................. 37 
5.8 
Subgroup Analyses ...................................................................................................... 37 
5.9 
Interim Analyses .......................................................................................................... 37 
5.10 
Data Monitoring Committee (DMC) or Other Review Board ..................................... 37 
6 
SUPPORTING DOCUMENTATION ............................................................................. 38 
6.1 
Appendix 1: Non-key analysis specifications .............................................................. 38 
6.1.1 
Baseline characteristics and demographics ......................................................... 38 
6.1.1.1 
Demographics ............................................................................................ 38 
6.1.1.2 
Other Baseline characteristics ................................................................... 39 
6.1.2 
Important protocol deviations .............................................................................. 39 
6.1.3 
Impact of COVID-19 on study visits ................................................................... 39 
6.1.4 
Medical history and concomitant diseases .......................................................... 39 
6.1.5 
Prior and concomitant medications ..................................................................... 40 
6.1.5.1 
Definitions of prior and concomitant medications .................................... 40 
6.1.5.2 
Presentation of prior and concomitant medications data ........................... 40 
6.1.6 
Compliance .......................................................................................................... 41 
6.2 
Appendix 2: Changes to Protocol-Planned Analyses .................................................. 41 
7 
REFERENCES ................................................................................................................ 41 
 
LIST OF TABLES 
Table 1‒1: 
Plasma Pharmacokinetic Parameters After Single Dose Administration ........ 11 
Table 5‒1: 
Expected Baseline Visits.................................................................................. 18 
Table 5‒2: 
Calculation rules for duration (days) of AEs (applicable also to ADEs) ......... 20 
Table 5‒3: 
Pharmacokinetic Parameter and Estimation .................................................... 26 
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Table 5‒4: 
Clinical laboratory measurements.................................................................... 33 
Table 5‒5: 
Reference ranges for vital signs ....................................................................... 36 
 
LIST OF FIGURES 
Figure 1‒1: 
Study Schematic............................................................................................... 14 
 
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VERSION HISTORY 
This Statistical Analysis Plan (SAP) for study UP0119 is based on the Protocol Amendment 1 
dated 21Mar2022. 
SAP Version 
Approval Date 
Change 
Rationale 
1.0 
29 Apr 2022 
Not Applicable 
Original version 
2.0 
02 Feb 2023 
1. Update the rules in Section 
5.4.1.1 Concentration 
Summary Tables 
2. Update the guidelines in 
Section 5.4.1.2 
Pharmacokinetics Parameters 
3. Add a sensitivity analysis in 
Section 5.4.2.3 to include all 
excluded and available PK 
parameters in primary analysis 
model 
1. To exclude PK 
concentration data from 
summary statistics if the 
blood samples for BKZ 
plasma concentrations 
collected -/+7 days from the 
scheduled study assessment 
2. To clarify if participants 
withdrew early from the 
study the PK scientist’s best 
knowledge will determine 
which PK parameters from 
these study participants shall 
be included in the statistical 
analysis, and the impact of 
any excluded values will be 
assessed in the sensitivity 
analysis. 
3. To check the impact of 
any excluded PK parameters 
on the statistical analysis of 
bioequivalence 
 
LIST OF ABBREVIATIONS 
List of Abbreviations 
%AUCextr 
Percentage of the AUC Extrapolated from Clast 
ADAb 
Anti-Drug Antibody 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AI 
Auto-Injector 
ALP 
Alkaline Phosphatase 
ALQ 
Above the Limit of Quantification 
ALT 
Alanine Aminotransferase 
ANOVA 
Analysis of Variance 
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List of Abbreviations 
aPTT 
Activated Partial Thromboplastin Time 
AST 
Aspartate Aminotransferase 
AUC 
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity 
AUC0-t 
Area Under the Plasma Concentration-Time Curve from Time Zero to Last 
Quantifiable Concentration 
BE 
Bioequivalence 
BLQ 
Below the Limit of Quantification 
BMI 
Body Mass Index 
BUN 
Blood Urea Nitrogen 
CF 
Correction Factor 
CI 
Confidence Interval 
CL/F  
Apparent Total Body Clearance 
Cmax 
Maximum Observed Plasma Drug Concentration 
COVID-19 
Coronavirus Disease 2019 
CRO 
Contract Research Organization 
CSR 
Clinical Study Report 
CTMS 
Clinical Trial Management System 
CV% 
Between Subject Variability 
DCP 
Data Cleaning Plan 
DEM 
Data Evaluation Meeting 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form 
EMA 
European Medicines Agency 
EudraCT 
European Union Drug Regulating Authorities Clinical Trials 
FDA 
Food and Drug Administration 
FSH 
Follicle Stimulating Hormone 
geoCV 
Geometric Coefficient of Variation 
geoMean 
Geometric Mean 
GMR 
Geometric Mean Ratio 
GGT 
Gamma Glutamyl Transferase 
HbA1c 
Glycosylated Hemoglobin 
HBc-Ab 
Hepatitis B Core Antibody 
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List of Abbreviations 
HBsAg 
Hepatitis B Surface Antigen 
hCG 
Human Chorionic Gonadotropin 
HCV- Ab 
Hepatitis C Virus Antibody 
HDL 
High Density Lipoprotein 
HIV 
Human Immunodeficiency Virus 
HIV1/2-Ab 
HIV1/2 Antibody 
HIV1-Ag 
HIV1 Antigen 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation 
IMP 
Investigational Medicinal Product 
IPD 
Important Protocol Deviation 
LDH 
Lactate Dehydrogenase 
LDL 
Low Density Lipoprotein 
LLOQ 
Lower Limit of Quantification 
LSM 
Least Squares Mean 
max 
maximum 
MedDRA 
Medical Dictionary for Regulatory Activities 
min 
minimum 
MRD 
Minimum Required Dilution 
n 
number of participants with available measurements 
NCA 
Non-Compartmental Analysis 
NI 
Negative Immunodepletion 
NS 
Negative Screen 
NV 
No Value 
PDILI 
Potential Drug-Induced Liver Injury 
PI 
Positive Immunodepletion 
PK 
Pharmacokinetic 
PKS 
Pharmacokinetic set 
PS 
Positive Screen 
PT 
Preferred Term 
QTcF 
QT Corrected for Heart Rate Using Fridericia’s Formula 
RBC 
Red Blood Cell 
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List of Abbreviations 
RS 
Randomized Set 
RT-PCR 
Real-Time Reverse Transcriptase Polymerase Chain Reaction 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis plan 
SARS-CoV-2 
Severe Acute Respiratory Syndrome Coronavirus 2 
sc 
Subcutaneous 
SD 
Standard Deviation 
SFU 
Safety Follow-Up 
SOC 
System Organ Class 
SS 
Safety Set 
t½ 
Apparent Terminal Half-Life 
TEAE 
Treatment-Emergent Adverse Event 
TFL 
Tables, Figures and Listings 
tmax 
Time of Occurrence of Cmax 
TMF 
Trial Master File 
ULN 
Upper Limit of Normal 
Vz/F 
Apparent Volume of Distribution 
WBC 
White Blood Cell 
WHO-DD 
World Health Organization Drug Dictionary 
λz 
Apparent Terminal Elimination Rate Constant 
 
