A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Subjects (>=6 To <18 Years of Age)
Phase: PHASE3
Conditions: Psoriasis
Sponsor: Janssen Research & Development, LLC

CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
1
Status: Approved,  Date: 29 August 2024
Janssen Research & Development*
Clinical Protocol
Protocol Title
A Phase 3, Multicenter, Randomized, Placebo-and Active Comparator-Controlled Study
Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered
Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants (≥6
To <18 Years of Age)
PROTOSTAR
Short Title
A Study of Efficacy, Safety, and Pharmacokinetics of Guselkumab in the Treatment of
Chronic Plaque Psoriasis in Pediatric Participants
Protocol CNTO1959PSO3011; Phase 3
AMENDMENT 5
CNTO 1959 (guselkumab)
*Janssen Research & Development is a global organization that operates through different legal entities in
various countries. Therefore, the legal entity acting as the sponsor for Janssen Research & Development
studies may vary, such as, but not limited to Janssen Biotech, Inc.; Janssen Products, LP; Janssen
Biologics, BV; Janssen-Cilag International NV; Janssen, Inc; Janssen Pharmaceutica NV; Janssen
Sciences Ireland UC; or Janssen Research & Development, LLC. The term “sponsor” is used throughout
the protocol to represent these various legal entities; the sponsor is identified on the Contact Information
page that accompanies the protocol.
This compound has been investigated in adult Phase 3 clinical studies.
US sites of this study will be conducted under US Food & Drug Administration IND regulations
(21 CFR Part 312).
Studies conducted at sites in the European Economic Area (EEA) will be conducted under
Regulation [EU] No 536/2014.
EU Trial Number: 2023-503378-19
EudraCT NUMBER: 
 2017-003053-42
Status: 
Approved
Date: 
29 August 2024
Prepared by: Janssen Research & Development, LLC
EDMS number: 
EDMS-ERI-138623051, 13.0
GCP Compliance: This study will be conducted in compliance with Good Clinical Practice, and applicable regulatory
requirements.
Confidentiality Statement
The information provided herein contains Company trade secrets, commercial or financial information that the Company
customarily holds close and treats as confidential.  The information is being provided under the assurance that the recipient
will maintain the confidentiality of the information under applicable statutes, regulations, rules, protective orders or
otherwise.
NCT03451851

CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3011 Amendment 5
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
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Status: Approved,  Date: 29 August 2024
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE
DOCUMENT HISTORY
Document 
Date
Amendment 5 
29 August 2024
Amendment 4 
24 February 2022
Amendment 3 
19 Feb 2020
Amendment 2 
08 May 2019
Amendment 1 
09 May 2018
Original Protocol 
21 Dec 2017
Amendment 5 (29 August 2024)
Overall Rationale for the Amendment: The changes in this protocol amendment are implemented for
compliance with EU CTR.
The changes made to the clinical protocol CNTO1959PSO3011 as part of Protocol Amendment 5 are listed
below, including the rationale of each change and a list of all applicable sections. Changes made in previous
protocol amendments are listed in Section 10.23 Appendix 23: Protocol Amendment History.
Section Number 
and Name
Description of Change 
Brief Rationale
Title page 
Added the following sentence:
Studies conducted at sites in the European
Economic Area (EEA) will be conducted
under Regulation [EU] No 536/2014.
For compliance with EU CTR
Title page 
Added EU Trial number
Synopsis 
Added a section on Benefit-Risk Assessment
Synopsis 
Added EU Trial number
Section 6.1 
Added IMP/NIMP/AxMP table
Section 7.3 
Revised to allow site (rather than sponsor) to
engage a third party to search public sources
for participant information.
Section 8.3.3 Regulatory 
Reporting Requirements for
Serious Adverse Events and
Anticipated Events
Added anticipated events requirements.
Appendix 2 
RECRUITMENT 
STRATEGY 
Added section, explaining that a recruitment
strategy is not applicable as enrollment for
this study has stopped.
Appendix 2 DATA 
PROTECTION
Updated text on Privacy of Personal data.
Appendix 2 PUBLICATION 
POLICY/DISSEMINATION 
OF CLINICAL STUDY
DATA
Added clarification on disclosure of the study
results.
Appendix 2 RECORD 
RETENTION  
Added text regarding record retention under
EU regulation.
Throughout the protocol 
Minor grammatical, formatting, or spelling
changes were made.
Minor errors were noted

CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3011 Amendment 5
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
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Status: Approved,  Date: 29 August 2024
TABLE OF CONTENTS
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE ............................................................... 2
TABLE OF CONTENTS ............................................................................................................................... 3
LIST OF IN-TEXT TABLES AND FIGURES................................................................................................ 6
1. 
PROTOCOL SUMMARY..................................................................................................................... 7
1.1. 
Synopsis........................................................................................................................................... 7
1.2. 
Schema.......................................................................................................................................... 13
1.3. 
Schedule of Activities (SoA)........................................................................................................... 14
1.3.1. 
Screening Through Week 52 –Part 1a and 1b.......................................................................... 14
1.3.2. 
Screening Through Week 52 –Part 2 ........................................................................................ 18
1.3.3. 
Long-term Extension Phase (Week 60 Through Study Completion/Termination) ..................... 21
2. 
INTRODUCTION................................................................................................................................ 23
2.1. 
Study Rationale.............................................................................................................................. 23
2.2. 
Background.................................................................................................................................... 24
2.2.1. 
Clinical Studies ........................................................................................................................... 25
2.2.2. 
Comparator................................................................................................................................. 26
2.3. 
Benefit/Risk Assessment ............................................................................................................... 27
2.3.1. 
Guselkumab................................................................................................................................ 27
2.3.2. 
Etanercept .................................................................................................................................. 28
3. 
OBJECTIVES AND ENDPOINTS ..................................................................................................... 28
4. 
STUDY DESIGN ................................................................................................................................ 30
4.1. 
Overall Design................................................................................................................................ 30
4.2. 
Scientific Rationale for Study Design............................................................................................. 33
4.2.1. 
Study-Specific Ethical Design Considerations ........................................................................... 34
4.3. 
Justification for Dose...................................................................................................................... 35
4.4. 
End of Study Definition................................................................................................................... 36
5. 
STUDY POPULATION ...................................................................................................................... 36
5.1. 
Inclusion Criteria............................................................................................................................ 36
5.2. 
Exclusion Criteria........................................................................................................................... 41
5.3. 
Lifestyle Considerations................................................................................................................. 46
5.4. 
Screen Failures.............................................................................................................................. 47
6. 
STUDY INTERVENTION................................................................................................................... 48
6.1. 
Study Interventions Administered .................................................................................................. 48
6.2. 
Preparation/Handling/Storage/Accountability ................................................................................ 52
6.3. 
Measures to Minimize Bias: Randomization and Blinding............................................................. 53
6.4. 
Study Intervention Compliance...................................................................................................... 54
6.5. 
Concomitant Therapy..................................................................................................................... 55
6.5.1. 
Rescue Medication ..................................................................................................................... 55
6.5.2. 
Topical Therapies for Psoriasis .................................................................................................. 56
6.5.3. 
Phototherapy or Systemic Therapies for Psoriasis .................................................................... 56
6.5.4. 
Concomitant Therapies for Conditions Other Than Psoriasis .................................................... 56
6.5.5. 
Concomitant Therapies After Week 52....................................................................................... 56
6.5.6. 
Vaccinations (including COVID-19)............................................................................................ 57
6.6. 
Dose Modification........................................................................................................................... 57
6.7. 
Intervention After the End of the Study.......................................................................................... 57
7. 
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL............................................................................................... 57
7.1. 
Discontinuation of Study Intervention ............................................................................................ 57
7.2. 
Participant Discontinuation/Withdrawal From the Study................................................................ 59

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7.2.1. 
Withdrawal From the Use of Research Samples ....................................................................... 60
7.3. 
Lost to Follow-up............................................................................................................................ 60
8. 
STUDY ASSESSMENTS AND PROCEDURES ............................................................................... 60
8.1. 
Efficacy Assessments .................................................................................................................... 66
8.1.1. 
Investigator’s Global Assessment .............................................................................................. 67
8.1.2. 
Psoriasis Area and Severity Index.............................................................................................. 67
8.1.3. 
Body Surface Area...................................................................................................................... 67
8.1.4. 
Children’s Dermatology Life Quality Index ................................................................................. 67
8.1.5. 
Family Dermatology Life Quality Index....................................................................................... 67
8.1.6. 
Blinded Efficacy Evaluator.......................................................................................................... 68
8.2. 
Safety Assessments....................................................................................................................... 68
8.2.1. 
Physical Examination.................................................................................................................. 69
8.2.2. 
Vital Signs................................................................................................................................... 69
8.2.3. 
Clinical Safety Laboratory Assessments .................................................................................... 69
8.2.4. 
Columbia-Suicide Severity Rating Scale (C-SSRS)................................................................... 69
8.2.5. 
Immunogenicity Assessments .................................................................................................... 72
8.2.6. 
Concomitant Medication Review ................................................................................................ 72
8.2.7. 
Injection-site Reactions............................................................................................................... 72
8.2.8. 
Injection Pain .............................................................................................................................. 72
8.2.9. 
Allergic Reactions....................................................................................................................... 72
8.2.10. 
Early Detection of Active Tuberculosis....................................................................................... 72
8.3. 
Adverse Events and Serious Adverse Events ............................................................................... 73
8.3.1. 
Time Period and Frequency for Collecting Adverse Events and Serious Adverse Event
Information.................................................................................................................................. 74
8.3.1.1. 
All Adverse Events .................................................................................................................. 74
8.3.1.2. 
Serious Adverse Events .......................................................................................................... 75
8.3.2. 
Follow-up of Adverse Events and Serious Adverse Events ....................................................... 75
8.3.3. 
Regulatory Reporting Requirements for Serious Adverse Events and Anticipated
Events......................................................................................................................................... 76
8.3.4. 
Pregnancy................................................................................................................................... 76
8.3.5. 
Events of Special Interest........................................................................................................... 76
8.4. 
Treatment of Overdose .................................................................................................................. 77
8.5. 
Pharmacokinetics........................................................................................................................... 77
8.6. 
Pharmacodynamics........................................................................................................................ 78
8.7. 
Genetics ......................................................................................................................................... 78
8.8. 
Biomarkers..................................................................................................................................... 78
8.9. 
Medical Resource Utilization and Health Economics .................................................................... 78
8.10. 
Usability Assessment..................................................................................................................... 78
9. 
STATISTICAL CONSIDERATIONS.................................................................................................. 78
9.1. 
Statistical Hypotheses.................................................................................................................... 79
9.2. 
Sample Size Determination ........................................................................................................... 79
9.3. 
Populations for Analyses................................................................................................................ 81
9.4. 
Statistical Analyses ........................................................................................................................ 81
9.4.1. 
Efficacy Analyses........................................................................................................................ 81
9.4.1.1. 
Analysis Data Set .................................................................................................................... 81
9.4.1.2. 
Efficacy Definitions .................................................................................................................. 81
9.4.1.3. 
Primary Analysis...................................................................................................................... 82
9.4.1.4. 
Major Secondary Analyses...................................................................................................... 82
9.4.1.5. 
Other Secondary Analyses...................................................................................................... 83
9.4.2. 
Usability Assessments................................................................................................................ 84
9.4.3. 
Safety Analyses.......................................................................................................................... 84
9.4.4. 
Other Analyses ........................................................................................................................... 86
9.5. 
Interim Analysis.............................................................................................................................. 87
9.5.1. 
Data Monitoring Committee........................................................................................................ 87
10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ............................ 88

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10.1. 
Appendix 1: Abbreviations and Trademarks.................................................................................. 88
10.2. 
Appendix 2: Regulatory, Ethical, and Study Oversight Considerations......................................... 89
REGULATORY AND ETHICAL CONSIDERATIONS .......................................................................... 89
FINANCIAL DISCLOSURE .................................................................................................................. 92
INFORMED CONSENT PROCESS AND ASSENT FORM ................................................................. 92
RECRUITMENT STRATEGY............................................................................................................... 94
This section is not applicable as the enrollment part of this study is closed. .................................................. 94
DATA PROTECTION ........................................................................................................................... 94
LONG-TERM RETENTION OF SAMPLES FOR ADDITIONAL FUTURE RESEARCH...................... 94
COMMITTEES STRUCTURE .............................................................................................................. 95
PUBLICATION POLICY/DISSEMINATION OF CLINICAL STUDY DATA........................................... 95
DATA QUALITY ASSURANCE ............................................................................................................ 96
SOURCE DOCUMENTS ...................................................................................................................... 97
CASE REPORT FORM COMPLETION ............................................................................................... 98
MONITORING ...................................................................................................................................... 98
ON-SITE AUDITS................................................................................................................................. 99
RECORD RETENTION ........................................................................................................................ 99
STUDY AND SITE CLOSURE ........................................................................................................... 100
10.3. 
Appendix 3: Contraceptive and Barrier Guidance and Collection of Pregnancy Information...... 101
10.4. 
Appendix 4: Adverse Events: Definitions and Procedures for Recording, Evaluating,
Follow-up, and Reporting............................................................................................................. 104
ADVERSE EVENT DEFINITIONS AND CLASSIFICATIONS............................................................ 104
ATTRIBUTION DEFINITIONS............................................................................................................ 105
SEVERITY CRITERIA........................................................................................................................ 105
SPECIAL REPORTING SITUATIONS ............................................................................................... 106
PROCEDURES .................................................................................................................................. 106
CONTACTING SPONSOR REGARDING SAFETY........................................................................... 107
PRODUCT QUALITY COMPLAINT HANDLING................................................................................ 107
10.5. 
Appendix 5: Tuberculin Skin Testing ........................................................................................... 109
10.6. 
Appendix 6: Hepatitis B Virus (HBV) Screening With HBV DNA Testing.................................... 110
10.7. 
Appendix 7: Investigator’s Global Assessment (IGA).................................................................. 111
10.8. 
Appendix 8: Psoriasis Area and Severity Index (PASI) ............................................................... 112
10.9. 
Appendix 9: Children’s Dermatology Life Quality Index............................................................... 113
10.10. Appendix 10: Family Dermatology Life Quality Index.................................................................. 114
10.11. Appendix 11: Clinical Laboratory Tests ....................................................................................... 116
10.12. Appendix 12: Guideline Algorithm for Monitoring, Assessment, and Evaluation of
Abnormal Liver Tests in Participants with No Underlying Liver Disease ..................................... 117
10.13. Appendix 13: Columbia-Suicide Severity Rating Scale (Children’s Baseline)............................. 121
10.14. Appendix 14: Columbia-Suicide Severity Rating Scale (Baseline/Screening)............................. 124
10.15. Appendix 15: Columbia-Suicide Severity Rating Scale (Children’s Since Last Visit).................. 127
10.16. Appendix 16: Columbia-Suicide Severity Rating Scale (Since Last Visit)................................... 130
10.17. Appendix 17: Faces Pain Scale –Revised (FPS-R) for Injection Pain........................................ 133
10.18. Appendix 18: Injection Pain Visual Analog Scale (VAS).............................................................. 134
10.19. Appendix 19: Anticipated Events ................................................................................................. 135
10.20. 
.................................................................. 136
10.21. 
..................................................... 138
10.22. Appendix 22: Guidance on Study Conduct During the COVID-19 Pandemic ............................. 140
10.23. Appendix 23: Protocol Amendment History................................................................................. 142
11. REFERENCES................................................................................................................................. 150
INVESTIGATOR AGREEMENT............................................................................................................... 152
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LIST OF IN-TEXT TABLES AND FIGURES
TABLES
Table 1: 
Approximate Total Volume of Blood Per Type of Sample to be Collected Through
Week 52 from Each Participant ................................................................................................ 61
Table 2: 
Approximate Volume of Blood to be Collected per Visit Through Week 52 ............................. 62
Table 3: 
Approximate Volume of Blood to be Collected Annually from Each Participant in the
Long-term Extension................................................................................................................. 62
Table 4: 
Power to Detect a Treatment Effect for Guselkumab Based on Different Assumptions
of Response Rates ................................................................................................................... 80
Table 5: 
Power to Detect a Treatment Effect for Etanercept Based on Different Assumptions of
Response Rates ....................................................................................................................... 81
FIGURES
Figure 1: Schematic Overview of the Study............................................................................................. 13

CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3011 Amendment 5
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Status: Approved,  Date: 29 August 2024
1. 
PROTOCOL SUMMARY
1.1. 
Synopsis
A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the
Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of
Chronic Plaque Psoriasis in Pediatric Participants (≥6 To <18 Years of Age)
EU TRIAL NUMBER: 2023-503378-19
Protocol Number: CNTO1959PSO3011
Guselkumab (CNTO 1959) is a fully human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody
that binds to the p19 protein subunit of human interleukin (IL)-23 with high specificity and affinity. The
binding of guselkumab to the IL-23p19 subunit blocks the binding of extracellular IL-23 to the cell surface
IL-23 receptor, inhibiting IL-23-specific intracellular signaling and subsequent activation and cytokine
production. Guselkumab has been studied in Phase 1, Phase 2, and ongoing Phase 3 studies for the treatment
of moderate to severe plaque psoriasis in adults. Guselkumab has been approved for the treatment of adults
with moderate to severe plaque psoriasis in the United States, Europe, and Canada.
BENEFIT-RISK ASSESSMENT
Guselkumab has a well-defined long-term safety profile and has been extensively studied for the following
approved indications: adults with moderate to severe psoriasis and active psoriatic arthritis. Taking into
account the measures taken to minimize risk to pediatric participants in this study, the potential risks
identified in association with guselkumab are justified by the anticipated benefits that may be afforded to
pediatric participants with moderate to severe psoriasis. More detailed information about the known and
expected benefits and risks of guselkumab can be found in the IB.
OBJECTIVES AND ENDPOINTS
Objectives
Primary Objectives
The primary objective of this study is to evaluate the efficacy and safety of guselkumab in pediatric
participants aged ≥6 through <18 years with chronic plaque psoriasis.
Secondary Objectives
The secondary objectives of this study are:
To evaluate the pharmacokinetics (PK) and immunogenicity of guselkumab in pediatric participants
aged ≥6 through <18 years with chronic plaque psoriasis.
To evaluate the effect of guselkumab on the dermatologic health-related quality of life in pediatric
participants aged ≥6 through <18 years with chronic plaque psoriasis.
To evaluate maintenance of response in participants who have active treatment withdrawn.
To evaluate the efficacy and safety of retreatment with guselkumab.
To generate clinical usability data and use experience with the 
 in
pediatric participants with chronic plaque psoriasis and a body weight <70 kg.
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CNTO 1959 (guselkumab)
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Hypotheses
The primary hypothesis is that guselkumab treatment is superior to placebo as assessed by the proportion
of participants achieving an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal (1) and
the proportion of participants achieving a Psoriasis Area and Severity Index (PASI) 75 response at Week 16.
The major secondary hypotheses are that guselkumab treatment is:
superior to placebo as assessed by the proportion of participants achieving a PASI 90 response at
Week 16.
superior to placebo as assessed by the proportion of participants achieving an IGA score of cleared (0)
at Week 16.
superior to placebo as assessed by the proportion of participants achieving a PASI 100 response at
Week 16.
superior to placebo in improving the dermatologic health-related quality of life in pediatric participants
as assessed by the change from baseline in Children’s Dermatology Life Quality Index (CDLQI) at
Week 16.
OVERALL DESIGN
This is a Phase 3, multicenter, randomized, placebo- and active comparator-controlled study evaluating the
efficacy, safety, and PK of subcutaneously (SC) administered guselkumab for the treatment of chronic
plaque psoriasis in pediatric participants ≥6 to <18 years of age that cannot be adequately controlled with
phototherapy and/or topical agents.
The main study will be conducted in 2 parts. In Part 1, the efficacy, safety, and PK of a weight-based dose
regimen of guselkumab will be evaluated in pediatric participants during a 16-week randomized,
placebo- and active comparator-controlled period followed by an uncontrolled period of withdrawal and
retreatment or initiation of treatment with guselkumab through Week 52. Etanercept (active comparator)
will be administered in an open-label fashion during the controlled period of the study and efficacy will be
assessed by a blinded efficacy evaluator. Part 1 of the study will be divided into Part 1a (≥12 to <18 years
of age [ie, adolescents]) and Part 1b (≥6 to <12 years of age). Enrollment of participants ≥6 to <12 years of
age in Part 1b will commence only after all participants ≥12 to <18 years of age in Part 1a have completed
Week 16, all available safety data have been reviewed by an independent Data Monitoring Committee
(DMC), with no important safety concerns identified, and all available guselkumab PK data for the ≥12 to
<18-year-old participants through Week 16 have been evaluated via PK modeling and simulation to confirm
that the body weight-based dose used in Part 1a provided systemic exposure comparable to adults.
Part 2 of the study will be an open-label, single-arm study to collect additional efficacy, safety, and PK data
for pediatric participants with a weight-based dose regimen of guselkumab through Week 52. Part 2 will
begin after the reviews of safety and PK data through Week 16 for all participants ≥12 to <18 years of age
in Part 1a have been completed and will enroll enough additional participants to achieve a total of at least
100 participants exposed to guselkumab in this study. Enrollment of participants ≥6 to <12 years of age in
Part 2 will commence only after all participants in Part 1b have completed 16 weeks of treatment, all
available safety data have been reviewed by an independent DMC, and all PK data through Week 16 from
Part 1b have been evaluated via PK modeling and simulation to confirm that the body weight-based dose
used in Part 1b provided systemic exposure comparable to adults. Clinical usability data of the
to-be-marketed
 will be collected in Part 2 of the study.
A long-term extension (LTE) of the study will be initiated at Week 52.
There are 3 database locks (DBL) planned for this study at Week 16, Week 52 (end of the main study), and
at the end of the study (end of the LTE). The Week 16 database lock will occur after all participants in
Part 1 of the study complete their Week 16 visit and will include only data from Part 1. The sponsor will
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CNTO 1959 (guselkumab)
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be unblinded after the Week 16 database lock for Part 1 has occurred. The Week 52 database lock will
occur after all participants in both Part 1 and Part 2 of the study complete their Week 52 visit.  Additional
database locks may be performed if deemed necessary.
NUMBER OF PARTICIPANTS
At least 100 boys and girls, ≥6 and <18 years of age, with a diagnosis of plaque-type psoriasis (with or
without psoriatic arthritis [PsA]) for at least 6 months before the first administration of study intervention
will be enrolled. Participants must have chronic plaque-type psoriasis defined as having an IGA ≥3, a
PASI ≥12, a ≥10% BSA involvement, and at least one of the following: very thick lesions, clinically
relevant facial, genital, or hand/ foot involvement, PASI≥20, >20% BSA involvement, or IGA=4.
Participants are also required to be a candidate for phototherapy or systemic treatment of plaque psoriasis
and have plaque psoriasis considered by the investigator as inadequately controlled with phototherapy
and/or topical therapy after an adequate dose and duration of therapy.
In Part 1a, a minimum of 60 participants will be randomized in a 2:1:1 ratio to guselkumab, placebo, and
etanercept. In Part 1b, a minimum of 30 participants will be randomized in a 1:1:1 ratio to guselkumab,
placebo, and etanercept. In Part 2, at least 10 participants will be enrolled to achieve a total of at least
100 participants exposed to guselkumab in this study.
INTERVENTION GROUPS AND DURATION
Guselkumab and placebo for guselkumab will be provided in a single-use prefilled syringe (PFS) assembled
with the UltraSafe Plus™ Passive Needle Guard (PFS-U) or a 
Commercially available etanercept will be provided in a prefilled syringe or as a powder and solvent for
solution for injection.
Participants randomized to guselkumab will receive a dose based on body weight. Participants will receive
1 of the following dose levels depending on their weight:
Weight <70 kg:
 administered
Weight ≥70 kg:
 administered using the PFS-U
Participants randomized to placebo will receive injections with a volume determined using the same weight
based dose calculation for guselkumab.
Commercially available etanercept will be supplied and participants will receive a dose based on body
weight:
<63 kg: 0.8 mg/kg once weekly using a powder and solvent for solution for injection.
≥63 kg: 50 mg once weekly administered using a prefilled syringe.
Dose Regimen:
Participants in Part 1 will be randomized to 1 of 3 treatment groups to receive:
Group I: Weight-based guselkumab dose
 SC at Weeks 0, 4, and 12.
Group II: Weight-based placebo for guselkumab dose administered SC at Weeks 0, 4, and 12.
Group III: Weight-based etanercept dose up to 50 mg SC weekly through Week 15.
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From Week 16 through Week 52:
Group Ia: Participants randomized to guselkumab who are PASI 90 responders at Week 16 will not
receive any additional doses of guselkumab until they lose ≥50% of their Week 16 PASI response, at
which time they will receive a weight-based guselkumab SC dose, followed by a dose 4 weeks later,
and every 8 weeks (q8w) thereafter through Week 52.
Group Ib: Participants randomized to guselkumab who are PASI 90 nonresponders at Week 16 will
receive a placebo injection at Week 16 and continue treatment with guselkumab q8w from Week 20
through Week 52.
Group IIa: Participants randomized to placebo who are PASI 90 responders at Week 16 will not receive
any additional doses of study intervention until they lose ≥50% of their Week 16 PASI response, at
which time they will receive a weight-based guselkumab SC dose, followed by a dose 4 weeks later,
and q8w thereafter through Week 52.
Group IIb: Participants randomized to placebo who are PASI 90 nonresponders at Week 16 will receive
a weight-based guselkumab dose at Weeks 16 and 20, followed by q8w dosing thereafter through
Week 52.
Group III: Participants randomized to etanercept who elect to continue in the study will receive a
weight-based guselkumab dose at Weeks 20 and 24, followed by q8w dosing thereafter through
Week 48.
Participants enrolled in Part 2 of the study will receive a weight-based dose of open-label guselkumab SC
at Weeks 0, 4 and q8w thereafter through Week 52.
Participants who complete Week 52 of the main study and who have had a beneficial response from
guselkumab treatment as determined by the investigator, will have the option of continuing with a
weight-based guselkumab q8w regimen until one of the following occurs: 1) they have reached 18 years of
age and reside in a country where guselkumab is approved for treatment of plaque psoriasis in adults, and
have had the opportunity to complete up to 1 year in the LTE, 2) marketing authorization is obtained for
guselkumab for treatment of plaque psoriasis for patients ≥6 to <18 years of age, 3) marketing authorization
is denied for guselkumab for the treatment of plaque psoriasis in pediatric patients, or 4) the company
decides to no longer pursue an indication in plaque psoriasis in the pediatric population.
EFFICACY EVALUATIONS
Efficacy evaluations include:
Investigator’s Global Assessment (IGA)
Psoriasis Area and Severity Index (PASI)
Body Surface Area (BSA)
Children’s Dermatology Life Quality Index (CDLQI)
Family Dermatology Life Quality Index (FDLQI)
ENDPOINTS
The co-primary and major secondary endpoints for Part 1, with the primary comparisons between the
guselkumab and placebo groups, include:
Co-primary Endpoints
The proportion of participants achieving an IGA score of cleared (0) or minimal (1) at Week 16.
The proportion of participants with a PASI 75 response at Week 16.

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Major Secondary Endpoints
The proportion of participants achieving a PASI 90 response at Week 16.
The proportion of participants achieving an IGA score of cleared (0) at Week 16.
The proportion of participants achieving a PASI 100 response at Week 16.
The change from baseline in CDLQI at Week 16.
Other Secondary Endpoints
Secondary endpoints for Part 1 of the study include:
The proportion of retreated participants that achieve a PASI 90 response over time after retreatment.
The proportion of retreated participants that achieve PASI responses (PASI 50, 75, 90, and 100) or
IGA responses (IGA of cleared [0], minimal [1], or mild [2], IGA of cleared [0] or minimal [1], and
IGA of cleared [0]) over time after retreatment.
The time to loss of 50% of the Week 16 PASI improvement (ie, time to retreatment) after withdrawal.
The time to loss of PASI 90 response after withdrawal.
The proportion of participants achieving a PASI 50 response at Week 16.
The proportion of participants who achieve an IGA score of mild or better (≤2) at Week 16.
The percent improvement from baseline in PASI over time through Week 16.
The proportion of PASI responses (PASI 50, 75, 90, and 100) over time through Week 16.
The proportion of IGA responses (IGA of cleared [0], minimal [1], or mild [2], IGA of cleared [0] or
minimal [1], and IGA of cleared [0]) over time through Week 16.
The proportion of participants with CDLQI=0 or 1 at Week 16 among randomized participants with a
baseline CDLQI>1
Body surface area involved (BSA) and change from baseline in BSA at Week 16 will be compared
between the guselkumab group and the placebo group.
BSA and change from baseline in BSA will be summarized over time through Week 16.
The proportion of participants with FDLQI=0 or 1 at Week 16 among randomized participants with a
baseline FDLQI>1.
The change from baseline in FDLQI at Week 16.
For Part 2 of the main study, PASI responses, IGA responses, PASI percent improvement, change from
baseline in CDLQI and FDLQI, the proportion of participants achieving a CDLQI of 0 or 1, and the
proportion of participants achieving a FDLQI of 0 or 1 will be summarized over time through Week 52.
USABILITY ASSESSMENTS
The usability of the
 will be assessed using a
.
PHARMACOKINETIC AND IMMUNOGENICITY EVALUATIONS
Venous blood samples will be collected for the measurement of serum guselkumab concentrations and
detection of antibodies to guselkumab at the time points presented in the Schedule of Activities. Serum
samples will also be collected at the final visit from participants who terminate study participation early.
CCI
CCI

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SAFETY EVALUATIONS
Safety evaluations include assessments of the following: adverse events (AEs, including injection site and
allergic reactions), clinical laboratory tests (hematology, chemistry, liver function, and pregnancy testing),
physical examinations, vital sign measurements, concomitant medication review, Columbia-Suicide
Severity Rating Scale (C-SSRS) questionnaires, and early detection of tuberculosis.
STATISTICAL METHODS
Sample Size Determination
In Part 1 of the main study, a minimum of 90 participants, including at least 60 in Part 1a, randomized in a
2:1:1 ratio, and at least 30 in Part 1b, randomized in a 1:1:1 ratio to guselkumab (n=40), placebo (n=25),
and etanercept (n=25) will have at least 99% power to detect differences for each co-primary endpoint for
the guselkumab versus placebo comparison at a significance level of 0.05. This sample size was also chosen
to provide adequate power for the major secondary endpoint comparisons between the guselkumab and
placebo groups. The number of participants enrolled in Part 2 will be at least 10, and depend on the number
of participants actually exposed to guselkumab in Part 1, so that a total of at least 100 participants from
Part 1 and Part 2 will be exposed to guselkumab.
Efficacy Analyses
All randomized participants will be included in the efficacy analyses for Part 1. Participants will be analyzed
according to the treatment group to which they were randomized, regardless of the treatment they actually
received.
The binary endpoints will be compared between the guselkumab group or the active comparator and the
placebo group using a Fisher’s exact test, stratified by age and region. Continuous response parameters will
be compared using a Mixed effect Model Repeat Measurement (MMRM) approach, or an analysis of
covariance (ANOVA) model, adjusting for baseline value, age group, and region. All statistical testing will
be performed 2 sided at a significance level of 0.05. In order to control the overall Type 1 error rate, the
primary analysis and major secondary analyses will be tested in a fixed sequence for the comparison
between the guselkumab and placebo groups. That is, the first major secondary endpoint will be tested only
if both co-primary endpoints are positive. Similarly, the second major secondary endpoint will be tested
only if the first major secondary endpoint is positive. In addition, the comparison between etanercept and
placebo for the co-primary and major secondary endpoints will be performed and nominal p-values will be
reported.
Analyses for other efficacy endpoints will be performed and nominal p-values will be provided.
In addition, efficacy will be summarized over time through Week 52 for participants in Part 2 of the study.
Usability Analyses
Endpoints related to usability of the
will be summarized for participants or their caregivers who
self-administer guselkumab in Part 2 of the study.
Safety Analyses
Safety data, including but not limited to, AEs, SAEs, infections, serious infections, changes in laboratory
assessments, changes in vital signs, and suicidal ideation and behavior based on C-SSRS and AEs will be
summarized. Treatment emergent AEs will be summarized by treatment group and Medical Dictionary for
Regulatory Activities (MedDRA) system organ class and preferred terms.
CCI

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1.2. 
Schema
Figure 1: 
Schematic Overview of the Study

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Footnotes:
a. 
The screening visit should occur within approximately 10 weeks before the Week 0 visit.
b. 
Participants randomized to guselkumab or placebo who are PASI 90 responders at Week 16 will be withdrawn from treatment. Upon loss of ≥50% of the
improvement in PASI achieved at Week 16, these participants will initiate guselkumab, followed by a second dose 4 weeks later followed by q8w administration
through Week 52.
c. 
A participant who discontinues study intervention but does not terminate study participation will continue to return for protocol-specified procedures and
evaluations for at least 12 weeks following the last dose of study intervention (see Section 7.1) and complete all procedures and evaluations listed under the Study
Termination Visit at the final visit. If a participant discontinues study intervention and terminates study participation, the procedures and evaluations for the Study
Termination Visit should be performed at the last visit (Section 7.2).
d. 
Participants who choose not to continue in the long-term extension of this study will not receive any administration of study intervention at Week 52 and will be
asked to return for a study termination visit 12 weeks after their last administration of study intervention.
e. 
All study procedures and evaluations are to be completed before study intervention administration.
f. 
Must be signed before first study-related activity.
g. 
Participants randomized to guselkumab who are PASI 90 nonresponders at Week 16 will receive a placebo injection at Week 16 to maintain the blind and continue
guselkumab q8w dose regimen from Week 20 through Week 52.
h. 
Participants randomized to placebo who are PASI 90 nonresponders at Week 16 will initiate guselkumab at Week 16 and Week 20 followed by q8w administration
through Week 52.
i. 
Participants randomized to etanercept will receive an etanercept dose weekly from Week 0 through Week 15. Participants will have the option of returning to the
study site weekly for dose administration or the option to self-administer at home for the weeks when no regular site visit is scheduled (ie, Weeks 1, 2, 3, 5, 6, 7, 9,
10, 11, 13, 14, and 15). Participants who decide to administer etanercept at home will record study drug administration information on a paper questionnaire.
Participants randomized to etanercept will then have the option to initiate a weight-based guselkumab dose regimen with injections at Week 20 and 24 followed by
q8w administration through Week 48 or terminate study participation after a study termination visit at Week 28.
j. 
PASI 90 responders withdrawn from treatment at Week 16 who have not met loss of response criteria prior to Week 52 and are continuing into the long-term
extension of the study will receive guselkumab at Week 52 followed by q8w administration beginning at Week 60 in the long-term extension. Participants
withdrawn from treatment at Week 16 who met loss of response criteria prior to Week 48 and received a guselkumab dose at Week 48 and continue into the
long-term extension will receive their next administration of guselkumab at Week 60 followed by q8w thereafter. Participants who meet loss of response criteria at
Week 48 will receive a weight-based dose of guselkumab at Week 48 followed by a dose at Week 52 and q8w administration starting at Week 60.
k. 
Vital signs include heart rate, blood pressure, and temperature.
l. 
Girls of childbearing potential must have a negative urine pregnancy test before randomization and at all study visits through Week 16. After Week 16 a negative
urine pregnancy test is required at all visits at which study intervention is to be administered.
m. Head circumference will be measured for participants ≥6 to <12 years of age
n. 
Pain experienced with each placebo or guselkumab injection will be assessed at each study visit at which an injection is administered. Pain will be assessed using
the Faces Pain Scale-Revised for injection pain in children ≥6 to <12 years of age (Appendix 17 [Section 10.17]), and the linear Injection Pain Visual Analog Scale
for adolescents ≥12 to <18 years of age (Appendix 18 [Section 10.18]).
o. 
The C-SSRS should be completed as the first assessment at screening after signing informed consent and at all post-baseline visits after the CDLQI assessment and
before any other tests, procedures, or other consultations to prevent influencing participant perceptions (Section 8.2.4). There are 4 versions of the C-SSRS;
a Baseline version to be completed at screening by children ≥6 to <12 years of age (Appendix 13 [Section 10.13]), a Baseline/Screening version to be completed
by adolescents ≥12 years of age (Appendix 14 [Section 10.14]), a Children’s Since Last Visit version to be completed at all other visits (Appendix 15
[Section 10.15]), and a Since Last Visit version for adolescents (Appendix 16 [Section 10.16]).
p. 
PASI, IGA, and BSA to be performed by a blinded efficacy evaluator until the Week 16 database lock is completed for all participants in Part 1 of the study.

