Conditions: Psoriasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 78
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.

Detailed description:

Arms:
arm 1: Participants will receive 100 milligram (mg) guselkumab administered as a 100 milligram per milliliter (mg/mL) solution in a single-use prefilled syringe (PFS) assembled in a SelfDose device at Weeks 0, 4, 12, 20, and 28; liquid placebo for guselkumab 100 mg at Week 16 to maintain the study blind. arm 2: Partcipants will receive placebo at Weeks 0, 4, and 12 followed by guselkumab 100 mg at Weeks 16, 20, and 28.

Interventions: intervention 1: Guselkumab intervention 2: Placebo
Intervention descriptions: intervention 1: Participants will receive 100 mg of Guselkumab as 100 mg/mL solution via SelfDose device. intervention 2: Participants will receive matching placebo supplied in a PFS assembled in a SelfDose device.

Protocol document:
Prot_000.pdf: 
1
Status: Approval, Date: 16 November 2016
Janssen Research & Development*
Clinical Protocol
A Phase 3, Multicenter, Randomized, Double-blind Placebo-controlled Study Evaluating 
the Efficacy and Safety of CNTO 1959 (Guselkumab) Delivered via a SelfDose™ Device in 
the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Protocol CNTO1959PSO3006; Phase 3
Amendment 1
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 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 Phase 3 clinical studies. 
This study will be conducted under US Food & Drug Administration IND regulations (21 CFR 
Part 312).
EudraCT NUMBER: 2016-002022-37
Status:
Approved
Date:
16 November 2016
Prepared by:
Janssen Research & Development, LLC
EDMS number:
EDMS-ERI-119199023
GCP Compliance: This study will be conducted in compliance with Good Clinical Practice, and applicable regulatory 
requirements. 
Confidentiality Statement
The information in this document contains trade secrets and commercial information that are privileged or confidential and may 
not be disclosed unless such disclosure is required by applicable law or regulations. In any event, persons to whom the 
information is disclosed must be informed that the information is privileged or confidential and may not be further disclosed by 
them. These restrictions on disclosure will apply equally to all future information supplied to you that is indicated as privileged or 
confidential.
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CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
2
Status: Approved, Date: 16 November 2016
TABLE OF CONTENTS
TABLE OF CONTENTS ............................................................................................................................... 2
LIST OF IN-TEXT TABLES.......................................................................................................................... 5
LIST OF IN-TEXT FIGURES ........................................................................................................................ 5
PROTOCOL AMENDMENTS....................................................................................................................... 6
SYNOPSIS.................................................................................................................................................. 12
TIME AND EVENTS SCHEDULE .............................................................................................................. 16
ABBREVIATIONS ...................................................................................................................................... 18
INTRODUCTION......................................................................................................................................... 19
1.1.
Background .................................................................................................................................... 19
1.1.1.
Clinical Development of Guselkumab......................................................................................... 19
1.1.2.
SelfDose Device ......................................................................................................................... 22
1.2.
Overall Rationale for the Study...................................................................................................... 22
1.2.1.
Role of Interleukin-23 in the Treatment of Psoriasis .................................................................. 22
1.2.2.
Dose Justification........................................................................................................................ 23
1.2.3.
Device Justification..................................................................................................................... 23
2.
OBJECTIVES, ENDPOINTS, AND HYPOTHESES.......................................................................... 24
2.1.
Objectives and Endpoints .............................................................................................................. 24
2.1.1.
Objectives ................................................................................................................................... 24
2.1.2.
Endpoints.................................................................................................................................... 24
2.2.
Hypotheses .................................................................................................................................... 25
3.
STUDY DESIGN AND RATIONALE ................................................................................................. 25
3.1.
Overview of Study Design.............................................................................................................. 25
3.2.
Study Design Rationale.................................................................................................................. 26
4.