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1 
INTRODUCTION 
The bimekizumab (BKZ) 320mg dose was assessed in Phase 3 psoriasis [PSO] studies and was 
approved in the EU on 20 Aug 2021 for the treatment of moderate to severe PSO. After protocol 
approval, bimekizumab (BKZ) 320mg has also been approved in GB by MHRA on 25 Aug 
2021, valid in England, Scotland, and Wales, in Japan by PMDA on 20 Jan 2022 (for the 
treatment of plaque psoriasis, generalized pustular psoriasis and psoriatic erythroderma) , in 
Canada by Health Canada on 14 Feb 2022, and in Australia by TGA on 17 Mar 2022. Currently, 
the dose is administered as 2x1mL subcutaneous (sc) injections of 160mg. To provide additional 
options to healthcare professionals and patients, it is considered of benefit by UCB to develop 
bimekizumab 320mg device presentations (ie, functional secondary packaging) where the dose 
can be delivered as a single 2mL sc injection. Study UP0119 aims to compare the 
pharmacokinetics (PK) of bimekizumab 320mg when administered sc using a 2mL auto-injector 
(AI; bimekizumab-AI-2mL, test) versus 2x1mL AI (bimekizumab-AI-2x1mL, reference) to 
support the development of the 2mL AI device presentations. 
The purpose of this statistical analysis plan (SAP) is to provide all necessary information to 
perform the required statistical analyses of study UP0119. It also defines the summary Tables, 
Figures and listings (TFLs) to be included in the final Clinical Study Report (CSR) according to 
the study protocol. 
This SAP is based on and assumes familiarity with Protocol Amendment 1, dated 21 Mar 2022. 
Unless specified in the sections below, the study will be analyzed as described in the most recent 
version of the protocol. If a future protocol amendment necessitates a substantial change to the 
statistical analysis of the study data, this SAP will be amended accordingly. In addition, if the 
analysis definitions are modified or updated prior to database lock, a SAP amendment will be 
required. If, after database lock, additional analyses are required to supplement the planned 
analyses described in this SAP, these changes will be described in the CSR together with the 
associated rationale. 
The content of this SAP is compatible with: 
• The International Council for Harmonisation (ICH) and E9 Guidance documents1 
• Food and Drug Administration (FDA) guidance2 
• European Medicines Agency (EMA) guidelines3,4  
• Canada Health ministry guidance5,6  
UCB is the Sponsor and PAREXEL is the Contract Research Organization (CRO) for this study. 
1.1 
Objectives and Estimands/Endpoints 
1.1.1 
Study objectives 
1.1.1.1 
Primary objective 
The primary objective of the study is: 
• To compare the PK of single sc dose of bimekizumab 320mg when administered using the 
bimekizumab-AI-2mL presentation (test) versus the bimekizumab-AI-2x1mL presentation 
(reference) in healthy study participants 
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1.1.1.2 
Secondary objectives 
The secondary objectives of the study are: 
• To assess the safety and tolerability of a single sc dose of bimekizumab 320mg when 
administered using the bimekizumab-AI-2x1mL or bimekizumab-AI-2mL presentation in 
healthy study participants 
• To assess additional PK parameters of a single sc dose of bimekizumab 320mg when 
administered using the bimekizumab-AI-2x1mL or bimekizumab-AI-2mL presentation in 
healthy study participants 
1.1.1.3 
Other/Exploratory objectives 
The other/exploratory objectives of the study are: 
• To assess additional PK parameters of a single sc dose of bimekizumab 320mg when 
administered using the bimekizumab-AI-2x1mL or bimekizumab-AI-2mL presentation in 
healthy study participants 
• To assess immunogenicity of a single sc dose of bimekizumab 320mg when administered 
using the bimekizumab-AI-2x1mL or bimekizumab-AI-2mL presentation in healthy study 
participants 
• To assess additional safety and tolerability of a single sc dose of bimekizumab 320mg when 
administered using the bimekizumab-AI-2x1mL or bimekizumab-AI-2mL presentation in 
healthy study participants 
1.1.2 
Study endpoints 
1.1.2.1 
Pharmacokinetic endpoints 
Pharmacokinetic concentration data will be obtained at the following nominal time points, as 
described in the protocol: predose (within a maximum of 60 minutes prior to dosing), 1.5h, 5h, 
24h, 48h postdose, and from Day 4 onwards at every visit (ie, Days 4 to 10, 13, 16, 19, 22, 25, 
28, 56, 84, 112, and 140). The PK parameters provided in this section will be derived from the 
plasma concentration data. If calculable, the following PK parameters listed in Table 1‒1 will be 
determined for bimekizumab in plasma for each presentation of a single sc injection dose 
administration 
Table 1‒1: 
Plasma Pharmacokinetic Parameters After Single Dose Administration 
PK Parameter 
WNL1  
Name 
CDISC 
Name 
Definition 
Primary 
Cmax 
Cmax 
CMAX 
Maximum observed 
concentration 
AUC0-t 
AUClast 
AUCLST 
AUC from time zero to the 
last quantifiable 
concentration 
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PK Parameter 
WNL1  
Name 
CDISC 
Name 
Definition 
AUC 
AUCINF_obs 
AUCIFO 
AUC from time zero 
extrapolated to infinity 
Secondary 
tmax 
Tmax 
TMAX 
Time corresponding to 
occurrence of Cmax 
t½ 
HL_Lambda_z 
LAMZHL 
Apparent terminal 
elimination half-life 
Exploratory 
%AUCextr 
AUC_%Extrap_obs AUCPEO 
Percentage of AUC0-inf 
obtained by extrapolation 
beyond tlast 
CL/F 
Cl_F_obs 
CLFO 
Apparent clearance 
following sc administration 
Vz/F 
Vz_F_obs 
VZFO 
Apparent volume of 
distribution during terminal 
phase 
1 WNL: WinNonlin 
1.1.2.2 
Safety endpoints 
1.1.2.2.1 
Secondary safety endpoints 
The secondary safety and tolerability endpoints are: 
• Treatment-emergent adverse events (TEAEs) 
• Treatment-emergent serious adverse events (SAEs) 
1.1.2.2.2 
Other/Exploratory safety endpoints 
The other/exploratory safety and tolerability endpoints are: 
• Vital signs (pulse rate, blood pressure, and tympanic body temperature) 
• Safety laboratory data (hematology [including coagulation/hemostasis tests], clinical 
chemistry, and urinalysis) 
• 12-lead electrocardiogram (ECG) assessments 
1.1.2.3 
Immunogenicity endpoints 
1.1.2.3.1 
Other/Exploratory immunogenicity endpoint 
The other/exploratory immunogenicity endpoint is: 
• Incidence of bimekizumab antidrug antibodies (ADAbs) 
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1.2 
Study Design 
This is a Phase 1, open label, randomized, parallel-group, single dose, 2-arm bioequivalence 
(BE) study to compare the PK of bimekizumab 320mg when administered as either a 1x2mL or 
2x1mL sc injection in healthy male and female study participants using an AI presentation. The 2 
arms will be:  
1. bimekizumab-AI-2mL (test) 
2. bimekizumab-AI-2x1mL (reference) 
The aim of this study is to demonstrate the BE of bimekizumab administered as either 1x2mL or 
2x1mL sc injections using the bimekizumab-AI presentation in healthy study participants. 
Approximately 120 healthy male and female study participants will participate at a maximum of 
2 sites in the study (approximately 60 study participants in each of 2 arms). Enrollment between 
the 2 sites will be balanced and treatments will be assigned using an approximate 1:1 ratio within 
each site, resulting in an approximate 1:1 ratio in the study. Each study participant will receive a 
single dose administration of bimekizumab 320mg, as either 1x2mL or 2x1mL sc injections.  
Each eligible study participant will be matched with another participant for gender and body 
weight prior to randomization. The intention is that the body weights in each pair should differ 
by ≤10kg. Ideally, the participant’s body weight at admission (Day -1) should be used for 
pairing. One participant within each pair will be randomly allocated to receive 1 of the 2 
treatments; the other participant will be automatically allocated to the other treatment. 
The duration of the study will be approximately 168 days, including 27 days of Screening, 
admission on Day -1, an inhouse Treatment Period from Day 1 to Day 3, Outpatients Visits until 
Day 112, and a Safety Follow-Up (SFU) Visit on Day 140. Randomization will occur on Day 1 
prior to dosing. The schematic diagram of the study is presented in Figure 1‒1. 
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Figure 1‒1: 
Study Schematic 
 
AI=auto-injector 
Note: Approximately 120 study participants will participate at 2 sites in the study, 60 study participants per each 
site. Within each site the 60 study participants will be assigned to treatment groups in a 1:1 ratio: 30 study 
participants will receive bimekizumab-AI-2mL and 30 study participants will receive bimekizumab-AI-2x1mL. In 
addition, when assigning treatment only the first member of each pair will be randomly assigned. The treatment 
assignment of second member will depend on that of the first member. 
The study design is deemed appropriate for conduct in healthy study participants during the 
COVID-19 pandemic. 
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2 
STATISTICAL HYPOTHESES 
The primary endpoint will be AUC, AUC(0-t), and Cmax, and the key comparison will be for 
bimekizumab-AI-2mL presentation (test) versus bimekizumab-AI-2x1mL presentation. 
Bioequivalence will be concluded if the 90% CIs for the geometric mean ratio of the comparison 
is fully included in the acceptance range from 0.8 to 1.25. Please refer to Section 5.4.2.1 for 
details. 
3 
SAMPLE SIZE DETERMINATION 
This is a BE study to compare the PK of bimekizumab-AI-2mL (test) versus bimekizumab-AI-
2x1mL (reference). 
The sample size estimation was based upon variability observed in studies UP0033 and UP0068. 
These were the 2 most recent studies which included the AI device with a single administration 
of bimekizumab in healthy study participants. The respective inter-participant variabilities 
(coefficient of variation [CV%]) observed in these studies were up to 32%, 33% for AUC and up 
to 31%, 25% for Cmax. The geometric mean ratios (GMRs) for all primary PK parameters were 
between 0.97 and 1.02 (UP0033) and between 1.03 and 1.15 (UP0068). The individual study 
CV% and GMRs are presented in Appendix 11 of the protocol. 
Assuming a GMR of 1.08 (or 0.93) and inter-participant variability (CV%) of 32%, 54 study 
participants per group are required to assess BE with 80% power assuming that BE will be 
declared if the 90% CI for the GMR is contained entirely within the acceptance range (0.8, 1.25). 
Sample size estimation was performed using SAS software (version 9.4). 
Assuming a dropout rate and non-evaluable study participants of approximately 10%, 60 study 
participants per group for a total of approximately 120 study participants are to be enrolled in the 
study. 
4 
POPULATIONS FOR ANALYSIS 
4.1 
All Study Participants Set 
The All Study Participants Set will consist of all study participants who signed the informed 
consent form (ICF). 
4.2 
Randomized Set 
The Randomized Set (RS) will consist of all randomized study participants. Note: This set will 
only be produced if it differs from the Safety Set (SS). If RS is the same as SS then all analyses 
mentioned in this Statistical Analysis Plan to be performed based on the RS will be performed 
based on the SS. 
4.3 
Safety Set 
The Safety Set will consist of all study participants who are randomized and receive full or 
partial IMP according to the treatment the participants actually received. The Safety Set will be 
used for summaries of demographics, medical history, prior and concomitant medications, IMP 
exposure, and general safety outcomes such as AEs, laboratory parameters, vital signs, and 
ECGs. 
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4.4 
Pharmacokinetic Set 
The Pharmacokinetic Set (PKS) will be a subset of the Safety Set, consisting of those study 
participants that received at least 1 total dose of IMP and have at least 1 observable concentration 
measurement and who have no important protocol deviations affecting the PK during the whole 
study phase. Partial data exclusion for PKS will be defined during the data evaluation meeting. 
5 
STATISTICAL ANALYSES 
5.1 
General Considerations 
Statistical analysis and generation of tables, figures, participant data listings, and statistical 
output will be performed using Statistical Analysis System® (SAS®) version 9.4 or later (SAS 
Institute, Cary, NC, USA). 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 participants with available 
measurements (n), mean, standard deviation (SD), median, minimum (min), and maximum 
(max). 
For categorical variables, the number and percentage of participants in each category will be 
presented. Unless otherwise noted, the denominator for percentages should be based on the 
number of participants included in the respective analysis set. For simple summaries, participants 
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 participants in the analysis set and include a “Missing” category (corresponding to 
participants with missing data at the time of the variable being summarized) as the last row in 
the list of categories being summarized. 
• For summaries of safety endpoints, unless otherwise specified: summarize percentages based 
only on those participants with observed data for the variable being summarized. As the 
denominator may be different from the number of participants 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%, do not present a 
decimal. If the percentage is 0, do not present the percentage. Typically, the % sign should be 
presented in the column header, but not with each individual value. 
For PK parameters other than tmax, summary statistics will include geometric mean (geoMean), 
geometric coefficient of variation (geoCV), 95% confidence intervals (CIs) for the geoMean, 
arithmetic mean, SD, median, min and max. 
For tmax, summary statistics will include median, min and max. 
All summaries of PK parameters will be based on the observed values. No imputation of missing 
data will be used. Imputation rules for PK concentration are provided in Section 5.4.1. 
All results, regardless of local or central laboratory or repeated or unscheduled values, will be 
listed. However, only scheduled results from the central laboratory will be used in the summary 
statistics. In addition, if data from central laboratory is missing and meant to be presented, and a 
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local value is available, the local value will not be included in the summary statistics as it may be 
biased. 
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 
• Min and max 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 
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. 
If participants have more than one observation for a given time point, the observation closest to 
the intended time point will be used. If both observations are equidistant from the intended time 
point, then the later value will be used. 
Data listings containing all documented data and all derived data will be generated. 
5.1.1 
General study level definitions 
5.1.1.1 
Analysis Time Points 
5.1.1.1.1 
Relative day 
Relative day for an event will be derived with the date of the sc injection of investigational 
medicinal product (IMP) as reference. 
Relative days for an event or measurement occurring before the date of the sc injection of IMP 
are calculated as follows: 
 
