Conditions: Moderate to Severe Psoriasis Generalized Pustular Psoriasis and Erythrodermic Psoriasis
Keywords: Psoriasis PSO Chronic plaque psoriasis Certolizumb Pegol Cimzia Generalized pustular psoriasis and erythrodermic psoriasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 127
Healthy volunteers: no

Brief summary:
The purpose of this study is to demonstrate the efficacy and safety of Certolizumab Pegol (CZP) in the treatment of moderate to severe chronic plaque Psoriasis (PSO) in Japanese subjects.

Detailed description:

Arms:
arm 1: Placebo subcutaneous (sc) injection every two weeks (Q2W) arm 2: Certolizumab Pegol subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) with PBO administered to maintain the blind, starting at Week 6 arm 3: Certolizumab Pegol subcutaneous (sc) injection 400 mg every two weeks (Q2W).

Interventions: intervention 1: Placebo intervention 2: Certolizumab Pegol
Intervention descriptions: intervention 1: * Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 0.9 % saline
* Route of Administration: Subcutaneous use Q2W intervention 2: * Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 200 mg/mL
* Route of Administration: Subcutaneous use

Protocol document:
Prot_000.pdf: 
UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 1of 119
PROTOCOL PS0017AMENDMENT 4
PHASE 2/3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, 
PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY TO 
EVALUATE THE EFFICACY AND SAFETY OF 
CERTOLIZUMAB PEGOL IN JAPANESE SUBJECTS WITH 
MODERATE TO SEVERE CHRONICPSORIASIS
Sponsor:
UCB Biopharma SPRL
Allée de la Recherche 60
1070 Brussels
BELGIUM
Protocol/Amendment number
Date
Type of 
amendment
Final Protocol
23 Sep 2016 
Not applicable
Protocol Amendment 1
11 Oct 2016 
Nonsubstantial
Protocol Amendment 2
22 Nov 2016 
Nonsubstantial
Protocol Amendment 3
11 Apr 2017 
Nonsubstantial
Protocol Amendment 4
25Jan 2018
Nonsubstantial
Confidential Material
Confidential
This document is the property of UCB and may not – in full or in part –be passed on, 
reproduced, published, or otherwise used without the express permission of UCB.
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echerche 60
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Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 2of 119
STUDY CONTACT INFORMATION
Sponsor
UCB Biopharma SPRL
Allée de la Recherche 60
1070 Brussels
BELGIUM
Sponsor in Japan
UCB Japan Co. Ltd.
Shinjuku Grand Tower 
8-17-1 Nishi-Shinjuku
Shinjuku-ku
Tokyo 160-0023
JAPAN
Sponsor Study Physician
Name:
, MD, PhD
Address:
UCB Japan Co. Ltd.
Shinjuku Grand Tower 
8-17-1 Nishi-shinjuku
Shinjuku-ku
Tokyo 160-0023
JAPAN
Phone:
Fax:
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o 160
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o 160-0023
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JAPAN
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25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 3of 119
Clinical Project Manager
Name:
Address:
UCB Japan Co. Ltd.
Shinjuku Grand Tower, 
8-17-1 Nishi-shinjuku
Shinjuku-ku
Tokyo 160-0023
JAPAN
Phone:
Fax:
Clinical Trial Biostatistician
Name:
Address:
UCB Japan Co. Ltd.
Shinjuku Grand Tower 
8-17-1 Nishi-shinjuku
Shinjuku-ku
Tokyo 160-0023
JAPAN
Phone:
Fax:
Clinical Monitoring Contract Research Organization
Name:
PAREXEL International
Address:
6F Kayabacho First Building
1-17-21 Shinkawa
Chuo-ku
Tokyo 104-0033
JAPAN
Phone:
+81 33537 5899
Fax:
+81 3 3552 0451
Other study contact information will be provided in separate documents.
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PAREXEL
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25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 4of 119
SERIOUS ADVERSE EVENT REPORTING
Serious adverse event reporting (24h)
Fax
Japan:+81 3 6864 7400
Email
Japan:UCBJ-Safety@ucb.com
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25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 5of 119
TABLE OF CONTENTS
LIST OF ABBREVIATIONS.................................................................................................. 12
1
SUMMARY..................................................................................................................... 15
2
INTRODUCTION ................................ ................................ ........................................... 16
3 STUDY OBJECTIVES.................................................................................................... 18
3.1 Primary objective............................................................................................................. 18
3.2 Secondary objectives....................................................................................................... 18
3.3 Other objectives............................................................................................................... 19
4
STUDY VARIABLES..................................................................................................... 19
4.1 Efficacy variables............................................................................................................. 19
4.1.1
Primary efficacy variable..................................................................................... 19
4.1.2
Secondary efficacy variables............................................................................... 19
4.1.3
Other efficacy variables 
................................ 
....................................................... 19
4.1.3.1 
For subjects with moderate to severe chronic plaque PSO ....................... 19
4.1.3.2 
For subjects with generalized pustular PSO or erythrodermic PSO.......... 20
4.2 Pharmacokinetic and pharmacodynamic variable............................................................ 21
4.3 Immunological variable ................................ ................................ ................................... 21
4.4 Safety variables................................................................................................................ 21
5
STUDY DESIGN............................................................................................................. 21
5.1 Study description............................................................................................................. 21
5.1.1
Study design for subjects with moderate to severe chronic plaque PSO............. 22
5.1.1.1 
Period 1: Screening ................................ ................................................... 22
5.1.1.2 
Period 2: Week 0 to Week 16.................................................................... 22
5.1.1.3 
Period 3:  Week 16 to Week 52................................................................. 22
5.1.1.4 
Period 4:  Safety Follow-up: Week 52 to Week 60................................... 23
5.1.2
Study design for subjects with generalized pustular PSO or erythrodermic PSO23
5.1.2.1 
Period 1: Screening ................................ ................................................... 23
5.1.2.2 
Period 2: Week 0 to Week 16.................................................................... 23
5.1.2.3 
Period 3: Week 16 to Week 52.................................................................. 23
5.1.2.4 
Period 4: Safety Follow-up: Week 52 to Week 60.................................... 24
5.1.3
Study duration per subject ................................ ................................................... 24
5.1.4 
Planned number of subjects and site(s) ............................................................... 24
5.1.5 
Anticipated regions and countries ................................ ....................................... 24
5.2 Schedule of study assessments......................................................................................... 25
5.3 Schematic diagram........................................................................................................... 28
5.4 Rationale for study design and selection of dose............................................................. 29
6
SELECTION AND WITHDRAWAL OF SUBJECTS................................................... 30
6.1 Inclusion criteria ................................ ................................ .............................................. 30
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Period 1: Screening
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4.1.3.1 
For subjects with moderate to severe chronic plaque PSO ....................... 19
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4.1.3.1 
For subjects with moderate to severe chronic plaque PSO ....................... 19
For subjects with generalized pustular PSO or ery
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For subjects with generalized pustular PSO or ery
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 design for subjects with moderate to severe chronic plaque PSO............. 22
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 design for subjects with moderate to severe chronic plaque PSO............. 22
Period 1: Screening
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Period 1: Screening................................
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5.1.1.2 
Period 2: Week 0 to Week 16................................
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5.1.1.2 
Period 2: Week 0 to Week 16................................
Period 3:  Week 16 to Week 52
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Period 3:  Week 16 to Week 52
Period 4:  Safety
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Period 4:  Safety
 design for subjects with generalized pustular PSO or ery
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 design for subjects with generalized pustular PSO or ery
Period 1: Screening
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Period 1: Screening
5.1.2.2 
Period 2: Week 0 to Week 16................................
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5.1.2.2 
Period 2: Week 0 to Week 16................................
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5.1.2.3 
Period 3: Week 16 to Week 52................................
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5.1.2.3 
Period 3: Week 16 to Week 52................................
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5.1.2.4
5.1.3
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5.1.5
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5.1.5
5.2
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25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
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Page 6of 119
6.1.1
Inclusion criteria for all subjects.......................................................................... 30
6.1.2
Inclusion criteria for subjects with moderate to severe chronic plaque PSO ...... 31
6.1.3
Inclusion criteria for subjects with generalized pustular PSO or erythrodermic 
PSO..................................................................................................................... 31
6.2 Exclusion criteria ................................ ................................ ............................................. 31
6.2.1 
Exclusion criteria for all subjects ................................ ........................................ 31
6.2.2 
Exclusion criteria for subjects with moderate to severe chronic 
 plaque PSO 
..... 34
6.2.3 
Exclusion criteria for subjects with generalized pustular PSO or erythrodermic 
PSO..................................................................................................................... 35
6.3 Withdrawal criteria ................................ ................................ .......................................... 36
6.3.1 
Potential drug-induced liver injury IMP discontinuation criteria........................ 38
7 STUDY TREATMENTS................................................................................................. 38
7.1 Description of investigational medicinal products .......................................................... 38
7.2 Treatments to be administered 
................................ 
......................................................... 39
7.3 Packaging......................................................................................................................... 39
7.4 Labeling ................................ ................................ ........................................................... 39
7.5 Handling and storage requirements.................................................................................. 39
7.6 Drug accountability.......................................................................................................... 40
7.7 Procedures for monitoring subject compliance................................................................ 40
7.8 Concomitant medications/treatments............................................................................... 40
7.8.1 
Permitted concomitant treatments (medications and therapies) 
.......................... 41
7.8.1.1 
Permitted concomitant treatments (medications and therapies) for subjects 
with moderate to severe chronic plaque PSO who escape from 
double-blind treatment ................................ .............................................. 41
7.8.1.2 
Permitted concomitant treatments (medications and therapies) for subjects 
with generalized pustular PSO or erythrodermic PSO.............................. 41
7.8.2 
Prohibited concomitant treatments (medications and therapies) 
......................... 41
7.8.2.1 
Prohibited concomitant treatments (medications and therapies) for 
subjects with moderate to severe chronic plaque PSO.............................. 41
7.8.2.2 
Prohibited  
concomitant treatments (medications and therapies) for 
subjects with generalized pustular PSO or erythrodermic PSO................ 42
7.9 Blinding............................................................................................................................ 42
7.9.1 
Procedures for maintaining and breaking the treatment blind............................. 43
7.9.1.1 
Maintenance of study treatment blind....................................................... 43
7.9.1.2 
Breaking the treatment blind in an emergency situation........................... 43
7.10 Randomization and numbering of subjects...................................................................... 43
8 STUDY PROCEDURES BY VISIT ................................ ............................................... 44
8.1 Visit 1 (Screening) 
................................ 
................................ 
........................................... 44
8.2 Visit 2 (Baseline)............................................................................................................. 45
8.3 Visit 3 (Week 2)............................................................................................................... 46
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6.2.2 
Exclusion criteria for subjects with moderate to severe chronic 
 plaque PSO 
..... 34
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6.2.2 
Exclusion criteria for subjects with moderate to severe chronic 
 plaque PSO 
..... 34
throdermic 
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throdermic 
..................... 35
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..................... 35
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.......................................... 36
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MP discontinuation criteria........................
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MP discontinuation criteria........................
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Procedures for monitoring subject compliance
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Procedures for monitoring subject compliance................................
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7.8 Concomitant medications/treatments................................
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7.8 Concomitant medications/treatments................................
Permitted concomitant treatments (medications and therapies)
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Permitted concomitant treatments (medications and therapies)
Permitted concomitant treatments (medications and therapies) for subjects 
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Permitted concomitant treatments (medications and therapies) for subjects 
with moderate to severe chronic plaque PSO who escape from 
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with moderate to severe chronic plaque PSO who escape from 
blind treatment
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blind treatment
Permitted concomitant treatments (medications and therapies) fo
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Permitted concomitant treatments (medications and therapies) fo
with generalized pustular PSO or ery
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with generalized pustular PSO or ery
Prohibited concomitant treatments (medications and therapies)
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Prohibited concomitant treatments (medications and therapies)
Prohibited c
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Prohibited c
subjects with moderate to severe chronic plaque PSO
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subjects with moderate to severe chronic plaque PSO
Prohibited 
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Prohibited 
7.9 Blinding................................
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7.9 Blinding................................
7.9.1
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7.9.1
7.9.1.1
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7.9.1.1
7.10
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Clinical Study Protocol
Certolizumab Pegol
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Page 7of 119
8.4 Visit 4 (Week 4)............................................................................................................... 47
8.5 Visit 5 (Week 6)............................................................................................................... 47
8.6 Visit 6 (Week 8)............................................................................................................... 48
8.7 Visit 7 (Week 10)............................................................................................................. 48
8.8 Visit 8 (Week 12)............................................................................................................. 49
8.9 Visit 9 (Week 14)............................................................................................................. 50
8.10 Visit 10 (Week 16)........................................................................................................... 50
8.11 Visit 11 (Week 18)........................................................................................................... 51
8.12 Visit 12 (Week 20)........................................................................................................... 51
8.13 Visit 13 (Week 22)........................................................................................................... 52
8.14 Visit 14 (Week 24)........................................................................................................... 52
8.15 Visit 15 (Week 26)........................................................................................................... 53
8.16 Visit 16 (Week 28)........................................................................................................... 53
8.17 Visit 17 (Week 30)........................................................................................................... 54
8.18 Visit 18 (Week 32)........................................................................................................... 54
8.19 Visit 19 (Week 34)........................................................................................................... 55
8.20 Visit 20 (Week 36)........................................................................................................... 55
8.21 Visit 21 (Week 38)........................................................................................................... 55
8.22 Visit 22 (Week 40)........................................................................................................... 56
8.23 Visit 23 (Week 42)........................................................................................................... 56
8.24 Visit 24 (Week 44)........................................................................................................... 57
8.25 Visit 25 (Week 46)........................................................................................................... 57
8.26 Visit 26 (Week 48)........................................................................................................... 58
8.27 Visit 27 (Week 50)........................................................................................................... 58
8.28 Visit 28 (Week 52)........................................................................................................... 58
8.29Safety Follow-Up Visit.................................................................................................... 59
8.30 Withdrawal Visit 
................................ 
................................ 
.............................................. 60
8.31 Unscheduled Visit 
................................ 
................................ 
............................................ 61
9 ASSESSMENT OF EFFICACY...................................................................................... 61
9.1 Psoriasis Area Severity Index (PASI).............................................................................. 61
9.2 BSA affected by psoriasis................................................................................................ 62
9.3 Physician’s Global Assessment of Psoriasis (PGA) 
........................................................ 62
9.4 Dermatology Life Quality Index (DLQI)......................................................................... 63
9.5 Modified Nail Psoriasis Severity Index (mNAPSI)......................................................... 63
9.6 Itch Numeric Rating Scale 
................................ 
............................................................... 63
9.7 Assessments for subjects with PsA.................................................................................. 64
9.7.1 
ACR20, ACR50, and ACR70 responses ............................................................. 64
9.7.2 
Swollen and tender joint counts (66/68 joints evaluation) .................................. 64
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8.24 Visit 24 (Week 44)................................
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8.25 Visit 25 (Week 46)................................
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8.26 Visit 26 (Week 48)................................
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8.27 Visit 27 (Week 50)................................
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8.27 Visit 27 (Week 50)................................
8.28 Visit 28 (Week 52)................................
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8.28 Visit 28 (Week 52)................................
Up Visit
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Up Visit................................
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Withdrawal Visit
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Withdrawal Visit................................
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................................
Unscheduled Visit
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Unscheduled Visit
ASSESSMENT OF EFFICA
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ASSESSMENT OF EFFICA
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Psoriasis Area Severity
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Psoriasis Area Severity
BSA affected b
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BSA affected b
Phy
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9.4
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9.5
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9.7.3 
Swollen and tender joint counts (28 joints evaluation)........................................ 64
9.7.4
Disease Activity Score......................................................................................... 64
9.7.5 
Health Assessment Questionnaire Disability Index score................................... 65
9.7.6 
Patient’s Global Assessment of Arthritis Pain (VAS) 
......................................... 65
9.7.7
Physician’s Global Assessment of Disease Activity (VAS)................................ 65
9.7.8 
Patient’s Global Assessment of Disease Activity (VAS).................................... 65
9.8 Assessments for subjects with generalized pustular PSO or erythrodermic PSO........... 66
9.8.1 
ClinicalGlobal Impression of Improvement (CGI-I).......................................... 66
9.8.2
Global Improvement Score for Pustular PSO...................................................... 66
9.8.3
JDA severity index score for generalized pustular PSO...................................... 67
10 ASSESSMENT OF PHARMACOKINETIC/ 
PHARMACODYNAMIC/PHARMACOGENOMIC VARIABLES 
.............................. 67
11 ASSESSMENT OF IMMUNOLOGICAL VARIABLES............................................... 68
12 ASSESSMENT OF SAFETY.......................................................................................... 68
12.1Adverse events................................................................................................................. 68
12.1.1 Definitions ................................ ................................ ........................................... 68
12.1.1.1 
Adverse event............................................................................................ 68
12.1.1.2 
Serious adverse event 
................................ 
................................................ 68
12.1.1.3 
Adverse events of interest ................................ ......................................... 69
12.1.1.4 
Malfunctions and Health Damage 
............................................................. 70
12.1.2 Procedures for reporting and recording adverse events....................................... 70
12.1.2.1 
Description of adverse events.................................................................... 70
12.1.2.2 
Rule for repetition of an adverse event...................................................... 71
12.1.2.3 
Additional procedures for reporting serious adverse events ..................... 71
12.1.3 Follow up of adverse events ................................ ................................................ 71
12.1.4
Pregnancy............................................................................................................ 72
12.1.5 Procedures for reporting malfunctions/health damage 
........................................ 73
12.1.5.1 
Response to subjects.................................................................................. 73
12.1.5.2 
Expedited reporting of serious health damage .......................................... 73
12.1.5.3 
Reporting of malfunctions or nonserious health damage 
.......................... 73
12.1.6 Suspected transmission of an infectious agent via a medicinal product.............. 74
12.1.7 Overdose of investigational medicinal product 
................................................... 74
12.1.8
Safety signal detection......................................................................................... 74
12.2Laboratory measurements................................................................................................ 74
12.2.1 Evaluation of PDILI ................................ ............................................................ 76
12.2.1.1 
Consultation with Medical Monitor and local hepatologist 
...................... 79
12.2.1.2
Immediate action: determination of IMP discontinuation......................... 79
12.2.1.3 
Testing: identification/exclusion of alternative etiology........................... 79
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Description of adverse events................................
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Malfunctions and Health Damage
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Malfunctions and Health Damage
12.1.2 Procedures for reporting and recording adverse events................................
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12.1.2 Procedures for reporting and recording adverse events................................
12.1.2.1 
Description of adverse events................................
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12.1.2.1 
Description of adverse events................................
Rule for repetition of an adverse event
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Rule for repetition of an adverse event
Additional procedures for reporting serious adverse events
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Additional procedures for reporting serious adverse events
Follow up of adverse events
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Follow up of adverse events
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12.1.5 Procedures for reporting malfunctions/health damage 
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12.1.5 Procedures for reporting malfunctions/health damage 
................................
Response to subjects
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Response to subjects
Expedited reporting of serious health damage
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Expedited reporting of serious health damage
12.1.5.3 
Reporting of malfunctions or nonserious health damage 
.......................... 73
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12.1.5.3 
Reporting of malfunctions or nonserious health damage 
.......................... 73
12.1.6
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12.1.6
Suspected transmission of an infectious agent via a medicinal product
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Suspected transmission of an infectious agent via a medicinal product
12.1.7
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12.1.7
12.1.8
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12.1.8
12.2
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12.2.1.4 
Follow-up evaluation................................................................................. 81
12.3Physical examination ................................ ................................ ....................................... 81
12.4 Blood pressure ................................ ................................ ................................................. 81
12.5 12-lead electrocardiogram................................................................................................ 82
12.6 Tuberculosis assessments and management ................................ .................................... 82
12.7 Chest x-ray for TB........................................................................................................... 83
12.8Interferon-gamma release assay (IGRA) testing for TB.................................................. 83
12.9 Subject questionnaire for TB ................................ ........................................................... 83
12.10
Pregnancy testing................................................................................................... 83
12.11
Height and weight.................................................................................................. 84
12.12
Other study measurements..................................................................................... 84
12.12.1 Demographic information.................................................................................... 84
12.12.2 Medical history 
................................ 
................................ 
.................................... 84
12.12.3 Psoriasis history................................................................................................... 84
13 STUDY MANAGEMENT AND ADMINISTRATION 
................................................. 84
13.1Adherence to protocol...................................................................................................... 84
13.2 Monitoring ................................ ................................ ....................................................... 84
13.2.1 Definition of source data ................................ ..................................................... 85
13.2.2
Source data verification....................................................................................... 85
13.3 Data handling 
................................ 
................................ 
................................................... 85
13.3.1 Case Report form completion.............................................................................. 85
13.3.2
Database entry and reconciliation........................................................................ 86
13.3.3 Subject Screening and Enrollment log/Subject Identification C ode list.............. 86
13.4 Termination of the study.................................................................................................. 86
13.5 Archiving and data retention............................................................................................ 86
13.6 Audit and inspection ................................ ................................ ........................................ 87
13.7 Good Clinical Practice 
................................ 
................................ 
..................................... 87
14 STATISTICS................................................................................................................... 87
14.1Definition of analysis sets................................................................................................ 87
14.2 General statistical considerations..................................................................................... 88
14.3Planned efficacy analyses................................................................................................ 89
14.3.1
Analysis of the primary efficacy variable for subjects with moderate to severe 
chronic plaque PSO ................................ ............................................................. 89
14.3.2
Other efficacy analyses........................................................................................ 91
14.3.2.1
Analysis of the secondary efficacy variables for subjects with moderate to 
severe chronic plaque PSO........................................................................ 91
14.3.2.2
Analysis of the other efficacy variables for subjects with moderate to 
severe active plaque PSO ................................ .......................................... 91
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..................................................... 84
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..................... 84
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.................................................... 84
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.................... 84
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13.3.1 Case Report form completion................................
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13.3.1 Case Report form completion................................
 and reconciliation
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 and reconciliation
13.3.3 Subject Screening and Enrollment log/Subject Identification C ode list.............. 86
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13.3.3 Subject Screening and Enrollment log/Subject Identification C ode list.............. 86
y................................
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y................................
13.5 Archiving and data retention................................
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13.5 Archiving and data retention................................
Audit and inspection
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Audit and inspection................................
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................................
Good Clinical Practice
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Good Clinical Practice
STICS
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STICS................................
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................................
Definition of anal
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Definition of anal
General statistical considerations
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General statistical considerations
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Planned efficacy
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Planned efficacy
14.3.1
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14.3.2
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Clinical Study Protocol
Certolizumab Pegol
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Page 10of 119
14.3.2.3
Analysis of the other efficacy variables for subjects with generalized 
pustular PSO and erythrodermic PSO....................................................... 92
14.4Planned safety and other analyses.................................................................................... 92
14.4.1
Safety analyses..................................................................................................... 92
14.4.2
Other analyses...................................................................................................... 92
14.5 Handling of protocol deviations....................................................................................... 93
14.6 Handling of dropouts or missing data 
................................ 
.............................................. 93
14.7 Planned interim analysis and data monitoring 
................................ 
................................. 93
14.8 Determination of sample size........................................................................................... 93
14.8.1 Determination of sample size for double-blind for plaque PSO.......................... 93
14.8.2 Determination of sample size for generalized pustular PSO and e ry
throdermic 
PSO cohort........................................................................................................... 94
15 ETHICS AND REGULATORY REQUIREMENTS...................................................... 94
15.1Informed consent ................................ ................................ ............................................. 94
15.2 Subject identification cards.............................................................................................. 95
15.3 Institutional Review Boards............................................................................................. 95
15.4Subject privacy................................................................................................................. 95
15.5 Protocol amendments....................................................................................................... 96
16 FINANCE, INSURANCE, AND PUBLICATION......................................................... 96
17 REFERENCES ................................ ................................ ................................................ 96
18 APPENDICES................................................................................................................. 99
18.1 Protocol Amendment 1 ................................ ................................ .................................... 99
18.2 Protocol Amendment 2 ................................ ................................ .................................. 103
18.3 Protocol Amendment 3 ................................ ................................ .................................. 108
18.4 Protocol Amendment 4 ................................ ................................ .................................. 110
19 DECLARATION AND SIGNATURE OF INVESTIGATOR ..................................... 118
20 SPONSOR DECLARATION 
................................ 
........................................................ 119
LIST OF TABLES
Table 5‒1: 
Schedule of study assessments......................................................................... 25
Table 5‒2: 
Percentage of subjects achieving endpoint at 12 weeks in C87040................. 29
Table 5‒3:
PASI response rates after retreatment.............................................................. 30
Table 6‒1: 
Exclusions for prior treatments for subjects with moderate to severe 
active plaque PSO 
................................ 
............................................................ 35
Table 6‒2: 
Exclusions for prior treatments for subjects with generalized pustular 
PSO or erythrodermic PSO.............................................................................. 36
Table 9‒1:
Body areas for calculation of percentBSA for PASI...................................... 62
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.............. 93
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.............. 93
................................
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................................. 93
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. 93
........................... 93
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........................... 93
.......................... 93
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.......................... 93
ry
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rythrodermic 
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throdermic 
rythrodermic 
ry
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rythrodermic 
ry
................................
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................................
................................
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...................................................... 94
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................................
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................................
AND PUBLICATION
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AND PUBLICATION
................................
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................................
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................................
ARATION AND SI
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ARATION AND SIGN
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GN
20 SPONSOR DECLARATION 
................................
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20 SPONSOR DECLARATION 
................................
‒1:
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‒1:
Schedule of stud
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Schedule of stud
5
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5‒2: 
Percentage of subjects achieving endpoint at 12 weeks in C87040................. 29
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‒2: 
Percentage of subjects achieving endpoint at 12 weeks in C87040................. 29
Table
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Table5
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5‒3:
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‒3:
Table
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Table


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25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 11of 119
Table 9‒2: 
Swelling and tenderness grading ................................ ..................................... 64
Table 9‒3:
Global Improvement Score.............................................................................. 66
Table 9‒4:
JDA severity index score for generalized pustular PSO.................................. 67
Table 12‒1:
Laboratory measurements................................................................................ 75
Table 12‒2: Required investigations and follow up for PDILI............................................ 77
Table 12‒3:
PDILI laboratory measurements 
................................ 
...................................... 80
Table 12‒4:
PDILI information to be collected 
................................ 
................................... 80
Table 14‒1: Statistical testing procedure 
................................ 
............................................. 89
LIST OF FIGURES
Figure5‒1:
Schematic diagram........................................................................................... 28
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................................... 80
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... 80
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............. 89
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............. 89
................................
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........................................................... 28
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........................... 28


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Clinical Study Protocol
Certolizumab Pegol
PS0017
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Page 12of 119
LIST OF ABBREVIATIONS
ACR20/50/70
American College of Rheumatology 20%/ 50%/70% response criteria 
AE
adverse event
ALP
alkaline phosphatase
ALT
alanine aminotransferase
AST
aspartate aminotransferase
BSA
body surface area
CDMS
clinical data management system
CGI-I
Clinical Global Impressions -Improvement
CES
Cohort Enrolled Set
CFAS
Cohort Full Analysis Set
CPKS
Cohort Pharmacokinetics Set
CPM
Clinical Project Manager
CPMP
Committee for Proprietary Medicinal Products
CRO
contract research organization
CRS
Cohort Randomized Set
CSS
Cohort Safety Set
CZP
certolizumab pegol
DAS28(CRP) 
Disease Activity Score 28 joint count C-reactive protein
DLQI
Dermatology Life Quality Index
DNA
deoxyribonucleic acid
ECG
electrocardiogram
eCRF
electronic Case Report form
EPS
Erythrodermic Psoriasis Set
ES
Enrolled Set
EMA/EMEA 
European Medicines Agency
FAS
Full Analysis Set
FDA
Food and Drug Administration
GCP
Good Clinical Practice
GMP
Good Manufacturing Practice
GPPS
Generalized Pustular Psoriasis Set
HAQ-DI
Health Assessment Questionnaire-Disability Index
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 Medicinal Products
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 Medicinal Products
contract research organization
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contract research organization
Cohort Randomized Set
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Cohort Randomized Set
 Set
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 Set
certolizumab pegol
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certolizumab pegol
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 Medicinal Products
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 Medicinal Products
contract research organization
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contract research organization
certolizumab pegol
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certolizumab pegol
Disease Activity
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Disease Activity Score 28 joint count C
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 Score 28 joint count C
Disease Activity Score 28 joint count C
Disease Activity
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Disease Activity Score 28 joint count C
Disease Activity
Dermatology
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Dermatology L
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 L
Dermatology L
Dermatology
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Dermatology L
Dermatology
deox
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deoxyribonucleic acid
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yribonucleic acid
electrocardiogram
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electrocardiogram
electronic Case Report form
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electronic Case Report form
EMA/EMEA
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EMA/EMEA
FAS
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FAS
FDA
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FDA
GCP
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GCP


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HBc
hepatitis B core
HBs
hepatitis B surface
HBV
hepatitis type B virus
HCV
hepatitis type C virus
HIV
human immunodeficiency virus
HLA
human leukocyte antigen
IB
Investigator’s Brochure
ICH
International Council for Harmonisation
IGRA
interferon-gamma release assay
IMP
investigational medicinal product
IRB
Institutional Review Board
IRT
interactiveresponse technology
ITT
Intent-to-Treat
JDA
Japanese Dermatological Association
LTBI
latent tuberculosis infection
MCID
minimal clinically important difference
MCMC
Markov Chain Monte Carlo
mNAPSI
Modified Nail Psoriasis Severity Index
NAPSIS
Nail Psoriasis Severity Index Set
NRI
nonresponse imputation
NSAID
nonsteroidal anti-inflammatory drug
NTMB
nontuberculous mycobacterium
PASI
Psoriasis Activity and Severity Index
PBO
placebo
PDILI
potential drug-induced liver injury
PEG
polyethylene glycol
PFS
prefilled syringe
PGA
Physician’s Global Assessment
PGADA
Patient’s Global Assessment of Disease Activity
PhGADA
Physician’s Global Assessment of Disease Activity
PK
pharmacokinetic(s)
PK-PPS
Pharmacokinetics Per-Protocol Set
REDACTED COPY 
Japanese Dermatological Association
REDACTED COPY 
Japanese Dermatological Association
latent tuberculosis infection
REDACTED COPY 
latent tuberculosis infection
 important difference
REDACTED COPY 
 important difference
Markov Chain Monte Carlo
REDACTED COPY 
Markov Chain Monte Carlo
Modified Nail Psoriasis Severity
REDACTED COPY 
Modified Nail Psoriasis Severity
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Japanese Dermatological Association
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Japanese Dermatological Association
 important difference
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 important difference
Markov Chain Monte Carlo
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Markov Chain Monte Carlo
Modified Nail Psoriasis Severity
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Modified Nail Psoriasis Severity
Psoriasis Severity
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Psoriasis Severity
nonresponse imputation
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nonresponse imputation
nonsteroidal anti
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nonsteroidal anti
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nontuberculous my
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nontuberculous my
Psoriasis Activity
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Psoriasis Activity
PGA
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PGA
PGADA
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PGADA


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Clinical Study Protocol
Certolizumab Pegol
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PPS
Per-Protocol Set
PS
Patient Safety
PsA
psoriatic arthritis
PsAS
Psoriatic Arthritis Set
PSO
psoriasis
Q2W
every 2 weeks
RS
Randomized Set
SAE
serious adverse event
sc
subcutaneous
SFU
Safety Follow-Up
SOP
Standard Operating Procedure
SS
Safety Set
SPC
Summary of Product Characteristics
TB
tuberculosis
TEAE
treatment-emergent adverse event
TNF
tumor necrosis factor
ULN
upper limit of normal
VAS
visual analog scale
WBC
white blood cell
REDACTED COPY 
emergent adverse event
REDACTED COPY 
emergent adverse event
upper limit of normal
REDACTED COPY 
upper limit of normal
visual analog scale
REDACTED COPY 
visual analog scale
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emergent adverse event
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emergent adverse event
visual analog scale
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visual analog scale
white blood cell
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Clinical Study Protocol
Certolizumab Pegol
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1
SUMMARY
PS0017 is a randomized, double-blind, parallelgroup, placebo(PBO)-controlled, multicenter 
study designed to evaluatethe efficacy and safety of certolizumab pegol (CZP) in adult Japanese 
subjects with moderate to severe chronic plaque psoriasis (PSO). In addition, a cohort of subjects 
with generalized pustular PSO or erythrodermic PSO will be eligible for the study. 
Approximately 125 subjects with moderate to severe chronic plaque PSO, including psoriatic 
arthritis (PsA), will be randomly assigned in a 2:2:1 ratio at Baseline to either CZP 400mg every 
2 weeks (Q2W),CZP 200mg Q2W (loading dose of CZP 400mg at Weeks 0, 2,and 4), or PBO. 
Study drug will be administered by subcutaneous (sc) injection. Subjects will be followed in a 
blindedfashion up to Week 52following randomization.
The treatment from Week 16 through Week 52 for subjects who achieve a Psoriasis Activity and 
Severity Index (PASI) 50 response will be based on response to double-blind treatment at 
Week 16. Subjects randomized to CZP 400mg Q2W will remain on their a ssigned dose. Subjects 
initially randomized to CZP 200mg Q2W will be rerandomized (1:1) to receive either 
CZP200mg Q2W or CZP 400mg Q4W (with PBO administered on alternate dosing weeks to 
maintain the blind). Subjects randomized to PBO treatment whoachieve a PASI50 response at
Week 16 will continue on PBO. Subjects who do not achieve a PASI50 response at Week 16 will 
escape from double-blind treatment and enter the open-label arm of the study.
Subjects who do not achieve a PASI50 response at the Week 16, 24, 32, or 40 visit will escape 
from double-blind treatment and enter the open-label arm of the study. These subjects will 
receive open-label CZP (400mg Q2W as 3 loading doses followed by CZP 200mg Q2W) from 
the visit the response criterion is not met. Subjects receiving open-label CZP 200mg Q2W in the 
escape arm and not achieving a PASI50 response will be allowed to have their dose increased to 
CZP400mg Q2W, at the discretion of the Investigator.If, in the opinion of the Investigator, the 
subject is not receiving benefit (eg, a PASI50) at the 400mg Q2W dose, the subject should be 
withdrawn from the study.
A cohort of subjects with generalized pustular PSO or erythrodermic PSO will be eligible forthe 
study. At least 10 subjects with generalized pustular PSO or erythrodermic PSO will be 
randomly assigned in a 1:1 ratio at Baseline to open-label CZP 400mg Q2Wor CZP 200mg 
Q2W (loading dose of CZP 400mg at Weeks 0, 2, and 4). Study drug will be administered by sc 
injection.
The treatment from Week 16 through Week 52 for the cohort of subjects with generalized 
pustular PSO or erythrodermic PSO will be based on response to open-label treatment at 
Week 16. Subjects achieving a “much improved,” “very much improved,” or PASI50 will 
continue to receive the same treatment as randomized. Subjects in the CZP 200mg Q2W group 
who are not in response (not achieving “much improved” or “very much improved” in the Global 
Improvement Score [for subjects with generalized pustular PSO]or a PASI50 response [for 
subjects with erythrodermic PSO]) will be allowed to have their dose increased to 
CZP400mgQ2W, at the discretion of the Investigator. Subjects randomized to 
CZP400mgQ2W will continue to receive CZP 400mg Q2W at the discretion of the Investigator. 
If, in the opinion of the Investigator, the subject is not receiving benefit at the 400mg Q2W dose, 
the subject could be withdrawn from the study. Per the Withdrawal Criteria (Section 6.3), 
REDACTED COPY 
blind treatment and enter the open
REDACTED COPY 
blind treatment and enter the open-
REDACTED COPY 
-label arm of the study
REDACTED COPY 
label arm of the study
Subjects who do not achieve a PASI50 response at 
REDACTED COPY 
Subjects who do not achieve a PASI50 response at the 
REDACTED COPY 
the 
pen
REDACTED COPY 
pen-
REDACTED COPY 
-label arm of the study
REDACTED COPY 
label arm of the study
label CZP (400mg Q2W as 3 loading doses followed by
REDACTED COPY 
label CZP (400mg Q2W as 3 loading doses followed by
the visit the response criterion is not met. Subjects receiving open
REDACTED COPY 
the visit the response criterion is not met. Subjects receiving open
escape arm and not achieving a PASI50 response will be allowed to have their dose increased to 
REDACTED COPY 
escape arm and not achieving a PASI50 response will be allowed to have their dose increased to 
400mg Q2W, at the discretion of the 
REDACTED COPY 
400mg Q2W, at the discretion of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ever
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
every 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y 
or PBO. 
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or PBO. 
 subcutaneous (sc) injection. Subjects will be followed in a 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 subcutaneous (sc) injection. Subjects will be followed in a 
Psoriasis Activity
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Psoriasis Activity
blind treatment at 
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blind treatment at 
16. Subjects randomized to CZP 400mg Q2W will remain on their assigned dose. Subjects 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
16. Subjects randomized to CZP 400mg Q2W will remain on their assigned dose. Subjects 
 randomized to CZP 200mg Q2W will be rerandomized (1:1) to receive either 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 randomized to CZP 200mg Q2W will be rerandomized (1:1) to receive either 
200mg Q2W or CZP 400mg Q4W (with PBO administered on alternate dosing weeks to 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
200mg Q2W or CZP 400mg Q4W (with PBO administered on alternate dosing weeks to 
achieve a PASI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
achieve a PASI
Subjects who do not achieve a PASI
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Subjects who do not achieve a PASI
label arm of the study
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label arm of the study
Week 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Week 
label arm of the study
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label arm of the study
label CZP (400mg Q2W as 3 loading doses followed by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
label CZP (400mg Q2W as 3 loading doses followed by
the visit the response criterion is not met. Subjects receiving open
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
the visit the response criterion is not met. Subjects receiving open
escape arm and not achieving a PASI50 response will be allowed to have their dose increased to 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
escape arm and not achieving a PASI50 response will be allowed to have their dose increased to 
400mg Q2W, at the discretion of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
400mg Q2W, at the discretion of the Investigato
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Investigato
g, a PASI50) at the 400mg Q2W dose, the subject should be 
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g, a PASI50) at the 400mg Q2W dose, the subject should be 
ubjects with generalized pustular PSO or ery
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ubjects with generalized pustular PSO or ery
10 subjects with generalized pustular PSO or ery
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
10 subjects with generalized pustular PSO or ery
 assigned in a 1:1 ratio at Baseline to 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 assigned in a 1:1 ratio at Baseline to 
Q2W (loading dose of CZP 400mg at Weeks 0, 2, and 4)
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Q2W (loading dose of CZP 400mg at Weeks 0, 2, and 4)
The treatment from Week 16 through Week 52 for the coho
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The treatment from Week 16 through Week 52 for the coho
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pustular PSO or ery
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pustular PSO or ery
16. Subjects achieving a “much improved,” “very
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
16. Subjects achieving a “much improved,” “very
continue to receive the same treatment as randomized.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
continue to receive the same treatment as randomized.
who are not in response (
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who are not in response (
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Improvement Score [
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Improvement Score [
subjects with ery
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subjects with ery


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25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
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Page 16of 119
subjects who develop an aggravation of the primary disease or concomitant disease with 
hospitalization in the opinion of the Investigator must be withdrawn from the study.
All subjects, including those withdrawn from the study treatment, will have a Safety Follow-Up 
(SFU) Visit 10 weeks after their final dose of study medication.
The primary objective of the study is to demonstrate the efficacy of CZP administered sc at the 
doses of CZP 400mg Q2W and CZP 200mg Q2W (after a loading dose of CZP 400mg at 
Weeks 0, 2, and 4) in the treatment of moderate to severe chronicplaque PSO in Japanese 
subjects.
2
INTRODUCTION
Psoriasis is a common, chronic inflammatory disease characterized by a series of linked cellular 
changes in the skin: hyperplasia of epidermal keratinocytes, vascular hyperplasia and ectasia, and 
infiltration of T lymphocytes, neutrophils, and other types of leucocytes in affected skin. 
Although the pathophysiology of PSO is not fully understood, the importance of T-cells and 
inflammatory cytokines has been demonstrated by the clinical benefit provided by therapies 
directed at these targets (Kreuger and Ellis, 2005). 
Psoriasis has a variety of forms including plaque, guttate, pustular, erythrodermic,and PsA. 
Plaque PSO is the most common, comprising approximately 80% to 90% of all cases. 
Approximately 17% of those with PSO have moderate to severe disease (Kurd et al, 2008).
In addition to the impact on skin, PSO has a multitude of psychosocial and emotional effects on 
patients, including increased self-consciousness, frustration, fatigue, depression, and suicidal 
ideation. As a result, patients frequently report sleeping problems, difficulties at work, problems 
interacting with family members, disrupted leisure activities, and sexual difficulties 
(Dowlatshahi et al, 2014; Gottlieb, 2005; Mukhtar et al, 2004; Ortonne, 2004; Krueger et al, 
2001). 
A number of comorbidities have been associated with PSO, especially with more severe PSO. 
Psoriatic arthritis, cardiovascular disease, metabolic syndrome, chronic pulmonary disease, 
peptic ulcer disease, renal disease, and diabetes have all been demonstrated to have an increased 
prevalence in PSO patients (Yeung et al, 2013; Christophers et al, 2010; Gisondi et al, 2007; 
Gelfand et al, 2006). The development of PsAis a sequelae to the development of PSO in 
approximately 30% of patients (Christophers et al, 2010). On the other hand, generalized 
pustular PSO is the most severe type, producing sterile pustules over a wide area of the body and 
occasionally causes fatalsystemic symptoms. It is characterized by repeating recurrence or 
worsening. Erythrodermic PSOis another severe form characterized by diffuse redness and 
scaling covering nearly the whole body, potentially leading to fatal symptoms.
Therapy for patients with PSO varies according to the severity of disease. Limited or mild 
disease is often treated with topical therapies such as corticosteroids and vitamin D analogs. 
Patients with more severe diseaseare often treated with chemophototherapy, methotrexate, or 
biologic agents, such as tumor necrosis factor (TNF)antagonists, IL-12/23 inhibitors,and IL-17 
inhibitors. The effectiveness of TNF inhibitors in the treatment of PSO has been demonstrated in 
many Phase 3 clinical studiesand has led to the approval bythe Food and Drug Administration 
(FDA)and also by the minister of Ministry of Health, Labour, and Welfare (MHLW) in Japan of 
multiple TNF inhibitors for use in patients with moderate to severe PSO.Interleukin inhibitors 
REDACTED COPY 
Plaque PSO is the most common, comprising approximately
REDACTED COPY 
Plaque PSO is the most common, comprising approximately
 17% of those with PSO have moderate to severe disease (Kurd et al, 2008).
REDACTED COPY 
 17% of those with PSO have moderate to severe disease (Kurd et al, 2008).
In addition to the impact on skin, PSO has a multitude of ps
REDACTED COPY 
In addition to the impact on skin, PSO has a multitude of ps
consciousness, frustration, fatigue, depression
REDACTED COPY 
consciousness, frustration, fatigue, depression
y report sleeping problems, difficulties at work, problems 
REDACTED COPY 
y report sleeping problems, difficulties at work, problems 
mbers, disrupted leisure activities, and sexual difficulties 
REDACTED COPY 
mbers, disrupted leisure activities, and sexual difficulties 
(Dowlatshahi et al, 2014; Gottlieb, 2005; Mukhtar et al, 2004; Ortonne, 2004; Krueger et al, 
REDACTED COPY 
(Dowlatshahi et al, 2014; Gottlieb, 2005; Mukhtar et al, 2004; Ortonne, 2004; Krueger et al, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 a series of l
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 a series of linked cellular 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
inked cellular 
erplasia and ectasia, and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
erplasia and ectasia, and 
in affected skin. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
in affected skin. 
nderstood, the importance of T
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
nderstood, the importance of T
 the clinical benefit provided by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 the clinical benefit provided by
y of forms including plaque, guttate, pustular, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y of forms including plaque, guttate, pustular, er
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
er
Plaque PSO is the most common, comprising approximately
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Plaque PSO is the most common, comprising approximately 80
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 80
Plaque PSO is the most common, comprising approximately 80
Plaque PSO is the most common, comprising approximately
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Plaque PSO is the most common, comprising approximately 80
Plaque PSO is the most common, comprising approximately % to 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
% to 
 17% of those with PSO have moderate to severe disease (Kurd et al, 2008).
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 17% of those with PSO have moderate to severe disease (Kurd et al, 2008).
In addition to the impact on skin, PSO has a multitude of ps
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
In addition to the impact on skin, PSO has a multitude of ps
consciousness, frustration, fatigue, depression
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
consciousness, frustration, fatigue, depression
y report sleeping problems, difficulties at work, problems 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y report sleeping problems, difficulties at work, problems 
mbers, disrupted leisure activities, and sexual difficulties 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
mbers, disrupted leisure activities, and sexual difficulties 
(Dowlatshahi et al, 2014; Gottlieb, 2005; Mukhtar et al, 2004; Ortonne, 2004; Krueger et al, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(Dowlatshahi et al, 2014; Gottlieb, 2005; Mukhtar et al, 2004; Ortonne, 2004; Krueger et al, 
A number of comorbidities have been associated with PSO, especially
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
A number of comorbidities have been associated with PSO, especially
iatic arthritis, cardiovascular disease, metabolic sy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
iatic arthritis, cardiovascular disease, metabolic sy
peptic ulcer disease, renal disease, and diabetes have all been demonstrated to have an increased 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
peptic ulcer disease, renal disease, and diabetes have all been demonstrated to have an increased 
prevalence in PSO patients (Yeung et al, 2013; Christophers et al, 201
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
prevalence in PSO patients (Yeung et al, 2013; Christophers et al, 201
Gelfand et al, 2006). The development of 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Gelfand et al, 2006). The development of 
 30% of patients (Christophers et al, 2010). On the other hand, generalized 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 30% of patients (Christophers et al, 2010). On the other hand, generalized 
pustular PSO is the most severe t
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
pustular PSO is the most severe t
y causes fatal
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y causes fatal
worsening. Erythrodermic PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
worsening. Erythrodermic PSO
scaling 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
scaling covering nearl
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
covering nearl
Therap
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Therapy for patients 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y for patients 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
disease is often treated with topical therapies such as corticosteroids and vitamin D analogs. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
disease is often treated with topical therapies such as corticosteroids and vitamin D analogs. 
Patients with m
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Patients with m
biologic agents, such as 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
biologic agents, such as 


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25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
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Page 17of 119
include secukinumab and ixekizumab, IL-17A inhibitors approved for treatment of moderate to 
severe PSO. Brodalumab, an IL-17 receptor antagonist, has completed pivotal Phase 3 studies in 
PSO. Standard therapies for PSO are listed below:
Topical steroids (eg, triamcinolone, mometasone, clobetasol, betamethasone, hydrocortisone) 
are generally used as first-line treatment of PSO. High-strength steroids are typically 
reserved for use on the arms and legs. Areas such as the face and skin folds (axillary, 
inguinal regions, etc) are usually treated with a low potency steroid. Chronic use of topical 
steroids can lead to tachyphylaxis and corticosteroid-related side effects, such as skin atrophy 
and fragility, and is generally discouraged.
Topical vitamin D analogs (eg, calcipotriol and tacalcitol) are commonly used to treat mild to 
moderate PSO, and work best within the patients with mild disease. They are safe but lack 
efficacy for many patients with moderate to severe disease.
Phototherapy is a frequent option for moderate to severe patients, but the inconvenience of 
multiple treatment visits and varying efficacy limits its use in the market. The use of 
photosensitizing agents, such as 8-methoxypsoralen, followed by ultraviolet A (UVA)
exposure (so-called, chemophototherapy or phototherapy) has proven to be effective in 
extensive forms of the disease (Parrish et al, 1981; Henseler et al, 1981).
Systemic immunosuppressants such as cyclosporine are used in moderate to severe patients. 
Toxicity concerns are limitations to treatment and include nausea, vomiting, diarrhea, oral 
ulcers, loss of appetite, low blood counts, infection, and hepatoxicity and/or nephrotoxicity.
Biologics, including but not limited to TNFα inhibitors (infliximab, adalimumab), are the 
treatment options of choice for patients with moderate to severe plaque PSO who are 
candidates for systemic therapy or chemophototherapy. These products are injected 
subcutaneously or delivered via intravenous infusion and while effective, not all patients 
respond to current therapies and loss of response often occurs over time (Menter et al, 2011; 
Piaserico et al, 2014). In addition to loss of response, not all patients respond to currently 
available therapies; therefore, other treatment options are needed.
The efficacy of TNFα inhibitors in treating PSO has been attributed to their inhibition of Th17 
T-cells (Menter et al, 2011). Different from the traditional systemic drugs that impact the entire 
immune system, biologics target specific parts of the immune system. The efficacy and safety of 
these molecules is now well established and accepted in the management of the disease, yet a 
recent study has shown that patients who switched to a different TNFα inhibitor as a result of 
secondary loss of efficacy, adverse events (AEs), or intolerance were more likely to reach a 
PASI75 response than those who switched as a result of primary inefficacy (Piaserico et al, 
2014). Data consistently demonstrate that >50% of severely affected patients are dissatisfied 
with current treatments and up to 30% of severe patients are not receiving treatment in 
accordance with accepted therapy guidelines (Armstrong et al, 2013; Menter et al, 2011).
Certolizumab pegol (CDP870, CZP), the drug substance of Cimzia®, is a recombinant, 
humanized, antibody Fab´ fragment with specificity for human TNFα. The Fab´ fragment is 
manufactured in E. coli, purified, and conjugated via a maleimide group to polyethylene glycol 
(PEG) in order to extend its plasma half-life to thatof the whole antibody. Certolizumab pegol is 
an inhibitor of TNFα, which is a pro-inflammatory cytokine with multiple biologic actions. A 
unique feature of CZP among TNF antagonists is the lack of an Fc (fragment crystallizable) 
REDACTED COPY 
closporine are used in moderate to severe patients. 
REDACTED COPY 
closporine are used in moderate to severe patients. 
 concerns are limitations to treatment and include nausea, 
REDACTED COPY 
 concerns are limitations to treatment and include nausea, 
ulcers, loss of appetite, low blood counts, infection, and hepatoxicity
REDACTED COPY 
ulcers, loss of appetite, low blood counts, infection, and hepatoxicity
TNFα inhibitors (
REDACTED COPY 
TNFα inhibitors (
treatment options of choice for patients with 
REDACTED COPY 
treatment options of choice for patients with 
y or 
REDACTED COPY 
y or chemo
REDACTED COPY 
chemo
y or delivered via intravenous infusion and while effective, not all patients 
REDACTED COPY 
y or delivered via intravenous infusion and while effective, not all patients 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 steroid. Chronic use of topical 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 steroid. Chronic use of topical 
related side effects, such as skin atroph
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
related side effects, such as skin atrophy 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y 
 used to treat mild to 
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 used to treat mild to 
 are safe but lack 
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 are safe but lack 
the inconvenience of 
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the inconvenience of 
 limits its use in the market. The use of 
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 limits its use in the market. The use of 
psoralen, followed b
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psoralen, followed by 
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y ultraviolet A (
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ultraviolet A (
y) has pro
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y) has proven to be effective in 
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ven to be effective in 
extensive forms of the disease (Parrish et al, 1981; Henseler et al, 1981).
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extensive forms of the disease (Parrish et al, 1981; Henseler et al, 1981).
closporine are used in moderate to severe patients. 
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closporine are used in moderate to severe patients. 
 concerns are limitations to treatment and include nausea, 
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 concerns are limitations to treatment and include nausea, 
ulcers, loss of appetite, low blood counts, infection, and hepatoxicity
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ulcers, loss of appetite, low blood counts, infection, and hepatoxicity
TNFα inhibitors (
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TNFα inhibitors (
treatment options of choice for patients with 
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treatment options of choice for patients with moderate to severe plaque PSO who are 
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moderate to severe plaque PSO who are 
chemo
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chemophototherapy
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phototherapy
y or delivered via intravenous infusion and while effective, not all patients 
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y or delivered via intravenous infusion and while effective, not all patients 
respond to current therapies and loss of resp
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respond to current therapies and loss of resp
In addition to loss of response, not all patients respond to currentl
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In addition to loss of response, not all patients respond to currentl
available therapies; therefore, other treatment options are needed.
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available therapies; therefore, other treatment options are needed.
 of TNFα inhibitors in treating 
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 of TNFα inhibitors in treating 
cells (Menter et al, 2011). Different from the traditional sy
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cells (Menter et al, 2011). Different from the traditional sy
stem, biologics target specific parts of the immune sy
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stem, biologics target specific parts of the immune sy
ecules is now well established and accepted in the management of the disease, 
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ecules is now well established and accepted in the management of the disease, 
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y has shown that patients who switched to a different TNFα inhibitor as a result of 
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y has shown that patients who switched to a different TNFα inhibitor as a result of 
 loss of efficacy
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 loss of efficacy
75 response than those who switched as a result of primary
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75 response than those who switched as a result of primary
2014). Data consistently
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2014). Data consistently
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with current treatments and up to 30% of severe patients are not receiving treatment in 
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with current treatments and up to 30% of severe patients are not receiving treatment in 
accordance with accepted therap
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accordance with accepted therap
Certolizumab pegol (CDP870, CZP), the drug substance of Cimzia
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Certolizumab pegol (CDP870, CZP), the drug substance of Cimzia