SUBJECT POPULATION.................................................................................................................. 27
4.1.
Inclusion Criteria ............................................................................................................................ 27
4.2.
Exclusion Criteria ........................................................................................................................... 30
4.3.
Prohibitions and Restrictions ......................................................................................................... 33
5.
TREATMENT ALLOCATION AND BLINDING................................................................................. 34
5.1.
Procedures for Randomization and Stratification .......................................................................... 34
5.2.
Blinding .......................................................................................................................................... 34
6.
DOSAGE AND ADMINISTRATION .................................................................................................. 35
7.
TREATMENT COMPLIANCE............................................................................................................ 35
8.
CONCOMITANT THERAPY.............................................................................................................. 36
8.1.
Concomitant Medications for Treatment of Psoriasis .................................................................... 36
8.1.1.
Topical Therapy.......................................................................................................................... 36
8.1.2.
Systemic or Phototherapy for Psoriasis...................................................................................... 36
8.2.
Concomitant Medications for Conditions Other Than Psoriasis .................................................... 37
9.
STUDY EVALUATIONS .................................................................................................................... 37
9.1.
Study Procedures........................................................................................................................... 37
9.1.1.
Overview..................................................................................................................................... 37
9.1.2.
Screening Phase ........................................................................................................................ 38
9.1.3.
Screen Failure/Rescreening ....................................................................................................... 39
9.1.4.
Placebo-Controlled and Guselkumab Treatment Periods.......................................................... 39
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CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
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Status: Approved, Date: 16 November 2016
9.1.5.
Follow-Up Phase ........................................................................................................................ 39
9.2.
Efficacy Evaluations....................................................................................................................... 40
9.3.
Usability and Acceptability Assessments....................................................................................... 40
9.3.1.
Observer Assessment of Device Usability.................................................................................. 40
9.3.2.
Self-Injection Assessment Questionnaire................................................................................... 41
9.3.3.
SelfDose Subject Questionnaire................................................................................................. 41
9.4.
Pharmacokinetics and Immunogenicity ......................................................................................... 41
9.4.1.
Sample Collection and Handling ................................................................................................ 41
9.4.2.
Pharmacokinetic Assessments................................................................................................... 42
9.4.3.
Immunogenicity Assessments .................................................................................................... 42
9.5.
Safety Evaluations ......................................................................................................................... 42
9.5.1.
Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)................................................ 45
9.6.
Sample Collection and Handling.................................................................................................... 47
10.
SUBJECT COMPLETION/DISCONTINUATION OF STUDY TREATMENT/ WITHDRAWAL 
FROM THE STUDY ........................................................................................................................... 47
10.1.
Completion ..................................................................................................................................... 47
10.2.
Discontinuation of Study Treatment............................................................................................... 47
10.3.
Withdrawal From the Study............................................................................................................ 49
11.
STATISTICAL METHODS................................................................................................................. 50
11.1.
Subject Information ........................................................................................................................ 50
11.2.
Sample Size Determination ........................................................................................................... 50
11.3.
Interim Analysis.............................................................................................................................. 51