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q. 
Performed prior to any tests, procedures, or other consultations (PASI, IGA, BSA) for that visit.
r. 
The FDLQI should be completed by a participant’s primary caregiver.
s. 
A tuberculin skin test is additionally required if the QuantiFERON-TB test is not approved/registered in the country in which this study is being conducted.
t. 
Titers for measles, mumps, rubella, and varicella only required if adequate documentation of complete vaccination schedule or healthcare provider verification of
previous infection is unavailable.
u. 
Serum IgG, IgM, and IgA sample should not be collected at study termination visit if a sample was collected at Week 52.
v. 
Laboratory tests are listed in Section 8.2.3 and Appendix 11 (Section 10.11).
w. Includes liver function testing described in Section 8.2.3. A description of the required approach for evaluation of specific LFT abnormalities is in Appendix 12
(Section 10.12).
x. 
Not required if participant is randomized within 4 weeks of blood draws for chemistry and hematology at screening.
y. 
All blood samples must be collected before study intervention administration at visits when a study intervention administration is scheduled. Details will be
provided in the Laboratory Manual.
z. 
Participants randomized to etanercept will not require a blood draw for pharmacokinetics and/or immunogenicity assessments at these visits.

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i. 
Vital signs include heart rate, blood pressure, and temperature.
j. 
Girls of childbearing potential must have a negative urine pregnancy test before randomization and at all study visits at which study intervention is to be
administered.
k. 
Weight should be measured at all study visits at which study intervention is to be administered.
l. 
Head circumference will be measured for participants ≥6 to <12 years of age
m. Pain experienced with each placebo or guselkumab injection will be assessed at each study visit at which an injection is administered. Pain will be assessed using
the Faces Pain Scale-Revised for injection pain in children ≥6 to <12 years of age (Appendix 17 [Section 10.17]), and the linear Injection Pain Visual Analog Scale
for adolescents ≥12- to <18 years of age (Appendix 18 [Section 10.18]).
n. 
The C-SSRS should be completed as the first assessment at screening after signing informed consent and at all post-baseline visits after the CDLQI assessment and
before any other tests, procedures, or other consultations to prevent influencing participant perceptions Section 8.2.4). There are 4 versions of the C-SSRS;
a Baseline version to be completed at screening by children ≥6 to <12 years of age (Appendix 13 [Section 10.13]), a Baseline/Screening version to be completed
by adolescents ≥12 years of age (Appendix 14 [Section 10.14]), a Children’s Since Last Visit version to be completed at all other visits (Appendix 15
[Section 10.15]) and a Since Last Visit version for adolescents (Appendix 16 [Section 10.16]).
o. 
PASI, IGA, and BSA to be performed by a blinded efficacy evaluator for all participants until completion of the Week 16 database lock for all participants in
Part 1 of the study.
p. 
Performed prior to any tests, procedures, or other consultations (PASI, IGA, BSA) for that visit.
q. 
The FDLQI should be completed by a participant’s primary caregiver.
r. 
A tuberculin skin test is additionally required if the QuantiFERON-TB test is not approved/registered in the country in which this study is being conducted.
s. 
Titers for measles, mumps, rubella, and varicella only required if adequate documentation of complete vaccination schedule or healthcare provider verification of
previous infection is unavailable.
t. 
Serum IgG, IgM, and IgA sample should not be collected at study termination visit if a sample was collected at Week 52.
u. 
Laboratory tests are listed in Section 8.2.3 and Appendix 11 (Section 10.11).
v. 
Includes liver function testing described in Section 8.2.3. A description of the required approach for evaluation of specific LFT abnormalities is in Appendix 12
(Section 10.2).
w. Not required if participant is randomized within 4 weeks of blood draws for chemistry and hematology at screening.
x. 
All blood samples must be collected before study intervention administration at visits when a study intervention administration is scheduled. Details will be
provided in the Laboratory Manual.

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k. 
Includes liver function testing described in Section 8.2.3. A description of the required approach for evaluation
of specific LFT abnormalities is in Appendix 12 (Section 10.12).

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2. 
INTRODUCTION
Guselkumab (CNTO 1959) is a fully human immunoglobulin (Ig) G1 lambda (G1λ) monoclonal
antibody (mAb) that binds to human interleukin (IL)-23 with high specificity and affinity. The
binding of guselkumab to IL-23 blocks the binding of extracellular IL-23 to the cell surface IL-23
receptor, inhibiting IL-23-specific intracellular signaling and subsequent activation and cytokine
production. In this manner, guselkumab inhibits the biological activity of IL-23 in all in vitro
assays examined.
Guselkumab has been approved in the United States of America (USA), the European Union (EU)
and Canada for the treatment of adult patients with moderate to severe plaque and Marketing
Authorization Applications (MAA) are currently under review in other regions. Data supporting
the approval of the plaque psoriasis indication in adults included safety and efficacy data from
2,700 participants from 3 global Phase 3 studies (CNTO1959PSO3001 [VOYAGE 1],
CNTO1959PSO3002 [VOYAGE 2], and CNTO1959PSO3003 [NAVIGATE]). Studies
CNTO1959PSO3001 and CNTO1959PSO3002 have ongoing long-term extensions (LTE).
The approved dosage in the adult plaque psoriasis indication is 100 mg administered by SC
injection at Week 0, Week 4, and every 8 weeks (q8w) thereafter. Guselkumab is not currently
approved for use in pediatric patients in any country.
For the most comprehensive nonclinical and clinical information regarding guselkumab, refer to
the latest version of the Investigator's Brochure (IB) for guselkumab.
The term "sponsor" used throughout this document refers to the entities listed in the Contact
Information page(s), which will be provided as a separate document.
2.1. 
Study Rationale
This study will evaluate the efficacy and safety of guselkumab for the treatment of chronic plaque
psoriasis in pediatric participants aged ≥6 through <18 years using a placebo control and an active
comparator (ENBREL® [etanercept]) through Week 16 by means of:
comparison of guselkumab to placebo to establish the efficacy of guselkumab.
utilization of etanercept as a benchmark for efficacy.
collection  of safety and tolerability data for guselkumab in the pediatric plaque psoriasis
population.
This study will also provide an evaluation of safety and the ability to recapture response with
retreatment following withdrawal from guselkumab.
In addition, the pharmacokinetics (PK) of guselkumab will be evaluated in this study to determine
whether the proposed weight-based dose in children with plaque psoriasis achieves PK exposure
comparable to that established in adults with the approved dose regimen. Furthermore, evaluations
will be done to assess whether, with comparable exposure, the observed clinical response in
pediatric participants treated with guselkumab is consistent with that observed in adults.

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2.2. 
Background
Plaque psoriasis is a chronic, immunologically-mediated, inflammatory skin disease of unknown
etiology affecting 2% to 4% of the general population.14,17,22,24,26,28 The pathogenesis of plaque
psoriasis involves environmental factors and immune dysregulation in genetically-predisposed
individuals.10,19 Substantial evidence indicates that IL-23 plays an important role in innate and
adaptive immune responses, and may play a pivotal role in the pathogenesis of psoriasis
vulgaris.1,15,34
Adult and pediatric plaque psoriasis share similar clinical manifestations, histological features,
genetic factors, and treatment options.6 Taken together, the data demonstrate that a complex
network of immune mediators (cells and cytokines) drive the inflammatory skin processes of
plaque psoriasis in adults and children.
Plaque psoriasis is characterized by symmetrically distributed, well-defined, sharply demarcated,
indurated, erythematous plaques that are covered by friable, dry, white-silvery scale and is reported
to account for up to 84% of psoriasis in pediatric patients.5,21,29 Areas of the body that are
frequently involved include the scalp, elbows, knees, buttocks, and genitalia. Definitions of plaque
psoriasis severity differ depending on the source, but are generally related to the extent of the body
surface involved, although the extent of exposed skin involved is also often considered.
Studies addressing the age of onset of psoriasis have suggested that 2 subgroups exist: early onset
disease (before 30 years of age, including pediatric onset) and late onset disease (after age 30).8
Generally, the clinical manifestations of plaque psoriasis in patients with pediatric onset and those
with adult or late onset disease are similar, and not clinically distinguishable.21,29 Therefore, the
consensus of the literature is essentially that plaque psoriasis is a life-long chronic disease with a
variable age of onset, and that pediatric plaque psoriasis is probably most accurately characterized
as early onset disease rather than as an entity distinct from adult plaque psoriasis.
The traditional paradigm for the treatment of plaque psoriasis follows a stepwise approach to
treatment starting with topical agents, followed by phototherapy, and then systemic agents.5,7
Recently, several biologic psoriasis treatments have been approved for use in patients with
pediatric plaque psoriasis. Currently, etanercept (ENBREL®), adalimumab (HUMIRA®) and
ustekinumab (STELARA®) are approved for various pediatric age groups in some jurisdictions.
Among these biologics, etanercept is currently approved in a broad pediatric age range and the
largest number of geographic regions.
Although stepwise therapy is mentioned frequently in the literature, the optimal treatment
approach for pediatric patients with chronic plaque psoriasis is far less clear than for adults due to
the practical scheduling issues of phototherapy in school aged children, the known, often
cumulative, toxicities of traditional systemic therapies and the paucity of rigorous clinical data or
approved therapeutic options for this age group. For these reasons, a proportion of pediatric
patients with plaque psoriasis are currently undertreated, and could benefit from additional safe,
effective, and convenient therapies. Based on currently available data, guselkumab could offer
efficacy, safety and convenience advantages compared with available therapies.

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2.2.1. 
Clinical Studies
The clinical development program to support use of guselkumab in the treatment of moderate to
severe plaque-type psoriasis included two Phase 1 studies (CNTO1959PSO1001,
CNTO1959PSO1002), one Phase 2 study (CNTO1959PSO2001), and three Phase 3 global studies
(CNTO1959PSO3001, CNTO1959PSO3002, and CNTO1959PSO3003). The two Phase 1 studies
and the Phase 2 study have been completed and formed the basis to proceed to Phase 3. Details
about these 3 individual studies are provided in the IB. The Phase 3 studies CNTO1959PSO3001
and CNTO1959PSO3002 were both conducted using placebo and an active comparator,
adalimumab (HUMIRA®). In these studies, guselkumab demonstrated superior efficacy to both
placebo and adalimumab. Results for studies CNTO1959PSO3001 and CNTO1959PSO3002 are
most relevant to the design of the pediatric studies and are presented below. Study
CNTO1959PSO3003 evaluated efficacy and safety in participants who were inadequate
responders to 16 weeks of treatment with ustekinumab and results for this study are presented in
the guselkumab IB.
Phase 3 Study (CNTO1959PSO3001, VOYAGE 1)
Study CNTO1959PSO3001 (VOYAGE 1) is a multicenter, Phase 3, randomized, double-blind,
placebo- and active-comparator-controlled study in participants with moderate to severe
plaque-type psoriasis with 3 parallel treatment groups: placebo, guselkumab 100 mg, and
adalimumab. In this study, 837 adult participants were randomized to receive guselkumab (n=329)
or adalimumab (n=334) or placebo (n=174). Participants in the placebo group crossed over to
guselkumab 100 mg beginning at Week 16.
At Week 16, a significantly greater proportion of participants randomized to guselkumab achieved
the co-primary endpoints of an Investigator’s Global Assessment (IGA) score of cleared (0) or
minimal (1) and Psoriasis Area and Severity Index (PASI) 90 response (85.1% and 73.3%,
respectively; p<0.001 for both endpoints) compared with placebo (6.9% and 2.9%, respectively).
At Week 24, a significantly higher proportion of participants achieved an IGA score of cleared (0),
an IGA score of cleared (0) or minimal (1), and a PASI 90 response in the guselkumab group than
in the adalimumab group. Similar to the observations at Week 24, a significantly higher proportion
of participants achieved an IGA score of cleared (0), an IGA score of cleared (0) or minimal (1),
and a PASI 90 response in the guselkumab group than in the adalimumab group at Week 48.
Treatment with guselkumab was well-tolerated through Week 48. The frequency of adverse events
(AE) was comparable between the guselkumab, placebo, and adalimumab groups through
Week 16 and between the guselkumab and adalimumab groups through Week 48. The most
common AEs were nasopharyngitis and upper respiratory tract infection. Through Week 16, the
percentage of participants with 1 or more serious adverse events (SAEs) was 1.7% (n=3) in the
placebo group, 2.4% (n=8) in the guselkumab group and 1.8% (n=6) in the adalimumab group,
and was comparable between the guselkumab (4.9% [n=16]) and adalimumab (4.5% [n=15])
groups through Week 48. The incidence of infections was comparable between placebo,
guselkumab and adalimumab groups through Week 16, and between the guselkumab group
(52.3%) and the adalimumab group (50.2%) through Week 48. No opportunistic infections or
active tuberculosis (TB) were reported. No anaphylactic or serum sickness-like reactions were

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reported in the guselkumab group, and the incidence of injection site reactions was lower in the
guselkumab group than the adalimumab group.
Phase 3 Study (CNTO1959PSO3002, VOYAGE 2)
Study CNTO1959PSO3002 (VOYAGE 2) is a multicenter, Phase 3, randomized, double-blind,
placebo- and active-comparator-controlled study in participants with moderate to severe
plaque-type psoriasis with 3 treatment groups: placebo, guselkumab 100 mg, and adalimumab. In
this study, 992 adult participants were randomized to either the placebo (n=248), guselkumab
(n=496), or adalimumab (n=248) treatment groups at Week 0. Participants in the placebo group
crossed over to guselkumab 100 mg beginning at Week 16. This study evaluated the benefit of
maintenance therapy using a randomized withdrawal design starting at Week 28.
At Week 16, a significantly greater proportion of participants randomized to guselkumab achieved
the co-primary endpoints of an IGA score of cleared (0) or minimal (1) and a PASI 90 response
(84.1% and 70.0%, respectively; p<0.001 for both endpoints) compared with placebo (8.5% and
2.4%, respectively). In addition, a significantly greater proportion of participants achieved an IGA
score of cleared (0), an IGA score of cleared (0) or minimal (1), and a PASI 90 response in the
guselkumab group than in the adalimumab group at Week 24.
Treatment with guselkumab was well tolerated. Through Week 16, the proportion of participants
experiencing 1 or more AEs was comparable between treatment groups. Nasopharyngitis and
upper respiratory tract infection were the most common AEs. The percentage of participants with
1 or more SAEs was comparable between the placebo and guselkumab groups, and slightly higher
in the adalimumab group. The incidence of infections was comparable between placebo,
guselkumab, and adalimumab groups through Week 16. Through Week 28, the proportion of
participants experiencing 1 or more AEs was comparable between the guselkumab and
adalimumab groups. Two adalimumab-treated participants reported active TB. No opportunistic
infections were reported. No anaphylactic or serum sickness-like reactions were reported and the
incidence of injection site reactions was lower in the guselkumab group  than the adalimumab
group.
2.2.2. 
Comparator
ENBREL® (etanercept)
Etanercept (ENBREL®) is a dimeric fusion protein genetically engineered by fusing the
extracellular ligand binding domain of human tumor necrosis factor (TNF) receptor-2
(TNFR2/p75) to the Fc domain of the human immunoglobulin G1 (IgG1). Etanercept binds
specifically to TNF and blocks its interaction with cell surface TNF receptors.
Etanercept was selected as the active comparator because it has demonstrated efficacy in pediatric
patients with moderate to severe plaque psoriasis and serves as a useful efficacy benchmark.25
Etanercept has been approved for treatment of moderate to severe plaque psoriasis in the pediatric
population in the United States of America, and severe plaque psoriasis in Canada, the European
Union, and the Asia-Pacific region. Pediatric participants randomized to etanercept will receive a

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weekly dose of 0.8 mg/kg body weight (up to a maximum of 50 mg/dose) administered
subcutaneously as per the approved label.
For further information regarding etanercept, refer to the product labeling applicable to the local
country in which the study is being conducted.
2.3. 
Benefit/Risk Assessment
2.3.1. 
Guselkumab
A large global Phase 3 program consisting of 3 studies (CNT1959PSO3001, CNTO1959PSO3002,
and CNTO1959PSO3003) has been conducted to investigate the efficacy and safety of SC
guselkumab in participants with moderate to severe plaque psoriasis (Section 2.2), and the
longer-term efficacy and safety of guselkumab is being assessed in 4-year extensions of studies
CNTO1959PSO3001 and CNTO1959PSO3002 (ie, both studies will have an overall study
duration of 5 years).
The data through Week 48 from these studies demonstrate high levels of efficacy for guselkumab
100 mg administered SC at Weeks 0, 4, and q8w thereafter. Guselkumab treatment led to an onset
of clinical responses as early as 2 weeks after initiating treatment. Significant improvements were
observed within 16 weeks of treatment that were maintained through 1 year, as assessed by IGA
scores, PASI response, regional measures of psoriasis and patient-reported outcome (PRO)
measures such as the DLQI and Psoriasis Symptom and Sign Diary (PSSD). Benefits were
demonstrated across all subpopulations representing the full spectrum of moderate to severe plaque
psoriasis.
Guselkumab was well-tolerated. Rates of AEs, SAEs, and discontinuations due to AEs, among
participants who received guselkumab were comparable to those reported for the placebo group
through Week 16, or for the adalimumab group through 48 weeks of treatment. Events identified
as possible adverse drug reactions (IB, Section 5) were generally mild, nonserious events that did
not require treatment discontinuation. Rates of serious infections, MACE, malignancies, and SIB
were low, not demonstrably different between treatment groups, and appeared to be generally
consistent with rates expected in the psoriasis population. The rate of development of antibodies
to guselkumab was low and did not appear to impact response rates or the frequency of
injection-site reactions. Overall, the safety profile for guselkumab was similar to that for placebo
through 16 weeks of treatment and comparable with adalimumab through 48 weeks of treatment.
In conclusion, the Phase 3 psoriasis data in adults demonstrate a favorable benefit:risk profile for
guselkumab when administered subcutaneously as a 100 mg dose at Weeks 0, 4, and q8w thereafter
in participants with moderate to severe plaque psoriasis who are candidates for systemic therapy,
and support evaluation of guselkumab in pediatric patients with chronic plaque psoriasis.
More detailed information about the known and expected benefits and risks of guselkumab can be
found in the guselkumab IB.

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2.3.2. 
Etanercept
The benefit:risk profile of etanercept in pediatric participants as young as 4 years of age was
established in a Phase 3 study,25 which was the basis of global approvals for etanercept in the
treatment of psoriasis in the pediatric population. More detailed information about the known and
expected benefits and risks of etanercept can be found in the etanercept product labeling.
3. 
OBJECTIVES AND ENDPOINTS
OBJECTIVES
Primary Objective
The primary objective of this study is to evaluate the efficacy and safety of guselkumab in pediatric
participants aged ≥6 through <18 years with chronic plaque psoriasis.
Secondary Objectives
The secondary objectives of this study are:
To evaluate the PK and immunogenicity of guselkumab in pediatric participants aged ≥6
through <18 years with chronic plaque psoriasis.
To evaluate the effect of guselkumab on the dermatologic health-related quality of life in
pediatric participants aged ≥6 through <18 years with chronic plaque psoriasis.
To evaluate maintenance of response in participants who have active treatment withdrawn.
To evaluate the efficacy and safety of retreatment with guselkumab.
To generate clinical usability data and use experience with the
in pediatric participants with chronic plaque psoriasis and a body weight <70 kg.
ENDPOINTS
The co-primary and major secondary endpoints for Part 1 of the study, with the primary
comparisons between the guselkumab and placebo groups, include:
Co-primary Endpoints
The proportion  of participants achieving an IGA score of cleared (0) or minimal (1) at
Week 16.
The proportion of participants with a PASI 75 response at Week 16.
Major Secondary Endpoints
The proportion of participants achieving a PASI 90 response at Week 16.
The proportion of participants achieving an IGA score of cleared (0) at Week 16.
The proportion of participants achieving a PASI 100 response at Week 16.
The change from baseline in CDLQI at Week 16.
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Other Secondary Endpoints
Secondary endpoints for Part 1 of the study include:
The proportion of retreated participants that achieve a PASI 90 response over time after
retreatment.
The proportion of retreated participants that achieve PASI responses (PASI 50, 75, 90, and
100) or IGA responses (IGA of cleared [0], minimal [1], or mild [2], IGA of cleared [0] or
minimal [1], and IGA of cleared [0]) over time after retreatment.
The time to loss of 50% of the Week 16 PASI improvement (ie, time to retreatment) after
withdrawal.
The time to loss of PASI 90 response after withdrawal.
The proportion of participants achieving a PASI 50 response at Week 16.
The proportion of participants who achieve an IGA score of mild or better (≤2) at Week 16.
The percent improvement from baseline in PASI over time through Week 16.
The proportion of PASI responses (PASI 50, 75, 90, and 100) over time through Week 16.
The proportion of IGA responses (IGA of cleared [0], minimal [1], or mild [2], IGA of cleared
[0] or minimal [1], and IGA of cleared [0]) over time through Week 16.
The proportion of participants with CDLQI=0 or 1 at Week 16 among randomized participants
with a baseline CDLQI>1
The proportion of participants with Family Dermatology Life Quality Index (FDLQI)=0 or 1
at Week 16 among randomized participants with a baseline FDLQI>1
The change from baseline in FDLQI at Week 16.
For Part 2 of the study, PASI responses, IGA responses, PASI percent improvement, change from
baseline in CDLQI and FDLQI, the proportion of participants achieving a CDLQI of 0 or 1, and
the proportion of participants achieving a FDLQI of 0 or 1 will be summarized over time through
Week 52.
In addition, efficacy in the LTE period for participants who continue in the LTE of the study will
be summarized.
Refer to Section 8, Study Assessments and Procedures for evaluations related to endpoints.
HYPOTHESIS
The primary hypothesis is that guselkumab treatment is superior to placebo as assessed by the
proportion of participants achieving an IGA score of cleared (0) or minimal (1) and the proportion
of participants achieving a PASI 75 response at Week 16.
The major secondary hypotheses are that guselkumab treatment is:
superiorto placebo as assessed by the proportion of participants achieving a PASI 90 response
at Week 16.

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superior to placebo as assessed by the proportion of participants achieving an IGA score of
cleared (0) at Week 16.
superior to placebo as assessed by the proportion of participants achieving a PASI 100
response at Week 16.
superior to placebo in improving the dermatologic health-related quality of life in pediatric
participants as assessed by the change from baseline in CDLQI at Week 16.
4. 
STUDY DESIGN
4.1. 
Overall Design
This is a Phase 3, multicenter, randomized, placebo- and active comparator-controlled study
evaluating the efficacy, safety, and PK of subcutaneously administered guselkumab for the
treatment of chronic plaque psoriasis in pediatric participants ≥6 to <18 years of age. The
participant population will be comprised of boys and girls who have had a diagnosis of chronic
plaque-type psoriasis, defined as having an IGA ≥3, a PASI ≥12, a ≥10% BSA involvement, and
at least one of the following: very thick lesions, clinically relevant facial, genital, or hand/ foot
involvement, PASI≥20, >20% BSA involvement, or IGA=4. Participants must also be a candidate
for phototherapy or systemic treatment of plaque psoriasis and have plaque psoriasis considered
by the investigator as inadequately controlled with phototherapy and/or topical therapy after an
adequate dose and duration of therapy.
The main study will be conducted in 2 parts. In Part 1, the efficacy, safety, and PK of guselkumab
will be evaluated in pediatric participants during a 16-week randomized, placebo- and active
comparator-controlled period followed by an uncontrolled period of withdrawal and retreatment
or initiation of treatment with guselkumab through Week 52.
Part 1 of the study will be divided into Part 1a (≥12 to <18 years of age [ie, adolescents]) and
Part 1b (≥6 to <12 years of age) and enroll a minimum of 90 participants. Part 1a will enroll at
least 60 participants randomized in a 2:1:1 ratio to guselkumab (n=30), placebo (n=15), and
etanercept (n=15). Part 1b will enroll at least 30 participants randomized in a 1:1:1 ratio to
guselkumab (n=10), placebo (n=10), and etanercept (n=10). Enrollment of participants ≥6 to
<12 years of age in Part 1b will commence only after:
1) All participants ≥12 to <18 years of age in Part 1a will have completed Week 16, and all
available safety data have been reviewed by an independent Data Monitoring Committee
(DMC), with no important safety concerns identified.
2) All available guselkumab PK data for the ≥12 to <18-year-old participants through
Week 16 have been evaluated to determine if the body weight-based dose used in Part 1a
has provided systemic exposure comparable to adults, or whether a revised body
weight-based dose should be instituted in Part 1b.
Participants randomized to guselkumab or placebo will receive a weight-based dose of study
intervention  at Weeks 0, 4, and 12. Participants randomized to etanercept will receive a
weight-based etanercept dose up to 50 mg SC weekly through Week 15. Participants randomized

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to etanercept will be given the option to self-administer or have their caregiver administer at home
or have the study intervention administered at the study site.
At Week 16:
Participants initially randomized to guselkumab will be treated as follows:
PASI 90 responders at Week 16 will not receive any additional doses of guselkumab until
they lose ≥50% of their Week 16 PASI response, at which time they will be retreated with
guselkumab followed by a dose 4 weeks later, and then guselkumab q8w thereafter
through Week 52.
PASI 90 nonresponders at Week 16 will receive a placebo injection at Week 16 to
maintain the blind and continue treatment with guselkumab q8w from Week 20 through
Week 52.
Participants initially randomized to placebo will be treated as follows:
PASI 90 responders at Week 16 will not receive any additional doses of study intervention
until they lose ≥50% of their Week 16 PASI response, at which time they will initiate
treatment with guselkumab SC followed by a dose 4 weeks later, and q8w thereafter
through Week 52.
PASI 90 nonresponders will initiate treatment with guselkumab at Weeks 16 and 20, and
q8w thereafter through Week 52.
Participants initially randomized to etanercept will receive their last administration of
etanercept at Week 15. Irrespective of PASI response at Week 16, participants or their legally
acceptable representative will be given the option, in consultation with the investigator, to
initiate treatment with guselkumab at Week 20 followed by a dose 4 weeks later, and then
q8w thereafter through Week 48, or discontinue from study intervention administration. This
option allows for participants receiving etanercept who have not attained an adequate level of
efficacy or have poor tolerance for weekly injections to switch to guselkumab.
Part 2 of the main study will be an open-label, single-arm study to collect additional efficacy,
safety, and PK data for pediatric participants with a continuous weight-based dose regimen of
guselkumab at Weeks 0, 4, and q8w thereafter through Week 52. Participants ≥12 to <18 years of
age will begin enrollment in Part 2 after the reviews of safety and PK data through Week 16 for
all participants ≥12 to <18 years of age in Part 1a have been completed, and an appropriate body
weight-based dose that matches adult exposure has been confirmed, or a revised body
weight-based dose has been determined. Enrollment of participants ≥6 to <12 years of age into
Part 2 will not occur until all participants in Part 1b have completed 16 weeks of treatment and all
efficacy data through Week 16 from Part 1 have been evaluated by the sponsor, and all available
safety data have been reviewed by an independent DMC. Part 2 will enroll enough additional
participants to achieve a total of at least 100 participants exposed to guselkumab (ie, at least
10 participants in Part 2, with the total number dependent on the number of participants
randomized in Part 1 who are exposed to guselkumab).
In Part 2 of the main study, participants will be given the option to self-administer or have their
caregiver administer study injections at the study site using the appropriate presentation (either a