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
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Page 18of 119
region, thereby the molecule cannot initiate potential Fc-mediated effects such as 
complement-mediated cytotoxicity or antibody dependent, cell-mediated cytotoxicity (Mease, 
2011).
Two Phase 2 clinical studieshave been completed assessing CZP in adult subjects with moderate 
to severe chronic plaque PSO. The first study, C87040, demonstrated that CZP in doses of 
200mg Q2W (with a 400mg loading dose at Week 0) or 400mg Q2W improved the signs and 
symptoms of PSO as measured by PASI75 and Physician’s Global Assessment (PGA), with up 
to82.8% of subjects responding to treatment (PASI75) at the higher dose. A second Phase 2 
study, C87044, provided safety and efficacy data on the withdrawal and retreatment of subjects 
who responded to their initial treatment course in study C87040. 
Based on the positive safety and efficacy results from Phase 2, and the need for new treatment 
options for PSO, three Phase 3 studies are ongoing (PS0002, PS0003, and PS0005). These Phase 
3 studies will study the efficacy of CZP in subjects with moderate to severe plaque PSO 
compared to PBOtreatment (PS0002 and PS0005) and to an active comparator (etanercept) and 
PBOtreatment (PS0003). The proposed study in Japan will study the efficacy of CZP in subjects 
with moderate to severe plaque PSO compared to PBO treatment, and an exploratory evaluation 
of this study will be performed in regard to efficacy on joint symptoms in patients with PsA who 
are enrolled having plaque eruptions and joint symptoms. 
In addition, the efficacy and safety of CZP in Japanese patients with generalized pustular PSO 
and erythrodermic PSO will be also assessed. As described above, plaque PSO is the most 
common form, but more severe variants include generalized pustular PSO and erythrodermic 
PSO. Patients with generalized pustular PSO or erythrodermic PSO are often refractory to 
currently available therapies, and there is a need for effective treatment for these types of PSO. 
Certolizumab pegol is a biological product that may be desirable to develop as a drug for PSO 
including these types of PSO. However, considering the very small population, the evaluation of 
generalized pustular PSO and erythrodermic PSO in a double-blind manner is not possible. 
Consequently, the efficacy and safety of CZP in these populations will be evaluated in an open-
label design in an exploratory fashion.
3
STUDY OBJECTIVES
3.1
Primary objective
The primary objective of the study is to demonstrate the efficacy of CZP administered sc at the 
doses of CZP 400mg Q2W and CZP 200mg Q2W (after a loading dose of CZP 400mg at 
Weeks 0, 2, and 4) in the treatment of moderate to severe chronic pla que PSO in Japan.
3.2
Secondary objectives
The secondary objectives of the study are to assess:
The optimal initial treatment dose for the treatment of moderate to severe chronic plaque
PSO
Durability of the clinical response with maintenance treatment
The safety and tolerability of CZP
Improvement of skin-related quality of life
REDACTED COPY 
mptoms. 
REDACTED COPY 
mptoms. 
y of CZP in Japanese patients 
REDACTED COPY 
y of CZP in Japanese patients 
throdermic PSO will be also assessed. As described above, plaque PSO is the most 
REDACTED COPY 
throdermic PSO will be also assessed. As described above, plaque PSO is the most 
common form, but more severe variants include generalized pustular PSO and ery
REDACTED COPY 
common form, but more severe variants include generalized pustular PSO and ery
PSO. Patients with generalized pustular PSO or er
REDACTED COPY 
PSO. Patients with generalized pustular PSO or er
y available therapies, and there is a need for effective treatment for these types of PSO. 
REDACTED COPY 
y available therapies, and there is a need for effective treatment for these types of PSO. 
is a biological product that may
REDACTED COPY 
is a biological product that may
f PSO. However, considering the very
REDACTED COPY 
f PSO. However, considering the very
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y PASI75 and Physician’s Global Assessment (PGA), with up 
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y PASI75 and Physician’s Global Assessment (PGA), with up 
75) at the higher dose. A second Phase 2 
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75) at the higher dose. A second Phase 2 
y and efficacy data on the withdrawal and retreatment of subjects 
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y and efficacy data on the withdrawal and retreatment of subjects 
 results from Phase 2, and the need for new treatment 
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 results from Phase 2, and the need for new treatment 
and PS0005). These Phase 
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and PS0005). These Phase 
re plaque PSO 
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re plaque PSO 
treatment (PS0002 and PS0005) and to an active comparator (etanercept) and 
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treatment (PS0002 and PS0005) and to an active comparator (etanercept) and 
 the efficacy
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 the efficacy
ment, and an exploratory
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ment, and an exploratory
ym
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ymptoms in patients with PsA who 
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ptoms in patients with PsA who 
y of CZP in Japanese patients 
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y of CZP in Japanese patients 
throdermic PSO will be also assessed. As described above, plaque PSO is the most 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
throdermic PSO will be also assessed. As described above, plaque PSO is the most 
common form, but more severe variants include generalized pustular PSO and ery
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
common form, but more severe variants include generalized pustular PSO and ery
PSO. Patients with generalized pustular PSO or er
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PSO. Patients with generalized pustular PSO or eryt
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yt
PSO. Patients with generalized pustular PSO or eryt
PSO. Patients with generalized pustular PSO or er
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
PSO. Patients with generalized pustular PSO or eryt
PSO. Patients with generalized pustular PSO or er hrodermic PSO are often refractory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
hrodermic PSO are often refractory
y available therapies, and there is a need for effective treatment for these types of PSO. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y available therapies, and there is a need for effective treatment for these types of PSO. 
is a biological product that may
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
is a biological product that may
f PSO. However, considering the very
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
f PSO. However, considering the very
throdermic PSO in a double
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throdermic PSO in a double
, the efficacy and safet
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, the efficacy and safety of CZP in these populations will be evaluated in an open
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y of CZP in these populations will be evaluated in an open
fashion
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fashion
STUDY OBJECTIVES
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STUDY OBJECTIVES
Primary
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Primary objective
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 objective
Primary objective
Primary
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Primary objective
Primary
 objective of the study
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 objective of the study
doses of CZP 400mg Q2W and CZP 200mg Q2W (after a loading dose of CZP 400mg at 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
doses of CZP 400mg Q2W and CZP 200mg Q2W (after a loading dose of CZP 400mg at 
0, 2, and 4) in the treatment of moderate to severe chronic plaque PSO in Japan.
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0, 2, and 4) in the treatment of moderate to severe chronic plaque PSO in Japan.
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The secondary
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The secondary

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The optimal initial treatment dose for the treatment of moderate to severe chronic plaque
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The optimal initial treatment dose for the treatment of moderate to severe chronic plaque


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
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Page 19of 119
Change from Baseline in Itch Numeric RatingScale at Week 16
3.3
Other objectives
The other objectives of the study are to demonstrate the effects of CZP on other aspects of 
disease:
Efficacy for PsAdisease in the subgroup of affected subjects at Baseline
Efficacy for psoriatic nail disease in the subgroup of subjects with nail disease at Baseline
Efficacy and safety in a cohort of patients with generalized pustular PSO or erythrodermic 
PSO 
Safety and efficacy of long-term use of CZP
Pharmacokinetics and immunogenicity of CZP
4 
STUDY VARIABLES
4.1
Efficacy variables
4.1.1
Primary efficacy variable
The primary efficacy variable for subjects with moderate to severe chronicplaque PSO is:
PASI75 at Week 16
For subjects with generalized pustular PSO or erythrodermic PSO, no primary efficacy variables 
are planned.
4.1.2
Secondary efficacy variables
The secondary efficacy variables for subjects with moderate to severe chronicplaque PSO are:
Physician’s Global Assessment clear or almost clear (with at least 2-category improvement) 
at Week 16
PASI90 at Week 16
Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Change from Baseline in Itch Numeric Rating Scale at Week 16
For subjects with generalized pustular PSO or erythrodermic PSO, no secondary efficacy 
variables are planned.
4.1.3
Other efficacy variables
The other efficacy variables are listed below and will be evaluated as per the schedule of 
assessments in Table 5‒1. This excludes the primary and secondary variables as specified in 
Sections 4.1.1 and 4.1.2.
4.1.3.1
For subjects with moderate to severe chronic plaque PSO
4.1.3.1.1 
Double-Blind Overall population
PASI75 at Week 24 and Week 52
PASI50, PASI75, PASI90,and PASI100 
REDACTED COPY 
ubjects with moderate to severe 
REDACTED COPY 
ubjects with moderate to severe 
For subjects with generalized pustular PSO or ery
REDACTED COPY 
For subjects with generalized pustular PSO or erythrodermic PSO, no primary
REDACTED COPY 
throdermic PSO, no primary
For subjects with generalized pustular PSO or erythrodermic PSO, no primary
For subjects with generalized pustular PSO or ery
REDACTED COPY 
For subjects with generalized pustular PSO or erythrodermic PSO, no primary
For subjects with generalized pustular PSO or ery
 variables
REDACTED COPY 
 variables
 variables for su
REDACTED COPY 
 variables for subjects 
REDACTED COPY 
bjects 
 variables for subjects 
 variables for su
REDACTED COPY 
 variables for subjects 
 variables for su
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
nail disease in the subgroup of subjects with nail disease at Baseline
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nail disease in the subgroup of subjects with nail disease at Baseline
a cohort of patients with generalized pustular PSO or erythrodermic 
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a cohort of patients with generalized pustular PSO or erythrodermic 
ubjects with moderate to severe 
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ubjects with moderate to severe 
throdermic PSO, no primary
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
throdermic PSO, no primary
 variables
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 variables
bjects 
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bjects 
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c
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clear or almost clear (with at least 2
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lear or almost clear (with at least 2
Change from Baseline in Dermatology
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Change from Baseline in Dermatology
Change from Bas
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Change from Baseline in 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
eline in 
For subjects with generalized pustular PSO or ery
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
For subjects with generalized pustular PSO or ery
variables are planned.
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variables are planned.
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The other efficacy
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The other efficacy
assessments in 
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assessments in 
Sections 4.1.1 and 4.1.2
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Sections 4.1.1 and 4.1.2
4.1.3.1
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4.1.3.1


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Certolizumab Pegol
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Page 20of 119
PGA clear or almost clear (with at least 2-category improvement) 
Absolute and percent change from Baseline in PASI score
PGA score distribution
Time to onset of action, defined as the time to PASI50
Time to onset of action, defined as the time to PASI75 
Time to onset of action, defined as the time to PASI90
Time to onset of action, defined as the time to PASI100
Absolute and percent change from Baseline in the body surface area (BSA)affected by PSO 
Change from Baseline in DLQI mean scores, percent of subjects achieving minimal clinically 
important difference (MCID), and percent achieving DLQI remission
Change from Baseline in Itch Numeric Rating Scale mean scores and percent of subjects 
achieving MCID
4.1.3.1.2 
Double-Blind PsA population
American College of Rheumatology 20, 50, 70% response criteria (ACR20, 50, 70)and 
change from Baseline in all individual ACR core components in the subpopulation of 
subjects with PsAat Baseline
Change from Baseline in DAS28(CRP)
4.1.3.1.3 
Double-Blind NAPSI population
Change from Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) in the 
subpopulation of subjects with nail disease at Baseline
4.1.3.1.4 
Escape treatment  population
PASI50, PASI75, PASI90,and PASI100 
PGA clear or almost clear (with at least 2-category improvement) 
Absolute and percent change from Baseline in PASI score
PGA score distribution
Absolute and percent change from Baseline in the BSA affected by PSO 
Change from Baseline in DLQI mean scores, percent of subjects achieving MCID, and 
percentachieving DLQI remission
4.1.3.2 
For subjects with generalized pustular PSOor erythrodermic PSO
4.1.3.2.1
Cohort overall population
Clinical Global Impressions of Improvement (CGI-I)
Change from Baseline in DLQI mean scores, percent of subjects achieving MCID, and 
percent achieving DLQI remission
REDACTED COPY 
 20, 50, 70% response criteria (
REDACTED COPY 
 20, 50, 70% response criteria (
change from Baseline in all individual ACR core components in the subpopulation of 
REDACTED COPY 
change from Baseline in all individual ACR core components in the subpopulation of 
PSI population
REDACTED COPY 
PSI population
Modified Nail Psoriasis Severity
REDACTED COPY 
Modified Nail Psoriasis Severity
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
affected b
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affected b
Change from Baseline in DLQI mean scores, percent of subjects achieving 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Change from Baseline in DLQI mean scores, percent of subjects achieving minimal clinically
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
minimal clinically
om Baseline in Itch Numeric Rating Scale mean scores and perc
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
om Baseline in Itch Numeric Rating Scale mean scores and perc
 20, 50, 70% response criteria (
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 20, 50, 70% response criteria (
change from Baseline in all individual ACR core components in the subpopulation of 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
change from Baseline in all individual ACR core components in the subpopulation of 
PSI population
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PSI population
Modified Nail Psoriasis Severity
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Modified Nail Psoriasis Severity
subpopulation of subjects with nail disease at Baseline
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subpopulation of subjects with nail disease at Baseline
Escape treatment  population
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Escape treatment  population
90
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90,
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,and PASI
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and PASI
PGA clear or almost clear 
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PGA clear or almost clear (with at least 2
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(with at least 2
Absolute and percent change from Baseline in PASI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Absolute and percent change from Baseline in PASI
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score distribution
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score distribution
Absolute and percent change from Baseline in the BSA affected by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Absolute and percent change from Baseline in the BSA affected by
Change from Baseline in DLQI mean scores, percent of subjects achieving MCI
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Change from Baseline in DLQI mean scores, percent of subjects achieving MCI
percent
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percent
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4.1.3.2
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4.1.3.2
4.1.3.2.1
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4.1.3.2.1


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Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 21of 119
Change from Baseline in Itch Numeric Rating Scale mean scores and percent of subjects 
achieving MCID
4.1.3.2.2
Cohort generalized pustular PSOpopulation
Global Improvement Score
Japanese Dermatological Association (JDA)severity index score 
4.1.3.2.3 
Cohort erythrodermic PSOpopulation
PASI50, PASI75, PASI90,and PASI100 
PGA clear or almost clear (with at least 2-category improvement) 
Absolute and percent change from Baseline in PASI score
PGA score distribution
Absolute and percent change from Baseline in the BSA affected by PSO 
4.2
Pharmacokinetic and pharmacodynamic variable
Plasma CZP concentration prior to and during study treatment
4.3
Immunological variable
Plasma anti-CZP antibody levels prior to and during study treatment
4.4 
Safety variables
Safety variables to be assessed are:
AEs
Blood pressure
Physical examination
Clinical laboratory values (hematology, biochemistry, and urinalysis)
Interferon-gamma release assay (IGRA) test for tuberculosis (TB)
5
STUDY DESIGN
5.1 
Study description
This is a Phase 2/3, multicenter, randomized, double-blind, PBO-controlled, parallel-groupstudy 
designed to evaluate the efficacy and safety of CZP in adult subjects with moderate to severe 
chronicPSO, including PsA, in Japanese subjects. In addition, a cohort of subjects with 
generalized pustular PSO or erythrodermic PSO will be eligible to receive open-label treatment 
in the study.
If the Investigator determines that the subject is no longer benefiting from CZP treatment, the 
subject should complete the Early Withdrawal Visit and return to the site for a SFU Visit 
10 weeks after his/her final dose of study drug.
After the Week 24 Visit of the finalsubject, the database will be locked and an interim study 
report will be written.
REDACTED COPY 
 levels prior to and during study
REDACTED COPY 
 levels prior to and during study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Absolute and percent change from Baseline in the BSA affected by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Absolute and percent change from Baseline in the BSA affected by PSO 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 PSO 
namic variabl
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
namic variabl
Plasma CZP concentration prior to and during study treatment
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Plasma CZP concentration prior to and during study treatment
 levels prior to and during study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 levels prior to and during study
 values (hematology
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 values (hematology
gamma release assay
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gamma release assay
STUDY DESIGN
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STUDY DESIGN
Stud
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Stud
This is a Phase 2/3, multicenter, randomized, double-
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This is a Phase 2/3, multicenter, randomized, double-
designed to evaluate the efficacy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
designed to evaluate the efficacy
chronic
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chronicPSO
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PSO
generalized pustular PSO or ery
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generalized pustular PSO or ery
in 
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in the study
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the study
If the 
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If the 


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 22of 119
The study includes 4 periods.
5.1.1 
Study design for subjects with moderate to severe chronic plaqu 
e 
PSO
5.1.1.1 
Period 1: Screening
The Screening Period of 2 to 5 weeks will be used to confirm eligibility;obtain laboratory data;
verify that the doses of nonsteroidal anti-inflammatory drugs (NSAIDs) and other pain relievers,
such as acetaminophen, paracetamol, or mild opiates, if used to treat PsA are stable; and enable 
washout of any medications not permitted for use during the study.
5.1.1.2
Period 2: Week 0 to Week 16
Eligible subjects will be allocated to the following study treatments in a 2:2:1 ratio:
CZP 400mg (n=50): CZP administered sc at the dose of CZP 400mg Q2W
CZP 200mg (n=50): CZP administered sc at the dose of CZP 400mg at Weeks 0, 2, and 4,
followed by CZP 200mg Q2W (starting at Week 6)
PBO (n=25): PBO administered sc Q2W
Study treatments (including PBO) will be administered by dedicated, unblinded, trained site 
personnel at Baseline and Q2W thereafter to Week 16.
5.1.1.3
Period 3:  Week 16 to Week 52 
The treatment received in Period 3 will be based on response to double-blind treatment at 
Week 16. All CZP and PBO treatments will be administered by dedicated unblinded site 
personnel at site visits, excluding the escape treatment.
Subjects who achieve a PASI50 response at Week 16 will continue therapy as follows:
Subjects initially randomized to CZP 400mg Q2W willcontinue to receive CZP 400mg 
Q2W.
Subjects initially randomized to CZP 200mg Q2W will be re-randomized (1:1) to receive 
either CZP 200mg Q2W or CZP 400mg Q4W (with PBO administered on alternate dosing 
weeks to maintain the blind).
Subjects initially randomized to PBO will be continue to receive PBO.
Subjects who do not achieve a PASI50 response at Week 16, 24, 32, or 40 will escape from 
double-blind treatment and receive open-label CZP treatment (400mg Q2W as 3 loading 
doses followed by CZP 200mg Q2W) from the visit the response criterion is not met. 
Subjects receiving open-label CZP 200mg Q2W in the escape arm and not achieving a 
PASI50 response will be allowed to have their dose increased to CZP 400mg Q2W at the 
visit the criterion is not met, at the discretion of the Investigator. If, in the opinion of the 
Investigator, the subject is not receiving benefit (eg, a PASI50) at the 400mg Q2W dose,the
subject should be withdrawn from the study.
Subjects who do not achieve a PASI50 response at Week 16 will escape from double-blind 
treatment and receive treatment as follows:
REDACTED COPY 
Q2W thereafter to Week 16.
REDACTED COPY 
Q2W thereafter to Week 16.
Period 3:  Week 16 to Week 52 
REDACTED COPY 
Period 3:  Week 16 to Week 52 
The treatment received in Period 3 will be based on response to double
REDACTED COPY 
The treatment received in Period 3 will be based on response to double
BO treatments will be administered by
REDACTED COPY 
BO treatments will be administered by
personnel at site visits, excluding the escape treatment.
REDACTED COPY 
personnel at site visits, excluding the escape treatment.
50 response at Week 16 will continue therapy
REDACTED COPY 
50 response at Week 16 will continue therapy
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and other pain relievers
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and other pain relievers,
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,
enable 
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enable 
 treatments in a 2:2:1 ratio:
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 treatments in a 2:2:1 ratio:
CZP 400mg (n=50): CZP administered sc at the dose of CZP 400mg Q2W
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CZP 400mg (n=50): CZP administered sc at the dose of CZP 400mg Q2W
CZP 200mg (n=50): CZP administered sc at the dose of CZP 400mg at 
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CZP 200mg (n=50): CZP administered sc at the dose of CZP 400mg at Weeks 0, 2, and
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Weeks 0, 2, and
y dedicated, unblinded, trained site 
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y dedicated, unblinded, trained site 
The treatment received in Period 3 will be based on response to double
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The treatment received in Period 3 will be based on response to double
BO treatments will be administered by
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BO treatments will be administered by
personnel at site visits, excluding the escape treatment.
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personnel at site visits, excluding the escape treatment.
50 response at Week 16 will continue therapy
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50 response at Week 16 will continue therapy
 randomized to CZP 400mg Q2W will
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 randomized to CZP 400mg Q2W will
 randomized to CZP 200mg Q2W will be re-randomized (1:1) to receive 
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 randomized to CZP 200mg Q2W will be re-randomized (1:1) to receive 
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CZP 200mg Q2W or CZP 400mg Q4W (with PBO administered on alternate dosing 
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CZP 200mg Q2W or CZP 400mg Q4W (with PBO administered on alternate dosing 
weeks to maintain the blind).
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weeks to maintain the blind).
Subjects initially
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Subjects initially rand
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 rand
Subjects initially rand
Subjects initially
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Subjects initially rand
Subjects initially
Subjects who do not achieve a PASI50 response at Week
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Subjects who do not achieve a PASI50 response at Week
double
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double-
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-blind treatment and receive open
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blind treatment and receive open
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doses followed b
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doses followed b
Subjects receiving open
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Subjects receiving open
PASI
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PASI
visit the criterion is not met, at the dis
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visit the criterion is not met, at the dis


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 23of 119
Escape treatment: Subjects entering the escape arm of the study will receive open-label CZP 
treatment (400mg Q2W as 3 loading doses followed by CZP 200mg Q2W).Subjects 
receiving open-labelCZP 200mg Q2W in the escape arm and not achieving a PASI50 
response will be allowed to have their dose increased to CZP 400mg Q2W, at the discretion 
of the Investigator.If, in the opinion of the Investigator, the subject is not receiving benefit 
(eg, a PASI50) at the CZP 400mg Q2W dose, the subject should be withdrawn from the 
study. 
5.1.1.4 
Period 4:  Safety Follow-up: Week 52 to Week 60
All subjects, including those withdrawn from study treatment, will have a Safety Follow-Up 
Visit 10 weeks after their finaldose of study medication.
5.1.2 
Study design for subjects with generalized pustular PSO or 
erythrodermic PSO
5.1.2.1
Period 1: Screening 
The Screening Period of 2 to 5 weeks will be used to confirmeligibility and obtain laboratory 
data.
5.1.2.2
Period 2: Week 0 to Week 16
At least 10 subjects in the cohort with generalized pustular PSO or erythrodermic PSO will be 
allocated in a 1:1 ratio to the following open-label study treatments:
CZP 400mg (n ≥5): CZP administered sc at the dose of CZP 400mg Q2W
CZP 200mg (n ≥5): CZP administered sc at the dose of CZP 400mg at Weeks 0, 2, and 4,
followed by CZP 200mg Q2W (starting at Week 6)
5.1.2.3
Period 3: Week 16 to Week 52 
The treatment received in Period 3 will be based on the initial study treatmentand on response to 
open-label treatment at Week 16:
Subjects achieving a “much improved” or“very much improved” in the Global Improvement 
Score (for subjects with generalized pustular PSO) or a PASI50 response (for subjects with 
erythrodermic PSO) will continue to receive the same treatment as randomized. 
Subjects in the CZP 200mg Q2W group who are not in response (not achieving “much 
improved” or “very much improved” in the Global Improvement Score [for subjects with 
generalized pustular PSO] or a PASI50 response [for subjects with erythrodermic PSO]) will 
be allowed to have their dose increased to CZP 400mg Q2W, at the discretion of the 
Investigator. Subjects randomized to CZP 400mg Q2W will continue to receive CZP 400mg 
Q2W at the discretion of the Investigator. If, in the opinion of the Investigator, the subject is 
not receiving benefit at the 400mg Q2W dose, the subject could be withdrawn from the 
study. Per the Withdrawal Criteria (Section 6.3), subjects who develop an aggravation of the 
primary disease or concomitant disease with hospitalization in the opinion of the Investigator 
must be withdrawn from the study.
REDACTED COPY 
least 10 subjects in the cohort with generalized pustular PSO or ery
REDACTED COPY 
least 10 subjects in the cohort with generalized pustular PSO or ery
label 
REDACTED COPY 
label study
REDACTED COPY 
study
≥5): CZP administered sc at the dose of CZP 400mg Q2W
REDACTED COPY 
≥5): CZP administered sc at the dose of CZP 400mg Q2W
istered sc at the dose of CZP 400mg at 
REDACTED COPY 
istered sc at the dose of CZP 400mg at 
y CZP 200mg Q2W (starting at Week 6)
REDACTED COPY 
y CZP 200mg Q2W (starting at Week 6)
Period 3: Week 16 to Week 52 
REDACTED COPY 
Period 3: Week 16 to Week 52 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y Follow
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y Follow-
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-Up 
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Up 
Study design for subjects with generalized pustular PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Study design for subjects with generalized pustular PSOor 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
or 
eligibi
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eligibility
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lity and obtain laboratory
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 and obtain laboratory
lity and obtain laboratory
lity
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
lity and obtain laboratory
lity
least 10 subjects in the cohort with generalized pustular PSO or ery
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
least 10 subjects in the cohort with generalized pustular PSO or ery
study
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study treatments:
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 treatments:
study treatments:
study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
study treatments:
study
≥5): CZP administered sc at the dose of CZP 400mg Q2W
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
≥5): CZP administered sc at the dose of CZP 400mg Q2W
istered sc at the dose of CZP 400mg at 
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istered sc at the dose of CZP 400mg at 
y CZP 200mg Q2W (starting at Week 6)
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y CZP 200mg Q2W (starting at Week 6)
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Period 3: Week 16 to Week 52 
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Period 3: Week 16 to Week 52 
The treatment received in Period 3 will be based on 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The treatment received in Period 3 will be based on 
t Week 16
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
t Week 16:
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:
ects achieving a “much improved
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ects achieving a “much improved
s with generalized pustular PSO
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s with generalized pustular PSO
hrodermic PSO
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hrodermic PSO) will continue to receive the same treatment as 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
) will continue to receive the same treatment as 
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Subjects in the CZP 200mg Q2W group who are not in response (not achieving “much 
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Subjects in the CZP 200mg Q2W group who are not in response (not achieving “much 
improved” or “very
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
improved” or “very
generalized pustular PSO] or a PASI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
generalized pustular PSO] or a PASI
be allowed to have their dose increased to CZP 400mg Q2W, at the discretion of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
be allowed to have their dose increased to CZP 400mg Q2W, at the discretion of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator. Subjects randomized to CZP 400mg Q2W will continue to receive CZP 400mg 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator. Subjects randomized to CZP 400mg Q2W will continue to receive CZP 400mg 
Q2W at the discretion of the I
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Q2W at the discretion of the I
not receiving benefit at the 400mg Q2W dose, the subject could be withdrawn from the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
not receiving benefit at the 400mg Q2W dose, the subject could be withdrawn from the 


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 24of 119
5.1.2.4 
Period 4: Safety Follow-up: Week 52 to Week 60
All subjects, including those withdrawn from study treatment, will have a Safety Follow-Up 
Visit 10 weeks after their finaldose of study medication.
5.1.3 
Study duration per subject
The study duration for each subject is estimated to be up to 65 weeks as follows:
Up to 5 weeks of Screening
16 weeks in the Initial Treatment Period
36 weeks in the Maintenance Treatment Period
Safety Follow-Up Visit 10 weeks afterfinal dose of study drug
The end of the study is defined as the date of the finalvisit of the finalsubject in the study.
5.1.4
Plannednumber of subjects and site(s)
Approximately 125 subjects with moderate to severe chronic plaque PSO will be randomized. In 
addition, a cohort of ≥10 subjects with generalized pustular PSO or erythrodermic PSO will be 
enrolled. The planned number of study sites is approximately 35. 
The study end is defined as the point at which the finalsubject completesthe final visit.
5.1.5
Anticipated regions and countries
Study sites will be located in Japan.
REDACTED COPY 
final
REDACTED COPY 
finalsubject 
REDACTED COPY 
subject 
REDACTED COPY 
ticipated regions and countries
REDACTED COPY 
ticipated regions and countries
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subject in the study
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subject in the study
plaque PSO will be randomized. I
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plaque PSO will be randomized. I
≥10 subjects with generalized pustular PSO or ery
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≥10 subjects with generalized pustular PSO or ery
enrolled. The planned number of study sites is approximately 35. 
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enrolled. The planned number of study sites is approximately 35. 
subject 
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subject completes
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completes
ticipated regions and countries
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ticipated regions and countries


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 25of 119
5.2
Schedule of study assessments
Table5‒1: Scheduleof study assessments 
                                           
Visit/ Week (Wk)
Protocol Activity
V1/Screening
V2/Baseline
Treatment Period
SFU Visit
V3/Wk 2
V4/Wk 4
V5/Wk 6
V6/Wk 8
V7/Wk 10
V8/Wk 12
V9/Wk14
V10/Wk16
V11/Wk 18
V12/Wk 20
V13/Wk 22
V14/Wk 24
V15/Wk 26
V16/Wk 28
V17/Wk 30
V18/Wk 32
V19/Wk 34
V20/Wk 36
V21/Wk 38
V22/Wk 40
V23/Wk42
V24/Wk 44
V25/Wk 46
V26/Wk 48
V27/Wk 50
Wk 52/
EWD
Inclusion/exclusion
X
X
Informed consent
X
Demographic data
X
Psoriasis history
X
Significant past 
medical history and 
concomitant 
diseases
X
Bloodpressure
X
X
X X
X
X
X
X
X
X
X
X
X
X
Temperature, pulse
X
Height
X
Weight
X
X
X
X
X
12-lead ECG
X
X
X
Hematology/
biochemistry
X
X
X X X
X
X
X
X
X
X
X
X
X
X
X
X
X
 
X
X
Beta-D-glucan
X
X
X
X
X
Sialylated 
carbohydrate 
antigen KL-6
X
X
X
Urinea
X X
X X X
X
X
X
X
X
X
X
X
X  
X
X
Pregnancy testingb
X
X
X
X
X
X
X
X 
X
X
X
X
X
X
 
X
X
Hepatitis B and C 
testing, HIV testing; 
HTLV-1 testingc
X
Plasma for CZP 
concentration and 
anti-CZP 
antibodies
d
X X X X X 
X 
X
X
X
X
X
X
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
X
X
X X
X
X
X
X
X
X
X
REDACTED COPY 
X
X
X X
X
X
X
X
X
X
X
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
X
REDACTED COPY 
X
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
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25 Jan 2018
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
25 Jan 2018
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
V19/Wk 34
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V19/Wk 34
V20/Wk 36
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
V20/Wk 36
V21/Wk 38
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V21/Wk 38
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
X
X
X X
X
X
X
X
X
X
X
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
X
X
X X
X
X
X
X
X
X
X
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
X
X
X X X
X
X
X
X
X
X
X
X
X
X
X
X
X
 
X
X
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
X
X
X X X
X
X
X
X
X
X
X
X
X
X
X
X
X
 
X
X
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
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UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 26of 119
Table5‒1: Scheduleof study assessments 
                                           
Visit/ Week (Wk)
Protocol Activity
V1/Screening
V2/Baseline
Treatment Period
SFU Visit
V3/Wk 2
V4/Wk 4
V5/Wk 6
V6/Wk 8
V7/Wk 10
V8/Wk 12
V9/Wk14
V10/Wk16
V11/Wk 18
V12/Wk 20
V13/Wk 22
V14/Wk 24
V15/Wk 26
V16/Wk 28
V17/Wk 30
V18/Wk 32
V19/Wk 34
V20/Wk 36
V21/Wk 38
V22/Wk 40
V23/Wk42
V24/Wk 44
V25/Wk 46
V26/Wk 48
V27/Wk 50
Wk 52/
EWD
Physical exam
e
X
X
X
X
X
X
Chest x-ray
Xf
X
X
X
IGRA
X
X
X
TB Questionnaire
X
X
X
X
X
X
X
PASIg
X
X
X X
X
X
X
X
X
X
X
X
X
X
X
 
X
PGAg
X
X
X X
X
X
X
X
X
X
X
X
X
X
X
 
X
Itch Numeric 
Rating Scale
X
X X
X
X
X
X
X
X
X
X
X
X
X
 
X
BSAaffected by 
PSOg
X
X
X
X
DLQI
X
X 
X 
X 
X
X
X
X
X
X
mNAPSIh
X
X 
X 
X 
X
X
X
X
X
X
Subject PsA 
assessments
i
X
X
X X
X
X
X
X
X
X
X
X
X
X
X
 
X
Physician PsA 
assessments
j
X
X
X X
X
X
X
X
X
X
X
X
X
X
X
 
X
Pustular and 
erythrodermic PSO 
assessments
g
X
X
X X
X
X
X
X
X
X
X
X
X
X
X
 
X
Medical procedures
X X
X X X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X X
X
Concomitant 
medication
X X
X X X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X X
X
Adverse eventsk
X X
X X X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X X
X
IRT
X X
X X X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X X
CZP or PBO 
administration
l
X
X X X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
BSA=body surface area; CGI-I= Clinical Global Impression-Improvement; CZP=certolizumab pegol; DLQI=Dermatology Life Quality Index;
DNA=deoxyribonucleic acid; ECG=electrocardiogram; EWD=Early Withdrawal Visit; HAQ-DI=Health Assessment Questionnaire-Disability Index; 
HBV=hepatitis Type B virus; HIV=human immunodeficiency virus; HTLV-1=human T-cell lymphotropic virus type-1; IGRA=interferon-gamma release assay; 
IMP=investigational medicinal product; IRT=interactive response technology; JDA=Japanese Dermatological Association; mNAPSI=modified Nail Psoriasis 
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REDACTED COPY 
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X
X
X X
X
X
X
X
X
X
X
X
X
X
X
 
X
REDACTED COPY 
X
X
X X
X
X
X
X
X
X
X
X
X
X
X
 
X
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
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I= Clinical Global Impression
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I= Clinical Global Impression
DNA=deoxyribonucleic acid; 
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DNA=deoxyribonucleic acid; ECG=electrocardiogram; 
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ECG=electrocardiogram; 
ype B virus; 
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ype B virus; HIV=human immunodeficiency virus; HTLV
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HIV=human immunodeficiency virus; HTLV
IMP=investigational medicinal product; 
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IMP=investigational medicinal product; 
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UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 27of 119
Table5‒1: Scheduleof study assessments 
                                           
Visit/ Week (Wk)
Protocol Activity
V1/Screening
V2/Baseline
Treatment Period
SFU Visit
V3/Wk 2
V4/Wk 4
V5/Wk 6
V6/Wk 8
V7/Wk 10
V8/Wk 12
V9/Wk14
V10/Wk16
V11/Wk 18
V12/Wk 20
V13/Wk 22
V14/Wk 24
V15/Wk 26
V16/Wk 28
V17/Wk 30
V18/Wk 32
V19/Wk 34
V20/Wk 36
V21/Wk 38
V22/Wk 40
V23/Wk42
V24/Wk 44
V25/Wk 46
V26/Wk 48
V27/Wk 50
Wk 52/
EWD
Severity Index; PASI=Psoriasis Area and Severity Index; PBO=placebo; PGA=Physician’s Global Assessment;PhGADA=Physician’s Global Assessment of 
Disease Activity;PGADA=Patient’s Global Assessment of Disease Activity; PsA=psoriatic arthritis; PSO=psoriasis; SFU=Safety Follow-Up; TB=tuberculosis; 
V=visit; VAS=visual analog scale; WBC=white blood cells; Wk=week
Note: The Screening Visit should occur between Week -5 and Week -2. The period between the Screening and Baseline Visits should not exceed 5 weeks. 
aUrine dipstick to be performed every 2 months after Week 16. If blood or WBC are present, a microscopic examination should be performed.
bPregnancy testing will be serum testing at Screening, and urine at all other visits. 
cHBV DNA to be performed at Screening. If the subject is either hepatitis B surface antibody-positive or hepatitis B coreantibody-positive at Screening, 
quantitative measurement of HBV-DNA should be performed every 4 weeks from Baseline to Week 52 and at SFU.
dSubjects who are on escape treatments should have samples taken for plasma CZP concentration and anti-CZP antibodies at the time of escape from double-blind 
treatment and 10weeks after the finalstudy drug administration.
eIncludes evaluation of signs and symptoms of active TBand risk for exposure to TB.
fScreening chest x-ray must have been performed within 3  months prior to the Screening Visit.
gPASI, PGA, and BSA will not be performed for subjects with generalized pustular PSO. The Global Improvement Score,JDA Severity Index, and CGI-Iwill be 
performed for subjects with generalized pustular PSO. For subjectswith erythrodermic PSO, theCGI-Iwill be performed. Note: The CGI-I and Global 
Improvement Score will not be performed at Screening or Baseline.
hFor subjects with psoriatic nail disease only
iOnly for chronic plaque PSO subjects with PsA: HAQ-DI, Patient’s Assessment of Arthritis Pain (VAS), andPGADA (VAS)
jOnly for chronic plaque PSO subjects with PsA: swollen and tender joint countsandPhGADA (VAS)
kAdverse events should  be reported only if they occur after signing the Informed Consent form.
lIMP administration of the IMP will occur after all other visit assessments have been completed.
REDACTED COPY 
HBV DNA to be performed at Screening. If the subject is either hepatitis B surface antibody
REDACTED COPY 
HBV DNA to be performed at Screening. If the subject is either hepatitis B surface antibody
eeks from Baseline to Week 52 and at SFU.
REDACTED COPY 
eeks from Baseline to Week 52 and at SFU.
Subjects who are on escape treatments should have samples taken for plasma CZP concentration and anti
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Subjects who are on escape treatments should have samples taken for plasma CZP concentration and anti
and risk for exposure to 
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and risk for exposure to 
nths prior to the Screening Visit.
REDACTED COPY 
nths prior to the Screening Visit.
PASI, PGA, and BSA will not be performed for subjects with generalized pustular PSO. The 
REDACTED COPY 
PASI, PGA, and BSA will not be performed for subjects with generalized pustular PSO. The 
performed for subjects with generalized pustular PSO. For subjects
REDACTED COPY 
performed for subjects with generalized pustular PSO. For subjectswith 
REDACTED COPY 
with 
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25 Jan 2018
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V20/Wk 36
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V20/Wk 36
V21/Wk 38
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V21/Wk 38
V22/Wk 40
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V22/Wk 40
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Severity Index; PASI=Psoriasis Area and Severity Index; PBO=placebo; PGA=Physician’s Global Assessment;
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Severity Index; PASI=Psoriasis Area and Severity Index; PBO=placebo; PGA=Physician’s Global Assessment;P
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PhGADA=Physician’
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hGADA=Physician’
PSO=psoriasis; 
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PSO=psoriasis; 
een the Screening and Baseline Visits should not exceed 5 weeks. 
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een the Screening and Baseline Visits should not exceed 5 weeks. 
Urine dipstick to be performed every 2 months after Week 16. If blood or WBC are present, a microscopic examination should be
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Urine dipstick to be performed every 2 months after Week 16. If blood or WBC are present, a microscopic examination should be
HBV DNA to be performed at Screening. If the subject is either hepatitis B surface antibody
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HBV DNA to be performed at Screening. If the subject is either hepatitis B surface antibody-
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-positive or hepatitis 
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positive or hepatitis 
eeks from Baseline to Week 52 and at SFU.
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eeks from Baseline to Week 52 and at SFU.
Subjects who are on escape treatments should have samples taken for plasma CZP concentration and anti
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Subjects who are on escape treatments should have samples taken for plasma CZP concentration and anti
and risk for exposure to 
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and risk for exposure to TB
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TB.
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.
nths prior to the Screening Visit.
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nths prior to the Screening Visit.
PASI, PGA, and BSA will not be performed for subjects with generalized pustular PSO. The 
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PASI, PGA, and BSA will not be performed for subjects with generalized pustular PSO. The 
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with 
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with 
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erythrodermic 
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erythrodermic 
ent’s Assessment of Arthritis Pain (VAS)
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ent’s Assessment of Arthritis Pain (VAS)
llen and tender joint counts
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llen and tender joint counts
Adverse events should  be reported only if they occur after signing the Informed Consent form.
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Adverse events should  be reported only if they occur after signing the Informed Consent form.
IMP administration of the IMP will occur after all other visit assessments have been completed.
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IMP administration of the IMP will occur after all other visit assessments have been completed.
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Clinical Study Protocol
Certolizumab Pegol
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Page 28of 119
5.3
Schematic diagram
Figure5‒1: Schematic diagram
CZP=certolizumab pegol; PASI=Psoriasis Area and Severity Index; PBO=placebo; PsA=psoriatic arthritis; 
PSO=psoriasis; Q2W=every 2 weeks; Q4W=every 4 weeks
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
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Clinical Study Protocol
Certolizumab Pegol
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5.4
Rationale for study design and selection of dose
The dose regimens will be the same as those in the global Phase 3 studies (PS0002, PS0003, and 
PS0005); CZP 400mg Q2W and CZP 200mg Q2W with a loading dose of CZP 400mg at 
Weeks 0, 2, and 4. The dose rationale for the global Phase 3 studies  is as follows.
Two Phase 2 clinical studies, C87040 and C87044, with CZP have been completed in subjects 
with PSO. C87040 demonstrated that CZP at 400mg Q2W or 200mg Q2W (with a 400mg 
loading dose at Week 0) improved the signs and symptoms of PSO as measured by PASI75 and 
PGA. C87044 provides efficacy and safety data on the withdrawal and retreatment of subjects 
who responded to their initial treatment course in study C87040. These studies support the 
choice of doses to be evaluated in the global Phase 3 program.
In C87040, CZP at doses of 200 mg Q2W with a single loading dose of 400mg at Week 0, and 
400mg Q2W were evaluated in a 12-week, multicenter, randomized, PBO-controlled study. The 
study had co-primary endpoints: (1) a comparison of the percentage of subjects who achieved the 
PASI75 response; and (2) the percentage of subjects who achieved the state of Clear or Almost 
Clear using the PGA. Both primary endpoints were achieved at Week 12 in both CZP treatment 
groups relative to PBO (Table 5‒2).
Table5‒2: Percentage of subjects achieving endpoint at 12 weeks in C87040
Placebo
CZP 200mg Q2W 
CZP 400mg Q2W
PASI75
6.8%
74.6%a
82.8%a
PGA clear or almost clear
1.7%
52.5%a
72.4%a
CZP=certolizumab pegol; PASI75=Psoriasis Activity and Severity Index 75 response; PGA=Physician’s Global 
Assessment; Q2W=every 2 weeks
ap<0.001 v placebo
Although the study was not designed to show a difference between the 2 active treatment arms, 
the 400mg Q2W group trended toward greater response, particularly in PGA. 
Subjects who achieved a PASI75 at Week 12 in C87040 were observed for up to 24 weeks after 
discontinuing study drug. Those that lost response (ie, relapsed), defined as a loss of 50% of 
response during the observation period, were retreated for 12 weeks in C87044. The primary 
endpoint was the difference in the PASI score at the 12-week time point after retreatment, 
relative to the 12-week time pointafter initial treatment in the Intent-to-Treat population.
REDACTED COPY 
Percentage of subjects achieving endpoint at 12 weeks in C87040
REDACTED COPY 
Percentage of subjects achieving endpoint at 12 weeks in C87040
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
1.7%
REDACTED COPY 
1.7%
REDACTED COPY 
REDACTED COPY 
CZP=certolizumab pegol; PASI75=Psoriasis Activity and Severity Index 75 response; PGA=Physician’s Global 
REDACTED COPY 
CZP=certolizumab pegol; PASI75=Psoriasis Activity and Severity Index 75 response; PGA=Physician’s Global 
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75 and 
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75 and 
e withdrawal and retreatment of subjects 
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e withdrawal and retreatment of subjects 
 C87040. These studies support the 
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 C87040. These studies support the 
ose of 400mg at Week 0, and 
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ose of 400mg at Week 0, and 
controlled study
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controlled study
 endpoints: (1) a comparison of the percentage of subjects who achieved the 
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 endpoints: (1) a comparison of the percentage of subjects who achieved the 
subjects who achieved the state of Clear or Almost 
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subjects who achieved the state of Clear or Almost 
Clear using the PGA. Both primary endpoints were achieved at Week 12 in both CZP treatment 
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Clear using the PGA. Both primary endpoints were achieved at Week 12 in both CZP treatment 
Percentage of subjects achieving endpoint at 12 weeks in C87040
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Percentage of subjects achieving endpoint at 12 weeks in C87040
CZP 200mg Q2W 
CZP 400mg Q2W
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CZP 200mg Q2W 
CZP 400mg Q2W
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CZP=certolizumab pegol; PASI75=Psoriasis Activity and Severity Index 75 response; PGA=Physician’s Global 
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CZP=certolizumab pegol; PASI75=Psoriasis Activity and Severity Index 75 response; PGA=Physician’s Global 
y was not designed to show a difference be
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y was not designed to show a difference be
mg Q2W group trended toward greater response, particularl
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mg Q2W group trended toward greater response, particularl
Subjects who achieved a PASI
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Subjects who achieved a PASI75 at Week 12 in C87040 were observed for up to 24 weeks after 
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75 at Week 12 in C87040 were observed for up to 24 weeks after 
discontinuing study drug. Those that lost response (ie,
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discontinuing study drug. Those that lost response (ie,
response during the obs
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response during the observation period, were retreated for 12 weeks in C87044. The primary
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ervation period, were retreated for 12 weeks in C87044. The primary
endpoint was the difference in the PASI score at the 12
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endpoint was the difference in the PASI score at the 12
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-
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-week time point
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week time point


UCB
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Clinical Study Protocol
Certolizumab Pegol
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Page 30of 119
Table5‒3: PASI response rates after retreatment
CZP 200mg Q2W
CZP 400mg Q2W
PASI at Initial Baseline (SD)
21.89 (7.52) 
22.99 (8.79)
PASI at 12 Weeks in Initial Treatment  [Median (95% 
CI)]
1.60 (0.90, 2.70) 
1.80 (1.20, 2.60)
PASI at 12 Weeks in Retreatment [Median (95% CI)]
3.35 (1.40, 6.30) 
2.00 (0.60, 3.30)
Median difference in PASI at 12 Weeks 
[Initial Treatment –Retreatment (95% CI)] 
ITT Population (N=34; N=37)
1.25 (0.10, 4.40) 
0.20 (0.00, 0.70)
Per Protocol Population (N=23; N=25)
1.00 (-0.60, 5.80) 
0.00 (-0.50, 0.70)
CI=confidence interval; CZP=certolizumab pegol; ITT=Intent-to-Treat; PASI=Psoriasis Area and Severity Index; 
Q2W=every 2 weeks; SD=standard deviation 
After 12 weeks of retreatment, considerable reduction in median PASI scores was observed for 
both CZP doses. The primary analysis based on the ITT population indicated a modest decrease 
in response after 12 weeks of retreatment as compared to the initial 12 weeks of treatment at the 
200mg dose (the 95% CI did not contain 0). However, no statistical difference in median PASI 
scores was observed in sensitivity analyses based on the Per Protocol population. There was no 
significant change in median PASI scores at the 400mg dose in either the primary analysis based 
on the ITT population or the sensitivity analyses. 
Overall, both doses showedclear efficacy and an acceptable tolerability profile for 12 weeks. 
The higher dose appeared to be numerically more effective both for initial treatment up to Week 
12 and after retreatment without safety concerns at the 400mg Q2W dose. The 200mg Q2W and 
400mg Q2W doses will be further evaluated and confirmed in the proposed global Phase 3 
studies where the efficacy and safety can be assessed for a longer duration of time and also this 
study.
6 
SELECTION AND WITHDRAWAL OF SUBJECTS
To be eligible to participate in this study, all of the following criteria must be met:
6.1
Inclusion criteria 
6.1.1 
Inclusion criteria for all subjects 
1. An Institutional Review Board (IRB)-approved written Informed Consent form is signed and 
dated by the subject. 
2. Subject is considered reliable and capable of adhering to the protocol, visit schedule, or 
medication intake according to the judgment of the Investigator.
3. Subject is male and female, ≥20 years of age.
4. Female subjects must be either postmenopausal (defined as 12 months with no menses 
without an alternative medical cause), surgically incapable of childbearing, or effectively 
practicing an acceptable method of contraception (including oral hormonal contraceptives, 
intrauterine device or barrier and spermicide or contraception methods that are considered as 
REDACTED COPY 
mg dose (the 95% CI did not contain 0). However, no statistical difference in median PASI 
REDACTED COPY 
mg dose (the 95% CI did not contain 0). However, no statistical difference in median PASI 
REDACTED COPY 
sed on the Per Protocol population. There was no 
REDACTED COPY 
sed on the Per Protocol population. There was no 
ores at the 400
REDACTED COPY 
ores at the 400mg dose in either the primary
REDACTED COPY 
mg dose in either the primary
ys
REDACTED COPY 
yses. 
REDACTED COPY 
es. 
clear efficacy
REDACTED COPY 
clear efficacy and an acceptable
REDACTED COPY 
 and an acceptable
clear efficacy and an acceptable
clear efficacy
REDACTED COPY 
clear efficacy and an acceptable
clear efficacy
The higher dose appeared to be numericall
REDACTED COPY 
The higher dose appeared to be numerically more effective both for initial treatment up to Week 
REDACTED COPY 
y more effective both for initial treatment up to Week 
12 and after retreatment without safety concerns at the 400mg 
REDACTED COPY 
12 and after retreatment without safety concerns at the 400mg 
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3.35 (1.40, 6.30) 
2.00 (0.60, 3.30)
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3.35 (1.40, 6.30) 
2.00 (0.60, 3.30)
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1.25 (0.10, 4.40) 
0.20 (0.00, 0.70)
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1.25 (0.10, 4.40) 
0.20 (0.00, 0.70)
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1.00 (-0.60, 5.80) 
0.00 (-0.50, 0.70)
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1.00 (-0.60, 5.80) 
0.00 (-0.50, 0.70)
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reat; PASI=Psoriasis Area and Severity Index; 
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reat; PASI=Psoriasis Area and Severity Index; 
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After 12 weeks of retreatment, considerable reduction in median PASI
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After 12 weeks of retreatment, considerable reduction in median PASI scores was observed for 
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 scores was observed for 
is based on the ITT population indicated
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is based on the ITT population indicated
in response after 12 weeks of retreatment as compared to the initial 1
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in response after 12 weeks of retreatment as compared to the initial 1
mg dose (the 95% CI did not contain 0). However, no statistical difference in median PASI 
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mg dose (the 95% CI did not contain 0). However, no statistical difference in median PASI 
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sed on the Per Protocol population. There was no 
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sed on the Per Protocol population. There was no 
mg dose in either the primary
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mg dose in either the primary
 and an acceptable
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 and an acceptable
y more effective both for initial treatment up to Week 
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y more effective both for initial treatment up to Week 
12 and after retreatment without safety concerns at the 400mg 
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12 and after retreatment without safety concerns at the 400mg 
aluated and confirmed in the proposed global Phase 3 
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aluated and confirmed in the proposed global Phase 3 
studies where the efficacy and safet
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studies where the efficacy and safety 
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y can be assessed for a longer duration of time and also this 
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can be assessed for a longer duration of time and also this 
6 
SELECTION A
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6 
SELECTION A
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To be eligible to participate in this study
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To be eligible to participate in this study
Inclusion criteria 
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Inclusion criteria 
Inclusion criteria for all 
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Inclusion criteria for all 
An Institutional Review Board (IRB)
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An Institutional Review Board (IRB)
dated b
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dated by the subject. 
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y the subject. 
Subject
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Subject
medication intake according to the judgment of the 
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medication intake according to the judgment of the 
3.
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3.