11.4.
Efficacy Analysis ............................................................................................................................ 52
11.4.1.
Analysis Data Set ....................................................................................................................... 52
11.4.2.
Primary Analysis ......................................................................................................................... 52
11.4.3.
Major Secondary Analyses......................................................................................................... 52
11.4.4.
Other Efficacy Analyses.............................................................................................................. 52
11.5.
Usability and Acceptability Assessments....................................................................................... 52
11.6.
Criteria for Endpoints ..................................................................................................................... 53
11.7.
Pharmacokinetic Analyses............................................................................................................. 53
11.8.
Immunogenicity Analyses .............................................................................................................. 53
11.9.
Safety Analyses ............................................................................................................................. 53
12.
ADVERSE EVENT REPORTING ...................................................................................................... 54
12.1.
Definitions ...................................................................................................................................... 54
12.1.1.
Adverse Event Definitions and Classifications ........................................................................... 54
12.1.2.
Attribution Definitions.................................................................................................................. 56
12.1.3.
Severity Criteria .......................................................................................................................... 56
12.2.
Special Reporting Situations.......................................................................................................... 57
12.3.
Procedures..................................................................................................................................... 57
12.3.1.
All Adverse Events...................................................................................................................... 57
12.3.2.
Serious Adverse Events ............................................................................................................. 59
12.3.3.
Pregnancy................................................................................................................................... 60
12.3.4.
Events of Special Interest........................................................................................................... 60
12.4.
Contacting Sponsor Regarding Safety........................................................................................... 60
13.
PRODUCT QUALITY COMPLAINT HANDLING.............................................................................. 60
13.1.
Procedures..................................................................................................................................... 61
13.2.
Contacting Sponsor Regarding Product Quality ............................................................................ 61
14.
STUDY DRUG INFORMATION......................................................................................................... 61
14.1.
Physical Description of Study Drugs.............................................................................................. 61
14.2.
Packaging ...................................................................................................................................... 61
14.3.
Labeling.......................................................................................................................................... 61
14.4.
Handling, and Storage ................................................................................................................... 62
14.5.
Drug Accountability ........................................................................................................................ 62
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CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
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Status: Approved, Date: 16 November 2016
15.
STUDY-SPECIFIC MATERIALS....................................................................................................... 63
16.
ETHICAL ASPECTS ......................................................................................................................... 63
16.1.
Study-Specific Design Considerations........................................................................................... 63
16.2.
Regulatory Ethics Compliance....................................................................................................... 64
16.2.1.
Investigator Responsibilities ....................................................................................................... 64
16.2.2.
Independent Ethics Committee or Institutional Review Board ................................................... 64
16.2.3.
Informed Consent ....................................................................................................................... 65
16.2.4.
Privacy of Personal Data ............................................................................................................ 66
16.2.5.