Relative Day = [(Event Date – Date of sc injection)] 
 
 
 
 
 
 
 
 
 
[1] 
The relative day for an event or measurement occurring on or after the reference date to the date 
of the sc injection of IMP is calculated as follows: 
 
Relative Day = [(Event Date – Date of sc injection) + 1] 
 
 
 
 
 
 
 
 
[2] 
There is no relative Day 0. Relative day is not calculated for partial dates in cases where relative 
day is shown in a participant data listing. In such cases, relative day should be presented as ‘- -’ 
in the participant data listings. 
5.1.1.1.2 
Study periods 
The duration of the study for a study participant will be approximately 168 days; consisting of 
the following periods:  
• Screening Period (Day -28 to Day -2) 
• Inhouse Treatment Period (Day -1 to Day 3). Study participants will be dosed on Day 1. 
• Outpatient Period (Day 4 to Day 112) 
• Safety follow-up (Day 140) 
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A study participant is considered to have completed the study if he/she has completed all phases 
of the study including the Day 140 SFU Visit or the last scheduled procedure. 
5.1.1.1.3 
Definition of Baseline values 
Baseline will be the last assessment prior to the sc injection of IMP, or if missing, the Screening 
value. Scheduled or unscheduled measurements can be used as the Baseline value. Expected 
measurement-specific Baseline time points are presented in Table 5‒1. If an unscheduled 
measurement occurs after the planned baseline measurement time point but before injection, then 
the unscheduled measurement will be used. 
Table 5‒1: 
Expected Baseline Visits 
Measurement 
Definition of Baseline 
Vital signs 
Day 1, Predose value or, if missing, Day -1 value or, if 
both are missing, the screening value. 
Body weight 
Day -1 value or, if missing, the screening value. 
Single 12-lead ECG 
Day 1, Predose value or, if missing, Day -1 value or, if 
both are missing, the screening value. 
Hematology (including coagulation/hemostasis) 
Day -1 value or, if missing, the screening value. 
Clinical Chemistry 
Day -1 value or, if missing, the screening value. 
Urinalysis 
Day -1 value or, if missing, the screening value. 
ADAb status 
Day 1 Predose value 
ADAb=anti-drug antibody; ECG=electrocardiogram 
5.1.1.2 
Handling of dropouts or missing data 
In general, there will be no imputation of missing data unless stated otherwise below. 
5.1.1.2.1 
Pharmacokinetic concentration data 
Detailed rules for PK data reporting and summaries are provided in Section 5.4.1. 
Pharmacokinetic concentration data will not be available to the study team until after the last 
scheduled procedure for the last study participant in the study, so the decision to replace 
participants who dropped out or are missing PK visits can be made in an unbiased manner. 
5.1.1.2.2 
Safety laboratory data 
Measurements BLQ will be imputed with half of the LLOQ for the purpose of calculating 
change and percentage change from Baseline for summaries and figures. Measurements above 
the limit of quantification (ALQ), if applicable, will be imputed to the upper limit of 
quantification. 
Descriptive statistics will be calculated if at most 33% of the individual data points at a time 
point are missing or are either not quantifiable (<LLOQ) or ALQ. If no participants have data at 
a given time point, then only n=0 will be presented. If n<3, then only the n, minimum and 
maximum will be presented. If n=3, then only n, minimum, median and maximum will be 
presented. The other descriptive statistics will be reported as missing (“-”). 
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5.1.1.2.3 
Anti-drug antibody data 
Detailed rules for immunogenicity data reporting and summaries are provided in Section 5.5.1. 
5.1.1.2.4 
Dates and times 
Partial dates/times may be imputed for the following reasons: 
• Classification of AEs as treatment-emergent 
• Classification of medications as prior or concomitant 
Imputed dates/times will not be shown in the listings; all dates will be displayed as reported in 
the database. 
The following rules will be applied for partial start dates/times: 
• If only the start month and year are specified, and these are not the same as the month and 
year of dosing then use the 1st of the month, or the date of Screening if this is later (if the 
latter imputation results in an end date that is earlier than the start date, then use the 1st of the 
month). If time is missing this will be imputed as 00:00 h; 
• If only the start month and year are specified, and the month and year of dosing are the same 
as the month and year of the start date, then use the date of dosing. If this results in an 
imputed start date that is after the specified end date, then use the 1st of the start month, or 
the date of Screening if this is later (if the latter imputation results in an end date that is 
earlier than the start date, then use the 1st of the month). If the imputed date is the date of 
dosing then time will be imputed as the start time of the sc injection (i.e., event will be 
regarded as treatment-emergent); 
• If only the year is specified, and the year of dosing is not the same as the year of the start date 
then use January 01 of the year of the start date. If time is missing this will be imputed as 
00:00 h; 
• If only the year is specified, and the year of dosing is the same as the year of the start date, 
then use the date of dosing. If this results in an imputed start date that is after the specified 
end date, then use January 01 of the year of the start date, or the date of Screening if this is 
later (if the latter imputation results in an end date that is earlier than the start date, then use 
January 01). If the imputed date is the date of dosing then time will be imputed as the start 
time of the sc injection (i.e., event will be regarded as treatment-emergent); 
• If the start date is completely unknown, then use the date of dosing. If this results in an 
imputed start date that is after the specified end date, then use January 01 of the year of the 
end date, or the date of Screening if this is later (if the latter imputation results in an end date 
that is earlier than the start date, then use January 01). If the imputed date is the date of 
dosing then time will be imputed as the start time of the sc injection (i.e., event will be 
regarded as treatment-emergent). 
Any medication with a start date on the dosing date and time unknown, will be assumed to be 
concomitant. 
The following rules will be applied for partial stop dates: 
• If only the month and year are specified, then use the last day of the month; 
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• If only the year is specified, then use December 31 of the known year; 
• If the stop date is completely unknown, do not impute the stop date. 
Missing or partially missing date and/or times will be imputed as described in Table 5‒2 for the 
calculation of duration of each AE. Adverse event duration is computed and reported in day and 
time format: xx d hh:mm. 
Table 5‒2: 
Calculation rules for duration (days) of AEs (applicable also to ADEs) 
Data 
Availability 
Onset 
Date/Time 
Outcome 
Date/Time 
Calculation Rules 
Complete data 
D1/T1 
D2/T2 
Duration = [(D2 – D1) *24 + (T2 – T1)]/24 d 
End time 
missing 
D1/T1 
D2/-- 
End time is substituted by time 23:59h (=23.98 in 
decimal format). 
Duration = < [(D2 – D1) *24 + (23.98 – T1)]/24 d 
Start time 
missing 
D1/-- 
D2/T2 
Onset time is substituted by 00:00h. 
Duration = < [(D2 – D1) *24 + T2]/24 d 
Start and end 
time missing 
D1/-- 
D2/-- 
Duration = < (D2 – D1) + 1 
Start day and 
time missing 
--/-- 
D2/T2 
Duration = < [(D2 – D0) *24 + (T2 – T0)] / 24 d 
For a participant in the SS, D0 and T0 are the date and 
time of dosing and for screen failures, D0 = the 
Screening Visit date and T0 = 0. 
End day and 
time missing 
D1/T1 
--/-- 
For ongoing AE duration = > Discharge day – D1 d 
For resolved AE duration = < Discharge day – D1 d 
Where Discharge Day refers to the date of the SFU Visit 
or date of discontinuation. 
For any AEs with known start date/time after the date of 
discontinuation, the date of last contact will be used as 
the discharge day. 
Start and end 
date missing 
 