UCB
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Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 31of 119
at least assafe for contraception). Abstinence only is not an acceptable method. Subjects 
must agree to use adequate contraception during the study and for at least 5 months (in 
accordance with the Summary of Product Characteristics, SPC) after the last dose of study 
treatment. Male subjects must agree to ensure they or their female partner(s) use adequate 
contraception during the study and for at least 5 months (in accordance with the SPC) after 
the subject receives their last dose of study treatment.
6.1.2
Inclusion criteria for subjects with moderate to severe chronic 
plaque PSO
5. Have a diagnosis of chronic plaque PSO for at least 6 months.
6. Baseline PASI ≥12 and BSA affected by PSO ≥10% and PGA score of 3 or higher.
7. Candidates for systemic PSO therapy and/or phototherapy and/or chemophototherapy.
6.1.3 
Inclusion criteria for subjects with generalized pustular PSO o 
r 
erythrodermicPSO
8. Have a diagnosis of generalized pustular PSO or erythrodermic P SO at Screening. A 
diagnosis of generalized pustular PSO must be classified on the basis of the criteria for 
diagnosis of generalized pustular PSO by the JDA.
9. Have a history of plaque-type PSO if subjects have a diagnosis of erythrodermic PSO.
10.Baseline BSA affected by PSO ≥80% if subjects have a diagnosis of erythrodermic PSO.
6.2
Exclusion criteria
Subjects are not permitted to enroll in the study if any of the following criteria is met:
6.2.1
Exclusion criteria for all subjects
1. Female subject who isbreastfeeding, pregnant, or plans to become pregnant during the study 
or within 5 months following last dose of study drug. Male subject who isplanning a partner 
pregnancy during the study or within 5 months following the last dose of study drug.
2. Subject has previously participated in a CZP clinical studyor has received CZP treatment 
outside of a clinicalstudy.
3. Subjectparticipatedin another study of a medication or a medical device under investigation 
within the last 3 months or currently participating in another study of a medicationor 
medical device under investigation. 
4. Subjecthasa known hypersensitivity to any excipients of CZP or with a history of an adverse 
reaction to polyethylene glycol (PEG).
Psoriasis exclusion criteria
5. Subject has guttate PSO or drug-inducedPSO.
Prior medical history exclusions
6. Subjecthas a history of chronic or recurrent infections (more than 3 episodes requiring 
antibiotics/antivirals during the preceding year), recent serious or life-threatening infection 
within the 6 months prior to the Baseline Visit (including herpes zoster), hospitalization for 
REDACTED COPY 
pe PSO if subjects have a diagnosis of ery
REDACTED COPY 
pe PSO if subjects have a diagnosis of ery
0% if subjects have a diagnosis of ery
REDACTED COPY 
0% if subjects have a diagnosis of ery
Subjects are not permitted to enroll in the study
REDACTED COPY 
Subjects are not permitted to enroll in the study
Exclusion criteria for 
REDACTED COPY 
Exclusion criteria for 
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 PSO ≥10% and PGA score of 3 or higher.
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 PSO ≥10% and PGA score of 3 or higher.
and/or chemophototherapy
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and/or chemophototherapy
Inclusion criteria for subjects with generalized pustular PSO or 
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Inclusion criteria for subjects with generalized pustular PSO or 
Have a diagnosis of generalized pustular PSO or erythrodermic PSO at Screening. A 
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Have a diagnosis of generalized pustular PSO or erythrodermic PSO at Screening. A 
generalized pustular PSO must be classified on the basis of the criteria for 
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generalized pustular PSO must be classified on the basis of the criteria for 
pe PSO if subjects have a diagnosis of ery
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pe PSO if subjects have a diagnosis of ery
0% if subjects have a diagnosis of ery
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0% if subjects have a diagnosis of ery
Subjects are not permitted to enroll in the study
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Subjects are not permitted to enroll in the study if any
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 if any
Subjects are not permitted to enroll in the study if any
Subjects are not permitted to enroll in the study
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Subjects are not permitted to enroll in the study if any
Subjects are not permitted to enroll in the study
all subjects
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all subjects
breastfeeding, pregnant, or plan
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breastfeeding, pregnant, or plan
or within 5 months following last dose of study
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or within 5 months following last dose of study
 during the study
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 during the study or within 5 months following the last dose of study
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 or within 5 months following the last dose of study
 during the study or within 5 months following the last dose of study
 during the study
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 during the study or within 5 months following the last dose of study
 during the study
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ubject has previously
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ubject has previously
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 participated in a 
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 participated in a 
ubject has previously participated in a 
ubject has previously
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ubject has previously participated in a 
ubject has previously
study
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study
participated
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participatedin another study
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in another study
within the last 3 months or currently
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within the last 3 months or currently
medical device under investigation. 
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medical device under investigation. 
Subject
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Subject
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has
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has
reaction to pol
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reaction to pol
Psoriasis exclusion criteria
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Psoriasis exclusion criteria
5.
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5. Subject has guttate PSO or drug
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Subject has guttate PSO or drug


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25 Jan 2018
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Certolizumab Pegol
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Page 32of 119
any infection in the last 6 months, or any current sign or symptom that may indicate an 
infection.
7. Subjecthasconcurrent acute or chronic viral hepatitis B or C or with known human 
immunodeficiency virus infection (HIV) or T-cell lymphotropic virus type-1 (HTLV-1)  
infection.
8. Subjecthas a known history of or current clinically active infection with Histoplasma, 
Coccidiodes, Paracoccidioides, Pneumocystis, nontuberculous mycobacteria, Blastomyces, 
or Aspergillus.
9. Subjecthasa history of an infected joint prosthesis at any time with that prosthesis still in 
situ.
10. Subjectreceived any live (includes attenuated) vaccination within the 8 weeks prior to 
Baseline (eg, inactivated influenza and pneumococcal vaccines are allowed but nasal 
influenza vaccination is not permitted).
11. Subjecthas a high risk of infection in the Investigator’s opinion (eg, subjects with leg ulcers, 
indwelling urinary catheter, persistent or recurrent chest infections, subjects who are 
permanently bedridden or wheelchair bound).
12. Subject hasa history of a lymphoproliferative disorder including lymphoma or current signs 
and symptoms suggestive of lymphoproliferative disease.
13. Subject hasconcurrent malignancy or history of malignancy except for the following specific 
exceptions will be excluded. Subjects who meet the following criteria may be included:
a. ≤3 excised, or ablated, basal cell carcinomas of the skin
b. One squamous cell carcinoma (stage T1 maximum) of the skin succ essfully excised, or 
ablated, with no signs of recurrence or metastases for more than  2 years prior to 
screening (other treatments, ie,chemotherapy) are excluded
c. Actinic keratosis (-es)
d. Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 
months prior to Screening
e. Uterine cervical carcinoma in situ successfully surgically treated with no signs of 
recurrence or metastases for more than 5 years prior to Screening
14. Subject hasclass III or IV congestive heart failure as per the New York Heart Association 
1964 criteria.
15. Subject has a history of, or suspected, demyelinating disease of the central nervous system 
(eg, multiple sclerosis or optic neuritis).
16. Subject had major surgery (including joint surgery) within the 8 weeks prior to Screening, or 
having planned surgery within 6 months after entering the study.
17. Subject hasa current or recent history, as determined by the Investigator, of severe, 
progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, 
cardiac, or neurological disease.
REDACTED COPY 
mphoproliferative disorder including l
REDACTED COPY 
mphoproliferative disorder including l
mphoproliferative disease.
REDACTED COPY 
mphoproliferative disease.
 or history
REDACTED COPY 
 or history of malignancy
REDACTED COPY 
 of malignancy
 or history of malignancy
 or history
REDACTED COPY 
 or history of malignancy
 or history
exceptions will be excluded. Subjects who meet the following criteria may
REDACTED COPY 
exceptions will be excluded. Subjects who meet the following criteria may
≤3 excised, or ablated, basal cell carcinomas of the skin
REDACTED COPY 
≤3 excised, or ablated, basal cell carcinomas of the skin
One squamous cell carcinoma (stage T1 maximum) of the skin successfully excised, or 
REDACTED COPY 
One squamous cell carcinoma (stage T1 maximum) of the skin successfully excised, or 
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es, 
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es, 
 time with that prosthesis still in 
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 time with that prosthesis still in 
y live (includes attenuated) vaccination within the 8 weeks prior to 
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y live (includes attenuated) vaccination within the 8 weeks prior to 
s are allowed but nasal 
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s are allowed but nasal 
’s opinion (eg, subjects with leg ulcers, 
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’s opinion (eg, subjects with leg ulcers, 
 catheter, persistent or recurrent chest infections, subjects who are 
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 catheter, persistent or recurrent chest infections, subjects who are 
mphoproliferative disorder including l
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mphoproliferative disorder including l
mphoproliferative disease.
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mphoproliferative disease.
 of malignancy
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 of malignancy
exceptions will be excluded. Subjects who meet the following criteria may
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exceptions will be excluded. Subjects who meet the following criteria may
≤3 excised, or ablated, basal cell carcinomas of the skin
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≤3 excised, or ablated, basal cell carcinomas of the skin
One squamous cell carcinoma (stage T1 maximum) of the skin successfully excised, or 
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One squamous cell carcinoma (stage T1 maximum) of the skin successfully excised, or 
ated, with no signs of recurrence or metastases for more than  2 
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ated, with no signs of recurrence or metastases for more than  2 
screening (other treatments, ie
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screening (other treatments, ie
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,
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,chemotherap
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chemotherap
d. Squamous cell carcinoma-
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d. Squamous cell carcinoma-
months prior to Screening
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months prior to Screening
Uterine cervical carcinoma in situ successfully
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Uterine cervical carcinoma in situ successfully
recurrence or metastases for more than 5 
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recurrence or metastases for more than 5 
has
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hasclass III or IV congestive heart failure as per the New York Heart A
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class III or IV congestive heart failure as per the New York Heart A
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1964 criteria.
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1964 criteria.
15. Subject 
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15. Subject 
(eg, multiple sclerosis or optic neuritis).
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(eg, multiple sclerosis or optic neuritis).
16.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
16.Subject had major surgery
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Subject had major surgery


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25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
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Page 33of 119
18. Subject hasany of the following clinically significant laboratory abnormalities at the 
Screening:
a. Aspartate aminotransferase (AST)≥3 x upper limit of normal (ULN)
b. Alanine aminotransferase (ALT)≥3 x ULN
c. Alkaline phosphatase (ALP) ≥3 x ULN
d. Creatinine >ULN
e. White blood cell (WBC)<3.0 x109/L
f. Hepatitis B surface (HBs) antigen, hepatitis B core (HBc) antibody, hepatitis B surface 
(HBs) antibody, Hepatitis type B virus (HBV) DNA assay: Positive to any of these
(However, patients with  negative HBs antigen and HBV-DNA and positive HBc 
antibody and/or HBs antibody may be included provided that they undergo a HBV-DNA 
assay every 4 weeks (from Baseline to Week 52)and then at SFU.
g. Hepatitis type C virus (HCV) antibody: Positive
h. Human immunodeficiency virus (HIV) antigen or antibody: Positive to either test
i. T-cell lymphotropic virus type-1 (HTLV-1) antibody: Positive
19. Subject has >ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert’s syndrome). If 
subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate 
bilirubin to identify possible undiagnosed Gilbert’s syndrome (ie, direct bilirubin <35%).
20. Subjecthasa diagnosis of any other inflammatory arthritis other than PsA, eg, rheumatoid 
arthritis, sarcoidosis, systemic lupus erythematosus, or a diagnosis of fibromyalgia.
21. Subjecthasany other condition which, in the Investigator’s judgment, would make the 
subject unsuitable for inclusion in the study.
22. Subject withknown TB infection, at high risk of acquiring TB infection, or with untreated 
LTBI (ie, pending anti-TB prophylactic course) or current or history of nontuberculous 
mycobacterial (NTMB) infection.
a. Known TB infection whether present or past is defined as:
Active TB infection or clinical signs and symptoms suspicious for TB (pulmonary 
or extra-pulmonary)
History of active TB infection involving any organ system or findings in other 
organ systems consistent with TB infection unless adequately treated and proven to 
be fully recovered upon consult with a TB specialist.
Any evidence by radiography or other imaging modalities consistent with 
previously active TB infection that is not reported in the subject’s medical history
REDACTED COPY 
N total bilirubin if known Gilbert’s sy
REDACTED COPY 
N total bilirubin if known Gilbert’s sy
total bilirubin that are >ULN and <1.5xULN, fractionate 
REDACTED COPY 
total bilirubin that are >ULN and <1.5xULN, fractionate 
 possible undiagnosed Gilbert’s sy
REDACTED COPY 
 possible undiagnosed Gilbert’s sy
a diagnosis of any other inflammatory arthritis other than PsA, eg, 
REDACTED COPY 
a diagnosis of any other inflammatory arthritis other than PsA, eg, 
stemic lupus ery
REDACTED COPY 
stemic lupus erythematosus, or a diagnosis of fibromy
REDACTED COPY 
thematosus, or a diagnosis of fibromy
stemic lupus erythematosus, or a diagnosis of fibromy
stemic lupus ery
REDACTED COPY 
stemic lupus erythematosus, or a diagnosis of fibromy
stemic lupus ery
y other condition which, in the 
REDACTED COPY 
y other condition which, in the 
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, hepatitis B surface 
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, hepatitis B surface 
: Positive to any
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: Positive to any of these
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 of these
-DNA and positive HBc 
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-DNA and positive HBc 
 undergo a HBV
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 undergo a HBV
and then at SFU.
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and then at SFU.
deficiency virus (HIV) antigen or antibody
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deficiency virus (HIV) antigen or antibody: Positive to either test
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: Positive to either test
: Positive
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: Positive
N total bilirubin if known Gilbert’s sy
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N total bilirubin if known Gilbert’s sy
total bilirubin that are >ULN and <1.5xULN, fractionate 
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total bilirubin that are >ULN and <1.5xULN, fractionate 
 possible undiagnosed Gilbert’s sy
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 possible undiagnosed Gilbert’s sy
a diagnosis of any other inflammatory arthritis other than PsA, eg, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
a diagnosis of any other inflammatory arthritis other than PsA, eg, 
stemic lupus ery
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stemic lupus erythematosus, or a diagnosis of fibromy
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thematosus, or a diagnosis of fibromy
stemic lupus erythematosus, or a diagnosis of fibromy
stemic lupus ery
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stemic lupus erythematosus, or a diagnosis of fibromy
stemic lupus ery
y other condition which, in the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y other condition which, in the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
subject unsuitable for inclusion in the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
subject unsuitable for inclusion in the study
known TB infection, at high risk of acquiring TB infection, or with untreated 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
known TB infection, at high risk of acquiring TB infection, or with untreated 
TB proph
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
TB proph
cobacterial (NTMB) infection.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
cobacterial (NTMB) infection.
Known TB infection whether present or past is defined as:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Known TB infection whether present or past is defined as:
Active TB infection or clinical signs and s
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Active TB infection or clinical signs and s
or extra
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or extra
History
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History
organ s
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organ s


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25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
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Page 34of 119
b. High risk of acquiring TB infection is defined as:
Known close exposure (eg, sleeping in the same room) to another person with 
active TB infection within the 3 months prior to Screening
Time spent in a healthcare delivery setting or institution where individuals infected 
with TB are housed and where the risk of transmission of infectionis high
c.LTBI is defined as an infection by mycobacteria TBwith:
A positive IGRA (or 2 indeterminate IGRAs) AND
Chest imaging (or other imaging) negative for TB infection, AND
Absence of signs, symptoms (eg, evidence of organ-specific involvement), or 
physical findings suggestive of TB infection.
Exceptions for considering subjects for study participation despiteidentification of 
LTBI:
- Subject who hasrecently (no more than 12 months prior to Screening) completed 
full treatment course of prophylaxis for LTBI.
- Subject who hasstarted prophylactic therapy (as defined above) for LTBI at least 
4 weeks prior to receiving the study medication and are committed to completing 
the full course of therapy may be considered for study participation.
d. NTMB is defined as a group of lung infections caused by mycobacteria different from 
mycobacterium TBinfections.
6.2.2
Exclusion criteria for subjects with moderate to severe chronic 
plaque PSO
Psoriasis exclusion criteria
23. Subjecthaswith erythrodermicor pustular form ofPSO.
Prior medications exclusions
24. Subject has been exposed to more than 2 biological response mod ifiers (including anti-TNF) 
for PsA or PSO prior to Baseline Visit. Prior use must be in accordance to Table 6‒1.
Subjects must not have been a primary failure to any prior biologic therapy (primary 
failure defined as no response within the first 12 weeks of treatment with the biologic) 
and may have been a secondary failure (ie, subject initially responded to therapy and then 
stopped treatment due to loss of response after Week 12) to no more than 2. Subjects who 
stopped biologic therapy for intolerance or reasons unrelated to efficacy are not 
considered secondary failures.
25. Subject used the following medications in the manner as detailed by the exclusion criteria in 
Table 6‒1.
REDACTED COPY 
lactic therapy
REDACTED COPY 
lactic therapy
y medication and are committ
REDACTED COPY 
y medication and are committ
y may be considered for study participation.
REDACTED COPY 
y may be considered for study participation.
NTMB is defined as a group of lung infections caused by
REDACTED COPY 
NTMB is defined as a group of lung infections caused by
lusion criteria for subjects with moderate to severe 
REDACTED COPY 
lusion criteria for subjects with moderate to severe 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
specific involvement), or 
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specific involvement), or 
 participation despite
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 participation despiteidentification of 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
identification of 
y (no more than 12 months prior to Screening) completed 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y (no more than 12 months prior to Screening) completed 
 (as defined above) for LTBI at least 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 (as defined above) for LTBI at least 
y medication and are committ
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y medication and are committ
y may be considered for study participation.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y may be considered for study participation.
NTMB is defined as a group of lung infections caused by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
NTMB is defined as a group of lung infections caused by
lusion criteria for subjects with moderate to severe 
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lusion criteria for subjects with moderate to severe 
throdermic
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
throdermicor 
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or 
Prior medications exclusions
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Prior medications exclusions
Subject has been exposed to more than 2 biological response modifiers (including anti
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subject has been exposed to more than 2 biological response modifiers (including anti
for PsA or PSO prior to Baseline Visit. Prior use must be in accordance to 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for PsA or PSO prior to Baseline Visit. Prior use must be in accordance to 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects must not have been a primary
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects must not have been a primary
failure defined as no response within the first 12 weeks of treatment with the biologic) 
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failure defined as no response within the first 12 weeks of treatment with the biologic) 
and may
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and may have been a secondary failure (ie, subject initi
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 have been a secondary failure (ie, subject initi
and may have been a secondary failure (ie, subject initi
and may
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and may have been a secondary failure (ie, subject initi
and may
stopped treatment due to loss of response after Week 12) to no more than 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
stopped treatment due to loss of response after Week 12) to no more than 
stopped biologic therap
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stopped biologic therap
considered secondary
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considered secondary
25.
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25.


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Certolizumab Pegol
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Page 35of 119
Table6‒1: Exclusions for prior treatments for subjects with moderate to s evere 
active plaque PSO
Drug class
Dose 
Exclusion criteriarelative to 
Baseline Visit
Systemic retinoids
Any dose
12 weeks
Systemic treatment (nonbiological)
Systemic immunosuppressants agents (eg,  
methotrexate, cyclosporine, azathioprine)
Systemic corticosteroids
Phototherapy or chemophototherapy
Any dose 
4 weeks 
Anti-TNFs
Infliximab (including biosimilar)
Adalimumab 
Etanercept 
Golimumab 
Any dose
12 weeksfor infliximab   
(including biosimilar), 
adalimumab, and golimumab
4 weeks for etanercept
Other biologicalsand other systemic therapies
Ustekinumab
Secukinumab
Brodalumab
Ixekizumab
Rituximab
Any dose
2 years for rituximab 
24 weeks for ustekinumab,
secukinumab, brodalumab and 
ixekizumab
Any other antipsoriatic agent (systemic) under 
investigation (or approved after the protocol is 
approved)
Any dose
24 weeks 
Topical agents
Any other antipsoriatic agent (topical) under 
investigation(or approved after the protocol is 
approved)
Any dose
4 weeks 
Topicalcorticosteroidsfor dermatologic use
Vitamin D analogues and topical retinoids
Keratolitic and coal tar 
Any dose
2 weeks
Other Exclusion Criteria
26. SubjecttakesPsA medications. Subjects are allowed to take stable doses of NSAIDs to treat 
their PsA symptoms during the study. Subjects are allowed as neededuse of acetaminophen, 
paracetemol, or pain medications
6.2.3 
Exclusion criteria for subjects with generalized pustular PSOor 
erythrodermic PSO
Psoriasis exclusion criteria
27. Subject hasa total score on the JDA severity index for generalized pustular PSO ≥14 at 
Baseline if subjects have a diagnosis of generalized pustular PSO.
REDACTED COPY 
REDACTED COPY 
investigation (or approved after the protocol is 
REDACTED COPY 
investigation (or approved after the protocol is 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for infliximab   
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for infliximab   
(including biosimilar), 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(including biosimilar), 
adalimumab, and golimumab
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
adalimumab, and golimumab
eeks for etanercept
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eeks for etanercept
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2 years for rituximab 
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2 years for rituximab 
24 w
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
24 w
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Any dose
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Any dose
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Any other antipsoriatic agent (topical) under 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Any other antipsoriatic agent (topical) under 
(or approved after the protocol is 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(or approved after the protocol is 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for dermatologic use
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for dermatologic use
Vitamin D analogues and topical retinoids
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Vitamin D analogues and topical retinoids
Keratolitic and coal tar 
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Keratolitic and coal tar 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Other Exclusion Criteria
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Other Exclusion Criteria
Subject
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjecttakes
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
takes
their PsA sy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
their PsA sy
paracetemol, or pain medications
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paracetemol, or pain medications
6.2.3
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6.2.3


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Certolizumab Pegol
PS0017
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Page 36of 119
28. Subject has a differential diagnosis of the erythroderma (eg, erythroderma caused by 
lymphoma or drug eruption) other than erythrodermic PSO.
Prior medications exclusions
29. Subjectwith a primary failure to any prior biologic therapy (primary failure defined as no 
response within the first 12 weeks of treatment with the biologic).
30. Subject used the following medications and therapies in the manner as detailed by the 
exclusion criteria in Table 6‒2:
Table6‒2: Exclusions for prior treatments for subjects with generalized 
pustular PSOor erythrodermic PSO
Drug class
Dose
Exclusion criteria relative to 
Baseline Visit
Systemic treatment (nonbiological)a
Phototherapy or chemophotoherapy
Granulocyte and monocyte adsorption apheresis
-
4 weeks for phototherapy or 
chemophototherapy
1week for granulocyte and 
monocyte adsorption apheresis
Anti-TNFs
Infliximab (including biosimilar)
Adalimumab 
Etanercept 
Golimumab 
Any dose
12 weeksfor infliximab   
(including biosimilar), 
adalimumab, and golimumab
4 weeks for etanercept
Other biologicalsand other systemic therapies
Ustekinumab
Secukinumab
Brodalumab
Ixekizumab
Rituximab
Any dose
2 years for rituximab 
24 weeks for ustekinumab,
secukinumab, brodalumab and 
ixekizumab
Any other antipsoriatic agent (systemic) under 
investigation (or approved after the protocol is 
approved)
Any dose
24 weeks 
Topical agents
Antipsoriatic agent (topical) under investigation(or 
approved after the protocol is approved)
Any dose
4 weeks
a   The use of systemic retinoids, systemic immunosuppressants agents (eg: methotrexate, cyclosporine, 
azathioprine) and/or systemic corticosteroids(at a daily dose ≤10 mg/day of prednisone or its equivalent) 
areallowed provided the patient hasbeen using such medication(s) since before starting the study. Dose 
reduction of these drugs isallowed as well;however, dose increase after dose reduction islimited to the 
level at the start of the study.
6.3
Withdrawal criteria
Subjects are free to withdraw from the study at any time, without prejudice to their continued 
care.
Subjects should be withdrawn from the study if any of the following events occur:
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Exclusions for prior treatments for subjects with generalized 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Exclusions for prior treatments for subjects with generalized 
criteria
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
criteriarelative to 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
relative to 
Baseline Visit
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Baseline Visit
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
eeks for 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
eeks for p
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
phototherapy or 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
hototherapy or 
phototherapy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
phototherapy
eek for 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
eek for granulocyte and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
granulocyte and 
mo
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
monocyte adsorption apheresis
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
nocyte adsorption apheresis
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12 w
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12 w
(including biosimilar), 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(including biosimilar), 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Any dose
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Any dose
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Any other antipsoriatic agent (systemic) under 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Any other antipsoriatic agent (systemic) under 
investigation (or approved after the protocol is 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
investigation (or approved after the protocol is 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
psoriatic agent (topical) under investigation
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
psoriatic agent (topical) under investigation
approved after the protocol is approved)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
approved after the protocol is approved)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The use of systemic retinoids, systemic immunosuppressants agents (eg: methotrexate, cyclosporine, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The use of systemic retinoids, systemic immunosuppressants agents (eg: methotrexate, cyclosporine, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
azathioprine) and/or systemic corticosteroids
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
azathioprine) and/or systemic corticosteroids
allow
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
allowed provided the patient ha
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ed provided the patient ha
reduction of these drugs 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
reduction of these drugs 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
level at the start of the study.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
level at the start of the study.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
6.3
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
6.3


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
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Page 37of 119
1. Subject develops an illness that would interfere with his/her c ontinued participation.
2. Subject is noncompliant with the study procedures or medications in the opinion of the 
Investigator.
3. Subject considered as having either a suspected new latent or who develop active TB or 
NTMB infection during the study (including but not limited to, conversion demonstrated by 
IGRA or other diagnostic means) must be immediately discontinued from study medication, 
and an Early Termination Visit must be scheduled as soon as possible, but not later than the 
next regular visit.
Confirmed active TB is a serious adverse event (SAE) and must be captured on an SAE 
report form and provided to the Sponsorin accordance with SAE reporting requirements.  As 
with all SAEs, periodic follow-up reports should be completed as per protocol requirements 
until such time as the TB infection resolves. 
Subjects who prematurely discontinue treatment for latent TB, or, in the opinion of the 
Investigatoror Sponsor, are noncompliant with anti-TB therapy must discontinue further use 
of study mediation and be immediately withdrawn.
4. There is confirmation of a positive HBV-DNA assay during the study period, subject with 
positive HBc antibody and/or HBs antibody at Screening. Appropriate actions such as 
administration of a nucleic acid analog should be taken after prompt consultation with a 
hepatologist.
5. Subjects developing aggravation of the primary disease or concomitant disease with 
hospitalization in the opinion of the Investigator.
6. Subjectswith generalized pustular PSOdeveloping a total score on the JDA Severity Index 
for Generalized PustularPSO ≥14at any post-Baseline visit.
7. Subject withdraws his/her consent.
8. There is confirmation of a subject pregnancy during the study, as evidenced by a positive 
pregnancy test.
9. The Sponsor or a regulatory agency requests withdrawal of the subject.
10. Subjects developsguttatePSO.
Once withdrawn from study treatment, subjects must return for the Early Withdrawal Visit and 
complete all Early Withdrawal assessments, and complete a final Safety Follow-Up Visit 
10 weeks after the last dose of study medication.
Investigators should attempt to obtain information on subjects in the case of withdrawal or 
discontinuation. For subjects considered as lost to follow up, the Investigator should make an 
effort (at least 1 phone call and 1 written message to the subject), and documenthis/her effort 
(date and summary of the phone call and copy of the written message in the source documents), 
to complete the final evaluation. All results of these evaluations and observations, together with a 
narrative description of the reason(s) for removing the subject, must be recorded in the source 
documents. The Case Report form must document the primary reason for withdrawal or 
discontinuation.
REDACTED COPY 
DNA assay
REDACTED COPY 
DNA assay
 at Screening. Appropriate actions such as 
REDACTED COPY 
 at Screening. Appropriate actions such as 
administration of a nucleic acid analog should be taken after prompt consultation with a 
REDACTED COPY 
administration of a nucleic acid analog should be taken after prompt consultation with a 
Subjects developing aggravation of the primary
REDACTED COPY 
Subjects developing aggravation of the primary
the opinion of the Investigator
REDACTED COPY 
the opinion of the Investigator
lized pustular PSO
REDACTED COPY 
lized pustular PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 medication, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 medication, 
isit must be scheduled as soon as possible, but not later than the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
isit must be scheduled as soon as possible, but not later than the 
active TB is a serious adverse event (SAE) and must be captured on an SAE 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
active TB is a serious adverse event (SAE) and must be captured on an SAE 
requirements.  As 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
requirements.  As 
-up reports should be completed as per protocol requirements 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
-up reports should be completed as per protocol requirements 
Subjects who prematurely discontinue treatment for latent TB, or, in the opinion of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects who prematurely discontinue treatment for latent TB, or, in the opinion of the 
TB therap
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
TB therapy must discontinue further use 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y must discontinue further use 
 during the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 during the study
 at Screening. Appropriate actions such as 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 at Screening. Appropriate actions such as 
administration of a nucleic acid analog should be taken after prompt consultation with a 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
administration of a nucleic acid analog should be taken after prompt consultation with a 
Subjects developing aggravation of the primary
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects developing aggravation of the primary disease or concomitant disease with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 disease or concomitant disease with 
Subjects developing aggravation of the primary disease or concomitant disease with 
Subjects developing aggravation of the primary
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects developing aggravation of the primary disease or concomitant disease with 
Subjects developing aggravation of the primary
the opinion of the Investigator
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
the opinion of the Investigator
lized pustular PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
lized pustular PSOdeveloping
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
developing
≥14
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
≥14at any
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
at any
Subject withdraws his/her consent.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subject withdraws his/her consent.
There is confirmation of a subject pr
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
There is confirmation of a subject pr
or a regulatory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
or a regulatory
Subjects develop
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects develops
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sguttate
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
guttate
Once withdrawn from study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Once withdrawn from study
complete all Earl
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
complete all Earl
weeks after the last dose of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
weeks after the last dose of study
Investigator
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator
discontinuation. For subjects considered as lost to follow up, the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
discontinuation. For subjects considered as lost to follow up, the 
effort (at least 1 phone call and 1 written message to the subject), and document
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
effort (at least 1 phone call and 1 written message to the subject), and document


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 38of 119
Investigators should contact the Medical Monitor, whenever possible, to discuss the withdrawal 
of a subject in advance.
Subjects withdrawn from the study will not be replaced.
6.3.1 
Potential drug-induced liver injury IMP discontinuation criteria
Subjects with potential drug-induced liver injury (PDILI) must be assessed to determine if IMP 
must be discontinued. In addition, all concomitant medications and herbal supplements that are 
not medically necessary should also be discontinued. 
The PDILI criteria below require immediate and permanent discontinuation of IMP: 
Subjects with eitherof the following:
ALT or AST ≥ 8xULN
ALTor AST≥3xULN and coexisting total bilirubin ≥2xULN 
The PDILI criterionbelow requires immediate discontinuation of IMP:
Subjects with ALT or AST ≥3xULN who exhibit temporally associated symptoms of 
hepatitis or hypersensitivity. Hepatitis symptoms include fatigue, nausea, vomiting, right 
upper quadrant pain or tenderness. Hypersensitivity symptoms includefever (without clear 
alternative cause), rash, or eosinophilia (ie, >5%).
The PDILI criterionbelow allows for subjects to continue on IMP at the discretion of the 
Investigator. 
Subjects with ALT or AST ≥3xULN (and ≥2x baseline)and<8xULN,total bilirubin 
<2xULN, and no eosinophilia (ie, ≤5%), with no fever, rash,or symptoms of hepatitis (eg, 
fatigue, nausea, vomiting, right upper quadrant pain or tenderness).
Evaluation of PDILI must be initiated as described in Section 12.2.1. If subjects are unable to 
comply with the applicable monitoring schedule, IMP must be discontinued immediately.
Investigators should attempt to obtain information on subjects in the case of IMP discontinuation 
to complete the final evaluation. Subjects with PDILI should not be withdrawn from the study 
until investigation and monitoring are complete. All results of these evaluations and 
observations, as well as the reason(s) for IMP discontinuation and subject withdrawal (if 
applicable), must be recorded in the source documents. The CRF must document the primary 
reason for IMP discontinuation.
7
STUDY TREATMENTS
7.1
Description of investigational medicinal products
The investigational medicinal products (IMPs) used in this study are CZP and PBO. These 
products willbe supplied by the UCB Clinical Supply Unit. Drug and supplies will consist of the 
following:
Certolizumab pegol is supplied as a sterile, clear, colorless to slightly yellow liquid solution with 
a pH of approximately 4.7 in 1mL single use glass prefilledsyringe (PFS) with a 25G ½-inch 
thin-wall needle for sc injection. Each syringe contains an extractable volume of 1mL at a 
REDACTED COPY 
persensitivity
REDACTED COPY 
persensitivity sy
REDACTED COPY 
 sy
persensitivity sy
persensitivity
REDACTED COPY 
persensitivity sy
persensitivity
alternative cause), rash, or eosinophilia (ie, >5%).
REDACTED COPY 
alternative cause), rash, or eosinophilia (ie, >5%).
allows for subjects to continue on I
REDACTED COPY 
allows for subjects to continue on I
≥3xULN (
REDACTED COPY 
≥3xULN (and 
REDACTED COPY 
and 
N, and no eosinophilia (ie, 
REDACTED COPY 
N, and no eosinophilia (ie, ≤5%), with no fever, rash
REDACTED COPY 
≤5%), with no fever, rash
fatigue, nausea, vomiting, right upper quadrant pain or tenderness)
REDACTED COPY 
fatigue, nausea, vomiting, right upper quadrant pain or tenderness)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
addition, all concomitant medications and herbal supplements that are 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
addition, all concomitant medications and herbal supplements that are 
:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
:
 associated 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 associated 
fatigue, nausea, vomiting, right 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
fatigue, nausea, vomiting, right 
mptoms include
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
mptoms include
allows for subjects to continue on I
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
allows for subjects to continue on I
≥2x baseline)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
≥2x baseline)
≤5%), with no fever, rash
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
≤5%), with no fever, rash
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
fatigue, nausea, vomiting, right upper quadrant pain or tenderness)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
fatigue, nausea, vomiting, right upper quadrant pain or tenderness)
of PDILI must be initiated as described in 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
of PDILI must be initiated as described in 
 with the applicable monitoring schedule
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 with the applicable monitoring schedule
s should attempt to obtain information on subjects in the case of IMP discontinuation 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
s should attempt to obtain information on subjects in the case of IMP discontinuation 
to complete the final evaluation. Subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
to complete the final evaluation. Subjects with 
until investigation and monitoring are complete. All results of these
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
until investigation and monitoring are complete. All results of these
observations, as well as the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
observations, as well as the 
applicable), must be recorded in 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
applicable), must be recorded in 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
reason for IMP discontinuation.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
reason for IMP discontinuation.
STUDY TREA
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
STUDY TREA
The investigational medicinal products (IMPs) used in this study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The investigational medicinal products (IMPs) used in this study
products will
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
products will
following:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
following:


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 39of 119
concentration of 200mg/mL of CZP in 10mM sodium acetate bufferand 125mM sodium 
chloride as a tonicity agent.
Placebo is supplied in a PFS with a 25G ½-inch thin-wall needle, containing an injectable 
volume of 1mL 0.9% saline for single use. Due to the difference in presentation and viscosity 
between CZP and PBO, special precautions will be taken in order to ensure maintained blinding 
of the study (unblinded/blinded site personnel and monitors).
7.2
Treatments to be administered
The study medication is to be administered every 2 weeks by sc injections.
Study injections will be administered by study site staff. Suitable areas for sc injections are the 
upper arm, lateral abdominal wall, and upper outer thigh. During each dosing visit if 2 injections 
are being administered, each of the 2 injections should be administered at a separate injection 
site.
Injections should be administered with a minimum of 10 days between study injections. Each 
deviation less than these minimum timeframes must be discussed immediately with the Medical 
Monitor.
A pharmacy manual will be provided to each site containing instructions regarding drug 
preparation and dosing.
7.3
Packaging
Certolizumab pegol and PBO are packaged and labelled according to Good Manufacturing 
Practice (GMP) guidelines and applicable laws or regulations. They are suitably packaged in 
such a way as to protect the IMPs from deterioration during transportation and storage.
7.4 
Labeling
Clinical drug supplies will be labeled in accordance with the current International Council for
Harmonisation (ICH) guidelines on Good Clinical Practice (GCP) and GMPand will include any 
locally required statements. If necessary, labels will be translated into the local language.
7.5
Handling and storage requirements
Investigational medicinal product (IMP) must be stored under the conditions defined in the IMP 
Handling Manual.
The Investigator(or designee) is responsible for the safe and proper storage of IMP at the site. 
Investigational medicinal product stored by the Investigatoris to be kept in a secured area with 
limited access.
Appropriate storage conditions must be ensured by controlled temperature and by completion of 
a temperature log in accordance with local requirements on a regular basis, per Study Manuals, 
showing minimum and maximum temperatures reached over the time interval.
Study drug will be shipped to the study sites in temperature controlled containers. Out-of-range 
shipping or storage conditions must be brought to the attention of the Sponsoror designee, 
immediately. Authorization to use any out-of-range IMP must be documented and received prior 
to dispensing or administering the IMP at the study site.
REDACTED COPY 
Certolizumab pegol and PBO are packaged and labelled according to 
REDACTED COPY 
Certolizumab pegol and PBO are packaged and labelled according to 
guidelines and applicable laws or regulations. They
REDACTED COPY 
guidelines and applicable laws or regulations. They
 as to protect the IMPs from deterioration during transp
REDACTED COPY 
 as to protect the IMPs from deterioration during transp
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 site staff. Suitable areas for sc injectio
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 site staff. Suitable areas for sc injections are the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ns are the 
and upper outer thigh. During each dosing visit
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and upper outer thigh. During each dosing visitif 2 injections 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
if 2 injections 
, each of the 2 injections should be administered at a separate injection 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, each of the 2 injections should be administered at a separate injection 
imum of 10 days between study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
imum of 10 days between study injections. Each 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 injections. Each 
imum of 10 days between study injections. Each 
imum of 10 days between study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
imum of 10 days between study injections. Each 
imum of 10 days between study
deviation less than these minimum timeframes must be discussed immediately
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
deviation less than these minimum timeframes must be discussed immediately
 manual will be provided to each site containing instructions regarding drug 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 manual will be provided to each site containing instructions regarding drug 
Certolizumab pegol and PBO are packaged and labelled according to 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Certolizumab pegol and PBO are packaged and labelled according to 
guidelines and applicable laws or regulations. They
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
guidelines and applicable laws or regulations. They
 as to protect the IMPs from deterioration during transp
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 as to protect the IMPs from deterioration during transp
Clinical drug supplies will be labeled in accordance with the current International 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Clinical drug supplies will be labeled in accordance with the current International 
Harmonisation (ICH) guidelines on Good Clinical Practice (GCP) and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Harmonisation (ICH) guidelines on Good Clinical Practice (GCP) and 
f necessary
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
f necessary
Handling and storage requirements
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Handling and storage requirements
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigational medicinal product
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigational medicinal product
Investigator
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator(or designee) is responsible for the safe and proper storage of IMP at the site. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(or designee) is responsible for the safe and proper storage of IMP at the site. 
Investigational medicinal product stored b
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigational medicinal product stored b
limited access.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
limited access.
Appropriate storage conditions must be
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Appropriate storage conditions must be
a temperature log in accordance with local requirements on a regular basis, per Study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
a temperature log in accordance with local requirements on a regular basis, per Study
showing minimum and maximum temperatures reached over the time interval.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
showing minimum and maximum temperatures reached over the time interval.


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 40of 119
7.6
Drug accountability
A Drug Accountability form will be used to record IMP dispensing and return information on a 
by-subject basis and will serve as source documentation during the course of the study. Details of 
any IMP lost, damaged(due to breakage or wastage), not used, partially used, disposed of at the 
study site, or returned to the Sponsoror designee must also be recorded on the appropriate forms. 
All supplies and pharmacy documentation must be made available throughout the study for UCB 
(or designee) to review.
All study drug documentation (eg, shipping receipts, drug accountability logs, IRT
randomization materials) must be maintained and accessed by unblinded, trained site personnel 
only. Designated, unblinded site personnel must be appropriately trained and licensed (per 
country guidelines) to administer injections.
Blinded study staff may be delegated the responsibility to receive, inventory and destroy the used 
kits. The packaging identifies each kit by a unique number that does not correlate to the contents 
and therefore, does not unblind study site staff. Unblinded study staff will be responsible for 
preparation (breaking tamper proof sticker on kit, etc) and administration of the clinical trial 
material to the subject, including recording the administration information on source documents.
The Investigator(or designee) is responsible for retaining all used, unused, and partially used 
containers of IMP until returned or destroyed.
The Investigatormay assign some of the Investigator’s duties for drug accountability at the study 
site to an appropriate pharmacist/designee.
The Investigatormust ensure that the IMP is used only in accordance with the protocol.
Periodically, and/or after completion of the clinical phase of the study, all used (including empty 
containers)/partially used,unusedand unused IMP containers must be reconciled and returned to 
the Sponsor, or designee, preferably in their original package. Onsite destruction of used kits 
only may be allowed with prior approval from the Sponsoror designee after reconciliation.
7.7
Procedures for monitoring subject compliance
Study medication will be administered in the clinic and compliance will be determined at the 
visit by study personnel. Drug accountability must be recorded on the Drug Accountability form.
If a subject is found tobe persistently noncompliant (missing 2 or more doses during the first 
16 weeks of treatment and missing 3 or more doses from Week 16 the reafter), the Sponsor, in 
conjunction with the Investigator, will make a decision as to whether the subject should be 
withdrawn from the study.
7.8
Concomitant medications/treatments
All medications (including over-the-counter drugs, vitamins, antacids) being taken at the time of 
the Baseline Visit or during study participation will be collected and recorded on the eCRF. 
Medication entries should be specific to the generic name (if a combination drug, then marketed 
product name) and will include the dose, unit, and frequency of administration and/or treatment, 
route of administration, start date, discontinuation date, and indication.
The Investigatorshould examine the acceptability of all concomitant procedures, medications, 
topical preparations,and dietary supplements not explicitly prohibited in this study. 
REDACTED COPY 
Investigator
REDACTED COPY 
Investigator’s duties for drug accountability
REDACTED COPY 
’s duties for drug accountability
must ensure that the IMP is used only
REDACTED COPY 
must ensure that the IMP is used only
completion of the clinical phase of the stud
REDACTED COPY 
completion of the clinical phase of the stud
and unused IMP containers must be reconciled and returned to 
REDACTED COPY 
and unused IMP containers must be reconciled and returned to 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 for UCB 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 for UCB 
y unblinded, trained site personnel 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y unblinded, trained site personnel 
y trained and licensed (per 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y trained and licensed (per 
 to receive, inventory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 to receive, inventory and destroy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 and destroy
 to receive, inventory and destroy
 to receive, inventory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 to receive, inventory and destroy
 to receive, inventory
y a unique number that does not correlate to the contents 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y a unique number that does not correlate to the contents 
 staff will be responsible for 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 staff will be responsible for 
preparation (breaking tamper proof sticker on kit, etc) and administration of the clinical t
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
preparation (breaking tamper proof sticker on kit, etc) and administration of the clinical t
material to the subject, including recording the administration information on source documents.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
material to the subject, including recording the administration information on source documents.
(or designee) is responsible for retaining all used, unused, and partiall
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(or designee) is responsible for retaining all used, unused, and partiall
’s duties for drug accountability
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
’s duties for drug accountability
must ensure that the IMP is used only
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
must ensure that the IMP is used only
completion of the clinical phase of the stud
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
completion of the clinical phase of the stud
and unused IMP containers must be reconciled and returned to 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and unused IMP containers must be reconciled and returned to 
y in their original package. Onsite destruction of u
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y in their original package. Onsite destruction of u
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 be allowed with prior approval from the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 be allowed with prior approval from the 
Procedures for monitoring subject compliance
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Procedures for monitoring subject compliance
 medication will be administered in the clinic and compliance will be determined at the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 medication will be administered in the clinic and compliance will be determined at the 
rsonnel. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
rsonnel. Drug accountability must be recorded on the Drug Accountability
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Drug accountability must be recorded on the Drug Accountability
If a subject is found to
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
If a subject is found tobe persistently
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
be persistently
weeks of treatment and missing 3 or more doses from Week 16 thereafter
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
weeks of treatment and missing 3 or more doses from Week 16 thereafter
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
conjunction with the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
conjunction with the 
withdrawn from the study.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
withdrawn from the study.
All medications (including over
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
All medications (including over
the Baseline Visit or during study participation will be collected and recorded on the eCRF. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
the Baseline Visit or during study participation will be collected and recorded on the eCRF. 
Medication entries should be specific to the generic name (if a combination drug, then marketed 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Medication entries should be specific to the generic name (if a combination drug, then marketed 


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 41of 119
In order to ensure that appropriate concomitant therapy is administered, subjects will be 
instructed to consult with the Investigatorprior to taking any medication (either 
self-administered nonprescription drugs or prescription therapy prescribed by another physician).
7.8.1 
Permitted concomitant treatments (medications and therapies)
The use of concomitant medications for medical conditions (eg, hypertension, diabetes, acute 
infections) or treatment of an AE is permitted during this study as long as medications are not 
explicitly prohibited by the protocol. The following concomitant medication is permitted during 
the study:
NSAIDs, acetaminophen, paracetamol and opioids for PsA
7.8.1.1
Permitted concomitant treatments (medications and therapies) for 
subjects with moderate to severe chronic plaque PSO who escape
from double-blind treatment
For subjects who escape from double-blind treatment, the following medications are permitted:
Moderate potency (class III to V) topical corticosteroids for PSO
Vitamin D analogues and topical retinoids for PSO
Keratolytic and coal tar for PSO
7.8.1.2
Permitted concomitant treatments (medications and therapies) for 
subjects with generalized pustular PSO or erythrodermic PSO
The use of systemic retinoids, systemic immunosuppressants agents (eg, methotrexate, 
cyclosporine, azathioprine),and/or systemic corticosteroids (at a daily dose ≤10mg/day of 
prednisone or its equivalent) are allowed provided the subjecthad been using such medication(s) 
since before starting the study. Dose reduction of these drugs is allowed as well; however, dose 
increase after dose reduction is limited to the level at the start of the study.
7.8.2 
Prohibited concomitant treatments (medications and therapies)
Prohibited concomitant treatments (medications and therapies) differ based on whether the 
subject is in the moderate to severe chronic plaque PSO, generalized pustular PSO,or 
erythrodermic PSOtreatment group. 
7.8.2.1
Prohibited concomitant treatments (medications and therapies) for 
subjects with moderate to severe chronic plaque PSO
The following concomitant medications are prohibited for subjects with moderate to severe 
chronic plaque PSO:
Systemic retinoids
Systemic treatmentsfor PSO
Systemic immunosuppressants agents (eg, methotrexate, cyclosporine, azathioprine, 
thioguanine)
Systemic corticosteroids
Phototherapy or chemophototherapy
REDACTED COPY 
Permitted concomitant treatments (medications and therapies) for 
REDACTED COPY 
Permitted concomitant treatments (medications and therapies) for 
subjects with generalized pustular PSO or ery
REDACTED COPY 
subjects with generalized pustular PSO or ery
stemic immunosuppressants agents (eg, methotrexate, 
REDACTED COPY 
stemic immunosuppressants agents (eg, methotrexate, 
temic corticosteroids (at a dail
REDACTED COPY 
temic corticosteroids (at a dail
prednisone or its equivalent) are allowed provided the 
REDACTED COPY 
prednisone or its equivalent) are allowed provided the 
. Dose reduction of these drugs is allowed as well; however, dose 
REDACTED COPY 
. Dose reduction of these drugs is allowed as well; however, dose 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 the protocol. The following concomitant medication is permitted during 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 the protocol. The following concomitant medication is permitted during 
d therapies) for 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
d therapies) for 
with moderate to severe chronic plaque PSO 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
with moderate to severe chronic plaque PSO who escape
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
who escape
, the following medications are permitted:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, the following medications are permitted:
corticosteroids for PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
corticosteroids for PSO
Permitted concomitant treatments (medications and therapies) for 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Permitted concomitant treatments (medications and therapies) for 
subjects with generalized pustular PSO or ery
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
subjects with generalized pustular PSO or ery
stemic immunosuppressants agents (eg, methotrexate, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
stemic immunosuppressants agents (eg, methotrexate, 
temic corticosteroids (at a dail
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
temic corticosteroids (at a dail
prednisone or its equivalent) are allowed provided the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
prednisone or its equivalent) are allowed provided the 
. Dose reduction of these drugs is allowed as well; however, dose 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
. Dose reduction of these drugs is allowed as well; however, dose 
increase after dose reduction is limited to the level at the start of the stud
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
increase after dose reduction is limited to the level at the start of the stud
Prohibited concomitant treatments (medications and therapies)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Prohibited concomitant treatments (medications and therapies)
ant treatments (medications and therapies) differ based on whether the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ant treatments (medications and therapies) differ based on whether the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
subject is in the moderate to severe chronic plaque PSO, g
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
subject is in the moderate to severe chronic plaque PSO, g
treatment group. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
treatment group. 
Prohibited concomitant treatments (medications and therapies)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Prohibited concomitant treatments (medications and therapies)
subjects with moderate to 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
subjects with moderate to 
The following concomitant medications are prohibited
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The following concomitant medications are prohibited
chronic plaque PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
chronic plaque PSO
Sy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Systemic retinoids
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
stemic retinoids

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Sy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Sy


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 42of 119
Anti-TNFs: infliximab(including biosimilar), adalimumab, golimumab, etanercept 
Other biologics and systemic therapies: ustekimumab, secukinumab,ixekizumab, and 
brodalumab
Any other antipsoriatic agent (systemic) under investigation (or approved after the 
protocol is approved)
Rituximab
Topical agents for dermatologic use:
High potency topical corticosteroids (class I and II)
Any other antipsoriatic agent (topical) under investigation (or approved after the protocol 
is approved)
Moderate potency (class III to V) topical corticosteroids 
Vitamin D analogues and topical retinoids 
Keratolitic and coal tar 
7.8.2.2
Prohibited concomitant treatments (medications and therapies) for 
subjects with generalized pustular PSO or erythrodermic PSO
The following concomitant medications are prohibited for subjects with generalized pustular 
PSO or erythrodermic PSO:
Systemic treatmentsfor PSO

Phototherapy or chemophototherapy

Granulocyte and monocyte adsorption apheresis

Anti-TNFs: infliximab(including biosimilar), adalimumab, golimumab, etanercept)

Other biologics and systemic therapies: ustekimumab, secukinumab, ixekizumab, and 
brodalumab

Any other antipsoriatic agent (systemic) under investigation (or approved after the 
protocol is approved)

Antipsoriatic agent (topical) under investigation (or approved after the protocol is 
approved)

Rituximab
7.9 
Blinding
Due to differences in presentation of the IMP (CZP andPBO), special precautions will be taken 
to ensure study blinding, and study sites will have blinded and unblinded personnel.
Certolizumab pegol and placebo injections will be prepared and administered at the study sites 
by unblinded dedicated study personnel who will only be responsible for dosing and drug 
accountability. 
REDACTED COPY 
subjects with generalized pustular PSO or ery
REDACTED COPY 
subjects with generalized pustular PSO or ery
The following concomitant medications are prohibited
REDACTED COPY 
The following concomitant medications are prohibited
emophototherapy
REDACTED COPY 
emophototherapy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(or approved after the protocol 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(or approved after the protocol 
Prohibited concomitant treatments (medications and therapies) for 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Prohibited concomitant treatments (medications and therapies) for 
subjects with generalized pustular PSO or ery
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
subjects with generalized pustular PSO or ery
The following concomitant medications are prohibited
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The following concomitant medications are prohibitedfor subjects with generalized 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for subjects with generalized 
emophototherapy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
emophototherapy
te and monocyte adsorption apheresis
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
te and monocyte adsorption apheresis
(including biosimilar)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(including biosimilar)
ys
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ystemic therapies: ustekimumab, secukinumab, ixekizumab, and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
temic therapies: ustekimumab, secukinumab, ixekizumab, and 
antipsoriatic agent (s
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
antipsoriatic agent (s
protocol is approved)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
protocol is approved)
Antipsoriatic agent (topical) under investigation
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Antipsoriatic agent (topical) under investigation
approved)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
approved)
Rituximab
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Rituximab
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
7.9
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
7.9
Due to differences in presentation of the IMP 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Due to differences in presentation of the IMP 
to ensure stud
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
to ensure stud


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 43of 119
Study sites will be required to have a written blinding plan in place, signed by the Principal 
Investigator, which will detail the site’s steps for ensuring that the double-blindnature of the 
study is maintained. 
During the study, the Sponsor will provide blinded and unblinded site monitors for the purposes 
of verifying safety, efficacy, and drug administration and documentation records. Blinded study 
monitors and study site personnel, blinded to treatment assignment, will not discuss or have 
access to any drug-related information.
When the study is unblinded after the final subject completes the Week 24 Visit, preassigned 
PS0017 study team members will have access to subject-level data. This operational unblinding 
to treatment assignment will pertain to preassigned clinical PS0017 study team members, but 
will not extend to blinded staff at the investigational sites.
While the blinding of Sponsor clinical study team members is important for ensuring the 
integrity of data collection and analysis in a controlled study, this unblinding is considered 
acceptable because the primary evaluation of efficacy, upon which sample size calculations were 
based, will be performed in a blinded manner using Week 24data. Additionally, because 
investigational site staff collecting and recording study data remain blinded, those data will not 
be impacted by the unblinding of selected Sponsor clinical study team members. Finally, to 
ensure that unblinding of study team members did not impact the primary efficacyoutcome, 
sensitivity analyses will be outlined in the SAP to evaluate what, if any, impact there was on the 
results based on queries that resulted in changes to the data following the unblinding of Week 24
data.
Further details are provided in the study manuals and site blinding plan.
7.9.1 
Procedures for maintaining and breaking the treatment blind
7.9.1.1
Maintenance of study treatment blind
All subject treatment details will be allocated and maintained by the interactive response 
technology (IRT) system.
7.9.1.2
Breaking the treatment blind in an emergency situation
The integrity of this clinical study must be maintained by observing the treatment blind. In the 
event of an emergency, it will be possible to determine to which treatment arm and dose the 
subject has been allocated by contacting the IRT.All sites will be provided with details of how to 
contact the system for code breaking at the start ofthe study. The Medical Monitor or equivalent 
should be consulted prior to unblinding, whenever possible.
The CPM will be informed immediately via the IRT when a code is broken, but will remain 
blinded to specific treatment information. Any unblinding of the IMP performed by the 
Investigator must be recorded in the source documents and on the Study  Termination CRF page.
7.10
Randomization and numbering of subjects
An IRT will be used for assigning eligible subjects to a treatment regimen (as applicable) based 
on a predetermined production randomization and/or packaging sche dule provided by UCB(or 
designee). The randomization schedule will be produced by the IRT vendor. Subject treatment 
assignment will be stratified by prior biologic exposure (yes/no) and psoriatic arthritis (yes/no). 
REDACTED COPY 
 team members did not impact the primary
REDACTED COPY 
 team members did not impact the primary
es will be outlined in the SAP to evaluate what, if any
REDACTED COPY 
es will be outlined in the SAP to evaluate what, if any
results based on queries that resulted in changes to the data following the unblinding 
REDACTED COPY 
results based on queries that resulted in changes to the data following the unblinding 
 manuals and site blinding plan.
REDACTED COPY 
 manuals and site blinding plan.
REDACTED COPY 
Procedures for maintaining and breaking the treatment blind
REDACTED COPY 
Procedures for maintaining and breaking the treatment blind
Maintenance of study treatment blind
REDACTED COPY 
Maintenance of study treatment blind
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 is unblinded after the final subject completes the Week 24 Visit, preassigned 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 is unblinded after the final subject completes the Week 24 Visit, preassigned 
This operational unblinding 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This operational unblinding 
 team members, but 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 team members, but 
ortant for ensuring the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ortant for ensuring the 
, this unblinding is considered 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, this unblinding is considered 
, upon which sample size calculations were 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, upon which sample size calculations were 
. Additionally
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
. Additionally
investigational site staff collecting and recording study data remain blinded, those data will not 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
investigational site staff collecting and recording study data remain blinded, those data will not 
y the unblinding of selected Sponsor clinical study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y the unblinding of selected Sponsor clinical study team members. Finall
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 team members. Finall
y the unblinding of selected Sponsor clinical study team members. Finall
y the unblinding of selected Sponsor clinical study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y the unblinding of selected Sponsor clinical study team members. Finall
y the unblinding of selected Sponsor clinical study
 team members did not impact the primary
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 team members did not impact the primary
es will be outlined in the SAP to evaluate what, if any
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
es will be outlined in the SAP to evaluate what, if any
results based on queries that resulted in changes to the data following the unblinding 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
results based on queries that resulted in changes to the data following the unblinding 
 manuals and site blinding plan.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 manuals and site blinding plan.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Procedures for maintaining and breaking the treatment blind
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Procedures for maintaining and breaking the treatment blind
Maintenance of study treatment blind
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Maintenance of study treatment blind
All subject treatment details will be allocated and maintained by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
All subject treatment details will be allocated and maintained by
Breaking the treatment blind in an emergency
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Breaking the treatment blind in an emergency
 of this clinical study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 of this clinical study
event of an emergency
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
event of an emergency, it will be possible to determine to which treatment arm and dose the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, it will be possible to determine to which treatment arm and dose the 
subject has been allocated by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
subject has been allocated by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ys
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ystem for code breaking at the start of
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
tem for code breaking at the start of
should be consulted prior to unblinding, whenever possible.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
should be consulted prior to unblinding, whenever possible.
The CPM will be informed immediately
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The CPM will be informed immediately
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
blinded to specific treatment information. An
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
blinded to specific treatment information. An
Investigator
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator
7.10
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
7.10