Long-Term Retention of Samples for Additional Future Research ............................................ 67
16.2.6.
Country Selection ....................................................................................................................... 67
17.
ADMINISTRATIVE REQUIREMENTS .............................................................................................. 67
17.1.
Protocol Amendments.................................................................................................................... 67
17.2.
Regulatory Documentation ............................................................................................................ 68
17.2.1.
Regulatory Approval/Notification ................................................................................................ 68
17.2.2.
Required Prestudy Documentation............................................................................................. 68
17.3.
Subject Identification, Enrollment, and Screening Logs ................................................................ 69
17.4.
Source Documentation................................................................................................................... 69
17.5.
Case Report Form Completion ...................................................................................................... 70
17.6.
Data Quality Assurance/Quality Control ........................................................................................ 71
17.7.
Record Retention ........................................................................................................................... 71
17.8.
Monitoring ...................................................................................................................................... 72
17.9.
Study Completion/Termination....................................................................................................... 72
17.9.1.
Study Completion/End of Study.................................................................................................. 72
17.9.2.
Study Termination....................................................................................................................... 72
17.10.
On-Site Audits ................................................................................................................................ 73
17.11.
Use of Information and Publication................................................................................................ 73
REFERENCES............................................................................................................................................ 75
ATTACHMENT 1:
QUANTIFERON®-TB GOLD TESTING..................................................................... 77
ATTACHMENT 2:
HEPATITIS B VIRUS (HBV) SCREENING WITH HBV DNA TESTING .................. 79
ATTACHMENT 3:
INVESTIGATOR’S GLOBAL ASSESSMENT .......................................................... 80
ATTACHMENT 4:
PSORIASIS AREA AND SEVERITY INDEX ............................................................ 81
ATTACHMENT 5:
OBSERVER INJECTION CHECKLIST..................................................................... 82
ATTACHMENT 6:
SELF-INJECTION ASSESSMENT QUESTIONNAIRE ............................................ 84
ATTACHMENT 7:
SELFDOSE SUBJECT QUESTIONNAIRE ............................................................. 91
ATTACHMENT 8:
ANTICIPATED EVENTS ........................................................................................... 92
INVESTIGATOR AGREEMENT ................................................................................................................. 93
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CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
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Status: Approved, Date: 16 November 2016
LIST OF IN-TEXT TABLES
Table 1:
Time and Events Schedule....................................................................................................... 16
Table 2:
Power to Detect a Treatment Effect Based on Different Proportions of Subjects 
Achieving the Co primary Endpoints......................................................................................... 51
LIST OF IN-TEXT FIGURES
Figure 1:
Schematic Overview of the Guselkumab SelfDose Device Study............................................ 26
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
6
Status: Approved, Date: 16 November 2016
PROTOCOL AMENDMENTS
Protocol Version 
Issue Date
Original Protocol
6 June 2016
Amendment 1
16 Nov 2016
Amendments below are listed beginning with the most recent amendment.
Amendment 1 (16 Nov 2016)
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of Directive 
2001/20/EC of the European Parliament and the Council of the European Union.
The overall reason for the amendment: The overall reasons for the amendment are to: 1) as requested by a health 
authority, include and describe the use of the electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) as an 
additional safety assessment to be performed at screening, Week 0/baseline, and at each study visit post-baseline; 2) 
include an exclusion criterion related to the eC-SSRS assessment; 3) update the Time and Events Schedule to reflect 
addition of the eC-SSRS for assessment of suicide-related thoughts and behavior; 4) clarification that all shampoos 
used to treat psoriasis must also be reported on the subject electronic case report form (eCRF); 5) modification of a 
criterion to allow subjects who have completed antiviral treatment for hepatitis C virus (HCV) to participate; and 6) 
inclusion of data from the eC-SSRS in the safety analyses for the study and in the section for steps taken to assure 
data quality/quality control.
Applicable Section(s)
Description of Change(s)
Rationale: Based on health authority feedback, the electronic Columbia-Suicide Severity Rating Scale (eC-