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prefilled syringe (PFS) assembled with the UltraSafe Plus™Passive Needle Guard (PFS-U) device,
designed to deliver a single, fixed dose of
 Participants must be at least 12 years of age to self-administer study injections.
Participants or their caregivers will be trained on proper use of the device(s) and deemed capable,
as determined by study staff. Otherwise injections will continue to be performed by study staff.
All participants who complete either Part 1 or Part 2 of the main study through Week 52 will be
offered the opportunity to participate in an open-label LTE. Participants will be required to return
to the study site every 8 weeks for safety and efficacy assessments in addition to study intervention
administration. Additional details on the LTE can be found in Section 8.
Efficacy assessments (IGA, PASI, BSA, CDLQI, and FDLQI) will be performed according to the
Schedules of Activities. Serum samples for PK and immunogenicity analyses will be collected at
the timepoints shown in the Schedules of Activities.
Rescue Treatment
In Part 1 of the study, participants with a PASI score increase of ≥50% from their baseline PASI
score at Week 8 or Week 12 will be allowed to use a topical steroid as rescue treatment, with the
exception of ultra-high potency topical steroids (eg, clobetasol propionate, halobetasol propionate)
which are not allowed at any time. It is recommended that participants use no more than 60 grams
of topical steroids per week. In addition, participants should be managed using the lowest possible
potency and frequency of rescue topical steroid. Participants must discontinue the use of rescue
topical steroids by Week 20 (should not initiate rescue topical steroids at or after Week 16).
Safety and tolerability will be assessed by monitoring AEs, SAEs, clinical laboratory tests, vital
signs, physical examinations, growth, development and sexual maturity, concomitant medication
review, injection site evaluations, collection of Columbia-Suicide Severity Rating Scale (C-SSRS)
data, measurement of serum immunoglobulins, observations for allergic reactions,
immunogenicity, and assessments for early detection of TB.
An independent DMC  will be commissioned for this study. Refer to Committees Structure in
Appendix 2 (Section 10.2), Regulatory, Ethical, and Study Oversight Considerations for details.
An interim analysis of the PK data will occur when all participants in Part 1a of the study complete
their Week 16 visit (Section 9.5, Interim Analysis). All available guselkumab PK data for
participants ≥12 to <18 years of age through Week 16 will be evaluated via modeling and
simulation, to determine if the body weight-based dose used in Part 1a provided exposure
comparable with the exposure observed in adults, or whether a revised body weight-based dose
should be instituted in Part 1b and Part 2 of the study.
There are 3 database locks (DBL) planned for this study at Week 16, Week 52 (end of the main
study), and at the end of the study. The Week 16 DBL will occur after all participants in Part 1 of
the study complete their Week 16 visit and will include only data from Part 1. The sponsor will be
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unblinded for Part 1 after the Week 16 DBL for Part 1 has occurred. The Week 52 DBL will occur
after all participants in both Part 1 and Part 2 of the study complete their Week 52 visit. The
investigators, participants, and site monitors can be unblinded after the Week 52 DBL has occurred.
Additional database locks may be performed if deemed necessary.
The end of the main study is defined as the timepoint when the last participant completes the
Week 52 visit. The end of the complete study is defined as the timepoint when the last participant
completes the last follow-up visit after guselkumab receives regulatory approval for use in
pediatric patients or the sponsor discontinues development of guselkumab for the treatment of
plaque psoriasis in pediatric patients.
A diagram of the study design is provided in Section 1.2, Schema.
4.2. 
Scientific Rationale for Study Design
Blinding, Control, Study Phase/Periods, Intervention Groups
The screening phase of up to 10 weeks will allow for sufficient time to perform screening study
evaluations, determine study eligibility, and allows time for immunization of participants requiring
them for eligibility. A placebo control will be used to establish the frequency and magnitude of
changes in clinical endpoints that may occur in the absence of active treatment. In addition to
placebo control, an active control will be used to determine the sensitivity of the clinical endpoints
in this study. Randomization will be used to minimize bias in the assignment of participants to
treatment groups, to increase the likelihood that known and unknown participant attributes
(eg, demographic and baseline characteristics) are evenly balanced across treatment groups, and
to enhance the validity of statistical comparisons across treatment groups. In Part 1, treatment for
participants randomized to guselkumab or placebo will be blinded through Week 16  and since
etanercept will be open-label, a blinded efficacy evaluator will be used to reduce potential bias
during data collection and evaluation of clinical endpoints. Participants in Part 1 randomized to
guselkumab or placebo who are PASI 90 responders at Week 16 will be withdrawn from treatment.
Upon loss of ≥50% of the improvement in PASI achieved at Week 16, participants will receive
guselkumab SC, followed by a dose 4 weeks later, and then guselkumab q8w thereafter through
Week 52.
Open label treatment with guselkumab in Part 2 will continue through Week 52 (last guselkumab
injection at Week 44) and will provide adequate time to demonstrate the efficacy and safety of
guselkumab as maintenance therapy for pediatric plaque psoriasis.
Participants who continue with the LTE will receive a weight-based guselkumab SC dose q8w
until they have reached 18 years of age and reside in a country where guselkumab is approved for
treatment of plaque psoriasis in adults and have had the opportunity to complete up to 1 year in
the LTE, marketing authorization is obtained for guselkumab for treatment of plaque psoriasis for
patients ≥6 to <18 years of age, marketing authorization is denied for guselkumab for the treatment
of plaque psoriasis in pediatric patients, or the company decides to no longer pursue an indication
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Efficacy Evaluations
Efficacy evaluations chosen for this study are consistent with applicable EU and US regulatory
guidance and precedent established in previous studies of therapeutic agents for the treatment of
plaque psoriasis.
Patient-reported outcomes (PROs) chosen for this study are consistent with clinically relevant
measurements that have been described in the medical literature for other studies in  pediatric
plaque psoriasis. Health-related quality of life impairment in dermatologic diseases like plaque
psoriasis has been shown to be as, or even more, burdensome than other chronic diseases like
diabetes and asthma in the pediatric population.4 Skin disease in the pediatric population
specifically impacts physical, social, and emotional health with the potential for negatively
affecting school functioning.32 Effective treatment of plaque psoriasis may allow for
improvements in physical, social, emotional, and school functioning and overall health. Data
collected directly from the participant can best capture these concepts.
Psoriasis response evaluations include:
Investigator’s Global Assessment (IGA)
Psoriasis Area and Severity Index (PASI)
Percent of body surface area with psoriasis skin involvement (BSA)
Children’s Dermatology Life Quality Index (CDLQI)
Family Dermatology Life Quality Index (FDLQI)
To help improve objectivity, given the open-label active-comparator study design, clinical efficacy
assessments (IGA, PASI, and BSA) will be performed by blinded efficacy evaluators until all
participants in Part 1 of the study complete their Week 16 visit and the Week 16 database lock is
complete.
Pharmacokinetic Evaluations
To assess the PK of guselkumab in pediatric participants ≥6 and <18 years of age with plaque
psoriasis and to evaluate the similarity in exposure-response relationship between pediatric
participants and adult participants, serum samples will be collected at selected visits in this study.
Immunogenicity Evaluations
Serum samples for immunogenicity assessment will be collected at selected visits in this study.
Samples that test positive for antibodies to guselkumab will be further characterized to determine
if antibodies to guselkumab could neutralize the biological effects of guselkumab in vitro
(ie, neutralizing antibodies [NAbs] to guselkumab).
4.2.1. 
Study-Specific Ethical Design Considerations
Potential participants (and their caregivers) will be fully informed of the risks and requirements of
the study and, during the study, participants will be given any new information that may affect their
decision to continue participation. They will be told that their consent to participate in the study is

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voluntary and may be withdrawn at any time with no reason given and without penalty or loss of
benefits to which they would otherwise be entitled. Only participants who are fully able to
understand the risks, benefits, and potential adverse events of the study, and provide their consent
voluntarily will be enrolled.
When referring to the signing of the informed consent form (ICF), the terms legal guardian and
legally acceptable representative refer to the legally appointed guardian of the child with authority
to authorize participation in research. For each participant, his or her parent(s) (preferably both
parents, if available) or legally acceptable representative(s), as required by local regulations, must
give written consent (permission) according to local requirements after the nature of the study has
been fully explained and before the performance of any study-related assessments. Assent must be
obtained from children (minors) capable of understanding the nature of the study, typically
participants 7 years of age and older, depending on the institutional policies. For the purposes of this
study, all references to participants who have provided consent (and assent as applicable) refers to
the participants and his or her parent(s) or the participant's legal guardian(s) or legally acceptable
representative(s) who have provided consent according to this process. Minors who assent to a study
and later withdraw that assent should not be maintained in the study against their will, even if their
parent(s) still want them to participate.
The total blood volume to be collected is considered to be within the normal range allowed for the
pediatric population.
4.3. 
Justification for Dose
In the guselkumab Phase 3 studies CNTO1959PSO3001 and CNTO1959PSO3002 in adult
participants with moderate to severe plaque psoriasis, the dose and dosing regimen of guselkumab
 SC at Weeks 0, 4, and q8w thereafter, produced high levels of efficacy and a favorable
benefit:risk profile across the entire adult study population. In addition, an association between
systemic exposure to guselkumab and clinical responses (IGA and PASI) was observed. Since
adult and pediatric plaque psoriasis share similar clinical manifestations, histological features,
genetic factors, and treatment options, it is reasonable to assume that pediatric participants who
attain similar systemic exposure to guselkumab will likely exhibit similar clinical responses as
observed in the adult population. Therefore, the goal for selection of the dose and dosing regimen
in the proposed guselkumab pediatric plaque psoriasis study was to achieve exposure in the
pediatric population similar to the exposure attained in the adult plaque psoriasis study population.
. Therefore, dose selection for this pediatric
study was based on body weight only, typical for systemic therapeutic biologics administered in
pediatric patients.16,18,25
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Pharmacokinetic simulations were performed to select an appropriate dose for pediatric
participants that would achieve similar systemic exposure to guselkumab as seen in the adult
Phase 3 studies. The results from these simulations suggested that the dose regimen of guselkumab
 SC at Week 0, 4, and q8w thereafter, which has been approved for use in adults with
moderate to severe plaque psoriasis, would achieve a guselkumab exposure in pediatric
participants with body weight ≥70 kg similar to that achieved in adult participants. For pediatric
participants with a body weight <70 kg, several weight-based dose regimens (in mg/kg) were
simulated to identify the regimen that would achieve consistent guselkumab exposures across age
groups and weight ranges in the pediatric population. The results from these simulations suggested
that a dose regimen of guselkumab
 at Weeks 0, 4, and q8w thereafter in pediatric
participants weighing <70 kg would achieve an exposure comparable to that observed for adult
participants.
In summary, the proposed weight-based dose regimen selected for the Phase 3 plaque psoriasis
study in pediatric (≥6 to <18 years of age) participants is expected to achieve a guselkumab
exposure comparable to that established in the adult plaque psoriasis Phase 3 studies.
4.4. 
End of Study Definition
The end of study is considered as the last scheduled study assessment shown in the Schedule of
Activities for the last participant in the study. The final data from the study site will be sent to the
sponsor (or designee) after completion of the final participant assessment at that study site, in the
time frame specified in the Clinical Trial Agreement. The end of the complete study is defined as
the timepoint when the last participant completes the last follow-up visit after guselkumab receives
regulatory approval for use in pediatric patients or the sponsor discontinues development of
guselkumab for the treatment of plaque psoriasis in pediatric patients.
The end of the main study is defined as the timepoint when the last participant completes the
Week 52 visit.
5. 
STUDY POPULATION
Screening for eligible participants will be performed within 10 weeks prior to administration of
the study intervention. Refer to Section 5.4, Screen Failures for conditions under which the repeat
of any screening procedures is allowed.
The inclusion and exclusion criteria for enrolling participants in this study are described below. If
there is a question about these criteria, the investigator must consult with the appropriate sponsor
representative and resolve any issues before enrolling a participant in the study. Waivers are not
allowed.
5.1. 
Inclusion Criteria
Each potential participant must satisfy all of the following criteria to be enrolled in the study:
1. 
Participant must be a boy or girl ≥6 to <18 years of age.
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2. 
Have a diagnosis of chronic plaque-type psoriasis for at least 6 months (with or without
PsA), prior to first administration of study intervention, defined as having at screening
and baseline:
IGA ≥3 and
PASI ≥12 and
≥10% BSA involvement and
at least one of the following:
o very thick lesions or
o clinically relevant facial, genital, or hand/ foot involvement or
o PASI≥20 or
o >20% BSA involvement or
o IGA=4
3. 
Be a candidate for phototherapy or systemic treatment of plaque psoriasis (either naive or
history of previous treatment).
4. 
Have plaque psoriasis considered by the investigator as inadequately controlled with
phototherapy and/or topical therapy after an adequate dose and duration of therapy.
5. 
Be considered, in the opinion of the investigator, a suitable candidate for etanercept
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6. 
Be otherwise healthy on the basis of physical examination, medical history, and vital signs
performed at screening. Any abnormalities, must be consistent with the underlying illness
in the study population and this determination must be recorded in the participant's source
documents and initialed by the investigator.
7. 
Contraceptive use by boys or girls should be consistent with local regulations regarding
the use ofcontraceptive methods for those participating in clinical studies.
Before randomization, a girl must be either:
Not of childbearing potential defined as:
premenarchal.
A premenarchal state is one in which menarche has not yet occurred.
permanently sterile
Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral
tubal occlusion/ligation procedures, and bilateral oophorectomy.
or otherwise be incapable of pregnancy.
Of childbearing potential and practicing a highly effective method of contraception
(failure rate of <1% per year when used consistently and correctly) and agrees to remain
on a highly effective method while receiving study intervention and until 12 weeks after
last dose - the end of relevant systemic exposure. Examples of highly effective methods
of contraception are in Appendix 3 (Section 10.3); however, the method selected must
meet local/regional regulations/guidelines for highly effective contraception
Typical use failure rates may differ from those when used consistently and correctly. Use
should be consistent with local regulations regarding the use of contraceptive methods for
participants participating in clinical studies.
Note: If the childbearing potential changes after start of the study (eg, a premenarchal girl
experiences menarche) or the risk of pregnancy changes (eg, a girl who is not
heterosexually active becomes active), a girl must begin a highly effective method of
contraception, as described above and in Appendix 3 (Section 10.3).
If reproductive status is questionable, additional evaluation should be considered
8. 
A girl must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during the study and for a period of at least 12 weeks following the last dose
of study intervention.

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9. 
A girl of childbearing potential must have a negative urine pregnancy test at screening
and at all visits when study intervention is to be administered.
10. 
A boy who is sexually active with a female of childbearing potential and who has not had
a vasectomy must agree to use a barrier method of birth control (eg, either a condom [with
spermicidal foam/gel/film/cream/suppository if available in their locale] or a partner with
an 
occlusive 
cap 
[diaphragm 
or 
cervical/vault 
caps] 
plus 
spermicidal
foam/gel/film/cream/suppository if available in their locale), during the study and for at
least 12 weeks after receiving the last administration of study intervention. All boys must
also agree to not donate sperm during the study and for at least 12 weeks after receiving
the last administration of study intervention.
11. 
Criterion modified per Amendment 4.
11.1. Are considered eligible according to the following TB screening criteria:
Have no history of latent or active TB before screening.
Have no signs or symptoms suggestive of active TB upon medical history and/or
physical examination.
Have had no recent close contact with a person with active TB.
Within 10 weeks before the first administration of study intervention, have a negative
QuantiFERON®-TB test result (Appendix 5 [Section 10.5]). Within 10 weeks before
the first administration of study intervention, a negative tuberculin skin test
(Appendix 5 [Section 10.5]) is additionally required if the QuantiFERON-TB test is
not approved/registered in that country or the tuberculin skin test is mandated by
local health authorities.
Indeterminate or suspected false-positive QuantiFERON®-TB test results should be
handled as outlined in Section 8.
12. 
Must have acceptable evidence of immunity to measles, mumps, rubella, and varicella,
which includes any one of the following:
a. Documentation of age-appropriate vaccination for measles, mumps, rubella, and
varicellathat includes both doses of each vaccine (unless local guidelines specify
otherwise).
OR
b. Documentation of past measles, mumps, rubella, and varicella infection by a
healthcare provider.
OR
c. In the absence of (a) or (b) above, must have positive protective antibody titers
to measles, mumps, rubella, and varicella prior to the first administration of
study intervention.
For participants who have not completed the recommended vaccination schedule for
varicella and measles, mumps, and rubella (MMR), and the subsequent vaccination falls
within the next 4 years, an accelerated vaccination schedule must be completed prior to

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study enrollment if available and required or strongly recommended for the location. If
varicella or MMR vaccines are utilized, it is necessary for 2 weeks to elapse between the
vaccination and receipt of study intervention.
13. 
Must agree not to receive a live virus or live bacterial vaccination at least 3 months (or
longer as indicated in the package insert of the relevant vaccine) prior to the first
administration of study intervention (except for varicella and MMR vaccines), during the
study, or within 3 months after the last administration of study intervention.
14. 
Must agree not to receive a bacille Calmette-Guérin (BCG) vaccination within 12 months
of screening, during the study, or within 12 months after the last administration of study
intervention.
15. 
Must avoid prolonged sun exposure and use of tanning booths or other ultraviolet light
sources during study.
16. 
Must have screening laboratory test results within the following parameters:
Hemoglobin  
≥10 g/dL (SI: ≥100 g/L; 6 to 11 years of age)
≥12 g/dL (SI: ≥120 g/L; ≥12 years of age)
White blood cells 
≥3.0 x 103 cells/µL (SI: ≥3.0 x 109 cells/L; 6 to 11 years of
age)
≥4.5 x 103 cells/µL (SI: ≥4.5 x 109 cells/L; ≥12 years of
age)
Neutrophils 
≥1.5 x 103 cells/µL (SI: ≥1.5 x 109 cells/L)
Platelets 
≥150 x 109/L
Serum creatinine 
≤0.7 mg/dL (SI: 62 µmol/L; 6 to 10 years of age)
≤1.0 mg/dL (SI: 88 µmol/L; 11 to 12 years of age)
<1.5 mg/dL (SI: <133 µmol/L; >12 years of age)
Aspartate aminotransferase (AST) ≤72 IU/L (6 to 11 years of age)
<1.5 x ULN for the laboratory conducting
the test (≥12 years of age)
Alanine aminotransferase (ALT) 
≤54 IU/L (6 to <18 years of age)
If one or more of the above laboratory parameters is out of range, a single retest of
laboratory values is permitted.
17. 
Must be willing and able to adhere to the prohibitions and restrictions specified in this
protocol.
18. 
Must sign an ICF (or their legally acceptable representative must sign) indicating that he
or she understands the purpose of, and procedures required for, the study and is willing to

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participate in the study. Parent(s) (preferably both if available or as per local
requirements) (or their legally acceptable representative) must sign an ICF indicating that
he or she understands the purpose of, and procedures required for, the study and is willing
to allow the child to participate in the study, as per local requirements. Assent is also
required of children capable of understanding the nature of the study (typically 7 years of
age and older) as described in Informed Consent Process in Appendix 2 (Section 10.2),
Regulatory, Ethical, and Study Oversight Considerations.
5.2. 
Exclusion Criteria
Any potential participant who meets any of the following criteria will be excluded from
participating in the study:
Medical history-related exclusion criteria
1. 
Currently has nonplaque forms of psoriasis (eg, erythrodermic, guttate, or pustular).
2. 
Has current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of
psoriasis from beta blockers, calcium channel blockers, or lithium).
3. 
Is pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the
study or within 12 weeks after receiving the last administration of study intervention.
4. 
Has a history of or current signs or symptoms of severe, progressive, or uncontrolled
renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac,
neurologic, cerebral, or psychiatric disease.
5. 
Has a transplanted organ (with exception of a corneal transplant > 3 months prior to the
first administration of study intervention).
6. 
Has had major surgery (eg, requiring general anesthesia and hospitalization) within
8 weeks before screening, or will not have fully recovered from such surgery, or has
such surgery planned during the time the participant is expected to participate in the
study.
Note: Participants with planned surgical procedures to be conducted under local
anesthesia may participate.
7. 
Has unstable suicidal ideation or suicidal behavior:
Participants ≥12 to <18 years of age may not be randomized if they have:
o a C-SSRS rating at screening of: suicidal ideation with intention to act
(“Ideation level 4”), suicidal ideation with specific plan and intent
(“Ideation level 5”), or non-suicidal self-injurious behavior within the
past 6 months, OR

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o a C-SSRS rating at screening of suicidal behavior (actual suicide attempt,
interrupted suicide attempt, aborted suicide attempt, or preparatory
behaviors for making a suicide attempt) ever (lifetime)
Participants ≥6 to <12 years of age may not be randomized if they have:
o a C-SSRS rating at screening of: suicidal ideation with intention to act
(“Ideation level 4”), suicidal ideation with specific plan and intent
(“Ideation level 5”), or suicidal behavior (actual suicide attempt,
interrupted suicide attempt, aborted suicide attempt, or preparatory
behaviors for making a suicide attempt) or any self-injurious behavior
ever (lifetime)
Participants with a C-SSRS rating at screening of Wish to be Dead (“Ideation level
1”), Non-Specific Active Suicidal Thoughts (“Ideation level 2”), or Active Suicidal
Ideation with Any Methods (Not Plan) without Intent to Act (“Ideation level 3”)
may not be randomized if:
o participants ≥12 to <18 years of age have one of the above C-SSRS
ratings within the past 6 months and are determined to be at risk by the
investigator after being discussed with the medical monitor or designee.
o participants ≥6 to <12 years of age have one of the above C-SSRS ratings
ever (lifetime) and are determined to be at risk by the investigator after
being discussed with the medical monitor or designee.
8. 
Is known to have had a substance abuse (drug or alcohol) problem within the previous
12 months.
Medical therapies-related exclusion criteria
9. 
Has previously received guselkumab or etanercept.
10. 
Has any contraindications to the use of etanercept per local prescribing information.
11. 
Has received any anti-TNFα biologic therapy (with the exception of etanercept, see
exclusion 9) within the previous 3 months before the first administration of study
intervention.
12. 
Is not a suitable candidate for anti-TNFα therapy for the following reasons:
Has a history of known demyelinating diseases such as multiple sclerosis or optic
neuritis.
Has known or suspected intolerance or hypersensitivity to anti-TNFα medications
(eg, clinical lupus-like syndrome, serum sickness-like reaction).
Has a history of, or concurrent congestive heart failure (CHF), including medically
controlled CHF.

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13. 
Has received any therapeutic agent directly targeted to IL-12/23, IL-17, or IL-23 within
6 months of the first administration of study intervention (including but not limited to
ustekinumab, tildrakizumab, secukinumab, ixekizumab, risankizumab, or brodalumab).
14. 
Has received natalizumab, efalizumab, or agents that deplete B or T cells (eg, rituximab,
alemtuzumab, abatacept, anakinra, or visilizumab) within 12 months of screening, or,
if after receiving these agents, evidence is available at screening of persistent depletion
of the targeted lymphocyte population.
15. 
Has received any systemic immunosuppressants (eg, methotrexate [MTX],
azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil,
hydroxyurea, and tacrolimus) within 4 weeks of the first administration of study
intervention.
16. 
Has received phototherapy or any systemic medications/treatments that could affect
psoriasis or IGA evaluations (including, but not limited to, oral or injectable
corticosteroids, retinoids, 1,25-dihydroxy vitamin D3 and analogues, psoralens,
sulfasalazine, hydroxyurea, fumaric acid derivatives, herbal treatments, or traditional
Taiwanese, Korean, or Chinese medicines) within 4 weeks of the first administration of
study intervention.
17. 
Has used topical medications/treatments that could affect psoriasis or IGA evaluations
(including, but not limited to, corticosteroids, anthralin, calcipotriene, topical vitamin
D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens, pimecrolimus,
tacrolimus, or topical traditional Taiwanese, Korean, or Chinese medicines) within
2 weeks of the first administration of study intervention.
18. 
Is currently receiving lithium, antimalarials, or intramuscular (IM) gold, or has received
lithium, antimalarials, or IM gold within 4 weeks of the first administration of study
intervention.
19. 
Has received an experimental antibody or biologic therapy within the previous
6 months or received any other experimental therapy or new investigational agent
(topical or systemic) within 30 days or 5 half-lives (whichever is longer) of any study
intervention  administration or is currently enrolled in another study using an
investigational agent or procedure.
20. 
Has received, or is expected to receive, any live virus or bacterial vaccination (with the
exception of varicella or MMR vaccines; see inclusion criterion 12) within 3 months
(or longer as indicated in the package insert of the relevant vaccine) prior to the first
administration of study intervention, during the study, or within 12 weeks after the last
administration of study intervention.
21. 
Has had a BCG vaccination within 12 months of screening.

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22. 
Has shown a previous immediate hypersensitivity response, including anaphylaxis, to
an immunoglobulin product (eg, plasma derived or recombinant mAb).
23. 
Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
(refer to Investigator's Brochure) or etanercept or its excipients.
24. 
Has known allergy or sensitivity to latex.
Infections or predisposition to infections
25. 
Has a history of chronic or recurrent infectious disease, including but not limited to
chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary
tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal
infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or
ulcers.
26. 
Has or has had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or has been
hospitalized or received IV antibiotics for an infection during the 2 months before
screening.
27. 
Has or has had herpes zoster within the 2 months before screening.
28. 
Have a history of latent or active granulomatous infection, including TB,
histoplasmosis, or coccidioidomycosis, prior to screening.
29. 
Has had a nontuberculous mycobacterial infection.
30. 
Has ever had an opportunistic infection (eg, cytomegalovirus colitis or retinitis,
pneumocystosis pneumonia, or invasive aspergillosis).
31. 
Has persistently indeterminate (indeterminate on repeat sampling) QuantiFERON-TB
test results. Indeterminate results should be handled as described in Section 8, Study
Assessments and Procedures.
32. 
Is infected with human immunodeficiency virus (HIV, positive serology for HIV
antibody).
33. 
Tests positive for antibodies to hepatitis C virus (HCV) at screening.
34. 
Tests positive for hepatitis B virus (HBV) infection (Appendix 6 [Section 10.6]).
35. 
Has a documented history of immune deficiency syndrome (eg, severe combined
immunodeficiency syndrome, T cell deficiency syndromes, B cell deficiency
syndromes and chronic granulomatous disease).
Note: For COVID-19-related exclusion, see Exclusion Criterion 42.

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Malignancy or increased potential for malignancy
36. 
Has a known history of lymphoproliferative disease, including lymphoma; a history of
monoclonal gammopathy of undetermined significance (MGUS); or signs and
symptoms 
suggestive 
of possible 
lymphoproliferative 
disease, 
such 
as
lymphadenopathy or splenomegaly.
37. 
Has any known malignancy or a history of malignancy.
Other exclusion criteria
38. 
Is unable or unwilling to undergo multiple venipunctures because of poor tolerability
or lack of easy access to veins.
39. 
Lives in an institution on court or authority order.
40. 
Has any condition that, in the opinion of the investigator, would make participation not
be in the best interest (eg, compromise the well-being) of the participant or that could
prevent, limit, or confound the protocol-specified assessments.
41. 
Is an employee of the investigator or study site, with direct involvement in the proposed
study or other studies under the direction of that investigator or study site, as well as
family members of the employees or the investigator.
42. 
COVID-19 infection:
During the 6 weeks prior to baseline, has had any of the following (regardless of
vaccination status): (a) confirmed severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) infection (test positive) OR  (b) suspected SARS-CoV-2 infection
(clinical features of COVID-19 without documented test results) OR (c) close contact
with a person with known or suspected SARS-CoV-2 infection
Exception: may be included with a documented negative result for a validated
SARS-CoV-2 test
i) obtained at least 2 weeks after conditions (a), (b), (c) above (timed from
resolution of key clinical features if present, [eg, fever, cough, dyspnea])
AND
ii) with absence of all conditions (a), (b), (c) above during the period between the
negative test result and the baseline study visit
Note on COVID-related exclusion:
The field of COVID-related testing (for presence of, and immunity to, the
SARS-CoV-2 virus) is rapidly evolving. Additional testing may be performed as
part of screening and/or during the study if deemed necessary by the investigator

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and in accordance with current regulations/guidance from authorities/standards of
care.
Precaution: for those who may carry a higher risk for severe COVID-19 illness, follow
guidance from local health authorities when weighing the potential benefits and risks
of enrolling in the study, and during participation in the study.
NOTE: Investigators should ensure that all study enrollment criteria have been met at screening.
If a participant's clinical status changes (including any available laboratory results or receipt of
additional medical records) after screening but before the first dose of study intervention is given
such that he or she no longer meets all eligibility criteria, then the participant should be excluded
from participation in the study. Section 5.4, Screen Failures, describes options for retesting. The
required source documentation to support meeting the enrollment criteria are noted in Appendix 2
(Section 10.2), Regulatory, Ethical, and Study Oversight Considerations.
5.3. 
Lifestyle Considerations
Potential participants must be willing and able to adhere to the following lifestyle restrictions
during the course of the study to be eligible for participation:
1. 
a girl of childbearing potential who is heterosexually active must remain on a highly
effective method of birth control (Inclusion Criterion 5) during the study and for at least
12 weeks after receiving the last administration of study intervention.
2. 
all girls must agree not to donate eggs (ova, oocytes) during the study and for a period
of at least 12 weeks following the last administration of study intervention.
3. 
a boy who is sexually active with a female of childbearing potential and has not had a
vasectomy must agree to use a barrier method of birth control (ie, male condom, female
diaphragm or cervical cap, or condom, Inclusion Criterion 8) during the study and for
at least 12 weeks after receiving the last administration of study intervention.
4. 
all boys must agree to not donate sperm during the study and for at least 12 weeks after
receiving the last administration of study intervention.
5. 
participants must not receive a live virus or bacterial vaccination (except for varicella
and MMR vaccines prior to first administration of study intervention), during the study
and for 3 months after the last administration of any study intervention. See Lifestyle
Consideration 6 for information regarding BCG vaccination.
6. 
participants must not receive a BCG vaccination during the study and for 12 months
after the last administration of any study intervention.
7. 
participants must comply with restrictions on concomitant medications and therapies
specified in the protocol (refer to Section 6.5, Concomitant Therapy for details).

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8. 
participants must avoid prolonged sun exposure and avoid use of tanning booths or
other UV light sources during the study.
9. 
participants are recommended to be up to date on all age-appropriate vaccinations prior
to screening per routine local medical guidelines. It is strongly recommended that
participants will have completed a locally-approved (including emergency use-
authorized) COVID-19 vaccination regimen at least 2 weeks prior to study-related visits
or procedures. Study participants should follow applicable local vaccine labelling,
guidelines, and standards-of-care for participants receiving immune-targeted therapy
when determining an appropriate interval between vaccination and study enrollment
(see also Section5.2).
5.4. 
Screen Failures
Participant Identification, Enrollment, and Screening Logs
The investigator agrees to complete a participant identification and enrollment log to permit easy
identification of each participant during and after the study. This document will be reviewed by
the sponsor study-site contact for completeness.
The participant identification and enrollment log will be treated as confidential and will be filed
by the investigator in the study file. To ensure participant confidentiality, no copy will be made.
All reports and communications relating to the study will identify participants by participant
identification and date of birth (as allowed by local regulations). In cases where the participant is
not randomized into the study, the date seen and date of birth (as allowed by local regulations) will
be used.
The investigator must also complete a participant screening log, which reports on all participants
who were seen to determine eligibility for inclusion in the study.
If, during the screening phase, a participant has not met all inclusion criteria or has met any
exclusion criteria or is unable or unwilling to adhere to the prohibitions and restrictions of the
study, the participant is considered to be a screen failure and is not eligible to be randomized or
enrolled in the study.
In general, if a participant is a screen failure, but at some point in the future meets all of the
participant eligibility criteria, the participant may be rescreened after a new informed consent has
been obtained. Participants who are rescreened will be assigned a new participant number and will
restart a new screening phase. Rescreening will be permitted once.