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 44of 119
The IRT will generate individual assignments for subject kits of IMP, as appropriate, according 
to the visit schedule.
To enroll a subject (Visit 1), the Investigatoror designee will contact the IRT and provide brief 
details about the subject to be enrolled. Each subject will receive a 5-digit number assigned at 
screening that serves as the subject identifier throughout the study. The subject number will be 
required in all communication between the Investigatoror designee and the IRT regarding a 
particular subject. Subject numbers and kit numbers will be tracked via the IRT. 
To randomize a subject, the Investigatoror designee will contact the IRT and provide brief 
details about the subject to be randomized. The IRT will automatically inform the Investigator or 
designee of the subject’s randomization number. The IRT will allocate kit numbers to the subject 
based on the subject number during the course of the study. The randomization number must be 
incorporated into the CRF.
8
STUDY PROCEDURES BY VISIT 
After the Baseline Visit, subjects will have study assessments and procedures every 2 weeks 
through the Week52 Visit.
Visit windows of ±3 days on either side of the scheduled dosing are permitted; however, the 
Investigatorshould try tokeep the subjects on the original dosing schedule. The window of 
±3 days is relative to Baseline and applicable for all subsequent visits. Changes to the dosing 
schedule outside of the 3-day window must be discussed with the Medical Monitor and may 
resultin subject withdrawal. 
For the Safety Follow-up Visit (10 weeks after finaldose), the visit should occur no more 
than 3 days prior to the scheduled visit date and within 14 days after the scheduled visit date 
(-3days/+14 days).
8.1 
Visit 1 (Screening)
Prior to any study activities, subjects will be asked to read and sign an ICF that has been 
approved by an IRB and the Sponsorand which complies with regulatory requirements.
The period between the Screening and Baseline Visits should not exceed 5 weeks. 
Assessments at the Screening Visit include:
Confirm informed consent
Assess inclusion/exclusion criteria
Demographic data
Medical history
Medical procedures
Concomitant medications
AEs (only if it occurred after signing informed consent)
Psoriasis history
Blood pressure, pulse, and temperature
REDACTED COPY 
keep the subjects on the original dosing schedule. The window of 
REDACTED COPY 
keep the subjects on the original dosing schedule. The window of 
s is relative to Baseline and applicable for all subsequent visits. Changes to the dosing 
REDACTED COPY 
s is relative to Baseline and applicable for all subsequent visits. Changes to the dosing 
 window must be discussed with the Medical Monitor and may
REDACTED COPY 
 window must be discussed with the Medical Monitor and may
-up Visit (10 weeks after 
REDACTED COPY 
-up Visit (10 weeks after 
s prior to the scheduled visit date and within 14 day
REDACTED COPY 
s prior to the scheduled visit date and within 14 day
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and provide brief 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and provide brief 
Investigator
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator
will allocate kit numbers to the subject 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
will allocate kit numbers to the subject 
The randomization number must be 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The randomization number must be 
 assessments and procedures every
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 assessments and procedures every
Visit windows of ±3 days on either side of the scheduled dosing are permitted; however, the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Visit windows of ±3 days on either side of the scheduled dosing are permitted; however, the 
keep the subjects on the original dosing schedule. The window of 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
keep the subjects on the original dosing schedule. The window of 
s is relative to Baseline and applicable for all subsequent visits. Changes to the dosing 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
s is relative to Baseline and applicable for all subsequent visits. Changes to the dosing 
 window must be discussed with the Medical Monitor and may
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 window must be discussed with the Medical Monitor and may
-up Visit (10 weeks after 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
-up Visit (10 weeks after final
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
final
s prior to the scheduled visit date and within 14 day
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
s prior to the scheduled visit date and within 14 day
Screening
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Screening)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
)
 activities, subjects will be asked to read and sign an I
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 activities, subjects will be asked to read and sign an I
Sponsor
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Sponsor
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The period between the Screening and Baseline Visits should not exceed 5 weeks. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The period between the Screening and Baseline Visits should not exceed 5 weeks. 
essments at the Screening Visit include:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
essments at the Screening Visit include:
Confirm informed consent
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Confirm informed consent
Assess inclusion/exclusion criteria
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Assess inclusion/exclusion criteria
Demographic data
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Demographic data
Medical history
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Medical history

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Medical procedures
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Medical procedures


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 45of 119
12-lead ECG
Height
Weight
Hematology, biochemistry, and urine for clinical laboratory values, including a serum 
pregnancy test for women of childbearing potential, hepatitis B and C testing, HIV, HTLV-1 
testing, beta-D-glucan, and sialylated carbohydrate antigen KL-6
Physical examination, including evaluation for signs and symptoms of TB
Chest x-ray (not necessary if performed  within 3 months prior to Screening Visit and report 
is available)
IGRA
Subject TB questionnaire
PASI(will not be performed in subjects with generalized pustular PSO)
PGA(will not be performed in subjects with generalized pustular PSO)
BSAaffected by PSO (will not be performed in subjects with generalized pustular PSO)
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Pain, and PGADAfor 
subjects with PsA)
Physician PsA assessments (swollen and tender joint countsandPhGADAfor subjects with 
PsA)
Pustular and erythrodermic PSO assessments (JDA Severity Index for subjects with 
generalized pustular PSO)
IRTfor subject screening
Schedule Baseline visit within 5 weeks
8.2
Visit 2 (Baseline)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Review of inclusion/exclusion criteria and confirm study eligibility
Blood pressure 
Weight
Hematology, biochemistry, and urine for clinical laboratory values 
Urine pregnancy test for women of childbearing potential 
Plasma for PK and immunogenicity samples
Physical examination, including evaluation for signs and symptoms of TB
Subject TB questionnaire
REDACTED COPY 
, Patient’s Assessment of Arthritis Pain, and 
REDACTED COPY 
, Patient’s Assessment of Arthritis Pain, and 
sician PsA assessments (swollen and tender joint counts
REDACTED COPY 
sician PsA assessments (swollen and tender joint counts
throdermic PSO assessments (
REDACTED COPY 
throdermic PSO assessments (
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 if performed  within 3 months prior to Screening Visit and report 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 if performed  within 3 months prior to Screening Visit and report 
pustular PSO)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
pustular PSO)
pustular PSO)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
pustular PSO)
(will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(will not be performed in subjects with generalized 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
generalized 
, Patient’s Assessment of Arthritis Pain, and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, Patient’s Assessment of Arthritis Pain, and 
sician PsA assessments (swollen and tender joint counts
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sician PsA assessments (swollen and tender joint counts
throdermic PSO assessments (
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
throdermic PSO assessments (
Schedule Baseline visit within 5 weeks
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Schedule Baseline visit within 5 weeks
Visit 2 (Baseline)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Visit 2 (Baseline)
Subjects will have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
Review of inclusion/exclusion criteria 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Review of inclusion/exclusion criteria 
Blood pressure 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Blood pressure 
Weight
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Weight
Hematology
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Hematology

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 



UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 46of 119
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale 
BSA (will not be performed in subjects with generalized pustular PSO)
DLQI 
mNAPSI(for subjects with psoriatic nail disease)
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Pain, and PGADAfor 
subjects with PsA)
Physician PsA assessments (swollen and tender joint countsand PhGADAfor subjects with 
PsA)
Pustular and erythrodermic PSO assessments (JDA Severity Index for subjects with 
generalized pustular PSO)
Medical procedures
Concomitant medication
AEs
IRTto randomize subject and obtain kit number
Study drug administration (after all other visit assessments completed)
8.3
Visit 3 (Week 2)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Blood pressure 
Hematology, biochemistry, and urine for clinical laboratory values 
Plasma for PK and immunogenicity samples
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale 
DLQI
mNAPSI (for subjects with psoriatic nail disease)
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Pain, and PGADAfor 
subjects with PsA)
Physician PsA assessments (swollen and tender joint counts and PhGADAfor subjects with 
PsA)
REDACTED COPY 
to randomize subject and obtain kit number
REDACTED COPY 
to randomize subject and obtain kit number
g administration (after all other visit assessments completed)
REDACTED COPY 
g administration (after all other visit assessments completed)
Subjects will have the following procedures performed/recorded prior to administration of study
REDACTED COPY 
Subjects will have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
GADA
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
GADA
for subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for subjects with 
Index for subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Index for subjects with 
to randomize subject and obtain kit number
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
to randomize subject and obtain kit number
g administration (after all other visit assessments completed)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
g administration (after all other visit assessments completed)
Subjects will have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
, biochemistry
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, biochemistry, and urine for clinical laborator
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, and urine for clinical laborator
Plasma for PK and immunogenicity
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Plasma for PK and immunogenicity
 (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 (will not be performed in subjects with 
PGA (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
PGA (will not be performed in subjects with 
Itch Numeric Rating Scale 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Itch Numeric Rating Scale 
DLQI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
DLQI
mNAPSI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
mNAPSI

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 



UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 47of 119
Pustular and erythrodermic PSO assessments (Global Improvement Score,JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSO or CGI-Ifor subjects with 
erythrodermic PSO)
Medical procedures
Concomitant medication
AEs
IRT information
Study drug administration (after all other visit assessments completed)
8.4 
Visit 4 (Week 4)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Blood pressure 
Hematology, biochemistry, and urinefor clinical laboratory values, including beta-D-glucan
Urine pregnancy test for women of childbearing potential
Plasma for PK and immunogenicity samples
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale 
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Painand PGADAfor 
subjects with PsA)
Physician PsA assessments (swollen and tender joint counts and PhGADAfor subjects with 
PsA)
Pustular and erythrodermic PSO assessments (Global Improvement Score,JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSO or CGI-Ifor subjects with 
erythrodermic PSO)
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.5 
Visit 5(Week 6)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Hematology, biochemistry, and urine for clinical laboratory values 
REDACTED COPY 
 (will not be performed in subjects with 
REDACTED COPY 
 (will not be performed in subjects with generalized pustular PSO
REDACTED COPY 
generalized pustular PSO
PGA (will not be performed in subjects with 
REDACTED COPY 
PGA (will not be performed in subjects with 
DI
REDACTED COPY 
DI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
 values, including beta
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 values, including beta
test for women of childbearing potential
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
test for women of childbearing potential
generalized pustular PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
generalized pustular PSO
PGA (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
PGA (will not be performed in subjects with generalized pustular PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
generalized pustular PSO
, Patient’s
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, Patient’s
sician PsA assessments (swollen and tender joint counts and Ph
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sician PsA assessments (swollen and tender joint counts and Ph
throdermic PSO assessmen
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
throdermic PSO assessmen
for subjects with generalized pustular PSO or CGI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for subjects with generalized pustular PSO or CGI
hrodermic PSO)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
hrodermic PSO)
Medical procedures
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Medical procedures
Concomitant medication
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Concomitant medication
AEs
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
AEs
IRT
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
IRT

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 



UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 48of 119
Plasma for PK and immunogenicity samples
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.6 
Visit 6(Week 8)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Blood pressure
Hematology, biochemistry, and urine for clinical laboratory values 
Urine pregnancy test for women of childbearing potential
Plasma for PK and immunogenicity samples
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale 
DLQI
mNAPSI (for subjects with psoriatic nail disease)
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Pain, and PGADA for 
subjects with PsA)
Physician PsA assessments (swollen and tender joint counts and PhGADAfor subjects with 
PsA)
Pustular and erythrodermic PSO assessments (Global Improvement Score,JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSO or CGI-Ifor subjects with 
erythrodermic PSO)
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.7 
Visit 7(Week 10)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
REDACTED COPY 
generalized pustular PSO
REDACTED COPY 
generalized pustular PSO
will not be performed in subjects with 
REDACTED COPY 
will not be performed in subjects with generalized pustular PSO
REDACTED COPY 
generalized pustular PSO
 (for subjects with psoriatic nail disease)
REDACTED COPY 
 (for subjects with psoriatic nail disease)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
generalized pustular PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
generalized pustular PSO
generalized pustular PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
generalized pustular PSO
 (for subjects with psoriatic nail disease)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 (for subjects with psoriatic nail disease)
DI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
DI, Patient’
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, Patient’
sician PsA assessments (swollen and te
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sician PsA assessments (swollen and te
throdermic PSO assessments (Global I
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
throdermic PSO assessments (Global I
, and CGI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, and CGI-I
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
-Ifor subjects with generalized pustular PSO or CGI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for subjects with generalized pustular PSO or CGI
hrodermic PSO)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
hrodermic PSO)
Medical procedures
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Medical procedures
Concomitant medication
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Concomitant medication
AEs
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
AEs

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
IRT
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
IRT


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 49of 119
Hematology, biochemistry, and urine for clinical laboratory values 
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.8 
Visit 8(Week 12)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Blood pressure 
Hematology, biochemistry, and urine for clinical laboratory values, including beta-D-glucan
Urine pregnancy test for women of childbearing potential
Plasma for PK and immunogenicity samples
Chest x-ray
Subject TB questionnaire
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale 
DLQI
mNAPSI (for subjects with psoriatic nail disease)
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Pain, and PGADAfor 
subjects with PsA)
Physician PsA assessments (swollen and tender joint counts and PhGADA for subjects with 
PsA)
Pustular and erythrodermic PSO assessments (Global Improvement Score, JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSO or CGI-Ifor subjects with 
erythrodermic PSO)
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
REDACTED COPY 
 (will not be performed in subjects with 
REDACTED COPY 
 (will not be performed in subjects with 
PGA (will not be performed in subjects with 
REDACTED COPY 
PGA (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
, including beta-D-
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, including beta-D-
generalized pustular PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
generalized pustular PSO
PGA (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
PGA (will not be performed in subjects with generalized pustular PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
generalized pustular PSO
 (for subjects with psoriatic nail disease)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 (for subjects with psoriatic nail disease)
sA assessments (HAQ
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sA assessments (HAQ
sician PsA assessments (swollen and tender joint counts and PhGADA
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sician PsA assessments (swollen and tender joint counts and PhGADA
Pustular and ery
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Pustular and ery
, and CGI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, and CGI
yt
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ythrodermic PSO)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
hrodermic PSO)
Medical procedures
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Medical procedures

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Concomitant medication
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Concomitant medication


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 50of 119
8.9 
Visit 9(Week 14)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Hematology, biochemistry, and urine for clinical laboratory values 
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.10 
Visit 10(Week 16)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Blood pressure 
Weight
Hematology, biochemistry, and urine for clinical laboratory values 
Urine pregnancy test for women of childbearing potential
Subject TB questionnaire
Plasma for PK and immunogenicity samples
Physical examination, including evaluation for signs and symptoms of TB
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale 
DLQI 
mNAPSI (for subjects with psoriatic nail disease)
BSA affected by PSO (will not be performed in subjects with generalized pustular PSO)
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Pain, and PGADAfor 
subjects with PsA)
Physician PsA assessments (swollen and tender joint counts and PhGADA for subjects with 
PsA)
Pustular and erythrodermic PSO assessments (Global Improvement Score,JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSO or CGI-Ifor subjects with 
erythrodermic PSO)
Medical procedures
REDACTED COPY 
, and urine for clinical laboratory
REDACTED COPY 
, and urine for clinical laboratory
test for women of childbearing potential
REDACTED COPY 
test for women of childbearing potential
Plasma for PK and immunogenicity
REDACTED COPY 
Plasma for PK and immunogenicity samples
REDACTED COPY 
 samples
Plasma for PK and immunogenicity samples
Plasma for PK and immunogenicity
REDACTED COPY 
Plasma for PK and immunogenicity samples
Plasma for PK and immunogenicity
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administ
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administ
, and urine for clinical laboratory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, and urine for clinical laboratory
test for women of childbearing potential
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
test for women of childbearing potential
 samples
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 samples
n, including evaluation for signs and s
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
n, including evaluation for signs and s
 (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 (will not be performed in subjects with 
PGA (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
PGA (will not be performed in subjects with 
Itch Numeric Rating Scale 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Itch Numeric Rating Scale 
 (for subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 (for subjects with 
BSA affected b
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
BSA affected b
Subject P
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subject PsA assessments (HAQ
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sA assessments (HAQ
subjects with PsA
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
subjects with PsA

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Phy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Phy


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 51of 119
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.11 
Visit 11(Week 18)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.12 
Visit 12(Week 20)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Blood pressure 
Hematologyand biochemistry for clinical laboratory values 
Urine pregnancy test for women of childbearing potential
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale 
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Pain, and PGADA for 
subjects with PsA)
Physician PsA assessments (swollen and tender joint countsand PhGADAfor subjects with 
PsA)
Pustular and erythrodermic PSO assessments (Global Improvement Score,JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSO or CGI-Ifor subjects with 
erythrodermic PSO)
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
REDACTED COPY 
Subjects will have the following procedures performed/recorded prior to administration of study
REDACTED COPY 
Subjects will have the following procedures performed/recorded prior to administration of study
 for clinical laboratory
REDACTED COPY 
 for clinical laboratory
test for women of childbearing potential
REDACTED COPY 
test for women of childbearing potential
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
 drug administration (after all other visit assessments completed)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 drug administration (after all other visit assessments completed)
Subjects will have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
 for clinical laboratory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 for clinical laboratory
test for women of childbearing potential
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
test for women of childbearing potential
 (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 (will not be performed in subjects with 
PGA (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
PGA (will not be performed in subjects with 
Itch Numeric Rating Scale 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Itch Numeric Rating Scale 
Subject PsA assessments (
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subject PsA assessments (HAQ
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
HAQ
)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
)
sician PsA assessments (swollen and te
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sician PsA assessments (swollen and te
Pustular and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Pustular and 
Index
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Index, and CGI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, and CGI
er
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
eryt
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ythrodermic PSO)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
hrodermic PSO)

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Medical procedures
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Medical procedures

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 



UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 52of 119
8.13 
Visit 13(Week 22)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.14 
Visit 14 (Week 24)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Blood pressure 
12-lead ECG
Hematology, biochemistry, and urine (dipstick) for clinical laboratory values, including 
beta-D-glucan and sialylated carbohydrate antigen KL-6
Urine pregnancy test for women of childbearing potential 
Chest x-ray 
IGRA
Subject TB questionnaire
Plasma for PK and immunogenicity samples
Physical examination, including evaluation for signs and symptoms of TB
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale 
DLQI 
mNAPSI (for subjects with psoriatic nail disease)
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Pain, and PGADAfor 
subjects with PsA)
Physician PsA assessments (swollen and tender joint counts and PhGADAfor subjects with 
PsA)
Pustular and erythrodermic PSO assessments (Global Improvement Score,JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSO or CGI-Ifor subjects with 
erythrodermic PSO)
REDACTED COPY 
for cli
REDACTED COPY 
for cli
ydrate antigen KL
REDACTED COPY 
ydrate antigen KL
test for women of childbearing potential 
REDACTED COPY 
test for women of childbearing potential 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
nical laboratory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
nical laboratory
ydrate antigen KL
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ydrate antigen KL-6
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
-6
test for women of childbearing potential 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
test for women of childbearing potential 
Plasma for PK and immunogenicity
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Plasma for PK and immunogenicity samples
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 samples
Plasma for PK and immunogenicity samples
Plasma for PK and immunogenicity
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Plasma for PK and immunogenicity samples
Plasma for PK and immunogenicity
including evaluation for signs and s
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
including evaluation for signs and s
 (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 (will not be performed in subjects with 
PGA (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
PGA (will not be performed in subjects with 
Itch Numeric Rating Scale 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Itch Numeric Rating Scale 
mNAPSI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
mNAPSI (for subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 (for subjects with 
Subject P
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subject P
subjects with PsA
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
subjects with PsA

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 



UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 53of 119
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.15 
Visit 15(Week 26)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.16 
Visit 16(Week 28)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Blood pressure 
Hematologyandbiochemistry for clinical laboratory values 
Urine pregnancy test for women of childbearing potential 
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale 
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Pain, and PGADAfor 
subjects with PsA)
Physician PsA assessments (swollen and tender joint counts and PhGADAfor subjects with 
PsA)
Pustular anderythrodermic PSO assessments (Global Improvement Score,JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSO or CGI-Ifor subjects with 
erythrodermic PSO)
Medical procedures
Concomitant medication
AEs
IRTinformation
REDACTED COPY 
Subjects will have the following procedures performed/recorded prior to administration of study
REDACTED COPY 
Subjects will have the following procedures performed/recorded prior to administration of study
 for clinical laboratory
REDACTED COPY 
 for clinical laboratory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
her visit assessments completed)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
her visit assessments completed)
Subjects will have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
 for clinical laboratory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 for clinical laboratory
test for women of childbearing potential 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
test for women of childbearing potential 
 (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 (will not be performed in subjects with 
PGA (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
PGA (will not be performed in subjects with 
Itch Numeric Rating Scale 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Itch Numeric Rating Scale 
Subject PsA assessments (HAQ
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subject PsA assessments (HAQ
subjects with PsA
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
subjects with PsA)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
)
sician PsA assessments (swollen and te
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sician PsA assessments (swollen and te
Pustular and
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Pustular and
Index
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Index
er
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
eryt
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
yt

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 



UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 54of 119
Study drug administration (after all other visit assessments completed)
8.17 
Visit 17(Week 30)
Subjects will have the following procedures performed/recorded prior to admin istration of study 
drug:
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.18 
Visit 18(Week 32)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Blood pressure 
Hematology, biochemistry, and urine (dipstick) for clinical laboratory values 
Urine pregnancy test for women of childbearing potential
Subject TB questionnaire
Plasma for PK and immunogenicity samples
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale 
DLQI 
mNAPSI (for subjects with psoriatic nail disease)
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Pain, and PGADAfor 
subjects with PsA)
Physician PsA assessments (swollen and tender joint counts and PhGADAfor subjects with 
PsA)
Pustular anderythrodermic PSO assessments (Global Improvement Score,JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSO or CGI-Ifor subjects with 
erythrodermic PSO)
Medical procedures
Concomitant medication
AEs
IRTinformation
REDACTED COPY 
for clinical laboratory
REDACTED COPY 
for clinical laboratory
test for women of childbearing potential
REDACTED COPY 
test for women of childbearing potential
 samples
REDACTED COPY 
 samples
 (will not be performed in subjects with 
REDACTED COPY 
 (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
have the following procedures performed/recorded prior to administration of study
for clinical laboratory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for clinical laboratory
test for women of childbearing potential
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
test for women of childbearing potential
 samples
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 samples
 (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 (will not be performed in subjects with 
PGA (will not be performed in subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
PGA (will not be performed in subjects with 
 (for subjects with p
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 (for subjects with p
Subject PsA assessments (HAQ
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subject PsA assessments (HAQ
subjects with PsA
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
subjects with PsA)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
)
sician PsA assessments (swollen and tender joint counts and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sician PsA assessments (swollen and tender joint counts and 
Pustular and
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Pustular and
Index
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Index
er
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
eryt
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
yt

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 



UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 55of 119
Study drug administration (after all other visit assessments completed)
8.19 
Visit 19(Week 34)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.20 
Visit 20(Week 36)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Hematology and biochemistry for clinical laboratory values 
Urine pregnancy test for women of childbearing potential
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale 
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Painand PGADA for 
subjects with PsA)
Physician PsA assessments (swollen and tender joint counts and PhGADA for subjects with 
PsA)
Pustular and erythrodermic PSO assessments(Global Improvement Score,JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSO or CGI-Ifor subjects with 
erythrodermic PSO)
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.21 
Visit 21(Week 38)
Subjects will have the following procedures performed/recorded prior to admin istration of study 
drug:
Medical procedures
REDACTED COPY 
for women of childbearing potential
REDACTED COPY 
for women of childbearing potential
generalized pustular PSO
REDACTED COPY 
generalized pustular PSO
PGA (will not be performed in subjects with 
REDACTED COPY 
PGA (will not be performed in subjects with generalized pustular PSO
REDACTED COPY 
generalized pustular PSO
DI
REDACTED COPY 
DI, Patient’
REDACTED COPY 
, Patient’
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
for women of childbearing potential
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for women of childbearing potential
generalized pustular PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
generalized pustular PSO
generalized pustular PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
generalized pustular PSO
, Patient’
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, Patient’
sician PsA assessments (swollen and te
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sician PsA assessments (swollen and te
throdermic PSO assessments
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
throdermic PSO assessments
for subjects with generalized pustular PSO or CGI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for subjects with generalized pustular PSO or CGI
hrodermic PSO)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
hrodermic PSO)
Medical procedures
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Medical procedures
Concomitant medication
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Concomitant medication
IRT
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
IRTinformation
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
information

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Study
8.21
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
8.21


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 56of 119
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.22 
Visit 22(Week 40)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Blood pressure 
Hematology, biochemistry, and urine (dipstick) for clinical laboratory values 
Urine pregnancy test for women of childbearing potential
Plasma for PK and immunogenicity samples
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale 
DLQI
mNAPSI (for subjects with psoriatic nail disease)
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Pain, and PGADA for 
subjects with PsA)
Physician PsA assessments (swollen and tender joint countsand PhGADAfor subjects with 
PsA)
Pustular and erythrodermic PSO assessments(Global Improvement Score, JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSO or CGI-Ifor subjects with 
erythrodermic PSO)
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.23 
Visit 23(Week 42)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Medical procedures
Concomitant medication
REDACTED COPY 
 (for subjects with psoriatic nail disease)
REDACTED COPY 
 (for subjects with psoriatic nail disease)
, Patient’s Assessment of Arthritis Pain, 
REDACTED COPY 
, Patient’s Assessment of Arthritis Pain, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
have the following procedures performed/recorded prior to administration of study
 values 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 values 
generalized pustular PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
generalized pustular PSO
generalized pustular PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
generalized pustular PSO
 (for subjects with psoriatic nail disease)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 (for subjects with psoriatic nail disease)
, Patient’s Assessment of Arthritis Pain, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, Patient’s Assessment of Arthritis Pain, 
sician PsA assessments (swollen and te
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sician PsA assessments (swollen and te
throdermic PSO assessments
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
throdermic PSO assessments
for subjects with generalized pustular PSO or CGI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for subjects with generalized pustular PSO or CGI
Medical procedures
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Medical procedures
Concomitant medication
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Concomitant medication
information
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
information
Study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Study
8.23
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
8.23
Subjects will have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 57of 119
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.24 
Visit 24(Week 44)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Hematology and biochemistry for clinical laboratory values 
Urine pregnancy test for women of childbearing potential
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale 
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Pain, and PGADA for 
subjects with PsA)
Physician PsA assessments (swollen and tender joint counts,and PGADA for subjects with 
PsA)
Pustular and erythrodermic PSO assessments(Global Improvement Score,JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSO orCGI-Ifor subjects with 
erythrodermic PSO)
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.25 
Visit 25 (Week 46)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
REDACTED COPY 
sician PsA assessments (swollen and tender joint counts
REDACTED COPY 
sician PsA assessments (swollen and tender joint counts
throdermic PSO assessments
REDACTED COPY 
throdermic PSO assessments(Global I
REDACTED COPY 
(Global I
for subjects with generalized pustular PSO or
REDACTED COPY 
for subjects with generalized pustular PSO or
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
)
s Assessment of Arthritis Pain, and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
s Assessment of Arthritis Pain, and 
sician PsA assessments (swollen and tender joint counts
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sician PsA assessments (swollen and tender joint counts,
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
,and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and 
(Global I
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(Global I
for subjects with generalized pustular PSO or
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for subjects with generalized pustular PSO or
 drug administration (after all other visit assessments completed)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 drug administration (after all other visit assessments completed)
Visit 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Visit 25
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
25(W
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(W
Subjects will have the following procedures 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures 
Medical procedures
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Medical procedures
Concomitant medication
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Concomitant medication

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
AEs
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
AEs

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 



UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 58of 119
8.26 
Visit 26(Week 48)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Weight
Hematology, biochemistry, and urine (dipstick) for clinical laboratory values 
Urine pregnancytest for women of childbearing potential
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale 
DLQI
mNAPSI (for subjects with psoriatic nail disease)
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Pain, and PGADA for 
subjects with PsA)
Physician PsA assessments (swollen and tender joint counts and PhGADAfor subjects with 
PsA)
Pustular and erythrodermic PSOassessments (Global Improvement Score,JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSO or CGI-Ifor subjects with 
erythrodermic PSO)
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.27 
Visit 27(Week 50)
Subjects will have the following procedures performed/recorded prior to admin istration of study 
drug:
Medical procedures
Concomitant medication
AEs
IRTinformation
Study drug administration (after all other visit assessments completed)
8.28 
Visit 28(Week 52)
Subjects will have the following procedures performed/recorded:
REDACTED COPY 
sician PsA assessments (swollen and tender joint counts and P
REDACTED COPY 
sician PsA assessments (swollen and tender joint counts and P
assessments 
REDACTED COPY 
assessments (Global I
REDACTED COPY 
(Global I
for subjects with generalized pustular PSO or CGI
REDACTED COPY 
for subjects with generalized pustular PSO or CGI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
s Assessment of Arthritis Pain, and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
s Assessment of Arthritis Pain, and 
sician PsA assessments (swollen and tender joint counts and P
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sician PsA assessments (swollen and tender joint counts and P
(Global I
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(Global I
for subjects with generalized pustular PSO or CGI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for subjects with generalized pustular PSO or CGI
 drug administration (after all other visit assessments completed)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 drug administration (after all other visit assessments completed)
Visit 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Visit 27
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
27
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(Week 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(Week 
have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
have the following procedures performed/recorded prior to administration of study
Medical procedures
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Medical procedures
Concomitant medication
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Concomitant medication

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
AEs
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
AEs

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


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Blood pressure 
12-lead ECG
Weight
Hematology, biochemistry, and urine(dipstick) for clinical laboratory values, including 
beta-D-glucan and sialylated carbohydrate antigen KL-6
Urine pregnancy test for women of childbearing potential
Chest x-ray
IGRA
Subject TB questionnaire
Plasma for PK and immunogenicity samples
Physical examination, including evaluation for signs and symptoms of TB
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale 
BSA affected by PSO (will not be performed in subjects with generalized pustular PSO)
DLQI
mNAPSI (for subjects with psoriatic nail disease)
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Pain, and PGADAfor 
subjects with PsA)
Physician PsA assessments (swollen and tender joint counts and PhGADAfor subjects with 
PsA)
Pustular and erythrodermic PSO assessments(Global Improvement Score, JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSO or CGI-Ifor subjects with 
erythrodermic PSO)
Medical procedures
Concomitant medication
AEs
IRTinformation
8.29 
Safety Follow-Up Visit 
Subjects will have the following procedures performed/recorded 10 weeks after the last dose of 
study drug:
Blood pressure
Physical examination
REDACTED COPY 
y PSO (will not be performed in subjects with generalized pustular PSO)
REDACTED COPY 
y PSO (will not be performed in subjects with generalized pustular PSO)
 (for subjects with psoriatic nail disease)
REDACTED COPY 
 (for subjects with psoriatic nail disease)
-
REDACTED COPY 
-DI
REDACTED COPY 
DI, Patient’
REDACTED COPY 
, Patient’
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ptoms of TB
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ptoms of TB
generalized pustular PSO
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generalized pustular PSO
generalized pustular PSO
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generalized pustular PSO
y PSO (will not be performed in subjects with generalized pustular PSO)
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y PSO (will not be performed in subjects with generalized pustular PSO)
 (for subjects with psoriatic nail disease)
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 (for subjects with psoriatic nail disease)
, Patient’
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, Patient’
sician PsA assessments (swollen and te
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sician PsA assessments (swollen and te
throdermic PSO assessments
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throdermic PSO assessments
for subjects with generalized pustular PSO or CGI
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for subjects with generalized pustular PSO or CGI
hrodermic PSO)
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hrodermic PSO)
Medical procedures
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Medical procedures
Concomitant medication
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Concomitant medication
AEs
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AEs
IRT
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IRT
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information
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information
8.29
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8.29
Subjects will have the following procedures perfor
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Subjects will have the following procedures perfor


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Hematology, biochemistry, and urine (dipstick) for clinical laboratory values
Urine pregnancy test for women of childbearing potential
Plasma for PK and immunogenicity samples
AEs
Medical procedures
Concomitant medications
8.30
Withdrawal Visit
Subjects will have the following procedures performed/recorded:
Blood pressure 
12-lead ECG
Weight
Hematology, biochemistry, and urine for clinical laboratory values, including beta-D-glucan 
and sialylated carbohydrate antigen KL-6
Urine pregnancy test for women of childbearing potential
Plasma for PK and immunogenicity samples
Physical examination, including evaluation for signs and symptoms of TB
Chest x-ray
IGRA
Subject TB questionnaire
PASI (will not be performed in subjects with generalized pustular PSO)
PGA (will not be performed in subjects with generalized pustular PSO)
Itch Numeric Rating Scale
DLQI 
BSA affected by PSO (will not be performed in subjects with generalized pustular PSO)
mNAPSI (for subjects with psoriatic nail disease)
Subject PsA assessments (HAQ-DI, Patient’s Assessment of Arthritis Pain, and Patient’s 
Global Assessment of Disease Activityfor subjects with PsA)
Physician PsA assessments (swollen and tender joint counts and Physician’s Global 
Assessment of Disease Activity for subjects with PsA)
Pustular and erythrodermic PSO assessments(Global Improvement Score, JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSO or CGI-Ifor subjects with 
erythrodermic PSO)
Medical procedures
REDACTED COPY 
test for women of childbearing potential
REDACTED COPY 
test for women of childbearing potential
 samples
REDACTED COPY 
 samples
sical examination, including evaluation for signs and s
REDACTED COPY 
sical examination, including evaluation for signs and s
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 values, in
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 values, in
test for women of childbearing potential
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test for women of childbearing potential
sical examination, including evaluation for signs and s
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sical examination, including evaluation for signs and s
 (will not be performed in subjects with 
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 (will not be performed in subjects with 
PGA (will not be performed in subjects with 
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PGA (will not be performed in subjects with 
Itch Numeric Rating Scale
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Itch Numeric Rating Scale
BSA affected b
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BSA affected b
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y PSO (will not be performed in subjects wit
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y PSO (will not be performed in subjects wit
mNAPSI
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mNAPSI (for subjects with psoriatic nail disease)
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 (for subjects with psoriatic nail disease)
Subject P
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Subject P
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Global Assessment of Disease Activity
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Global Assessment of Disease Activity

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Phy
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Phy


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Concomitant medication
AEs
IRTinformation
8.31
Unscheduled Visit
Unscheduled visits will be permitted during the study to allow follow-up of abnormal laboratory 
results or physical findings. Assessments during unscheduled visits may include:
Blood pressure 
Physical examination
Hematology, biochemistry, and urine for clinical laboratory values 
Urine pregnancy test for women of childbearing potential
AEs
Medical procedures
Concomitant medications
9
ASSESSMENT OF EFFICACY
All assessments will be completed as outlined in the Schedule of Study Assessments(Table 5‒
1).
9.1
Psoriasis Area Severity Index (PASI)
The PASI is the most commonly used and validated assessment for grading the severity of PSO
in clinical studies (Feldman, 2004). The PASI quantifies the severity and extent of the disease 
and weighs these with the percentage of BSA involvement. 
The percent area of involvement (BSA%) is estimated across 4 body areas; head, upper limbs, 
trunk, and lower limbs and then transferred into a grade (Table9‒1). 
The Investigatorassesses the average redness, thickness, and scaliness of lesions in each body 
area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. 
The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. 
REDACTED COPY 
CY
REDACTED COPY 
CY
All assessments will be completed as outlined in the Schedule of Stud
REDACTED COPY 
All assessments will be completed as outlined in the Schedule of Stud
rea Severity
REDACTED COPY 
rea Severity Index (
REDACTED COPY 
 Index (
rea Severity Index (
rea Severity
REDACTED COPY 
rea Severity Index (
rea Severity
 used and validated assessment for grading the severit
REDACTED COPY 
 used and validated assessment for grading the severit
in clinical studies (Feldman, 2004). The PASI quantifies the severit
REDACTED COPY 
in clinical studies (Feldman, 2004). The PASI quantifies the severit
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
up of abnormal laboratory
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up of abnormal laboratory
All assessments will be completed as outlined in the Schedule of Stud
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All assessments will be completed as outlined in the Schedule of Stud
 Index (
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 Index (
 used and validated assessment for grading the severit
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 used and validated assessment for grading the severit
in clinical studies (Feldman, 2004). The PASI quantifies the severit
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
in clinical studies (Feldman, 2004). The PASI quantifies the severit
and weighs these with the percentage of BSA involvement. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and weighs these with the percentage of BSA involvement. 
percent area of involvement (BSA%) is estimated across 4 body
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percent area of involvement (BSA%) is estimated across 4 body
trunk, and lower limbs and then transferred into a grade (
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
trunk, and lower limbs and then transferred into a grade (
assesses the average redness, thickness, and scaliness of lesions in each body
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
assesses the average redness, thickness, and scaliness of lesions in each body
point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very
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point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very
 score ranges from 0 to 72 with a higher score indic
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Table9‒1: Body areas for calculation of percent BSA for PASI
Body area
Details of area
BSA
Degree of 
involvement of 
body areaa
Head
Face, back of head
10% 
0 to 6
Upper limbs 
Left, right, upper lower, flexor 
surface, extensor surface
20% 
0 to 6
Trunk
Front, back, groin
30% 
0 to 6
Lower limbs 
Left, right, upper lower, flexor 
surface, extensor surface, including 
buttocks
40% 
0 to 6
Total
100% 
BSA=body surface area; PASI=Psoriasis Area and Severity Index
aWhere 0=none; 1=1% to <10% affected, 2=10% to <30% affected, 3=30% to <50% affected, 4=50% to <70% 
affected, 5=70% to <90% affected, 6=90% to 100% affected
The PASI50, PASI75, PASI90, and PASI100 responses are based on at least 50%, 75%, 90%, 
and 100% improvement in the PASI score.
9.2
BSA affected by psoriasis
The BSA palm method will be used for the evaluation of BSA as follows:
Body surface area estimation uses the palm (subject’s flat hand and thumb together, fingers 
included) as representing around 1% of the total BSA. 
Subject’s palm=1%
Head and neck=10% (10 palms)
Upper extremities=20 % (20 palms)
Trunk=30% (30 palms)
Lower extremities=40 % (40 palms) 
Total BSA=100%
9.3 
Physician’s Global Assessment of Psoriasis (PGA)
A static PGA for PSO will be used to assess disease severity in all subjects during the study. The 
Investigator will assess the overall severity of PSO using the following 5-point scale:
Physician’s Global Assessment
Score
Short Descriptor
Definition
0
Clear
No signs of psoriasis; post-inflammatory hyperpigmentation may be 
present
1
Almost clear
No thickening; normal to pink coloration; no to minimal focal 
scaling
REDACTED COPY 
The BSA palm method will be used for the evaluation of BSA as follows:
REDACTED COPY 
The BSA palm method will be used for the evaluation of BSA as follows:
y surface area estimation uses the palm (subject’s flat hand and thumb together, fingers 
REDACTED COPY 
y surface area estimation uses the palm (subject’s flat hand and thumb together, fingers 
included) as representing around 1% of the total BSA. 
REDACTED COPY 
included) as representing around 1% of the total BSA. 
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
0 to 6
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0 to 6
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0 to 6
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0 to 6
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
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affected, 3=30% to <50% affected, 4=50% to <70% 
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affected, 3=30% to <50% affected, 4=50% to <70% 
100 responses are based on at least 50%, 75%, 90%, 
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100 responses are based on at least 50%, 75%, 90%, 
The BSA palm method will be used for the evaluation of BSA as follows:
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The BSA palm method will be used for the evaluation of BSA as follows:
y surface area estimation uses the palm (subject’s flat hand and thumb together, fingers 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y surface area estimation uses the palm (subject’s flat hand and thumb together, fingers 
included) as representing around 1% of the total BSA. 
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included) as representing around 1% of the total BSA. 
(10 palms)
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(10 palms)
Upper extremities=20 % (20 palms)
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Upper extremities=20 % (20 palms)
Trunk=30% (30 palms)
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Trunk=30% (30 palms)
Lower extremities=40 % (40 palms) 
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Lower extremities=40 % (40 palms) 
Total BSA=100%
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Total BSA=100%
9.3 
Ph
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9.3 
Ph
A static PGA for PSO will be used to assess disease severit
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A static PGA for PSO will be used to assess disease severit
Investigator
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Investigator
Physician’s Global Assessment
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Physician’s Global Assessment
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2
Mild
Just detectable to mild thickening; pink to light red coloration; 
predominately fine scaling
3
Moderate
Clearly distinguishable to moderate thickening; dull to bright red,
clearly distinguishable to moderate thickening; moderate scaling
4
Severe
Severe thickening with hard edges; bright to deep dark red 
coloration; severe/coarse scaling covering almost all or all lesions
The PGA score will be entered into the eCRF. 
9.4
Dermatology Life Quality Index (DLQI)
The Dermatology Life Quality Index (DLQI) is a questionnaire designed for use in adult subjects 
with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how 
symptoms and treatment affect patients’ HRQoL. This instrument asks subjects about symptoms 
and feelings, daily activities, leisure, work and school, personal relationships and treatment. It 
has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 
30 with higher scores indicating lower HRQoL. A ≥4-point change in the DLQI score (DLQI 
response) has been reported to be meaningful for the patient (within-patient minimal important 
difference); a DLQI absolute score of ≤1 indicates DLQI remission (ie, no or small impact of the 
disease on HRQoL)(Basra et al, 2015). Subjects will be asked to complete the DLQI as outlined 
in the Schedule of Study Assessments(Table 5‒1).
Study site personnel should ensure that each subject completes the instrument prior to leaving the 
study site. 
Responses to the DLQI will beobtained, and studystaff should respond in the eCRF whether or 
not it was completed. 
9.5
Modified Nail Psoriasis Severity Index (mNAPSI)
Subjects with psoriatic nail disease will have a target nail selected at the Baseline visit for 
evaluation using the mNAPSI. The nail selected should be the most affected nail observed at 
Baseline and should be the only one assessed throughout the study. The target nail will be scored 
(0 to 3) for onycholysis/oil drop dyschromia, nail plate crumbling, and pitting and will be scored 
(0 for “no” or 1 for “yes”) for  leukonychia, nail bed hyperkeratosis, splinter haemorrhages and 
red spots in the lunula. 
Datawill be entered into the eCRF.
9.6
Itch Numeric Rating Scale
The Itch Numeric Rating Scale has been developed as a simple, single item instrument to assess 
the patient-reported severity of itch at its most intense during the past 24h period. Subjects 
indicate itch severity by circling the integer that best describes the worst level of itching due to 
PSO in the past 24h period on an 11-point scale anchored at 0, representing “no itching” and 10, 
representing “worst itch imaginable” (Kimball et al, 2016).
REDACTED COPY 
Subjects will be asked to complete the DLQI as outlined 
REDACTED COPY 
Subjects will be asked to complete the DLQI as outlined 
).
REDACTED COPY 
).
 site personnel should ensure that each subject completes the instrument prior to leaving the 
REDACTED COPY 
 site personnel should ensure that each subject completes the instrument prior to leaving the 
obtained
REDACTED COPY 
obtained, and study
REDACTED COPY 
, and study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ndex (DLQI) is a questionnaire designed for use in adult subjects 
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ndex (DLQI) is a questionnaire designed for use in adult subjects 
-specific questionnaire aimed at the evaluation of how 
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-specific questionnaire aimed at the evaluation of how 
atients’ HRQoL. This instrument asks subjects about s
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atients’ HRQoL. This instrument asks subjects about s
y activities, leisure, work and school, personal relationships and treatment. It 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y activities, leisure, work and school, personal relationships and treatment. It 
has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 
change in the DLQI score (DLQI 
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change in the DLQI score (DLQI 
response) has been reported to be meaningful for the patient (within
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response) has been reported to be meaningful for the patient (within-
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-patient minimal important 
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patient minimal important 
remission (ie, no or
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remission (ie, no or
Subjects will be asked to complete the DLQI as outlined 
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Subjects will be asked to complete the DLQI as outlined 
 site personnel should ensure that each subject completes the instrument prior to leaving the 
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 site personnel should ensure that each subject completes the instrument prior to leaving the 
, and study
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, and study
l Psoriasis Severity
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l Psoriasis Severity
Subjects with psoriatic nail disease will have a target nail selected at the Baseline visit for 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects with psoriatic nail disease will have a target nail selected at the Baseline visit for 
evaluation using the mNAPSI
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evaluation using the mNAPSI. The nail selected should be the most affected nail observed at 
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. The nail selected should be the most affected nail observed at 
Baseline and should be the only
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Baseline and should be the only one assessed throughout the study
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 one assessed throughout the study
Baseline and should be the only one assessed throughout the study
Baseline and should be the only
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Baseline and should be the only one assessed throughout the study
Baseline and should be the only
is/oil drop dy
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is/oil drop dy
(0 for “no” or 1 for “y
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(0 for “no” or 1 for “yes”) for  leukony
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es”) for  leukony
red spots in the lunula. 
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red spots in the lunula. 
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will be entered into the eCRF.
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will be entered into the eCRF.
Itch Numeric Rating Scale
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Itch Numeric Rating Scale
The Itch Numeric Rating Scale has been developed as a simple, single item instrument to assess 
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The Itch Numeric Rating Scale has been developed as a simple, single item instrument to assess 
the patient
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the patient
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indicate
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indicate
PSO in the past 24h period on an 11
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PSO in the past 24h period on an 11


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9.7
Assessments for subjects with PsA
9.7.1
ACR20, ACR50, and ACR70 responses 
For subjects with PsA, the ACR20, ACR50, and ACR70 response will be evaluated.The 
assessments are based on a 20%, 50%, 70% or greater improvement in the number of tender 
joints and swollen joints each and a 20%, 50%, 70% or greater improvement in at least 3 of the 5 
remaining core set measures: Patient’s and Physician’s Global Assessments of Disease Activity 
(Section 9.7.8  and Section9.7.7,respectively), Patient’s Assessment of Arthritis Pain 
(Section 9.7.6), HAQ-DI (Section 9.7.5), and C-reactive protein(CRP).
9.7.2
Swollen and tender joint counts (66/68 joints evaluation)
The following 68 joints are to be examined for tenderness by the Principal Investigator, another 
delegated physician, or an appropriately qualified medical professional (based on local 
requirements) who has had documented training on how to perform these assessments correctly. 
Preferably the same assessor should evaluate the subject at each arthritis assessment. 
Upper body (6): bilateral temporomandibular, sternoclavicular, and acromioclavicular joints
Upper extremity (34): bilateral shoulders, elbows, wrists (includes radiocarpal, and carpal 
and carpometacarpal bones considered as a single unit), MCP I, II, III, IV, and V, thumb 
interphalangeals (IP), PIP II, III, IV, and V and distal interphalangeals (DIP, II, III, IV, and 
V)
Lower extremity (28): bilateral hips, knees, ankles, tarsi (includes subtalar, transverse tarsal, 
and tarsometatarsal considered as a single unit), metatarsophalangeals (MTP I, II, III, IV, and 
V), great toe interphalangeals, and proximal interphalangeals (PIP II, III, IV, and V)
The assessment for swelling is made on 66 joints from the above list. The hip joints are 
excluded. Artificial and ankylosed joints are excluded from both tenderness and swelling 
assessments.
These assessments are completed as outlined in the Schedule of Study Assessments(Table 5‒1).
Table9‒2: Swelling and tenderness grading
Grade
Swelling response (66)
Tenderness response (68)
0
None
None (not tender)
1 
Detectable 
Positive (tenderness)
9.7.3
Swollen and tender joint counts (28 joints evaluation)
The following 28 joints will be used for calculation of the DAS28(CRP).
Upper extremity (26): bilateral shoulders, elbows, wrists (includes radiocarpal, and carpal 
and carpometacarpal bones considered as a single unit), MCP I, II, III, IV, and V, thumb 
interphalangeals (IP), PIP II, III, IV, and V
Lower extremity (2): knees
9.7.4
Disease Activity Score 
The DAS28(CRP) will be calculated using CRP (mg/dL) (see Table12‒1) and the Patient’s 
Global Assessment of Disease Activity (VAS) (see Section 9.7.8).
REDACTED COPY 
interphalangeals (IP), PIP II, III, IV, and V and distal interphalangeals 
REDACTED COPY 
interphalangeals (IP), PIP II, III, IV, and V and distal interphalangeals 
bilateral hips, knees, ankles, tarsi (includes subtalar, transverse tarsal, 
REDACTED COPY 
bilateral hips, knees, ankles, tarsi (includes subtalar, transverse tarsal, 
and tarsometatarsal considered as a single unit), metatarsophalangeals (MTP I
REDACTED COPY 
and tarsometatarsal considered as a single unit), metatarsophalangeals (MTP I
proximal interphalan
REDACTED COPY 
proximal interphalan
The assessment for swelling is made on 66
REDACTED COPY 
The assessment for swelling is made on 66
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sician’s Global Assessments of Disease Activity
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sician’s Global Assessments of Disease Activity
Investigator
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Investigator, another 
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, another 
y qualified medical professional (based on local 
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y qualified medical professional (based on local 
o has had documented training on how to perform these assessments correctly
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o has had documented training on how to perform these assessments correctly
 the same assessor should evaluate the subject at each arthritis assessment. 
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 the same assessor should evaluate the subject at each arthritis assessment. 
bilateral temporomandibular, sternoclavicular, and acromioclavicular joints
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bilateral temporomandibular, sternoclavicular, and acromioclavicular joints
bilateral shoulders, elbows, wrists (includes radiocarpal, and carpal 
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bilateral shoulders, elbows, wrists (includes radiocarpal, and carpal 
and carpometacarpal bones considered as a single unit), MCP I
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and carpometacarpal bones considered as a single unit), MCP I, II, III, IV, and V, thumb 
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, II, III, IV, and V, thumb 
interphalangeals (IP), PIP II, III, IV, and V and distal interphalangeals 
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interphalangeals (IP), PIP II, III, IV, and V and distal interphalangeals 
bilateral hips, knees, ankles, tarsi (includes subtalar, transverse tarsal, 
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bilateral hips, knees, ankles, tarsi (includes subtalar, transverse tarsal, 
and tarsometatarsal considered as a single unit), metatarsophalangeals (MTP I
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and tarsometatarsal considered as a single unit), metatarsophalangeals (MTP I
proximal interphalan
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proximal interphalan
The assessment for swelling is made on 66
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The assessment for swelling is made on 66
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joints from the above list. The hip joints are 
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joints from the above list. The hip joints are 
losed joints are excluded from both tenderness and swelling 
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losed joints are excluded from both tenderness and swelling 
nts are completed 
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nts are completed as outlined in the Schedule of Stud
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as outlined in the Schedule of Stud
Swelling and tenderness grading
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Swelling and tenderness grading
Swelling response (66)
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Swelling response (66)
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Detectable 
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Detectable 
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Sw
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Sw
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The following 28 joints 
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The following 28 joints 
Upper extremity
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Upper extremity
and carpometacarpal bones considered as a single unit), MCP I
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and carpometacarpal bones considered as a single unit), MCP I