SSRS) will be included as a safety assessment at each study visit.
Synopsis, Safety 
Evaluations
Safety evaluations include assessments of the following: adverse events (AEs, including 
injection site and allergic reactions), clinical laboratory tests (hematology, chemistry, 
and pregnancy testing), physical examinations, vital sign measurements, concomitant 
medication review, eC-SSRS questionnaires, and early detection of tuberculosis.
Rationale: Clarification of the Time and Events Schedule regarding how and when the Self-Injection Assessment 
Questionnaire (SIAQ) and the electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) are to be completed 
during the study. Footnote h has been added regarding the use of the eC-SSRS; accordingly, old footnotes h and i 
have been re-numbered and are now i and j, respectively. Footnote k has been added regarding the eligibility 
requirements for participation in the study by a subject who tests positive for antibodies to hepatitis C at 
screening.
Time and Events 
Schedule
Safety Assessments (new category): eC-SSRSh [Footnote h added to clarify that the 
eC-SSRS should be completed by the subject]: 1) as the first assessment at 
screening after signing informed consent and before any tests, procedures, or other 
consultations, 2) after the pre-SIAQ at Week 0/baseline and before any tests, 
procedures, or other consultations, and 3) as the first assessment for all post-
baseline visits, before any tests, procedures, or other consultations to prevent 
influencing subject perceptions.
Clinical Laboratory Assessments: Hepatitis B and C virus (HBV and HCV) serology 
Footnote k added to clarify that subjects who are seropositive for antibodies to 
hepatitis C virus (at screening) may be allowed to participate in the study provided 
they have 2 negative HCV RNA test results 6 months apart after completing 
antiviral treatment and prior to screening, and have a third negative HCV RNA 
test result at screening.
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
7
Status: Approved, Date: 16 November 2016
Applicable Section(s)
Description of Change(s)
Rationale: Modification of a criterion to allow subjects who have completed antiviral treatment for hepatitis C 
virus (HCV) to participate if they have 2 negative HCV RNA test results 6 months apart after completing 
antiviral treatment and prior to screening, and have a third negative HCV RNA test result at screening.
4.2 Exclusion Criteria
Criterion #31.
Tests positive for hepatitis B virus (HBV) infection (Attachment 2) or is seropositive for 
antibodies to hepatitis C virus (HCV) at screening; unless they have 2 negative HCV 
RNA test results 6 months apart after completing antiviral treatment and prior to 
screening, and have a third negative HCV RNA test result at screening.
Rationale: Addition of a criterion for excluding subjects who have an eC-SSRS rating at screening indicative of 
unstable suicidal ideation or suicidal behavior who are confirmed to be at risk based on an evaluation by a mental 
health professional.
4.2 Exclusion Criteria
Criterion #38.
Has unstable suicidal ideation or suicidal behavior, that may be defined as an eC-
SSRS rating at screening of: Suicidal ideation with intention to act (“4”), Suicidal 
ideation with specific plan and intent (“5”), or a suicide attempt (interrupted 
suicide attempt, aborted suicide attempt, or preparatory behaviors for making a 
suicide attempt) in the last 6 months and is confirmed to be at risk by the 
investigator based on an evaluation by a mental health professional. The final 
decision on excluding a subject will be made at the judgment of the investigator.
Rationale: Clarification that all shampoos used to treat psoriasis must be included in the list of all therapies, 
other than the study drug, that must be recorded in the electronic Case Report Form (eCRF).
8. Concomitant 
Therapy
Paragraph 2
All therapies (prescription or over-the-counter medications, including vaccines, 
vitamins, herbal supplements) different from the study drug, as well as all shampoos,
moisturizers or emollients used to treat psoriasis, must be recorded in the eCRF.
Rationale: Clarification regarding the sequence in which planned assessments should be completed by the 
subject including the addition of the eC-SSRS questionnaire at screening.
9.1.2. Screening 
Phase
Paragraph 3
The recording of AEs and concomitant medications will start after the signing of the 
informed consent and will continue until the last study-related procedure has been 
completed. The eC-SSRS (‘Baseline/Screening’ version) should be completed after 
the subject signs consent but as the first assessment by the subject before any tests, 
procedures, or other consultations to prevent influencing subject perceptions.
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
8
Status: Approved, Date: 16 November 2016
Applicable Section(s)
Description of Change(s)
Rationale: Clarification regarding the sequence in which planned assessments should be completed by the 
subject including the addition of the eC-SSRS at Week 0/randomization, the placebo-controlled period (Week 4 
through 12), and the study drug treatment period (Weeks 16 through 32).
9.1.4. Placebo-
Controlled and 
Guselkumab 
Treatment Periods
Week 0/Randomization
Randomization visit procedures will be performed as specified in the Time and Events 
Schedule. The PRE self injection SIAQ (pre-SIAQ) should be completed by the 
subject first followed by the ‘Since Last Visit’ version of the eC-SSRS 
questionnaire in order to prevent influencing subject perceptions. All tests, 
procedures and other consultations will be performed after these questionnaires 
and before study agent administration (Section 9.5.1).
At Week 0, if a mental health evaluation is required based on the Week 0 eC-SSRS 