--/-- 
--/-- 
For ongoing AE duration = > Discharge day – D0 d 
For resolved AE duration = < Discharge day – D0 d 
Where Discharge Day refers to the date of the SFU Visit 
or date of discontinuation. 
For a participant in the SS, D0 is the date of dosing and 
for screen failures, D0 = the Screening Visit date. 
ADE=Adverse Device Effect; AE = Adverse Event; SS=Safety Set 
5.1.1.2.5 
Impact of COVID-19 
The FDA and EMA (see Section 7) have provided guidance to help assure the safety of study 
participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to 
study integrity during the COVID-19 pandemic. One of the recommendations is a risk 
assessment of the impact of COVID-19 on study integrity and interpretability of potential study 
results. In particular, the major statistical principles need to be considered regarding the impact 
of COVID-19 on studies and how to handle missing or delayed assessments resulting from the 
pandemic. The impact of the COVID-19 pandemic, at the visit level, will be assessed by data 
collected on a specific COVID-19 impact CRF. Any dropouts due to COVID-19 will be handled 
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in the same way as dropouts for other reasons. Should one of the ongoing reviews of COVID-19 
related PDs (see Section 5.1.1.4) suggest that the impact of COVID-19 is more significant than 
expected, the SAP may be updated to include details of strategies to handle missing data and/or 
sensitivity analyses. 
5.1.1.3 
Handling of repeated and unscheduled measurements 
All repeated and unscheduled measurements will be presented in the listings. Repeated and 
unscheduled measurements will not be used for statistical analysis or summary tables, unless the 
repeated measurement was performed due to technical reasons, or the repeated measurement 
occurred prior to IMP administration and is defined as the 'Baseline'. The following general rules 
will apply to all repeated and unscheduled measurements: 
• For repeated measurements obtained prior to the IMP administration, the latest reported 
value (which may be scheduled or unscheduled) will be used in the calculation of descriptive 
statistics  
• For repeated measurements obtained at any time point after dosing, the first reported value of 
any repeated measurements will be used in the calculation of changes from Baseline and for 
the descriptive statistics.  
5.1.1.4 
Protocol deviations 
Important protocol deviations (IPDs) are identified as part of the data cleaning process in the 
Data Cleaning Plan (DCP). The objective of the data cleaning meeting will be to review and 
update (if necessary) the important protocol deviations in the DCP and discuss exclusion of study 
participants from analysis populations. 
Furthermore, overall trends in protocol deviations will be discussed at the Data Evaluation 
Meetings (DEMs). Through this data cleaning and evaluation process, all decisions regarding 
important protocol deviations and exclusions from analysis populations will be made. Protocol 
deviations (eg, missing assessments or visits) related to COVID-19 will be listed separately. 
Accepted deviations from theoretical time points will be described in the appropriate documents 
and included in the trial master file (TMF). 
After resolution of all issues, and documentation of all decisions, the database will be locked. 
5.1.1.4.1 
COVID-19 related protocol deviation 
UCB guidance on deviations and amendments related to SARS-CoV2 pandemic states that the 
identified COVID-19 related PDs need to be reviewed on an ongoing basis in case they 
collectively or individually may give reason to consider a protocol amendment (for example 
study design changes or changes to primary analysis methods etc). To facilitate this ongoing 
review, IPDs will be categorized as related to COVID-19 within the Clinical Trial Management 
System (CTMS). The COVID-19 related IPDs will be listed separately for consideration at the 
DEM. 
5.1.1.5 
Treatment assignment and treatment groups 
Treatment assignment for the SS and PKS will be according to the actual treatment received. 
Listings and summaries will be presented by treatment group and overall where applicable. The 
following order will be used in the TFLs: 
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• Bimekizumab-AI-2mL: Single dose sc injection, bimekizumab 1x320mg, device presentation 
2mL AI 
• Bimekizumab-AI-2x1mL: Single dose sc injection, bimekizumab 2x160mg, device 
presentation 1mL AI  
• All study participants 
For analysis conducted using the all study participants set, an additional group for participants 
not randomized may be displayed, as applicable. 
5.1.1.6 
Coding dictionaries 
All AEs and medical history will be coded for analysis according to the Medical Dictionary for 
Regulatory Activities (MedDRA® 19.0) coding dictionary. Prior and concomitant medications 
will be coded for analysis using the World Health Organization Drug dictionary (WHO-DD Mar 
2021). Medical procedures will not be coded. 
5.1.1.7 
Multicenter studies 
This is a multicenter study with participation of at a maximum of 2 sites. In general, the data 
from both sites will be pooled for the purpose of the analysis. However, the effect of center on 
results will be evaluated in sensitivity analysis as mentioned in Section 5.4.2.3. 
5.2 
Participant Dispositions 
Participant screening and primary reason for screen failure will be summarized using the All 
Study Participants Set. The summary will include the following: 
• Number of participants screened 
• Number and proportion of participants with screen failures (Not counting successfully 
rescreened participants) 
• Number and proportion of screen failures by primary reason for screen failure (based on the 
later screening visit, in case of rescreen). 
Additionally, the reasons for screen failures will be summarized by during and post the COVID-
19 pandemic based on the screen failure date relative to the pandemic cut-off date. 
Disposition of analysis sets will be summarized using the All Study Participants Set. The 
summary will include the total number of participants in the All Study Participants Set, as well 
as the number and percentage of participants in each analysis set by treatment group. The 
percentages will be calculated based on the RS. 
Study completion/discontinuation and primary reason for discontinuation will be summarized by 
treatment group and overall using the RS. The summary will include the following: 
• Number and percentage of participants that started the study  
• Number and percentage of participants completing the study 
• Number and percentage of participants discontinuing the study 
• Number and percentage of participants discontinuing the study by primary reason for 
discontinuation. 
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Study participants that started the study are defined as participants that were randomized. Study 
participants completing the study are those participants completing the SFU Visit, i.e., the 
participant will be regarded as a completer if the SFU (Day 140) Visit was completed. 
Study discontinuation due to AEs will be summarized using the RS. The summary will present 
the number and percentage of participants who discontinued the study due to an AE by treatment 
group and overall. 
By-participant listings of study participant disposition will be provided by treatment group using 
the All Study Participants Set, and will include the following: 
• Study termination/completion status 
• Date of informed consent 
• Date of randomization 
• Date and time of study medication administration 
• Date of last contact 
• Date of premature study termination for successfully screened participants dropping out of 
the study 
• Date of screen failure for screen failure participants (based on the later screening visit in case 
of rescreen) 
• Primary reason for premature study termination, as applicable 
• Primary reason for screen failure, as applicable (based on the later screening visit in case of 
rescreen). 
By-participant listings of study discontinuation will be presented by treatment group using the 
RS. The listing will include the primary reason for discontinuation and the number of days since 
IMP administration. 
By-participant listings of visit dates will be presented by treatment group using the SS. 
By-participant listings of study participants who did not meet study eligibility criteria will be 
presented by treatment group using the All Study Participants Set. The listing will include 
inclusion criteria that were not met and the exclusion criteria that were met. A glossary listing of 
inclusion and exclusion criteria will also be provided. 
By-participant listings of study participant inclusion in each analysis set will be presented by 
treatment group using the All Study Participants Set. 
5.3 
Efficacy Analyses 
Efficacy is not evaluated in this study. 
5.4 
Pharmacokinetics and Pharmacodynamics Analyses 
5.4.1 
Pharmacokinetics 
Unless otherwise specified, all analysis described in this section will be performed on the PKS. 
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5.4.1.1 
Descriptive analysis of Pharmacokinetics data 
Concentration Listings 
Individual plasma concentrations of bimekizumab will be listed by treatment group for the SS 
and will include the actual and nominal PK sampling times, the corresponding time deviations 
and concentrations. The window allowance document will define the acceptable deviations at 
each timepoint; samples obtained outside this tolerance will be considered as protocol deviations. 
All protocol deviations will be discussed at the DEM (Section 5.1.1.4). If a concentration 
measurement is to be excluded from the analysis of PK parameters, it will be flagged in the 
listings and the reason for exclusion will be listed/footnoted. 
When reporting individual data in listings the following rules will apply: 
• Missing data should be reported as no value (NV) 
• Concentrations below the lower limit of quantification (LLOQ) will be presented as below 
the limit of quantification (BLQ) in the listings and the LLOQ value presented as a 
footnote.  
• Concentrations should be listed to the same number of significant figures supplied by the 
bioanalytical laboratory. Concentrations will be reported in µg/mL. 
Concentration Summary Tables 
Plasma concentrations of bimekizumab will be summarized by treatment group and nominal 
sampling time for the PKS. The following descriptive statistics will be presented for plasma 
concentrations obtained at each nominal time point: n, n(BLQ), arithmetic mean, SD, geometric 
mean, 95% CI for the geometric mean, geometric CV%, median, minimum, and maximum 
values. 
The geoCV will be calculated using the following formula where SD is the standard deviation of 
the log-transformed values: 
𝐺𝑒𝑜𝑚𝑒𝑡𝑟𝑖𝑐 𝐶𝑉 (%) = √(exp(𝑆𝐷2) −1) x 100  
When summarizing the data in tables the following rules will apply: 
• To calculate descriptive statistics, all BLQs will be set to half the LLOQ, and the number 
of BLQs and non-BLQs at each scheduled time point will be reported. Also missing values 
should be excluded. 
• When the total number of BLQ and missing values exceeds one third of the total then only 
minimum and maximum should be reported for this time point. Other descriptive statistics 
should be reported as missing (“-”). The minimum should be reported as BLQ. 
• When the mean value includes one or more replaced BLQ values then a footnote should be 
included to say “contains one or more BLQ value replaced by half the LLOQ value”.  
• A minimum of 3 values are required to calculate summary statistics. If only 2 values are 
available, then these should be presented as the minimum and maximum with other 
descriptive statistics reported as missing (“-”). 
• Blood samples for BKZ plasma concentrations collected -/+7 days from the scheduled 
study assessment will be excluded from the descriptive statistics. 
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Concentration Figures  
Individual study participant plasma concentration-time profiles of bimekizumab will be 
displayed graphically on linear and semi-logarithmic scale for the SS. In addition, combined 
individual (spaghetti) plots will be displayed by treatment group with all study participants in a 
given treatment group overlaid on the same plot (linear and semi-logarithmic scale) for the SS.  
For individual linear/linear and log/linear graphs, actual sampling times should be used and all 
BLQ values will be substituted as follows: 
• BLQs at the beginning of a participant profile (i.e., before the first incidence of a 
measurable concentration) will be assigned to zero. When using log/linear scale, these 
timepoints will be considered missing. 
• BLQs at the end of a participant profile (i.e., after the last incidence of a measurable 
concentration) will be set to missing. 
• Single BLQs which fall between two measurable concentrations will be set to missing.  
• Consecutive BLQs which fall between measurable concentrations will be set to missing.  
When summarizing the data in figures the following rules will apply: 
• The data plotted in the figure should match the data presented in the summary table (with 
the exception of missing values prior to Cmax which should be set to 0 in the figure to 
capture lag-time).  
• Geometric mean should be plotted (as opposed to arithmetic mean) due to the log-normal 
distribution of concentrations. Variability should be plotted as detransformed SD computed 
on ln-transformed data. 
• Nominal sampling times should be used.  
• Both linear and semi-logarithmic scales should normally be presented.  
• All BLQ values will be substituted with ½ the LLOQ and displayed in the figures. 
Geometric mean profiles for each treatment group with lower and upper limits of the 95% CI for 
the linear scale and the semilogarithmic scale will be displayed for the PKS. The plots on the 
linear and semilogarithmic scales will be displayed on the same page. 
All figures will include a reference line for the LLOQ on the semi-logarithmic panel. 
Figures will be generated in black and white using unique line style and marker for each plot in 
the graph. For all PK concentration-time plots, linear scale will be used for x-axis (e.g., do not 
use an ordinal scale). 
5.4.1.2 
Pharmacokinetics Parameters 
PK parameters will be calculated by Non-Compartmental Analysis (NCA) methods from the 
concentration-time data using Phoenix® WinNonlin® Version <8.2> or higher following these 
guidelines: 
• 
Actual time from dose will be used in the calculation of all derived pharmacokinetic 
parameters. 
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• 
There will be no imputation of missing data.  
• 
Handling of BLQ samples for derivation of plasma PK parameters after single dose 
administration 
o BLQs at the beginning of a participant profile (i.e., before the first incidence of a 
measurable concentration) will be assigned to zero. 
o BLQs at the end of a participant profile (i.e., after the last incidence of a measurable 
concentration) will be set to missing. 
o Single BLQs which fall between two measurable concentrations will be set to 
missing. 
o Consecutive BLQs which fall between measurable concentrations will be set to 
missing. 
• 
If participants withdrew early from the study the PK scientist’s best knowledge will determine 
which PK parameters from these study participants shall be included in the statistical analysis. 
The impact of any excluded values will be assessed in the sensitivity analysis. 
Pharmacokinetic parameters will be estimated according to the guidelines presented in Table 5‒
3. 
Table 5‒3: 
Pharmacokinetic Parameter and Estimation 
Parameter 
Guideline for Derivation 
AUC0-t  
The AUC from zero time (pre-dose) to the time of last quantifiable concentration will be 
calculated by a combination of linear and logarithmic trapezoidal methods. Unless 
specifically requested and justified, the linear up/log down trapezoidal method will be 
employed. 
The AUC0-t is the sum of areas up to the time of the last quantifiable sample: 
𝐴𝑈𝐶0−𝑡= ∫𝐶last ∗𝑑𝑡
t
0
 