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The joint assessment utilized for the DAS calculation will be based on 28 of the joints assessed 
for the 66/68-joint assessments (see Section 9.7.2, using the same 2-point scale for the 
assessment of swelling and tenderness of each joint.
DAS28(CRP) is calculated as follows: 




96
.
 0
1
ln
36
.
0
014
.
0
28
.
0
56
.
0
28

 
 

 


 

 

 

 

 

CRP
PGADA
SJC
TJC
CRP
DAS
9.7.5
Health Assessment Questionnaire Disability Index score 
The HAQ-DI contains 20 items divided into 8 domains that measure: dressing and grooming, 
arising, eating, walking, hygiene, reach, grip, and common daily activities. Subjects are required 
to indicate the degree of difficulty they have experienced in each domain in the past week on a 4-
point scale that ranges from 0 (without difficulty) to 3 (unable to do). Any individual score of 
less than 2 is adjusted to 2 if the activity requires assistance from another individual or the use of 
an assistive device. The highest score in each category is then summed (0 to 24) and divided by 
the number of categories scored to give a score that ranges from 0 to 3 (Matsuda et al, 2003).
The HAQ-DI will be completed outlined in the Schedule of Study Assessments(Table 5‒1).
9.7.6
Patient’s Global Assessment of Arthritis Pain (VAS)
The Patient’s Assessment of Arthritis Pain VAS or “Pain VAS” is part of the ACR core set of 
measures in arthritis (Felson et al, 1993). 
The Pain VAS consists of a horizontal line 100mm in length on which subjects are asked to 
indicate the level of their arthritis pain at the day of the visit between 0 (“no pain”) and 100 
(“most severe pain”), in response to the question: “Please mark a vertical line on the scale below 
to show how much pain you have from your arthritis today” (Dworkin et al, 2008).
The Pain VAS will be completed as outlined in the Schedule of Study Assessments(Table 5‒1).
9.7.7
Physician’s Global Assessment of Disease Activity (VAS)
The Investigatorwill assess the overall status of the subject with respect to their PsA signs and 
symptoms and functional capacity (considering both joint and skin components) using a VAS 
where 0 is “very good, asymptomatic and no limitation of normal activities” and 100 is “very 
poor, very severe symptoms which are intolerable and inability to carry out all normal activities.”
This assessment by the Investigatorshould be made blind to the PGADA.
The Physician’s Global Assessment of Disease Activity (VAS) will be completed as outlined in 
the Schedule of Study Assessments(Table 5‒1).
9.7.8
Patient’s Global Assessment of Disease Activity (VAS)
Subjects will score their Global Assessment of Disease Activity in response to the question, 
“Considering all the ways your arthritis affects you, please mark a vertical line on the scale 
below to show how you are feeling today”, using a VAS where 0 is “very good, no symptoms” 
and 100 is “very poor, severe symptoms.” The subject should be asked to consider both joint and 
skin components in their response to this question.
The PGADA will be completed as outlined in the Schedule of Study Assessments(Table 5‒1).
REDACTED COPY 
sment of Arthritis Pain VAS or “Pain VAS” is part of the ACR core set of 
REDACTED COPY 
sment of Arthritis Pain VAS or “Pain VAS” is part of the ACR core set of 
The Pain VAS consists of a horizontal line 100mm in length on which subjects are asked to 
REDACTED COPY 
The Pain VAS consists of a horizontal line 100mm in length on which subjects are asked to 
indicate the level of their arthritis pain at the day
REDACTED COPY 
indicate the level of their arthritis pain at the day of the visit between 0 (“no pain”) and 100 
REDACTED COPY 
 of the visit between 0 (“no pain”) and 100 
indicate the level of their arthritis pain at the day of the visit between 0 (“no pain”) and 100 
indicate the level of their arthritis pain at the day
REDACTED COPY 
indicate the level of their arthritis pain at the day of the visit between 0 (“no pain”) and 100 
indicate the level of their arthritis pain at the day
(“most severe pain”), in response to the question: “Please mark a ver
REDACTED COPY 
(“most severe pain”), in response to the question: “Please mark a ver
ou have from y
REDACTED COPY 
ou have from your arthritis today
REDACTED COPY 
our arthritis today
outlined in the Schedule of Study
REDACTED COPY 
outlined in the Schedule of Study
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 contains 20 items divided into 8 domains that measure: dressing and grooming, 
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 contains 20 items divided into 8 domains that measure: dressing and grooming, 
 activities. Subjects are required 
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 activities. Subjects are required 
 have experienced in each domain in the past week on a 4
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 have experienced in each domain in the past week on a 4
vidual score of 
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vidual score of 
 requires assistance from another individual or the use of 
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 requires assistance from another individual or the use of 
 is then summed (0 to 24) and divided by
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 is then summed (0 to 24) and divided by
(
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(Matsuda et al, 2003
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Matsuda et al, 2003
y Assessments
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y Assessments
rthritis Pain (VA
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rthritis Pain (VA
sment of Arthritis Pain VAS or “Pain VAS” is part of the ACR core set of 
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sment of Arthritis Pain VAS or “Pain VAS” is part of the ACR core set of 
The Pain VAS consists of a horizontal line 100mm in length on which subjects are asked to 
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The Pain VAS consists of a horizontal line 100mm in length on which subjects are asked to 
 of the visit between 0 (“no pain”) and 100 
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 of the visit between 0 (“no pain”) and 100 
(“most severe pain”), in response to the question: “Please mark a ver
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(“most severe pain”), in response to the question: “Please mark a ver
our arthritis today
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our arthritis today
outlined in the Schedule of Study
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outlined in the Schedule of Study
sician’s Global A
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sician’s Global Assessment of Disease A
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ssessment of Disease A
will assess the overall status of the subject with respect to their PsA signs and 
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will assess the overall status of the subject with respect to their PsA signs and 
mptoms and functional capacity
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mptoms and functional capacity
 good, asy
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 good, asymptomatic and no limitation of normal activities” and 100 is “very
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mptomatic and no limitation of normal activities” and 100 is “very
 good, asymptomatic and no limitation of normal activities” and 100 is “very
 good, asy
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 good, asymptomatic and no limitation of normal activities” and 100 is “very
 good, asy
ym
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ymptoms which are intolerable and inability
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ptoms which are intolerable and inability
This assessment by
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This assessment by th
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 th
This assessment by th
This assessment by
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This assessment by th
This assessment by
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e 
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e Investigator
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Investigator
sician’s Global Assessment of Disease Activity
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sician’s Global Assessment of Disease Activity
the Schedule of Study
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the Schedule of Study
Subjects will score their Global Assessment of Disease Activity
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Subjects will score their Global Assessment of Disease Activity
“Considering all the ways y
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“Considering all the ways y
below to show how 
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below to show how 


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9.8
Assessments for subjects with generalized pustular PSO or 
erythrodermic PSO
9.8.1 
Clinical Global Impression of Improvement (CGI-I)
The CGI-I is evaluated by the Investigators on a 4-point scale (remission, improved, no change, 
worsened) based on changes from the Baseline findings of PSO. The CGI will be completed as 
outlined in the Schedule of Study Assessments (Table5‒1).
9.8.2 
Global Improvement Score for Pustular PSO
The Global Improvement Score is evaluated by the Investigators as “very much improved,” 
“much improved,” “minimally improved,” “no change,” or “worsened” based on changes from 
the baseline JDA severity index scores and components, as presented in Table 9‒3. 
Table9‒3: Global Improvement Score
Change in JDA Severity 
Classification Score
Other criteria
Very much improved
Reduction by ≥3 points
or
Clear or almost clear of signs of 
generalized pustular PSO
Much improved
Reduction of 1 or 2 points
or
At least 1 of the following:
Erythema area with pustules (%) 
reduced by ≤30% compared to 
Baselinea
Clinically meaningful improvement 
in at least 2 other components of the 
JDA Severity Index for generalized 
pustular PSO (erythema area, edema 
area, WBC, CRP, albumin)
Minimally improved
0 points (no change)
and At least 1 of the following:
Erythema area with pustules (%) 
reduced by ≤20% compared to 
Baselinea
Clinically meaningful improvement 
in at least 1 other component of the 
JDA Severity Index for generalized 
pustular PSO (erythema area, edema 
area, WBC, CRP, albumin)
No change
0 points (no change)
and Not meeting the other criteria of 
minimally improved
Worsened
≥+1 point
-
Not applicable
CRP=C-reactive protein; JDA=Japanese Dermatological Association; PSO=psoriasis; WBC=white blood cell
aPrior to first study drug administration at Baseline (Visit 2)
REDACTED COPY 
or
REDACTED COPY 
or
REDACTED COPY 
REDACTED COPY 
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 much improved,” 
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 much improved,” 
 improved,” “no change,” or “worsened” based on changes from 
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 improved,” “no change,” or “worsened” based on changes from 
3
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3. 
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. 
Other criteria
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Other criteria
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Clear or almost clear of signs of 
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Clear or almost clear of signs of 
generalized pustular PSO
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generalized pustular PSO
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At least 1 of the following:
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At least 1 of the following:
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0 points (no change)
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0 points (no change)
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
No change
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No change
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9.8.3
JDA severity index score for generalized pustular PSO
The JDA severity index score for generalized pustular PSO consists of area of erythema with 
pustules, area of erythema (total), area of edema, fever, WBC, CRP, and serum albumin. 
The total score of JDA severity index for generalized pustular PSO is assigned a score of 0 to 
17(0=best, 17=worst).
Table9‒4: JDA severity index score for generalized pustular PSO
Severity classification
Mild
Moderate
Severe
A + B (combined scores)
0 to 6
7 to 10
11 to 17
A. Skin symptoms (total scores: 0 to 9)
Scores
3
2
1
0
Erythematous area (BSA %)
≥75
≥25, <75
<25
0
Erythematous area with 
pustule (BSA %)
≥50
≥10, <50
<10
0
Edematous area (BSA %)
≥50
≥10, <50
<10
0
B. Systemic symptoms and laboratory findings (total scores: 0 to 8)
Scores
2
1
0
Fever (◦C)
≥38.5
≥37.0, <38.5
<37.0
WBC count (/µL)
≥15,000 
≥10,000, <15,000
<10,000
CRP (mg/dL)
≥7.0
≥0.3, <7.0
<0.3
Serum albumin (g/dL)
<3.0
≥3.0, <3.8
≥3.8
BSA=body surface area; CRP=C-reactive protein; JDA=Japanese Dermatological Association; PSO=psoriasis; 
WBC=white blood cell
10
ASSESSMENT OF PHARMACOKINETIC/ 
PHARMACODYNAMIC/PHARMACOGENOMIC VARIABLES
Plasma samples for the measurement of CZP concentrations will be taken as outlined in the 
Schedule of Study Assessments (Table 5-1). Study site staff will record the time and date of each 
sample collected. Plasma samples will be analyzed for CZP levels using a validated method. 
For all PK samples, at each time point, collect at least 5mL blood into heparinized tube and 
centrifuged. Plasma will be aliquoted into 3 labeled transport tubes and stored frozen at -20
oC or 
colder and shipped on dry ice. 
Supplies for PK will be provided by the central laboratory. Additional information will be 
outlined in the study Laboratory Manual.  
REDACTED COPY 
≥10, <50
REDACTED COPY 
≥10, <50
REDACTED COPY 
(total scores: 0 to 8)
REDACTED COPY 
(total scores: 0 to 8)
REDACTED COPY 
2
REDACTED COPY 
2
REDACTED COPY 
≥38.5
REDACTED COPY 
≥38.5
REDACTED COPY 
REDACTED COPY 
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Severe
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Severe
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11 to 17
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11 to 17
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
1
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1
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<25
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<25
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<10
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<10
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≥10, <50
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≥10, <50
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(total scores: 0 to 8)
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(total scores: 0 to 8)
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≥38.5
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≥38.5
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≥15,000
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≥15,000
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
BSA=body surface area; CRP=C
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BSA=body surface area; CRP=C
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-
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-reactive protein
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reactive protein
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SESSMENT OF PHA
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SESSMENT OF PHA
PHA
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PHARM
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RM
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Plasma samples for the measurement of CZP concentrations will be taken as outlined in the 
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Plasma samples for the measurement of CZP concentrations will be taken as outlined in the 
Schedule of 
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Schedule of Study
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Study
sample collected. Plasma samples will be anal
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sample collected. Plasma samples will be anal
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For all PK samples, at each time point, collect at least 5mL
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For all PK samples, at each time point, collect at least 5mL
centrifuged. Plasma will be aliquoted into 
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centrifuged. Plasma will be aliquoted into 
colder and shipped on dry
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colder and shipped on dry


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11
ASSESSMENT OF IMMUNOLOGICAL VARIABLES
Plasma samples for the measurement of anti-CZP antibodies will be taken as outlined in the 
Schedule of Study Assessments(Table 5‒1).
Additional information will be outlined in the study Laboratory Manual. 
12
ASSESSMENT OF SAFETY
All assessments will be completed as outlined in the Schedule of Study Assessments (Table 5-1).
12.1
Adverse events
12.1.1
Definitions
12.1.1.1
Adverse event
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation 
subject administered a pharmaceutical product that does not necessarily have a causal 
relationship with this treatment. An AE can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding), symptom, or disease temporally associated with the 
use of a medicinal (investigational) product, whether or not related to the medicinal 
(investigational) product.
In order to ensure complete safety data collection, all AEs occurring during the study (ie,after 
the signing of the Informed Consent form), including any pretreatmentand posttreatment periods 
required by the protocol, must be reported in the eCRF even if no IMPwas taken but specific 
study procedures were conducted. This includes all AEs not present prior to the initial visit and 
all AEs that recurred or worsened after the initial visit.
Signs or symptoms of the condition/disease for which the IMPis being studied should be 
recorded as AEs only if their nature changes considerably or their frequency or intensity 
increases in a clinically significant manner as compared to the clinical profile known to the 
Investigator from the subject’s history or the Baseline Period.
12.1.1.2 
Serious adverse event
Once it is determined that a subject experienced an AE, the seriousness of the AE must be 
determined. An SAE must meet 1 or more of the following criteria:
Death
Life-threatening
(Life-threatening does not include a reaction that might have caused death had it occurred in 
a more severe form.)
Significant or persistent disability/incapacity
Congenital anomaly/birth defect (including that occurring in a fetus)
Important medical event that, based upon appropriate medical judgment, may jeopardize the 
patient or subject and may require medical or surgical intervention to prevent 1 of the other 
outcomes listed in the definition of serious
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, all AEs occurring during the study
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, all AEs occurring during the study
the signing of the Informed Consent form), including an
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the signing of the Informed Consent form), including an
y the protocol, must be reported in the 
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y the protocol, must be reported in the e
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eCRF even if no 
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CRF even if no 
 procedures were conducted. This includes all AEs not present prior to the initial visit and 
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 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.
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all AEs that recurred or worsened after the initial visit.
ptoms of the condition/disease for which the 
REDACTED COPY 
ptoms of the condition/disease for which the 
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y Assessments (Table 5
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y Assessments (Table 5-
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-1).
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1).
 untoward medical occurrence in a patient or clinical investigation 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 untoward medical occurrence in a patient or clinical investigation 
 have a causal 
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 have a causal 
y unfavorable and unintended sign 
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y unfavorable and unintended sign 
ptom, or disease temporally
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ptom, or disease temporally
stigational) product, whether or not related to the medicinal 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
stigational) product, whether or not related to the medicinal 
, all AEs occurring during the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, all AEs occurring during the study
the signing of the Informed Consent form), including an
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
the signing of the Informed Consent form), including any pretreatment
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y pretreatment
CRF even if no 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
CRF even if no 
 procedures were conducted. This includes all AEs not present prior to the initial visit and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 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.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
all AEs that recurred or worsened after the initial visit.
ptoms of the condition/disease for which the 
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ptoms of the condition/disease for which the 
y if their nature changes considerabl
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y if their nature changes considerabl
ignificant manner as compared to the clinical profile known to the 
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ignificant manner as compared to the clinical profile known to the 
from the subject’s history
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from the subject’s history
Serious adverse event
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Serious adverse event
Once it is determined that a subject experienced an AE, the seriousness of the AE must be 
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Once it is determined that a subject experienced an AE, the seriousness of the AE must be 
determined. An SAE must meet 1 or more of the following criteria:
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determined. An SAE must meet 1 or more of the following criteria:
threatening
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threatening
ife
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ife-threatening does not include a reaction that might have caused death had it occurred in 
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-threatening does not include a reaction that might have caused death had it occurred in 
a more severe form.)
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a more severe form.)
Significant or persistent disability
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Significant or persistent disability

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


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25 Jan 2018
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Certolizumab Pegol
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(Important medical events may include, but are not limited to, potential Hy’s Law [see 
Section12.1.1.3], allergic bronchospasm requiring intensive treatment in an emergency room 
or at home, blood dyscrasias that do not result in inpatient hospitalization, or the 
development of drug dependency or drug abuse.)
Initial inpatient hospitalization or prolongation of hospitalization
(A patient admitted to a hospital, even if he/she is released on the same day, meets the 
criteria for the initial inpatient hospitalization. An emergency room visit that results in 
admission to the hospital would also qualify for the initial inpatient hospitalization criteria. 
However, emergency room visits that do not result in admission to the hospital would not 
qualify for this criteria and, instead, should be evaluated for 1 of the other criteria in the 
definition of serious [eg,life-threatening adverse experience, important medical event].
Hospitalizations for reasons not associated with the occurrence of an AE [eg,preplanned 
surgery or elective surgery for a pre-existing condition that has not worsened or manifested 
in an unusual or uncharacteristic manner] do not qualify for reporting. For example, if a 
subject has a condition recorded on his/her medical history and later has a preplanned surgery 
for this condition, it is not appropriate to record the surgery or hospitalization as an SAE, 
since there is no AE upon which to assess the serious criteria. Please note that, if the 
pre-existing condition has worsened or manifested in an unusual or uncharacteristic manner, 
this would then qualify as an AE and, if necessary, the seriousness of the event would need to 
be determined.)
12.1.1.3
Adverse events of interest
An AE of interest is any AE which is listed in the European Risk Management Plan, or meets 
another commitment requiring nonstandard expedited reporting, even if the AE does not fulfill 
the expedited reporting criteria of “serious,” “unexpected,” and “associated with the use of the 
drug.” The following AEs of interest will be reported as SAEs, even if not meeting the definition 
as outlined in Section 12.1.1.2:
Serious infections including opportunistic infections
Malignancies including lymphoma
Congestive heart failure
Demyelinating-like disorders
Aplastic anemia, pancytopenia, thrombocytopenia, neutropenia and leucopenia
Serious bleeding events
Lupus and lupus-like illness
Serious skin reactions (eg, Stevens Johnson Syndrome, toxic epidermal necrosis, and
erythema multiforme)
Potential Hy’s Law, defined as ≥3xULN ALT or AST with coexisting ≥2xULNtotal 
bilirubinin the absence of ≥2xULN ALP, with no alternative explanation for the biochemical 
abnormality, must ALWAYS be reported to UCB as an AEof special interest (ie, without 
waiting for any additional etiologic investigations to have been concluded). Follow-up 
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ted in an unusual or uncharacteristic manner, 
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ted in an unusual or uncharacteristic manner, 
 as an AE and, if necessary, the seriousness of the event would need to 
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 as an AE and, if necessary, the seriousness of the event would need to 
verse events of interest
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verse events of interest
 AE which is listed in the European Risk Managem
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 AE which is listed in the European Risk Managem
another commitment requiring nonstandard expedited reporting, even if the AE does not fulfill 
REDACTED COPY 
another commitment requiring nonstandard expedited reporting, even if the AE does not fulfill 
the expedited reporting criteria of “serious,” “unexpected,” and “associated with the use of the 
REDACTED COPY 
the expedited reporting criteria of “serious,” “unexpected,” and “associated with the use of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 for the initial inpatient hospitalization criteria. 
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 for the initial inpatient hospitalization criteria. 
 room visits that do not result in admission to the hospital would not 
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 room visits that do not result in admission to the hospital would not 
his criteria and, instead, should be evaluated for 1 of the other criteria in the 
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his criteria and, instead, should be evaluated for 1 of the other criteria in the 
threatening adverse experience, important medical event].
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threatening adverse experience, important medical event].
Hospitalizations for reasons not associated with the occurrence of an AE [eg,
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Hospitalizations for reasons not associated with the occurrence of an AE [eg,prepla
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prepla
-existing condition that has not worsened or manifested 
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-existing condition that has not worsened or manifested 
in an unusual or uncharacteristic manner] do not qualify for reporting. For example, if a 
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in an unusual or uncharacteristic manner] do not qualify for reporting. For example, if a 
 and late
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 and later has a preplanned surgery
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r has a preplanned surgery
for this condition, it is not appropriate to record the surgery or hospitalization as an SAE, 
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for this condition, it is not appropriate to record the surgery or hospitalization as an SAE, 
since there is no AE upon which to assess the serious criteria. Please note that, if the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
since there is no AE upon which to assess the serious criteria. Please note that, if the 
ted in an unusual or uncharacteristic manner, 
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ted in an unusual or uncharacteristic manner, 
 as an AE and, if necessary, the seriousness of the event would need to 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 as an AE and, if necessary, the seriousness of the event would need to 
 AE which is listed in the European Risk Managem
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 AE which is listed in the European Risk Managem
another commitment requiring nonstandard expedited reporting, even if the AE does not fulfill 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
another commitment requiring nonstandard expedited reporting, even if the AE does not fulfill 
the expedited reporting criteria of “serious,” “unexpected,” and “associated with the use of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
the expedited reporting criteria of “serious,” “unexpected,” and “associated with the use of the 
drug.” The following AEs of interest will be r
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drug.” The following AEs of interest will be r
Serious infections including opportunistic infections
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Serious infections including opportunistic infections
es including ly
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es including lymphoma
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mphoma
es including lymphoma
es including ly
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es including lymphoma
es including ly
Congestive heart failure
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Congestive heart failure
elinating
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elinating-
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-like disorders
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like disorders
Aplastic anemia, pancy
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Aplastic anemia, pancy
Serious bleeding events
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Serious bleeding events
Lupus and lupus
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Lupus and lupus

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Serious skin reactions (eg, Stevens Johnson Sy
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Serious skin reactions (eg, Stevens Johnson Sy


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25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 70of 119
information should then be reported if an alternative etiology is identified during 
investigation and monitoring of the subject.
12.1.1.4 
Malfunctions and Health Damage
Malfunction is condition of a device part in a study drug which does not broadly meet specific 
standards, such as a break and failure, concerning quality, safety, performance and other, 
whether or not it is confirmed on any phases of design, delivery, storage, or usage. Health 
damage is a suspected event being affected by a malfunction ofa device part in a study drug.
Serious health damage is defined as health damage that meets any of the following criteria:
Results in death
Is life-threatening
The term “life-threatening” refers to an event in which the subject 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.
Requires inpatient hospitalization or prolongation of existing hospitalization,“Inpatient 
hospitalization for treatment” refers to admission of a subject to a medical institution 
overnight or more for the treatment of health damage. This includes hospitalization for the 
treatment of health damage without special treatment (resting). On the other hand, “inpatient 
hospitalization for treatment” does not include any hospitalization for tests or procedures for 
the underlying disease that has not exacerbated since study entry or a complication, social or 
expedient hospitalization not for the treatment of an adverse event, or hospitalization for a 
planned treatment or test before study entry.
Results in persistent or significant disability/incapacity
Is a congenital anomaly/birth defect
Is some other occurrence, such as an important medical event that may not be immediately 
life-threatening or result in death or hospitalization, but may jeopardize the subject or may 
require measures to prevent one of the other outcomes listed in the criteria above. These 
should also be considered serious. Examples of such events are bronchospasm requiring 
intensive treatment in an emergency room, blood disorders or convulsions that do not result 
in hospitalization, or the development of drug dependency or drug abuse.
12.1.2
Procedures for reporting and recording adverse events
The subject will be given the opportunity to report AEs spontaneously. A general prompt will 
also be given at each study visit to detect AEs. For example:
“Did you notice anything unusual about your health (since your last visit)?”
12.1.2.1 
Description of adverse events
When recording an AE, the Investigatorshould use the overall diagnosis or syndrome using 
standard medical terminology, rather than recording individual symptoms or signs. The eCRF 
and source documents should be consistent. Any discrepancies between the subject’s own words 
on his/her own records (eg,diary card) and the corresponding medical terminology should be 
clarified in the source documentation.
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overnight or more for the treatment of health damage. This includes hospitalization for the 
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overnight or more for the treatment of health damage. This includes hospitalization for the 
treatment of health damage without special treatment (resting). On the other hand, “inpatient 
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treatment of health damage without special treatment (resting). On the other hand, “inpatient 
hospitalization for treatment” does not include an
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hospitalization for treatment” does not include any hospitaliz
REDACTED COPY 
y hospitaliz
ng disease that has not exacerbated since study
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ng disease that has not exacerbated since study
expedient hospitalization not for the treatment of an adverse event, or hospitalization for a 
REDACTED COPY 
expedient hospitalization not for the treatment of an adverse event, or hospitalization for a 
study
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study entry
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 entry
study entry
study
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study entry
study
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Results in persistent or significant disability
REDACTED COPY 
Results in persistent or significant disability
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 drug.
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 drug.
following criteria
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following criteria:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
:
-threatening” refers to an event in which the subject was at risk of death at the 
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-threatening” refers to an event in which the subject was at risk of death at the 
y might have caused death 
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y might have caused death 
Requires inpatient hospitalization or prolongation of existing hospitalization,“Inpatient 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Requires inpatient hospitalization or prolongation of existing hospitalization,“Inpatient 
hospitalization for treatment” refers to admission of a subject to a medical inst
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
hospitalization for treatment” refers to admission of a subject to a medical inst
overnight or more for the treatment of health damage. This includes hospitalization for the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
overnight or more for the treatment of health damage. This includes hospitalization for the 
treatment of health damage without special treatment (resting). On the other hand, “inpatient 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
treatment of health damage without special treatment (resting). On the other hand, “inpatient 
y hospitaliz
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y hospitaliz
ng disease that has not exacerbated since study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ng disease that has not exacerbated since study
expedient hospitalization not for the treatment of an adverse event, or hospitalization for a 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
expedient hospitalization not for the treatment of an adverse event, or hospitalization for a 
 entry
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 entry.
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.
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Results in persistent or significant disability
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Results in persistent or significant disability
birth defect
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birth defect
Is some other occurrence, such as an important medical event that may
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Is some other occurrence, such as an important medical event that may
-threatening or result in death or hospitalization, bu
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-threatening or result in death or hospitalization, bu
require measures to prevent one of the other outcomes listed 
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require measures to prevent one of the other outcomes listed 
should also be considered serious. Examples of such events are bronchospasm requiring 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
should also be considered serious. Examples of such events are bronchospasm requiring 
intensive treatment in an emergency
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intensive treatment in an emergency
in hospitalization, or the development of drug dependency
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in hospitalization, or the development of drug dependency
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Procedures for reporting and recording adverse events
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Procedures for reporting and recording adverse events
The subject will be given the opportunity
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The subject will be given the opportunity
also be given at each study
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also be given at each study
12.1.2.1
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12.1.2.1


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25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 71of 119
Details for completion of the Adverse Event eCRF (including judgment of relationship to IMP) 
are described in the eCRF Completion Guidelines.
12.1.2.2 
Rule for repetition of an adverse event
An increase in the intensity of an AE should lead to the repetition of the AE being reported with:
The outcome date of the first AE that is not related to the natural course of the disease being 
the same as the start date of the repeated AE, and the outcome of “worsening”
The AE verbatim term being the same for the first and repeated AE, so that the repeated AE 
can be easily identified as the worsening of the first one
12.1.2.3
Additional procedures for reporting serious adverse events
If an SAE is reported, UCB must be informed within 24 hours of receipt of this information by 
the site (see contact information for SAE reporting listed in the Serious Adverse Event Reporting 
section at the front of the protocol). The Investigator must forward to UCB (or its representative) 
a duly completed “Investigator SAE Report Form for Development Drug” (SAE report form) 
provided by UCB, even if the data are incomplete, or if it is obvious that more data will be 
needed in order to draw any conclusions. Information recorded on this form will be entered into 
the global safety database.
An InvestigatorSAE report form will be provided to the Investigator. The InvestigatorSAE 
Report form must be completed in English. 
It is important for the Investigator, when completing the SAE report form, to include the 
assessment as to a causal relationship between the SAE and the IMP administration. This insight 
from the Investigatoris very important for UCB to consider in assessing the safety of the IMP 
and in determining whether the SAE requiresreporting to the regulatory authorities in an 
expedited manner.
Additional information (eg,autopsy or laboratory reports) received by the Investigator must be 
provided within 24 hours. All documents in the local language must be accompanied by a 
translation in English, or the relevant information included in the same document must be 
summarized in the InvestigatorSAE report form.
The Investigatoris specifically requested to collect and report to UCB (or its representative) any
SAEs (even if the Investigatoris certain that they are in no way associated with the IMP), up to 
10 weeksfrom the end of the studytreatmentforeach subject, and to also inform participating 
subjects of the need to inform the Investigatorof any SAE within this period. Serious AEs that 
the Investigator thinks may be associated with the IMP must be reported to UCB regardless of 
the time between the event and the end of the study.
Upon receipt of the SAE report form, UCB will perform an assessment of expectedness of the 
reported SAE. The assessment of the expectedness of the SAE is based on theIB.
12.1.3
Follow up of adverse events
An AE should be followed until it has resolved, has a stable sequelae, the Investigator
determines that it is no longer clinically significant, or the subject is lost to follow up. This 
follow-up requirement applies to AEs, SAEs, and AEs of special interest; further details 
regarding followup of PDILI events is provided in Section12.2.1.4. 
REDACTED COPY 
SAE report form will be provided to the 
REDACTED COPY 
SAE report form will be provided to the 
, when completing the SAE report form, to include the 
REDACTED COPY 
, when completing the SAE report form, to include the 
assessment as to a causal relationship between the SAE and the IMP administration. This insight 
REDACTED COPY 
assessment as to a causal relationship between the SAE and the IMP administration. This insight 
 important for UCB to consider in assessing the safet
REDACTED COPY 
 important for UCB to consider in assessing the safet
and in determining whether the SAE requires
REDACTED COPY 
and in determining whether the SAE requires
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The AE verbatim term being the same for the first and repeated AE, so that the repeated AE 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The AE verbatim term being the same for the first and repeated AE, so that the repeated AE 
ditional procedures for reporting serious adverse events
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ditional procedures for reporting serious adverse events
t be informed within 24 hours of receipt of this information by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
t be informed within 24 hours of receipt of this information by
the site (see contact information for SAE reporting listed in the Serious Adverse Event Reporting 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
the site (see contact information for SAE reporting listed in the Serious Adverse Event Reporting 
must forward to UCB (or its representa
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
must forward to UCB (or its representa
SAE Report Form for Development Drug” (SAE report form) 
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SAE Report Form for Development Drug” (SAE report form) 
y UCB, even if the data are incomplete, or if it is obvious that more data will be 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y UCB, even if the data are incomplete, or if it is obvious that more data will be 
 conclusions. Information recorded on this 
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 conclusions. Information recorded on this 
In
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Investigator
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
vestigator
, when completing the SAE report form, to include the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, when completing the SAE report form, to include the 
assessment as to a causal relationship between the SAE and the IMP administration. This insight 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
assessment as to a causal relationship between the SAE and the IMP administration. This insight 
 important for UCB to consider in assessing the safet
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 important for UCB to consider in assessing the safet
and in determining whether the SAE requires
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and in determining whether the SAE requires
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
reporting to the regulatory
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reporting to the regulatory
autops
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autopsy or laboratory reports) received b
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y or laboratory reports) received b
provided within 24 hours. All documents in the local language must be accompanied by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
provided within 24 hours. All documents in the local language must be accompanied by
ion in English, or the relevant information included in the same document must be 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ion in English, or the relevant information included in the same document must be 
vestigator
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vestigator
is specifically
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is specifically
Investig
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Investig
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from the end of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
from the end of the 
subjects of the need to inform the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
subjects of the need to inform the 
vestigator
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
vestigator
the time between the event and the end of the study.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
the time between the event and the end of the study.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Upon receipt of the SAE report form, UCB will perform an assessment of expectedness of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Upon receipt of the SAE report form, UCB will perform an assessment of expectedness of the 
reported SAE. The assessment of the expectedness of the SAE is based on the
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
reported SAE. The assessment of the expectedness of the SAE is based on the
12.1.3
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12.1.3


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If an AE is ongoing at the end of the study for a subject, follow up should be provided until 
resolution/stable level of sequelae is achieved, or until the Investigator no longer deems that it is 
clinically significant, or until the subject is lost to follow up. If no follow up is provided, the 
Investigator must provide a justification. The follow up will usually be continued for 10 weeks 
after the subject has discontinued his/her IMP.
Information on SAEs obtained after clinical database lock will be captured through the Patient 
Safety (PS) database without limitation of time.
12.1.4 
Pregnancy
If an Investigator is notified that a subject hasbecome pregnant after the first intake of anyIMP, 
the Investigator must immediately notifyUCB’s PS department by providing the completed 
Pregnancy Report and Outcome form (forcontact details see Serious Adverse Event reporting 
information at the beginning of this protocol). The subject should be withdrawn from the study 
as soon as pregnancy is known(by positive pregnancy test), and the following should be 
completed:
The subject should return for an early discontinuation visit.
The subject should immediately stop the intake of the IMP. 
A Safety Follow-Up Visit should be scheduled 10 weeks after the subject has discontinued 
her IMP.
The Investigatormust inform the subject of information currently known about potential risks 
and about available treatment alternatives.
The pregnancy will be documented on the Pregnancy Report and Outcome form provided to the 
Investigator. The progression of the pregnancy and the eventual birth (if applicable) must be 
followedup using the Pregnancy Report and Outcome form in which the Investigatorhas to 
report on the health of the mother and of the child. Every reasonable attempt should be made to 
follow the health of the child for 30 days after birth for any significant medical issues. In certain 
circumstances, UCB may request that follow up is continued for a period longer than 30 days. If 
the subject is lost to follow up and/or refuses to give information, written documentation of 
attempts to contact the subject needs to be provided by the Investigatorandfiled at the site. 
UCB’s PS department is the primary contact for any questions related to the data collection for 
the pregnancy, eventual birth, and follow up.
In cases where the partner of a male subject enrolled in a clinical study becomes pregnant, the 
Investigator or designee is asked to contact the subject to request consent of the partner via the 
Partner Pregnancy Consent formthat has been approved by the responsible IRB and should be 
available in the Investigator site file. In case of questions aboutthe consent process, the 
Investigatormay contact the UCB/contract research organization (CRO) contract monitor forthe 
study. The Investigatorwill complete the Pregnancy Report and Outcome form and send it to 
UCB’s PSdepartment(for contact details see Serious Adverse Event reporting information at the 
beginning of this protocol)only after the partner has agreed that additional information can be 
captured and has providedthe signed Partner Pregnancy Consent form. UCB’s PSdepartment is 
also the primary contact for any questions related to the data collection for the partner pregnancy, 
eventual birth, and follow up.
REDACTED COPY 
10 weeks 
REDACTED COPY 
10 weeks 
must inform the subject of information currently known about potential risks 
REDACTED COPY 
must inform the subject of information currently known about potential risks 
ted on the Pregnancy
REDACTED COPY 
ted on the Pregnancy
. The progression of the pregnancy
REDACTED COPY 
. The progression of the pregnancy
 Report and Outcome form in which the 
REDACTED COPY 
 Report and Outcome form in which the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
become pregnant after the first intake of any
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become pregnant after the first intake of anyIMP, 
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IMP, 
 providing the completed 
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 providing the completed 
vent 
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vent reporting 
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reporting 
withdrawn from the stud
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withdrawn from the stud
, and the following should be 
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, and the following should be 
MP. 
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MP. 
10 weeks 
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10 weeks after the subject has discontinued 
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after the subject has discontinued 
must inform the subject of information currently known about potential risks 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
must inform the subject of information currently known about potential risks 
ted on the Pregnancy
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ted on the Pregnancy
. The progression of the pregnancy
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. The progression of the pregnancy and the eventual birth (if applicable) must be 
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 and the eventual birth (if applicable) must be 
. The progression of the pregnancy and the eventual birth (if applicable) must be 
. The progression of the pregnancy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
. The progression of the pregnancy and the eventual birth (if applicable) must be 
. The progression of the pregnancy
 Report and Outcome form in which the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 Report and Outcome form in which the 
e health of the mother and of the child. Every
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
e health of the mother and of the child. Every
follow the health of the child for 30 day
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follow the health of the child for 30 day
circumstances, UCB may request that follow up is continued for a perio
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circumstances, UCB may request that follow up is continued for a perio
the subject is lost to follow 
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the subject is lost to follow up and/or refuses to give information, written documentation of 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
up and/or refuses to give information, written documentation of 
attempts to contact the subject needs to be provided by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
attempts to contact the subject needs to be provided by
S department 
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S department is the primary
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is the primary
, eventual birth
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, eventual birth
In cases where the partner of a male subject enrolled in a clinical study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
In cases where the partner of a male subject enrolled in a clinical study
Investigator
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Investigatoror designee 
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or designee 
Partner Pregnancy
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Partner Pregnancy
available in the 
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available in the 
Investigator
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Investigator
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study
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study
UCB’s P
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UCB’s P


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25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 73of 119
A pregnancy becomes a serious adverse event (SAE) in the following circumstances: 
miscarriage, abortion (elective or spontaneous), unintended pregnancy after hormonal 
contraceptive failure (if the hormonal contraceptive was correctly used), ectopic pregnancy, fetal 
demise, or any congenital anomaly/birth defect of the baby. Those SAEs must be additionally 
reported using the InvestigatorSAE Report form.
12.1.5
Procedures for reporting malfunctions/health damage
12.1.5.1 
Response to subjects
The Investigatorwill take sufficient medical measures for all study-related clinically significant 
health damage during and after the participation of each subject in the clinical study. If a subject 
needs treatment for health damage, the Investigatorwill inform the subject of the need to receive 
treatment.
12.1.5.2 
Expedited reporting of serious health damage
12.1.5.2.1
Serious adverse events requiring expedited reporting
1. All serious health damage that occursduring the study periodmust be reported.
2. All infections: Infections induced by suspected contamination by a pathogen in a biological 
preparation or study drug, etc., including hepatitis B virus (HBV), hepatitis C virus (HCV), 
HIV, etc. Common colds due to changes in the season are not included.
12.1.5.2.2
Procedure for expedited reporting
1. In the occurrence of any of the events that correspond toany of the criteria listed in 
Section 12.1.1.2, the Investigatorwill notify the Sponsor promptly after first knowledge of 
the event (within 24 hours, as a rule) either orally, by telephone, or by e-mail.
2. The Investigatorwill subsequently submit a detailed report on any serious health damage that 
occursafter initiation of administration of the study drug to the head of the study site and the 
Sponsor within 10 days of first knowledge using either the report form of the study site or 
that of the Sponsor.
Additional information will also be notified promptly (within 24 hours, as a rule) to the 
Sponsororally, by telephone, or by e-mail, and if necessary, an additional report will be 
made.
3. If requested, the Investigator will provide additional information (autopsy report, terminal 
medical records, and/or other necessary information) about any serious health damage 
reported to the Sponsor, the head of the study site, and the IRB.
12.1.5.3 
Reporting of malfunctions or nonserious health damage
1. Malfunctions or nonserious health damage that requirereporting:
All malfunctions or nonserious health damage that occur during the study period.
2. Procedure for expedited reporting:
In the occurrence of any malfunctions or health damage, the Investigatorwill notify the 
Sponsorpromptly after first knowledge of the event (within 24 hours, as a rule) either orally, 
by telephone, or by e-mail.
REDACTED COPY 
 drug, etc., including hepatitis B virus (HBV), hepatitis C virus (HCV), 
REDACTED COPY 
 drug, etc., including hepatitis B virus (HBV), hepatitis C virus (HCV), 
V, etc. Common colds due to changes in the s
REDACTED COPY 
V, etc. Common colds due to changes in the season are not included.
REDACTED COPY 
eason are not included.
Procedure for expedited reporting
REDACTED COPY 
Procedure for expedited reporting
of the events that correspond 
REDACTED COPY 
of the events that correspond 
will notify
REDACTED COPY 
will notify
REDACTED COPY 
the event (within 24 hours, as a rule) either orally
REDACTED COPY 
the event (within 24 hours, as a rule) either orally
will subsequently
REDACTED COPY 
will subsequently submit a detailed report on any
REDACTED COPY 
 submit a detailed report on any
will subsequently submit a detailed report on any
will subsequently
REDACTED COPY 
will subsequently submit a detailed report on any
will subsequently
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 significant 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 significant 
. I
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
. If a subject 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
f a subject 
will inform the subject of the need to receive 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
will inform the subject of the need to receive 
Serious adverse events requiring expedited reporting
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Serious adverse events requiring expedited reporting
must be reported
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
must be reported
 suspected contamination by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 suspected contamination by a pathogen in a biological 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 a pathogen in a biological 
 suspected contamination by a pathogen in a biological 
 suspected contamination by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 suspected contamination by a pathogen in a biological 
 suspected contamination by
 drug, etc., including hepatitis B virus (HBV), hepatitis C virus (HCV), 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 drug, etc., including hepatitis B virus (HBV), hepatitis C virus (HCV), 
eason are not included.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
eason are not included.
Procedure for expedited reporting
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Procedure for expedited reporting
of the events that correspond 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
of the events that correspond 
will notify
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
will notify the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 the 
will notify the 
will notify
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
will notify the 
will notify
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
the event (within 24 hours, as a rule) either orally
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
the event (within 24 hours, as a rule) either orally
 submit a detailed report on any
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 submit a detailed report on any
after initiation of administration of the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
after initiation of administration of the study
s of first knowledge using either the report form of the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
s of first knowledge using either the report form of the study
Additional information will also b
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Additional information will also b
 telephone, or by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 telephone, or by
If requested, the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
If requested, the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator
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Investigator
medical records, and/or other necessary
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medical records, and/or other necessary
reported to the 
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reported to the 
12.1.5.3
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12.1.5.3
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Malfunct
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Malfunct
All malfunctions or nonserious health damage that occur during the stud
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
All malfunctions or nonserious health damage that occur during the stud


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25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
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Page 74of 119
12.1.6
Suspected transmission of an infectious agent via a medicinal 
product
For the purposes of reporting, any suspected transmission of an infectious agent via a medicinal 
product should be considered as anSAE; such cases mustbe reported immediately, recorded in 
the AE module of the eCRF, and followed as any other SAE. Any organism, virus, or infectious 
particle (eg, prion protein transmitting transmissible spongiform encephalopathy), pathogenic or 
nonpathogenic, is considered an infectious agent.
12.1.7
Overdose of investigational medicinal product
Excessive dosing (beyond that prescribed in the protocol and including overdose) should be 
recorded in the eCRF. Any SAE or nonserious AE associated with excessive dosing must be 
followed as any other SAE or nonserious AE. These events are only considered AEs or SAEs if 
there are associated clinical signs and symptoms or if the act of taking the excess medicine itself 
is an AE or SAE (eg,suicide attempt).
12.1.8
Safety signal detection
Selected data from this study will be reviewed periodically to detect as early as possible any 
safety concern(s) related to the IMP so that Investigators, clinical study subjects, regulatory 
authorities, and IRBs will be informed appropriately and as early as possible.
The Study Physician or medically qualified designee/equivalent will conduct an ongoing review 
of SAEs and perform ongoing SAE reconciliations in collaboration with the PSrepresentative.
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 electrocardiogram [ECG] results) for which data will be periodically 
reviewed during the course of the study.
12.2
Laboratory measurements
The following laboratory parameters will be measured as outlined in the Schedule of Study 
Assessments (Table 5‒1):
REDACTED COPY 
 and as early
REDACTED COPY 
 and as early
 qualified designee/equivalent will conduct an ongoing review 
REDACTED COPY 
 qualified designee/equivalent will conduct an ongoing review 
m ongoing SAE reconciliations in collaboration with the 
REDACTED COPY 
m ongoing SAE reconciliations in collaboration with the 
As appropriate for the stage of development and accumulated experience with the I
REDACTED COPY 
As appropriate for the stage of development and accumulated experience with the I
 qualified personnel at UCB may
REDACTED COPY 
 qualified personnel at UCB may
REDACTED COPY 
 identify
REDACTED COPY 
 identify
 qualified personnel at UCB may identify
 qualified personnel at UCB may
REDACTED COPY 
 qualified personnel at UCB may identify
 qualified personnel at UCB may
 or electrocardiogram [ECG] results) for which data will be periodicall
REDACTED COPY 
 or electrocardiogram [ECG] results) for which data will be periodicall
reviewed during the course of the stud
REDACTED COPY 
reviewed during the course of the study.
REDACTED COPY 
y.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
protocol and including overdose) should be 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
protocol and including overdose) should be 
 SAE or nonserious AE associated with excessive dosing must be 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 SAE or nonserious AE associated with excessive dosing must be 
y considered AEs or SAEs if 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y considered AEs or SAEs if 
mptoms or if the act of taking the excess medicine itself 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
mptoms or if the act of taking the excess medicine itself 
 to detect as earl
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 to detect as earl
s, clinical study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
s, clinical study
 and as early
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 and as early as possible.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 as possible.
 and as early as possible.
 and as early
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 and as early as possible.
 and as early
 qualified designee/equivalent will conduct an ongoing review 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 qualified designee/equivalent will conduct an ongoing review 
m ongoing SAE reconciliations in collaboration with the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
m ongoing SAE reconciliations in collaboration with the 
As appropriate for the stage of development and accumulated experience with the I
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
As appropriate for the stage of development and accumulated experience with the I
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 identify
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 identify additional safet
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 additional safet
 identify additional safet
 identify
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 identify additional safet
 identify
 or electrocardiogram [ECG] results) for which data will be periodicall
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 or electrocardiogram [ECG] results) for which data will be periodicall
y.
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y.
 measurements
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 measurements
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The following laboratory parameters will be measured
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The following laboratory parameters will be measured


UCB
25 Jan 2018
Clinical Study Protocol
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Page 75of 119
Table12‒1:Laboratory measurements
Hematology
Chemistry
Urinalysis
Basophils 
Calcium
Albumin
Eosinophils 
Chloride
Bacteria
Lymphocytes 
C-reactive protein
Crystals
Atypical lymphocytes 
Magnesium
Glucose
Monocytes 
Potassium
pH
Neutrophils 
Sodium
RBC
Hematocrit 
Glucose
WBC
Hemoglobin 
BUN
Urine dipstick for 
pregnancy testing
a
MCH
Creatinine
MCHC
ALP
MCV
AST
Platelet count 
ALT
RBC count 
GGT
WBC count 
Total bilirubin
LDH
Total cholesterol
Albumin
Beta-D-glucan
Sialylated carbohydrate antigen 
KL-6
Hepatitis B surface antigen
b
Hepatitis B core antibodyb,c
Hepatitis B surface antibodyb,c
Hepatitis type B virus DNAc
Hepatitis type C virus antibodyb
Human immunodeficiency virus 
antigen
b
Human immunodeficiency virus 
antibody
b
T-cell lymphotropic virus type-1 
antibody
b
Serum pregnancy testinga
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
Total bilirubin
REDACTED COPY 
Total bilirubin
REDACTED COPY 
REDACTED COPY 
Total cholesterol
REDACTED COPY 
Total cholesterol
REDACTED COPY 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Urine dipstick for 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Urine dipstick for 
pregnancy testing
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
pregnancy testing
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Total cholesterol
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Total cholesterol
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Albumin
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Albumin
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Beta
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Beta-D-
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-D-
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Sialylated carbohydrate antigen 
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Sialylated carbohydrate antigen 
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
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Clinical Study Protocol
Certolizumab Pegol
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Confidential
Page 76of 119
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea 
nitrogen; DNA=deoxyribonucleic acid; GGT=gamma-glutamyltransferase;HBc=hepatitis type C virus; 
HBs=hepatitis B surface; HBV=hepatitis type B virus; LDH=lactate dehydrogenase; MCH=mean corpuscular 
hemoglobin; MCHC=mean corpuscular hemoglobin concentration; MCV=mean corpuscular volume; RBC=red 
blood cell; SFU=Safety Follow-Up; WBC=white blood cell
aPregnancy testing will consist of serum testing at Screening. The pregnancy test will be urine at all other visits.
bPerformed at Screening only
cIf the subject is either HBs antibody-positive or HBc antibody-positive at Screening, quantitative measurement of 
HBV-DNA should be performed every 4 weeks from Baseline to Week 52 and at SFU.
12.2.1
Evaluationof PDILI
The PDILI IMP discontinuation criteria for this study are provided in Section6.3.1, with the 
accompanying required follow-up investigation and monitoring detailed below. All PDILI events 
must be reported as anAE and reported to the study site and Sponsor within 24 hours of learning 
of their occurrence. AnyPDILI event that meets the criterionfor potential Hy’s Law must be 
reported as an AEof special interest (see Section12.1.1.3), and, if applicable, also reported as an
SAE(see Section12.1.1.2). 
Evaluation of PDILI consists of the diagnostic testing and continued monitoring included in 
Table 12‒2(specific tests dependent on laboratoryresults and corresponding symptoms) and 
consultation with a local hepatologist (if applicable; discussed in Section12.2.1.1). The local 
hepatologist is the expert usually consulted by the treating physician for assessment and 
management of potential hepatic disease. This would usually be a hepatologist, but may be a 
gastroenterologist. Additional investigation and monitoring may be required and adapted based 
on the diagnosis after the cause of the liver injury/abnormality is confirmed (details in 
Section12.2.1.4). 
The results of all monitoring, including laboratory testingand other testing, should be made 
available to the study site and Sponsor.
All initial tests resulting in abnormal hepaticlaboratoryvalues need to be repeated, but 
appropriate medical action must not be delayed waiting for the repeat result.
If tests are done locally for more rapid results, a concurrent sample shouldalso be sent to the 
central laboratory whenever possible.Medical care decisions are to be made initially using the 
most rapidly available results and a conservative approach must be taken if the results from the 
2laboratory tests are significantly different. Data from the local and central laboratoryare to be 
recorded on the applicable eCRF pages.
When IMP is discontinued, all concomitant medications and herbal supplements that are not 
medically necessary should also be discontinued. In these cases, the Investigatorshould also 
consider dose reduction for medically necessary concomitant medication and consider changing 
any medically required concomitant medication known to be hepatotoxic to a suitable 
alternative.
Rechallenge with a substance potentially causing drug-induced liver injury is dangerous,may be 
fatal, and must not occur.
The table below summarizes the approach to investigate PDILI.
REDACTED COPY 
y the treating ph
REDACTED COPY 
y the treating ph
management of potential hepatic disease. This would usually
REDACTED COPY 
management of potential hepatic disease. This would usually
gastroenterologist. Additional investigation and monitoring may
REDACTED COPY 
gastroenterologist. Additional investigation and monitoring may
on the diagnosis after the cause of the liver injury
REDACTED COPY 
on the diagnosis after the cause of the liver injury
The results of all monitoring, including lab
REDACTED COPY 
The results of all monitoring, including lab
Sponsor
REDACTED COPY 
Sponsor
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at Screening, quantitative measurement of 
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at Screening, quantitative measurement of 
, with the 
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, with the 
up investigation and monitoring detailed below. All PDILI events 
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up investigation and monitoring detailed below. All PDILI events 
within 24 hour
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within 24 hours of learning 
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s of learning 
Hy
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Hy’s 
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’s L
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Law must be 
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aw must be 
), and, if applicable, also reported as an
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), and, if applicable, also reported as an
continued monitoring included in 
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continued monitoring included in 
results and corresponding s
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results and corresponding s
with a local hepatologist (if applicable; discussed in 
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with a local hepatologist (if applicable; discussed in Section
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Section
y the treating ph
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y the treating phys
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ysician for assessment and 
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ician for assessment and 
management of potential hepatic disease. This would usually
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management of potential hepatic disease. This would usually be a hepatolo
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 be a hepatolo
management of potential hepatic disease. This would usually be a hepatolo
management of potential hepatic disease. This would usually
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management of potential hepatic disease. This would usually be a hepatolo
management of potential hepatic disease. This would usually
gastroenterologist. Additional investigation and monitoring may
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gastroenterologist. Additional investigation and monitoring may
on the diagnosis after the cause of the liver injury
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on the diagnosis after the cause of the liver injury/abnormality
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/abnormality
on the diagnosis after the cause of the liver injury/abnormality
on the diagnosis after the cause of the liver injury
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on the diagnosis after the cause of the liver injury/abnormality
on the diagnosis after the cause of the liver injury
The results of all monitoring, including lab
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The results of all monitoring, including laboratory
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oratory
abnormal hepatic
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abnormal hepatic
appropriate medical action must not be delayed waiting for the repeat result.
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appropriate medical action must not be delayed waiting for the repeat result.
y for more rapid results, a concurrent sample 
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y for more rapid results, a concurrent sample 
 whenever possible.
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 whenever possible.
results and a conservative approach must be taken if the results from the 
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results and a conservative approach must be taken if the results from the 
s are significantly
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s are significantly
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recorded on the applicable 
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recorded on the applicable 
MP is discontinued, all concomitant medications and herbal supplements that are not 
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MP is discontinued, all concomitant medications and herbal supplements that are not 
medically
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medically necessary
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 necessary
medically necessary
medically
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medically necessary
medically
consider dose reductio
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consider dose reductio
any
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any medicall
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 medicall
alternative.
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alternative.
Rechallenge with a substance potentiall
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Rechallenge with a substance potentiall