score, either this evaluation must be conducted prior to randomization or, if not 
feasible, the subject should be screen-failed and then re-screened after a completed 
mental health evaluation, if appropriate (see Section 9.5.1).
Week 4 through Week 12 (placebo-controlled period) and Week 16 through Week 
32 (guselkumab treatment period)
All visit procedures will be performed as specified in the Time and Events Schedule. 
The ‘Since Last Visit’ version of the eC-SSRS should be completed by the subject 
first before any tests, procedures, or other consultations at post-baseline study 
visits to prevent influencing subject perceptions (Section 9.5.1).  All other study 
procedures and evaluations should be completed before the subject self-administers the 
study drug at each visit, except for the POST self injection SIAQ (post-SIAQ) at Weeks 
4, 12, and 28 which must be completed by the subject after completion of study drug 
administration (Section 9.3.2) and the SelfDose Subject Questionnaire which must be 
completed after the POST-self-injection post-SIAQ (Section 9.3.3) at Week 12.
Rationale: Clarification regarding the sequence in which planned assessments should be completed by the 
subject including the addition of the eC-SSRS questionnaire at the follow-up phase (Week 40).
9.1.5. Follow-Up 
Phase
Subjects will be followed for safety, efficacy, PK, and immunogenicity information
through week 40 are indicated in the Time and Events Schedule. The ‘Since Last Visit’ 
version of the eC-SSRS should be completed by the subject first before any tests, 
procedures, or other consultations at the follow-up visit to prevent influencing 
subject perceptions (Section 9.5.1). If a subject discontinues study treatment before his 
or her last scheduled injection, procedures described in Section 10.2, Discontinuation of 
Study Treatment, should be followed.
Rationale: The description of the SIAQ has been corrected to a 5 or 6-point Likert-type scale.
9.3.2 Self-Injection 
Assessment 
Questionnaire
Paragraph #2
The subject rates each item of the SIAQ on a 5 or 6-point semantic Likert-type scale.
Rationale: Addition of the eC-SSRS to the list of safety and tolerability assessments to be collected during the 
study.
9.5. Safety 
Evaluations
Paragraph 1
The safety and tolerability of study drugs (guselkumab and placebo) will be monitored 
by collecting information on AEs, including injection site and allergic reactions, clinical 
laboratory tests, physical examinations, vital sign measurements, eC-SSRS 
questionnaires, concomitant medication review, and early detection of TB at specified 
time points in the Time and Events Schedule and as described below.
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
9
Status: Approved, Date: 16 November 2016
Applicable Section(s)
Description of Change(s)
Rationale: A description of the eC-SSRS is provided as well as how and when this subject-completed 
questionnaire is to be used during the study, and the steps/actions that site staff should take to review the eC-
SSRS findings report with a subject.
9.5.1. Electronic 
Columbia-Suicide 
Severity Rating Scale
(eC-SSRS)
In light of the recent reports concerning suicidal ideation and behavior in patients 
with plaque psoriasis treated with an IL-17R antagonist (brodalumab), the 
electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) will be used as a 
screening tool to prospectively evaluate the potential of guselkumab to induce 
suicidal ideation and behavior. The eC-SSRS defines five subtypes of suicidal 
ideation and behavior in addition to self-injurious behavior with no suicidal intent, 
and is a fully-structured, subject self-report C-SSRS questionnaire, including 
standardized questions, follow-up prompts, error handling routines, and scoring 
conventions.11,18 Two versions of the eC-SSRS will be used in this study, the 
‘Baseline/Screening’
version 
and 
the 
‘Since 
Last 
Visit’
version. 
The 
‘Baseline/Screening’ version of the eC-SSRS will be conducted during the screening 
visit followed by the ‘Since Last Visit’ version of the eC-SSRS at all other visits 
through Week 40.
Subjects will complete the eC-SSRS questionnaire using the sponsor-provided 
electronic tablets. Study site personnel will train the subjects on how to use the 
electronic device. The eC-SSRS will be provided in the local languages in 
accordance with local guidelines.
The eC-SSRS will be performed during each evaluation visit according to the 
assessment schedule. During a visit, subjects will be directed to a private, quiet 
place with the electronic device to complete the assessment. Subjects who do not 
have suicidal behavior or ideation will answer a limited number of questions and 
will usually complete the assessment in about 3 minutes. Subjects with significant 
suicidal ideation and behavior may require up to 10 minutes to answer all relevant 
questions. The eC-SSRS will be performed first at the screening visit (after signing
informed consent) after the pre-SIAQ at Week 0/baseline and before study agent 
administration. At all post-baseline visits, the eC-SSRS will be the first 
assessment/questionnaire that the subject must complete.
At the conclusion of each assessment, the site will receive an eC-SSRS Findings 
Report. At screening and Week 0, subjects with a eC-SSRS score greater than 0 or 
a response to the question of “Self-injurious behavior without suicidal intent” other 
than ‘NO’ must be determined to be not at risk by the investigator based on an 
evaluation by a mental health professional in order to be randomized.  Subjects 
with a score on the eC-SSRS that is greater than 0 or a response to the question of 
“Self-injurious behavior without suicidal intent” other than ‘NO’ at any post-
baseline visit will also be referred to an appropriate mental health professional for 
evaluation. If a subject’s psychiatric disorder can be adequately treated with 