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6. 
STUDY INTERVENTION
6.1. 
Study Interventions Administered
Designation 
Product
Investigational Medicinal Product(s) 
Guselkumab
Authorization status in the EU/EEA:
Authorized
Unauthorized 
X
Placebo
Authorization status in the EU/EEA:
Etanercept
Authorization status in the EU/EEA:
Authorized
Unauthorized 
X
Authorized 
X
Unauthorized
Guselkumab or placebo will be administered SC using a sponsor-supplied, single use
administration device. This will be either the 
 PFS assembled with the UltraSafe Plus™
Passive Needle Guard (PFS-U) device, designed to deliver a single, fixed dose of 
, or a
 Identical devices containing placebo will be used
to deliver a volume equivalent to that of active treatment for participants randomized to the placebo
arm. Guselkumab will be supplied as a 
 solution of guselkumab in a single-use 
or
PFS. The PFS-U is assembled with a PFS containing 1.0 mL of study
intervention and the
Participants will receive a dose based on body weight. At each dosing visit, participant weight will
be measured and the dose of guselkumab will be adjusted accordingly. Participants will receive 1
of the following dose levels depending on their weight:
Weight <70 kg:
 administered
Weight ≥70 kg:
 administered using the PFS-U
Placebo for guselkumab will also be supplied in a PFS assembled with either the UltraSafe Plus™
Passive Needle Guard or the 
. Participants who weigh <70 kg will receive 1 or
2 injections of either guselkumab or placebo with a volume(s) determined using the weight-based
dose calculation for guselkumab. In Part 2 of the study, participants or their caregiver will be given
the option to self-administer guselkumab at the study site. Participants must be ≥12 years of age
to self-administer guselkumab.
Commercially available etanercept (25 mg powder and solvent for solution for injection and 50 mg
prefilled syringes) will be supplied and administered subcutaneously based on body weight:
CCI
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<63 kg: 0.8 mg/kg once weekly using powder and solvent for solution for injection.
≥63 kg: 50 mg once weekly administered using a prefilled syringe.
Participants receiving etanercept or their caregiver will also be given the option to self-administer
study injections either at the study site when a visit is scheduled or at-home for doses required
between regular visits. Participants who weigh <63 kg will receive 1 or 2 injections with a
volume(s) determined using the weight-based calculation for etanercept.
Study staff will receive training on study intervention administration using either PFS-U or
,
which must be documented. For participants/caregivers who will self-administer, training on study
intervention administration will be provided by study staff. This will include education regarding
instructions for use (IFU), proper handling and storage of devices, guidance on study intervention
injection, and proper handing and accounting for used devices. Required storage conditions and
expiration date are indicated on the label.
At any time, if participants or caregivers are uncertain about how to administer the study
intervention or have questions regarding self-administration, the sponsor recommends that study
staff review the IFU with the participant/caregiver along with practice injections with a training
device if necessary. Patients or caregivers may be retrained at any time during the study, including
if there is a use issue reported by the patient or caregiver. If at any time there is a change in the
device required for dosing (eg, 
 to PFS-U) due to a change in a participant’s body weight,
and the participant/caregiver wishes to continue with self-administration, they must receive
training on the new device and the participant/caregiver using the device must be witnessed
self-administering a successful injection by study staffprior to performing self-administration.
Different sites should be used for consecutive injections or for two injections administered on the
same day. Sites that are tender for any reason should be avoided. Study intervention and injections
of other concomitant medications should be given at different anatomic sites.
Details on dose preparation and administration can be found in the Study Site Investigational
Product Procedures Manual.
Part 1
Week 0 to Week 16 (Placebo-Controlled Period)
The guselkumab and placebo administrations will be administered by site personnel at the study
site. Etanercept will be administered at the study site at Week 0. Subsequent weekly doses of
etanercept through Week 15 may be administered at the study site or be self-administered at home
by the participant or caregiver on weeks without a site visit. The dose regimens are as follows:
Group I: Weight-based guselkumab dose up to 
 SC at Weeks 0, 4, and 12.
Group II: Weight-based placebo for guselkumab dose administered SC at Weeks 0, 4, and 12.
Group III: Weight-based etanercept dose up to 50 mg SC weekly through Week 15.
CCI
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Week 16 through Week 52 (Withdrawal and Retreatment Period)
Group Ia: Participants randomized to guselkumab who are PASI 90 responders at Week 16
will not receive any additional doses of guselkumab until they lose ≥50% of their Week 16
PASI improvement, at which time they will receive a weight-based guselkumab SC dose,
followed by a dose 4 weeks later, and q8w thereafter through Week 52.
Group Ib: Participants randomized to guselkumab who are PASI 90 nonresponders at
Week 16 will receive a placebo SC injection at Week 16 and continue treatment with
guselkumab SC q8w from Week 20 through Week 52.
Group IIa: Participants randomized to placebo who are PASI 90 responders at Week 16 will
not receive any additional doses of study intervention until they lose ≥50% of their Week 16
PASI improvement, at which time they will receive a weight-based guselkumab SC dose,
followed by a dose 4 weeks later, and q8w thereafter through Week 52.
Group IIb: Participants randomized to placebo who are PASI 90 nonresponders at Week 16
will receive a weight-based guselkumab SC dose at Weeks 16 and 20, followed by q8w dosing
thereafter through Week 52.
Group III: Participants randomized to etanercept who elect to continue in the study will
receive a weight-based guselkumab SC dose at Weeks 20 and 24, followed by q8w dosing
thereafter through Week 48.
Participants in any of the treatment groups who elect to end study participation at Week 52 and
not participate in the LTE will not receive any administration of study intervention at Week 52
and should return to the site 12 weeks after receiving the last administration of study intervention
for a safety follow-up visit.
Part 2
Participants enrolled in Part 2 of the study will receive a weight-based dose of open-label
guselkumab SC at Weeks 0, 4 and q8w thereafter through Week 52. Participants in Part 2 of the
study who elect to end study participation at Week 52 and not participate in the LTE will not
receive any administration of study intervention at Week 52 and should return to the site 12 weeks
after receiving the last administration of study intervention for a safety follow-up visit.
In Part 2 of the main study, participants or their caregiver will be given the option to self-administer
study injections at the study site using the appropriate presentation (either PFS-U or 
Participants must be at least 12 years of age to self-administer study injections. Participants or their
caregivers will be trained on proper use of the device(s) and deemed capable, as determined by
study staff. Otherwise injections will continue to be performed by study staff.
Long-term Extension (From Week 52 until study termination)
Following completion of the Week 52 visit, participants who have had a beneficial response from
guselkumab treatment as determined by the investigator, and are willing to continue guselkumab
treatment, may enter the LTE of the study. Participants who decide to participate in the LTE will
continue to receive guselkumab at Week 52 and q8w thereafter until one of the following occurs:
CCI

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The participant turns 18 years of age and resides in a country where marketing authorization
has been granted for guselkumab treatment of plaque psoriasis in adult patients, and have had
the opportunity to complete up to 1 year in the LTE.
Marketing authorization is obtained for guselkumab for treatment of plaque psoriasis for
patients ≥6 to <18 years of age in the participant’s country of residence.
Marketing authorization is denied for guselkumab for the treatment of plaque psoriasis for
patients ≥6 to <18 years of age in the participant’s country of residence.
A company decision is made to no longer pursue an indication in plaque psoriasis in the
pediatric population (≥6 to <18 years of age) in the participant’s country of residence.
Participants in Part 1 who continue in the LTE portion of the study will receive guselkumab as
follows:
Participants withdrawn from guselkumab or placebo at Week 16 who meet loss of response
criteria and are retreated with or initiated guselkumab prior to Week 52 and receive
guselkumab at Week 48 will not receive study intervention administration at Week 52 and
will resume guselkumab administration at Week 60 and q8w thereafter.
Participants who meet loss of response criteria at Week 48 will receive guselkumab at
Weeks 48 and 52 followed by q8w administration beginning at Week 60.
Participants withdrawn from treatment at Week 16 who have not been retreated with
guselkumab prior to Week 52 will receive a weight-based guselkumab dose at Week 52 and
q8w thereafter.
Physical Description of Study Intervention(s)
Guselkumab
The guselkumab supplied for this study is a sterile liquid for SC injection in a single-use PFS. Each
single-use PFS is 1 mL glass syringe with a 27 gauge, 1/2 inch fixed needle and a latex-free rigid
needle shield and contains
 of guselkumab with either a 1 mL fill of liquid for the
PFS-U (
 No preservatives
are present. Guselkumab will be manufactured and provided under the responsibility of the
sponsor. Refer to the guselkumab IB for a list of excipients in the drug product.
Placebo is supplied as a sterile liquid for SC injection at a fill volume of 1.0 mL in single-use
PFS-U or
 Each placebo PFS contains the same excipients as the drug product.
ENBREL (etanercept)
Commercial etanercept (ENBREL) will be supplied as an active comparator to the study sites.
Details on etanercept are available in the etanercept (ENBREL) package insert in the Site
Investigational Product Procedures Manual.
CCI
CCI
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Packaging
Two dosage forms for guselkumab and placebo will be used in this study, PFS-U and 
assembled with a PFS. Both dosage forms will be packaged in individual participant kits in tamper
evident packaging.
Etanercept (ENBREL) will be provided in commercial primary packaging. Secondary packaging
may be changed to facilitate clinical labeling.
Study intervention administration must be captured in the source documents and the case report
form (CRF). Study-site personnel will instruct participants on how to store study intervention for
at-home use as indicated for this protocol.
For details on rescue medications, refer to Section 6.5.1, Rescue Medication. For a definition of
study intervention overdose, refer to Section 8.4, Treatment of Overdose.
6.2. 
Preparation/Handling/Storage/Accountability
Study intervention labels will contain information to meet the applicable regulatory requirements.
All study intervention must be stored at controlled temperatures ranging from 36°F to 46°F (2°C
to 8°C), not frozen, and protected from light. Vigorous shaking of the product should be avoided.
The sterile product does not contain preservatives and is designed for single use only. Prior to
administration, the product should be inspected visually for particulate matter and discoloration.
If discoloration (other than a slight yellow color), visible opaque particles, or other foreign
particles are observed in the solution, the product should not be used. Study intervention in PFS-U
and 
 will be ready to use. Aseptic procedures must be used during the preparation and
administration of the study material. Exposure to direct sunlight should be avoided during
preparation and administration.
Further details regarding the preparation and storage of guselkumab and placebo will be provided
in the Site Investigational Product Procedures Manual. Further details regarding the preparation
and storage of etanercept can be found in the ENBREL package insert in the Site Investigational
Product Procedures Manual.
The investigator is responsible for ensuring that all study intervention  received at the site is
inventoried and accounted for throughout the study. The dispensing of study intervention to the
participant, and the return of study intervention  from the participant (if applicable), must be
documented on the drug accountability form. Participants, or their legally acceptable
representatives where applicable, must be instructed to return all original containers, whether
empty or containing study intervention. The study interventionadministered to the participantmust
be documented on the drug accountability form. All study intervention will be stored and disposed
of according to the sponsor's instructions. Study-site personnel must not combine contents of the
study intervention containers.
Study intervention must be handled in strict accordance with the protocol and the container label
and must be stored at the study site in a limited-access area or in a locked cabinet under appropriate
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environmental conditions. Unused study intervention  must be available for verification by the
sponsor's study site monitor during on-site monitoring visits. The return to the sponsor of unused
study intervention  will be documented on the drug return form. When the study site is an
authorized destruction unit and study intervention supplies are destroyed on-site, this must also be
documented on the drug return form.
Potentially hazardous materials such as used ampules, needles, syringes and vials containing
hazardous liquids, should be disposed of immediately in a safe manner and therefore will not be
retained for drug accountability purposes.
Study intervention should be dispensed under the supervision of the investigator or a qualified
member of the study-site personnel, or by a hospital/clinic pharmacist. Study intervention will be
supplied only to participants participating in the study. Study intervention may not be relabeled or
reassigned for use by other participants. The investigator agrees to neither dispense the study
intervention from, nor store it at, any site other than the study sites agreed upon with the sponsor.
6.3. 
Measures to Minimize Bias: Randomization and Blinding
Intervention Allocation
Procedures for Randomization and Stratification
Central randomization will be implemented in this study. Participants in Part 1a (≥12 to <18 years
of age) will be randomized in a 2:1:1 ratio to guselkumab, placebo, or etanercept and participants
in Part 1b (≥6 to <12 years of age) will be randomized separately in a 1:1:1 ratio to 1 of same
3 treatment groups using computer-generated randomization schedules, prepared before the study
by, or under the supervision of the sponsor. The randomization will be balanced by using randomly
permuted blocks and will be stratified by region. The interactive web response system (IWRS) will
assign a unique treatment code, which will dictate the treatment assignment and matching study
intervention kit(s) for the participant. The requestor must use his or her own user identification
and personal identification number when contacting the IWRS  and will then give the relevant
participant details to uniquely identify the participant.
Randomization will not be used in Part 2 of this study. All participants in Part 2 will receive
open-label guselkumab.
Blinding
For Part 1 of the main study, the investigator will not be provided with randomization codes. The
codes will be maintained within the IWRS, which has the functionality to allow the investigator to
break the blind for an individual participant.
Data that may potentially unblind the treatment assignment (eg, treatment allocation) will be
handled with special care to ensure that the integrity of the blind is maintained and the potential
for bias is minimized. This can include making special provisions, such as segregating the data in
question from view by the investigators, clinical team, or others as appropriate until the time of
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Under normal circumstances, the blind should not be broken until the Week 52 database lock is
completed. Otherwise, the blind should be broken only if specific emergency treatment/course of
action would be dictated by knowing the treatment status of the participant. In such cases, the
investigator may in an emergency determine the identity of the treatment using the IWRS. It is
recommended that the investigator contact the sponsor or its designee, if possible, to discuss the
particular situation, before breaking the blind. Telephone contact with the sponsor or its designee
will be available 24 hours per day, 7 days per week. In the event the blind is broken, the sponsor
must be informed as soon as possible. The date and reason for the unblinding must be documented
by the IWRS, in the appropriate section of the CRF, and in the source document. The
documentation received from the IWRS indicating the code break must be retained with the
participant's source documents in a secure manner.
Participants who have had their treatment assignment unblinded should continue to return for
scheduled evaluations. The decision to continue or discontinue study treatment for these
participants will be based upon consultation of the investigator with the medical monitor.
One interim PK analysis is planned for this study after all participants ≥12 to <18 years of age in
Part 1a have completed Week 16. This evaluation will be conducted by sponsor personnel who are
otherwise not participating in the conduct of this study. Efficacy data will not be analyzed in this
interim analysis.
The Sponsor will be unblinded after the last participant in Part 1 has completed their Week 16 visit
and the Week 16 DBL has occurred. The investigators, participants, and sponsor site monitors can
be unblinded after the last participants in Part 1 and Part 2 have completed the Week 52 visit, and
the Week 52 DBL has occurred.
Blinding procedures are not applicable for participants in Part 1 who are randomized to open-label
etanercept, with the exception of the blinded efficacy evaluator (see Section 8.1.6), and all
participants in Part 2 of the main study who will receive open-label guselkumab and will not be
blinded in this study.
6.4. 
Study Intervention Compliance
Because guselkumab and placebo will be administered at the investigational site by trained study
staff or self-administered by the participant or their caregiver, treatment compliance for these study
interventions will be controlled by site personnel.
From Week 0 through Week 52, it is expected that all visits will occur within a range of ±7 days
of the scheduled visit. Any visits outside of these ranges should be discussed with the sponsor. If
a study visit occurs outside the specified visit window, the participant should then resume his or
her normal dose schedule relative to the baseline visit (Week 0) as soon as possible. All other
follow-up study visits should occur within ±14 days of the scheduled study visit. Any out-of-range
visit should be documented in the participant’s source notes. Guidelines for study intervention
administration affected by the COVID-19 pandemic are found in Appendix 22 (Section 10.22).

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Study-site personnel will maintain a log of all study intervention administered. Drug supplies for
each participant will be inventoried and accounted for. Information regarding study intervention
administrations that are administered outside of the scheduled windows or missed will be recorded.
Participant charts and worksheets may be reviewed and compared with the data entries on the
CRFs to ensure accuracy. Although it is understood that treatment may be interrupted for many
reasons, compliance with the treatment schedule is strongly encouraged.
When etanercept is administered by the participant or caregiver away from the site, the amount of
study intervention dispensed will be recorded and compared with the amount returned and the
participant or caregiver will be asked to record administration information on a paper
questionnaire. Etanercept dosing should occur within a range of ±3 days of the scheduled date.
Participants (and parent/caregiver) will receive instructions on compliance with study treatment
when they begin self-administration of etanercept at home. During the course of the study, the
investigator or designated study research personnel will be responsible for providing additional
instruction to reeducate any participant who is not compliant with taking the study intervention.
6.5. 
Concomitant Therapy
Concomitant therapies must be recorded throughout the study from screening and continuing until
12 weeks after the last dose of study intervention. Concomitant therapies should also be recorded
beyond that point only in conjunction with SAEs that meet the criteria outlined in Serious Adverse
Events in Section 8.3.1, Time Period and Frequency for Collecting Adverse Event and Serious
Adverse Event Information.
All therapies (prescription or over-the-counter medications, including vaccines, vitamins, herbal
supplements) different from the study intervention, as well as all shampoos used to treat plaque
psoriasis, moisturizers, or emollients, must be recorded in the CRF. Modification of an effective
preexisting therapy should not be made for the explicit purpose of entering a participant into the
study.
If a prohibited therapy is administered during the active treatment phase including the LTE, unless
agreed to by the medical monitor, the participant should be discontinued from study treatment. If
a prohibited therapy is initiated during the safety follow-up period (12 weeks between last
administration of study intervention and final site visit), the participant should still complete his
or her final study visit, and the medication should be recorded as a concomitant medication.
6.5.1. 
Rescue Medication
In Part 1 of the study, participants with a PASI score increase of ≥50% from their baseline PASI
score at Week 8 or Week 12 will be allowed to use a topical steroid as rescue treatment, with the
exception of ultra-high potency topical steroids (eg, clobetasol propionate, halobetasol propionate)
which are not allowed at any time. It is recommended that participants use no more than 60 grams
of topical steroid per week. In addition, participants should be managed using the lowest possible
potency and frequency of rescue topical steroid. Participants must discontinue the use of rescue
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6.5.2. 
Topical Therapies for Psoriasis
With the exception of the use of topical steroids by participants who qualify for rescue therapy
(see Section 6.5.1, Rescue Medication), topical therapies that could affect psoriasis or the IGA
evaluation (eg, corticosteroids, tar, anthralin, calcipotriene, tazarotene, methoxsalen,
pimecrolimus, tacrolimus, and traditional Taiwanese, Korean, or Chinese medicines) are not
permitted at any time during the study. The only allowable concomitant treatments on areas
affected by plaque psoriasis throughout the study are shampoos (containing tar or salicylic acid
only) and topical moisturizers. Participants should not use these topical agents (shampoos,
moisturizers) on the day of a study visit. Nonmedicated shampoos may be used on the day of the
study visit.
6.5.3. 
Phototherapy or Systemic Therapies for Psoriasis
The use of phototherapy or systemic antipsoriatic medications is not permitted at any time during
the study. These medications include those targeted for reducing TNFα (including but not limited
to infliximab or adalimumab), drugs targeted for reducing IL-12, IL-17A, IL-17R, or IL-23
(including but not limited to ustekinumab, tildrakizumab [MK3222], risankizumab [BI-655066],
ixekizumab [LY2439821], or brodalumab [AMG827]), alpha-4 integrin antagonists (including but
not limited to natalizumab), apremilast, steroids, any conventional systemic therapy that could
affect psoriasis or the IGA evaluation (including but not limited to MTX, cyclosporine, acitretin),
herbal treatments, or traditional Taiwanese, Korean, or Chinese medicines, and any other
biological agent or other systemic medication that could affect psoriasis or the IGA evaluation.
6.5.4. 
Concomitant Therapies for Conditions Other Than Psoriasis
Every effort should be made to keep participants on stable concomitant medications. If the
medication is temporarily discontinued because of abnormal laboratory values, side effects,
concurrent illness, or the performance of a procedure, the change and reason forit should be clearly
documented in the participant’s medical record.
The use of stable doses of nonsteroidal anti-inflammatory drugs is allowed. However, disease
modifying agents such as MTX, sulfasalazine, or IM gold are prohibited during the study. Lithium
and antimalarial agents may not be used.
The use of corticosteroids for indications other than psoriasis should be limited to situations for
which, in the opinion of the treating physician, there are no adequate alternatives. They should be
used on a short-term basis, preferably for ≤2 weeks. Longer term use of corticosteroids should be
discussed with the medical monitor or designee and may require discontinuation of study
intervention. Inhaled, otic, ocular, nasal or other routes of mucosal delivery ofcorticosteroids are
allowed throughout the study.
6.5.5. 
Concomitant Therapies After Week 52
After the Week 52 visit, the medication rules outlined above still apply except that most topical
therapies are permitted for treatment of psoriasis; ultra-high potency corticosteroids are still
prohibited during this period.

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The sponsor must be notified in advance (or as soon as possible thereafter) of any instances in
which prohibited therapies are administered.
6.5.6. 
Vaccinations (including COVID-19)
When considering use of locally-approved non-live vaccines (including emergency use-authorized
COVID 19 vaccines) in study participants, follow applicable local vaccine labelling, guidelines,
and standards-of-care for participants receiving immune-targeted therapy.
For study participants receiving a locally-approved (including emergency use-authorized)
COVID-19 vaccine, in order to help identify acute reactions potentially related to COVID-19
vaccine, it is recommended where possible that vaccine and study intervention be administered on
different days, separated by as large an interval as is practical within the protocol.
6.6. 
Dose Modification
Participants will receive a dose based on body weight as described in Section 6.1, Study
Interventions Administered.
6.7. 
Intervention After the End of the Study
The LTE is described in Section 4.1, Overall Design. There are no plans for post-study provision
of study intervention.
7. 
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL
A participant will be considered to have completed the main study if he or she has completed
assessments at Week 52. Participants who prematurely discontinue study treatment for any reason
before completion of the study will not be considered to have completed the study.
7.1. 
Discontinuation of Study Intervention
A participant's study intervention must be discontinued ifany of the following occur:
The investigator believes that for safety reasons or tolerability reasons (eg, AE) it is in the
best interest of the participant to discontinue study intervention
An AE temporally associated with study intervention injection, resulting in bronchospasm
with wheezing and/or dyspnea requiring ventilatory support, or symptomatic hypotension
(defined as systolic BP < [70 + (2 x age in years])30.
The participant or their legally acceptable representative withdraws consent/assent for
administration of study intervention.
Pregnancy, or pregnancy planned within the study period or within 12 weeks after the last
study intervention injection.
The initiation of protocol-prohibited medications or treatments as outlined in Section 6.5,
Concomitant Therapy, unless agreed to by the sponsor medical monitor.
The participant is diagnosed with a malignancy.

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An opportunistic infection.
A recurrent or chronic serious infection.
A severe study intervention injection-site reaction.
The participant meets one of the following TB criteria:
A diagnosis of active or latent TB is made.
A participant has symptoms suggestive of active TB based on follow-up assessment
questions and/or physical examination or has had recent close contact with a person with
active TB and cannot or will not continue to undergo additional evaluation.
A participant undergoing evaluation has chest imaging with evidence of TB and/or a
positive IGRA test result and/or 2 indeterminate/borderline IGRA test results.
Indeterminate/borderline or suspected false-positive tests should be handled as outlined
in Section 8.
The participant has liver test abnormalities as described in Section 8.2.3 and Appendix 12
(Section 10.2). Such abnormalities would include the following:
‒ 
ALT or AST >8 x ULN
‒ 
ALT or AST >5 x ULN for more than 2 weeks
‒ 
ALT or AST >3 x ULN and (total bilirubin >2 x ULN or international normalized ratio
[INR] >1.5)
‒ 
ALT or AST >3 x ULN and symptoms of hepatitis (eg, fatigue, nausea, vomiting, right
upper quadrant pain or tenderness, fever, rash, and/or eosinophilia [>5%])
The participant is unable to adhere to the study visit schedule or comply with protocol
requirements.
The participant has a reaction resulting in myalgia and/or arthralgia with fever and/or rash
(suggestive of serum sickness and not representative of signs and symptoms of other
recognized clinical syndromes) occurring 1 to 14 days after an injection of study intervention.
These may be accompanied by other events including pruritus, facial, hand, or lip edema,
dysphagia, urticaria, sore throat, and/or headache.
Discontinuation of a participant’s study intervention should be considered for:
Participants with any type of suicidal ideation or behavior, or any self-injurious behavior, who
are deemed to be at risk by the investigator. Discussion of such participants with the medical
monitor or designee is required. For participants who report suicidal ideation with intention
to act (“Ideation level 4”), suicidal ideation with specific plan and intent (“Ideation level 5”),
suicidal behavior (actual suicide attempt, interrupted suicide attempt, aborted suicide attempt,
or preparatory behaviors for making a suicide attempt) or any self-injurious behavior on a
post-baseline C-SSRS assessment, the investigator risk assessment must be based upon
evaluation by a mental health professional.
Participants who have shown insufficient improvement in their psoriasis with up to 28 weeks
of treatment.

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Participants who decide to discontinue study intervention administration for reasons other than
those outlined above must be interviewed by the investigator to determine if a specific reason for
discontinuing study intervention can be identified. Participants should be explicitly asked about
the possible contribution of AEs to their decision to discontinue study intervention; investigators
should confirm that any AE information elicited has been documented. If a participant elects to
discontinue study intervention due to an AE, the event should be recorded as the reason for study
intervention discontinuation, even if the investigator’s assessment is that the AE would not require
study intervention  discontinuation. The reason for study intervention  discontinuation must be
documented in the CRF and in source documents. Study intervention assigned to a participant who
discontinues may not be assigned to another participant.
A participant will not be automatically withdrawn from the study if he or she must discontinue
treatment before the end of the treatment regimen. Participants who discontinue study intervention
but do not terminate study participation will continue to return for protocol-specified procedures
and evaluations for at least 12 weeks following the last dose of study intervention. The procedures
and evaluations listed for the Study Termination Visit, should also be performed 12 weeks after
the last dose of study intervention.
All procedures and evaluations must be conducted prior to a participant’s withdrawal of consent.
7.2. 
Participant Discontinuation/Withdrawal From the Study
A participant will be withdrawn from the study for any of the following reasons:
Lost to follow-up
Withdrawal of consent
Death
To ensure access for participant follow-up, study sites should try to obtain both primary and
secondary telephone contact numbers from participants (eg, home, work, and mobile phones), as
well as other contact information such as email addresses, and emphasize the importance of
follow-up information to the participant, before randomization. For participants who withdraw
from study participation, every effort should be made to conduct the Study Termination Visit
assessments, as indicated in the Schedule of Activities.
Withdrawal of consent should be a very unusual occurrence in a clinical trial; the investigator
should make every effort to maintain good participant relationships to avoid withdrawals of
consent. For participants who truly request withdrawal of consent, it is recommended that the
participant withdraw consent in writing; if the participantor the participant’s representative refuses
to do so or is physically unavailable, the study site should document the reason for the participant’s
failure to withdraw consent in writing, sign the documentation, and maintain it with the
participant’s source records. When a participantwithdraws before completing the study, the reason
for withdrawal is to be documented in the CRF and in the source document. Study intervention
assigned to the withdrawn participant may not be assigned to another participant. Participants who
withdraw will not be replaced.

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7.2.1. 
Withdrawal From the Use of Research Samples
The participant may withdraw consent for use of samples for research (refer to Long-Term
Retention of Samples for Additional Future Research in Appendix 2 (Section 10.2), Regulatory,
Ethical, and Study Oversight Considerations). In such a case, samples will be destroyed after they
are no longer needed for the clinical study. Details of the sample retention for research are
presented in the main ICF and in the separate ICF for optional research samples.
7.3. 
Lost to Follow-up
To reduce the chances of a participant being deemed lost to follow-up, attempts should be made
to obtain contact information from each participant, such as home, work, and mobile telephone
numbers and email addresses for both the participant as well as appropriate family members.
A participant will be considered lost to follow-up if the participant repeatedly fails to return for
scheduled visits and is unable to be contacted by the study site. A participant cannot be deemed
lost to follow-up until all reasonable efforts made by the study site personnel to contact the
participant are deemed futile. The following actions must be taken if a participant fails to return to
the study site for a required study visit:
The study site personnel must attempt to contact the participant to reschedule the missed visit
as soon as possible, to counsel the participant on the importance of maintaining the assigned
visit schedule, to ascertain whether the participant wishes to or should continue in the study.
Before a participant is deemed lost to follow-up, the investigator or designee must make every
reasonable effort to regain contact with the participant and/or their parent or legal guardian
(where possible, 3 telephone calls, emails, fax, and, if necessary, a certified letter to the
participant’s last known mailing address), or local equivalent methods. These contact attempts
should be documented in the participant’s medical records.
Should the participant and/or their parent or legal guardian continue to be unreachable, they
will be considered to have withdrawn from the study.
Should a study site close, eg, for operational, financial, or other reasons, and the investigator cannot
reach the participant to inform them, their contact information will be transferred to another study
site.
8. 
STUDY ASSESSMENTS AND PROCEDURES
Overview
The Schedule of Activities summarizes the frequency and timing of efficacy, PK, immunogenicity,
and safety measurements applicable to this study.
Patient-reported assessments should be conducted/completed before any tests, procedures, or other
consultations to prevent influencing participant perceptions and the CDLQI should be completed
before the C-SSRS  (except at screening where C-SSRS is the first assessment after signing
informed consent). Investigator-reported efficacy assessments (ie, IGA, PASI, and BSA) should

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be completed before any study intervention administrations and will be performed by an assessor
trained by the sponsor, as outlined in the Schedule of Activities.
The CDLQI and FDLQI will be completed at appropriate visits, as outlined in the Schedule of
Activities.
A urine pregnancy test will be performed for girls of child-bearing potential to confirm the absence
of pregnancy at every study interventionadministration visit. Additional urine pregnancy tests may
be performed, as determined necessary by the investigator or required by local regulation, to
establish the absence of pregnancy at any time during the participant's participation in the study.
The approximate total volume of blood per type of sample to be collected through Week 52 is
presented in Table 1. The total blood volume to be collected from each participant per visit through
Week 52 of the study will be approximately 79.5 mL with maximum volume of 17.5 mL at
screening and 10.5 mL at other study visits (Table 2).
Where possible, tests are combined to allow for fewer draw tubes and in the interest of keeping
blood volumes to a minimum. Therefore, the total volume is less than that presented in Table 1.
The annual blood volume to be collected from each participant participating in the LTE of the
study will be approximately 9 mL (Table 3). In addition, repeat or unscheduled samples may be
collected for safety reasons or for technical issues with the samples.
Table 1: 
Approximate Total Volume of Blood Per Type of Sample to be Collected Through Week 52
from Each Participant
Type of Sample 
Volume per 
Sample (mL) 
No. of Samples 
per Participant 
Approximate
Total Volume of
Blood (mL)a
Hematology  
2 
8 
16
Serum chemistry  
2.5 
8 
20
Serology (HIV, hepatitis) 
6.5 
1 
6.5
Serum antibody titers for varicella, measles, mumps, and 
rubellab
2.5 
1 
2.5
QuantiFERON®-TB testing 
4 
1 
4
Pharmacokinetic samples onlyc 
2.5 
2 
5
Pharmacokinetics and immunogenicity samplesd 
3.5 
6 
21
Serum immunoglobulin levelse 
2.5 
3 
7.5
Approximate Totalf 
82.5
a. Calculated as number of samples multiplied by amount of blood per sample.
b. Titers for measles, mumps, rubella, and varicella only required if adequate documentation of complete
vaccination schedule or healthcare provider verification ofprevious infection is unavailable.
c. Blood samples collected for pharmacokinetics only evaluation (approximately 2.5 mL each): each serum
sample will be split into 2 aliquots (approximately 0.5 mL each).
d. Blood samples collected for pharmacokinetic and immunogenicity evaluations (approximately 3.5 mL each):
each serum sample will be split into 3 aliquots (approximately 0.5 mL each).
e. IgG, IgM, IgA
f. Repeat or unscheduled samples may be taken for safety reasons or technical issues with the samples.

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Table 2: 
Approximate Volume of Blood to be Collected per Visit Through Week 52
Weeks 
Screening 
0a 
4 
8 
12 
16a 
20 
28 
36 
44 
52a 
Totalb
Volume
(mL)
17.5 
10.5 3.5 4.5 
3.5 
9.0 
2.5 
8.0 
7.0 
8.0 
5.5 
79.5
a. Where possible, tests are combined to allow for fewer draw tubes and in the interest of keeping
blood volumes to a minimum.  Therefore, the total volume is less than that presented in Table 1.
b. Repeat or unscheduled samples may be taken for safety reasons or technical issues with the
samples.
Table 3: 
Approximate Volume of Blood to be Collected Annually from Each Participant in the Long-
term Extension
Type of Sample 
Volume per 
Sample (mL) 
No. of Samples 
per Participant 
Approximate
Total Volume of
Blood (mL)a
Hematology  
2 
2 
4
Serum chemistry  
2.5 
2 
5
Approximate Totalb 
9
a. Calculated as number of samples multiplied by amount of blood per sample.
b. Repeat or unscheduled samples may be taken for safety reasons or technical issues with the samples
Screening Phase
Each participant’s legally acceptable representative will be asked to sign the consent form at the
screening visit before any study-related procedures are conducted. Assent is also required of
children capable of understanding the nature of the study (typically 7 years of age and older) as
described in Appendix 2 (Section 10.2), Regulatory, Ethical, and Study Oversight Considerations.
After written informed consent has been obtained and within a maximum period of approximately
10 weeks before enrollment into the study, all screening evaluations establishing participant
eligibility must be performed. Participants who meet all of the inclusion and none of the exclusion
criteria will be enrolled in the study as soon as practically possible. There is no need to wait for
the maximum 10-week screening period. Every effort should be made to adhere to the study
Schedule of Activities for each participant.
Girls of childbearing potential must have a negative urine -human chorionic gonadotroptin
( hCG) pregnancy test at screening and before enrollment. Girls who are sexually active must
consent to use a highly effective method of contraception and continue to use contraception for
the duration of the study and for 12 weeks after the last dose of study intervention. The method(s)
of contraception used by each participant must be documented. A boy who is sexually active with
a woman of childbearing potential and who has not had a vasectomy must agree to use a barrier
method of birth control and continue to use contraception for the duration of the study and for
12 weeks after the last dose of study intervention.
As outlined in the eligibility criteria, participants must undergo testing for TB and their medical
history assessment must include specific questions about a history of TB or known exposure to
individuals with active TB. The participant should be asked about past testing for TB, including
chest radiograph results and responses to tuberculin skin or other TB testing.

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Participants with a negative QuantiFERON®-TB test result (and a negative tuberculin skin test
result in countries in which the QuantiFERON-TB® test is not approved/registered or the
tuberculin skin test is mandated by local health authorities) are eligible to continue with
procedures. Participants with a newly identified positive QuantiFERON®-TB (or tuberculin skin)
test result must be excluded from the study unless determined to be a false positive as described
below.
A suspected false-positive initial IGRA test must be repeated. If the repeat testing is negative, the
participant must be referred to a physician specializing in TB to determine if the initial test can be
considered a false-positive. This evaluation and final decision must be discussed with the sponsor
and adequately documented prior to the first administration of study intervention. If the repeat
testing is positive or indeterminate, however, it will be considered a true-positive and the
participant must be excluded from the study.
A participant whose first QuantiFERON®-TB test result is indeterminate should have the test
repeated. In the event that the second QuantiFERON®-TB test result is also indeterminate, the
participant must be excluded from the study.
Participants that do not have positive protective antibody titers to measles, mumps, rubella, and
varicella based on screening laboratory test results, or appropriate documentation of prior
immunization or documentation of prior infection from a health care provider, can be immunized
during the 10-week screening period prior to receiving study intervention. These participants
should receive both an initial immunization and a booster 4 weeks later. If local guidelines specify
otherwise, local guidelines may be followed. Also note that if a live attenuated viral vaccine is
utilized, it is also necessary for 2 weeks to elapse between the booster shot and receipt of study
intervention.
Participants will undergo screening for HBV (see Appendix 6 [Section 10.6]) and antibodies to
HCV and HIV.
Screen Failure/Rescreening
If, during the screening phase, the participanthas not met all inclusion criteria or met any exclusion
criteria or is unable or unwilling to adhere to the prohibitions and restrictions of the study, the
participant is considered to be a screen failure and is not eligible to be randomized at that time.
In general, if a participant is a screen failure, but at some point in the future meets all of the
participant eligibility criteria, the participant may be rescreened after a new informed consent has
been obtained. Participants who are rescreened will be assigned a new participant number and will
restart a new screening phase. Rescreening will be permitted once.
Part 1: Placebo-controlled and Withdrawal/Retreatment Periods
Week 0/Randomization
At Week 0, participants who meet all inclusion criteria and do not demonstrate any exclusion
criteria will be randomized.