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Page 77of 119
Table12‒2:Required investigations and follow up for PDILI
Laboratoryvalue
Immediate
Followup
ALT or 
AST
Total 
bilirubin
Symptomsaof 
hepatitis or 
hypersensitivity
Consultation 
requirements
Actions
Testing
Evaluation
≥3xULN
≥2xULN
b
NA
Hepatology consult.c
Medical Monitor 
must be notified 
within 24hours 
(eg, by laboratory 
alert) and subject 
discussed with 
Medical Monitor 
ASAP.
Immediate, 
permanent IMP 
discontinuation.
Essential: Must 
have repeat liver 
chemistry values 
and additional 
testing completed 
ASAP (see 
Section12.2.1.3); 
recommended to 
occur at the site 
with HCP.
Monitoring of liver chemistry 
values at least twice per week 
until values normalize, stabilize, 
or return to within baseline 
values.
d
≥8xULN
NA 
NA
≥3xULN
NA
Yes
Immediate, 
temporary or 
permanent, IMP 
discontinuation.
≥3xULN 
(and ≥2x 
baseline) 
and 
<5xULN
<2xULN
No
Discussion with 
Medical Monitor 
required if the 
criterion that allows 
for IMP continuation 
is met.
Further investigation 
–immediate IMP 
discontinuation not 
required(see 
Section12.2.1.2).
Not required 
unless otherwise 
medically 
indicated (at 
discretion of 
Investigator).
REDACTED COPY 
temporary 
REDACTED COPY 
temporary 
permanent, IMP 
REDACTED COPY 
permanent, IMP 
discontinuation.
REDACTED COPY 
discontinuation.
REDACTED COPY 
Medical Monitor 
REDACTED COPY 
Medical Monitor 
required if the 
REDACTED COPY 
required if the 
criterion that allows 
REDACTED COPY 
criterion that allows 
REDACTED COPY 
Further investigation 
REDACTED COPY 
Further investigation 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
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25 Jan 2018
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Follow
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Follow
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Evaluation
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Evaluation
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Essential: Must 
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Essential: Must 
have repeat liver 
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have repeat liver 
chemistry values 
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chemistry values 
and additional 
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and additional 
testing completed 
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testing completed 
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permanent, IMP 
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permanent, IMP 
discontinuation.
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discontinuation.
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Further investigation 
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Further investigation 
–
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–immediate IMP 
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immediate IMP 
discontinuation not 
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discontinuation not 
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criterion that allows 
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criterion that allows 
for IMP continuation 
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for IMP continuation 
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Table12‒2:Required investigations and follow up for PDILI
≥5xULN 
(and ≥2x 
baseline) 
and 
<8xULN
<2xULN
No
Hepatology consult if 
there is no evidence 
of resolution(see 
Follow up 
requirements).
c
Discussion with 
Medical Monitor 
required.
IMP discontinuation 
required if any of 
the following occur:
Subject cannot 
comply with 
monitoring 
schedule.
Liver chemistry 
values continue to 
increase during 
2 weekmonitoring 
period.
Liver chemistry 
values remain 
≥5xULN (and 
≥2xbaseline) after 
2week monitoring 
period.
Essential: Every 
attempt must be 
made to have 
repeat liver 
chemistry values
and additional 
testing completed 
within 48 hours 
at the site with 
HCP(see 
Section12.2.1.3).
Monitoring of liver chemistry 
valuesat least twiceper week 
for 2weeks.
d
Immediate IMP 
discontinuation required if 
liver chemistry values 
continue to increase.
After 2 weeks of monitoring
liver chemistry values:
Discontinue IMP if levels 
remain ≥5xULN (and ≥2x 
baseline); monitor until values 
normalize, stabilize, or return 
to within baseline values.d
Continue IMP if levels are no 
longer ≥5xULN (and ≥2x 
baseline); continue to monitor 
at least twice per week until 
values normalize, stabilize, or 
return to within baseline 
values.d
ALP=alkaline phosphatase; ALT=alanine aminotransferase; ASAP=as soon as possible; AST=aspartate aminotransferase; HCP=healthcare practitioner; 
IMP=investigational medicinal product; NA=not applicable; PDILI=potential drug-induced liver injury; ULN=upper limit of normal 
aHepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or tenderness; hypersensitivity symptoms include eosinophilia (>5%), 
rash, and fever (without clear alternative cause).
bIf the subject also has ≥2xULN ALP, the possibility of an indication of biliary obstruction should be discussed with t he Medical Monitor.
.cDetails provided in Section12.2.1.1. The local hepatologist is the expert usually consulted by the treating physician for assessment and management of 
potential hepatic disease. This would usually be a hepatologist, but may be a gastroenterologist.
dUnless an alternative monitoring schedule is agreed by the Investigator and UCB responsible physician. Determination of stabilization is at the discretion of the 
Investigator in consultation with the hepatologist (as applicable) and UCB responsible physician, as needed.
REDACTED COPY 
monitoring 
REDACTED COPY 
monitoring 
period.
REDACTED COPY 
period.
Liver chemistry 
REDACTED COPY 
Liver chemistry 
values 
REDACTED COPY 
values 
≥5xULN (and 
REDACTED COPY 
≥5xULN (and 
REDACTED COPY 
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25 Jan 2018
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25 Jan 2018
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monitoring 
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monitoring 
Liver chemistry 
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Liver chemistry 
values 
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values remain 
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remain 
≥5xULN (and 
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≥5xULN (and 
≥2x
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≥2x
2
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2
chemistry values
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chemistry values
and additional 
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and additional 
testin
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testing completed 
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g completed 
within 48
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within 48
at the site with 
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at the site with 
HCP
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HCP
Monitoring of liver chemistr
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Monitoring of liver chemistr
values
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values
for 2
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for 2
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ALP=alkaline phosphatase; ALT=alanine aminotransferase; ASAP=as soon as possible; 
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ALP=alkaline phosphatase; ALT=alanine aminotransferase; ASAP=as soon as possible; 
IMP=investigational medicinal product; NA=not applicable; PDILI=potential drug
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IMP=investigational medicinal product; NA=not applicable; PDILI=potential drug
Hepatitis symptoms include fatigue, nausea, vomiting, and right u
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Hepatitis symptoms include fatigue, nausea, vomiting, and right u
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fever (without clear alternative cause).
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fever (without clear alternative cause).
≥2xULN ALP, the possibility of an indication of biliary obstruction should be discussed with t he Medical Monitor.
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≥2xULN ALP, the possibility of an indication of biliary obstruction should be discussed with t he Medical Monitor.
. The local hepatologist is the expert usually consulted by the
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. The local hepatologist is the expert usually consulted by the
ould usually be a hepatologist, but may be a gastroenterologist.
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ould usually be a hepatologist, but may be a gastroenterologist.
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Unless an alternative monitoring schedule is agreed by the 
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Unless an alternative monitoring schedule is agreed by the 
Investigator in consultation with the hepatologist 
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Investigator in consultation with the hepatologist 


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12.2.1.1 
Consultation with Medical Monitor and local hepatologist 
Potential drug-induced liver injury events require notification of the Medical Monitor within 
24hours (eg, by laboratoryalert),and the subject must be discussed with the Medical Monitor as 
soon as possible. If required, the subject must also be discussed with the local hepatologist. The 
local hepatologistis the expert usually consulted by the treating physician for assessment and 
management of potential hepatic disease. This would usually be a hepatologist, but may be a 
gastroenterologist. If determined necessary, this discussion should be followed by a full 
hepatology assessment (see Section12.2.1.3) and SAE report(if applicable).
12.2.1.2 
Immediate action: determination of IMP discontinuation
All PDILI events require immediate action, testing, and monitoring. 
The immediate action is dependent on the laboratoryvalues and symptoms of hepatitis or 
hypersensitivity and ranges from continuation of IMP (followed by immediate investigation) to 
immediate and permanent discontinuation (see Section 6.3.1and Table 12‒2for details).
When IMP is discontinued, all concomitant medications and herbal supplements that are not 
medically necessary should also be discontinued. The Investigatorshould also consider dose 
reduction for medically necessary concomitant medication and consider changing any medically 
required concomitant medication known to be hepatotoxic to a suitable alternative.
12.2.1.3 
Testing: identification/exclusion of alternative etiology
The measurements and additional information required for the assessment of PDILI events when 
there is a reasonable possibilitythat theymay have been caused by the IMP are detailed in 
Table 12‒3(laboratory measurements) and Table12‒4(additional information). Results of the 
laboratory measurements and information collected areto be submitted to the Sponsoron the 
corresponding eCRF. If the medical history of the subject indicates a requirement for other 
assessments not included below, these additional assessments should be completed and 
submitted, as applicable.
All blood samples should be stored, if possible. If tests are done  locally for more rapid results, a 
concurrent sample must also be sent to the central laboratory.
The following measurements are to be assessed:
REDACTED COPY 
required concomitant medication known to be hepatotoxic to a suitable alternative.
REDACTED COPY 
required concomitant medication known to be hepatotoxic to a suitable alternative.
Testing: identification/exclusion of alternative etiology
REDACTED COPY 
Testing: identification/exclusion of alternative etiology
and additional information required for the assessment of PDILI events when 
REDACTED COPY 
and additional information required for the assessment of PDILI events when 
may
REDACTED COPY 
may have been caused by
REDACTED COPY 
 have been caused by
may have been caused by
may
REDACTED COPY 
may have been caused by
may
 measurements) and 
REDACTED COPY 
 measurements) and 
REDACTED COPY 
Table
REDACTED COPY 
Table
 measurements and information 
REDACTED COPY 
 measurements and information 
medical history
REDACTED COPY 
medical history
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ptoms of hepatitis or 
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ptoms of hepatitis or 
 immediate investigation) to 
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 immediate investigation) to 
12
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12‒2
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‒2for details).
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for details).
MP is discontinued, all concomitant medications and herbal supplements that are not 
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MP is discontinued, all concomitant medications and herbal supplements that are not 
Investigator
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Investigatorshould also consider 
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should also consider 
 concomitant medication and consider changing an
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 concomitant medication and consider changing an
required concomitant medication known to be hepatotoxic to a suitable alternative.
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required concomitant medication known to be hepatotoxic to a suitable alternative.
Testing: identification/exclusion of alternative etiology
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Testing: identification/exclusion of alternative etiology
and additional information required for the assessment of PDILI events when 
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and additional information required for the assessment of PDILI events when 
 have been caused by
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 have been caused by
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Table
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Table12
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12
co
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collected 
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llected 
medical history
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medical history of the subject indicates a requirement for other 
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 of the subject indicates a requirement for other 
medical history of the subject indicates a requirement for other 
medical history
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medical history of the subject indicates a requirement for other 
medical history
assessments not included below, these 
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assessments not included below, these 
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additional assessments 
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additional assessments 
All blood samples should be stored, if possible. If tests are done  locall
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All blood samples should be stored, if possible. If tests are done  locall
concurrent sample must also be sent to the central laboratory
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concurrent sample must also be sent to the central laboratory
The following measurements are t
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The following measurements are t


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Page 80of 119
Table12‒3:PDILI laboratory measurements
Virology-
related
Hepatitis A IgM antibody
HBsAg
Hepatitis E IgM antibody
HBcAb-IgM
Hepatitis C RNA
Cytomegalovirus IgM antibody
Epstein-Barr viral capsid antigen IgM antibody (if unavailable, obtain 
heterophile antibody or monospot testing)
Immunology Anti-nuclear antibody (qualitative and quantitative)
Anti-smooth muscle antibody (qualitative and quantitative)
Type 1 anti-liver kidney microsomal antibodies (qualitative and quantitative)
Hematology
Eosinophil count
Urinalysis
Toxicology screen
Chemistry
Amylase
If total bilirubin ≥1.5xULN, obtain fractionated bilirubin to obtain % direct 
bilirubin
Serum CPK and LDH to evaluate possible muscle injury causing transaminase 
elevation
Additional
Prothrombin time/INR
a
Serum pregnancy test
PK sample
ALT=alanine aminotransferase; CPK=creatine phosphokinase; HBcAb-IgM=hepatitis B core antibody-IgM; 
HBsAg=hepatitis B surface antigen; IgM=immunoglobulinM; INR=international normalized ratio; LDH=lactate 
dehydrogenase; PDILI=potential drug-induced liver injury; PK=pharmacokinetic; RNA=ribonucleic acid; 
ULN=upper limit of normal
aMeasured only for subjects with ALT >8xULN, elevations in total bilirubin, and symptoms of hepatitis or 
hypersensitivity. Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or 
tenderness; hypersensitivity symptoms include eosinophilia (>5%), rash, and fever (without clear alternative 
cause).
The following additional information is to be collected:
Table12‒4:PDILI information to be collected
New or updated information
Concomitant prescription and over-the-counter medications (eg, acetaminophen, herbal remedies, 
vitamins); dosages and dates should be included.
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
1.5xULN, obtain fractionated bilirubin to obtain % direct 
REDACTED COPY 
1.5xULN, obtain fractionated bilirubin to obtain % direct 
REDACTED COPY 
DH to evaluate possible muscle injury
REDACTED COPY 
DH to evaluate possible muscle injury
REDACTED COPY 
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y (if unavailable, obtain 
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y (if unavailable, obtain 
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 (qualitative and quantitative)
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 (qualitative and quantitative)
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(qualitative and quantitative)
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(qualitative and quantitative)
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1.5xULN, obtain fractionated bilirubin to obtain % direct 
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1.5xULN, obtain fractionated bilirubin to obtain % direct 
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DH to evaluate possible muscle injury
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DH to evaluate possible muscle injury
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ombin time/INR
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ombin time/INR
a
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a
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Serum pregnancy
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Serum pregnancy test
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 test
Serum pregnancy test
Serum pregnancy
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Serum pregnancy test
Serum pregnancy
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PK sample
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PK sample
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ALT=alanine aminotransferase; CPK=creatine phosphokinase; HBcAb
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ALT=alanine aminotransferase; CPK=creatine phosphokinase; HBcAb
HBsAg=hepatitis B surface antigen; IgM=immunoglobulin
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HBsAg=hepatitis B surface antigen; IgM=immunoglobulin
dehydrogenase; PDILI=potential drug
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dehydrogenase; PDILI=potential drug
ULN=upper limit of normal
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ULN=upper limit of normal
Measured only for subjects w
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Measured only for subjects w
hypersensitivity. Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or 
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hypersensitivity. Hepatitis symptoms include fatigue, nausea, vomiting, and right upper quadrant pain or 
tendernes
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tendernes
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s; hypersensitivity symptoms include eosinophilia (>5%), rash, and fever (w
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s; hypersensitivity symptoms include eosinophilia (>5%), rash, and fever (w
cause).
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cause).
The following additional information is to be collected:
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The following additional information is to be collected:
Table
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Table


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Table12‒4:PDILI information to be collected
New or updated information
Pertinent medical history, including the following:
History of liver disease (eg, autoimmune hepatitis, nonalcoholic steatohepatitis or other “fatty 
liver disease”)
Adverse reactions to drugs
Allergies
Relevant family history or inheritable disorders (eg, Gilbert’s syndrome, alpha-1 antitrypsin 
deficiency)
Recent travel 
Progression of malignancy involving the liver (Note:Metastatic disease to the liver, by itself, 
should not be used as an explanation for significant AST and/or ALT elevations.)
The appearance or worsening of clinical symptoms ofhepatitis or hypersensitivity (eg, fatigue, nausea, 
vomiting, right upper quadrant pain or tenderness, decreased appetite, abdominal pain, jaundice, fever, or 
rash)
Recent clinically significant hypotension or hypoxemia with compromised cardiopulmonary function
Alcohol and illicit drug use
Results of liver imaging or liver biopsy, if done
Results of any specialist or hepatology consult, if done
Any postmortem/pathology reports
ALT=alanine aminotransferase; AST=aspartate aminotransferase; PDILI=potential drug-induced liver injury
12.2.1.4
Follow-up evaluation
Potential drug-induced liver injury events require follow-up monitoring as described in
Table 12‒2. Monitoring should continue until liver chemistry values normalize, stabilize, or 
return to baseline. Determination of stabilization is at the discretion of the Investigatorin
consultation with the hepatologist (asapplicable) and UCB responsible physician, as needed.
12.3 
Physical examination
The Investigator will conduct a complete physical examination in all subjects. The physical 
examination will cover the following general appearance, head, ears, eyes, nose, throat, hair, 
skin, respiratory, cardiovascular, gastrointestinal, musculoskeletal, hepatic, neurological, and 
mental status. Clinically relevant changes during the study will be recorded as AEs. In addition,
TB signs and symptoms will be assessed.
Findings will be recorded in the eCRF.
12.4
Blood pressure
Blood pressure will be measured prior to dosing with study drug. Subjects should be sitting for 
5 minutes prior and during the collection of blood pressure. Systolic and diastolic blood pressure 
should be recorded in mmHg.
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
Results of any specialist or hepatology consult, if done
REDACTED COPY 
Results of any specialist or hepatology consult, if done
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
ALT=alanine aminotransferase; AST=aspartate aminotransferase; 
REDACTED COPY 
ALT=alanine aminotransferase; AST=aspartate aminotransferase; 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
1 antitrypsin 
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1 antitrypsin 
etastatic disease to the liver, by itself, 
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etastatic disease to the liver, by itself, 
should not be used as an explanation for significant AST and/or ALT elevations
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should not be used as an explanation for significant AST and/or ALT elevations
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hepatitis or hypersensitivity (eg, fatigue, nausea, 
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hepatitis or hypersensitivity (eg, fatigue, nausea, 
vomiting, right upper quadrant pain or tenderness, decreased appetite, abdominal pain, jaundice, fever, or 
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vomiting, right upper quadrant pain or tenderness, decreased appetite, abdominal pain, jaundice, fever, or 
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Recent clinically significant hypotension or hypoxemia with compromised cardiopulmonary f
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Recent clinically significant hypotension or hypoxemia with compromised cardiopulmonary f
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Results of any specialist or hepatology consult, if done
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Results of any specialist or hepatology consult, if done
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ALT=alanine aminotransferase; AST=aspartate aminotransferase; 
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ALT=alanine aminotransferase; AST=aspartate aminotransferase; 
evaluation
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evaluation
induced liver injury
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induced liver injuryevents require follow
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events require follow
. Monitoring should continue until liver chemistry
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. Monitoring should continue until liver chemistry
return to baseline. Determination of stabilizati
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return to baseline. Determination of stabilizati
consultation with the hepatologist 
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consultation with the hepatologist 
ysical examination
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ysical examination
The Investigator will conduct a complete ph
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The Investigator will conduct a complete ph
examination will cover the following general appearance, head, ears, ey
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examination will cover the following general appearance, head, ears, ey
skin, respiratory
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skin, respiratory
mental status. Clinically
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mental status. Clinically
TB signs and s
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TB signs and s
Findings will be recorded in the eCRF.
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Findings will be recorded in the eCRF.
12.4
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12.4


UCB
25 Jan 2018
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Page 82of 119
Any abnormal findings which are clinically significant, in the opinion of the Investigator, will be 
recorded as an AE. Vital sign measurements will be recorded in the eCRF.
12.5
12-lead electrocardiogram
Twelve-lead standard ECGs will be recorded at the visits specified in Table 5‒1.
12.6
Tuberculosis assessments and management
All subjects will be assessed for TB at Screening and at the timepoints noted in the schedule of 
assessments (Table 5‒1)through the study through physical examination for signs and symptoms 
of TB, chest x-ray, laboratory testing, and patient questionnaire. 
At Screening, all subjects will have an IGRA test (QuantiFERON TB GOLDis recommended. 
However, a T-SPOT test may be performed by a local laboratory), a chest x-ray (unless already 
performed within 3 months of screening), and examination for signs and symptoms of TB. In 
addition, each subject will complete a TB questionnaire with questions directed at symptoms of 
TB and potential exposure to TB. Chest x-rays must be read by a qualified radiologist/pulmonary 
physician to determine whether there is evidence of active or latent TB. Chest x-ray reports must 
be consistent with standard reporting practices. 
At screening, subjects with latent TB must receive a full course of latent TB treatment (see 
Section 6.2.1, Exclusion Criterion 22) initiated at least 4 weeks prior to the first study drug 
injection. 
One rescreening of subjects with latent TB who are unable to complete a minimum of 4 weeks of 
TB therapy within the Screening Period is permitted. In this event, all Screening assessments 
must be repeated.
In case of a TB test conversion defined as a positive result (IGRA) for the current test but 
previous test results were negative (IGRA), the subject is considered to have either a suspected 
new latent or an active TB infection. The study drug administration must be stopped immediately 
and an appropriate specialist (ie, pulmonologist, infectious disease specialist) must be consulted  
for further evaluation if test conversion indicates either a new latent or a new active TB. 
Additional assessments (eg, blood tests in case of a positive IGRA test, chest x-rays) should be 
performed.
In case the evaluation by the appropriate specialist indicates a new latent TB:
A prophylactic TB treatment (as described inthisprotocol) can be initiated and IMP can be 
continued no earlier than 4 weeks after start of prophylactic TB treatment, if it is deemed likely 
that the entire course of prophylactic TB treatment will be completed. In case no prophylactic 
treatment is initiated, the subjecthas to be withdrawn. Every action should be discussed with the 
Medical Monitor. Latent TB must be reported as an AE.
Subjects who develop active TB or NTMB (nontuberculosis mycobacterium) infection during 
the study (including, but not limited to, conversion demonstrated by IGRA or other diagnostic 
means during the course of the study)must be immediately discontinued from IMPand a 
Withdrawal Visit must be scheduled as soon as possible, but not later than the next regular visit. 
REDACTED COPY 
) initiated at least 4 weeks prior to the first study
REDACTED COPY 
) initiated at least 4 weeks prior to the first study
One rescreening of subjects with latent TB who are unable to complete a minimum of 4 weeks of 
REDACTED COPY 
One rescreening of subjects with latent TB who are unable to complete a minimum of 4 weeks of 
y within the Screening Period is permitted. In this event, all Screening assessments 
REDACTED COPY 
y within the Screening Period is permitted. In this event, all Screening assessments 
In case of a TB test conversion defined
REDACTED COPY 
In case of a TB test conversion definedas a positive result (IGRA) for the current test but 
REDACTED COPY 
as a positive result (IGRA) for the current test but 
previous test results were negative (IGRA), the subject is considered to have either a suspected 
REDACTED COPY 
previous test results were negative (IGRA), the subject is considered to have either a suspected 
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the timepoints noted in the schedule of 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
the timepoints noted in the schedule of 
ym
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ymptoms 
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ptoms 
is recommended. 
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is recommended. 
ray
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ray (unless already
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 (unless already
ray (unless already
ray
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ray (unless already
ray
ymptoms of TB. In 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ymptoms of TB. In 
ete a TB questionnaire with questions directed at s
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ete a TB questionnaire with questions directed at s
a qualified radiologist/pulmonary
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a qualified radiologist/pulmonary
sician to determine whether there is evidence of active or latent TB. Chest x
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sician to determine whether there is evidence of active or latent TB. Chest x
At screening, subjects with latent TB must receive a full cours
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At screening, subjects with latent TB must receive a full course of latent TB treatment (see 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
e of latent TB treatment (see 
) initiated at least 4 weeks prior to the first study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
) initiated at least 4 weeks prior to the first study
One rescreening of subjects with latent TB who are unable to complete a minimum of 4 weeks of 
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One rescreening of subjects with latent TB who are unable to complete a minimum of 4 weeks of 
y within the Screening Period is permitted. In this event, all Screening assessments 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y within the Screening Period is permitted. In this event, all Screening assessments 
as a positive result (IGRA) for the current test but 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
as a positive result (IGRA) for the current test but 
previous test results were negative (IGRA), the subject is considered to have either a suspected 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
previous test results were negative (IGRA), the subject is considered to have either a suspected 
new latent or an active TB infection. The study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
new latent or an active TB infection. The study
,
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,pulmonologist, infectious disease specialist) must be consulted 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
pulmonologist, infectious disease specialist) must be consulted 
for further evaluation if test conversion indicates either a new latent or a new active TB. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
for further evaluation if test conversion indicates either a new latent or a new active TB. 
Additional assessments (eg
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Additional assessments (eg,
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,blood tests in case of a positive IGRA test, c
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blood tests in case of a positive IGRA test, c
In case the evaluation by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
In case the evaluation by the appropriate specialist indicates a new latent TB:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 the appropriate specialist indicates a new latent TB:
In case the evaluation by the appropriate specialist indicates a new latent TB:
In case the evaluation by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
In case the evaluation by the appropriate specialist indicates a new latent TB:
In case the evaluation by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
actic TB treatment (as described in
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actic TB treatment (as described in
continued no earlier than 4 weeks after start of p
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
continued no earlier than 4 weeks after start of p
that the entire course of prophy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
that the entire course of prophy
treatment is initiated, the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
treatment is initiated, the 
Medical Monit
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Medical Monit
Subjects who develop active TB or NTMB (nontuberculosis my
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects who develop active TB or NTMB (nontuberculosis my
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the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
the study
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UCB
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Clinical Study Protocol
Certolizumab Pegol
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Page 83of 119
Confirmed active TB is an SAE and must be captured on an SAE report form and provided to the 
Sponsor in accordance with SAE reporting requirements. As with all SAEs , periodic follow up 
reports should be completed as per protocol requirement until such time as the TB infection 
resolves.
Subjects who prematurely discontinue treatment for latent TB, or, in theopinion of the 
Investigator or Sponsor, are noncompliant with anti-TB therapy must discontinue further use of 
study medication and be immediately withdrawn.
12.7 
Chest x-ray for TB
A plain posteroanterior chest x-ray must be performed in the Screening Period unless one has 
been performed within 3 months prior to the Screening Visit. The chest x-ray must be clear of 
signs of TB infection (previous or current) before first study drug administration. Radiographic 
findings suggestive of inactive TB or active TB may include but are not limited to: apical 
fibrosis, pleural thickening, pulmonary nodules, fibrotic scars, calcified granulomas, upper lobe 
infiltrates, cavitations and pleural effusions, calcified lung nodules, calcified hilar lymph nodes, 
and pericardial calcification. The chest x-ray (or, if done, Computed Axial Tomography of the 
Chest) must be negative for TB infection as determined by a qualified radiologist/pulmonary 
physician. All chest imaging (particularly x-rays) should be available for review by the 
Investigator before randomization of the subject. Any new clinically significant findings during 
the physical examinations or on chest x-ray must be documented in the source documents and 
eCRF as an AE.
12.8
Interferon-gamma release assay (IGRA) testing for TB
All subjects will have IGRA testing conducted as part of the screening procedures and annually 
for those subjects with a previously negative chest x-ray. Interferon-gamma release assay test 
kits will be supplied by the central laboratory. Results from this test will be reported as positive, 
negative, or indeterminate. 
Interferon-gamma release assay test kits and the test results will be provided to the site by the 
central laboratory and electronically transferred to the clinical database. 
12.9 
Subject questionnaire for TB
The questionnaire “Evaluation of signs and symptoms of tuberculosis” will be used as a source 
document. The questionnaire will assist with the identification of subjects who may require 
therapy for TB. A subject who answers “Yes” to the question 
 
 Screening,excludes the subject from study entry. A “Yes” response to any of the other 
questions within the questionnaire at Screening should trigger further careful assessment to 
determine if subject has latent or active TB. Subjects with a latent TB infection must receive 
prophylactic therapy prior to continuing study drug (if allowed by prophylactic therapy specific 
protocol). Subjects with active TB infection must be withdrawn from the study and will have 
further assessments.
12.10
Pregnancy testing
Pregnancy testing will consist of serum testing at Screening. Urine testing will be done at all 
other study visits as outlinedin the Schedule of Study Assessments (Table 5‒1).
REDACTED COPY 
Investigator before randomization of the subject. Any
REDACTED COPY 
Investigator before randomization of the subject. Any new clinicall
REDACTED COPY 
 new clinicall
 must be documented in the source documents and 
REDACTED COPY 
 must be documented in the source documents and 
gamma release assay
REDACTED COPY 
gamma release assay
All subjects will have IGRA testing conducted as part of the screening procedures and annuall
REDACTED COPY 
All subjects will have IGRA testing conducted as part of the screening procedures and annuall
 negative chest x
REDACTED COPY 
 negative chest x
 the central laboratory
REDACTED COPY 
 the central laboratory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
unless one has 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
unless one has 
ray must be clear of 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ray must be clear of 
 drug administration. Radiographic 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 drug administration. Radiographic 
y include but are not limited to: apical 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y include but are not limited to: apical 
 nodules, fibrotic scars, calcified granulomas, upper lobe 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 nodules, fibrotic scars, calcified granulomas, upper lobe 
infiltrates, cavitations and pleural effusions, calcified lung nodules, calcified hilar ly
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
infiltrates, cavitations and pleural effusions, calcified lung nodules, calcified hilar ly
 (or, if done, Computed Axial Tomography
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 (or, if done, Computed Axial Tomography
 a qualified radiologist/pulmonary
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 a qualified radiologist/pulmonary
s) should be available for review by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
s) should be available for review by
 new clinicall
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 new clinicall
 must be documented in the source documents and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 must be documented in the source documents and 
gamma release assay
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
gamma release assay
All subjects will have IGRA testing conducted as part of the screening procedures and annuall
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
All subjects will have IGRA testing conducted as part of the screening procedures and annuall
 negative chest x
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 negative chest x
 the central laboratory
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 the central laboratory
gamma release assay
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gamma release assaytest kits and the test results will be provided to the site by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
test kits and the test results will be provided to the site by
 and electronicall
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 and electronicall
Subject 
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Subject q
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quest
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uest
The questionnaire “Evaluation of signs and s
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The questionnaire “Evaluation of signs and s
document. The questionnaire will assist with the identification of subjects who may
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
document. The questionnaire will assist with the identification of subjects who may
y for TB. A subject who answers “Yes” to the que
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y for TB. A subject who answers “Yes” to the que
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 Screening,
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 Screening,
questions within the questionn
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
questions within the questionn
determine if subject has latent or active TB. Subjects with a latent TB infection must receive 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
determine if subject has latent or active TB. Subjects with a latent TB infection must receive 
prophy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
prophy
p
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
protocol). Subjects with active TB infection must be withdrawn from the study and will have 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
rotocol). Subjects with active TB infection must be withdrawn from the study and will have 
further assessments.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
further assessments.
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UCB
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Clinical Study Protocol
Certolizumab Pegol
PS0017
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Page 84of 119
Urine pregnancy testing supplies will be provided by the central laboratory. Testing will be 
conducted on site and results will be entered into the eCRF. 
12.11
Height and weight
Height will be recorded in centimeters (cm) and weight will be recorded in kilogram (kg). Height 
and weight measurements will be recorded in the eCRF. 
12.12
Other study measurements
12.12.1
Demographic information
Demographic information will be collected in all subjects and include age, gender, race,and 
ethnicity. Information on demographics will be collected according to local rules and regulations. 
Demographic information will be recorded in the eCRF.
12.12.2 
Medical history
A complete medical history will be collected as part of the Screening assessment and include all 
clinically relevant past or coexisting medical conditions and surgeries. Findings will be recorded 
in the eCRF. 
12.12.3 
Psoriasis history
A detailed history of each subject’s PSO history will be collected and include the date of onset 
and past treatments for PSO.
13
STUDY MANAGEMENT ANDADMINISTRATION 
13.1
Adherence to protocol
The Investigatorshould not deviate from the protocol. However, the Investigatorshould take any 
measure necessary in deviation from or not defined by the protocol in order to protect clinical 
studysubjects from any immediate hazard to their health and safety.Inthis case, this action 
should be taken immediately,without prior notification of the regulatory authority,IRB,or 
Sponsor.
After implementation of such measure, the Investigatormust notify the CPM of the Sponsor
within 24 hours and follow any local regulatory requirements.
13.2
Monitoring
UCB (or designee) will monitor the study to meet the Sponsor’s monitoring Standard Operating 
Procedures (SOPs), ICH-GCP guideline, and applicable regulatory requirements, and to ensure 
that study initiation, conduct, and closure are adequate. Monitoring of the study may be 
delegated by UCB to a CRO or a contract monitor.
The Investigatorand his/her staff are expected to cooperate with UCB (or designee) and to be 
available during the monitoring visits to answer questions sufficiently and to provide any 
missing information. The Investigator(s)/institution(s) will permit direct access to source 
data/documents for study-related monitoring, audits, IRB review, and regulatory inspection(s).
The Investigatorwill allow UCB (or designee) to periodically review all eCRFs and 
corresponding source documents (eg,hospital and laboratory recordsfor each study participant). 
Monitoring visits will provide UCB (or designee) with the opportunity to evaluate the progress 
REDACTED COPY 
 will be collected and include the date of on
REDACTED COPY 
 will be collected and include the date of on
EMENT A
REDACTED COPY 
EMENT AND
REDACTED COPY 
ND
herence to protocol
REDACTED COPY 
herence to protocol
should not deviate from the protocol. 
REDACTED COPY 
should not deviate from the protocol. 
in deviation from or not defined by
REDACTED COPY 
in deviation from or not defined by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ace
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ace,
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
,and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and 
. Information on demographics will be collected according to local rules and regulations. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
. Information on demographics will be collected according to local rules and regulations. 
ning assessment and include all 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ning assessment and include all 
 relevant past or coexisting medical conditions and surgeries. Findings will be recorded 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 relevant past or coexisting medical conditions and surgeries. Findings will be recorded 
 will be collected and include the date of on
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 will be collected and include the date of on
ND
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
NDADM
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ADM
should not deviate from the protocol. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
should not deviate from the protocol. 
in deviation from or not defined by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
in deviation from or not defined by
 immediate hazard to their health and safet
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 immediate hazard to their health and safet
with
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
without prior notification of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
out prior notification of the 
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After implementation of such 
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After implementation of such measure
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measure
and follow an
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and follow an
Monitoring
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Monitoring
UCB (or designee) will monitor the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
UCB (or designee) will monitor the study
Procedures (SOPs), I
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Procedures (SOPs), I
that study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
that study initiation, conduct, and closure are adequate. Monitoring of the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 initiation, conduct, and closure are adequate. Monitoring of the study
that study initiation, conduct, and closure are adequate. Monitoring of the study
that study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
that study initiation, conduct, and closure are adequate. Monitoring of the study
that study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
delegated b
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
delegated b
The 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The Investigator
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator
available during the monitoring visits to answer questions sufficiently
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
available during the monitoring visits to answer questions sufficiently
missing information. The 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
missing information. The 


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25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
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Page 85of 119
of the study, verify the accuracy and completeness of eCRFs, ensure that all protocol 
requirements, applicable authorities regulations, and Investigator’s obligations are being 
fulfilled, and resolve any inconsistencies in the study records.
13.2.1
Definition of source data 
All source documents must be accurate, clear, unambiguous, permanent, and capable of being 
audited. They should be made using some permanent form of recording (ink, typing, printing, 
optical disc). They should not be obscured by correction fluid or have temporary attachments 
(such as removable self-stick notes). Photocopies and/or printouts of eCRFs are not considered 
acceptable source documents. 
Source documents are original records in which raw data are first recorded. These may include 
hospital/clinic/general practitioner records, charts, diaries, x-rays, laboratory results, printouts, 
pharmacy records, care records, ECG or other printouts, completed scales, or quality of life 
questionnaires, for example. Source documents should be kept in a secure, limited access area.
Source documents that are computer generated and stored electronically must be printed for 
review by the monitor (eg,ECG reports). Once printed, these copies should be signed and dated 
by the Investigator and become a permanent part of the subject’s source documents . The 
Investigator will facilitate the process for enabling the monitor to compare  the content of the 
printout and the data stored in the computer to ensure all data are consistent.
Electronic data records, such as Holter monitor records or electroencephalogram records, must 
be saved and stored as instructed by UCB (or designee).
13.2.2
Source data verification
The Investigator is responsible for prompt reporting of accurate, complete, and legible data in the 
eCRFs and in all required reports.
Any change or correction to the eCRF after saving must be accompanied by a reason for the 
change.
Corrections made after the Investigator’s review and approval (by means of a 
password/electronic signature) will be reapproved by the Investigator.
The Investigatorshould maintain a list of personnel authorized to enter data into the eCRF.
Detailed instructions will be provided in the eCRF Completion Guidelines.
13.3
Data handling
13.3.1
Case Report form completion
The Investigatoris responsible for prompt reporting of accurate, complete, and legible data in the 
eCRFs and in all required reports.
Any change or correction to the eCRF after saving must be accompanied by a reason for the 
change.
Corrections made after the Investigator’s review and approval (by means of a 
password/electronic signature) will be reapproved by the Investigator.
The Investigatorshould maintain a list of personnel authorized to enter data into the eCRF.
REDACTED COPY 
printout and the data stored in the computer to ensure all data are consistent.
REDACTED COPY 
printout and the data stored in the computer to ensure all data are consistent.
Electronic data records, such as Holter monitor records or electroencephalogram records, mus
REDACTED COPY 
Electronic data records, such as Holter monitor records or electroencephalogram records, mus
y UCB (or designee).
REDACTED COPY 
y UCB (or designee).
Source data verification
REDACTED COPY 
Source data verification
REDACTED COPY 
Investigator is responsible for prompt reporting of accurate, complete, and legible data in the 
REDACTED COPY 
Investigator is responsible for prompt reporting of accurate, complete, and legible data in the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 attachments 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 attachments 
eCRFs are not considered 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
eCRFs are not considered 
Source documents are original records in which raw data are first recorded. These may
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Source documents are original records in which raw data are first recorded. These may include 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 include 
Source documents are original records in which raw data are first recorded. These may include 
Source documents are original records in which raw data are first recorded. These may
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Source documents are original records in which raw data are first recorded. These may include 
Source documents are original records in which raw data are first recorded. These may
 results, printouts, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 results, printouts, 
, or quality
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, or quality
questionnaires, for example. Source documents should be kept in a secure, limited access area.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
questionnaires, for example. Source documents should be kept in a secure, limited access area.
Source documents that are computer generated and stored electronicall
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Source documents that are computer generated and stored electronically must be printed for 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y must be printed for 
ECG reports). Once printed, these copies should be signed and dated 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ECG reports). Once printed, these copies should be signed and dated 
vestigator and become a permanent part of the subject’s source documents . The 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
vestigator and become a permanent part of the subject’s source documents . The 
will facilitate the process for enabling the monitor to compare the content of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
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.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
printout and the data stored in the computer to ensure all data are consistent.
Electronic data records, such as Holter monitor records or electroencephalogram records, mus
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Electronic data records, such as Holter monitor records or electroencephalogram records, mus
y UCB (or designee).
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y UCB (or designee).
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator is responsible for prompt reporting of accurate, complete, and legible data in the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator is responsible for prompt reporting of accurate, complete, and legible data in the 
eCRF after saving must be accompanied b
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
eCRF after saving must be accompanied b
Investigator
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator
password/electronic signat
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
password/electronic signature) will be reapproved by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ure) will be reapproved by
password/electronic signature) will be reapproved by
password/electronic signat
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
password/electronic signature) will be reapproved by
password/electronic signat
should maintain a list of perso
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
should maintain a list of perso
Detailed instructions will be provided in the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Detailed instructions will be provided in the 
Data handling
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Data handling
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator
eCRFs and in all required reports.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
eCRFs and in all required reports.
Any
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Any
change.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
change.


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 86of 119
Detailed instructions will be provided in the eCRF Completion Guidelines.
13.3.2 
Database entry and reconciliation
Case Report forms/external electronic data will be entered/loaded into a validated electronic 
database using a clinical data management system (CDMS). Computerized data cleaning checks 
will be used in addition to manual review to check for discrepancies and to ensure consistency of 
the data. Case Report form data are entered into the clinical database using independent, 
double-data entry, with the exception of comment fields, which are verified by a second person.
The data are entered into the eCRFs once and are subsequently verifiedif the study is performed 
using electronic data capture.
An electronic audit trail system will be maintained within the CDMS to track all data changes in 
the database once the data have been saved initially into the system or electronically loaded. 
Regular backups of the electronic data will be performed.
13.3.3
Subject Screening and Enrollment log/Subject Identification Code list
The subject’s screening and enrollment will be recorded in the Subject Screening and Enrollment 
Log.
The Investigatorwill keep a Subject Identification Code list. This list remains with the 
Investigator and is used for unambiguous identification of each subject.
The subject’s consent and enrollment in the study must be recorded in the subject’s medical 
record. These data should identify the study and document the dates of the subject’s 
participation.
13.4
Termination of the study
UCB reserves the right to temporarily suspend or prematurely discontinue this study either at a 
single site, multiple sites, or at all sites at any time for reasons including, but not limited to, 
safety or ethical issues, inaccurate or incomplete data recording, noncompliance, or 
unsatisfactory enrollment with respect to quality or quantity.
If the study is prematurely terminated or suspended, UCB (or its representative) will inform the 
Investigators/institutions and the regulatory authority(ies) of the termination or suspension and 
the reason(s) for the termination or suspension, in accordance with applicable regulatory 
requirement(s). The IRB should also be informed and provided with reason(s) for the termination 
or suspension by the Sponsoror by the Investigator/institution, as specified by the applicable 
regulatory requirement(s). In addition, arrangements will be made for the return of all unused 
IMPand other material in accordance with UCB procedures for the study.
13.5
Archiving and data retention
The Investigatorwill maintain adequate records for the study, including CRFs, medical records, 
laboratory results, Informed Consent documents, drug dispensing and disposition records, safety 
reports, information regarding participants who discontinued, and other pertinent data.
All essential documents are to be retained by the Investigatoruntil at least 2 years after the last 
approval of a marketing application in an ICH region and until there are no pending or 
contemplated marketing applications in an ICH region, or at least 2 years have elapsed since the 
formal discontinuation of clinical development of the IMP. These documents should be retained 
REDACTED COPY 
on of each subject.
REDACTED COPY 
on of each subject.
The subject’s consent and enrollment in the study must be recorded in the subject’s medical 
REDACTED COPY 
The subject’s consent and enrollment in the study must be recorded in the subject’s medical 
 and document the dates of the subject’s 
REDACTED COPY 
 and document the dates of the subject’s 
Termination of the study
REDACTED COPY 
Termination of the study
UCB reserves the right to temporaril
REDACTED COPY 
UCB reserves the right to temporarily suspend or prematurel
REDACTED COPY 
y suspend or prematurel
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 a second person.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 a second person.
 is performed 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 is performed 
An electronic audit trail system will be maintained within the CDMS to track all data changes in 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
An electronic audit trail system will be maintained within the CDMS to track all data changes in 
stem or electronically
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
stem or electronically loaded. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 loaded. 
stem or electronically loaded. 
stem or electronically
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
stem or electronically loaded. 
stem or electronically
Subject Screening and Enrollment log/Subject Identification Code list
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subject Screening and Enrollment log/Subject Identification Code list
The subject’s screening and enrollment will be recorded in the Subject Screening and Enrollment 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The subject’s screening and enrollment will be recorded in the Subject Screening and Enrollment 
bject Identification Code list. This list remains with the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
bject Identification Code list. This list remains with the 
on of each subject.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
on of each subject.
The subject’s consent and enrollment in the study must be recorded in the subject’s medical 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The subject’s consent and enrollment in the study must be recorded in the subject’s medical 
 and document the dates of the subject’s 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 and document the dates of the subject’s 
Termination of the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Termination of the study
y suspend or prematurel
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y suspend or prematurel
single site, multiple sites, or at all sites at an
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
single site, multiple sites, or at all sites at an
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y or ethical issues, inaccurate or incomplete data recording, noncompliance, or 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y or ethical issues, inaccurate or incomplete data recording, noncompliance, or 
 enrollment with respect to qualit
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 enrollment with respect to qualit
y is prematurely terminated or suspended, UCB (or its repr
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y is prematurely terminated or suspended, UCB (or its repr
s/institutions and the regulatory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
s/institutions and the regulatory
the reason(s) for the termination or suspension, in accordance with applicable regulatory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
the reason(s) for the termination or suspension, in accordance with applicable regulatory
requirement(s). The IRB should also be informed and provided with reason(s) for the termination 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
requirement(s). The IRB should also be informed and provided with reason(s) for the termination 
or suspension by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
or suspension by the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 the 
or suspension by the 
or suspension by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
or suspension by the 
or suspension by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Sponsor
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Sponsor
 requirement(s). In addition, arrangements will be made for the return of all unused 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 requirement(s). In addition, arrangements will be made for the return of all unused 
and other material in accordance with UCB procedures for the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and other material in accordance with UCB procedures for the study
The 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The Investigator
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator
laboratory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
laboratory
reports, information regarding participants who discontinued, and other pertinent data.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
reports, information regarding participants who discontinued, and other pertinent data.


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 87of 119
for a longer period, however, if required by the applicable regulatory requirement(s) or by an 
agreement with UCB (CPMP/ICH/135/95, 2002 [Section4.9.5]). 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 Investigatorwill also notify UCB should he/she 
relocate or move the study-related files to a location other than that specified in the Sponsor’s 
trial master file.
13.6
Audit and inspection
The Investigatorwill permit study-related audits mandated by UCB, after reasonable notice, and 
inspections by domestic or foreign regulatory authorities.
The main purposes of an audit or inspection are to confirm that the rights and well-being of the 
subjects enrolled have been protected, that enrolled subjects (ie,signing consent and undergoing 
study procedures) are appropriate for the study, and that all data relevant for the evaluation of the 
IMP have been processed and reported in compliance with the planned arrangements, the 
protocol, investigational site, and IRBSOPs, ICH GCP, and applicable regulatory requirements.
The Investigatorwill provide direct access to all study documents, source records, and source 
data. If an inspection by a regulatory authorityis announced, the Investigatorwill immediately 
inform UCB (or designee).
13.7
Good Clinical Practice
Noncompliance with the protocol, ICH-GCP, or local regulatory requirements by the 
Investigator, institution, institution staff, or designees of the Sponsorwill lead to prompt action 
by UCB to secure compliance. Continued noncompliance may result in the termination of the 
site’s involvement in the study.
14
STATISTICS
A description of statistical methods follows and will be described in more detail in the Statistical 
Analysis Plan.
14.1
Definition of analysis sets
The Enrolled Set (ES) will consist of all subjects who have given informed consent.
The Randomized Set (RS) will consist of all subjects randomized into the study.
The Safety Set (SS) will consist of all subjects in the RS who have received at least 1 dose of 
study medication.
The Full Analysis Set (FAS) will consist of all randomized subjects that received at least 1 dose 
of the study medication and have valid efficacy assessments for Baseline and for at least 1 post-
Baseline visit.
The Per-Protocol Set (PPS) will consist of subjects in the FAS who have completed a minimal 
exposure of 16 weeks to the treatment regimen without any important protocol deviations that 
may influence the validity of the data for the primary efficacy variable. Important protocol 
deviations will be predefined and evaluated during a data evaluation meeting prior to unblinding 
of the data.
The PPS mayexclude subjects who meet any of the following criteria:
REDACTED COPY 
GCP, or local regulatory
REDACTED COPY 
GCP, or local regulatory
, institution, institution staff, or designees of the 
REDACTED COPY 
, institution, institution staff, or designees of the 
 UCB to secure compliance. Continued noncompliance may
REDACTED COPY 
 UCB to secure compliance. Continued noncompliance may
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y UCB, after reasonable notice, and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y UCB, after reasonable notice, and 
The main purposes of an audit or inspection are to confirm that the rights and well
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The main purposes of an audit or inspection are to confirm that the rights and wellbeing of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
being of the 
signing consent and undergoing 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
signing consent and undergoing 
, and that all data relevant for the evaluation of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, and that all data relevant for the evaluation of the 
arrangements, the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
arrangements, the 
CH GCP, and applicable regulatory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
CH GCP, and applicable regulatory
 documents, source records, and source 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 documents, source records, and source 
is announced, the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
is announced, the Investigator
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator
GCP, or local regulatory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
GCP, or local regulatory
, institution, institution staff, or designees of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, institution, institution staff, or designees of the 
 UCB to secure compliance. Continued noncompliance may
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 UCB to secure compliance. Continued noncompliance may
A description of statistical methods follows and will be described in more detail in the Statisti
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
A description of statistical methods follows and will be described in more detail in the Statisti
Definition of analy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Definition of analy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The Enrolled Set (ES) will consist of all subjects who have given informed consent.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The Enrolled Set (ES) will consist of all subjects who have given informed consent.
The Randomized Set (RS) will consist of all subjects randomized into the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The Randomized Set (RS) will consist of all subjects randomized into the study
y Set (SS) will consist of all subje
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y Set (SS) will consist of all subje
 medication.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 medication.
The Full Anal
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The Full Anal
of the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
of the study
Baseline visit
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Baseline visit
The Per
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The Per
exposure of 16 weeks to the treatment regimen without any
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
exposure of 16 weeks to the treatment regimen without any


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 88of 119
Have taken any prohibited concomitant medications
Have not been compliant with the dosing regimen
The criteria for important protocol deviations leading to exclusion from the PPS will be 
discussed and appropriately documented (see Section 14.5).
The Pharmacokinetics Per-Protocol Set (PK-PPS) will consist of all randomized subjects who 
took at least 1 dose of the study medication and provided at least 1 quantifiable plasma 
concentration postdose.
The PsA Set (PsAS) will be consist of subjects in the FAS who with PsAdisease at Baseline.
The NAPSI Set (NAPSIS) will be consist of subjects in the FAS who with nail disease at 
Baseline.
Subjects with generalized pustular PSO or erythrodermic PSO will be analyzed by cohort as 
follows:
The Cohort Enrolled Set (CES) will consist of subjects with generalized pustular PSO or 
erythrodermic PSO who have given informed consent.
The Cohort Randomized Set (CRS) will consist of subjects with generalized pustular PSO or 
erythrodermic PSO randomized into the cohort.
The Cohort Safety Set (CSS) will consist of subjects with generalized pustular PSO or 
erythrodermic PSO in the CRS who have received at least 1 dose of study medication.
The Cohort Full Analysis Set (CFAS) will consist of subjects with generalized pustular PSO or 
erythrodermic PSO in the CRS whoreceived at least 1 dose of the study medication and have 
valid efficacy assessments for Baseline and for at least 1 post-Baseline visit.
The Cohort Pharmacokinetics Set (CPKS) will consist of subjects with generalized pustular PSO 
orerythrodermic PSO randomized into the cohort who took at least 1 dose of the study 
medication and provided at least 1 quantifiable plasma concentration postdose.
The Generalized Pustular PSO Set (GPPS) will consist of subjects in the CFAS with generalized
pustular PSO disease at Baseline.
The Erythrodermic PSO Set (EPS) will consist of subjects in the CFAS with erythrodermic PSO 
disease at Baseline.
14.2
General statistical considerations
The primary efficacy variable will be analyzed for subjects with moderate to severe chronic 
plaque PSO in the FAS. In order to verify the robustness of the efficacy results, primary efficacy 
variables in the primary analysis will also be analyzed for the PPS as sensitivity analysis.
The statistical analysis of the primary and secondary efficacy variables will account for 
multiplicity by using a fixed sequence testing procedure. As these variables will be evaluated for 
both doses of CZP, the statistical analysis for each dose will be carried out in separation of one 
another. To account for the testing of multiple doses, the alpha level of 0.05 will be split evenly 
between CZP 400mg Q2W and CZP 200mg Q2W so that each dose is evaluated at an alpha level 
of 0.025. 
REDACTED COPY 
subjects with 
REDACTED COPY 
subjects with 
hrodermic PSO in the CRS who have received at least 1 dose of study
REDACTED COPY 
hrodermic PSO in the CRS who have received at least 1 dose of study
is Set (CFAS) will consist of 
REDACTED COPY 
is Set (CFAS) will consist of 
received at least 1 dose of the stud
REDACTED COPY 
received at least 1 dose of the stud
 assessments for Baseline and for at least 1 post-
REDACTED COPY 
 assessments for Baseline and for at least 1 post-
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disease at Baseline.
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disease at Baseline.
 Set (NAPSIS) will be consist of subjects in the FAS who with nail disease at 
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 Set (NAPSIS) will be consist of subjects in the FAS who with nail disease at 
throdermic PSO will be analy
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throdermic PSO will be analyzed by
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zed by
throdermic PSO will be analyzed by
throdermic PSO will be analy
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throdermic PSO will be analyzed by
throdermic PSO will be analy
generalized pustular PSO or 
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generalized pustular PSO or 
The Cohort Randomized Set (CRS) will consist of subjects with 
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The Cohort Randomized Set (CRS) will consist of subjects with generalized pustular PSO or 
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generalized pustular PSO or 
subjects with 
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subjects with generalized pustular PSO or 
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generalized pustular PSO or 
hrodermic PSO in the CRS who have received at least 1 dose of study
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hrodermic PSO in the CRS who have received at least 1 dose of study
is Set (CFAS) will consist of 
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is Set (CFAS) will consist of 
received at least 1 dose of the stud
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received at least 1 dose of the stud
 assessments for Baseline and for at least 1 post-
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 assessments for Baseline and for at least 1 post-
(CPKS) will consist of 
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(CPKS) will consist of 
hrodermic PSO randomized into the cohort who took at least 1 dose of the study
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hrodermic PSO randomized into the cohort who took at least 1 dose of the study
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medication and provided at least 1 quantifiable plasma concentration postdose.
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medication and provided at least 1 quantifiable plasma concentration postdose.
The Generalized Pustular PSO Set (GPPS) will consist of subjects in the CFAS with generalized
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The Generalized Pustular PSO Set (GPPS) will consist of subjects in the CFAS with generalized
pustular PSO disease at Baseline.
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pustular PSO disease at Baseline.
throdermic PSO Set (EPS) will consist of subjects in the CFAS with ery
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throdermic PSO Set (EPS) will consist of subjects in the CFAS with ery
disease at Baseline.
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disease at Baseline.
General statistical considerations
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General statistical considerations
The primary
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The primary efficacy
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 efficacy
The primary efficacy
The primary
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The primary efficacy
The primary
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plaque PSO in the FAS. In order to verify
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plaque PSO in the FAS. In order to verify
variables in the primary
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variables in the primary
The statistical anal
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The statistical anal
multiplicity
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multiplicity