psychotherapy and/or pharmacotherapy then the subject, at the discretion of the 
investigator, should be continued with treatment. Ultimately, the determination of 
suicidality and risk is up to the investigator’s clinical judgment following 
evaluation by a mental health professional (e.g. psychiatrist, psychologist, or
appropriately trained social worker or nurse).
Positive reports are generated from the eC-SSRS vendor for ANY of the following 
findings:
•
Suicidal ideation with intention to act (“4”)
•
Suicidal ideation with specific plan and intent (“5”)
•
Made suicide attempt
•
Interrupted suicide attempt
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
10
Status: Approved, Date: 16 November 2016
Applicable Section(s)
Description of Change(s)
•
Aborted suicide attempt
•
Preparatory behaviors for making a suicide attempt.
9.5.1. Electronic 
Columbia-Suicide 
Severity Rating Scale 
(eC-SSRS)—
continued
Negative suicidality indication reports are generated from the eC-SSRS vendor 
when there are NO indications of the above.
The subject should not be released from the site until the eC-SSRS Findings Report 
(both for negative and positive reports) is reviewed by the investigator and the 
subject’s risk has been assessed and follow-up determined, as appropriate.
For each score, the following actions and associated alerts will be generated, if 
applicable:
•
Score of 0: No further action is needed. 
•
Score > 0: Subject risk assessed and referral to a mental health professional.
Score of 1, 2, or 3: Negative findings report will be generated.
Score of 4 or higher: Positive findings report will be generated. When the 
system reports that the subject has a positive suicidal indication (including 
for an incomplete assessment), the site will be immediately notified by 
fax/email and a telephone call from the eC-SSRS vendor.
•
Self-injurious behavior without suicidal intent = YES or ‘Question Mark 
(ambiguous response)’: Subject risk assessed and referral to a mental health 
professional. Negative findings report will be generated.
Interruption or the discontinuation of study treatment should be considered for
any subject who reports suicidal ideation with intention to act (“4”), suicidal 
ideation with specific plan and intent (“5”), or a suicide attempt (interrupted 
suicide attempt, aborted suicide attempt, or preparatory behaviors for making a 
suicide attempt) on a post-baseline eC-SSRS assessment and who is deemed to be at 
risk by the investigator based upon evaluation by a mental health professional. 
Discussion of such subjects with the medical monitor or designee is required (See 
section 10.2). The final decision on suitability for continuing in the study will be 
made by the investigator.
Any eC-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 eCRF 
(see section 12).
Rationale: Addition of a criterion for discontinuation of study treatment for subjects who have a post-baseline 
eC-SSRS rating indicative of unstable suicidal ideation or suicidal behavior.
10.2 Discontinuation 
of Study Treatment
Bullet # 11
• Discontinuation of study treatment should be considered for subjects who report 
suicidal ideation with intention to act (“4”), suicidal ideation with specific plan 
and intent (“5”), or a suicide attempt (interrupted suicide attempt, aborted 
suicide attempt, or preparatory behaviors for making a suicide attempt) on a 
post-baseline eC-SSRS assessment. Discussion of such subjects with the medical 
monitor or designee is required. The final decision on suitability for continuing 
with study agent will be made by the investigator, based upon evaluation by a 
mental health professional.
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
11
Status: Approved, Date: 16 November 2016
Applicable Section(s)
Description of Change(s)
Rationale: Inclusion of the subject-completed eC-SSRS as a part of the safety analyses for adverse events in 
subjects who participate in the study.
11.9. Safety Analyses
Adverse Events
(Heading) Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)
Suicide-related thoughts and behaviors based on the eC-SSRS will be summarized 
descriptively by treatment group.
Rationale: Inclusion of the subject-completed eC-SSRS as a component of the study-specific materials for 
investigators and site staff involved in the study.
15. Study-Specific 
Materials
Bullet # 10
Electronic Columbia-Suicide Severity Rating Scale
Rationale: Inclusion of the subject-completed eC-SSRS as a part of the source documentation for the data 
obtained during the study.
17.4. Source 
Documentation
Paragraph 5
Investigator-completed efficacy evaluations (IGA, PASI), the Observer Injection 
Checklist, and the subject-completed eC-SSRS will be recorded directly into an 
electronic tablet device during the visit at the study site. These data will be considered 
electronic source documentation.
Rationale: Inclusion of the subject-completed eC-SSRS as a part of the steps to be taken for data quality 
assurance and quality control.
17.6. Data Quality 
Assurance/Quality 
Control
Paragraph 1
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, direct transmission of clinical laboratory data from a central laboratory, and 
direct transmission of efficacy data, eC-SSRS questionnaires, and the Observer 
Injection Checklist to the vendor database and then to the sponsor’s database.
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
12
Status: Approved, Date: 16 November 2016
SYNOPSIS
A Phase 3, Multicenter, Randomized, Double-blind Placebo-controlled Study Evaluating the 
Efficacy and Safety of CNTO 1959 (Guselkumab) Delivered via a SelfDose™ Device in the 
Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Protocol Number: CNTO1959PSO3006
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. 
OBJECTIVES, ENDPOINTS, AND HYPOTHESES
Primary Objectives