AUC 
The area from zero time extrapolated to infinite time will be calculated as follows:  
𝐴𝑈𝐶= 𝐴𝑈𝐶0−𝑡+ 𝐶𝑙𝑎𝑠𝑡
𝜆𝑧 
where Clast is the last observed quantifiable concentration.  
%AUCextr 
The percentage of AUC obtained by extrapolation will be calculated as follows:  
%𝐴𝑈𝐶𝑒𝑥𝑡𝑟= 𝐴𝑈𝐶−𝐴𝑈𝐶0−𝑡
𝐴𝑈𝐶
∗100 
Unless otherwise determined by PK Scientist’s best knowledge and judgment, if the 
%AUCextr is greater than 20% the value, %AUCextr, and all dependent parameters (ie, AUC, 
MRT, Vz and CL) will be flagged in summary tables and will still be included in the 
calculation of summary statistics. The reason for flagging will be listed/footnoted in 
parameter summary tables.  
Cmax 
Maximum concentration, obtained directly from the observed concentration versus time 
curve. In the case of bioequivalence studies, the FDA guidance1 should be followed: if the 
predose concentration is ≤ 5 percent of the Cmax value in that study participant, the study 
participant’s data without any adjustments can be included in all pharmacokinetic 
measurements and calculations. It is recommended that if the predose value is > 5 percent of 
Cmax, the study participant be dropped from all bioequivalence study evaluations.  
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Parameter 
Guideline for Derivation 
CL/F 
Apparent systemic clearance of parent drug will be calculated from:  
𝐶𝐿/𝐹= 𝐷𝑜𝑠𝑒
𝐴𝑈𝐶 
λz   
First order terminal elimination constant or apparent first order terminal elimination rate 
constant, for compound representing release/absorption as limiting steps 
1. The apparent terminal phase rate-constant (λz) will be estimated by linear regression of 
concentration versus time data presented in a log-linear scale. 
2. Data are primarily monotonically decreasing in magnitude and are representative of the 
actual decline in the log concentration-time curve. 
3. Only those data points that are judged to describe the terminal log-linear decline will be 
used in the regression.  
4. A minimum number of three data points in the terminal phase will be used in calculating 
λz with the line of regression starting at any post-Cmax data point (Cmax should not be part of 
the regression slope). Unless otherwise determined by PK Scientist’s best knowledge and 
judgment or if instructed by the Sponsor, if the adjusted correlation coefficient (R2 adjusted) 
is <0.8, then λz and all the λz dependent parameters (i.e. t½, AUC, CL, MRT, and Vz) will be 
flagged in summary tables of PK parameters and will still be included in the calculation of the 
summary statistics. The reason for flagging will be listed/footnoted in parameter summary 
tables.  
5. Unless otherwise determined by PK Scientist’s best knowledge and judgment, the interval 
used to determine λz should be equal or greater than 2-fold the estimated t½, and if less than 
2-fold, λz will be flagged in summary tables and statistical analysis of PK parameters and will 
still be included in the calculation of the summary statistics. All the derived parameters (i.e. 
t½, AUC, CL, MRT, and Vz) may also be flagged in summary tables of PK parameters. The 
reason for flagging will be listed/footnoted in parameter summary tables.  
7. Best practice is to let Phoenix determine the terminal λz automatically. Each determination 
must then be checked manually. Data points may be dropped from the linear regression if the 
PK Scientist considers the reported values to be anomalous. Any data points so designated 
should remain in the PK concentration listings with a footnote and be identified in the study 
report with a rationale for exclusion. 
tmax 
Time of Cmax, obtained directly from the observed concentration versus time curve [if two 
identical values are recorded for Cmax, the first one will be considered tmax] 
t½ 
The terminal elimination half-life will be calculated as follows:  
𝑡1/2 = 𝐿𝑛2
𝜆𝑧
= 0.693
𝜆𝑍
 
Vz/F 
Apparent volume of distribution 
𝑉𝑧= 𝐶𝐿/𝐹
𝜆𝑧
 
 
1 FDA Guidance for Industry: Bioavailability and Bioequivalence – Studies for Orally Administered Drug Products 
– General Considerations (2003) 
PK Parameter Summaries 
PK parameters will be listed in summary tables by participant for the PKS.  
When reporting individual data in summary tables the following rules will apply: 
• Individual PK parameters should be reported to 3 significant figures. 
• If a parameter cannot be calculated it should be reported as NE (not estimable ie, if input 
data is missing which prevents calculation). 
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• Based on the rules in Table 5‒3, individual PK parameters in the summary tables that are 
flagged as unreliable will be footnoted with the reason and will be included in the 
calculation of the summary statistics. 
Biostatistics group will consider the derived PK parameters as source data and will use this data 
without rounding for calculation of PK parameters summary statistics tables.   
PK parameters will be summarized by treatment group for the PKS. 
When summarizing the data in tables the following rules will apply: 
• Tabular summaries for PK parameters will report N (number of study participants per 
treatment group) and n (number of study participants with non-missing values). 
• For most PK parameters (ie, for continuous variables) the following descriptive statistics 
should be calculated: arithmetic mean, median, SD, minimum, maximum, geometric 
mean, geoCV and 95% CI for the geometric mean. For tmax (ie, for discontinuous 
variables) only median, minimum and maximum should be reported. 
• Descriptive statistics should be reported to 4 significant figures for mean, median and SD 
and to 3 significant figures for all others.  
• If at least two thirds of the study participants have a PK parameter reported then 
descriptive statistics will be calculated, otherwise only minimum and maximum will be 
reported for this PK parameter and all other descriptive statistics will be reported as NE 
(ie, not estimable). 
• A minimum of 3 values are required to calculate summary statistics. If only 2 values are 
available, then these should be presented as the minimum and maximum with other 
descriptive statistics reported as missing (“-”).  
 