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Page 89of 119
Within each dose, the primary endpoints of PASI75 at Week 16 will be evaluated first. Statistical 
testing of PGA (clear or almost clear) response at Week 16 will be performed only if primary 
endpoint (PASI75) is significant at the 0.025 alpha level for a given dose. 
Similarly, testing of PASI90 at Week 16 will be performed only if  primary endpoint (PASI75) 
and PGA are significant at the 0.025 level, and similarly, testing of change from Baseline in 
DLQI at Week 16 will be performed only if  PASI75, PGA, and PASI90 are significant at the 
0.025 level.
Table 14‒1outlines the testing procedure.
Table14‒1:Statistical testing procedure
CZP 200mgQ2W vs Placebo
CZP 400mgQ2W vs Placebo
1. PASI75 response at Week 16
1. PASI75 response at Week 16
2. PGA response at Week 16
2. PGA response at Week 16
3. PASI90 response at Week 16
3. PASI90 response at Week 16
4. Change from Baseline in DLQI at Week 16
4. Change from Baseline in DLQI at Week 16
CZP=certolizumab pegol; DLQI=Dermatology Life Quality Index; PASI=Psoriasis Activity and Severity Index; 
PGA=Physician’s Global Assessment; Q2W=every 2 weeks
Note: All significance tests are performed at an alpha level of 0.025.
14.3
Planned efficacy analyses
Because the majority of PBO subjects will be switched to CZP treatment at Week 16, all 
statistical comparisons between CZP and PBO will be limited to the time period through 
Week 16 for subjects with moderate to severe chronic plaque PSO. After Week 16, data will be 
summarized using descriptive statistics only. Tabular summaries of efficacy data will be based 
on treatment groups. Variables evaluated over time will be summarized using imputed and 
observed case values. Further details on data summarization will be provided in the SAP.
14.3.1
Analysis of the primary efficacy variable for subjects with moderate 
to severe chronic plaque PSO
The primary efficacy variable for this study is PASI75 response at Week 16. A subject will be 
classified as a PASI75 responder if the PASI score at the visit has improved at least 75% from 
Baseline. The primary analysis for this variable will be based on a logistic regression model 
which will include fixed effects for treatment group and prior biologic exposure (yes/no). Prior 
biologic exposure was selected as a fixed effect in the logistic regression model as it is a 
stratification variable for randomization and because it may have an impact on efficacy. The 
odds ratioand associated confidence intervalwill be presented.
The Markov Chain Monte Carlo (MCMC) method for multiple imputation will be used to 
account for missing values in the primary analysis of PASI75 at Week 16. The multiple 
imputation procedure for PASI 75 will be based on the actual PASI score.
Multiple imputation and subsequent analysis will involve 4 principal tasks as described below:
1.  Calculate the number of missing values to be estimated by MCMC (nmiss) for the Week 16 
value.
REDACTED COPY 
rmed at an alpha level of 0.025.
REDACTED COPY 
rmed at an alpha level of 0.025.
ses
REDACTED COPY 
ses
 of PBO subjects will be switched to CZP treatment at Week 16, all 
REDACTED COPY 
 of PBO subjects will be switched to CZP treatment at Week 16, all 
statistical comparisons between CZP and PBO will be limited to the time period through 
REDACTED COPY 
statistical comparisons between CZP and PBO will be limited to the time period through 
with moderate to severe chronic plaque PSO. After Week 16, data will be 
REDACTED COPY 
with moderate to severe chronic plaque PSO. After Week 16, data will be 
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
PASI75 response at Week 16
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PASI75 response at Week 16
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PGA response at Week 16
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PGA response at Week 16
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PASI90 response at Week 16
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PASI90 response at Week 16
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Change from Baseline in DLQI at Week 16
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Change from Baseline in DLQI at Week 16
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CZP=certolizumab pegol; DLQI=Dermatology Life Quality Index; PASI=Psoriasis Activity and Severity Index; 
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CZP=certolizumab pegol; DLQI=Dermatology Life Quality Index; PASI=Psoriasis Activity and Severity Index; 
rmed at an alpha level of 0.025.
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rmed at an alpha level of 0.025.
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 of PBO subjects will be switched to CZP treatment at Week 16, all 
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 of PBO subjects will be switched to CZP treatment at Week 16, all 
statistical comparisons between CZP and PBO will be limited to the time period through 
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statistical comparisons between CZP and PBO will be limited to the time period through 
with moderate to severe chronic plaque PSO. After Week 16, data will be 
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with moderate to severe chronic plaque PSO. After Week 16, data will be 
summarized using descriptive statistics only
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summarized using descriptive statistics only
on treatment groups. Variables evaluated over time will be summarized using imputed and 
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on treatment groups. Variables evaluated over time will be summarized using imputed and 
bserved case values. Further details on data summarization will be provided in the SAP.
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bserved case values. Further details on data summarization will be provided in the SAP.
sis of the primary
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sis of the primary
to severe chronic plaque PSO
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to severe chronic plaque PSO
 efficacy
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 efficacy variable for this study
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 variable for this study
 efficacy variable for this study
 efficacy
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 efficacy variable for this study
 efficacy
classified as a PASI75 responder if the PASI score at the visit has improved at least 75% from 
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classified as a PASI75 responder if the PASI score at the visit has improved at least 75% from 
Baseline. The primary
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Baseline. The primary
which will include fixed effects for tre
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which will include fixed effects for tre
biologic exposure was selected as a fixed effect in the logistic regression model as it is a 
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biologic exposure was selected as a fixed effect in the logistic regression model as it is a 
stratification variable for randomization and because it may
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stratification variable for randomization and because it may
odds ratio
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odds ratio
The Markov Chain Monte Carlo (MCMC) method for multiple imputation will be used to 
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The Markov Chain Monte Carlo (MCMC) method for multiple imputation will be used to 
account for missing values in the primary
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account for missing values in the primary


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Clinical Study Protocol
Certolizumab Pegol
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Page 90of 119
2.  Create a data set, one for each treatment group, of subjects with observed values and those 
needing estimation by MCMC. The missing PASI75  values in each data set will be filled in 
using the MCMC method “5 x nmiss” times to generate “5 x nmiss” data sets. The resulting 
data sets for each treatment arm will be combined into one complete data set by imputation.
3.  For each complete data set, the dichotomous responder rate will  be computed. Each complete 
data set will be analyzed with a logistic regression model with factors of treatment group and 
prior biologic exposure (yes/no).
4.  The results from these analyses will be combined into a single inference using SAS PROC 
MIANALYZE.
For derivation of PASI75 response, no rounding will be performed. That is, the imputed Week 
16 PASIvalue will be compared directly to the observed Baseline PASI value to determine 
whether or not a reduction of at least 75% was achieved.
Each CZP dose will be compared against PBOto establish superiority over PBOand will be 
tested sequentially at an alpha of 0.025 as outlined in Table 14‒1.
Analyses will be performed to evaluate the sensitivity of the efficacy results to the method for 
handling missing data and the statistical analysis method. The following sensitivity analyses will 
be performed on the primary variable. 
1. Nonresponse imputation (NRI) will be used to impute missing values. Specifically, any
subject with a missing PASI75 value at Week 16 will be treated as a nonresponderfor 
analysis purposes.
2. A model-based multiple imputation method to impute missing data for the PASI75
responder data.
a) Calculate the number of missing values (nmiss) for PASI75 responder at Week 16
b) Intermittent missing values will be imputed first. Intermittent  missing values are defined
as values where data are missing at 1 time point but available at future time points for the 
same subject (ie, missing data not associated withstudy discontinuation). Multiple
imputation for these missing values will be performed using the MCMC method to
generate “5 x nmiss” times to generate “5 x nmiss” data sets.
c) With intermittent missing values imputed, only monotone missing data will remain. That
is, the only remaining missing data will be for subjects who discontinue study treatment
and are missing data at every time point following discontinuation. The imputation model
for these missing data will use logistic regression with factors of treatment group, and 
prior biologic exposure (yes/no) (ie, the imputation model will be the same as the 
analysis model). The data set used here is the output data set of the partial imputation
using MCMC. Since this data set already has “5 x nmiss” imputed values at each visit,
only one imputation will be performed.
a. For each complete data set, the dichotomous responder rate will be computed. 
Each complete data set will be analyzed with a logistic regression with factors of 
treatment group and prior biologic exposure (yes/no).
b. The results from these analyses will be combined into a single inference using 
SAS PROC MIANALYZE. 
REDACTED COPY 
response imputation (NRI) will be used to impute missing values. Specificall
REDACTED COPY 
response imputation (NRI) will be used to impute missing values. Specificall
eek 16 will be treated as a non
REDACTED COPY 
eek 16 will be treated as a non
based multiple imputation method to impute missing data for the PASI
REDACTED COPY 
based multiple imputation method to impute missing data for the PASI
Calculate the number of missing values (nmiss) for PASI
REDACTED COPY 
Calculate the number of missing values (nmiss) for PASI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
treatment group and 
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treatment group and 
The results from these analyses will be combined into a single inference using SAS PROC 
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The results from these analyses will be combined into a single inference using SAS PROC 
75 response, no rounding will be performed. That is, the imputed Week 
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75 response, no rounding will be performed. That is, the imputed Week 
 to the observed Baseline PASI value to determine 
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 to the observed Baseline PASI value to determine 
 over 
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 over PBO
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PBO
 of the efficac
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 of the efficacy results to the method for 
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y results to the method for 
sis method. The following sensitivity
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sis method. The following sensitivity
response imputation (NRI) will be used to impute missing values. Specificall
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response imputation (NRI) will be used to impute missing values. Specificall
eek 16 will be treated as a non
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eek 16 will be treated as a non
based multiple imputation method to impute missing data for the PASI
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based multiple imputation method to impute missing data for the PASI
Calculate the number of missing values (nmiss) for PASI
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Calculate the number of missing values (nmiss) for PASI
Intermittent missing values will be imputed first. Intermittent missing values are defined
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Intermittent missing values will be imputed first. Intermittent missing values are defined
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as values where data are missing at 1
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as values where data are missing at 1
same subject (ie, missing data not associated with
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same subject (ie, missing data not associated with
imputation for these missing values will be performed using the MCMC method to
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imputation for these missing values will be performed using the MCMC method to
5 x nmiss
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5 x nmiss”
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”times to generate 
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times to generate 
With intermittent missing values imputed, only monotone missing data will remain.
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With intermittent missing values imputed, only monotone missing data will remain.
is, the only
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is, the only
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 remaining missing data will be for subjects who discontinue study
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 remaining missing data will be for subjects who discontinue study
is, the only remaining missing data will be for subjects who discontinue study
is, the only
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is, the only remaining missing data will be for subjects who discontinue study
is, the only
and are missing data at every
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and are missing data at every
for these missing data will use logistic regression with factors of trea
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for these missing data will use logistic regression with factors of trea
prior biologic exposure (yes/no) (ie, the imputation model will be the same as
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prior biologic exposure (yes/no) (ie, the imputation model will be the same as
anal
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anal
using MCMC. Since this data set alread
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using MCMC. Since this data set alread


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Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 91of 119
Subgroup analyses will be conducted for age, gender, duration of disease, BMI, weight, CRP, 
prior systemic chemotherapy/phototherapy, prior systemic therapy (nonbiologic), prior biologic 
exposure, prior anti-TNF exposure and overall anti-CZP antibodystatus. These subgroup 
analyses will be performed on the primary efficacy variable and will contain only descriptive 
statistics for Week 16.
14.3.2 
Other efficacy analyses
14.3.2.1
Analysis of the secondary efficacy variables for subjects with 
moderate to severe chronic plaque PSO
The secondary efficacy variables will be analyzed for all subjects in the FAS.
Secondary efficacy variables are PASI90, PGAresponse, and change from Baseline in DLQI at 
Week 16.
A subject will be classified as a PGA responder if the PGA is Clear or Almost clear with at least 
a 2-category improvement relative to Baseline. The analysis of PASI90 and PGA response at 
Week 16 will be analyzed for treatment effects using pairwise comparisons based on the same 
method as that for the primary efficacy variable.
The MCMC algorithm is based on the multivariate normal model; imputed values for PGA will 
not generally be one of the discretevalues actually used in PGA scoring (0, 1, 2, 3, or 4). 
Therefore, standard rounding rules will be applied to the imputed values in order to derive the 
binary PGA response variable. For example, if a subject has a PGA score imputed as 1.4 (and 
assuming a Baseline PGA score of 3), this imputed value would be rounded down to 1, and the 
minimum change from Baseline of 2 would have been met. Therefore, this subject would be 
considered a responder.
The significance testing of each CZP treatment group vsPBOwill be part of the fixed sequential 
testing proceduredescribed in Section 14.2.
The analysis of DLQI will be based on the change from Baseline at Week 16. Treatment group 
comparisons for each CZP treatment group vs PBOwill be performed using an analysis of
covariance (ANCOVA) model with treatment group and prior biologic exposure (yes/no) as 
factors and Baseline DLQI score as a covariate. The treatment differences and corresponding 
97.5% confidence intervals will be calculated based on the adjusted means. Missing values will 
be imputed using last observation carried forward (LOCF). Each CZP dose will be compared 
against PBOto establish superiority over PBOand will be tested at an alpha of 0.025 as part of 
the fixed sequence testing procedure described in Section 14.2.
14.3.2.2
Analysis of the other efficacy variablesfor subjects with moderate to 
severe active plaque PSO
All other efficacy variables (eg, PASI50, PASI75, PASI90, PASI100, PGA, MCID) will be 
analyzedfor all subjects in the FAS.
All categorical variables (eg, PASI score, PGA score, BSA score, DLQI) will be summarized 
using frequency tables by each visit.
All continuous variables (eg, number of available observations[n],mean, median, standard 
deviation, minimum, and maximum) will be summarized using descriptive statistics by each 
visit.In addition, absolute and percent change from baseline by each visit.
REDACTED COPY 
 used in PGA scoring (0, 1, 2, 3, or 4). 
REDACTED COPY 
 used in PGA scoring (0, 1, 2, 3, or 4). 
Therefore, standard rounding rules will be applied to the imputed values in order to derive the 
REDACTED COPY 
Therefore, standard rounding rules will be applied to the imputed values in order to derive the 
 PGA response variable. For example, if a subject has a PGA score imputed as 1.4 (and 
REDACTED COPY 
 PGA response variable. For example, if a subject has a PGA score imputed as 1.4 (and 
Baseline PGA score of 3), this imputed value would be rounded down to 1, and the 
REDACTED COPY 
Baseline PGA score of 3), this imputed value would be rounded down to 1, and the 
minimum change from Baseline of 2 would have been met. Therefore, this subject would be 
REDACTED COPY 
minimum change from Baseline of 2 would have been met. Therefore, this subject would be 
P treatment group 
REDACTED COPY 
P treatment group 
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and change from Baseline in DLQI at 
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and change from Baseline in DLQI at 
A subject will be classified as a PGA responder if the PGA is Clear or Almost clear with at least 
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A subject will be classified as a PGA responder if the PGA is Clear or Almost clear with at least 
is of PASI90 and PGA response at 
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is of PASI90 and PGA response at 
ed for treatment effects using pairwise comparisons based on the same 
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ed for treatment effects using pairwise comparisons based on the same 
The MCMC algorithm is based on the multivariate normal model; i
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The MCMC algorithm is based on the multivariate normal model; imputed values for PGA will 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
mputed values for PGA will 
 used in PGA scoring (0, 1, 2, 3, or 4). 
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 used in PGA scoring (0, 1, 2, 3, or 4). 
Therefore, standard rounding rules will be applied to the imputed values in order to derive the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Therefore, standard rounding rules will be applied to the imputed values in order to derive the 
 PGA response variable. For example, if a subject has a PGA score imputed as 1.4 (and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 PGA response variable. For example, if a subject has a PGA score imputed as 1.4 (and 
Baseline PGA score of 3), this imputed value would be rounded down to 1, and the 
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Baseline PGA score of 3), this imputed value would be rounded down to 1, and the 
minimum change from Baseline of 2 would have been met. Therefore, this subject would be 
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minimum change from Baseline of 2 would have been met. Therefore, this subject would be 
P treatment group 
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P treatment group 
described in Section 14.2
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described in Section 14.2
is of DLQI will be based on the change from Baseline at Week 16. Treatment group 
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is of DLQI will be based on the change from Baseline at Week 16. Treatment group 
comparisons for each CZP treatment group vs 
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comparisons for each CZP treatment group vs 
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covariance (ANCOVA) model with treatment group and prior biologic exposure (y
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covariance (ANCOVA) model with treatment group and prior biologic exposure (y
factors and Baseline DLQI score as a covariate. The treatment differences and corresponding 
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factors and Baseline DLQI score as a covariate. The treatment differences and corresponding 
97.5% confidence intervals will be calculated based on the adjusted means. M
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97.5% confidence intervals will be calculated based on the adjusted means. M
be imputed using last observation carried forward (LOCF). Each CZP dose will be compared 
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be imputed using last observation carried forward (LOCF). Each CZP dose will be compared 
to establish superiority
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to establish superiority
the fixed sequence testing procedure described in 
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the fixed sequence testing procedure described in 
14.3.2.2
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14.3.2.2
All other efficacy
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All other efficacy
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anal
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anal
All categorical variables 
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All categorical variables 


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Clinical Study Protocol
Certolizumab Pegol
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Page 92of 119
Additionally, PASI(eg, PASI50, PASI75, PASI90 and PASI100) and PGA response variables
will be analyzed at scheduled time points prior to Week 16 using the same model described for 
the primary analysis. The p-values will not be adjusted for multiplicity and will be considered 
nominal.
The time to event variables (such as time to PASI50 and time to PASI75 response during the 
Initial Treatment Period) will be analyzed using Kaplan-Meier methods, and between group 
comparisons will be based on log-rank test statistic. For the response of PsAdisease to treatment, 
the ACR20, 50, 70 and change from Baseline in all individual ACR core components will be 
investigated in the PsAS.
For the response of nail disease to treatment, the total mNAPSI score and change from Baseline 
in all individual nail severity index score components will be investigated in the NAPSIS.
Summary statistics will be provided for other efficacy variables.
14.3.2.3
Analysis of the other efficacy variables for subjects with generalized 
pustular PSOand erythrodermic PSO
All other efficacy variables will be analyzed for all subjects in the CFAS. 
All categorical variables (eg, CGI-I) will be summarized using frequency tables by each visit.
All continuous variables will be summarized using descriptive statistics by each visit.
For the response of generalized pustular PSOto treatment, the Global Improvement Scores, 
change from Baseline inall individual JDA severity index score, and the clinical global 
impression will be investigated in the GPPS.
For the response of erythrodermic PSOto treatment, the clinical global impression will be 
investigated in the EPS.
14.4
Planned safety and other analyses
All safety summaries will be performed using the safety set (SS) or Cohort safety set (CSS).
14.4.1
Safety analyses
The frequency of all AEs during the study period will be presented for each treatment group 
separatelyby System Organ Class, high level term, and preferred term (MedDRA
®version 18.1). 
The data will be displayed as number of subjects experiencing the AE, percentage of subjects, 
and number of AEs. Additional tables will summarize TEAEs by intensity and relationship to 
study drug, TEAEs leading to withdrawal from the study, treatment-emergent SAEs, and deaths. 
Data will also be corrected for exposure and reported by 100 patient-years.
Laboratory evaluations and vital signs will be analyzed over time in the SS (or CSS) for 
observed cases and end of observation.
14.4.2 
Other analyses
Summaries of other analyses will be performed using the PK-PPS or the CPKS.  Certolizumab 
pegol plasma concentration data will be tabulated and summarized by treatment group (overall 
and by anti-CZP antibody status within each treatment group) for each visit at which samples 
were taken using the geometric mean, arithmetic mean, minimum, maximum, SD, and % 
REDACTED COPY 
All continuous variables will be summarized using descriptive statistics by each visit.
REDACTED COPY 
All continuous variables will be summarized using descriptive statistics by each visit.
to treatment, the Global Imp
REDACTED COPY 
to treatment, the Global Imp
all individual JDA severity
REDACTED COPY 
all individual JDA severity
impression will be investigated in the GPPS.
REDACTED COPY 
impression will be investigated in the GPPS.
PSO
REDACTED COPY 
PSOto treatment, the clinical global impression will be 
REDACTED COPY 
to treatment, the clinical global impression will be 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
disease to treatment, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
disease to treatment, 
all individual ACR core components will be 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
all individual ACR core components will be 
For the response of nail disease to treatment, the total mNAPSI score and change from Baseline 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
For the response of nail disease to treatment, the total mNAPSI score and change from Baseline 
 index score components will be investigated in the NAPSI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 index score components will be investigated in the NAPSI
 variables for subjects with generalized 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 variables for subjects with generalized 
ed for all subjects in the CFAS. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ed for all subjects in the CFAS. 
will be summarized using frequency
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
will be summarized using frequency
All continuous variables will be summarized using descriptive statistics by each visit.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
All continuous variables will be summarized using descriptive statistics by each visit.
to treatment, the Global Imp
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
to treatment, the Global Imp
all individual JDA severity
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
all individual JDA severity index score, and the clinical global 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 index score, and the clinical global 
all individual JDA severity index score, and the clinical global 
all individual JDA severity
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
all individual JDA severity index score, and the clinical global 
all individual JDA severity
to treatment, the clinical global impression will be 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
to treatment, the clinical global impression will be 
 and other analy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 and other analy
y summaries will be performed using the safet
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y summaries will be performed using the safet
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 analy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 analyses
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ses
 of all AEs during the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 of all AEs during the study
tem Organ Class, high level term, and preferred term (MedDRA
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
tem Organ Class, high level term, and preferred term (MedDRA
The data will be display
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The data will be display
and number of AEs. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and number of AEs. 
 drug, TEAEs leading to withdrawal from the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 drug, TEAEs leading to withdrawal from the study
Data will also be corrected for exposure and reported by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Data will also be corrected for exposure and reported by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Laboratory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Laboratory
observed cases and end of obs
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
observed cases and end of obs
14.4.2
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
14.4.2


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Clinical Study Protocol
Certolizumab Pegol
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Confidential
Page 93of 119
coefficient of variation. For each treatment group, plasma concentration time curves will be 
plotted overall and by antibody status.
Frequency tables of anti-CZP antibody status by visit will be presented. In addition, safety and 
efficacy profiles by anti-CZP antibody status will be investigated.
Subjects will be classified as anti-CZP antibody positive if the anti-CZP antibody level is > cut 
point at any measurement during the treatment.
14.5
Handling of protocol deviations
Important protocol deviations are deviations from the protocol which potentially could have a 
meaningful impact on study conduct, or on the primary efficacy, key safety, or PK outcomes for 
an individual subject. The criteria for identifying important protocol deviations will be defined 
within the appropriate protocol-specific document. Important protocol deviations will be
reviewed as part of the ongoing data cleaning process and all important deviations will be 
identified and documented prior to unblinding to confirm exclusion from analysis sets.
14.6
Handling of dropouts or missing data
Missing data for the primary endpoint will handled using the MCMC method for multiple 
imputation. Sensitivity analyses which apply different methods of handling missing data for the 
primary endpoint are planned. Further details are provided in Section 14.3.1.
Other binary efficacy variables evaluated during the initial Treatment Period which use a logistic 
regression model similar to the one described for the primary endpoint will handle missing data 
using the MCMC method for multiple imputation. Other binary efficacy variables evaluated 
during the initial treatment period that are summarized without statistical modeling will use NRI  
as the method for handling missing data.
Additionally, algorithms for imputing missing or partial dates for safety evaluations will be 
detailed in the SAP.
14.7
Planned interim analysis and data monitoring
After the Week 24 Visitof the finalsubject, the database will be locked and a first interim study 
report will be written.
14.8
Determination of sample size
14.8.1
Determination of sample size for double-blindfor plaque PSO
A total of 125 subjects will be randomly assigned in a 2:2:1 ratio to the following treatment 
groups: 
CZP 200mg Q2W (with CZP 400mg loading dose at Weeks 0, 2, and 4) (n=50)
CZP 400mg Q2W (n=50)
Placebo (n=25)
Both CZP doses will be evaluated for superiority to PBO. The assumed response rates for 
PASI75 at Week 16 are 75%, 70%, and 15% for CZP 400mg Q2W, CZP 200mg Q2W, and PBO, 
respectively. Under these assumptions, 43 subjects for each CZP groups and 22 for PBO group 
were required to detect a difference between CZP (either dose) group and the PBO group with 
REDACTED COPY 
 endpoint are planned. Further details are provided in 
REDACTED COPY 
 endpoint are planned. Further details are provided in 
 variables evaluated during the initial 
REDACTED COPY 
 variables evaluated during the initial 
regression model similar to the one described for the primary
REDACTED COPY 
regression model similar to the one described for the primary
using the MCMC method for multiple imputation. Other binary
REDACTED COPY 
using the MCMC method for multiple imputation. Other binary
during the initial treatment period that are summarized without statistical modeling will use NRI  
REDACTED COPY 
during the initial treatment period that are summarized without statistical modeling will use NRI  
REDACTED COPY 
as the method for handling missing data.
REDACTED COPY 
as the method for handling missing data.
gorithms for imputing missing or partial dates for safety evaluations will be 
REDACTED COPY 
gorithms for imputing missing or partial dates for safety evaluations will be 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 could have a 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 could have a 
y, or PK outcomes for 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y, or PK outcomes for 
ing important protocol deviations will be defined 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ing important protocol deviations will be defined 
mportant protocol deviations will be
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
mportant protocol deviations will be
reviewed as part of the ongoing data cleaning process and all important deviations will be 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
reviewed as part of the ongoing data cleaning process and all important deviations will be 
identified and documented prior to unblinding to confirm exclusion from analy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
identified and documented prior to unblinding to confirm exclusion from analy
ll handled using the MCMC method for multiple 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ll handled using the MCMC method for multiple 
y different methods of handling missing data for the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y different methods of handling missing data for the 
 endpoint are planned. Further details are provided in 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 endpoint are planned. Further details are provided in Section 14.3.1
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Section 14.3.1
 variables evaluated during the initial 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 variables evaluated during the initial Treatment Period 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Treatment Period 
regression model similar to the one described for the primary
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
regression model similar to the one described for the primary
using the MCMC method for multiple imputation. Other binary
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
using the MCMC method for multiple imputation. Other binary
during the initial treatment period that are summarized without statistical modeling will use NRI  
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
during the initial treatment period that are summarized without statistical modeling will use NRI  
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
gorithms for imputing missing or partial dates for safety evaluations will be 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
gorithms for imputing missing or partial dates for safety evaluations will be 
Planned interim analy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Planned interim analy
of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
of the final
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
final
Determination of sample size
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Determination of sample size
Determination of sample size for d
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Determination of sample size for d
A total of 125 subjects will be randomly
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
A total of 125 subjects will be randomly
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
CZP 200mg Q2W (with CZP 400mg loading dose at Weeks
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
CZP 200mg Q2W (with CZP 400mg loading dose at Weeks

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
CZP 400mg Q2W (n=50)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
CZP 400mg Q2W (n=50)

This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 



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25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 94of 119
the power of at least 98% and a 2-sided significance level of 0.025. To allow a margin for some 
subjects to be excluded from analysis and to consider ensuring the safety assessment cases, the 
target number of subjects is set to 50 subjects for each CZP groups and 25 for PBO group. The 
power to detect a statistically significant difference between CZP (either dose) and PBObased 
on PASI75 given the above assumptions and using a 2-sided test significance level of 0.025 is 
>99%.
14.8.2
Determination of sample size for generalized pustular PSOand 
erythrodermic PSO cohort
Expected number of subjects (n ≥10) will be randomly assigned in a 1:1 ratio to the following 
treatment groups:
CZP 200mg Q2W (with CZP 400mg loading dose at Weeks 0, 2, and 4) (n ≥5)
CZP 400mg Q2W (n ≥5). 
Patients with plaque PSOaccount for 88.6% of all types of PSO, while generalized pustular PSO
and erythrodermic PSOaccount for only 1.8% and 1.1%, respectively (Kawadaet al, 2010). 
Thus, in view of subject enrollment, it is difficult to perform a clinical study in patients with 
generalized pustular PSOor erythrodermic PSO.
Therefore, sample size could notbecalculated.
15
ETHICS AND REGULATORY REQUIREMENTS
15.1
Informed consent
Subject’s informed consent must be obtained and documented in accordance with local 
regulations, ICH-GCP requirements, and the ethical principles that have their origin in the 
principles of the Declaration of Helsinki.
Prior to obtaining informed consent, information should be given in a language and at a level of 
complexity understandable to the subject in both oral and written form by the Investigator(or 
designee). Each subject will have the opportunity to discuss the study and its alternatives with 
the Investigator.
Prior to participation in the study, the Informed Consent form should be signed and personally 
dated by the subjectand by the person who conducted the informed consent discussion 
(Investigatoror designee). The subject must receive a copy of the signed and dated Informed 
Consent form. As part of the consent process, each subject must consent to direct access to 
his/her medical records for study-related monitoring, auditing, IRB review, and regulatory 
inspection.
If the Informed Consent form is amended during the study, the Investigator (or the Sponsor, if 
applicable) must follow all applicable regulatory requirements pertaining to the approval of the 
amended Informed Consent form by the IRB and use of the amended form.
The subject may withdraw his/her consent to participate in the study at any time. A subject is 
considered as enrolled in the study when he/she has signed the Informed Consent form. A CRF 
must not be started, nor may any study specific procedure be performed for a given subject, 
without having obtained his/her written consent to participate in the study.
REDACTED COPY 
TOR
REDACTED COPY 
TORY REQUIREMENTS
REDACTED COPY 
Y REQUIREMENTS
TORY REQUIREMENTS
TOR
REDACTED COPY 
TORY REQUIREMENTS
TOR
Subject’s informed consent must be obtained and documented in accordance with local 
REDACTED COPY 
Subject’s informed consent must be obtained and documented in accordance with local 
-GCP requirements, and the ethical principles that have their origin in the 
REDACTED COPY 
-GCP requirements, and the ethical principles that have their origin in the 
principles of the Declaration of Helsinki.
REDACTED COPY 
principles of the Declaration of Helsinki.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 assigned in a 1:1 ratio to the following 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 assigned in a 1:1 ratio to the following 
≥5)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
≥5)
, while generalized pustular 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, while generalized pustular 
y 1.8% and 1.1%, respectively (Kawad
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y 1.8% and 1.1%, respectively (Kawad
Thus, in view of subject enrollment, it is difficult to perform a clinical study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Thus, in view of subject enrollment, it is difficult to perform a clinical study
Y REQUIREMENTS
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Y REQUIREMENTS
Subject’s informed consent must be obtained and documented in accordance with local 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subject’s informed consent must be obtained and documented in accordance with local 
-GCP requirements, and the ethical principles that have their origin in the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
-GCP requirements, and the ethical principles that have their origin in the 
principles of the Declaration of Helsinki.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
principles of the Declaration of Helsinki.
Prior to obtaining informed consent, information should be given in a language and at a level of 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Prior to obtaining informed consent, information should be given in a language and at a level of 
 understandable to the subject in both oral and written form by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 understandable to the subject in both oral and written form by
ct will have the opportunity to discuss the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ct will have the opportunity to discuss the study
participation in the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
participation in the study
y the subject
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y the subjectand by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
or designee). The subject must receive a copy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
or designee). The subject must receive a copy
Consent form. As part of the consent process, each subject must consent to direct access to 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Consent form. As part of the consent process, each subject must consent to direct access to 
his/her medical records for study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
his/her medical records for study
inspection.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
inspection.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
If the Informed Consent form is amended during the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
If the Informed Consent form is amended during the study
applicable) must follow all applicable regulatory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
applicable) must follow all applicable regulatory
amended Infor
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
amended Infor


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Clinical Study Protocol
Certolizumab Pegol
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15.2
Subject identification cards
Upon signing the Informed Consent, the subject will be provided with a subject identification 
card in the language of the subject. The Investigator will fill in the subject identifying 
information and medical emergency contact information. The Investigatorwill instruct the 
subject to keep the card with him/her at all times.
15.3
Institutional Review Boards
The study will be conducted under the auspices of an IRB, as defined in local regulations, 
ICH-GCP, and in accordance with the ethical principles that have their origin in the Declaration 
of Helsinki.
The Investigator/UCB will ensure that an appropriately constituted IRB that complies with the 
requirements of the current ICH-GCP version or applicable country-specific regulations will be 
responsible for the initial and continuing review and approval of the clinical study. Prior to 
initiation of the study, the Investigator/UCB will forward copies of the protocol, Informed 
Consent form, IB;Investigator’s curriculum vitae (if applicable), advertisement (if applicable), 
and all other subject-related documents to be used for the studyto the IRB for its review and 
approval.
Before initiating a study, the Investigatorwill have written and dated full approval from the 
responsible IRBfor the protocol.
The Investigatorwill also promptly report to the IRB all changes in the study, all unanticipated 
problems involving risks to human subjects or others, and any protocol deviations, to eliminate 
immediate hazards to subjects.
The Investigatorwill not make any changes in the study or study conduct without IRB approval, 
except where necessaryto eliminate apparent immediate hazards to the subjects. For minor 
changes to a previously approved protocol during the period covered by the original approval, it 
may be possible for the Investigatorto obtain an expedited review by the IRB as allowed.
As part of the IRB requirements for continuing review of approved studies, the Investigator will 
be responsible for submitting periodic progress reports to the IRB (based on IRB requirements), 
at intervals appropriate to the degree of subject risk involved, but no less than once per year. The 
Investigator should provide a final report to the IRB following study completion.
UCB (or its representative) will communicate safety information to the appropriate regulatory 
authorities and all active Investigators in accordance with applicable regulatory requirements. 
The appropriate IRB will also be informed by the Investigatoror the Sponsor, as specified by the 
applicable regulatory requirements in each concerned country. Where applicable, Investigators 
are to provide the Sponsor(or its representative) with evidence of such IRB notification.
15.4
Subject privacy
UCB staff (or designee) will affirm and uphold the subject’s confidentiality. Throughout this 
study, all data forwarded to UCB (or designee) will be identifiedonly by the subject number 
assigned at Screening.
The Investigatoragrees that representatives of UCB, its designee, representatives of the relevant
IRB, or representatives of regulatory authorities will be allowed to review that portion of the 
REDACTED COPY 
will have written and dated full approval from the 
REDACTED COPY 
will have written and dated full approval from the 
 report to the 
REDACTED COPY 
 report to the IRB 
REDACTED COPY 
IRB 
problems involving risks to human subjects or others, and an
REDACTED COPY 
problems involving risks to human subjects or others, and an
 changes in the study
REDACTED COPY 
 changes in the study
to eliminate apparent immediate hazards to the subjects. For minor 
REDACTED COPY 
to eliminate apparent immediate hazards to the subjects. For minor 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
-GCP, and in accordance with the ethical principles that have their origin in the Declaration 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
-GCP, and in accordance with the ethical principles that have their origin in the Declaration 
RB that complies with the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
RB that complies with the 
specific regulations will be 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
specific regulations will be 
responsible for the initial and continuing review and approval of the clinical study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
responsible for the initial and continuing review and approval of the clinical study
/UCB will forward copies of the protocol, Informed 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
/UCB will forward copies of the protocol, Informed 
’s curriculum vitae (if applicable), advertisement (if applicable), 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
’s curriculum vitae (if applicable), advertisement (if applicable), 
to the I
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
to the IRB for its review and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
RB for its review and 
will have written and dated full approval from the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
will have written and dated full approval from the 
IRB 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
IRB all changes in the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
all changes in the study
problems involving risks to human subjects or others, and an
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
problems involving risks to human subjects or others, and an
 changes in the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 changes in the study
to eliminate apparent immediate hazards to the subjects. For minor 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
to eliminate apparent immediate hazards to the subjects. For minor 
 approved protocol during the period covered by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 approved protocol during the period covered by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigatorto obtain an expedited review by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
to obtain an expedited review by
As part of the IRB requirements for continuing review of approved studies, the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
As part of the IRB requirements for continuing review of approved studies, the 
be responsible for submitting periodic progress reports to the I
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
be responsible for submitting periodic progress reports to the I
at intervals appropriate to the degree of subject risk involved
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
at intervals appropriate to the degree of subject risk involved
should provide a final report to the IRB following study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
should provide a final report to the IRB following study
UCB (or its representative) will communicate safety
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
UCB (or its representative) will communicate safety
authorities and all active 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
authorities and all active 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The appropriate 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The appropriate 
applicable regulatory
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
applicable regulatory
are to pro
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
are to pro
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
vide the Sponsor
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
vide the Sponsor
15.4
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
15.4
UCB staff (or designee) will affirm and uphold the subject’s confidentiality. Throughout this 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
UCB staff (or designee) will affirm and uphold the subject’s confidentiality. Throughout this 


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Clinical Study Protocol
Certolizumab Pegol
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Page 96of 119
subject’s primary medical records that directly concerns this study (including, but not limited to, 
laboratory test result reports, ECG reports, admission/discharge summaries for hospital 
admissions occurring during a subject’s study participation, and autopsy reports for deaths 
occurring during the study).
15.5
Protocol amendments
Protocol changes may affect the legal and ethical status of the study and may also affect the 
statistical evaluations of sample size and the likelihood of the study fulfilling its primary 
objective.
Significant changes to the protocol will only be made as an amendment to the protocol and must 
be approved by UCB, theIRB, and the regulatory authorities (if required), prior to being 
implemented.
16
FINANCE, INSURANCE, AND PUBLICATION
Insurance coverage will be handled according to local requirements.
Finance, insurance, and publication rights are addressed in the Investigatorand/or CRO 
agreements, as applicable.
17
REFERENCES
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REDACTED COPY 
Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatm
REDACTED COPY 
Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatm
trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the 
REDACTED COPY 
trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the 
United States: findings from the National Psoriasis Foundation Survey
REDACTED COPY 
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, Sturk
REDACTED COPY 
, Sturkey
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ey
important difference and responsiveness of the Dermatology
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important difference and responsiveness of the Dermatology
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 be made as an amendment to the protocol and must 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 be made as an amendment to the protocol and must 
 authorities (if required), prior to being 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 authorities (if required), prior to being 
TION
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
TION
Investigator
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Investigator
Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatm
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatm
trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the 
United States: findings from the National Psoriasis Foundation Survey
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
United States: findings from the National Psoriasis Foundation Survey
ey
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ey R, Finlay
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 R, Finlay
ey R, Finlay
ey
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ey R, Finlay
ey
important difference and responsiveness of the Dermatology
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
important difference and responsiveness of the Dermatology
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
-33.
CH/135/95 Note for guidance on Good Clinical Practice (EMEA) Jul 2002
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
CH/135/95 Note for guidance on Good Clinical Practice (EMEA) Jul 2002
Christophers E, Barker JN, Griffiths CE, Daudén E, Milligan G, Molta C, et al. The risk of 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Christophers E, Barker JN, Griffiths CE, Daudén E, Milligan G, Molta C, et al. The risk of 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
psoriatic arthritis remains constant following initial diagnosis of psoriasis among patients seen in 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
psoriatic arthritis remains constant following initial diagnosis of psoriasis among patients seen in 
European dermatology
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
European dermatology clinics. J Eur Acad Dermatol Venereol. 20
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 clinics. J Eur Acad Dermatol Venereol. 20
European dermatology clinics. J Eur Acad Dermatol Venereol. 20
European dermatology
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
European dermatology clinics. J Eur Acad Dermatol Venereol. 20
European dermatology
Dowlatshahi EA, Wakkee M, Arends LR, Nijsten T. The prevalence and odds of depressive 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Dowlatshahi EA, Wakkee M, Arends LR, Nijsten T. The prevalence and odds of depressive 
mptoms and clinical depression in psoriasis patients: a sy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
mptoms and clinical depression in psoriasis patients: a sy
Invest Dermatol. 201
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Invest Dermatol. 201
Dworkin RH, Turk DC, Wy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Dworkin RH, Turk DC, Wy
clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
recommendations. J Pain. 2008;9(2):105-21.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
recommendations. J Pain. 2008;9(2):105-21.
Feldman SR. A quantitative definition of severe psoriasis for u
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Feldman SR. A quantitative definition of severe psoriasis for u
Treat. 2004;15(1):27
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infarction in patients with psoriasis. JAMA. 2006;296:1735-41. 
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metabolic syndrome in patients with psoriasis: a hospital-based case-control study. Br J 
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Gottlieb A. Psoriasis: Emerging therapeutic strategies. Nat Rev Drug Discov. 2005;4:19 34.
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Kawada A, Nakamura K, Kaneko F, Ito H, Nakagawa H. National survey of psoriasis 
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Krueger G, Ellis CN. Psoriasis--recent advances in understanding its pathogenesis and treatment. 
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Krueger G, Koo J, Lebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on 
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Kurd SK, Smith N, Vanvoorhees A, Troxel AB, Badmaev V, Seykora JT, et al. Oral curcumin in 
the treatment of moderate to severe psoriasis vulgaris: a prospective clinical trial. Am Acad 
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Matsuda Y, Singh G, Yamanaka H, Tanaka E, Urano W, Taniguchi A, et al. Validation of a 
Japanese version of the Stanford Health Assessment Questionnaire in 3,763 patients with 
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of its clinical efficacy and safety. Rheumatology. 2011;50:261-70. 
Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, et al. Guidelines of 
care for the management of psoriasis and psoriatic arthritis Section 6. Guidelines of care for the 
treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based 
conclusions. J Am Acad Dermatol. 2011;65:137-74.
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J Drugs Dermatol. 2004;3:13-20.
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Heredia E, Lin CY, Gaich C, Nikaï E, et al. 
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Heredia E, Lin CY, Gaich C, Nikaï E, et al. 
ch Numeric Rating Scale in patients with moderate-
REDACTED COPY 
ch Numeric Rating Scale in patients with moderate-
nt advances in understanding its pathogenesis and treatment. 
REDACTED COPY 
nt advances in understanding its pathogenesis and treatment. 
J Am Acad Dermatol. 2005 Jul;53(1 Suppl 1):S94
REDACTED COPY 
J Am Acad Dermatol. 2005 Jul;53(1 Suppl 1):S94
ebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on 
REDACTED COPY 
ebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on 
 of Life. Results of a 1998 National Psoriasis Fo
REDACTED COPY 
 of Life. Results of a 1998 National Psoriasis Fo
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Revised (DHEW Publ No 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Revised (DHEW Publ No 
338). Rockville, MD, U.S. Department of Health, Education, and Welfare, Public 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
338). Rockville, MD, U.S. Department of Health, Education, and Welfare, Public 
 Research Branch, Division of Extramural Research Programs, 1976, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 Research Branch, Division of Extramural Research Programs, 1976, 
psoralen 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
psoralen 
a cooperative study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
a cooperative study
awada A, Nakamura K, Kaneko F, Ito H, Nakagawa H. National survey
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
awada A, Nakamura K, Kaneko F, Ito H, Nakagawa H. National survey
Heredia E, Lin CY, Gaich C, Nikaï E, et al. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Heredia E, Lin CY, Gaich C, Nikaï E, et al. 
ch Numeric Rating Scale in patients with moderate-
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ch Numeric Rating Scale in patients with moderate-
nt advances in understanding its pathogenesis and treatment. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
nt advances in understanding its pathogenesis and treatment. 
J Am Acad Dermatol. 2005 Jul;53(1 Suppl 1):S94
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
J Am Acad Dermatol. 2005 Jul;53(1 Suppl 1):S94-100.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
-100.
ebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on 
 of Life. Results of a 1998 National Psoriasis Fo
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 of Life. Results of a 1998 National Psoriasis Fo
Kurd SK, Smith N, Vanvoorhees A, Troxel AB, Badmaev V, Sey
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Kurd SK, Smith N, Vanvoorhees A, Troxel AB, Badmaev V, Sey
the treatment of moderate to severe psoriasis vulgaris: a prospective clinical trial. Am Acad 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
the treatment of moderate to severe psoriasis vulgaris: a prospective clinical trial. Am Acad 
31.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
31.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Matsuda Y, Singh G, Yamanaka H, Tanaka E, Urano W, Taniguchi A, et al. Validation of a 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Matsuda Y, Singh G, Yamanaka H, Tanaka E, Urano W, Taniguchi A, et al. Validation of a 
Japanese version of the Stanford Health Assessment Questionnaire in 3,763 patients with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Japanese version of the Stanford Health Assessment Questionnaire in 3,763 patients with 
rheumatoid arthritis. Arthritis Rheum. 2003;49:784
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
rheumatoid arthritis. Arthritis Rheum. 2003;49:784
e PJ. Certolizumab pegol in the treatment of rheumatoid arthritis: a comprehensive review 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
e PJ. Certolizumab pegol in the treatment of rheumatoid arthritis: a comprehensive review 
of its clinical efficacy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
of its clinical efficacy
Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, et al. Guidelines of 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, et al. Guidelines of 
care for t
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care for t
treatment of psoriasis and psoriatic arthritis: case
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treatment of psoriasis and psoriatic arthritis: case
conclusions. J Am Acad Dermatol. 2011;65:137-
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conclusions. J Am Acad Dermatol. 2011;65:137-


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Parrish JA, Jaenicke KF. Action spectrum for phototherapy of psoriasis. J Invest Dermatol. 
1981;76:359-62.
Piaserico S, Cazzaniga S, Chimenti S, Giannetti A, Maccarone M, Picardo M, et al. Efficacy of 
switching between tumor necrosis factor-alfa inhibitors in psoriasis: results from the Italian 
Psocare Registry. J Am Acad Dermatol. 2014;70:257-62. 
Yeung H, Takeshita J, Mehta NN, Kimmel SE, Ogdie A, Margolis DJ, et al. Psoriasis severity 
and the prevalence of major medical comorbidity: a population-based study. JAMA Dermatol. 
2013:149 1173-9.
REDACTED COPY 
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y. JAMA Dermatol. 
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18
APPENDICES
18.1 
Protocol Amendment 1
Rationale for the amendment
The purpose of this amendment is the following:
Correct some inconsistencies between Table 5-1 and Section 8
Clarify prohibited concomitant treatments
Clarify that no down-titration is required upon early discontinuation
Modifications and changes
Global changes
The following changes were made throughout the protocol:
Minor editorial revisions were made.
Specific changes
Change #1
Table 5-1 Schedule of assessments
c
HBV DNA to be performed at Screening. If the subject is either hepatitis B surface 
antibody-positive or hepatitis type C virus antibody-positive at Screening, quantitative 
measurement of HBV-DNA should be performed every 4 weeks from Baseline to Week 52 
and at SFU.
Has been changed to
c
HBV DNA to be performed at Screening. If the subject is either hepatitis B surface 
antibody-positive or hepatitis B coretype C virusantibody-positive at Screening, 
quantitative measurement of HBV-DNA should be performed every 4 weeks from Baseline 
to Week 52 and at SFU.
Change #2
Section 7.8.3 Prohibited concomitant treatments (medications and therapies)
The following concomitant medications are prohibited during the double-blind study period:
Systemic retinoids
Systemic treatment for PSO (nonbiological)
Systemic immunosuppressants agents (eg, methotrexate, cyclosporine, azathioprine, 
thioguanine)
Systemic fumarate
REDACTED COPY 
HBV DNA to be performed at Screening. 
REDACTED COPY 
HBV DNA to be performed at Screening. 
yp
REDACTED COPY 
ype C virus antibody
REDACTED COPY 
e C virus antibody
DNA should be performed every
REDACTED COPY 
DNA should be performed every
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
HBV DNA to be performed at Screening. 
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HBV DNA to be performed at Screening. If the 
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If the 
e C virus antibody
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e C virus antibody
DNA should be performed every
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
DNA should be performed every
performed at Screening. 
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performed at Screening. 
positive or hepatitis 
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positive or hepatitis 
quantitative measurement of HBV
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quantitative measurement of HBV
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to Week 52 and at SF
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to Week 52 and at SF
2
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2
Section 7.8.3 Prohibited concomitant treatments (medications and therapies)
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Section 7.8.3 Prohibited concomitant treatments (medications and therapies)
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The following concomitant medications are prohibited during the double
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The following concomitant medications are prohibited during the double

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Sy
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Sy


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Systemic corticosteroids
Has been changed to
The following concomitant medications are prohibited during the double-blind study period:
Systemic retinoids
Systemic treatment for PSO (nonbiological)
Systemic immunosuppressants agents (eg, methotrexate, cyclosporine, azathioprine, 
thioguanine)
Systemic fumarate
Systemic corticosteroids
Change #3
Section 8.2 Visit 2 (Baseline)
Pustular and erythrodermic PSO assessments (Global Improvement Score, JDA Severity 
Index, and CGI-I for subjects with generalized pustular PSO or CGI-I for subjects with 
erythrodermic PSO)
Has been changed to
Pustular and erythrodermic PSO assessments (Global Improvement Score,JDA Severity 
Index, and CGI-Ifor subjects with generalized pustular PSOor CGI-I for subjects with 
erythrodermic PSO)
Change #4
Section 8.5 Visit 5 (Week 6)
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Hematology, biochemistry, and urine for clinical laboratory values 
Urine pregnancy test for women of childbearing potential
Plasma for PK and immunogenicity samples
Has been changed to
Subjects will have the following procedures performed/recorded prior to administration of study 
drug:
Hematology, biochemistry, and urine for clinical laboratory values 
Urine pregnancy test for women of childbearing potential
Plasma for PK and immunogenicity samples
REDACTED COPY 
I for subjects with generalized pustular PSO or CGI
REDACTED COPY 
I for subjects with generalized pustular PSO or CGI
throdermic PSO assessments (
REDACTED COPY 
throdermic PSO assessments (
for subjects with generalized pustular PSO
REDACTED COPY 
for subjects with generalized pustular PSO
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closporine, azathioprine, 
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closporine, azathioprine, 
mprovement Score, JDA Severity
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mprovement Score, JDA Severity
I for subjects with generalized pustular PSO or CGI
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I for subjects with generalized pustular PSO or CGI
throdermic PSO assessments (
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throdermic PSO assessments (Global Improvement Score,
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Global Improvement Score,
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for subjects with generalized pustular PSO
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for subjects with generalized pustular PSO
Subjects will have the following procedures performed/recorded prior to administration of study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to administration of study
, biochemistry
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, biochemistry
Urine pregnancy
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Urine pregnancy test for women of childbearing potential
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 test for women of childbearing potential
Urine pregnancy test for women of childbearing potential
Urine pregnancy
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Urine pregnancy test for women of childbearing potential
Urine pregnancy
Plasma for PK and immunogenicity
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Plasma for PK and immunogenicity
Has been changed to
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Has been changed to
Subjects will have the following procedures performed/recorded p
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Subjects will have the following procedures performed/recorded p
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
drug:
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drug:


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Change #5
Section 8.29 Safety Follow-Up Visit
Subjects will have the following procedures performed/recorded 10 weeks after the last dose of 
study drug:
Blood pressure
Physical examination
Hematology, biochemistry, and urine (dipstick) for clinical laboratory values, including 
beta-D-glucan and sialylated carbohydrate antigen KL-6
Urine pregnancy test for women of childbearing potential
Has been changed to
Subjects will have the following procedures performed/recorded 10 weeks after the last dose of 
study drug:
Blood pressure
Physical examination
Hematology, biochemistry, and urine (dipstick) for clinical laboratory values, including 
beta-D-glucan and sialylated carbohydrate antigen KL-6 
Urine pregnancy test for women of childbearing potential
Change #6
Section 8.30 Withdrawal Visit
Subjects will have the following procedures performed/recorded:
Blood pressure 
12-lead ECG
Weight
Hematology, biochemistry, and urine for clinical laboratory values
Urine pregnancy test for women of childbearing potential
Has been changed to
Subjects will have the following procedures performed/recorded:
Blood pressure 
12-lead ECG
Weight
Hematology, biochemistry, and urine for clinical laboratory values, including beta-D-glucan 
and sialylated carbohydrate antigen KL-6
REDACTED COPY 
, and urine (dipstick) for clinical laboratory values
REDACTED COPY 
, and urine (dipstick) for clinical laboratory values
glucan and sialylated carbohydrate antigen KL
REDACTED COPY 
glucan and sialylated carbohydrate antigen KL
REDACTED COPY 
 test for women of childbearing potential
REDACTED COPY 
 test for women of childbearing potential
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, including 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, including 
Subjects will have the following procedures performed/recorded 10 weeks after the last dose of 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded 10 weeks after the last dose of 
, and urine (dipstick) for clinical laboratory values
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, and urine (dipstick) for clinical laboratory values
glucan and sialylated carbohydrate antigen KL
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glucan and sialylated carbohydrate antigen KL
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 test for women of childbearing potential
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 test for women of childbearing potential
e the following procedures performed/recorded:
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e the following procedures performed/recorded:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Hematology
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Hematology
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, biochemistry
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, biochemistry
Urine pregnancy
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Urine pregnancy
Has been changed to
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Has been changed to
Subjects will have the followi
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Subjects will have the followi

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Blood pressure 
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Blood pressure 