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Randomization visit procedures will be performed as specified on the Schedule of Activities. After
completion of required study procedures, participants will be administered study intervention
according to their randomization assignment (guselkumab, placebo, or etanercept).
Week 1 to Week 15 (Placebo-controlled Period)
All visit procedures will be performed as specified in the Schedule of Activities. All study
procedures and evaluations should be completed before the participant is administered study
intervention. Participants randomized to receive etanercept and who elect to self-administer at
home will receive 3 dose kits at site visits through Week 12 to accommodate self-administration
of etanercept at home between site visits through Week 15.
Week 16 to Week 52 (Withdrawal/Retreatment Period)
Participants will return to the study site for q4w visits until the Week 52 visit. All visit procedures
will be performed as specified in the Schedule of Activities.
Participants randomized to guselkumab or placebo who are PASI 90 responders at Week 16 will
be withdrawn from treatment. Upon loss of ≥50% of the improvement in PASI achieved at
Week 16, participants will receive a weight-based guselkumab SC dose, followed by a dose
4 weeks later with subsequent q8w dosing through Week 52.
Participants randomized to guselkumab who are PASI 90 nonresponders at Week 16 will receive
a placebo injection at Week 16 to maintain the blind and continue guselkumab SC q8w beginning
at Week 20.
Participants randomized to placebo who are PASI 90 nonresponders at Week 16 will initiate
weight-based guselkumab SC at Week 16 and 20 followed by q8w thereafter through Week 52.
Participants randomized to etanercept who elect to continue in the study will receive a
weight-based guselkumab dose at Weeks 20 and 24, followed by q8w dosing thereafter through
Week 48.
Part 2: Open-Label Treatment from Week 0 through Week 52
All visit procedures for participants participating in Part 2 of the study will be performed as
specified in the Schedule of Activities. Participants in Part 2 will receive guselkumab treatment
through Week 52. This phase of the study will begin for participants ≥12 years of age after the
safety and PK reviews in Part 1a have been completed, and an appropriate body weight-based dose
that matches adult exposure has been confirmed. Enrollment of participants ≥6 to <12 years of age
into Part 2 will not occur until all participants in Part 1b have completed 16 weeks of treatment
and all efficacy data through Week 16 from Part 1 have been evaluated by the sponsor after the
Week 16 DBL, and all available safety data have been reviewed by the independent DMC.
In Part 2 of the main study, participants or their caregiver will be given the option to self-administer
study injections at the study site using the appropriate presentation (PFS-U or
). Participants
must be at least 12 years of age to self-administer study injections. Participants or their caregivers
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will be trained on proper use of the device(s) and deemed capable, as determined by study staff.
Otherwise injections will continue to be performed by study staff.
Long-Term Extension Phase
Following completion of the Week 52 visit, participants who have had a beneficial response from
guselkumab treatment as determined by the investigator, and are willing to continue guselkumab
treatment, may enter the LTE of the study. Participants who decide to participate in the LTE will
continue to receive guselkumab q8w until one of the following occurs:
The participant turns 18 years of age and resides in a country where marketing authorization
has been granted for guselkumab treatment of plaque psoriasis in adult patients, and have had
the opportunity to complete up to 1 year in the LTE.
Marketing authorization is obtained for guselkumab for treatment of plaque psoriasis for
patients ≥6 to <18 years of age in the participant’s country of residence.
Marketing authorization is denied for guselkumab for the treatment of plaque psoriasis for
patients ≥6 to <18 years of age in the participant’s country of residence.
A company decision is made to no longer pursue an indication in plaque psoriasis in the
pediatric population (≥6 to <18 years of age) in the participant’s country of residence.
All participants will begin q8w administration of guselkumab at Week 52, except for participants
who have initiated or been retreated with guselkumab prior to Week 48 and receive a guselkumab
injection at Week 48. Those participants will receive their first dose of guselkumab in the LTE at
Week 60 and q8w thereafter. Participants who are retreated with or initiate guselkumab treatment
at Week 48 will also receive a guselkumab dose at Week 52 followed by q8w administration
beginning at Week 60. The same guidance for self-administration in Part 2 applies to the LTE.
Safety Follow-Up
Participants should return to the study site at least 12 weeks after their last dose of study
intervention  for a safety follow-up visit. This includes participants who discontinue study
intervention administration in the main study or the LTE, and participants who receive their final
dose of guselkumab at the final dosing visit of the LTE (see Section 8, Study Assessments and
Procedures). Assessments listed in the study termination visit entry of the Schedule of Activities
should be completed.
Sample Collection and Handling
The actual dates and times of sample collection must be recorded in the CRF or laboratory
requisition form.
Refer to the Schedule of Activities for the timing and frequency of all sample collections.
Instructions for the collection, handling, storage, and shipment of samples are found in the
Laboratory Manual that will be provided. Collection, handling, storage, and shipment of samples
must be under the specified, and where applicable, controlled temperature conditions as indicated
in the Laboratory Manual.

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Study-Specific Materials
The investigator will be provided with the following supplies:
Investigator's Brochure for guselkumab
Package Leaflet for etanercept
Site Investigational Product Procedures Manual
Laboratory Manual
IWRS Manual
Electronic Data Capture (eDC) Manual
Sample ICF
iPad® and site user guide, if the study site is participating in electronic informed consent
PFS-U and 
 Instructions for Use
Participant Study Participation Card
Investigative Site File
Recruitment materials, as needed
The following assessments are included as appendices to the protocol.
Faces Pain Scale-Revised for Injection Pain
Injection Pain Visual Analog Scale
Investigator’s Global Assessment
Psoriasis Area and Severity Index
Children’s Dermatology Life Quality Index
Family Dermatology Life Quality Index
Columbia-Suicide Severity Rating Scale (Children’s Baseline)
Columbia-Suicide Severity Rating Scale (Baseline/Screening)
Columbia-Suicide Severity Rating Scale (Children’s Since Last Visit)
Columbia-Suicide Severity Rating Scale (Since Last Visit)
8.1. 
Efficacy Assessments
Efficacy evaluations are consistent with those used to evaluate other therapies for plaque psoriasis
and will include the following:
IGA
CCI
CCI
CCI

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PASI
BSA
CDLQI
FDLQI
8.1.1. 
Investigator’s Global Assessment
The IGA documents the investigator’s assessment of the participant’s plaque psoriasis at a given
timepoint (Appendix 7 [Section 10.7]). Overall lesions are graded for induration, erythema, and
scaling. The patient’s plaque psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate
(3), or severe (4). A higher score indicates more severe disease.
8.1.2. 
Psoriasis Area and Severity Index
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their
response to therapy (Appendix 8 [Section 10.8]).13 In the PASI system, the body is divided into 4
regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed
separately for the percentage of the area involved, which translates to a numeric score that ranges
from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration,
and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that
could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
8.1.3. 
Body Surface Area
The percentage of a participant’s total body surface area affected by psoriasis will be assessed.
8.1.4. 
Children’s Dermatology Life Quality Index
The CDLQI is an adapted version of the Dermatology Life Quality Index (DLQI) for the pediatric
population. The adaption and validation of the CDLQI was undertaken by the original developer
of the DLQI to ensure it addressed the specific needs of the pediatric population.20 The CDLQI
questionnaire is frequently used to assess the patient’s perspective on the impact of skin disorders
on daily living.20,25 The development of the instrument included a wide variety of dermatologic
conditions.12 The content validity and other psychometric properties were further assessed in a
subsequent study in patients with plaque psoriasis.11 Additional validation work was completed on
the children’s version.20 The CDLQI, a 10-item instrument, has 4 item response options and a
recall period of 1 week. The instrument is designed for use in children (ie, participants from 4 to
16 years of age), is self-explanatory and can be simply handed to the participant who is asked to
fill it in with the help of the child's parent or caregiver. A sample CDLQI is provided in Appendix 9
(Section 10.9).
8.1.5. 
Family Dermatology Life Quality Index
The FDLQI is a dermatology-specific QoL instrument for the family members of patients having
any skin disease.2,3 It has 10 items asking the family members/partners about the impact of a
patient’s skin disease on different aspects of their QoL (e.g. emotional, physical well-being,
relationships, social life, leisure activities, burden of care, job/study, housework and expenditure).

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The frame of reference for items is over the last 1 month. Each item has a four-point response
option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The
scores of individual items (0–3) are added to give a total scale score that ranges from 0 to 30; a
higher score indicates greater impairment of QoL. The FDLQI is designed to be used as an
additional outcome measure in conjunction with the DLQI or any other patient-completed
questionnaire. This instrument should be completed by a participant’s primary care-giver.
A sample FDLQI is provided in Appendix 10 (Section 10.10).
8.1.6. 
Blinded Efficacy Evaluator
A blinded efficacy evaluator, qualified by the sponsor, will be designated at each  study site to
perform all PASI, IGA, and BSA efficacy assessments, including the screening visit. Blinded
efficacy evaluation will be performed in both Part 1 and Part 2 of the study until all participants in
Part 1 complete their Week 16 visit and the Week 16 database lock is completed.
The blinded efficacy evaluator should have no contact with the participant during the study other
than the efficacy assessments, should not discuss the participant’s treatment with the participant,
participant’s caregiver, or other site personnel at any time, and will not be permitted to review the
participant’s medical records, questionnaires, or the electronic CRF prior to each assessment. The
blinded efficacy evaluator should be documented in the source documents at each visit.
The sponsor will provide PASI, IGA, and BSA training for each site’s designated efficacy
evaluator(s) prior to the screening of the first participant at each site. If the efficacy evaluator was
trained by the Sponsor in a previous clinical study and there is adequate documentation of this
training (certification), that training will be considered adequate for this study; however, repeat
training prior to start of the study is encouraged. Training documentation of each efficacy evaluator
should be maintained at the study site.
All efficacy evaluators at a site must be listed on the Delegation Log at the study.
8.2. 
Safety Assessments
Adverse events will be reported by the participant (or, when appropriate, by a caregiver or the
participant's legally acceptable representative) for the duration of the study and will be followed
by the investigator as specified in Section 8.3, Adverse Events and Serious Adverse Events and
Appendix 4 (Section 10.4), Adverse Events: Definitions and Procedures for Recording,
Evaluating, Follow-Up, and Reporting.
Any clinically relevant changes occurring during the study must be recorded on the Adverse Event
section of the CRF.
Any clinically significant abnormalities persisting at the end of the study/early withdrawal will be
followed by the investigator until resolution or until a clinically stable endpoint is reached.
The study will include the following evaluations of safety and tolerability according to the time
points provided in the Schedule of Activities:

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8.2.1. 
Physical Examination
Physical Examination
Physical examinations, including Tanner staging every 12 months for sexual maturity, and a skin
examination, will be performed according to the Schedule of Activities. Review of systems will
be performed at all visits to evaluate for new symptomatology and if necessary, full physical
examination may be performed at investigator discretion. Any clinically significant abnormalities
persisting at the end of the study will be followed by the investigator until resolution or until
reaching a clinically stable endpoint.
Height and Weight
Height and weight will be measured as specified in the Schedules of Activities. Participants will
be instructed to remove shoes and outdoor apparel and gear prior to these measurements.
8.2.2. 
Vital Signs
Heart rate, blood pressure, and temperature will be measured.
8.2.3. 
Clinical Safety Laboratory Assessments
Blood samples for serum chemistry and hematology will be collected as noted in Appendix 11
(Section 10.11), Clinical Laboratory Tests. The investigator must review the laboratory results,
document this review, and record any clinically relevant changes occurring during the study in the
adverse event section of the CRF. The laboratory reports must be filed with the source documents.
During the study, all abnormal laboratory values will require further explanation from the
investigator. Clinically significant abnormal laboratory values should be repeated until they return
to normal or are otherwise explained by the investigator.
If laboratory testing for a participant who is enrolled in the study and receiving study intervention
reveals an increase of serum aminotransferases (ALT or AST) to >3 x ULN, see Appendix 12
(Section 10.12; Guideline Algorithm for Monitoring, Assessment, and Evaluation of Abnormal
Liver Tests in Participants with No Underlying Liver Disease) for information on monitoring and
assessment of abnormal liver function tests.
8.2.4. 
Columbia-Suicide Severity Rating Scale (C-SSRS)
In light of the recent reports concerning suicidal ideation and behavior in adult patients with plaque
psoriasis treated with an IL-17R antagonist (brodalumab),9 the C-SSRS will be used as a screening
tool to prospectively evaluate the potential of guselkumab to induce suicidal ideation and behavior
in children and adolescents ≥6 to <18 years of age. The C-SSRS is an investigator-administered
questionnaire that defines 5 subtypes of suicidal ideation and four possible suicidal behaviors, as
well as non-suicidal self-injurious behavior (NSSIB) and completed suicide.23,27 Four versions of
the C-SSRS will be used in this study, a Baseline version to be completed at screening by children
≥6 to <12 years of age (Appendix 13, Section 10.13), a Baseline/Screening version to be completed
by adolescents ≥12 years of age (Appendix 14, Section 10.14), a Children’s Since Last Visit
version to be completed at all other visits (Appendix 15, Section 10.15), and a Since Last Visit

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version for adolescents (Appendix 16, Section 10.16). The children’s version should be used for
participants ≥6 to <12 years of age and the standard version for adolescents ≥12 years of age. The
‘Baseline’ and ‘Baseline/Screening’ versions of the C-SSRS will be conducted during the
screening visit followed by the ‘Since Last Visit’ versions of the C-SSRS at all other visits through
the end of the study. Participants who are <12 years of age when enrolled in the study should
continue using the children’s ‘Since Last Visit’ version of the C-SSRS for the entire duration of
the study.
The investigator or trained study site personnel will interview the participant and complete the
C-SSRS. The investigator and study site personnel will be trained to administer the C-SSRS. The
C-SSRS will be provided in the local languages in accordance with local guidelines.
The C-SSRS will be performed during each evaluation visit according to the assessment schedule
and should be performed after the CDLQI and before any other study procedure (except at
screening where C-SSRS is the first assessment after signing informed consent). Participants will
be interviewed by the investigator or study site personnel in a private, quiet place.
At the conclusion of each assessment, the trained personnel administering the C-SSRS will
determine the level of suicidal ideation or behavior, if any. They will then determine the next
course of action if any level of suicidal ideation or behavior is reported. The participant should not
be released from the site until the C-SSRS has been reviewed and the participant’s risk has been
assessed and follow-up determined, as appropriate.
At screening, the necessary course of action is indicated below by age category and C-SSRS
result:
Participants ≥12 to <18 years of age who have one of the following C-SSRS ratings may not
be randomized into the study:
a C-SSRS rating at screening of: Suicidal ideation with intention to act (“Ideation level
4”), Suicidal ideation with specific plan and intent (“Ideation level 5”), or non-suicidal
self-injurious behavior within the past 6 months, OR
a C-SSRS rating of suicidal behavior (actual suicide attempt, interrupted suicide attempt,
aborted suicide attempt, or preparatory behaviors for making a suicide attempt) ever
(lifetime)
Participants ≥6 to <12 years of age who have one of the following C-SSRS ratings may not
be randomized into the study:
a C-SSRS rating at screening of: Suicidal ideation with intention to act (“Ideation level
4”), Suicidal ideation with specific plan and intent (“Ideation level 5”), or any
self-injurious behavior ever (lifetime), OR
a C-SSRS rating of suicidal behavior (actual suicide attempt, interrupted suicide attempt,
aborted suicide attempt, or preparatory behaviors for making a suicide attempt) ever
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For C-SSRS ratings of Wish to be Dead (“Ideation level 1”), Non-Specific Active Suicidal
Thoughts (“Ideation level 2”), or Active Suicidal Ideation with Any Methods (Not Plan)
without Intent to Act (“Ideation level 3”):
o a participant ≥12 to <18 years of age who has had one of the above C-SSRS ratings
within the past 6 months must be determined not to be at risk by the investigator and
discussed with the medical monitor or designee in order to be randomized.
o a participant ≥6 to <12 years of age who has had one of the above C-SSRS ratings
ever (lifetime) must be determined not to be at risk by the investigator and discussed
with the medical monitor or designee in order to be randomized.
At Week 0, the above guidance applies with the time frame of “since last visit”.  Any questions
regarding eligibility of participants should be discussed with the medical monitor or designee.
For each assessment after Week 0, the following actions should be taken for all age groups, if
applicable:
No suicidal ideation, suicidal behavior, or other self-injurious behavior: No further action is
needed.
Suicidal ideation levels 1-3: Participant risk is assessed by the investigator.
Suicidal ideation levels 4 or 5 or any suicidal or self-injurious behavior: Participant risk is
assessed and referral is made to a mental health professional.
Interruption or discontinuation of study treatment should be considered for any participant with
any type of suicidal ideation or behavior, or any self-injurious behavior, who is deemed to be at
risk by the investigator. Participants with any type of ideation or behavior reported during
treatment with the study intervention must be discussed with the medical monitor or designee to
determine if study intervention can be continued (see Section 7.1, Discontinuation of Study
Intervention). For participants who report suicidal ideation with intention to act (“Ideation level
4”), suicidal ideation with specific plan and intent (“Ideation level 5”), suicidal behavior (actual
suicide attempt, interrupted suicide attempt, aborted suicide attempt, or preparatory behaviors for
making a suicide attempt) or any self-injurious behavior on a post-baseline C-SSRS assessment,
the investigator risk assessment must be based upon evaluation by a mental health professional
(eg, psychiatrist, psychologist, or appropriately trained social worker or nurse). For participants
who are referred to a mental health professional for evaluation, if that participant can be adequately
treated with psychotherapy and/or pharmacotherapy based on the judgment of the mental health
professional, then the participant, at the discretion of the investigator, may continue to receive
study treatment if agreed to by the medical monitor or designee.
Any C-SSRS finding, which in the opinion of the investigator is new or considered to be a
worsening and clinically significant, should be reported on the AE CRF (see Appendix 4
[Section 10.4], Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-
up, and Reporting).

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8.2.5. 
Immunogenicity Assessments
Anti-guselkumab  antibodies will be evaluated in serum samples collected from all participants
according to the Schedule of Activities. Additionally, serum samples should also be collected at
the final visit from participants who are discontinued from intervention or withdrawn from the
study. These samples will be tested by the sponsor or sponsor's designee.
Samples that test positive for antibodies to guselkumab will be further characterized to determine
if antibodies to guselkumab could neutralize the biological effects of guselkumab in vitro
(ie, NAbs to guselkumab). All samples will be tested by the sponsor or sponsor's designee.
8.2.6. 
Concomitant Medication Review
Concomitant medications will be reviewed at each visit.
8.2.7. 
Injection-site Reactions
A study intervention injection-site reaction is any adverse reaction at an SC study intervention
injection site. The injection sites will be evaluated for reactions and any injection-site reactions
will be recorded as an AE. In addition, the duration of adverse events of injection site reactions,
including injection-site pain, will be captured with the standard AE information which includes
information on the start and end date, as well as the start and end time of the AE. Discontinuations
due to injection-site reactions, including injection-site pain, will also be recorded.
8.2.8. 
Injection Pain
Pain experienced during study intervention injection will be assessed using the Faces Pain Scale-
Revised for children ≥6 to <12 years of age (Appendix 17, Section 10.17), and the linear Injection
Pain Visual Analog Scale for children ≥12 to <18 years of age (Appendix 18, Section 10.18).31,33
8.2.9. 
Allergic Reactions
All participants must be observed carefully for symptoms of an allergic reaction (eg, urticaria,
itching, hives) for at least 30 minutes after study intervention injection for all injections performed
at the study site.
Participants with reactions following an injection resulting in bronchospasm with wheezing
and/or dyspnea requiring ventilatory support, or symptomatic hypotension (defined as a
systolic BP < [70 + (2 x age in years])30, will not be permitted to receive any additional study
intervention injections.
8.2.10. 
Early Detection of Active Tuberculosis
To aid in the early detection of new active TB infection during study participation, participants
must be evaluated for signs and symptoms of active TB at each scheduled visit (refer to Schedule
of Activities). The following series of questions is suggested for use during the evaluation:
“Has your child had a new cough of > 14 days’ duration or a change in a chronic cough?”
“Has your child had any of the following symptoms:

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Persistent fever?
Unintentional weight loss?
Night sweats?”
“Has your child had close contact with an individual with active TB?” (If there is uncertainty
as to whether a contact should be considered “close,” a physician specializing in TB should
be consulted.)
Participants who experience close contact with an individual with active TB during the conduct of
the study must have a repeat QuantiFERON®-TB test, a repeat tuberculin skin test in countries in
which the QuantiFERON®-TB test is not approved/registered or the tuberculin skin test is
mandated by local health authorities, and, if possible, referral to a physician specializing in TB to
determine the participant’s risk of developing active TB and whether treatment for latent TB is
warranted. If the QuantiFERON®-TB test result is indeterminate or suspected false-positive, the
test should be repeated (with expert consultation, as applicable) as outlined under Screening Phase
in Section 8, Study Assessments and Procedures.
If the evaluation raises suspicion that a participant may have TB reactivation or new (active or
latent) TB infection, no additional study intervention  should be given, and an immediate and
thorough investigation should be undertaken, including, where possible, consultation with a
physician specializing in TB.
Investigators should be aware that TB reactivation in immunocompromised participants may
present as disseminated disease or with extrapulmonary features. Participants with evidence of
active TB should be referred for appropriate treatment.
8.3. 
Adverse Events and Serious Adverse Events
Timely, accurate, and complete reporting and analysis ofsafety information from clinical studies
are crucial for the protection of participants, investigators, and the sponsor, and are mandated by
regulatory agencies worldwide. The sponsor has established Standard Operating Procedures in
conformity with regulatory requirements worldwide to ensure appropriate reporting of safety
information; all clinical studies conducted by the sponsor or its affiliates will be conducted in
accordance with those procedures.
Adverse events will be reported by the participant (or, when appropriate, by a caregiver or the
participant's legally acceptable representative) for the duration of the study.
Anticipated events will be recorded and reported as described in Appendix 19, Section 10.19.
For further details on adverse events and serious adverse events (Definitions and Classifications;
Attribution Definitions; Severity Criteria; Special Reporting Situations; Procedures) as well as
product quality complaints, refer to Appendix 4 (Section 10.4), Adverse Events: Definitions and
Procedures for Recording, Evaluating, Follow-Up, and Reporting.

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8.3.1. 
Time Period and Frequency for Collecting Adverse Events and
Serious Adverse Event Information
8.3.1.1. 
All Adverse Events
All adverse events and special reporting situations, whether serious or non-serious, will be reported
from the time a signed and dated ICF is obtained until completion of the participant's last
study-related procedure, which may include contact for follow-up of safety. Serious adverse
events, including those spontaneously reported to the investigator within 12 weeks after the last
dose of study intervention, must be reported using the Serious Adverse Event Form. The sponsor
will evaluate any safety information that is spontaneously reported by an investigator beyond the
time frame specified in the protocol.
All events that meet the definition of a serious adverse event will be reported as serious adverse
events. Anticipated events will be recorded and reported as described in  Appendix 19,
Section 10.19.
All adverse events, regardless of seriousness, severity, or presumed relationship to study
intervention, must be recorded using medical terminology in the source document and the CRF.
Whenever possible, diagnoses should be given when signs and symptoms are due to a common
etiology (eg, cough, runny nose, sneezing, sore throat, and head congestion should be reported as
"upper respiratory infection"). Investigators must record in the CRF their opinion concerning the
relationship of the adverse event to study therapy. All measures required for adverse event
management must be recorded in the source document and reported according to sponsor
instructions.
All SAEs and nonserious AEs that represent events of suicidal ideation or suicidal behavior,
including any of the following diagnoses, must be reported to the sponsor following the procedures
outlined in Section 8.3.1.2:
Suicidal ideation
Suicidal behavior, including completed suicide
Self-injurious behavior
For all studies with an outpatient phase, including open-label studies, the participant must be
provided with a "wallet (study) card" and instructed to carry this card with them for the duration
of the study indicating the following:
Study number
Statement, in the local language(s), that the participant is participating in a clinical study
Investigator's name and 24-hour contact telephone number
Local sponsor's name and 24-hour contact telephone number (for medical staff only)
Site number
Participant number

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Any other information that is required to do an emergency breaking of the blind
8.3.1.2. 
Serious Adverse Events
All serious adverse events occurring during the study must be reported to the appropriate sponsor
contact person by study-site personnel within 24 hours oftheir knowledge of the event.
Information regarding serious adverse events will be transmitted to the sponsor using the Serious
Adverse Event Form, which must be completed and signed by a physician from the study site, and
transmitted to the sponsor within 24 hours. The initial and follow-up reports of a serious adverse
event should be made by facsimile (fax).
Suspected transmission of an infectious agent by a medicinal product will be reported as a serious
adverse event. Any event requiring hospitalization (or prolongation of hospitalization) that occurs
during the course of a participant's participation in a study must be reported as a serious adverse
event, except hospitalizations for the following:
Hospitalizations not intended to treat an acute illness or adverse event (eg, social reasons such
as pending placement in long-term care facility)
Surgery or procedure planned before entry into the study (must be documented in the CRF).
Note: Hospitalizations that were planned before the signing of the ICF, and where the
underlying condition for which the hospitalization was planned has not worsened, will not be
considered serious adverse events. Any adverse event that results in a prolongation of the
originally planned hospitalization is to be reported as a new serious adverse event.
Any possible Hy’s law case (AST or ALT ≥ 3X ULN together with bilirubin ≥ 2X ULN or INR
>1.5 if measured) is considered an important medical event and must be reported to the sponsor in
an expedited manner using the Serious Adverse Event form, even before all other possible causes
of liver injury have been excluded (INR criterion is not applicable to participants receiving
anticoagulants).
The cause of death of a participant in a study within 12 weeks of the last dose of study intervention,
whether or not the event is expected or associated with the study intervention, is considered a
serious adverse event.
8.3.2. 
Follow-up of Adverse Events and Serious Adverse Events
Adverse events, including pregnancy, will be followed by the investigator as specified in
Appendix 4 (Section 10.4), Adverse Events: Definitions and Procedures for Recording,
Evaluating, Follow-up, and Reporting.
All SAEs that have not resolved by the end of the study, or that have not resolved upon
discontinuation of the participant's participation in the study, must be followed until any of the
following occurs:
The event resolves
The event stabilizes

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The event returns to baseline, if a baseline value/status is available
The event can be attributed to agents other than the study intervention or to factors unrelated
to study conduct
It becomes unlikely that any additional information can be obtained (participant or health care
practitioner refusal to provide additional information, lost to follow-up after demonstration of
due diligence with follow-up efforts)
8.3.3. 
Regulatory Reporting Requirements for Serious Adverse Events and
Anticipated Events
The sponsor assumes responsibility for appropriate reporting of the Safety Information  to the
regulatory authorities/IECs/IRBs in each respective country/territory, as applicable. The sponsor
will also report to the investigator (and the head of the investigational institute where required) all
suspected unexpected serious adverse reactions (SUSARs). For anticipated events reported as
individual serious adverse events the sponsor will make a determination of relatedness in addition
to and independent of the investigator’s assessment. The sponsor will periodically evaluate the
accumulating data and, when there is sufficient evidence and the sponsor has determined there is
a reasonable possibility that the intervention caused a serious anticipated event, they will submit a
safety report in narrative format to the investigators (and the head of the institute where required).
The sponsor assumes responsibility for appropriate reporting of anticipated events to the regulatory
authorities according to requirements of the countries in which the studies are conducted. The
investigator (or sponsor where required) must report SUSARs to the appropriate Independent
Ethics Committee/Institutional Review Board (IEC/IRB) that approved the protocol unless
otherwise required and documented by the IEC/IRB. A SUSAR will be reported to regulatory
authorities unblinded. Participating investigators and IEC/IRB will receive a blinded SUSAR
summary, unless otherwise specified.
8.3.4. 
Pregnancy
All initial reports of pregnancy in female participants or partners of male participants must be
reported to the sponsor by the study-site personnel within 24 hours of their knowledge of the event
using the appropriate pregnancy notification form and reported as an adverse event in the CRF.
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital
anomalies, ectopic pregnancy) are considered serious adverse events and must be reported using
the Serious Adverse Event Form. Any participant who becomes pregnant during the study must
discontinue further study intervention.
Because the effect of the study intervention on sperm is unknown, pregnancies in partners of male
participants included in the study will be reported as noted above.
Follow-up information regarding the outcome of the pregnancy and any postnatal sequelae in the
infant will be required.
8.3.5. 
Events of Special Interest
Any newly identified malignancy or case of active TB occurring after the first administration of
study intervention(s) in participants participating in this clinical study must be reported by the

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investigator according to the procedures in Section 8.3.1.2. Investigators are also advised that
active TB is considered a reportable disease in most countries. These events are to be considered
serious only if they meet the definition of an SAE.
8.4. 
Treatment of Overdose
For this study, any dose ofguselkumab or etanercept greater than twice the weight-based dose of
study intervention described in Section 6.1, Study Interventions Administered, within a 24-hour
time period will be considered an overdose.
As all blinded study interventions will be administered at the study site, overdoses are unlikely to
occur. In the event of an overdose, the investigator or treating physician should closely monitor
the participant for any signs or symptoms of adverse reaction(s) and administer appropriate
symptomatic treatment immediately.
8.5. 
Pharmacokinetics
Blood samples will be collected for the measurement of serum guselkumab concentrations and
evaluation of antibodies to guselkumab at the timepoints presented in the Schedules of Activities.
Serum samples will also be collected at the final visit from participants who terminate study
participation early. Blood samples collected for serum guselkumab concentrations may also be
used for exploratory biomarker analyses.
Serum guselkumab concentrations will also be used for population PK modelling to characterize
the PK of guselkumab in this pediatric population and for exposure-response modeling and
simulation analysis. These analyses will be presented in a separate technical report.
Evaluations
Samples of approximately 2.5 mLfor PKonly evaluations will be collected and each serum sample
will be divided into 2 aliquots (1 for serum guselkumab concentration and 1 for back-up). Venous
blood samples of approximately 3.5 mL for both PK and immunogenicity evaluations will be
collected and each serum sample will be divided into 3 aliquots (1 for serum guselkumab
concentration, 1 for antibodies to guselkumab, and 1 for back-up). Samples collected for analyses
of guselkumab  serum concentration and antibodies to guselkumab may additionally be used to
evaluate safety or efficacy aspects that address concerns arising during or after the study period,
or for further characterization of immunogenicity. Samples must be collected before study
intervention administration at visits when a study intervention administration is scheduled. The
exact dates and times of blood sample collection must be recorded in the laboratory requisition
form. See the Laboratory Manual for further information regarding collection, handling, and
shipment of biological samples. Genetic analyses will not be performed on these serum samples.
Participant confidentiality will be maintained.
Pharmacokinetic Analytical Procedures
Serum samples will be analyzed to determine serum guselkumab concentrations using a validated,
specific, and sensitive immunoassay method by the sponsor’s bioanalytical facility or under the

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supervision of the sponsor. The sponsor, or its designee, under conditions in which the participants’
identity remains blinded, will assay these samples.
8.6. 
Pharmacodynamics
Pharmacodynamics are not evaluated in this study.
8.7. 
Genetics
Genetics are not evaluated in this study.
8.8. 
Biomarkers
Biomarkers are not evaluated in this study. However, blood samples collected for serum
guselkumab concentrations may be used for exploratory biomarker analyses.
8.9. 
Medical Resource Utilization and Health Economics
Medical Resource Utilization and Health Economics parameters are not evaluated in this study.
8.10. Usability Assessment
In Part 2 of the main study and in the LTE, pediatric participants ≥12 years of age and caregivers
of pediatric participants of any age will be given the option to administer study intervention.
For participants or caregivers using the 
 a 
 will be completed by study  staff to assess
whether the user is able to correctly administer the injection. Based on this information, the study
staff will determine whether the participant (≥12 years of age) or their caregiver is able to
administer the injection in a home-like setting at the site.
Following subsequent independent self- or caregiver- administrations with the
, all study
participants performing the injection will be asked to complete a 
 If the injections have been performed by the caregiver,
the questionnaire will be completed by the caregiver. If the injections have been performed by the
participant, the participant will complete the questionnaire with parent or caregiver assistance, if
needed.
9. 
STATISTICAL CONSIDERATIONS
Statistical analysis will be done by the sponsor or under the authority of the sponsor. A general
description of the statistical methods to be used to analyze the efficacy and safety data is outlined
below. Specific details will be provided in the Statistical Analysis Plan (SAP).
Descriptive statistics will include counts and proportions for categorical data, and median, mean,
interquartile range, and range for continuous data. Life table estimates will be provided for the
time to event variables. Graphical data displays may also be used to summarize the data.
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Fisher’s exact test, stratified by age and region, will be used to compare the proportion of
participants responding to treatment. Continuous response parameters will be compared using a
Mixed effect Model Repeat Measurement (MMRM) analysis or an analysis of covariance
(ANOVA) model, adjusting for baseline value, age group, and region. All statistical testing will
be performed 2-sided at a significance level of 0.05.
In general, the baseline measurement is defined as the closest measurement taken at or before
Week 0.
9.1. 
Statistical Hypotheses
The primary hypothesis is that guselkumab treatment is superior to placebo as assessed by the
proportion of participants achieving an IGA score of cleared (0) or minimal (1) and the proportion
of participants achieving a PASI 75 response at Week 16.
The major secondary hypotheses are that guselkumab treatment is:
superior to placebo as assessed by the proportion of participants achieving a PASI 90 response
at Week 16.
superior to placebo as assessed by the proportion of participants achieving an IGA score of
cleared (0) at Week 16.
superior to placebo as assessed by the proportion of participants achieving a PASI 100
response at Week 16.
superior to placebo in improving the dermatologic health-related quality of life in pediatric
participants as assessed by the change from baseline in CDLQI at Week 16.
9.2. 
Sample Size Determination
The assumptions for the sample size calculations for Part 1 of the study are based on the historical
response rates from the adults and/or pediatric studies for placebo, guselkumab and the active
comparator, etanercept. A power of at least 99% is targeted for the guselkumab versus placebo
comparisons for the co-primary endpoints while a power of at least 81%  is targeted for the
etanercept versus placebo comparisons. Hereby, it is to be acknowledged that etanercept has
already been established as an efficacious therapeutic agent for the treatment of pediatric plaque
psoriasis. The etanercept active comparator arm is thus included as a “benchmark” (ie, assessment
of the efficacy of etanercept compared to placebo is intended to help internally validate the overall
results of the pediatric psoriasis study). No formal efficacy comparisons between etanercept and
guselkumab will be performed because the relatively small number of participants does not provide
sufficient power to detect a difference between these two active treatment groups.
Assumptions for Placebo Response Rates
Across completed adult studies in moderate to severe plaque psoriasis, the placebo response rates
for the endpoint of PGA (0 or 1) have varied between 3.9% and 8.5%, and PASI 75 rates have
varied between 3.1% and 8.1% for clinical studies of ENBREL, STELARA, guselkumab, and
HUMIRA. In the completed pediatric plaque psoriasis studies (ENBREL, STELARA), the placebo

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response rates were slightly higher. The PGA responder (0 or 1) rates were 13% and 5.4%, while
the PASI 75 rates were 11% and 10.8%, respectively.18,25 Therefore, based on consideration of all
the available data, an assumption of a 13% placebo response rate for both IGA 0/1 and PASI 75
was utilized for the proposed guselkumab pediatric study.
Assumptions for Guselkumab Response Rates
The IGA responder (0 or 1) rates in the active treatment arm of the adult guselkumab Phase 3
studies (CNTO1959PSO3001 and CNTO1959PSO3002) were 85.1% and 84.1%, respectively,
and the PASI 75 rates were 91.2% and 86.3%, respectively. For the proposed pediatric study, a
range of the response rates from 65% to 85% for both IGA 0/1 and PASI 75 in the guselkumab
treatment group were utilized.
Power for Guselkumab and Placebo Comparisons
At baseline in Part 1, approximately 40 participants (30 in Part 1a and 10 in Part 1b) will be
randomized to guselkumab, and approximately 25 participants (15 in Part 1a and 10 in Part 1b)
will be randomized to placebo.
As shown in Table 4, with the conservative assumptions of response rates of 65% in the
guselkumab treatment group and 13% in the placebo group, the proposed 40 participants in the
guselkumab group and 25 in the placebo group provide at least 99% power to detect a significant
difference in the proportion of IGA responders (0 or 1) and PASI 75 responders at Week 16
separately between the guselkumab and placebo treatment groups at a 2-sided significance level
of 0.05. These sample sizes are also chosen to ensure sufficient power for major secondary
endpoints.
Table 4: 
Power to Detect a Treatment Effect for Guselkumab Based on Different Assumptions of
Response Rates
Endpoint
Power
IGA Score of 0 or 1/PASI 75 at Week 16
Placebo 
(n=25) 
Guselkumab
(n=40)
13%  
65% 
>99%
13%  
70% 
>99%
13%  
75% 
>99%
13%  
85%  
>99%
IGA=Investigator’s Global Assessment; PASI=Psoriasis Area and Severity Index
Assumptions for Etanercept Response Rates
The PGA responder (0 or 1) rate in the etanercept group of the etanercept pediatric plaque psoriasis
study was 53% and the PASI 75 rate was 57%.25 Therefore, a range of response rates from 53% to
60% for both IGA 0/1 and PASI 75 in the etanercept active comparator treatment group is utilized
for the proposed pediatric study.