 
 
 
 
 
PK Parameter Figures 
Box plots of primary PK parameters (AUC, AUC0-t and Cmax) will be generated comparing two 
treatment groups. 
5.4.2 
Statistical analysis of bioequivalence 
5.4.2.1 
Primary analysis 
Following loge-transformation, the primary PK parameters (AUC, AUC(0-t) and Cmax) will each 
be evaluated according to an analysis of variance (ANOVA) model with a fixed effect term for 
pair and treatment.  
For comparison of bimekizumab-AI-2mL (test) versus bimekizumab-AI-2x1mL (reference) 
treatment, the difference between the least squares means (LSMs) will be estimated and back 
transformed in order to obtain the GMR and associated 90% CI for the ratio. Bioequivalence will 
be concluded if the 90% CIs for the ratio of the comparison is fully included in the acceptance 
range from 0.8 (80%) to 1.25 (125%) for AUC, AUC(0-t), and Cmax. 
All study participants in the PKS will be included in the analysis as far as the data permit; a 
study participant may be included in the analysis for one or more PK parameters (i.e., if it was 
not possible to calculate AUC for a given participant, the participant may be included in the 
analysis of BE for AUC(0-t) and Cmax). 
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The results of the BE analysis will be tabulated, including the geometric LSMs and 95% CI for 
treatment group, the estimated GMR and 90% CI, and CV% for the bimekizumab-AI-2mL (test) 
versus bimekizumab-AI-2x1mL (reference) treatment. 
5.4.2.2 
Secondary analysis 
A similar ANOVA, as described in Section 5.4.2.1, will be performed on loge-transformed t½ to 
compare elimination characteristics between treatment groups. 
The point estimate and the 90% CI for the median treatment differences for tmax will be 
computed according to the Hodges-Lehmann’s method. 
5.4.2.3 
Sensitivity analysis 
The following sensitivity analyses will be performed following the same model as described for 
the primary analysis (Section 5.4.2.1): 
1. Including main effect of site 
2. Including both main effect of site and site-by-treatment interaction 
3. Based on all nonpositive ADAb study participants (defined as any positive ADAb observed 
post-Baseline) 
4. Including body weight at Day -1 as covariate 
5. Corrected for measured protein content: 
For compliance with Canadian Health ministry guidance, AUC and Cmax ratio estimates and 90% 
CIs will be also presented as corrected for measured protein content (potency). A correction 
factor (CF) will be obtained as the ln-transformed ratio of the percent protein content 
(Reference/Test). Then, this factor will be added to the difference in LSMs to obtain, by 
exponentiation, the corrected AUC and Cmax geometric mean ratios and the corresponding 90% 
CIs. 
For a given Reference/Test, the correction factor will be calculated using the below formula: 
𝐶𝐹= ln(
% 𝑀𝑒𝑎𝑠𝑢𝑟𝑒𝑑 𝐶𝑜𝑛𝑡𝑒𝑛𝑡 𝑅𝑒𝑓𝑒𝑟𝑒𝑛𝑐𝑒
% 𝑀𝑒𝑎𝑠𝑢𝑟𝑒𝑑 𝐶𝑜𝑛𝑡𝑒𝑛𝑡 𝑇𝑒𝑠𝑡
)                     [3] 
The corrected ratio estimate for the PK parameter (AUC or Cmax) is calculated using the below 
formula: 
𝑅𝑎𝑡𝑖𝑜= 100 × exp(𝐿𝑆𝑀 𝑑𝑖𝑓𝑓𝑒𝑟𝑒𝑛𝑐𝑒+ 𝐶𝐹)                   [4] 
Where,  
𝐿𝑆𝑀 𝑑𝑖𝑓𝑓𝑒𝑟𝑒𝑛𝑐𝑒= 𝐿𝑆𝑀(𝑇𝑒𝑠𝑡) −𝐿𝑆𝑀(𝑅𝑒𝑓𝑒𝑟𝑒𝑛𝑐𝑒)     [5] 
The corrected 90% CI for the ratio is obtained using the below formula: 
90% 𝐶𝐼= 100 × exp[(𝐿𝑆𝑀 𝑑𝑖𝑓𝑓𝑒𝑟𝑒𝑛𝑐𝑒+ 𝐶𝐹) ± 𝑡0.05,𝑑𝑓× 𝑠𝑒(𝐿𝑆𝑀 𝑑𝑖𝑓𝑓𝑒𝑟𝑒𝑛𝑐𝑒)]   [6] 
6. Including all excluded and available PK parameters 
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5.5 
Immunogenicity Analyses 
5.5.1 
Anti-drug antibodies 
Antidrug antibodies will be measured using a 3-tiered assay approach: screening assay, 
confirmatory assay and titration assay. 
A screening cut point will be determined by the bioanalytical laboratory that will be used to 
determine the status of ADAb as “Positive Screen” (PS) or “Negative Screen” (NS). For samples 
presenting ADAb levels as PS, further confirmatory assay will be performed, and the result of 
which will be reported as either “Positive Immunodepletion” (PI) or “Negative 
Immunodepletion” (NI). Samples that are confirmed as positive (reported as PI) will be titrated, 
and the titer (reciprocal dilution factor including minimum required dilution [MRD]: 100) will be 
reported.  
ADAb status at any time point: 
• An ADAb status of positive (ADAb+) will be concluded for any sample with an ADAb level 
that is PS and PI; 
• An ADAb status of negative (ADAb-) will be concluded for any sample with an ADAb level 
that is either NS or PS and NI; 
• Missing or a non-evaluable sample will be defined as missing; 
Study participant Classification: 
• A study participant will be classified as having ADAb positivity at Baseline if the Day 1, 
Predose result is ADAb+; 
• A study participant will be classified as overall positive if at least one post-Baseline 
measurement is ADAb+; 
• A study participant will be classified as overall negative if at all post-Baseline visits the 
ADAb status is negative (this includes study participants who have ADAb+ results at 
Baseline) or only one sample is missing and all other ADAb samples are negative; 
• Missing if the study participant has missed more than one ADAb sample and all other 
available ADAb samples are negative; 
• A participant will be classified as having treatment-emergent ADAb positivity when meeting 
one of the following criteria: 
− The Baseline result is ADAb-, and at least one post-Baseline time point is ADAb+; 
− The Baseline result is ADAb+, and at least one post-Baseline measurement shows a 1.81-
fold increase in titer from the Baseline value (the Minimum Significant Ratio [MSR] in 
healthy study participants). 
Analysis: 
Immunogenicity will be assessed through summary tables and figures and listing of individual 
results by study participant. All analyses will be run on the SS, unless specified otherwise. For 
all tabulations, percentages will be calculated based on the number of study participants with 
non-missing data. 
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• All individual participant-level ADAb results will be listed by treatment group. This will 
include the screening assay, confirmatory assay, and titer (if applicable). ADAb samples that 
are negative but have drug concentration above the drug tolerance characteristics of the assay 
will be flagged. 
• Number and percentage of participants with a positive and negative ADAb status will be 
summarized at the time of each visit and overall, separated by treatment group and for all 
bimekizumab treated participants. 
• In addition, the first occurrence of treatment-emergent ADAb positivity (based on the 
definitions above) will be summarized (number and percentage of study participants) at each 
post-Baseline visit, based on the SS. This tabulation will present the number and percentage 
of study participants at each post-Baseline visit who fulfill at least one of the above defined 
criteria for treatment-emergent positivity; study participants will be counted in the numerator 
based on the earliest visit at which one of these criteria is fulfilled. At other visits, study 
participants will be counted in the denominator (assuming a measurement is available). For 
all tabulations, percentages will be based on the number of observations at each visit. This 
summary will exclude any samples with bimekizumab concentrations confirmed to be above 
the drug tolerance. 
A listing will be presented showing the bimekizumab concentrations and ADAb measurements 
in the same output in adjacent columns, based on the SS. The listing will include the 
bimekizumab concentration, ADAb status (positive or negative) and screening assay results (PS 
or NS) and confirmatory assay results if applicable (PI or NI), together with the titer if 
applicable. Titer values will be reported as <100 or as 100 (Minimum Required Dilution, MRD) 
and above in the listing. In addition, the time since the administration of study medication will be 
reported (in days). 
5.6 
Safety Analyses 
Unless otherwise stated, all safety analyses will be presented for the SS. 
5.6.1 
Extent of Exposure 
All IMP administration details (including date/time of administration), injection site (left thigh or 
right thigh), duration of injection (seconds) and comments reported during the administration 
with the medical device will be listed using the SS. In addition, a listing of batch and devices 
numbers used will be created using the SS. 
5.6.2 
Adverse Events 
Adverse events will be recorded from the time of informed consent until study completion. All 
AEs will be coded (Section 5.1.1.6) and categorized by relationship to bimekizumab. 
The following definitions will be used in the analysis of AEs: 
• A TEAE is defined as any event not present prior to the administration of IMP or any 
unresolved event already present before administration of IMP that worsens in intensity 
following exposure to study treatment 
• An ADE is defined as an adverse event related to the use of an investigational medical 
device. This definition includes any adverse events resulting from insufficient or inadequate 
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instructions for use, deployment, implantation, installation, or operation, or any malfunction 
of the investigational medical device as well as any event resulting from use error or from  
intentional misuse of the investigational medical device. 
• An AE of special interest is any AE that a regulatory authority has mandated be reported on 
an expedited basis, regardless of the seriousness, expectedness, or relatedness of the AE to 
the administration of a UCB product/compound. Potential Hy’s Law, defined as ≥3xULN 
alanine aminotransferase (ALT) or aspartate aminotransferase (AST) with coexisting 
≥2xULN total bilirubin in the absence of ≥2xULN alkaline phosphatase (ALP), confirmed by 
repeat measurement, with no alternative explanation for the biochemical abnormality, must 
ALWAYS be reported to UCB as an AE of special interest (i.e., without waiting for any 
additional etiologic investigations to have been concluded). 
By definition, all ADEs are also classified as TEAEs. 
The number and percentage of participants who experience TEAEs will be summarized by 
treatment group, SOC, and PT, based on the SS (unless otherwise stated). 
If it is not possible (due to partial dates) to determine whether an AE is treatment emergent or 
not, it will be assumed to be a TEAE (Section 5.1.1.2.4). 
An overview of the occurrence and incidence of TEAEs will be provided by treatment group and 
overall. The overview will present individual occurrences as well as number and percentage of 
(unique) study participants experiencing each of the following: 
• TEAEs 
• Serious TEAEs 
• Discontinuation due to TEAEs 
• Drug related TEAEs 
• Severe TEAEs 
• All Deaths (AEs leading to death) 
• Deaths (TEAEs leading to death) 
• ADEs 
Summaries of the occurrence and incidence of TEAEs and SAEs will be provided by treatment 
group and overall. The summary will present individual occurrences as well as number and 
percentage of (unique) participants, by MedDRA SOC and PT. These summaries will be 
provided for the following: 
• Incidence of TEAEs 
• Incidence of serious TEAEs 
• Incidence of TEAEs by maximum causal relationship with IMP 
• Incidence of TEAEs by maximum intensity 