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


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Urine pregnancy test for women of childbearing potential
Change #7
Section 8.31 Unscheduled Visit
Urine pregnancy test for women of childbearing potential
AEs
Concomitant medications
Has been changed to
Urine pregnancy test for women of childbearing potential
AEs
Medical procedures
Concomitant medications
Change #8
Section 12.1.4 Pregnancy
If an Investigator is notified that a subject has become pregnant after the first  intake of any
 IMP, 
the Investigator must immediately notify UCB’s PS department by providing the completed 
Pregnancy Report and Outcome form (for contact details see Serious Adverse Event reporting 
information at the beginning of this protocol). The subject should be withdrawn from the study 
as soon as pregnancy is known (by positive pregnancy test), and the following should be 
completed:
The subject should return for an early discontinuation visit.
The subject should immediately stop the intake of the IMP or be down-titrated as instructed 
at the early discontinuation visit. 
A Safety Follow-Up Visit should be scheduled 10 weeks after the subject has discontinued 
her IMP.
Has been changed to
If an Investigator is notified that a subject has become pregnant after the first  intake of any
 IMP, 
the Investigator must immediately notify UCB’s PS department by providing the completed 
Pregnancy Report and Outcome form (for contact details see Serious Adverse Event reporting 
information at the beginning of this protocol). The subject should be withdrawn from the study 
as soon as pregnancy is known (by positive pregnancy test), and the following should be 
completed:
The subject should return for an early discontinuation visit.
The subject should immediately stop the intake of the IMP or be down-titrated as 
instructed at the early discontinuation visit. 
REDACTED COPY 
is notified that a subject has become pregnant after the first intake of any
REDACTED COPY 
is notified that a subject has become pregnant after the first intake of any
 notify
REDACTED COPY 
 notify UCB’s PS department by
REDACTED COPY 
 UCB’s PS department by
 notify UCB’s PS department by
 notify
REDACTED COPY 
 notify UCB’s PS department by
 notify
me form (for contact details see Serious Adverse Event reporting 
REDACTED COPY 
me form (for contact details see Serious Adverse Event reporting 
information at the beginning of this protocol). The subject should be withdrawn from the stud
REDACTED COPY 
information at the beginning of this protocol). The subject should be withdrawn from the stud
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
is notified that a subject has become pregnant after the first intake of any
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
is notified that a subject has become pregnant after the first intake of any
 UCB’s PS department by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 UCB’s PS department by
me form (for contact details see Serious Adverse Event reporting 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
me form (for contact details see Serious Adverse Event reporting 
information at the beginning of this protocol). The subject should be withdrawn from the stud
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information at the beginning of this protocol). The subject should be withdrawn from the stud
 positive pregnancy
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 positive pregnancy
The subject should return for an earl
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The subject should return for an earl
The subject should immediately
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The subject should immediately
y discontinuation visit. 
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y discontinuation visit. 
y Follow
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y Follow-
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-Up Visit should be scheduled 10 weeks after th
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Up Visit should be scheduled 10 weeks after th
Has been changed to
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Has been changed to
Investigator
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Investigator
In
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Investigator
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vestigator
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Pregnancy
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Pregnancy
information at the beginning of this protocol). The subject should be withdrawn from the stud
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information at the beginning of this protocol). The subject should be withdrawn from the stud
as soon as pregnancy
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as soon as pregnancy


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A Safety Follow-Up Visit should be scheduled 10 weeks after the subject has discontinued 
her IMP.
18.2
Protocol Amendment 2
Rationale for the amendment
The purpose of this amendment is the following:
Update administrative information
Clarify withdrawalcriteria for PDILI
Clarify that the CGI-I and Global Improvement Scale will not be performed at Screening or 
Baseline for subjects with generalized pustular PSO or erythrodermic PSO
Clarify actions and follow up required for PDILI
Modifications and changes
Global changes
The following changes were made throughout the protocol:
Minor editorial revisions were made.
Specific changes
Change #1
Study contact information
Clinical Monitoring Contract Research Organization
Name:
PAREXEL International
Address:
6F Kayabacho First Building
1-17-21 Shinkawa
Chuo-ku
Tokyo 104-0033
JAPAN
Phone: 
+81 3 3537 5460
Fax:
+81 3 3552 0451
Has been changed to
REDACTED COPY 
e made throughout the protocol:
REDACTED COPY 
e made throughout the protocol:
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will not be performed at Screening 
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will not be performed at Screening 
Clinical Monitoring Contract Research Organization
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Clinical Monitoring Contract Research Organization
PAREXEL
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PAREXEL
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6F Kay
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6F Kay
1
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1-17
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-17
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Phone:
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Phone:
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Has been changed to
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Has been changed to


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Page 104of 119
Name:
PAREXEL International
Address:
6F Kayabacho First Building
1-17-21 Shinkawa
Chuo-ku
Tokyo 104-0033
JAPAN
Phone: 
+81 3 3537 5899460
Fax:
+81 3 3552 0451
Change #2
Table 5-1 Footnote g
gPASI, PGA, and BSA will not be performed for subjects with generalized pustular PSO. The 
Global Improvement Score, JDA Severity Index, and CGI-I will be performed for subjects with 
generalized pustular PSO. For subjects with erythrodermic PSO, the CGI-I will be performed. 
Note: The CGI-I will not be performed at Screening.
Has been changed to
g PASI, PGA, and BSA will not be performed for subjects with generalized pustular PSO. The 
Global Improvement Score, JDA Severity Index, and CGI-I will be performed for subjects with 
generalized pustular PSO. For subjects with erythrodermic PSO, the CGI-I will be performed. 
Note: The CGI-I and Global Improvement Scorewill not be performed at Screeningor 
Baseline.
Change #3
Exclusion criteria #18and #19
18. Subject has any of the following clinically significant laboratory abnormalities at the 
Screening: 
a. AST >3 x upper limit of normal (ULN)
b. ALT >3 x ULN
c. Total bilirubin >1.5 x ULN
d. Creatinine >ULN
e. White blood cell (WBC)<3.0 x109/L
f. Hepatitis B surface (HBs) antigen, hepatitis B core (HBc) antibody, hepatitis B surface 
(HBs) antibody, Hepatitis type B virus (HBV) DNA assay: Positive to any of these
(However, patients with  negative HBs antigen and HBV-DNA and positive HBc 
antibody and/or HBs antibody may be included provided that they undergo a HBV-DNA 
assay every 4 weeks (from Baseline to Week 52) and then atSFU.
REDACTED COPY 
g.
REDACTED COPY 
g.
, PGA, and BSA will not be performed for subjects with generalized pustular PSO. The 
REDACTED COPY 
, PGA, and BSA will not be performed for subjects with generalized pustular PSO. The 
mprovement Score, JDA Severity
REDACTED COPY 
mprovement Score, JDA Severity I
REDACTED COPY 
 I
mprovement Score, JDA Severity I
mprovement Score, JDA Severity
REDACTED COPY 
mprovement Score, JDA Severity I
mprovement Score, JDA Severity ndex, and CGI
REDACTED COPY 
ndex, and CGI
generalized pustular PSO. For subjects with ery
REDACTED COPY 
generalized pustular PSO. For subjects with ery
and Global Improvement Score
REDACTED COPY 
and Global Improvement Score
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, PGA, and BSA will not be performed for subjects with generalized pustular PSO. The 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, PGA, and BSA will not be performed for subjects with generalized pustular PSO. The 
I will be performed for subjects with 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
I will be performed for subjects with 
throdermic PSO, the CGI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
throdermic PSO, the CGI
, PGA, and BSA will not be performed for subjects with generalized pustular PSO. The 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, PGA, and BSA will not be performed for subjects with generalized pustular PSO. The 
ndex, and CGI
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ndex, and CGI
generalized pustular PSO. For subjects with ery
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generalized pustular PSO. For subjects with erythrodermic PSO, the CGI
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throdermic PSO, the CGI
generalized pustular PSO. For subjects with erythrodermic PSO, the CGI
generalized pustular PSO. For subjects with ery
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generalized pustular PSO. For subjects with erythrodermic PSO, the CGI
generalized pustular PSO. For subjects with ery
and Global Improvement Score
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and Global Improvement Score
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and #19
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and #19
y of the following clinicall
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y of the following clinicall
AST >3 x upper limit of normal (ULN)
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AST >3 x upper limit of normal (ULN)
T >3 
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T >3 x UL
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x UL
Total bilirubin >1.5 x ULN
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Total bilirubin >1.5 x ULN
d.
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d. Creatinine >ULN
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Creatinine >ULN
e.
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e.


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g. Hepatitis type C virus (HCV) antibody: Positive
h. Human immunodeficiency virus (HIV) antigen or antibody: Positive to either test
i. T-cell lymphotropic virus type-1 (HTLV-1) antibody: Positive
19. Subject has ≥3x upper limit of normal (ULN) of any of the following: alanine 
aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or 
>ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert’s syndrome). If subject has 
elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to 
identify possible undiagnosed Gilbert’s syndrome (ie, direct bilirubin <35%).
Has been changed to
18. Subject has any of the following clinically significant laboratory abnormalities at the 
Screening: 
a. Aspartate aminotransferase (AST)>≥3 x upper limit of normal (ULN)
b. Alanineaminotransferase (ALT)>≥3 x ULN
c. Total bilirubin >1.5 x ULN
c. Alkaline phosphatase (ALP) ≥3 x ULN
d. Creatinine >ULN
e. White blood cell (WBC) <3.0 x109/L
f. Hepatitis B surface (HBs) antigen, hepatitis B core (HBc) antibody, hepatitis B surface 
(HBs) antibody, Hepatitis type B virus (HBV) DNA assay: Positive to any of these
(However, patients with  negative HBs antigen and HBV-DNA and positive HBc 
antibody and/or HBs antibody may be included provided that they undergo a HBV-DNA 
assay every 4 weeks (from Baseline to Week 52) and then at SFU.
g. Hepatitis type C virus (HCV) antibody: Positive
h. Human immunodeficiency virus (HIV) antigen or antibody: Positive to either test
i. T-cell lymphotropic virus type-1 (HTLV-1) antibody: Positive
19. Subject has ≥3x upper limit of normal (ULN) of any of the following: alanine 
aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase 
(ALP), or>ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert’s syndrome). If 
subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate 
bilirubin to identify possible undiagnosed Gilbert’s syndrome (ie, direct bilirubin <35%).
Change #4
Section 6.3.1 Potential drug-induced liver injury IMP discontinuation criteria
The PDILI criteria below require immediate and permanent discontinuation of IMP: 
Subjects with either of the following:
ALT or AST ≥5xULN
REDACTED COPY 
hepatitis B core (HBc) antibody
REDACTED COPY 
hepatitis B core (HBc) antibody
pe B virus (HBV) DNA assay
REDACTED COPY 
pe B virus (HBV) DNA assay
(However, patients with  negative HBs antigen and HBV
REDACTED COPY 
(However, patients with  negative HBs antigen and HBV
 and/or HBs antibody
REDACTED COPY 
 and/or HBs antibody may
REDACTED COPY 
 may
 and/or HBs antibody may
 and/or HBs antibody
REDACTED COPY 
 and/or HBs antibody may
 and/or HBs antibody
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yndrome). If subject has 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
yndrome). If subject has 
y significant laboratory abnormalities at the 
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y significant laboratory abnormalities at the 
≥3 x upper limit of normal (UL
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≥3 x upper limit of normal (ULN)
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N)
≥3 x upper limit of normal (ULN)
≥3 x upper limit of normal (UL
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≥3 x upper limit of normal (ULN)
≥3 x upper limit of normal (UL
hepatitis B core (HBc) antibody
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hepatitis B core (HBc) antibody
pe B virus (HBV) DNA assay
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pe B virus (HBV) DNA assay
(However, patients with  negative HBs antigen and HBV
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(However, patients with  negative HBs antigen and HBV
 may
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 may be included pr
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 be included pr
 may be included pr
 may
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 may be included pr
 may
 4 weeks (from Baseline to Week 52) and then at SFU.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 4 weeks (from Baseline to Week 52) and then at SFU.
pe C virus (HCV) antibody
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pe C virus (HCV) antibody
Human immunodeficiency virus (HIV) antigen or antibody: Positive to either test
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Human immunodeficiency virus (HIV) antigen or antibody: Positive to either test
photropic virus ty
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photropic virus ty
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≥3x upper limit of normal (ULN) of any of the following: alanine 
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≥3x upper limit of normal (ULN) of any of the following: alanine 
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aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase 
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aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase 
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This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
>ULN total 
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>ULN total 
subject has elevations only
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subject has elevations only
bilirubin to identify
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bilirubin to identify
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Change #
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Change #
Section 6.3.1 Potential drug
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Section 6.3.1 Potential drug


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ALT or AST ≥3xULN and coexisting total bilirubin ≥2xULN 
The PDILI criterion below requires immediate discontinuation of IMP:
Subjects with ALT or AST ≥3xULN who exhibit temporally associated symptoms of 
hepatitis or hypersensitivity. Hepatitis symptoms include fatigue, nausea, vomiting, right 
upper quadrant pain or tenderness. Hypersensitivity symptoms include fever (without clear 
alternative cause), rash, or eosinophilia (ie, >5%).
If a nondrug-related cause for the symptoms can be confirmed, these subjects may resume IMP 
administration after discussion with the responsible UCB physician, but only when the 
requirements for rechallenge with IMP as provided in Section 12.2.1.2.1 are followed.
The PDILI criterion below allows for subjects to continue on IMP at the discretion of the 
Investigator. 
Subjects with ALT or AST ≥3xULN (and ≥2x baseline) and {8xULN or 5xULN},total 
bilirubin <2xULN, and no eosinophilia (ie, ≤5%), with no fever, rash, or symptoms of 
hepatitis (eg, fatigue, nausea, vomiting, right upper quadrant pain or tenderness).
Has been changed to
The PDILI criteria below require immediate and permanent discontinuation of IMP: 
Subjects with either of the following:
ALT or AST ≥85xULN
ALT or AST ≥3xULN and coexisting total bilirubin ≥2xULN 
The PDILI criterion below requires immediatediscontinuation of IMP:
Subjects with ALT or AST ≥3xULN who exhibit temporally associated symptoms of 
hepatitis or hypersensitivity. Hepatitis symptoms include fatigue, nausea, vomiting, right 
upper quadrant pain or tenderness. Hypersensitivity symptoms include fever (without clear 
alternative cause), rash, or eosinophilia (ie, >5%).
If a nondrug-related cause for the symptoms can be confirmed, these subjects may resume 
IMP administration after discussion with the responsible UCB physician, but only when 
the requirements for rechallenge with IMP as provided in Section 12.2.1.2.1 are followed.
The PDILI criterion below allows for subjects to continue on IMP at the discretion of the 
Investigator. 
Subjects with ALT or AST ≥3xULN (and ≥2x baseline) and <{8xULNor 5xULN},total 
bilirubin <2xULN, and no eosinophilia (ie, ≤5%), with no fever, rash, or symptoms of 
hepatitis (eg, fatigue, nausea, vomiting, right upper quadrant pain or tenderness).
Change #5
Section 7.8.3.1 Prohibited concomitant treatments (medications and therapies) for subjects 
with generalized pustular PSO or erythrodermic PSO
REDACTED COPY 
The PDILI criteria below require immediate and permanent discontinuation of IMP: 
REDACTED COPY 
The PDILI criteria below require immediate and permanent discontinuation of IMP: 
N and coexisting total bilirubin ≥2xUL
REDACTED COPY 
N and coexisting total bilirubin ≥2xUL
The PDILI criterion below requires immediate
REDACTED COPY 
The PDILI criterion below requires immediate
≥3xULN who exhibit temporally
REDACTED COPY 
≥3xULN who exhibit temporally
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ptoms can be confirmed, these subjects may resume IMP 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ptoms can be confirmed, these subjects may resume IMP 
are followed
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are followed.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
.
The PDILI criterion below allows for subjects to continue on IMP at the discretion of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The PDILI criterion below allows for subjects to continue on IMP at the discretion of the 
{8xULN or 
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{8xULN or 5xULN
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
5xULN
≤5%), with no fever, rash, or s
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
≤5%), with no fever, rash, or s
hepatitis (eg, fatigue, nausea, vomiting, right upper quadrant pain or tenderness).
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
hepatitis (eg, fatigue, nausea, vomiting, right upper quadrant pain or tenderness).
The PDILI criteria below require immediate and permanent discontinuation of IMP: 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The PDILI criteria below require immediate and permanent discontinuation of IMP: 
N and coexisting total bilirubin ≥2xUL
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
N and coexisting total bilirubin ≥2xUL
The PDILI criterion below requires immediate
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The PDILI criterion below requires immediatediscontinuation of I
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discontinuation of I
≥3xULN who exhibit temporally
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≥3xULN who exhibit temporally
. Hepatitis sy
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. Hepatitis sy
upper quadrant pain or tenderness
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upper quadrant pain or tenderness. Hy
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. Hy
alternative cause), rash, or eosinophilia (ie, >5%).
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
alternative cause), rash, or eosinophilia (ie, >5%).
related cause for the symptoms can be confirmed, these subjects may resume 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
related cause for the symptoms can be confirmed, these subjects may resume 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
IMP administration after discussion with the responsible UCB physician, but only when 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
IMP administration after discussion with the responsible UCB physician, but only when 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
the requirements for rechallenge with IMP as provided in Section 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
the requirements for rechallenge with IMP as provided in Section 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The PDILI criterion below allows for subjects to continue on IMP at the discretion of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The PDILI criterion below allows for subjects to continue on IMP at the discretion of the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects with AL
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Subjects with AL
bilirubin <2xUL
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bilirubin <2xUL
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
hepatitis (eg, fatigue, nausea, vomiting, right upper quadrant pain or tenderness).
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hepatitis (eg, fatigue, nausea, vomiting, right upper quadrant pain or tenderness).


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The following concomitant medications are prohibited for subjects with generalized pustular 
PSO or erythrodermic PSO:
Systemic treatment for PSO (nonbiological)
Phototherapy or chemophototherapy
Granulocyte and monocyte adsorption apheresis
Anti-TNFs: infliximab, adalimumab, golimumab, etanercept
Has been changed to
The following concomitant medications are prohibited for subjects with generalized pustular 
PSO or erythrodermic PSO:
Systemic treatment for PSO (nonbiological)
Phototherapy or chemophototherapy
Granulocyte and monocyte adsorption apheresis
Anti-TNFs: infliximab(including biosimilar), adalimumab, golimumab, etanercept
Change #6 
Section 10 Assessment of pharmacokinetic/pharmacodynamic/pharmacogenomic variables
For all PK samples, at each time point, collect at least 5mL blood into heparinized tube and 
centrifuged. Plasma will be aliquoted into 2 labeled transport tubes and stored frozen at -20
oC or 
colder and shipped on dry ice. 
Has been changed to
For all PK samples, at each time point, collect at least 5mL blood into heparinized tube and 
centrifuged. Plasma will be aliquoted into 23labeled transport tubes and stored frozen at -20
oC 
or colder and shipped on dry ice. 
Change #7 
Section 14.3.1 Analysis of the primary efficacy variable for subjects with mod erate to 
severe chronic plaque PSO
The following paragraph has been deleted
The primary efficacy variable will be analyzed for subjects with moderate to severe chronic 
plaque PSO in the FAS. In order to verify the robustness of the efficacy results, primary efficacy 
variables in the primary analysis will also be analyzed for the PPS as sensitivity analysis.
REDACTED COPY 
of pharmacokinetic/pharmacodynamic/pharmacogenomic variables
REDACTED COPY 
of pharmacokinetic/pharmacodynamic/pharmacogenomic variables
For all PK samples, at each time point, collect at least 5mL
REDACTED COPY 
For all PK samples, at each time point, collect at least 5mL
centrifuged. Plasma will be aliquoted into 2
REDACTED COPY 
centrifuged. Plasma will be aliquoted into 2
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The following concomitant medications are prohibited for subjects with generalized pustular 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The following concomitant medications are prohibited for subjects with generalized pustular 
, adalimumab, golimumab, etanercept
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, adalimumab, golimumab, etanercept
of pharmacokinetic/pharmacodynamic/pharmacogenomic variables
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
of pharmacokinetic/pharmacodynamic/pharmacogenomic variables
For all PK samples, at each time point, collect at least 5mL
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
For all PK samples, at each time point, collect at least 5mL
labeled transport tubes and stored frozen at 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
labeled transport tubes and stored frozen at 
For all PK samples, at each time point, collect at least 5mL
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
For all PK samples, at each time point, collect at least 5mL
centrifuged. Plasma will be aliquoted into 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
centrifuged. Plasma will be aliquoted into 
pped on dry
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
pped on dry ice. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 ice. 
pped on dry ice. 
pped on dry
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
pped on dry ice. 
pped on dry
14.3.1 Analysis of the primary efficacy variable for subjects with mod erate to 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
14.3.1 Analysis of the primary efficacy variable for subjects with mod erate to 
severe chronic plaque PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
severe chronic plaque PSO
The following paragraph has been deleted
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The following paragraph has been deleted
The primary
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The primary
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
plaque PSO in the FAS. In order to verify
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
plaque PSO in the FAS. In order to verify
variables in the primary
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variables in the primary


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18.3
Protocol Amendment 3
Rationale for the amendment
The purpose of this amendment is the following:
Clarify prohibited concomitant treatments
Clarify that study medication will not be administered at Visit 28 (Week 52)
Clarify that subject treatment assignment will be stratified by prior biologic exposure and 
psoriatic arthritis
Allow theT-SPOTtestfor TB if the QuantiFERON TB GOLD testis not available
Modifications and changes
Specific changes
Change #1
Section 7.8.2.1 Prohibited concomitant treatments (medications and therapies) for subjects 
with generalized pustular PSO or erythrodermic PSO
The following concomitant medications are prohibited for subjects with generalized pustular 
PSO or erythrodermic PSO:
Systemic treatment for PSO (nonbiological)
Phototherapy or chemophototherapy
Granulocyteand monocyte adsorption apheresis
Anti-TNFs: infliximab(including biosimilar), adalimumab, golimumab, etanercept
Other biologics and systemic therapies: ustekimumab, secukinumab, ixekizumab, and 
brodalumab
Any other antipsoriatic agent (systemic) under investigation (or approved after the 
protocol is approved)
Antipsoriatic agent (topical) under investigation
Has been changed to
The following concomitant medications are prohibited for subjects with generalized pustular 
PSO or erythrodermic PSO:
Systemic treatment for PSO (nonbiological)
Phototherapy or chemophototherapy
Granulocyte and monocyte adsorption apheresis
Anti-TNFs: infliximab(including biosimilar), adalimumab, golimumab, etanercept
Other biologics and systemic therapies: ustekimumab, secukinumab, ixekizumab, and 
brodalumab
REDACTED COPY 
ith generalized pustular PSO or erythrodermic PSO
REDACTED COPY 
ith generalized pustular PSO or erythrodermic PSO
The following concomitant medications are prohibited for subjects with generalized pustular 
REDACTED COPY 
The following concomitant medications are prohibited for subjects with generalized pustular 
stemic treatment for PSO (nonbiological)
REDACTED COPY 
stemic treatment for PSO (nonbiological)
 or chemophototherapy
REDACTED COPY 
 or chemophototherapy
and monocyte adsorption apheresis
REDACTED COPY 
and monocyte adsorption apheresis
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
xposure and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
xposure and 
is not available
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
is not available
Prohibited concomitant treatments (medications and therapies) for subjects 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Prohibited concomitant treatments (medications and therapies) for subjects 
The following concomitant medications are prohibited for subjects with generalized pustular 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The following concomitant medications are prohibited for subjects with generalized pustular 
and monocyte adsorption apheresis
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and monocyte adsorption apheresis
(including biosimilar)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(including biosimilar)
temic therapies: ustekimumab, secukinumab, ixekizumab, and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
temic therapies: ustekimumab, secukinumab, ixekizumab, and 
 other antipsoriatic agent (s
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 other antipsoriatic agent (s
protocol is approved)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
protocol is approved)
Antipsoriatic agent (topical) under investigation
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Antipsoriatic agent (topical) under investigation
Has been changed to
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Has been changed to
The following concomitant medications are prohibited for subjects with generalized pustular 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The following concomitant medications are prohibited for subjects with generalized pustular 
PSO or ery
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
PSO or erythrodermic PSO:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
throdermic PSO:
PSO or erythrodermic PSO:
PSO or ery
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
PSO or erythrodermic PSO:
PSO or ery
Sy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Systemic treatment for PSO (nonbiological)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
stemic treatment for PSO (nonbiological)


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Any other antipsoriatic agent (systemic) under investigation (or approved after the 
protocol is approved)
Antipsoriatic agent (topical) under investigation
Rituximab
Change #2
Section 7.10 Randomization and numbering of subjects
An IRT will be used for assigning eligible subjects to a treatment regimen (as applicable) based 
on a predetermined production randomization and/or packaging schedule provided by UCB (or 
designee). The randomization schedule will be produced by the IRT vendor. The IRT will 
generate individual assignments for subject kits of IMP, as appropriate, according to the visit 
schedule.
Has been changed to
An IRT will be used for assigning eligible subjects to a treatment regimen (as applicable) based 
on a predetermined production randomization and/or packaging schedule provided by UCB (or 
designee). The randomization schedule will be produced by the IRT vendor. Subject treatment 
assignment will be stratified by prior biologic exposure (yes/no) and psoriatic arthritis 
(yes/no).The IRT will generate individual assignments for subject kits of IMP, as appropriate, 
according to the visit schedule.
Change #3
Section 8.28 Visit 28 (Week 52)
Subjects will have the following procedures performed/recorded prior to administration of study
drug:
Blood pressure 
12-lead ECG
Has been changed to
Subjects will have the following procedures performed/recorded prior to administration of 
study drug:
Blood pressure 
12-lead ECG
Change #4
Section 12.6 Tuberculosis assessments and management
At Screening, all subjects will have an IGRA test (QuantiFERON TB GOLD), a chest x-ray
(unless already performed within 3 months of screening), and examination for signs and 
REDACTED COPY 
designee). The randomization schedule will be produced b
REDACTED COPY 
designee). The randomization schedule will be produced b
assignment will be stratified by prior biologic exposure (yes/no) and psoriatic
REDACTED COPY 
assignment will be stratified by prior biologic exposure (yes/no) and psoriatic
The IRT will generate individual assignments for subject kits of IMP, as appropriate, 
REDACTED COPY 
The IRT will generate individual assignments for subject kits of IMP, as appropriate, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
RT will be used for assigning eligible subjects to a treatment regimen (as applicable) based 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
RT will be used for assigning eligible subjects to a treatment regimen (as applicable) based 
on a predetermined production randomization and/or packaging schedule provided b
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
on a predetermined production randomization and/or packaging schedule provided by UCB (or 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y UCB (or 
e IRT vendor. The IRT will 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
e IRT vendor. The IRT will 
generate individual assignments for subject kits of IMP, as appropriate, according to the visit 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
generate individual assignments for subject kits of IMP, as appropriate, according to the visit 
RT will be used for assigning eligible subjects to a treatment regimen (as applicable) based 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
RT will be used for assigning eligible subjects to a treatment regimen (as applicable) based 
predetermined production randomization and/or packaging schedule provided by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
predetermined production randomization and/or packaging schedule provided by
designee). The randomization schedule will be produced b
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
designee). The randomization schedule will be produced by the IRT vendor
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y the IRT vendor
assignment will be stratified by prior biologic exposure (yes/no) and psoriatic
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
assignment will be stratified by prior biologic exposure (yes/no) and psoriatic
The IRT will generate individual assignments for subject kits of IMP, as appropriate, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The IRT will generate individual assignments for subject kits of IMP, as appropriate, 
Subjects will have the following procedures performed/recorded prior to a
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded prior to a
Has been changed to
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Has been changed to
Subjects will have the following procedures performed/recorded 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Subjects will have the following procedures performed/recorded 
study drug
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
study drug:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Blood pressure 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Blood pressure 
12
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12-
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
-lead ECG
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
lead ECG


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symptoms of TB. In addition, each subject will complete a TB questionnaire with questions 
directed at symptoms of TB and potential exposure to TB. Chest x-rays must be read by a 
qualified radiologist/pulmonary physician to determine whether there is evidence of active or 
latent TB. Chest x-ray reports must be consistent with standard reporting practices.
Has been changed to
At Screening, all subjects will have an IGRA test (QuantiFERON TB GOLDis recommended. 
However, a T-SPOT test may be performed by a local laboratory), a chest x-ray (unless 
already performed within 3 months of screening), and examination for signs and symptoms of 
TB. In addition, each subject will complete a TB questionnaire with questions directed at 
symptoms of TB and potential exposure to TB. Chestx-rays must be read by a qualified 
radiologist/pulmonary physician to determine whether there is evidence of active or latent TB. 
Chest x-ray reports must be consistent with standard reporting practices. 
18.4
Protocol Amendment 4
Rationale for the amendment
The purpose of this amendment is the following:
Clarify prohibited concomitant treatmentsand that they are prohibited throughout the study
Clarify that antipsoriatic agents (topical) under investigation or approved after the protocol is 
approved are prohibited
Add time to onset of action, defined as the time to PASI90 and time to onset of action, 
defined as time to PASI100 as other efficacy variables for subjects in the Double-Blind 
Overall population for subjects with moderate to severe chronic plaque PSO
Change the Sponsor Study Physician to  
 MD, PhD
Modifications and changes
Specific changes
Change #1
Sponsor Study Physician
Name:
, MD, PhD
Address:
UCB Japan Co. Ltd.
Shinjuku Grand Tower 
8-17-1 Nishi-shinjuku
Shinjuku-ku
Tokyo 160-0023
JAPAN
Phone:
REDACTED COPY 
and that they
REDACTED COPY 
and that they
 that antipsoriatic agents (topical) under investigation or approved after the protocol is 
REDACTED COPY 
 that antipsoriatic agents (topical) under investigation or approved after the protocol is 
Add time to onset of action, defined as the time to PASI
REDACTED COPY 
Add time to onset of action, defined as the time to PASI
ther efficacy
REDACTED COPY 
ther efficacy
Overall population for subjects with moderate to severe chronic plaque PSO
REDACTED COPY 
Overall population for subjects with moderate to severe chronic plaque PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
is recommended. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
is recommended. 
y performed within 3 months of screening), and examination for signs and symptoms of 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y performed within 3 months of screening), and examination for signs and symptoms of 
TB. In addition, each subject will complete a TB questionnaire with questions directed at 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
TB. In addition, each subject will complete a TB questionnaire with questions directed at 
 a qualified 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 a qualified 
sician to determine whether there is evidence of active or latent TB. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sician to determine whether there is evidence of active or latent TB. 
and that they
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and that theyare prohibited throughout the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
are prohibited throughout the study
 that antipsoriatic agents (topical) under investigation or approved after the protocol is 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 that antipsoriatic agents (topical) under investigation or approved after the protocol is 
Add time to onset of action, defined as the time to PASI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Add time to onset of action, defined as the time to PASI
ther efficacy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ther efficacy
Overall population for subjects with moderate to severe chronic plaque PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Overall population for subjects with moderate to severe chronic plaque PSO
 Phy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 Physician to  
 MD, PhD
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
sician to  
 MD, PhD
Modifications and changes
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Modifications and changes
Sponsor Study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Sponsor Study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Name:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Name:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Address:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Address:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 


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Fax:
Has been changed to
Name:
MD, PhD
Address:
UCB Japan Co. Ltd.
Shinjuku Grand Tower 
8-17-1 Nishi-shinjuku
Shinjuku-ku
Tokyo 160-0023
JAPAN
Phone:
Fax:
Change #2
Section 4.1.3.1.1 Double-Blind Overall population
The following bullets were added:
Time to onset of action, defined as the time to PASI90
Time to onset of action, defined as the time to PASI100
Change #3
Section 5.2
Schedule of study assesssments
Table 5-1 Footnotes i and j
iFor subjects with PsA: HAQ-DI, Patient’s Assessment of Arthritis Pain (VAS), and PGADA 
(VAS)
j For subjects with PsA: swollen and tender joint counts and PhGADA (VAS)
Has been changed to
iOnly Ffor chronic plaque PSOsubjects with PsA: HAQ-DI, Patient’s Assessment of Arthritis 
Pain (VAS), and PGADA (VAS)
j Only Fforchronic plaque PSOsubjects with PsA: swollen and tender joint counts and 
PhGADA (VAS)
REDACTED COPY 
Blind Overall population
REDACTED COPY 
Blind Overall population
Time to onset of action, defined as the time to PASI
REDACTED COPY 
Time to onset of action, defined as the time to PASI
Time to onset of action, defined as the time to PASI
REDACTED COPY 
Time to onset of action, defined as the time to PASI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Time to onset of action, defined as the time to PASI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Time to onset of action, defined as the time to PASI90
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
90
Time to onset of action, defined as the time to PASI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Time to onset of action, defined as the time to PASI
study assesssments
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
study assesssments
For subjects with PsA: HAQ
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
For subjects with PsA: HAQDI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
DI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
For subjects with PsA: swollen and tender joint counts and PhGADA (VAS)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
For subjects with PsA: swollen and tender joint counts and PhGADA (VAS)
Has been changed to
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Has been changed to
or 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
or 
Ffor 
Ff
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Ffor 
Ff chronic 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
chronic 
Pain (VAS), and PGADA (VAS)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Pain (VAS), and PGADA (VAS)
Only 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Only Ff
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Ff
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
PhGADA (VAS)
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PhGADA (VAS)


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Change #4
Section 6.2.1 Exclusion criterion #25, Table 6-1
Topical agents
Any other antipsoriatic agent (topical) under 
investigation
Any dose
4 weeks 
Has been changed to
Topical agents
Any other antipsoriatic agent (topical) under 
investigation(or approved after the protocol is 
approved)
Any dose
4 weeks 
Change #5
Section 6.2.3 Exclusion criterion #30, Table 6-2
Topical agents
Antipsoriatic agent (topical) under investigation
Any dose
4 weeks
Has been changed to
Topical agents
Antipsoriatic agent (topical) under investigation(or 
approved after the protocol is approved)
Any dose
4 weeks
Change #6
The heading for Section 7.8.1.1 
Permitted concomitant treatments (medications andtherapies) for subjects who escape
Has been changed to
Permitted concomitant treatments (medicationsandtherapies) forsubjectswith moderate to 
severe chronic plaque PSO who escapefrom double-blind treatment
Change #7
Section 7.8.2 Prohibited concomitant treatments (medications and therapies)
The following text was added:
Prohibited concomitant treatments (medications and therapies) differ based on whether the 
subject is in the moderate to severe chronic plaque PSO, generalized pustular PSO,or 
erythrodermic PSOtreatment group. 
REDACTED COPY 
REDACTED COPY 
(or 
REDACTED COPY 
(or 
Any dose
REDACTED COPY 
Any dose
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
4 w
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4 weeks
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
eeks
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Any dose
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Any dose
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Permitted concomitant treatment
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Permitted concomitant treatments
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
s(medications 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(medications 
Permitted concomitant treatment
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Permitted concomitant treatment
severe chronic plaque PSO 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
severe chronic plaque PSO 
Change #7
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Change #7
Section 7.8.2
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Section 7.8.2
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The following text was added:
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The following text was added:
Prohibited concomitant treatments (medications 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Prohibited concomitant treatments (medications 


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Page 113of 119
Change #8
The following heading was added, subsequent headings renumbered as appropriate, and text 
revised.
Section 7.8.2.1 Prohibited concomitant treatments (medications and therapies) f or 
subjects with moderate to severe chronic plaque PSO
The following concomitant medications are prohibited during the double-blind study period:
Systemic retinoids
Systemic treatment for PSO(nonbiological)
Systemic immunosuppressants agents (eg, methotrexate, cyclosporine, azathioprine, 
thioguanine)
Systemic corticosteroids
Phototherapy or chemophototherapy
Anti-TNFs: infliximab (including biosimilar), adalimumab, golimumab, etanercept 
Other biologics and systemic therapies: ustekimumab, secukinumab, ixekizumab, and 
brodalumab 
Any other antipsoriatic agent (systemic) under investigation 
Rituximab
Topical agents for dermatologic use:
High potency topical corticosteroids (class I and II)
Any other antipsoriatic agent (topical) under investigation
Moderate potency (class III to V) topical corticosteroids during the double-blind study 
period
Vitamin D analogues and topical retinoids during the double-blind studyperiod
Keratolitic and coal tar 
Has been changed to
The following concomitant medications are prohibited for subjects with moderate to severe 
chronic plaque PSO:
Systemic retinoids
Systemic treatmentsfor PSO(nonbiological)
Systemic immunosuppressants agents (eg, methotrexate, cyclosporine, azathioprine, 
thioguanine)
Systemic corticosteroids
Phototherapy or chemophototherapy
Anti-TNFs: infliximab (including biosimilar), adalimumab, golimumab, etanercept 
REDACTED COPY 
temic) under investigation 
REDACTED COPY 
temic) under investigation 
Topical agents for dermatologic use:
REDACTED COPY 
Topical agents for dermatologic use:
ticosteroids (class I and II)
REDACTED COPY 
ticosteroids (class I and II)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
closporine, azathioprine, 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
closporine, azathioprine, 
umab, golimumab, etanercept 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
umab, golimumab, etanercept 
temic therapies: ustekimumab, secukinumab, ixekizumab, and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
temic therapies: ustekimumab, secukinumab, ixekizumab, and 
temic) under investigation 
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temic) under investigation 
ticosteroids (class I and II)
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ticosteroids (class I and II)
 other antipsoriatic agent (topical) under investigation
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 other antipsoriatic agent (topical) under investigation
 (class III to V) topical corticosteroids during the double-
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 (class III to V) topical corticosteroids during the double-
Vitamin D analogues and topical retinoids during the double-
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Vitamin D analogues and topical retinoids during the double-
Keratolitic and coal tar 
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Keratolitic and coal tar 
Has been changed to
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Has been changed to
The following concomitant medications are prohibited
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The following concomitant medications are prohibited
chronic plaque PSO
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chronic plaque PSO
Sy
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Systemic retinoids
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stemic retinoids
Sy
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Systemic treatment
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stemic treatment


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Other biologics and systemic therapies: ustekimumab, secukinumab, ixekizumab, and 
brodalumab 
Any other antipsoriatic agent (systemic) under investigation (or approved after the 
protocol is approved)
Rituximab
Topical agents for dermatologic use:
High potency topical corticosteroids (class I and II)
Any other antipsoriatic agent (topical) under investigation(or approved after the 
protocol is approved)
Moderate potency (class III to V) topical corticosteroids during the double-blind study
Vitamin D analogues and topical retinoids during the double-blind study
Keratolitic and coal tar during the double-blind study
Change #9
Section 7.8.2.2 Prohibited concomitant treatments (medications and therapies) f or subjects 
with generalized pustular PSO or erythrodermic PSO
The following concomitant medications are prohibited for subjects with generalized pustular 
PSO or erythrodermic PSO:
Systemic treatment for PSO(nonbiological)
Phototherapy or chemophototherapy
Granulocyte and monocyte adsorption apheresis
Anti-TNFs: infliximab(including biosimilar), adalimumab,golimumab, etanercept)
Other biologics and systemic therapies: ustekimumab, secukinumab, ixekizumab, and 
brodalumab
Any other antipsoriatic agent (systemic) under investigation (or approved after the 
protocol is approved)
Antipsoriatic agent (topical) under investigation
Rituximab
Has been changed to
The following concomitant medications are prohibited for subjects with generalized pustular 
PSO or erythrodermic PSO:
Systemic treatmentsfor PSO(nonbiological)
Phototherapy or chemophototherapy
Granulocyte and monocyte adsorption apheresis
REDACTED COPY 
Prohibited concomitant treatments (medications and therapies) for subjects 
REDACTED COPY 
Prohibited concomitant treatments (medications and therapies) for subjects 
with generalized pustular PSO or erythrodermic PSO
REDACTED COPY 
with generalized pustular PSO or erythrodermic PSO
prohibited for subjects with generalized pustular 
REDACTED COPY 
prohibited for subjects with generalized pustular 
REDACTED COPY 
(nonbiological)
REDACTED COPY 
(nonbiological)
 or chemophototherapy
REDACTED COPY 
 or chemophototherapy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(or approved after the 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(or approved after the 
during the double-
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during the double-
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blind st
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blind study
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udy
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Prohibited concomitant treatments (medications and therapies) for subjects 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Prohibited concomitant treatments (medications and therapies) for subjects 
with generalized pustular PSO or erythrodermic PSO
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
with generalized pustular PSO or erythrodermic PSO
prohibited for subjects with generalized pustular 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
prohibited for subjects with generalized pustular 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
(nonbiological)
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(nonbiological)
 or chemophototherapy
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 or chemophototherapy
te and monocyte adsorption apheresis
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te and monocyte adsorption apheresis
TNFs: infliximab
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TNFs: infliximab(including biosimilar)
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(including biosimilar)
Other biologics and s
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Other biologics and sys
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ystemic therapies: ustekimumab, secukinumab, ixekizumab, and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
temic therapies: ustekimumab, secukinumab, ixekizumab, and 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 other antipsoriatic agent (s
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 other antipsoriatic agent (s
protocol is approved)
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protocol is approved)
Antipsoriatic agent (topical) und
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Antipsoriatic agent (topical) und
Rituximab
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Rituximab
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Has been changed to
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Has been changed to
The following concomitant medications are prohibited for subjects with generalized pustular 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The following concomitant medications are prohibited for subjects with generalized pustular 
PSO or ery
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PSO or ery


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Anti-TNFs: infliximab(including biosimilar), adalimumab, golimumab, etanercept)
Other biologics and systemic therapies: ustekimumab, secukinumab, ixekizumab, and 
brodalumab
Any other antipsoriatic agent (systemic) under investigation (or approved after the 
protocol is approved)
Antipsoriatic agent (topical) under investigation(or approved after the protocol is 
approved)
Rituximab
Change #10
Section 11 Assessment of immunological variables
Anti-CZP antibody supplies will be provided by the central laboratory. Additional information 
will be outlined in the study Laboratory Manual. 
Has been changed to
Anti-CZP antibody supplies will be provided by the central laboratory.Additional 
information will be outlined in the study Laboratory Manual. 
Change #11
Section 14.1 Definition of analysis sets
The Full Analysis Set (FAS) will consist of all randomized subjects that received at least 1 dose 
of the study medication and have valid measurement of the primary efficacy variable at Baseline.
Has been changed to
The Full Analysis Set (FAS) will consist of all randomized subjects that received at least 1 dose 
of the study medication and have valid efficacy assessments for Baseline and for at least 1 
post-Baseline visitmeasurement of the primary efficacy variable at Baseline.
Change #12
Section 14.1 Definition of analysis sets
The NAPSI Set (NAPSIS) will be consist of subjects in the FAS who with nail disease at 
Baseline.
The Cohort Enrolled Set (CES) will consist of subjects with generalized pustular PSO or 
erythrodermic PSO who have given informed consent.
Has been changed to
The NAPSI Set (NAPSIS) will be consist of subjects in the FAS who with nail disease at 
Baseline.
REDACTED COPY 
-CZP antibody supplies will be provided by the central laboratory.
REDACTED COPY 
-CZP antibody supplies will be provided by the central laboratory.
REDACTED COPY 
aboratory
REDACTED COPY 
aboratory Manual. 
REDACTED COPY 
 Manual. 
aboratory Manual. 
aboratory
REDACTED COPY 
aboratory Manual. 
aboratory
Definition of analysis sets
REDACTED COPY 
Definition of analysis sets
is Set (FAS) will consist of all randomized subjects that received at least 1 dose 
REDACTED COPY 
is Set (FAS) will consist of all randomized subjects that received at least 1 dose 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y the central laboratory. Additional information 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
y the central laboratory. Additional information 
-CZP antibody supplies will be provided by the central laboratory.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
-CZP antibody supplies will be provided by the central laboratory.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 Manual. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 Manual. 
is Set (FAS) will consist of all randomized subjects that received at least 1 dose 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
is Set (FAS) will consist of all randomized subjects that received at least 1 dose 
have valid measurement of the primary
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
have valid measurement of the primary
is Set (FAS) will consist of all randomized subjects that received at least 1 dose 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
is Set (FAS) will consist of all randomized subjects that received at least 1 dose 
and have valid efficacy assessments for Basel
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and have valid efficacy assessments for Basel
measurement of the primary efficacy variable at Baseline
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
measurement of the primary efficacy variable at Baseline
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Section 14.1
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Section 14.1 Definition of analysis sets
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Definition of analysis sets
The NAPSI
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The NAPSI
Baseline.
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Baseline.
The Co
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
The Co
er
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er


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 116of 119
Subjects with generalized pustular PSO or erythrodermic PSO will be analyzed by cohort 
as follows:
The Cohort Enrolled Set (CES) will consist of subjects with generalized pustular PSO or 
erythrodermic PSO who have given informed consent.
Change #13
Section 14.1 Definition of analysis sets
The Cohort Full Analysis Set (CFAS) will consist of subjects with generalized pustular PSO or 
erythrodermic PSO in the CRS who received at least 1 dose of the study medication and have a 
valid measurement of the primary efficacy variable at Baseline.
Has been changed to
The Cohort Full Analysis Set (CFAS) will consist of subjects with generalized pustular PSO or 
erythrodermic PSO in the CRS who received at least 1 dose of the study medication and have 
valid efficacy assessments for Baseline and for at least 1 post-Baseline visita valid 
measurement of the primary efficacy variable at Baseline.
Change #14
Section 14.3.2.3 Analysis of the other efficacy variables for subjects with gene ralized 
pustular PSO and erythrodermic PSO
All other efficacy variables will be analyzed for all subjects in the CFAS. 
All categorical variables (eg, CGI-I) will be summarized using frequency tables by each visit.
All continuous variables (eg, CGI-I) will be summarized using descriptive statistics by each visit.
Has been changed to
All other efficacy variables will be analyzed for all subjects in the CFAS. 
All categorical variables (eg, CGI-I) will be summarized using frequency tables by each visit.
All continuous variables (eg, CGI-I)will be summarized using descriptive statistics by each 
visit.
Change #15
14.8.2 Determination of sample size for generalized pustular PSO and e rythrodermic PSO 
cohort
Patients with plaque PSO account for 88.6% of all types of PSO, while generalized pustular PSO 
and erythrodermic PSO account for only 1.8% and 1.1%, respectively (Kawata et al, 2010). 
Thus, in view of subject enrollment, it is difficult to perform a clinical study in patients with 
generalized pustular PSO or erythrodermic PSO.
Has been changed to
REDACTED COPY 
Section 14.3.2.3 Analysis of the other efficacy variables for subjects with gene ralized 
REDACTED COPY 
Section 14.3.2.3 Analysis of the other efficacy variables for subjects with gene ralized 
 variables will be anal
REDACTED COPY 
 variables will be analyz
REDACTED COPY 
yzed for all subjects in the CFAS. 
REDACTED COPY 
ed for all subjects in the CFAS. 
All categorical variables (eg, CGI-I) will be summarized using frequency
REDACTED COPY 
All categorical variables (eg, CGI-I) will be summarized using frequency
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
is Set (CFAS) will consist of subjects with generalized pustular PSO or 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
is Set (CFAS) will consist of subjects with generalized pustular PSO or 
 medication
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 medicationand have a 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
and have a 
is Set (CFAS) will consist of subjects with generalized pustular PSO or 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
is Set (CFAS) will consist of subjects with generalized pustular PSO or 
hrodermic PSO in the CRS who received at least 1 dose of the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
hrodermic PSO in the CRS who received at least 1 dose of the study medication 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 medication 
hrodermic PSO in the CRS who received at least 1 dose of the study medication 
hrodermic PSO in the CRS who received at least 1 dose of the study
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
hrodermic PSO in the CRS who received at least 1 dose of the study medication 
hrodermic PSO in the CRS who received at least 1 dose of the study
Baseline visit
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Baseline visit
Section 14.3.2.3 Analysis of the other efficacy variables for subjects with gene ralized 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Section 14.3.2.3 Analysis of the other efficacy variables for subjects with gene ralized 
ed for all subjects in the CFAS. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
ed for all subjects in the CFAS. 
All categorical variables (eg, CGI-I) will be summarized using frequency
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
All categorical variables (eg, CGI-I) will be summarized using frequency
I) will be summarized using descriptive statistics by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
I) will be summarized using descriptive statistics by
 variables will be anal
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
 variables will be anal
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
All categorical variables (eg, CGI-I) will be summarized using frequency
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
All categorical variables (eg, CGI-I) will be summarized using frequency
All continuous variables 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
All continuous variables 
Change #1
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Change #15
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
5
14.8.2
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
14.8.2Determination of sample size for generalized pustular PSO and erythrodermic PSO 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Determination of sample size for generalized pustular PSO and erythrodermic PSO 
cohort
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
cohort
Patients with plaque PSO account for 88.6% of all types of PSO, while generalized pust
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Patients with plaque PSO account for 88.6% of all types of PSO, while generalized pust


UCB
25 Jan 2018
Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 117of 119
Patients with plaque PSO account for 88.6% of all types of PSO, while generalized pustular PSO 
and erythrodermic PSO account for only 1.8% and 1.1%, respectively (Kawadta et al, 2010). 
Thus, in view of subject enrollment, it is difficult to perform a clinical study in patients with 
generalized pustular PSO or erythrodermic PSO.
Change #16
Section 17References
The following reference was added:
Kawada A, Nakamura K, Kaneko F, Ito H, Nakagawa H. National survey of psoriasis 
(commentary). Practical Dermatology. 2010;11:1238-42.
REDACTED COPY 
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 of psoriasis 
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 of psoriasis 


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Clinical Study Protocol
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Page 118of 119
19
DECLARATION AND SIGNATURE OF INVESTIGATOR
I confirm that I have carefully read and understood this protocol and agree to conduct this 
clinical study as outlined in this protocol, according to current Good Clinical Practice and local 
laws and requirements.
I will ensure that all subinvestigators and other staff members read and understand all aspects of 
this protocol.
I have received and read all study-related information provided to me.
The objectives and content of this protocol as well as the results deriving from it will be treated 
confidentially, and will not be made available to third parties without prior authorization by 
UCB.
All rights of publication of the results reside with UCB, unless other agreements were made in a
separate contract.
Investigator:
Printed name
Date/Signature
REDACTED COPY 
Date/Signature
REDACTED COPY 
Date/Signature
REDACTED COPY 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
col as well as the results deriving from it will be treated 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
col as well as the results deriving from it will be treated 
, and will not be made available to third parties without prior authorization by
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
, and will not be made available to third parties without prior authorization by
All rights of publication of the results reside with UCB, unless other agreements were made in a
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
All rights of publication of the results reside with UCB, unless other agreements were made in a
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Date/Signature
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
Date/Signature
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 


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Clinical Study Protocol
Certolizumab Pegol
PS0017
Confidential
Page 119of 119
20 
SPONSOR DECLARATION
I confirm that I have carefully read and understand this protocol and agree to conduct this 
clinical study as outlined in this protocol and according to current Good Clinical Practice.
REDACTED COPY 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 


REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
REDACTED COPY 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 
This document cannot be used to support any marketing authorization application and any extensions or variations thereof. 

SAP_001.pdf: 
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2.1.1 
Primary objective 
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3.1 
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3.2 
General study level definitions 
3.2.1 
Analysis time points 
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3.2.3 
Study periods 
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Table 3‒1: 
Study period description and windowing 
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3.2.4 
Mapping of assessments performed at Early Discontinuation Visit 
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3.2.5 
Subjects switching centers during the study 
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3.3 
Definition of Baseline values 
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3.4 
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3.5 
Analysis sets 
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3.5.1 
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Randomized Set 
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Full Analysis Set 
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3.5.5 
Per Protocol Set 
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3.5.6 
Pharmacokinetics Per-Protocol Set 
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6.1 
Demographics 
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6.3 
Medical history and concomitant diseases 
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7 
MEASUREMENTS OF TREATMENT COMPLIANCE 
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8 
EFFICACY ANALYSES 
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Statistical analysis of the primary efficacy variable(s) 
8.1.1 
Derivations of primary efficacy variable(s) 
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Physician’s Global Assessment (PGA) Clear or Almost Clear (with 
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PASI90 at Week 16 
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DLQI scoring 
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Analysis of other efficacy variables 
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Overview of analysis of other efficacy variables 
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8.3.11 
Physician’s Global Assessment of Disease Activity (PhGADA, 
VAS) 
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Patient’s Global Assessment of Arthritis Pain (PGAAP, VAS) 
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Disease Activity Score DAS28(CRP) (28 joints evaluation) 
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8.3.16 
mNAPSI (change from Baseline) 
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Clinical Global Impression of Improvement (CGI-I) 
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PHARMACOKINETICS AND IMMUNOLOGICAL 
PROCEDURES  
9.1 
Pharmacokinetics 
9.1.1 
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Vital signs, physical findings, and others related to safety 
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Pregnancy testing 
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11 
REFERENCES 
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12 
AMENDMENT(S) TO THE STATISTICAL ANALYSIS PLAN 
12.1 
Amendment 1 – Summary of Changes 
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13 
APPENDICES 
13.1 
Schedule of study assessments 
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14 
STATISTICAL ANALYSIS PLAN SIGNATURE PAGE 
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Approval Signatures
Name:
ps0017-sap
Version:
5. 0
Document Number:
CLIN-000075238
Title:
Statistical Analysis Plan
Approved Date:
07 May 2019
Document Approvals
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 23-Apr-2019 08:50:04 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 07-May-2019 00:28:58 GMT+0000
OPY
App
OPY 
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