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Power for Etanercept and Placebo Comparisons
With approximately 25 participants (15 in Part 1a and 10 in Part 1b) randomized to receive
etanercept, and approximately 25 participants (15 in Part 1a and 10 in Part 1b) in the placebo
group, there will be at least 81% power to detect a significant difference in the proportion of IGA
responders (0 or 1) and PASI 75 responders at Week 16 separately between etanercept and placebo
treatment groups at a 2-sided significance level of 0.05 (Table 5).
Table 5: 
Power to Detect a Treatment Effect for Etanercept Based on Different Assumptions of
Response Rates
Endpoint
Power
IGA Score of 0 or 1/PASI 75 at Week 16 
Placebo 
(n=25) 
Etanercept
(n=25)
13%  
53%  
81%
13%  
55%  
85%
13%  
60% 
92%
IGA=Investigator’s Global Assessment; PASI=Psoriasis Area and Severity Index
In Part 2, at least 10 participants will be enrolled, and will depend on the number of participants
in Part 1 who are exposed to guselkumab, to ensure a total of at least 100 participants from Part 1
and Part 2 will be exposed to guselkumab in this study.
9.3. 
Populations for Analyses
Descriptive statistics will be provided for participant disposition, demographics, baseline disease
characteristics, and prior psoriasis medications for all participants randomized in Part 1 and all
participants enrolled in Part 2. Details will be provided in the SAP.
9.4. 
Statistical Analyses
9.4.1. 
Efficacy Analyses
9.4.1.1. 
Analysis Data Set
For the efficacy analyses, all randomized participants in Part 1 will be included. Participants will
be analyzed according to the treatment group to which they were randomized, regardless of the
treatment they actually received. In addition, efficacy summaries will also be provided for
participants enrolled in Part 2.
9.4.1.2. 
Efficacy Definitions
Treatment Failure: Participants who discontinue study treatment due to lack of efficacy or an AE
of worsening of psoriasis, or who started a protocol-prohibited medication/therapy during the study
that could improve psoriasis are considered treatment failures. The treatment failure rules will be
documented in detail in the SAP.
PASI 50 Responders: Participants with ≥50% improvement in PASI from baseline.
PASI 75 Responders: Participants with ≥75% improvement in PASI from baseline.

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PASI 90 Responders: Participants with ≥90% improvement in PASI from baseline.
PASI 100 Responders: Participants with 100% improvement in PASI from baseline.
Loss of PASI 90 Response: Defined as <90% improvement in PASI from baseline after Week 16
in a participant who had achieved ≥90% improvement in PASI from baseline at Week 16.
Loss of 50% of PASI Improvement: Defined as a loss of ≥50% of the improvement in PASI at
Week 16 after treatment is withdrawn.
9.4.1.3. 
Primary Analysis
There are 2 primary estimands corresponding to the 2 co-primary endpoints in this study for
participants randomized in Part 1 of this study: the proportion of participants who achieve an IGA
score of cleared (0) or minimal (1) and the proportion of participants who achieve a PASI 75
response at Week 16. These 2 co-primary endpoints will be compared between the guselkumab
group and the placebo group. In the primary efficacy analysis, data from all randomized
participants will be analyzed according to their assigned treatment group. Participants who meet
treatment failure criteria or initiate use with a low to high potency topical steroid as rescue
treatment before Week 16 will be considered nonresponders for the primary endpoints at Week 16.
In addition, participants who do not return for evaluation at Week 16 will be considered
nonresponders at Week 16.
To address the primary objective, a 2-sided (α=0.05) Fisher’s exact test, stratified by age and
region, will be used for the co-primary endpoints. The exact 95% confidence interval for treatment
difference between guselkumab and placebo treatment groups will be provided.
The study will be considered positive if the guselkumab group is significantly different from the
placebo group for both co-primary endpoints. If one of the comparisons is not significant at the
2-sided α-level of 0.05, the co-primary endpoints will be considered not significant.
In addition, the comparison between etanercept and placebo for the co-primary endpoints will be
performed and nominal p-values will be reported.
Subgroup analyses will be performed to evaluate consistency of the co-primary endpoints over
demographics (including baseline weight), baseline disease characteristics and prior medications.
Sensitivity analyses and per-protocol analysis will be performed for the co-primary endpoints and
will be documented in the SAP.
9.4.1.4. 
Major Secondary Analyses
For the major secondary analyses, the Fisher’s exact test, stratified by age and region, will be used
to compare the proportion of participants responding to treatment. Continuous response parameters
will be compared using an MMRM analysis or an ANCOVA model, adjusting for baseline value,
age group, and region. All statistical testing will be performed at 2-sided (α=0.05). The major
secondary analyses are based on participants randomized in Part 1 of the study and are:

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The proportion of participants who achieve a PASI 90 response at Week 16 will be compared
between the guselkumab group and the placebo group.
The proportion of participants who achieve an IGA score of cleared (0) at Week 16 will be
compared between the guselkumab group and the placebo group.
The proportion of participants who achieve a PASI 100 response at Week 16 will be compared
between the guselkumab group and the placebo group.
The change from baseline in CDLQI at Week 16 will be compared between the guselkumab
group and the placebo group.
To control the overall Type 1 error rate, the primary analysis and major secondary analyses for the
comparisons between the guselkumab and placebo groups will be tested in a fixed sequence as
ordered above. That is, the first major secondary endpoint will be tested only if the co-primary
endpoints are positive, and the subsequent endpoint will be tested only if the preceding endpoint
in the sequence is positive. Details about the estimands corresponding to these major secondary
endpoints will be specified in the SAP.
In addition, the comparison between etanercept and placebo for the major secondary endpoints
will be performed and nominal p-values will be reported.
9.4.1.5. 
Other Secondary Analyses
In addition to the primary and major secondary analyses, the analyses for other efficacy endpoints
will be performed and nominal p-values will be provided. The Fisher’s exact test, stratified by age
and region, will be used to compare the proportion of participants responding to treatment.
Continuous response parameters will be compared using an MMRM analysis or an ANCOVA
model, adjusting for baseline value, age, and region. Life table estimates will be provided for the
time to event variables. All statistical testing will be performed at 2-sided (α=0.05). The other
secondary analyses are:
Secondary Analyses for Participants Randomized in Part 1
The proportion of retreated participants that achieve a PASI 90 response over time after
retreatment will be summarized.
The proportion of retreated participants that achieve PASI responses (PASI 50, 75, 90, and
100) or IGA responses (IGA of cleared [0], minimal [1], or mild [2], IGA of cleared [0] or
minimal [1], and IGA of cleared [0]) over time after retreatment will be summarized.
The time to loss of 50% of the Week 16 PASI improvement (ie, time to retreatment) after
withdrawal will be summarized for participants randomized to guselkumab group.
The time to loss of PASI 90 response after withdrawal will be summarized for participants
randomized to guselkumab group.
The proportion of participants who achieve a PASI 50 response at Week 16 will be compared
between the guselkumab group and the placebo group.
The proportion of participants who achieve an IGA score of mild or better (≤2) at Week 16
will be compared between the guselkumab group and the placebo group.

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The percent improvement from baseline in PASI will be summarized over time through
Week 16.
The proportion of PASI responses (PASI 50, 75, 90, and 100) will be summarized over time
through Week 16.
The proportion of IGA responses (IGA of cleared [0], minimal [1], or mild [2], IGA of cleared
[0] or minimal [1], and IGA of cleared [0]) will be summarized over time through Week 16.
The proportion of participants with CDLQI=0 or 1 at Week 16 will be compared between the
guselkumab group and the placebo group among randomized participants with a baseline
CDLQI>1.
Body surface area involved (BSA) and change from baseline in BSA at Week 16 will be
compared between the guselkumab group and the placebo group.
BSA and change from baseline in BSA will be summarized over time through Week 16.
The proportion of participants with FDLQI=0 or 1 at Week 16 will be compared between the
guselkumab group and the placebo group among randomized participants with a baseline
FDLQI>1.
The change from baseline in FDLQI at Week 16 will be compared between the guselkumab
group and the placebo group.
In addition, relevant comparisons at Week 16 will also be conducted between the etanercept group
and the placebo group.
Secondary Analyses for Participants Enrolled in Part 2
PASI responses, IGA responses, PASI percent improvement, the change from baseline in CDLQI
and FDLQI, the proportion of participants achieving a CDLQI of 0 or 1, and the proportion of
participants achieving an FDLQI of 0 or 1 will be summarized over time through Week 52 for
participants enrolled in Part 2.
In additional, efficacy in the LTE period will be summarized separately for participants in Part 1
and Part 2 of the study.
9.4.2. 
Usability Assessments
The usability of the
will be assessed in Part 2 of the study using a
and responses will be presented.
9.4.3. 
Safety Analyses
Safety data, including but not limited to, AEs, SAEs, infections, serious infections, changes in
laboratory assessments, changes in vital signs, and suicidal ideation and behavior based on
C-SSRS will be summarized. Treatment emergent AEs will be summarized by treatment group
and Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred
terms.
All participants who receive at least 1 administration of study intervention will be included in the
safety analyses.
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Adverse Events
The verbatim terms used in the CRF by investigators to identify adverse events will be coded using
MedDRA. Intervention-emergent adverse events are adverse events with onset during the
intervention phase or that are a consequence of a pre-existing condition that has worsened since
baseline. All reported adverse events will be included in the analysis. For each adverse event, the
percentage of participants who experience at least 1 occurrence of the given event will be
summarized by intervention group. Safety will be summarized separately for Part 1 and Part 2.
Summaries, listings, datasets, or participant narratives may be provided, as appropriate, for those
participants who die, who discontinue intervention due to an adverse event, or who experience a
severe or a serious adverse event.
The following analyses will be used to assess the safety of participants in the study:
The incidence and type of AEs.
The incidence and type of SAEs.
The incidence and type of related AEs as assessed by the investigator.
The incidence and type of injection site reactions.
The incidence of infections.
The incidence AEs of psoriasis.
Clinical Laboratory Tests
Laboratory data will be summarized by type of laboratory test. Descriptive statistics will be
calculated for each laboratory analyte and changes from baseline at each scheduled time point. In
addition, National Cancer Institute-Common Terminology Criteria for Adverse Events
(NCI-CTCAE) grades will be used in the summary of laboratory data. A listing of participants
with post-baseline abnormal laboratory results based on NCI-CTCAE grades will also be provided.
Vital Signs
Descriptive statistics of heart rate, blood pressure (systolic and diastolic) values, and temperature,
and changes from baseline will be summarized by treatment group.
Pain During Injection
Pain during injection assessed using FPS-R (Appendix 17, Section 10.17) and VAS (Appendix 18,
Section 10.18) will be summarized by study intervention received.
Head Circumference
Head circumference will be summarized over time by treatment group.
Immunoglobulin (Ig) Analyses
The serum levels of IgG, IgA and IgM will be summarized by treatment group.

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Suicidal Ideation and Behavior
Suicidal ideation and behavior based on the C-SSRS and AEs will be summarized descriptively.
Anticipated Events
An anticipated event is an AE (serious or non-serious) that commonly occurs as a consequence of
the underlying disease or condition under investigation (disease related) or background regimen.
For the purposes of this study the event of psoriasis will be considered an anticipated event. Serious
adverse events relating to lack of efficacy (eg, events attributed to “psoriasis”) or progression of
the disease under study will not be individually unblinded for expedited reporting. These
anticipated events will be recorded and reported as outlined in Appendix 19, Section 10.19.
9.4.4. 
Other Analyses
Pharmacokinetic Analyses
Serum guselkumab concentrations over time will be summarized for treated participants.
Descriptive statistics, including arithmetic mean, SD, median, interquartile range, minimum, and
maximum will be calculated at each nominal sampling timepoint. All concentrations below the
lowest quantifiable sample concentration of the assay (BQL) or missing data will be labeled as
such in the concentration data listing or Statistical Analysis System (SAS) dataset. The BQL
concentrations will be treated as zero in the summary statistics. In addition, serum guselkumab
concentrations will be summarized at the time of retreatment in participants who withdrawn from
guselkumab at Week 16.
A population PK analysis using a nonlinear mixed-effects modeling (NONMEM) approach will
be used to characterize the disposition characteristics of guselkumab in the current study. Data
may be combined with those of other selected studies to support a relevant structural model. The
CL/F and V/F values will be estimated. The influence of important variables (such as body weight
and age) on the population PK parameter estimates will be evaluated. Details will be given in a
population PK analysis plan, and results of the population PK analysis may be presented in a
separate technical report.
Pharmacokinetic/Pharmacodynamic Analyses
If feasible, a suitable population PK/pharmacodynamic (PD) model will be developed to describe
the exposure-response relationship  in this study. Data may be combined with those of other
selected studies to support a relevant structural PK/PD model. Details will be given in a population
PK/PD analysis plan, and results of the population PK/PD analysis may be presented in a separate
technical report.
Immunogenicity Analyses
The incidence and titers of anti-guselkumab antibodies will be summarized for all participants who
receive at least 1 dose of guselkumab and have appropriate samples for detection of antibodies to
guselkumab (ie, participants with at least 1 sample obtained after their first dose of guselkumab).
A listing of participants who are positive for antibodies to guselkumab will be provided.

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The incidence of NAbs to guselkumab will be summarized for participants who are positive for
antibodies to guselkumab and have samples evaluable for NAbs to guselkumab.
9.5. 
Interim Analysis
One interim analysis is planned for this study after all participants ≥12 to <18 years of age in
Part 1a have completed Week 16. All available guselkumab PK data for participants ≥12 to
<18 years of age through Week 16 will be evaluated via modeling and simulation, to determine if
the body weight-based dose used in Part 1a provided exposure comparable to adults, or whether a
revised body weight-based dose should be instituted in Part 1b. This evaluation will be conducted
by sponsor personnel who are otherwise not participating in the conduct of this study. Efficacy
data will not be analyzed in the interim analyses and no adjustment will be made for the
significance level.
The planned interim PK analyses will be documented separately.
9.5.1. 
Data Monitoring Committee
Safety monitoring will be performed by a sponsor medical monitor throughout the study, as well
as by an independent DMC. Any safety concerns will be communicated to the sponsor. The DMC
will be an independent committee of 3 members and will include individuals with expertise in
pediatric dermatology, and biostatistics. None of the members will be participating as investigators
in the study. The major function of this committee will be to monitor the safety of the study
intervention. The DMC will periodically review tabulated safety summaries and any additional
safety data that the DMC may request during the conduct of the study. Prior to any DMC review,
the DMC charter will define and document the content of the safety summaries, the DMC’s role
and responsibilities, and the general procedures (including communications).
Prior to enrollment of participants ≥6 to <12 years of age in Part 1b and enrollment of participants
≥12 to <18 years of age into Part 2, the DMC will review the available safety data from the
participants enrolled in Part 1a of the study who have completed their Week 16 visit, and provide
a recommendation as to whether the sponsor can initiate enrollment of Part 1b and Part 2.
Additionally, prior to enrollment of participants ≥6 to <12 years of age into Part 2, the DMC will
review all available safety data once all participants in Part 1b have completed 16 weeks of
treatment and provide a recommendation as to whether enrollment of participants ≥6 to <12 years
of age into Part 2 can be initiated.

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10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Abbreviations and Trademarks
AE 
adverse event
ANOVA  
analysis of covariance
ALT  
alanine aminotransferase
AST  
aspartate aminotransferase
BCG  
Bacille Calmette-Guérin
BSA 
body surface area
CDLQI 
Children’s Dermatology Life Quality Index
CHF  
congestive heart failure
CL/F  
clearance
COVID-19 
SARS-CoV-2
CRF  
case report form
CSR  
clinical study report
C-SSRS  
Columbia-Suicide Severity Rating Scale
DBL 
database lock
DLQI 
Dermatology Life Quality Index
DMC  
Data Monitoring Committee
FDLQI 
Family Dermatology Life Quality Index
HBc 
hepatitis B virus core
HBsAg 
hepatitis B virus surface antigen
HBV  
hepatitis B virus
ICF  
informed consent form
Ig 
immunoglobulin
IGA  
Investigator Global Assessment
IgG1 
Immunoglobulin G1
IgG1λ  
immunoglobulin G1 lambda
IGRA  
interferon gamma release assay
IL 
interleukin
IWRS  
interactive web response system
LTE  
long-term extension
mAb  
monoclonal antibody
MedDRA  
Medical Dictionary for Regulatory Activities
MMRM  
Mixed effect Model Repeat Measurement
MTX  
methotrexate
NAbs 
neutralizing antibodies
PASI 
Psoriasis Area and Severity Index
PD 
pharmacodynamic
PFS  
prefilled syringe
PFS-U 
Pre-filled syringe with an UltraSafe PLUS™ Passive Needle Guard or
Pre-filled syringe with an UltraSafe Passive® Needle Guard
 
PK 
pharmacokinetic
PK/PD  
pharmacokinetic/pharmacodynamic
PQC  
product quality complaint
PsA  
psoriatic arthritis
PSSD  
Psoriasis Symptom and Sign Diary
q8w  
every 8 weeks
SAE  
serious adverse event
SAP  
Statistical Analysis Plan
SC  
subcutaneous
SUSAR  
suspected unexpected serious adverse reactions
TB  
tuberculosis
TNF  
tumor necrosis factor
ULN  
upper limit of normal
V/F  
volume of distribution
CCI

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10.2. Appendix 2: Regulatory, Ethical, and Study Oversight Considerations
REGULATORY AND ETHICAL CONSIDERATIONS
Investigator Responsibilities
The investigator is responsible for ensuring that the study is performed in accordance with the
protocol, current ICH guidelines on Good Clinical Practice (GCP), and applicable regulatory and
country-specific requirements.
Good Clinical Practice is an international ethical and scientific quality standard for designing,
conducting, recording, and reporting studies that involve the participation of human participants.
Compliance with this standard provides public assurance that the rights, safety, and well-being of
study participants are protected, consistent with the principles that originated in the Declaration of
Helsinki, and that the study data are credible.
Protocol Amendments
Neither the investigator nor the sponsor will modify this protocol without a formal amendment by
the sponsor. All protocol amendments must be issued by the sponsor, and signed and dated by the
investigator. Protocol amendments must not be implemented without prior IEC/IRB approval, or
when the relevant competent authority has raised any grounds for non-acceptance, except when
necessary to eliminate immediate hazards to the participants, in which case the amendment must
be promptly submitted to the IEC/IRB and relevant competent authority. Documentation of
amendment approval by the investigator and IEC/IRB must be provided to the sponsor. When the
change(s) involve only logistic or administrative aspects of the study, the IEC/IRB (where
required) only needs to be notified.
During the course of the study, in situations where a departure from the protocol is unavoidable,
the investigator or other physician in attendance will contact the appropriate sponsor representative
listed in the Contact Information page(s), which will be provided as a separate document. Except
in emergency situations, this contact should be made before implementing any departure from the
protocol. In all cases, contact with the sponsor must be made as soon as possible to discuss the
situation and agree on an appropriate course of action. The data recorded in the case report form
(CRF) and source documents will reflect any departure from the protocol, and the source
documents will describe this departure and the circumstances requiring it.
Regulatory Approval/Notification
This protocol and any amendment(s) must be submitted to the appropriate regulatory authorities
in each respective country, if applicable. A study may not be initiated until all local regulatory
requirements are met.
Required Prestudy Documentation
The following documents must be provided to the sponsor before shipment of study intervention
to the study site:

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Protocol and amendment(s), if any, signed and dated by the principal investigator
A copy of the dated and signed (or sealed, where appropriate per local regulations), written
IEC/IRB approval of the protocol, amendments, ICF, any recruiting materials, and if
applicable, participant compensation programs. This approval must clearly identify the
specific protocol by title and number and must be signed (or sealed, where appropriate per
local regulations) by the chairman or authorized designee.
Name and address of the IEC/IRB, including a current list of the IEC/IRB members and their
function, with a statement that it is organized and operates according to GCP and the
applicable laws and regulations. If accompanied by a letter of explanation, or equivalent, from
the IEC/IRB, a general statement may be substituted for this list. If an investigator or a
member of the study-site personnel is a member of the IEC/IRB, documentation must be
obtained to state that this person did not participate in the deliberations or in the vote/opinion
of the study.
Regulatory authority approval or notification, if applicable
Signed and dated statement of investigator (eg, Form FDA 1572), if applicable
Documentation of investigator qualifications (eg, curriculum vitae)
Completed investigator financial disclosure form from the principal investigator, where
required
Signed and dated clinical trial agreement, which includes the financial agreement
Any other documentation required by local regulations
The following documents must be provided to the sponsor before enrollment of the first
participant:
Completed investigator financial disclosure forms from all subinvestigators
Documentation of subinvestigator qualifications (eg, curriculum vitae)
Name and address of any local laboratory conducting tests for the study, and a dated copy of
current laboratory normal ranges for these tests, if applicable
Local laboratory documentation demonstrating competence and test reliability
(eg, accreditation/license), if applicable
Independent Ethics Committee or Institutional Review Board
Before the start of the study, the investigator (or sponsor where required) will provide the IEC/IRB
with current and complete copies of the following documents (as required by local regulations):
Final protocol and, if applicable, amendments
Sponsor-approved ICF (and any other written materials to be provided to the participants)
Investigator's Brochure (or equivalent information) and amendments/addenda
Sponsor-approved participant recruiting materials
Information on compensation for study-related injuries or payment to participants for
participation in the study, if applicable

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Investigator's curriculum vitae or equivalent information (unless not required, as documented
by the IEC/IRB)
Information regarding funding, name of the sponsor, institutional affiliations, other potential
conflicts of interest, and incentives for participants
Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after the IEC/IRB has given full approval of the final protocol,
amendments (if any, excluding the ones that are purely administrative, with no consequences for
participants, data or study conduct, unless required locally), the ICF, applicable recruiting
materials, and participant compensation programs, and the sponsor has received a copy of this
approval. This approval letter must be dated and must clearly identify the IEC/IRB and the
documents being approved.
During the study the investigator (or sponsor where required) will send the following documents
and updates to the IEC/IRB for their review and approval, where appropriate:
Protocol amendments (excluding the ones that are purely administrative, with no
consequences for participants, data or study conduct)
Revision(s) to ICF and any other written materials to be provided to participants
If applicable, new or revised participant recruiting materials approved by the sponsor
Revisions to compensation for study-related injuries or payment to participants for
participation in the study, if applicable
New edition(s) of the Investigator's Brochure and amendments/addenda
Summaries of the status of the study at intervals stipulated in guidelines of the IEC/IRB (at
least annually)
Reports of adverse events that are serious, unlisted/unexpected, and associated with the study
intervention
New information that may adversely affect the safety of the participants or the conduct of the
study
Deviations from or changes to the protocol to eliminate immediate hazards to the participants
Report of deaths of participants under the investigator's care
Notification if a new investigator is responsible for the study at the site
Development Safety Update Report and Line Listings, where applicable
Any other requirements of the IEC/IRB
For all protocol amendments (excluding the ones that are purely administrative, with no
consequences for participants, data or study conduct), the amendment and applicable ICF revisions
must be submitted promptly to the IEC/IRB for review and approval before implementation of the
change(s).
At least once a year, the IEC/IRB will be asked to review and reapprove this study, where required.

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At the end of the study, the investigator (or sponsor where required) will notify the IEC/IRB about
the study completion.
Country Selection
This study will only be conducted in those countries where the intent is to launch or otherwise help
ensure access to the developed product if the need for the product persists, unless explicitly
addressed as a specific ethical consideration in Section 4.2.1, Study-Specific Ethical Design
Considerations.
Other Ethical Considerations
For study-specific ethical design considerations, refer to Section 4.2.1.
FINANCIAL DISCLOSURE
Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial
information in accordance with local regulations to allow the sponsor to submit complete and
accurate financial certification or disclosure statements to the appropriate regulatory authorities.
Investigators are responsible for providing information on financial interests during the course of
the study and for 1 year after completion of the study.
Refer to Required Prestudy Documentation (above) for details on financial disclosure.
INFORMED CONSENT PROCESS AND ASSENT FORM
A limited number of study sites will be asked by the Sponsor to obtain informed consent using a
validated electronic system instead of a paper-based process.  If both parties (Sponsor and the
Study Site) agree, and if participation is allowed by local regulations and EC/IRB requirements,
the Sponsor will provide an eTablet device (e.g., iPad®) to the study site to use for the electronic
informed consent. Overall the consent process will remain the same, as described in this section;
however, at the study sites utilizing electronic informed consent, participants or their legally
acceptable representatives will be able to review the entire informed consent form content on the
eTablet. The ability for participants or their legally acceptable representatives to review the paper
informed consent form is always an option at sites utilizing electronic informed consent.
Depending on local regulations and EC/IRB requirements, the participants or their legally
acceptable representatives and person obtaining consent will either apply their handwritten
signature electronically directly onto the eTablet, or apply their handwritten signature to a printed
paper copy of the informed consent in accordance with local regulations.
Each participant (or a legally acceptable representative) must give written consent according to
local requirements after the nature of the study has been fully explained. The ICF(s) must be signed
before performance of any study-related activity. The ICF(s) and assent form that is/are used must
be approved by both the sponsor and by the reviewing IEC/IRB and be in a language that the
participant can read and understand. The informed consent should be in accordance with principles
that originated in the Declaration of Helsinki, current ICH and GCP guidelines, applicable
regulatory requirements, and sponsor policy.

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Before enrollment in the study, the investigator or an authorized member of the study-site
personnel must explain to potential participants or their legally acceptable representatives the aims,
methods, reasonably anticipated benefits, and potential hazards of the study, and any discomfort
participation in the study may entail. Participants will be informed that their participation is
voluntary and that they may withdraw consent to participate at any time. They will be informed
that choosing not to participate will not affect the care the participant will receive for the treatment
of his or her disease. Participants will be told that alternative treatments are available if they refuse
to take part and that such refusal will not prejudice future treatment. Finally, they will be told that
the investigator will maintain a participant identification register for the purposes of long-term
follow up if needed and that their records may be accessed by health authorities and authorized
sponsor personnel without violating the confidentiality of the participant, to the extent permitted
by the applicable law(s) or regulations. By signing the ICF the participant or legally acceptable
representative is authorizing such access, which includes permission to obtain information about
his or her survival status. It also denotes that the participant agrees to allow his or her study
physician to recontact the participant for the purpose of obtaining consent for additional safety
evaluations, and subsequent disease-related treatments, if needed.
The participant or legally acceptable representative will be given sufficient time to read the ICF
and the opportunity to ask questions. After this explanation and before entry into the study, consent
should be appropriately recorded by means of either the participant's or his or her legally
acceptable representative's personally dated signature. After having obtained the consent, a copy
of the ICF must be given to the participant.
If the participant or legally acceptable representative is unable to read or write, an impartial witness
should be present for the entire informed consent process (which includes reading and explaining
all written information) and should personally date and sign the ICF after the oral consent of the
participant or legally acceptable representative is obtained.
Children (minors) or participants who are unable to comprehend the information provided can be
enrolled only after obtaining consent of a legally acceptable representative. Assent must be
obtained from children (minors) capable of understanding the nature of the study, typically
participants 7 years of age and older, depending on the institutional policies. Written assent should
be obtained from participants who are able to write. A separate assent form written in language the
participant can understand should be developed for adolescents. After having obtained the assent,
a copy of the assent form must be given to the participant, and to the participant's parent(s) or if
applicable legally acceptable representative.
When prior consent of the participant is not possible and the participant's legally acceptable
representative is not available, enrollment procedures should be described in the protocol with
documented approval/favorable opinion by the IEC/IRB to protect the rights, safety, and well-
being of the participant and to ensure compliance with applicable regulatory requirements. The
participant or legally acceptable representative must be informed about the study as soon as
possible and give consent to continue.