• Incidence of serious TEAEs by maximum causal relationship with IMP 
• Incidence of fatal TEAEs by causal relationship with IMP 
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• Incidence of non-serious TEAEs above threshold of 5% of participants 
In summaries including intensity, the following intensity categories will be summarized: ‘Mild’, 
‘Moderate’, ‘Severe’. Study participants who experience the same event multiple times will be 
included in the most severe category for tabulations by maximum intensity. Events with missing 
intensity will be considered as ‘Severe’ events for summary purposes but recorded as missing in 
the listings. 
In summaries including causal relationship to IMP, the following relationships will be 
summarized: ‘Not related’, ‘Related’. Study participants who experience the same event multiple 
times will be included in the most related category for tabulations by maximum relationship. 
Events with missing causal relationship to IMP will be considered as ‘Related’ for the 
tabulations but presented as missing in the listings. 
For the summary of non-serious TEAEs above threshold of 5% of participants, only TEAEs 
which are reported in 5% of participants within a treatment group will be included. 
Adverse event summaries will be ordered by alphabetical SOC and decreasing frequency of PT 
within SOC in terms of bimekizumab-AI-2mL for tables including event counts. For tables 
including only number and percentage of participants, summaries will be ordered by alphabetical 
SOC and decreasing incidence of PT within SOC in terms of bimekizumab-AI-2mL. 
A listing will be presented by treatment group and participant for all AEs. This will include the 
onset date/time and outcome date/time of the event (including relative days), the AE duration, 
pattern of event, intensity, relationship, action taken and outcome. In addition, the listing will 
flag TEAEs, hospitalization, SAEs, ADEs and AE of special interest. Confirmed and suspected 
cases of SARS-CoV-2 infection will be recorded as AEs (or SAE, as required). 
5.6.3 
Additional Safety Assessments 
5.6.3.1 
Clinical laboratory evaluations 
Laboratory variables will be grouped according to the laboratory function panel (Table 5‒4) and 
categorized as normal, high or low, if applicable, based on the reference range supplied by the 
analytical laboratory. 
Table 5‒4: 
Clinical laboratory measurements 
Category 
Panel 
Variables 
Serology 
Serology 
HbsAg, HBc-Ab (both IgG and IgM), 
HCV-Ab, HIV1-Ab, HIV1-Ag, HIV-2 
Ab, SARS-CoV-2 RT-PCR 
Hematology 
Red blood cell 
Hemoglobin, hematocrit, RBC 
Platelet 
Platelet count 
White blood cell 
WBC count 
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Table 5‒4: 
Clinical laboratory measurements 
Category 
Panel 
Variables 
White blood cell differential 
Absolute counts: neutrophils, 
basophils, eosinophils, lymphocytes, 
monocytes 
Percentages: neutrophils/leukocytes, 
basophils/leukocytes, 
eosinophils/leukocytes, 
lymphocytes/leukocytes, 
monocytes/leukocytes. 
Coagulation/Hemostasis 
Coagulation 
Prothrombin time, aPTT 
Clinical Chemistry 
Electrolytes 
Sodium, chloride, potassium, total 
calcium 
Enzymes 
Creatine kinase 
Hormones 
FSH 
Metabolic 
Glucose 
Kidney function 
BUN, creatinine 
Proteins 
Total protein, albumin 
Liver function 
AST, ALT, GGT, ALP, LDH, total 
bilirubin 
Lipids 
Total cholesterol, LDL cholesterol, 
HDL cholesterol, triglycerides 
Urinalysis 
Dipstick 
pH, protein, glucose, ketone, 
urobilinogen, bilirubin, blood, specific 
gravity, nitrite, and leukocytes 
Other tests 
Urine alcohol test/drug screen 
Ethanol (measured using a urine 
alcohol test).  
Urine drug screen: 
amphetamines/methamphetamines, 
barbiturates, benzodiazepines, 
tetrahydrocannabinol, cocaine, tricyclic 
antidepressants, phencyclidine, and 
morphine/opiates 
Pregnancy 
Prior to dosing, a serum pregnancy test 
(hCG) will be performed; post dosing 
the test may be performed in urine.  
The FSH test will be performed in 
postmenopausal women at the 
Screening Visit. 
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Table 5‒4: 
Clinical laboratory measurements 
Category 
Panel 
Variables 
ALP=alkaline phosphatase; ALT=alanine aminotransferase; aPTT=activated partial thromboplastin time; 
AST=aspartate aminotransferase; BUN=blood urea nitrogen; FSH=follicle stimulating hormone;  GGT=gamma 
glutamyl transferase; HBc-Ab=hepatitis B core antibody; HBsAg=hepatitis B surface antigen; hCG=human 
chorionic gonadotropin; HCV-Ab=hepatitis C virus antibody; HDL=high density lipoprotein; HIV=human 
immunodeficiency virus; HIV1/2-Ab=HIV1/2 antibody; HIV1-Ag=HIV1 antigen; LDH=lactate dehydrogenase; 
IgG=immunoglobulin G; IgM=immunoglobulin M; LDL=low density lipoprotein; RBC=red blood cell; RT-
PCR=real-time reverse transcriptase polymerase chain reaction; SARS-CoV-2=severe acute respiratory syndrome 
coronavirus 2; WBC=white blood cell 
For hematology, coagulation/hemostasis, clinical chemistry and urinalysis laboratory variables 
the following summaries will be presented by treatment group: 
• Observed results and change from Baseline for numeric variables at each post-Baseline time 
point. These summaries will report the number of participants with non-missing values, 
mean, SD, median, minimum and maximum. 
• Shift tables from Baseline to each post-Baseline time point. These summaries will present a 
cross-tabulation of Baseline values against post-Baseline values categorized as below normal 
range, within normal range and above normal range. Each cell will include the corresponding 
number and percentage of participants. These summaries will be presented for Hematology 
and Clinical Chemistry variables in Table 5‒4. 
The above-mentioned laboratory variables and change from Baseline for numeric variables will 
be listed for the SS by treatment group and time point. Any laboratory measurements that are 
BLQ or ALQ will be handled as described in Section 5.1.1.2.2. Values outside the normal ranges 
will be flagged and the listings will present reference ranges. Additionally, laboratory results 
outside reference ranges will be listed by treatment group and time point for the SS. 
Data for the following will only be listed using the SS by treatment group and time point: 
• Serology 
• Urine alcohol test/drug screen 
• Pregnancy tests (serum and urine) 
• Follicle stimulating hormone (FSH) (only for postmenopausal women). 
5.6.3.1.1 
Potential drug-induced liver injury 
A separate listing will present participants who meet one or more of the following potential drug 
induced liver injury (PDILI) criteria at any visit: 
• Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥3x Upper limit of 
normal (ULN) and Total bilirubin <2x ULN who do not exhibit temporally associated 
symptoms of hepatitis or hypersensitivity 
• ALT or AST ≥3x ULN and Total bilirubin ≥2x ULN 
• ALT or AST ≥3x ULN who exhibit temporally associated symptoms of hepatitis or 
hypersensitivity 
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Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or 
tenderness; hypersensitivity symptoms include eosinophilia (>5%), rash, and fever (without 
clear alternative cause). 
The listing will display only visits for which at least one of the above criteria was fulfilled for a 
given study participant and will display all results obtained at that visit for the specified 
parameters. 
A summary of study participants who met the criteria for PDILI will be presented together with 
any additional relevant data collected, if applicable. 
5.6.3.2 
Vital Signs 
The following vital signs measurements will be obtained: 
• Pulse rate 
• Systolic and diastolic blood pressure 
• Tympanic body temperature 
• Weight 
Descriptive statistics will be reported for the above vital sign measurements. Measured values 
and changes from Baseline will be summarized by vital sign variable and time point for each 
treatment group. These summaries will be presented for the SS. 
By-participant listings of all vital sign measurements and change from Baseline will be presented 
by treatment group and time point for the SS. The listing will also flag abnormal absolute values 
as per Table 5‒5. 
Table 5‒5: 
Reference ranges for vital signs 
Variable 
Unit 
Low 
High 
Systolic blood pressure 
mmHg 
Value <90 
Value >140 
Diastolic blood pressure 
mmHg 
Value <50 
Value >90 
Pulse rate 
beats/min 
Value <45 
Value >90 
Temperature 
°C 
Value <35 
Value >37.5 
Weight 
kg 
Change from Baseline <=-10% 
Change from Baseline >=10% 
5.6.3.3 
Electrocardiograms 
Single 12-lead ECG recordings will be taken prior blood sampling and with the study participant 
resting in the supine position for at least 3 minutes. The following variables will be reported: 
• Heart rate 
• PR interval 
• RR interval 
• QRS duration 
• QT interval 
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• QT corrected for heart rate using Fridericia’s formula (QTcF = QT/RR1/3) 
The results of all ECG variables will be reported in the by-participant listings for the SS. The 
listing will also include the change from Baseline and percentage change from Baseline and will 
be presented by treatment group and visit/timepoint. 
Measured values, changes from Baseline, and percentage changes from Baseline will be 
summarized for the SS for each variable by treatment group and visit/timepoint.  
The following cut-points in QTcF (raw data and change from Baseline) will be summarized 
categorically for the SS by treatment group (number and percentage of participants) and 
visit/timepoint. The denominator for the percentages will be the number of study participants 
with a non-missing measurement for the variable at the specific visit/timepoint. 
Raw QTcF data: 
• <450msec 
• ≥450msec to <480msec 
• ≥480msec to <500msec 
• ≥500msec 
Change from Baseline QTcF: 
• <30msec 
• ≥30ms to <60msec 
• ≥60msec 
Electrocardiogram findings will be listed separately. 
5.6.3.4 
Physical examinations 
Study participants with abnormalities in the physical examination will be listed including details 
of the abnormality. 
5.7 
Other Analyses 
A listing of comments will be provided, if applicable. This will be based on the RS. 
5.8 
Subgroup Analyses 
Not applicable. 
5.9 
Interim Analyses 
No formal interim analysis is planned for this study.  
5.10 
Data Monitoring Committee (DMC) or Other Review Board 
Not applicable. 
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6 
SUPPORTING DOCUMENTATION 
6.1 
Appendix 1: Non-key analysis specifications 
6.1.1 
Baseline characteristics and demographics 
6.1.1.1 
Demographics 
Baseline demographic variables will be summarized by treatment group and overall using the RS 
and SS. 
The following continuous variables will be summarized using descriptive statistics: 
• Age (years), as recorded in the electronic Case Report Form (eCRF) (will not be derived) 
• Height (cm) 
• Weight at screening (kg) (at Screening, Day -1 and Day 140) 
• Body Mass Index (BMI) (kg/m2) 
The BMI value collected in the eCRF at Screening will not be used for this summary. The BMI 
will be recalculated based on weight at Day -1 using the following formula and reported to 1 
decimal place: 
𝐵𝑀𝐼 (𝑘𝑔/𝑚2) = 
Weight (kg)
(Height (m))2  
 
 
 
 
 
 
 
 
 
 
 
 
 
[7] 
The following categorical variables will be summarized using frequency counts and percentages: 
• For the EudraCT reporting, the age categories will include:  
− 18 - < 65 years 
− 65 - < 85 years 
− ≥ 85 years 
• For the clinicaltrials.gov reporting, the age categories will include:  
− ≤18 years 
− 19 to <65 years 
− ≥65 years 
• Gender 
• Race 
• Ethnicity 
By-participant listings of demographic data will be provided by treatment group using the All 
Study Participants Set. This will include age (years), gender, race and ethnicity, height (cm), 
weight at Screening (kg), weight at Day -1 (kg), weight at Day 140 (kg), BMI (kg/m2) based on 
weight at Screening, and BMI (kg/m2) based on weight at Day -1. 
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By-participant listings of childbearing potential information will be provided by treatment group 
using the All Study Participants Set. 
6.1.1.2 
Other Baseline characteristics 
Lifestyle will be summarized by treatment group and overall using the SS. The following 
categorical variables will be summarized using frequency counts and percentages: 
• Alcohol use (Never, Current, Former) 
• Caffeinated beverages use (Never, Current, Former) 
• Tobacco use (Never, Current, Former) 
• Illicit drug use (Never, Current, Former). 
By-participant listings of lifestyle data will be provided by treatment group for the All Study 
Participants Set. In addition to the items presented above, the listing will include stop date of 
tobacco use (or ongoing, as applicable) and illicit drug use. 
6.1.2 
Important protocol deviations 
IPDs will be identified and classified by the deviation types listed in the IPD specification 
document. 
IPDs will be summarized by treatment group and overall using the RS. The summary will 
include the following: 
• Number and percentage of participants with no IPDs 
• Number and percentage of participants with at least one IPD 
• Number and percentage of participants by type of IPD 
By-participant listings of IPDs as identified in the DEMs will be provided by treatment group 
using the RS. This will include deviation type, deviation description, and whether the deviation 
led to exclusion from the PKS. Similar listings and tables will be produced for IPDs related to 
COVID-19. 
6.1.3 
Impact of COVID-19 on study visits 
A listing of visits impacted by COVID-19 will be presented for all study participants based on 
the All Study Participants Set. This will include visit, visit date, relative day, impact category, 
relationship to COVID-19 and the narrative of the event. The number and percentage of study 
participants with visits impacted by COVID-19 will be summarized for treatment group for 
relationship to COVID-19 and impact category by country. The denominator for the percentages 
will be the number of study participants in the All Study Participants Set. 
6.1.4 
Medical history and concomitant diseases 
Previous and ongoing medical history conditions will be summarized by treatment group and 
overall using the SS. The summary will include the following: 
• Number and percentage of participants with any previous and ongoing medical history 
conditions. 
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• Number and percentage of participants with previous and ongoing medical history conditions 
by MedDRA system organ class (SOC) and preferred term (PT). 
By-participant listings of previous and ongoing medical history conditions will be provided by 
treatment group for the SS. This will include MedDRA SOC and PT, reported condition, start 
date and stop date (or status ongoing, as applicable). 
By-participant listings of procedure history and concomitant medical procedures will be 
provided, by treatment group for the All Study Participants Set. This will include reported 
procedure term and procedure date. 
6.1.5 
Prior and concomitant medications 
6.1.5.1 
Definitions of prior and concomitant medications 
If a participant takes a medication before the date of study medication administration, this 
medication will be categorized as ‘prior medication’. With this definition, any medication 
recorded that has been taken for at least 1 day before the date of study medication administration 
will be considered as prior. This includes medications that started prior to study medication 
administration and continued after. 
Medication not stopped before the date of study medication administration will be classified as 
‘concomitant medication’. Medication will also be labeled as ‘concomitant medication’ when the 
start date is between the date (including the date) of study medication administration and the date 
of the participant’s last study visit.  
From the definitions above, any medication that started prior to dosing and continued after 
dosing will be classified as both prior and concomitant. 
Any medications with missing dates and/or times will be handled as described in 
Section 5.1.1.2.4 in order to classify them as prior or concomitant. 
6.1.5.2 
Presentation of prior and concomitant medications data 
Prior and concomitant medications will be summarized by treatment group and overall using the 
SS. The summary will include the following: 
• Number and percentage of participants with any prior medications. 
• Number and percentage of participants with prior medications by ATC class, presenting 
WHO-DD Anatomical Main Group (ATC Level 1), Pharmacological Subgroup (ATC Level 
3), and preferred term. 
• Number and percentage of participants with any concomitant medications. 
• Number and percentage of participants with concomitant medications by ATC class, 
presenting WHO-DD Anatomical Main Group (ATC Level 1), Pharmacological Subgroup 
(ATC Level 3), and preferred term. 
By-participant listings of prior and concomitant medications will be provided by treatment group 
for the SS. This will include Anatomical Main Group, Pharmacological Subgroup, preferred 
term, reported term, dose per intake and unit, frequency, formulation, route, indication, category 
(prior/concomitant/prior and concomitant), start date and end date (or ongoing, as applicable). 
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6.1.6 
Compliance 
As this is a single dose study and dosing is performed in-house by the investigator or member of 
staff, no specific assessment or compliance is warranted. Any dosing deviation will be addressed 
in the DEM and described in the CSR. 
6.2 
Appendix 2: Changes to Protocol-Planned Analyses 
Not applicable. 
7 
REFERENCES 
1. Phillips, A. and Haudiquet, V. (2003), ICH E9 guideline ‘Statistical principles for clinical 
trials’: a case study. Statist. Med., 22: 1-11. doi:10.1002/sim.1328 
2. Food and Drug Administration. Guidance for Industry. Bioavailability and Bioequivalence 
Studies Submitted in NDAs or INDs —General Considerations. US Dept of Health and 
Human Services, Center for Drug Evaluation and Research. Biopharmaceutics. March 2017. 
3. EMEA/CHMP/BMWP/42832/2005 Rev. 1 Guideline on similar biological medicinal 
products containing biotechnology-derived proteins as active substance: non -clinical and 
clinical issues, 18 Dec 2014. 
4. CPMP/EWP/QWP/1401/98 Rev. 1/Corr Guideline on the investigation of bioequivalence 
(EMEA), 20 January 2010. 
5. Health Canada Guidance, Conduct and Analysis of Comparative Bioavailability Studies, 8 
Jun 2018. 
6. Health Canada Guidance, Comparative Bioavailability Standards: Formulations use for 
Systemic Effects, 8 Jun 2018. 
7. EMA. Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) 
pandemic. Version 3. 28 Apr 2020. Available at: 
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-
10/guidanceclinicaltrials_covid19_en.pdf 
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Approval Signatures
Name:
up0119-sap-amend-1
Version:
2. 0
Document Number:
CLIN-000213693
Title:
UP0119 - Statistical Analysis Plan Amendment 1
Approved Date:
04 Feb 2023
Document Approvals
Approval
Verdict: Approved
Name: 
Capacity: Qualified Person
Date of Signature: 03-Feb-2023 14:51:01 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Subject Matter Expert
Date of Signature: 04-Feb-2023 10:01:21 GMT+0000
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