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RECRUITMENT STRATEGY
This section is not applicable as the enrollment part of this study is closed.
DATA PROTECTION
Privacy of Personal Data
The collection and processing of personal data from participants enrolled in this study  will be
limited to those data that are necessary to fulfill the objectives of the study.
These data must be collected and processed with adequate precautions to ensure confidentiality
and compliance with applicable data privacy protection laws and regulations. Appropriate
technical and organizational measures to protect the personal data against unauthorized disclosures
or access, accidental or unlawful destruction, or accidental loss or alteration must be put in place.
Sponsor personnel whose responsibilities require access to personal data agree to keep the identity
of participants confidential.
The informed consent obtained from the participant (or his or her legally designatedrepresentative)
includes information about, and where required per applicable regulations, explicit consent for the
processing of personal data and for the investigator/institution to allow direct access to his or her
original medical records (source data/documents) for study-related monitoring, audit, IEC/IRB
review, and regulatory inspection. The informed consent also provides information to address the
lawful transfer of the data to other entities and to other countries/territories.
The participant has the right to request through the investigator access to his or her personal data
and the right to request rectification of any data that are not correct or complete or make requests
concerning his or her personal data in accordance with applicable data protection law. Reasonable
steps will be taken to respond to such a request, taking into consideration the nature of the request,
the conditions of the study, and the applicable laws and regulations.
In the event of a data security breach, the sponsor will apply measures to adequately manage and
mitigate possible adverse effects taking into consideration the nature of the data security breach as
necessary to address other obligations such as notifying appropriate authorities in accordance with
applicable data protection law.
Exploratory research is not conducted under standards appropriate for the return of data to
participants. In addition, the sponsor cannot make decisions as to the significance of any findings
resulting from exploratory research. Therefore, exploratory research data will not be returned to
participants or investigators, unless required by law or local regulations. Privacy and
confidentiality of data generated in the future on stored samples will be protected by the same
standards applicable to all other clinical data.
LONG-TERM RETENTION OF SAMPLES FOR ADDITIONAL FUTURE RESEARCH
Samples collected in this study may be stored for up to 15 years (or according to local regulations)
for additional research. Samples will only be used to understand guselkumab, to understand

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psoriasis, to understand differential intervention responders, and to develop tests/assays related to
guselkumab and psoriasis. The research may begin at any time during the study or the post-study
storage period. The post-study storage period will begin after completion of the final clinical study
report.
Stored samples will be coded throughout the sample storage and analysis process and will not be
labeled with personal identifiers. Participants may withdraw their consent for their samples to be
stored for research (refer to Section 7.2.1, Withdrawal From the Use of Research Samples).
COMMITTEES STRUCTURE
Data Monitoring Committee
Safety monitoring will be performed by a sponsor medical monitor throughout the study, as well
as by an independent DMC. Any safety concerns will be communicated to the sponsor. The DMC
will be an independent committee of 3 members and will include individuals with expertise in
pediatric dermatology, and biostatistics. None of the members will be participating as investigators
in the study.
PUBLICATION POLICY/DISSEMINATION OF CLINICAL STUDY DATA
All information, including but not limited to information regarding guselkumab or the sponsor's
operations (eg, patent application, formulas, manufacturing processes, basic scientific data, prior
clinical data, formulation information) supplied by the sponsor to the study site or investigator and
not previously published, and any data, or analysis generated as a result of this study, are
considered confidential and remain the sole property of the sponsor. Study site and investigator
shall not use this information except in the performance of this study and shall not disclose this
information to anyone except to persons involved in the study that need such information to assist
in conducting the study, and then only on like terms of confidentiality and non-use. Data for all
indications will be submitted according to local requirements.
The investigator understands that the information developed in the study will be used by the
sponsor in connection with the continued development of guselkumab, and thus may be disclosed
as required to other clinical investigators or regulatory agencies. To permit the information derived
from the clinical studies to be used, the investigator is obligated to provide the sponsor with all
data obtained in the study.
The results of the study will be reported in a Clinical Study Report generated by the sponsor and
will contain data from all study sites that participated in the study as per protocol. Recruitment
performance or specific expertise related to the nature and the key assessment parameters of the
study will be used to determine a coordinating investigator for the study. Results of analyses
performed after the Clinical Study Report has been issued will be reported in a separate report and
will not require a revision of the Clinical Study Report.
Study participant identifiers will not be used in publication of results. Any work created in
connection with performance of the study and contained in the data that can benefit from copyright

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protection (except any publication by the investigator as provided for below) shall be the property
of the sponsor as author and owner of copyright in such work.
Consistent with Good Publication Practices and International Committee of Medical Journal
Editors (ICMJE) guidelines, the sponsor shall have the right to publish such primary (multicenter)
data and information without approval from the investigator. The investigator has the right to
publish study site-specific data after the primary data are published. If an investigator wishes to
publish information from the study, a copy of the manuscript must be provided to the sponsor for
review at least 60 days before submission for publication or presentation. Expedited reviews will
be arranged for abstracts, poster presentations, or other materials. If requested by the sponsor in
writing, the investigator will withhold such publication for up to an additional 60 days to allow for
filing of a patent application. In the event that issues arise regarding scientific integrity or
regulatory compliance, the sponsor will review these issues with the investigator. The sponsor will
not mandate modifications to scientific content and does not have the right to suppress information.
For multicenter study designs and substudy approaches, secondary results generally should not be
published before the primary endpoints of a study have been published. Similarly, investigators
will recognize the integrity of a multicenter study by not submitting for publication data derived
from the individual study site until the combined results from the completed study have been
submitted for publication, within 18 months after the study end date, or the sponsor confirms there
will be no multicenter study publication. Authorship of publications resulting from this study will
be based on the guidelines on authorship, such as those described in the ICMJE Recommendations
for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals, which
state that the named authors must have made a significant contribution to the conception or design
of the work; or the acquisition, analysis, or interpretation of the data for the work; and drafted the
work or revised it critically for important intellectual content; and given final approval of the
version to be published; and agreed to be accountable for all aspects of the work in ensuring that
questions related to the accuracy or integrity of any part of the work are appropriately investigated
and resolved.
Registration of Clinical Studies and Disclosure of Results
The sponsor will register and disclose the existence of and the results of clinical studies as required
by law.
DATA QUALITY ASSURANCE
Data Quality Assurance/Quality Control
Steps to be taken to ensure the accuracy and reliability of data include the selection of qualified
investigators and appropriate study sites, review of protocol procedures with the investigator and
study-site personnel before the study, periodic monitoring visits by the sponsor, and direct
transmission of clinical laboratory data from a central laboratory and direct transmission of
efficacy data to the vendor database and then into the sponsor's data base. Written instructions will
be provided for collection, handling, storage, and shipment of samples.

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Guidelines for CRF completion will be provided and reviewed with study-site personnel before
the start of the study. The sponsor will review the CRF for accuracy and completeness during
on-site monitoring visits and after transmission to the sponsor; any discrepancies will be resolved
with the investigator or designee, as appropriate. After upload of the data into the study database
they will be verified for accuracy and consistency with the data sources.
SOURCE DOCUMENTS
At a minimum, source documents consistent in the type and level of detail with that commonly
recorded at the study site as a basis for standard medical care must be available for the following:
participant identification, eligibility, and study identification; study discussion and date of signed
informed consent; dates of visits; results of safety and efficacy parameters as required by the
protocol; record of all adverse events and follow-up of adverse events; concomitant medication;
intervention receipt/dispensing/return records; study intervention administration information; and
date of study completion and reason for early discontinuation of study intervention or withdrawal
from the study, if applicable.
The author of an entry in the source documents should be identifiable.
At a minimum, the type and level of detail of source data available for a participant should be
consistent with that commonly recorded at the study site as a basis for standard medical care.
Specific details required as source data for the study and source data collection methods will be
reviewed with the investigator before the study and will be described in the monitoring guidelines
(or other equivalent document).
The minimum source documentation requirements for Section 5.1, Inclusion Criteria and
Section 5.2, Exclusion Criteria that specify a need for documented medical history are as follows:
Referral letter from treating physician or
Complete history of medical notes at the site
Discharge summaries
Inclusion and exclusion criteria not requiring documented medical history must be verified at a
minimum by participant interview or other protocol required assessment (eg, physical
examination, laboratory assessment) and documented in the source documents.
The investigator or trained study personnel administered C-SSRS will be recorded and will be
considered source documentation.
An eSource system may be utilized, which contains data traditionally maintained in a hospital or
clinic record to document medical care (eg, electronic source documents) as well as the clinical
study-specific data fields as determined by the protocol. This data is electronically extracted for
use by the sponsor. If eSource is utilized, references made to the CRF in the protocol include the
eSource system but information collected through eSource may not be limited to that found in the
CRF.

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CASE REPORT FORM COMPLETION
Case report forms are prepared and provided by the sponsor for each participant in electronic
format. All CRF entries, corrections, and alterations must be made by the investigator or authorized
study-site personnel. The investigator must verify that all data entries in the CRF are accurate and
correct.
The study data will be transcribed by study-site personnel from the source documents onto an
electronic CRF, if applicable. Study-specific data will be transmitted in a secure manner to the
sponsor.
Worksheets may be used for the capture of some data to facilitate completion of the CRF. Any
such worksheets will become part of the participant's source documents. Data must be entered into
the CRF in English. The CRF must be completed as soon as possible after a participant visit and
the forms should be available for review at the next scheduled monitoring visit.
All participative measurements (eg, pain scale information or other questionnaires) will be
completed by the same individual who made the initial baseline determinations whenever possible.
If necessary, queries will be generated in the eDC tool. If corrections to a CRF are needed after
the initial entry into the CRF, this can be done in either of the following ways:
Investigator and study-site personnel can make corrections in the eDC tool at their own
initiative or as a response to an auto query (generated by the eDC tool).
Sponsor or sponsor delegate can generate a query for resolution by the investigator and
study-site personnel.
MONITORING
The sponsor will perform on-site monitoring visits as frequently as necessary. The monitor will
record dates of the visits in a study site visit log that will be kept at the study site. The first post-
initiation visit will be made as soon as possible after enrollment has begun. At these visits, the
monitor will compare the data entered into the CRF with the source documents
(eg, hospital/clinic/physician’s office medical records); a sample may be reviewed. The nature and
location of all source documents will be identified to ensure that all sources of original data
required to complete the CRF are known to the sponsor and study-site personnel and are accessible
for verification by the sponsor study-site contact. If electronic records are maintained at the study
site, the method of verification must be discussed with the study-site personnel.
Direct access to source documents (medical records) must be allowed for the purpose of verifying
that the recorded data are consistent with the original source data. Findings from this review will
be discussed with the study-site personnel. The sponsor expects that, during monitoring visits, the
relevant study-site personnel will be available, the source documents will be accessible, and a
suitable environment will be provided for review of study-related documents. The monitor will
meet with the investigator on a regular basis during the study to provide feedback on the study
conduct.

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In addition to on-site monitoring visits, remote contacts can occur. It is expected that during these
remote contacts, study-site personnel will be available to provide an update on the progress of the
study at the site.
Central monitoring will take place for data identified by the sponsor as requiring central review.
ON-SITE AUDITS
Representatives of the sponsor's clinical quality assurance department may visit the study site at
any time during or after completion of the study to conduct an audit of the study in compliance
with regulatory guidelines and company policy. These audits will require access to all study
records, including source documents, for inspection. Participant privacy must, however, be
respected. The investigator and study-site personnel are responsible for being present and available
for consultation during routinely scheduled study-site audit visits conducted by the sponsor or its
designees.
Similar auditing procedures may also be conducted by agents of any regulatory body, either as part
of a national GCP compliance program or to review the results of this study in support of a
regulatory submission. The investigator should immediately notify the sponsor if he or she has
been contacted by a regulatory agency concerning an upcoming inspection.
RECORD RETENTION
In compliance with the ICH/GCP guidelines, the investigator/institution will maintain all CRF and
all source documents that support the data collected from each participant, as well as all study
documents as specified in ICH/GCP Section 8, Essential Documents for the Conduct of a Clinical
Trial, and all study documents as specified by the applicable regulatory requirement(s). The
investigator/institution will take measures to prevent accidental or premature destruction of these
documents.
Essential documents must be retained until at least 2 years after the last approval of a marketing
application in an ICH region and until there are no pending or contemplated marketing applications
in an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical
development of the investigational product. These documents will be retained for a longer period
if required by the applicable regulatory requirements or by an agreement with the sponsor. It is the
responsibility of the sponsor to inform the investigator/institution as to when these documents no
longer need to be retained. For trials performed under Regulation [EU] No. 536/2014, the sponsor
and the investigator shall archive the content of the clinical trial master file for at least 25 years
after the end of the clinical trial.
If the responsible investigator retires, relocates, or for other reasons withdraws from the
responsibility of keeping the study records, custody must be transferred to a person who will accept
the responsibility. The sponsor must be notified in writing of the name and address of the new
custodian. Under no circumstance shall the investigator relocate or dispose of any study documents
before having obtained written approval from the sponsor.

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If it becomes necessary for the sponsor or the appropriate regulatory authority to review any
documentation relating to this study, the investigator/institution must permit access to such reports.
STUDY AND SITE CLOSURE
Study Termination
The sponsor reserves the right to close the study site or terminate the study at any time for any
reason at the sole discretion of the sponsor. Study sites will be closed upon study completion. A
study site is considered closed when all required documents and study supplies have been collected
and a study-site closure visit has been performed.
The investigator may initiate study-site closure at any time, provided there is reasonable cause and
sufficient notice is given in advance of the intended termination.
Reasons for the early closure of a study site by the sponsor or investigator may include but are not
limited to:
Failure of the investigator to comply with the protocol, the requirements of the IEC/IRB or
local health authorities, the sponsor's procedures, or GCP guidelines
Inadequate recruitment of participants by the investigator
Discontinuation of further study intervention development

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10.3. Appendix 3: Contraceptive and Barrier Guidance and Collection of
Pregnancy Information
Participants must follow contraceptive measures as outlined in Section 5.1, Inclusion Criteria.
Pregnancy information will be collected and reported as noted in Section 8.3.4, Pregnancy and
Appendix 4 Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-up,
and Reporting.
Definitions
Girl of Childbearing Potential
A girl is considered fertile following menarche and until becoming postmenopausal unless
permanently sterile (see below).
Girl Not of Childbearing Potential
premenarchal
A premenarchal state is one in which menarche has not yet occurred.
postmenopausal
A postmenopausal state is defined as no menses for 12 months without an alternative medical
cause. A high follicle stimulating hormone (FSH) level (>40 IU/L or mIU/mL) in the
postmenopausal range may be used to confirm a postmenopausal state in women not using
hormonal contraception or hormonal replacement therapy (HRT), however in the absence of
12 months of amenorrhea, a single FSH measurement is insufficient.
permanently sterile
Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal
occlusion/ligation procedures, and bilateral oophorectomy.
Note: If the childbearing potential changes after start of the study (eg, a premenarchal girl
experiences menarche) or the risk of pregnancy changes (eg, a girl who is not heterosexually active
becomes active), a girl must begin a highly effective method of contraception, as described
throughout the inclusion criteria.
If reproductive status is questionable, additional evaluation should be considered.
Examples of Contraceptives
As noted in Inclusion Criterion 7, study participants who are girls of childbearing potential must
be using a highly effective method of contraception. Examples of highly effective methods of
contraception are provided below; however, the method selected must meet local/regional
regulations/guidelines for highly effective contraception.
EXAMPLES OF CONTRACEPTIVESa ALLOWED FOR FEMALE PARTICIPANTS
DURING THE STUDY INCLUDE:
USER INDEPENDENT
Highly Effective Methods That Are User Independent Failure rate of ≤1% per year when used
consistently and correctly.
Implantable progestogen-only hormone contraception associated with inhibition of ovulationb

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Intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)
Vasectomized partner
(Vasectomized partner is a highly effective contraceptive method provided that the partner is the
sole sexual partner of the woman of childbearing potential and the absence of sperm has been
confirmed. If not, additional highly effective method of contraception should be used.
Spermatogenesis cycle is approximately 74 days.)
USER DEPENDENT
Highly Effective Methods That Are User Dependent Failure rate of <1% per year when used
consistently and correctly.
Combined (estrogen- and progestogen-containing) hormonal contraception associated with
inhibition of ovulationb
oral
intravaginal
transdermal
injectable
Progestogen-only hormone contraception associated with inhibition of ovulationb
oral
injectable
Sexual abstinence
(Sexual abstinence is considered a highly effective method only if defined as refraining from
heterosexual intercourse during the entire period of risk associated with the study intervention.
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study
and the preferred and usual lifestyle of the participant.)
NOT ALLOWED AS SOLE METHOD OF CONTRACEPTION DURING THE STUDY for
girls of childbearing potential (not considered to be highly effective -failure rate of >1% per
year)
Progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary
mode of action.
Male or female condom with or without spermicidec
Cap, diaphragm, or sponge with spermicide
A combination of male condom with either cap, diaphragm, or sponge with spermicide
(double-barrier methods)c
Periodic abstinence (calendar, symptothermal, post-ovulation methods)
Withdrawal (coitus-interruptus)
Spermicides alone
Lactational amenorrhea method (LAM)
a) Typical use failure rates may differ from those when used consistently and correctly. Use should be
consistent with local regulations regarding the use of contraceptive methods for participants in
clinical studies.
b) Hormonal contraception may be susceptible to interaction with the study intervention, which may
reduce the efficacy of the contraceptive method. In addition, consider if the hormonal contraception
may interact with the study intervention.
c) Male condom and female condom should not be used together (due to risk of failure with friction).

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Pregnancy during the study
Any participant who becomes pregnant during the study must discontinue further study treatment.

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10.4. Appendix 4: Adverse Events: Definitions and Procedures for Recording,
Evaluating, Follow-up, and Reporting
ADVERSE EVENT DEFINITIONS AND CLASSIFICATIONS
Adverse Event
An adverse event is any untoward medical occurrence in a clinical study participant administered
a medicinal (investigational or non-investigational) product. An adverse event does not necessarily
have a causal relationship with the intervention. An adverse event can therefore be any unfavorable
and unintended sign (including an abnormal finding), symptom, or disease temporally associated
with the use of a medicinal (investigational or non-investigational) product, whether or not related
to that medicinal (investigational or non-investigational) product. (Definition per International
Conference on Harmonisation [ICH])
This includes any occurrence that is new in onset or aggravated in severity or frequency from the
baseline condition, or abnormal results of diagnostic procedures, including laboratory test
abnormalities.
Note: The sponsor collects adverse events starting with the signing of the ICF (refer to All Adverse
Events under Section 8.3.1, Time Period and Frequency for Collecting Adverse Events and Serious
Adverse Events Information, for time of last adverse event recording).
Serious Adverse Event
A serious adverse event based on ICH and EU Guidelines on Pharmacovigilance for Medicinal
Products for Human Use is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
(The participant was at risk of death at the time of the event. It does not refer to an event that
hypothetically might have caused death if it were more severe.)
Requires inpatient hospitalization or prolongation of existing hospitalization
Results in persistent or significant disability/incapacity
Is a congenital anomaly/birth defect
Is a suspected transmission of any infectious agent via a medicinal product
Is Medically Important*
*Medical and scientific judgment should be exercised in deciding whether expedited reporting is
also appropriate in other situations, such as important medical events that may not be immediately
life threatening or result in death or hospitalization but may jeopardize the participant or may
require intervention to prevent one of the other outcomes listed in the definition above. These
should usually be considered serious.

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If a serious and unexpected adverse event occurs for which there is evidence suggesting a causal
relationship between the study intervention and the event (eg, death from anaphylaxis), the event
must be reported as a serious and unexpected suspected adverse reaction.
Unlisted (Unexpected) Adverse Event/Reference Safety Information
An adverse event is considered unlisted if the nature or severity is not consistent with the applicable
product reference safety information. For guselkumab, the expectedness of an adverse event will
be determined by whether or not it is listed in the Investigator's Brochure. For etanercept, the
expectedness of an adverse event will be determined by whether or not it is listed in the package
insert/summary of product characteristics.
Adverse Event Associated With the Use of the Intervention
An adverse event is considered associated with the use of the intervention if the attribution is
possible, probable, or very likely by the definitions listed below (see Attribution Definitions).
ATTRIBUTION DEFINITIONS
Not Related
An adverse event that is not related to the use of the intervention.
Doubtful
An adverse event for which an alternative explanation is more likely, eg, concomitant treatment(s),
concomitant disease(s), or the relationship in time suggests that a causal relationship is unlikely.
Possible
An adverse event that might be due to the use of the intervention. An alternative explanation,
eg, concomitant treatment(s), concomitant disease(s), is inconclusive. The relationship in time is
reasonable; therefore, the causal relationship cannot be excluded.
Probable
An adverse event that might be due to the use of the intervention. The relationship in time is
suggestive (eg, confirmed by dechallenge). An alternative explanation is less likely,
eg, concomitant treatment(s), concomitant disease(s).
Very Likely
An adverse event that is listed as a possible adverse reaction and cannot be reasonably explained
by an alternative explanation, eg, concomitant treatment(s), concomitant disease(s). The
relationship in time is very suggestive (eg, it is confirmed by dechallenge and rechallenge).
SEVERITY CRITERIA
An assessment of severity grade will be made using the following general categorical descriptors:
Mild: Awareness of symptoms that are easily tolerated, causing minimal discomfort and not
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Moderate: Sufficient discomfort is present to cause interference with normal activity.
Severe: Extreme distress, causing significant impairment of functioning or incapacitation.
Prevents normal everyday activities.
The investigator should use clinical judgment in assessing the severity of events not directly
experienced by the participant (eg, laboratory abnormalities).
SPECIAL REPORTING SITUATIONS
Safety events of interest on a sponsor study intervention in an interventional study that may require
expedited reporting or safety evaluation include, but are not limited to:
Overdose of a sponsor study intervention
Suspected abuse/misuse of a sponsor study intervention
Accidental or occupational exposure to a sponsor study intervention
Medication error involving a sponsor product (with or without participant/patient exposure to
the sponsor study intervention, eg, name confusion)
Special reporting situations should be recorded in the CRF. Any special reporting situation that
meets the criteria of a serious adverse event should be recorded on the serious adverse event page
of the CRF.
PROCEDURES
All Adverse Events
All adverse events, regardless of seriousness, severity, or presumed relationship to study
intervention, must be recorded using medical terminology in the source document and the CRF.
Whenever possible, diagnoses should be given when signs and symptoms are due to a common
etiology (eg, cough, runny nose, sneezing, sore throat, and head congestion should be reported as
"upper respiratory infection"). Investigators must record in the CRF their opinion concerning the
relationship of the adverse event to study therapy. All measures required for adverse event
management must be recorded in the source document and reported according to sponsor
instructions.
For all studies with an outpatient phase, including open-label studies, the participant must be
provided with a "wallet (study) card" and instructed to carry this card with them for the duration
of the study indicating the following:
Study number
Statement, in the local language(s), that the participant is participating in a clinical study
Investigator's name and 24-hour contact telephone number
Local sponsor's name and 24-hour contact telephone number (for medical staff only)
Site number

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Participant number
Any other information that is required to do an emergency breaking of the blind
Serious Adverse Events
All serious adverse events that have not resolved by the end of the study, or that have not resolved
upon discontinuation of the participant's participation in the study, must be followed until any of
the following occurs:
The event resolves
The event stabilizes
The event returns to baseline, if a baseline value/status is available
The event can be attributed to agents other than the study intervention or to factors unrelated
to study conduct
It becomes unlikely that any additional information can be obtained (participant or health care
practitioner refusal to provide additional information, lost to follow-up after demonstration of
due diligence with follow-up efforts)
Suspected transmission of an infectious agent by a medicinal product will be reported as a serious
adverse event. Any event requiring hospitalization (or prolongation of hospitalization) that occurs
during the course of a participant's participation in a study must be reported as a serious adverse
event, except hospitalizations for the following:
Hospitalizations not intended to treat an acute illness or adverse event (eg, social reasons such
as pending placement in long-term care facility)
Surgery or procedure planned before entry into the study (must be documented in the CRF).
Note: Hospitalizations that were planned before the signing of the ICF, and where the
underlying condition for which the hospitalization was planned has not worsened, will not be
considered serious adverse events. Any adverse event that results in a prolongation of the
originally planned hospitalization is to be reported as a new serious adverse event.
The cause of death of a participant in a study within 16 weeks of the last dose of study intervention,
whether or not the event is expected or associated with the study intervention, is considered a
serious adverse event.
CONTACTING SPONSOR REGARDING SAFETY
The names (and corresponding telephone numbers) of the individuals who should be contacted
regarding safety issues or questions regarding the study are listed in the Contact Information
page(s), which will be provided as a separate document.
PRODUCT QUALITY COMPLAINT HANDLING
A PQC is defined as any suspicion of a product defect related to manufacturing, labeling, or
packaging, ie, any dissatisfaction relative to the identity, quality, durability, or reliability of a
product, including its labeling or package integrity. A PQC may have an impact on the safety and
efficacy of the product. Timely, accurate, and complete reporting and analysis of PQC information

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from studies are crucial for the protection of participants, investigators, and the sponsor, and are
mandated by regulatory agencies worldwide. The sponsor has established procedures in
conformity with regulatory requirements worldwide to ensure appropriate reporting of PQC
information; all studies conducted by the sponsor or its affiliates will be conducted in accordance
with those procedures.
All 
 associated with device-related PQCs will be investigated including the return of the
device to the sponsor for inspection. PFS-U should be retained for further investigation if requested
by the sponsor.
Procedures
All initial PQCs must be reported to the sponsor by the study-site personnel within 24 hours after
being made aware of the event.
If the defect is combined with a serious adverse event, the study-site personnel must report the
PQC to the sponsor according to the serious adverse event reporting timelines (refer to
Section 8.3.1.2, Serious Adverse Event Information). A sample of the suspected product should be
maintained for further investigation if requested by the sponsor.
Contacting Sponsor Regarding Product Quality
The names (and corresponding telephone numbers) of the individuals who should be contacted
regarding product quality issues are listed in the Contact Information page(s), which will be
provided as a separate document.
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10.5. Appendix 5: Tuberculin Skin Testing
Administering the Mantoux Tuberculin Skin Test
The Mantoux tuberculin skin test (CDC, 2000) is the standard method of identifying persons infected with
Mycobacterium tuberculosis. Multiple puncture tests (Tine and Heaf) should not be used to determine whether a
person is infected because the amount of tuberculin injected intradermally cannot be precisely controlled. Tuberculin
skin testing is both safe and reliable throughout the course of pregnancy. The Mantoux tuberculin test is performed
by placing an intradermal injection of 0.1 mL of tuberculin into the inner surface of the forearm. The test must be
performed with tuberculin that has at least the same strength as either 5 tuberculin units (TU) of standard purified
protein derivative (PPD)-S or 2 TU of PPD-RT 23, Statens Seruminstitut, as recommended by the World Health
Organization. PPD strengths of 1 TU or 250 TU are not acceptable (Menzies, 2000). Using a disposable tuberculin
syringe with the needle bevel facing upward, the injection should be made just beneath the surface of the skin. This
should produce a discrete, pale elevation of the skin (a wheal) 6 mm to 10 mm in diameter. To prevent needle-stick
injuries, needles should not be recapped, purposely bent or broken, removed from disposable syringes, or otherwise
manipulated by hand. After they are used, disposable needles and syringes should be placed in puncture-resistant
containers for disposal. Institutional guidelines regarding universal precautions for infection control (eg, the use of
gloves) should be followed. A trained health care worker, preferably the investigator, should read the reaction to the
Mantoux test 48 to 72 hours after the injection. Participants should never be allowed to read their own tuberculin skin
test results. If a participant fails to show up for the scheduled reading, a positive reaction may still be measurable up
to 1 week after testing. However, if a participant who fails to return within 72 hours has a negative test, tuberculin
testing should be repeated. The area of induration (palpable raised hardened area) around the site of injection is the
reaction to tuberculin. For standardization, the diameter of the induration should be measured transversely
(perpendicular) to the long axis of the forearm. Erythema (redness) should not be measured. All reactions should be
recorded in millimeters, even those classified as negative.
Interpreting the Tuberculin Skin Test Results
In the US and many other countries, the most conservative definition of positivity for the tuberculin skin test is
reserved for immunocompromised patients, and this definition is to be applied in this study to maximize the likelihood
of detecting latent TB, even though the participants may not be immunocompromised at baseline.
In the US and Canada, an induration of 5 mm or greater in response to the intradermal tuberculin skin test is considered
to be a positive result and evidence for either latent or active TB.
In countries outside the US and Canada, country-specific guidelines for immunocompromised patients should be
consulted for the interpretation of tuberculin skin test results. If no local country guidelines for immunocompromised
patients exist, US guidelines must be followed.
Treatment of Latent Tuberculosis
Local country guidelines for immunocompromised patients should be consulted for acceptable antituberculous
treatment regimens for latent TB. If no local country guidelines for immunocompromised patients exist, US guidelines
must be followed.
References
Centers for Disease Control and Prevention. Core curriculum on tuberculosis: What the clinician should know (Fourth
Edition). Atlanta, GA: Department of Health and Human Services; Centers for Disease Control and Prevention;
National Center for HIV, STD, and TB Prevention; Division of Tuberculosis Elimination; 2000:25-86.
Menzies RI. Tuberculin skin testing. In: Reichman LB, Hershfield ES (eds). Tuberculosis, a comprehensive
international approach. 2nd ed. New York, NY: Marcel Dekker, Inc; 2000:279-322.

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10.7. Appendix 7: Investigator’s Global Assessment (IGA)
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10.8. Appendix 8: Psoriasis Area and Severity Index (PASI)
The Psoriasis Area and Severity Index or PASI is a system used for assessing and grading the
severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that
can range from 0 to 72. The severity of the disease is calculated as follows.
In the PASI system, the body is divided into 4 regions: the head (h), trunk (t), upper extremities (u),
and lower extremities (l), which account for 10%, 30%, 20%, and 40% of the total BSA,
respectively. Each of these areas is assessed separately for erythema, induration and scaling, which
are each rated on a scale of 0 to 4.
The scoring system for the signs of the disease (erythema, induration, and scaling) are: 0 = none,
1 = slight, 2 = moderate, 3 = severe, and 4 = very severe.
The scale for estimating the area of involvement for psoriatic lesions is outlined below.
0 = no involvement
1 = 1% to 9% involvement
2 = 10% to 29% involvement
3 = 30% to 49% involvement
4 = 50% to 69% involvement
5 = 70% to 89% involvement
6 = 90% to 100% involvement
To help with the area assessments, the following conventions should be noted:
a. The neck is considered part of the head
b. The axillae and groin are part of the trunk
c. The buttocks are part of the lower extremities
The PASI formula is:
PASI = 0.1 (Eh + Ih + Sh) Ah + 0.3 (Et + It + St) At + 0.2 (Eu + Iu + Su) Au + 0.4 (El + Il + Sl) A  
l
Where E = erythema, I = induration, S = scaling, and A = area

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10.9. Appendix 9: Children’s Dermatology Life Quality Index
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10.10. Appendix 10: Family Dermatology Life Quality Index
                 The Family Dermatology Life Quality Index (FDLQI)
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© MKA Basra, AY Finlay. Cardiff University 2005.
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If INR is abnormal, prothrombin time (PT), partial thromboplastin time (PTT) should be
obtained and these values should be followed until normal, along with documentation of
whether parenteral vitamin K was given along with the effect of such treatment on INR.
4. If initial LTs and ultrasound do not suggest Gilbert’s syndrome,  biliary tract disease or
obstruction, viral hepatitis serology should be obtained including anti-hepatitis A virus
immunoglobin M (anti-HAV IgM), anti-HAV total,  hepatitis B surface antigen (HBsAg),
anti-HBs,  anti-HB core total,  anti-HB core IgM, anti-hepatitis C virus (anti-HCV),  anti-
hepatitis E virus IgM (anti-HEV IgM) (even if has not traveled to an endemic area for hepatitis
E), Epstein-Barr virus (EBV) and Cytomegalovirus (CMV) screen.
If patient is immunosuppressed, test for HCV RNA and HEV RNA.
If HBsAg or anti-HB core IgM or anti-HB core IgG positive, also get HBV DNA to detect
active HepB, especially in patients who are immunosuppressed.
If all other hepatitis B serologic tests are negative and anti-HBc total is the only positive
test, HBV DNA should be obtained to detect reactivation of hepatitis B.
5. Assuming that the history, physical, and initial imaging and laboratory has not revealed a
cause of elevated LTs, screen for other causes of liver disease including: Total protein and
albumin (estimate globulin fraction and obtain quantitative immunoglobulins if elevated),
antinuclear antibody (ANA), anti-liver kidney microsomal antibody type 1 (anti-LKM1), anti-
liver-kidney microsomal antibodies (anti-LKM antibodies), anti-smooth muscle antibodies
(ASMA), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP). If the pattern
of laboratory abnormalities is not hepatocellular, but cholestatic or a mixed pattern (see
definitions in table above), then gamma-glutamyl transferase (GGT), anti-mitochondrial
antibody (AMA) and anti-neutrophil cytoplasmic antibody (pANCA) should also be tested.
If there is an indication by history or elevated baseline LTs that there may be an underlying
chronic liver disease possibly exacerbated by exposure to the study intervention in the clinical
trial or making the participant more susceptible to DILI, test iron/Total iron binding capacity
(TIBC) and ferritin (hemochromatosis), and alpha-1-antitrypsin level.  If patient is <50 years
of age, ceruloplasmin should also be tested to screen for Wilson’s disease.  If patient is sick
enough to be hospitalized and is under age 50, a slit lamp examination to detect Kayser-
Fleischer rings and a 24-hour urine collection for copper should be measured. Consider serum
ethanol and/or acetaminophen level and urine drug screen as clinically appropriate.
6. A liver biopsy should be considered if autoimmune hepatitis remains a competing etiology
and if immunosuppressive therapy is contemplated.
A liver biopsy may be considered:
if there is unrelenting rise in liver biochemistries or signs of worsening liver function
despite stopping the suspected offending agent.
if peak ALT  level has not fallen by >50% at 30-60 days after onset in cases of
hepatocellular DILI, or if peak Alk P has not fallen by >50% at 180 days in cases of
cholestatic DILI despite stopping the suspected offending agent.
in cases of DILI where continued use or re-exposure to the implicated agent is expected.
if liver biochemistry abnormalities persist beyond 180 days to evaluate for the presence
of chronic liver diseases and chronic DILI.

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7. If pertinent, copies of hospital discharge summary, radiology, pathology and autopsy reports
should be obtained.
Abbreviations
AlkP  
alkaline phosphatase
ALT  
alanine aminotransferase
AMA  
anti-mitochondrial antibody
ANA  
antinuclear antibody
Anti-LKM1 
anti-liver kidney microsomal antibody type 1
ASMA  
anti-smooth muscle antibodies
AST  
aspartate aminotransferase
BMI 
body mass index
CBC 
complete blood count
CHF  
congestive heart failure
CMV  
cytomegalovirus
CRP  
C-reactive protein
CT  
computerized tomography
DM  
diabetes mellitus
DNA  
deoxyribonucleic acid
EBV  
Epstein-Barr virus
ERCP  
endoscopic retrograde cholangiopancreatography
ESR  
erythrocyte sedimentation rate
EOI 
end of intervention
GGT  
gamma-glutamyltransferase
HAV 
hepatitis A virus
HBsAg 
hepatitis B surface antigen
HCV  
hepatitis C virus
HepB  
hepatitis B virus
HEV  
hepatitis E virus
IgM  
immunoglobin M
INR  
international normalized ratio
LT/LFT  
liver tests/liver function tests
MRI 
magnetic resonance imaging
MRCP  
magnetic resonance cholangiopancreatography
NSAID  
nonsteroidal anti-inflammatory drug
OTC  
over the counter
PT  
prothrombin time
PTT  
partial thromboplastin time
RNA  
ribonucleic acid
Tbili 
total bilirubin
TIBC  
total iron binding capacity
ULN  
upper limit of normal
WBC  
white blood count

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10.13. Appendix 13: Columbia-Suicide Severity Rating Scale (Children’s
Baseline)

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10.14. Appendix 14: Columbia-Suicide Severity Rating Scale
(Baseline/Screening)

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10.15. Appendix 15: Columbia-Suicide Severity Rating Scale (Children’s Since
Last Visit)

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10.16. Appendix 16: Columbia-Suicide Severity Rating Scale (Since Last Visit)

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10.17. Appendix 17: Faces Pain Scale –Revised (FPS-R) for Injection Pain
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10.18. Appendix 18: Injection Pain Visual Analog Scale (VAS)
The participant will evaluate injection pain intensity by answering the following question:
Please rate the pain you experienced with the injection by placing a vertical mark on the line below.
The line will be 100 mm in length. The participant will be instructed to make a mark on the line to
indicate the intensity of the pain he/she experienced with the injection
Using a standard ruler, a trained observer (an individual under the supervision of the principal
investigator who observes and instructs participants regarding trial procedures) will measure the
distance in millimeters (0-100) from the left of the scale to the participant’s mark and record this
distance in the case report form.

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10.19. Appendix 19: Anticipated Events
Anticipated Event
An anticipated event is an adverse event (serious or non-serious) that commonly occurs as a
consequence of the underlying disease or condition under investigation (disease related) or
background regimen.
For the purposes of this study the event of psoriasis will be considered an anticipated event.
Reporting of Anticipated Events
All adverse events will be recorded in the CRF regardless of whether considered to be anticipated
events and will be reported to the sponsor as described under All Adverse Events in Section 8.3.1,
Time Period and Frequency for Collecting Adverse Event and Serious Adverse Event Information.
Any anticipated event that meets serious adverse event criteria will be reported to the sponsor as
described under Serious Adverse Events in Section 8.3.1. These anticipated events are exempt
from expedited reporting as individual single cases to Health Authorities. However, if based on an
aggregate review, it is determined that an anticipated event is possibly related to study intervention,
the sponsor will report these events in an expedited manner.
Anticipated Event Review Committee (ARC)
An Anticipated Event Review Committee (ARC) will be established to perform reviews of pre-
specified anticipated events at an aggregate level. The ARC is a safety committee within the
sponsor’s organization that is independent of the sponsor’s study team. The ARC will meet to aid
in the recommendation to the sponsor’s study team as to whether there is a reasonable possibility
that an anticipated event is related to the study intervention.
Statistical Analysis
Details of statistical analysis of anticipated events, including the frequency of review and threshold
to trigger an aggregate analysis of anticipated events will be provided in a separate Anticipated
Events Safety Monitoring Plan (ASMP).

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10.22. Appendix 22: Guidance on Study Conduct During the COVID-19 Pandemic
It is recognized that the Coronavirus Disease 2019 (COVID-19) pandemic may have an impact on
the conduct of this clinical study due to, for example, self-isolation or quarantine of participants
and study-site personnel; travel restrictions/limited access to public places, including hospitals;
study site personnel being unavailable, isolated, or reassigned to critical tasks.
The sponsor is providing options for study related participant management in the event of
disruption to the conduct of the study. This guidance does not supersede any local or government
guidelines or requirements or the clinical judgment of the investigator to protect the health and
well-being of participants and site staff. If, at any time, a participant’s safety is considered to be at
unacceptable risk, study intervention will be discontinued, and study follow-up will be conducted.
If, as a result of the COVID-19 pandemic, visits cannot be conducted in person at the study site,
they will be performed to the extent possible remotely/virtually or delayed until such time that on-
site visits can be resumed. At each contact, participants will be interviewed to collect safety data.
Key efficacy endpoint assessments should be performed if required and as feasible. Participants
will also be questioned regarding general health status to fulfill any physical examination
requirement.
Every effort should be made to adhere to protocol-specified assessments for participants on study
intervention, including follow-up. Modifications to protocol-required assessments may be
permitted, after consultation with the participant, investigator, and the sponsor..
The sponsor will continue to monitor the conduct and progress of the clinical study, and any
changes will be communicated to the sites and to the health authorities according to local guidance.
If a participant has tested positive for COVID-19, the investigator should contact the sponsor’s
medical officer or designee to discuss plans for administration of study intervention, performing
study assessments, and follow-up. Modifications made to the study conduct as a result of the
COVID-19 pandemic should be summarized in the CSR.
ADDITIONAL ELEMENTS, WHERE APPLICABLE:
Certain protocol-mandated visits to the study site may not be possible during the COVID-19
outbreak. Therefore, temporary measures may be implemented if considered appropriate by
the sponsor and investigator to maintain continuity of patient care and study integrity. Certain
measures, such as those listed below, may be necessary and should be instituted in accordance
with applicable (including local) laws, regulations, guidelines, and procedures:
remote (eg, by phone / telemedicine) or in-person, off-site (eg, in-home) interactions
between site staff (or designees) and patients for study procedures (eg, those related to
safety monitoring / efficacy evaluation / study intervention storage and administration
[including training where pertinent])
procurement of study intervention by patients (or designee) or shipment of study
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laboratory assessments using a suitably accredited local laboratory; for selected measures
(eg, urine pregnancy), home testing may be employed
other procedures may be conducted at an appropriate facility
Missed assessments/visits will be captured in the clinical trial management system for
protocol deviations. Discontinuations of study interventions and withdrawal from the study
should be documented with the prefix “COVID-19-related” in the eCRF.
other relevant study data elements impacted by the pandemic should also be documented
/ labeled as “COVID-19-related” in eCRFs and / or other study systems, as directed by
detailed sponsor guidance. These may include missed / delayed / modified study visits /
assessments / dosing, and instances where temporary measures such as those above are
implemented.
The sponsor will evaluate the totality of impact of COVID-19 on collection of key study data
and additional data analyses will be outlined in study SAP(s).

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10.23. Appendix 23: Protocol Amendment History
The Protocol Amendment Summary of Changes Table for the current amendment is located
directly before the Table of Contents (TOC).
Amendment 4 (24 February 2022)
Overall Rationale for the Amendment: Clarifications and additions to align with the latest
protocol template for COVID-19 situations, tuberculosis language, handling potential Hy’s law
situations, and a clarification on a post-trial access and the long-term extension.
Section Number 
and Name
Description of Change 
Brief Rationale
Section 1.1, Synopsis; 
Section 6.1, Study 
Interventions 
Administered; Section 8, 
Study Assessments and
Procedures
Update language for post-trial access 
Clarification of minimum post-
trial access for patients reaching
18 years of age prior to or during
the LTE
Section 1.3.3 Long-term 
Extension Phase (Week 
60 Through Study 
Completion/Termination)
Clarified that participants will be able to begin 
self-administration in the LTE 
Further clarification that self-
administration is allowed in the
LTE
Section 5.1. Inclusion 
Criteria 
Updated Inclusion Criteria 11 
Clarification for suspected false-
positive QuantiFERON®-TB
tests
Section 5.2 Exclusion 
Criteria 
Added Exclusion Criteria 42 for COVID-19 
infections 
Added language to align with the
latest immunology-specific
protocol template update
5.3 Lifestyle 
Considerations 
Added recommendation to be up to date on all 
vaccinations including COVID-19 
Added language to align with the
latest immunology-specific
protocol template update
6.5.6 Vaccinations 
(including COVID-19) 
Added vaccinations section to Concomitant 
Therapy Section  
Added language to align with the
latest immunology-specific
protocol template update
7.1 Discontinuation of 
Study Intervention  
Clarified language regarding discontinuation of 
study intervention for TB 
Updated language to align with
the latest immunology-specific
TB protocol template language
Section 8 Study 
Assessments and 
Procedures 
Clarified language regarding false-positive TB 
tests 
Added clarifying statement on
how to handle suspected false-
positive TB tests
8.3.1.2 Serious Adverse 
Events 
Updated Hy’s law language 
Added clarification statement on
how to handle potential Hy's law
cases
Section 10.3 Appendix 3: 
Contraceptive and Barrier 
Guidance and Collection 
of Pregnancy Information
Minor updates to the appendix. 
Incorporation of clarifying edits
from the latest protocol template
update.
Section 10.12 Appendix 
12: Guideline Algorithm 
for Monitoring, 
Assessment, and
Evaluation of Abnormal
Liver Tests in Participants
with No Underlying Liver
Disease
Minor updates to the appendix. 
Incorporation of clarifying edits
from the latest protocol template
update.

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Section Number 
and Name
Description of Change 
Brief Rationale
Section 10.22 Appendix 
22: Guidance on Study 
Conduct During the 
COVID-19 Pandemic
Added COVID-19 appendix  
COVID-19 appendix added to
align with latest Sponsor
COVID-19 protocol template
Throughout the protocol 
Minor grammatical, formatting, or spelling 
changes were made.
Minor errors were noted.
Amendment 3 (19 Feb 2020)
Overall Rationale for the Amendment: To clarify information related to the management of liver function
test abnormalities.
Section Number 
and Name
Description of Change 
Brief Rationale
1.3.1 Schedule of 
Activities—Screening 
Through Week 52 —  
Part 1a and 1b
Clinical LaboratoryAssessment—Chemistry 
Added footnote w: 
w. Includes liver function testing described in
Section 8.2.3. A description of the required
approach for evaluation of specific LFT
abnormalities is in Appendix 12 (Section 10.12).
Footnote added to clarify that
testing will be performed to
evaluate specific markers of liver
function abnormalities.
1.3.2 Schedule of 
Activities—Screening 
Through Week 52 —  
Part 2
Clinical Laboratory Assessment—Chemistry 
Added footnote v: 
v. Includes liver function testing described in
Section 8.2.3. A description of the required
approach for evaluation of specific LFT
abnormalities is in Appendix 12 (Section 10.12).
Footnote added to clarify that
testing will be performed to
evaluate specific markers of liver
function abnormalities.
1.3.3 Schedule of 
Activities—Long-term 
Extension Phase (Week 
60 Through Study
Completion/Termination)
Clinical Laboratory Assessment—Chemistry 
Added footnote k: 
k. Includes liver function testing described in
Section 8.2.3. A description of the required
approach for evaluation of specific LFT
abnormalities is in Appendix 12 (Section 10.12).
Footnote added to clarify that
testing will be performed to
evaluate specific markers of liver
function abnormalities.
7.1. Discontinuation of 
Study Intervention  
Item (bullet# 11) was inserted: 
The participant has liver test abnormalities as
described in Section 8.2.3 and Appendix 12
(Section 10.12). Such abnormalities would
include the following:
ALT or AST >8 x ULN
ALT or AST >5 x ULN for more than
2 weeks
ALT or AST >3 x ULN and (total
bilirubin >2 x ULN or international
normalized ratio [INR] >1.5)
ALT or AST >3 x ULN and
symptoms of hepatitis (eg, fatigue,
nausea, vomiting, right upper quadrant
pain or tenderness, fever, rash, and/or
eosinophilia [>5%])
This item was added to clarify the
criteria for discontinuation of
study intervention due to liver
test abnormalities.

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Section Number 
and Name
Description of Change 
Brief Rationale
8.2.3. Clinical Safety 
Laboratory Assessments 
Information regarding abnormal liver function 
tests and retesting was added as a third  
paragraph: 
If laboratory testing for a participant who is
enrolled in the study and receiving study
intervention reveals an increase of serum
aminotransferases (ALT or AST) to >3 x ULN,
study agent should be suspended immediately.
In addition, laboratory tests for ALT, AST,
alkaline phosphatase, and total bilirubin should
be confirmed by a retest within 24 hours, if
possible, but no later than 72 hours following
notification of test results. Additional clinical
and laboratory studies and consultations may be
performed to evaluate the underlying etiology of
abnormal findings. See Appendix 12 (Section
10.12; Guideline Algorithm for Monitoring,
Assessment, and Evaluation of Abnormal Liver
Tests in Participants with No Underlying Liver
Disease) for additional information on
monitoring and assessment of abnormal liver
function tests.
A paragraph was added to clarify
the cutoffs for abnormal liver
function tests, what action should
be taken in the event of an
abnormal test, that additional
testing may be requested, and the
appropriate appendix number for
liver function tests was added.
10.12. Appendix 12 
Added updated Appendix 12: Guideline 
Algorithm for Monitoring, Assessment, and 
Evaluation of Abnormal Liver Tests in 
Participants with No Underlying Liver Disease. 
This Appendix was added with
the most current updated version.
The Appendix provides detailed
guidance regarding additional
tests and evaluations to be
obtained in the setting of specific
patterns of liver enzyme
abnormalities.
Throughout the protocol 
Minor grammatical, formatting, or spelling 
changes were made.
Minor errors were noted
Amendment 2 (08 May 2019)
Overall Rationale for the Amendment:  To clarify that assessment of serum guselkumab
concentrations and antibodies to guselkumab are not required at Weeks 0, 4, and 12 for participants
who were randomized to etanercept.
Section number 
and Name
Description of Change 
Brief Rationale
Section 1.3.1.
Screening Through
Week 52 –Part 1a
and 1b.
Added footnote (y) to Week 0, 4, and 12 for rows
of Serum guselkumab concentration and
Antibodies to guselkumab.
Footnote added: y. Participants randomized to
etanercept will not require a blood draw for
pharmacokinetics and/or immunogenicity
assessments at these visits.
To clarify that assessment of serum
guselkumab concentrations and
antibodies to guselkumab are not
required at Weeks 0, 4, and 12 for
participants who were randomized
to etanercept.
Section 8. Study
Assessments and
Procedures.
Screening Phase.
Deletion of reference to Appendix 6: As outlined in
the eligibility criteria, participants must undergo
testing for TB (see Appendix 6) and their medical
history assessment must include specific questions
Inappropriate internal referencing
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Section number
and Name
Description of Change 
Brief Rationale
about a history of TB or known exposure to
individuals with active TB.
Throughout the
protocol
Minor grammatical, formatting, or spelling changes 
were made.
Minor errors were noted.
Amendment 1 (09 May 2018)
Overall Rationale for the Amendment:  The overall reason for the amendment is to address health
authority advice.
Section number 
and Name
Description of Change 
Brief Rationale
Sec 1.3.1. Schedule 
of Activities. 
Screening Through 
Week 52 –Part 1a 
and 1b  
Physical examination: added Week 20 visit 
Footnote added to Vital signsk; and all subsequent 
footnotes were updated.
Height: added Weeks 12, 20, and 36 visits
Hematology: added Weeks 8, 36, and 52 visits
Chemistry: added Weeks 8, 36, and 52 visits
Antibodies to guselkumab: added Week 4 visit
Footnoted added: k. Vital signs include heart rate,
blood pressure, and temperature.
To address regulatory authority’s
request.
Sec 1.3.1. Schedule
of Activities.
Screening Through
Week 52 –Part 1a
and 1b
Assessment of injection pain: removed Week 8. 
Removed to correct error. 
Sec 1.3.2. Schedule
of Activities.
Screening Through
Week 52 –Part 2
:
Added Weeks 4, 20, 28, 36, and 44 visits.
Physical examination: added Week 20 visit
Footnote added to Vital signsi; and all subsequent
footnotes were updated.
Height Assessment: added Weeks 12, 20, and 36
visits
Hematology: added Weeks 8, 36, and 52 visits
Chemistry: added Weeks 8, 36, and 52 visits
Antibodies to guselkumab: added Week 4 visit
Footnote f: updated “HCP” references with “study
staff”.
Footnote added: i. Vital signs include heart rate,
blood pressure, and temperature.
To address regulatory authority’s
request.
Section 1.3.3. Long-
Term Extension
Phase
Footnote added to Vital signsf; and all subsequent
footnotes were updated.
Footnoted added: f. Vital signs include heart rate,
blood pressure, and temperature.
To address regulatory authority’s
request.
Section 2.3.1.
Guselkumab
Updated internal reference from “(IB, Section 6)”
to “(IB, Section 5)”.
To address incorrect internal
reference.
Section 4.1: Overall
Design
Updated “HCP” references with “study staff”.
Updated “very” with “ultra-” high potency topical
steroids.
Consistent terminology.
Consistent terminology.
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Section number
and Name
Description of Change 
Brief Rationale
Added “(should not initiate rescue topical steroids 
at or after Week 16).” 
Clarification on initiating rescue
topical steroids.
Section 5.1.
Inclusion Criteria.
#16
Added “≥” to 4.5 x 103 cells/µL to white blood 
cells.
To address the missing sign.
Section 5.1.
Exclusion Criteria.
#20
Updated “(…see inclusion criterion 10)” to “(…see
inclusion criterion 12)”.
To address incorrect internal
reference.
Section 6.1 Study
Interventions
Administered
Removed “commercially available” to read “This
will be either the 
 PFS…” .
Added “Patients or caregivers may be retrained at
any time during the study, including if there is a
use issue reported by the patient or caregiver.”
Updated “HCP” references with “study staff”.
Updated to remove an error.
To address regulatory authority’s
request.
Consistent terminology.
Section 6.4.
Study Intervention
Compliance
Added “Etanercept dosing should occur within a
range of ±3 days of the scheduled date.”
Additional guidance on etanercept
dosing window.
Section 6.5.1.
Rescue Medication
Updated “very” with “ultra-” high potency topical
steroids.
Added “(should not initiate rescue topical steroids
at or after Week 16).”
Consistent terminology.
Clarification on initiating rescue
topical steroids.
Section 7.1.
Discontinuation of
Study Intervention
Updated “…symptomatic hypotension with a
decrease in systolic blood pressure greater than
40 mm mercury (Hg).” with “…symptomatic
hypotension (defined as systolic BP < [70 + 2 x age
in years]).30”
Updated “…shown no improvement…” with
“…shown insufficient improvement…”
To address regulatory authority’s
request.
Section 8. Study
Assessments and
Procedures.
Overview
Added “The approximate total volume of blood per
type of sample to be collected through Week 52 is
presented in Table 1.”
Updated “…approximately 66.5 mL (Table 1) with
maximum volumes of 10 mL at screening and
10.5 mL at other study visits.” with “approximately
79.5 mL with maximum volume of 17.5 mL at
screening and 10.5 mL at other study visits
(Table 2).”
Added “Where possible, tests are combined to
allow for fewer draw tubes and in the interest of
keeping blood volumes to a minimum. Therefore,
the total volume is less than that presented in Table
1.”
Updated volumes for Table 1:
-Hematology: from 5 to 8 for per participant, and
10 to 16 for total volume
-Serum chemistry: from 5 to 8 for per participant,
and 12.5 to 20 for total volume
To address regulatory authority’s
request and updated total volumes
based on additional laboratory
timepoints.
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Section number
and Name
Description of Change 
Brief Rationale
-Serology (HIV, hepatitis): from 6 to 6.5 for
volume per sample and for total volume
-QuantiFERON-TB testing: from 3 to 4 for volume
per sample and for total volume
-Pharmacokinetics sample only: from 3 to 2 for per
participant, and 7.5 to 5 for total volume
-Pharmacokinetics and immunogenicity samples:
from 5 to 6 for per participant, and 17.5 to 21 for
total volume
-Approximate total: from 66.5 mL to 82.5 mL
Added new Table 2: Approximate Volume of
Blood to be Collected per Visit Through Week 52.
Section 8.
Study Assessments
and Procedures. Part
2.
Updated “HCP” references with “study staff”. 
Consistent terminology.
Section 8.
Study Assessments
and Procedures.
Study-Specific
Materials.
Added “• iPad® and site user guide, if the study
site is participating in electronic informed consent”
Add information about electronic
informed consent.
Section 8.2.2. Vital
Signs
Updated “Heart rate and blood pressure will be
measured.” to “Heart rate, blood pressure, and
temperature will be measured.”
To address regulatory authority’s
request.
Section 8.2.9.
Allergic Reactions
Updated “…symptomatic hypotension with a
greater than 40 mm Hg decrease in systolic blood
pressure.” with “…symptomatic hypotension
(defined as systolic BP < [70 + 2 x age in
years]).30”
To address regulatory authority’s
request.
Section 8.3.1 Time
Period and
Frequency for
Collecting Adverse
Events and Serious
Adverse Event
Information
Changed subheadings “All Adverse Events” and
“Serious Adverse Events” to numbered
subheadings as Section 8.3.1.1. and Section
8.3.1.2, respectively.
Table of contents updated accordingly.
Administrative update to link to
appropriate protocol sections.
Section 8.3.1.1 All
Adverse Events
(new numbered
heading)
Added “All SAEs and nonserious AEs that
represent events of suicidal ideation or suicidal
behavior, including any of the following diagnoses,
must be reported to the sponsor following the
procedures outlined in Section 8.3.1.2:
• Suicidal ideation
• Suicidal behavior, including completed suicide
• Self-injurious behavior”
To address regulatory authority’s
request.
Section 8.3.5.
Events of Special
Interest
Updated internal reference from “Section 8.3.1” to
“Section 8.3.1.2.”
Internal consistency for reference.
Section 8.10.
Usability
Assessment
Updated “…the HCP will determine whether the
pediatric participant of their caregiver…” to “…the
study staff will determine whether the participant
(≥12 years of age) or their caregiver…”
Updated “Following the second independent self-
or caregiver-administration with the 
…” to
Internal consistency and to address
regulatory authority’s request.
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Section number
and Name
Description of Change 
Brief Rationale
“Following the subsequent independent self- or
caregiver-administrations with the
…”
Added internal reference “(See Section 1.3:
Schedule of Activities)”
Updated “If the self-injections have been
performed by the pediatric participant…”  to “If
the injections have been performed by the
participant…”
Section 9.4.1.3.
Primary Analysis
Updated “Participants who meet treatment failure 
criteria before Week 16…” to “Participants who 
meet treatment failure criteria or initiate use with a
low to high potency topical steroid as rescue
treatment before Week 16…”
Clarification of treatment failure
criteria.
Section 9.4.3. Safety
Analyses: Vital
Signs
Updated vital signs to add temperature: “…blood 
pressure (Systolic and diastolic) values, and 
temperature, and…”
To address regulatory authority’s
request.
Section 9.5.1. Data
Monitoring
Committee
Updated “…committee of approximately 3 to 
5 members and will include experts in pediatric 
dermatology, and biostatistics.” to “…committee of
3 members and will include individuals with
expertise in pediatric dermatology, and
biostatistics.”
To address regulatory authority’s
request.
Section 10.2.
Appendix 2.
Informed Consent
process and Assent
Form
Added “A limited number of study sites will be 
asked by the Sponsor to obtain informed consent 
using a validated electronic system instead of a
paper-based process.  If both parties (Sponsor and
the Study Site) agree, and if participation is
allowed by local regulations and EC/IRB
requirements, the Sponsor will provide an eTablet
device (e.g., iPad®) to the study site to use for the
electronic informed consent. Overall the consent
process will remain the same, as described in this
section; however, at the study sites utilizing
electronic informed consent, participants or their
legally acceptable representatives will be able to
review the entire informed consent form content on
the eTablet. The ability for participants or their
legally acceptable representatives to review the
paper informed consent form is always an option at
sites utilizing electronic informed consent.
Depending on local regulations and EC/IRB
requirements, the participants or their legally
acceptable representatives and person obtaining
consent will either apply their handwritten
signature electronically directly onto the eTablet,
or apply their handwritten signature to a printed
paper copy of the informed consent in accordance
with local regulations.”
Add information about electronic
informed consent.
Section 10.2.
Appendix 2.
Committees
Structure. Data
Monitoring
Committee
Updated “…committee of approximately 3 to 
5 members and will include experts in pediatric 
dermatology, and biostatistics.” to “…committee of
3 members and will include individuals with
expertise in pediatric dermatology, and
biostatistics.”
To address regulatory authority’s
request.
CCI

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Section number
and Name
Description of Change 
Brief Rationale
Section 10.4.
Appendix 4
Updated internal reference from “(refer to Section 
8.3.1, Time Period and Frequency for Collecting
Adverse Event and Serious Adverse Event
Information)” to “(refer to Section 8.3.1.2, Serious
Adverse Event Information)”
Internal consistency for reference.
Section 10.19.
Appendix 19.
Added a new step to the checklist: Step 1: Tap air 
bubbles to top.
Updated Step 3 text from “Was the orange band
visible after removing air bubbles?” to “Was the
orange priming band no longer visible after
removing air bubbles?”
Added “for Steps 1 through Step 3” in Step 3
Delete asterisk and its reference statement in Step 4
“*if No and the participant/caregiver injects the
wrong dose, follow procedures for reporting a
product quality complaint (PQC).”
Added “while the orange cover sleeve was fully
depressed” in Step 6.
Added “quality compliant” in Step 6.
To address corrections.
Section 10.21.
Appendix 21
Added “The Protocol Amendment Summary of 
Changes Table for the current amendment is 
located directly before the Table of Contents
(TOC).”
Update protocol amendment
history.
Throughout the
protocol
All references to the “QuantiFERON-TB Gold 
test” were updated to “QuantiFERON-TB test”, 
and Appendix 5 was deleted.
Updated based on revised
laboratory text.
Throughout the
protocol
Minor grammatical, formatting, or spelling changes 
were made.
Minor errors were noted.

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11. 
REFERENCES
1. 
Aggarwal S, Ghilardi N, Xie M-H, et al. Interleukin-23 promotes a distinct CD4 T cell activation state
characterized by the production of Interleukin-17. J Biol Chem. 2003;278:1910–1914.
2. 
Basra MKA, Edmunds O, Salek MS, Finlay AY. Measurement of family impact of skin disease: further
validation of the Family Dermatology Life Quality Index (FDLQI). J Eur Acad Dermatol Venereol.
2008;22:813-821.
3. 
Basra MKA, Sue-Ho R, Finlay AY. The Family Dermatology Life Quality Index: measuring the secondary
impact of skin disease. Br J Dermatol 2007;156(3): 528-538.
4. 
Beattie PE, Lewis-Jones MS. A comparative study of impairment of quality of life in children with skin disease
and children with other chronic childhood diseases. Br J Dermatol. 2006; 155(1):145-151.
5. 
Bhutani T, Kamangar F, Cordoro KM. Management of Pediatric Psoriasis. Pediatric Annals.
2012;41(1):e1-e7).
6. 
Bronckers IMGJ, Paller AS, van Geel MJ, van de Kerkhof PCM, Seyger MMB. Psoriasis in Children and
Adolescents: Diagnosis, Management and Comorbidities. Paediatr Drugs. 2015;17:373–384.
7. 
Busch AL, Landau JM, Moody MN, et.al. Pediatric psoriasis. Skin Therapy Lett. 2012;17(1):5-7.
8. 
Christophers E, Henseler T. Psoriasis type I and II as subtypes of nonpustular psoriasis. Semin Dermatol.
1992;11(4):261-266.
9. 
Danesh MJ, Kimball AB. Brodalumab and suicidal ideation in the context of a recent economic crisis in the
United States. J Am Acad Dermatol. 2016;74(1):190-192.
10. Eder L, Chandran V, Gladman DD. What have we learned about genetic susceptibility in psoriasis and
psoriatic arthritis? Curr Opin Rheumatol. 2015;27(1):91-98.
11. Feldman SR, Gordon KB, Bala M, et al. Infliximab treatment results in significant improvement in the quality
of life of patients with severe psoriasis: a double-blind placebo-controlled trial. Br J Dermatol.
2005;152:954-960.
12. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical
use. Clin Exp Dermatol. 1994;19(3):210-216.
13. Fredriksson T, Pettersson U. Severe psoriasis –oral therapy with a new retinoid. Dermatologica.
1978;157:238-244.
14. Griffiths CE, Barker JN. Pathogenesis and clinical features of psoriasis. Lancet. 2007;370(9583):263-271.
15. Hong K, Chu A, Lúdviksson BR, Berg EL, Ehrhardt RO. IL-12, independently of IFN-gamma, plays a crucial
role in the pathogenesis of a murine psoriasis-like skin disorder. J Immunol. 1999;162(12):7480-7491.
16. HUMIRA® Summary of Product Characteristics. AbbVie Inc. Maidenhead, SL6 4UB, United Kingdom. 2015.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/000481/WC500050870.pdf. accessed 23 Aug 2017.
17. Koo J. Population-based epidemiologic study of psoriasis with emphasis on quality of life enhancement.
Dermatol Clin. 1996;14(3):485-496.
18. Landells I, Marano C, Hsu M-C, et al. Ustekinumab in adolescent patients age 12 to 17 years with moderate-
to-severe plaque psoriasis: Results of the randomized phase 3 CADMUS study. J Am Acad Dermatol.
2015;73(4):594-603.
19. Lara-Corrales I, Xi N, Pope E. Childhood psoriasis treatment: evidence published over the last 5 years. Rev
Recent Clin Trials. 2011;6(1):36-43.
20. Lewis-Jones MS, Finlay AY. The children’s dermatology life quality index (CDLQI): Initial validation and
practical use. Br J Dermatol. 1995;132(6):942-949.
21. Lewkowicz D, Gottlieb AB. Pediatric psoriasis and psoriatic arthritis. Dermatol Ther. 2004;17(15):364 375.

CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3011 Amendment 5
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
151
Approved, Date: 29 August 2024
22. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic
arthritis : Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics.
J Am Acad Dermatol. 2008;58:5:826-850.
23. Mundt JC, Greist JH, Jefferson JW, et al. Prediction of suicidal behavior in clinical research by lifetime
suicidal ideation and behavior ascertained by the electronic Columbia-Suicide Severity Rating Scale. J Clin
Psych. 2013;74(9):887-893.
24. Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med 2009;361(5):496-509.
25. Paller AS, Siegfried EC, Langley RG, et al, for the Etanercept Pediatric Psoriasis Study Group. Etanercept
treatment for children and adolescents with plaque psoriasis. N Engl J Med. 2008; 358(3):241-251.
26. Parisi R, Symmons DP, Griffiths CE, Ashcroft DM. Identification and Management of Psoriasis and
Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of
incidence and prevalence. J Invest Dermatol. 2013;133(2):377-385.
27. Posner K, Brown GK, Stanley B, et al. The Columbia-Suicide Severity Rating Scale: Initial validity and
internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry.
2011;168(12):1266-1277.
28. Schön MP, Boehncke W-H. Medical Progress Psoriasis. N Engl J Med. 2005;352(18):1899-1912.
29. Silverberg, NB. Pediatric psoriasis: an update. Ther Clin Risk Manag. 2009;5:849–856.
30. Tschudy MM, Arcara KM. The Harriet Lane Handbook. A manual for pediatric house officers. 19th  edition.
2012.
31. Tsze D, von Baeyer CL, Bulloch B, Dayan PS. Validation of Self-Report Pain Scales in Children. Pediatrics.
2013;132(4):e971-979.
32. Varni JW, Globe DR, Gandra SR, Harrison DJ, Hooper M, Baumgartner S. Health-related quality of life of
pediatric patients with moderate to severe plaque psoriasis: comparisons to four common chronic diseases. Eur
J Pediatr. 2012;171(3):485-492.
33. Von Baeyer CL. Children’s self-reports of pain intensity: scale selection, limitations, and interpretation. Pain
Res Manage. 2006;11(3):157-162.
34. Yawalkar N, Karlen S, Hunger R, Brand CU, Braathen LR. Expression of interleukin-12 is increased in
psoriatic skin. J Invest Dermatol. 1998;111(6):1053-1057.

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INVESTIGATOR AGREEMENT
I have read this protocol and agree that it contains all necessary details for carrying out this study. I will
conduct the study as outlined herein and will complete the study within the time designated.
I will provide copies of the protocol and all pertinent information to all individuals responsible to me who
assist in the conduct of this study. I will discuss this material with them to ensure that they are fully informed
regarding the study intervention, the conduct of the study, and the obligations of confidentiality.
Coordinating Investigator (where required):
Name (typed or printed):
Institution and Address:
Signature: 
Date:
(Day Month Year)
Principal (Site) Investigator:
Name (typed or printed):
Institution and Address:
Telephone Number:
Signature: 
Date:
(Day Month Year)
Sponsor's Responsible Medical Officer:
Name (typed or printed): 
Institution: 
Janssen Research & Development
Signature: [electronic signature appended at the end of the protocol] 
Date:
(Day Month Year)
Note: If the address or telephone number of the investigator changes during the study, written notification will be
provided by the investigator to the sponsor, and a protocol amendment will not be required.
PPD

Signature
User 
Date 
Reason
 
30-Aug-2024
22:10:48
(GMT)
Document Approval
PPD