To evaluate the efficacy of guselkumab delivered using the SelfDose device for the treatment of 
subjects with moderate to severe plaque-type psoriasis.

To assess the safety and tolerability of guselkumab delivered using the SelfDose device in subjects 
with moderate to severe plaque-type psoriasis.
Secondary Objectives

To assess the pharmacokinetics (PK) and immunogenicity of guselkumab following subcutaneous
administration using the SelfDose device in subjects with moderate to severe plaque-type psoriasis.

To assess usability and acceptability of the SelfDose device.
Co-Primary Endpoints

The proportion of subjects who achieve an Investigator’s Global Assessment (IGA) score of 
cleared (0) or minimal (1) at Week 16.

The proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) 90 response at 
Week 16.
Major Secondary Endpoints

The proportion of subjects who achieve an IGA score of cleared (0) at Week 16.

The proportion of subjects who achieve a PASI 100 response at Week 16.
Other Secondary Endpoints

The proportion of subjects achieving an IGA score of mild or better (≤2) at Week 16. 

The proportion of subjects who achieve a PASI 75 response and a PASI 50 response at Week 16. 

The percent improvement from baseline in PASI response at Week 16.
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
13
Status: Approved, Date: 16 November 2016

The proportion of subjects with successful, problem-free injections (assessment of usability) at 
Week 0. 

Self-Injection Assessment Questionnaire (SIAQ) domain scores for the 3 domains with items 
common to the SIAQ PRE- (Week 0) and POST- (Week 0 and Week 12) self-injection modules. 

Self-Injection Assessment Questionnaire POST-self-injection domain scores and change from 
baseline scores for each domain at Weeks 0, 4, 12, and 28.

The proportion of subjects who had full delivery of the dose confirmed by inspection of the device at 
Weeks 4 and 12.
Additional Endpoints

Serum guselkumab concentrations and antibodies to guselkumab will be analyzed to assess the PK 
and immunogenicity of guselkumab.

Safety data will be summarized using descriptive statistics.

Ratings for the SelfDose Subject Questionnaire will be summarized using descriptive statistics.
Hypotheses
The hypotheses are that guselkumab treatment delivered using the SelfDose device is superior to placebo 
as demonstrated by 1) the proportion of subjects achieving an IGA score of cleared (0) or minimal (1);
and 2) the proportion of subjects achieving a PASI 90 response, both at Week 16.
OVERVIEW OF STUDY DESIGN
This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled study evaluating the 
efficacy, safety, PK, immunogenicity, usability, and acceptability of guselkumab delivered using the 
SelfDose device in subjects with moderate to severe plaque-type psoriasis.
There are 2 database locks (DBLs) in this study, 1 at Week 20, and 1 at Week 40. The sponsor, with 
exception below, will be unblinded after the last subject has completed the Week 20 visit and the 
Week 20 DBL has occurred. The investigators, subjects, and sponsor site monitors will be unblinded after 
the last subject has completed the Week 40 visit, and the Week 40 DBL has occurred.
SUBJECT POPULATION
The target population is adult men or women with a diagnosis of plaque-type psoriasis (with or without 
psoriatic arthritis) for at least 6 months before the first administration of study drug. Subjects must have 
moderate to severe plaque-type psoriasis defined by PASI ≥12, IGA ≥3, and involved body surface 
area ≥10%. Subjects must be candidates for either systemic therapy or phototherapy for psoriasis, and 
may have previously received some systemic therapies or phototherapy for psoriasis.
DOSAGE AND ADMINISTRATION
Guselkumab 100 mg and liquid placebo for guselkumab will be provided in a single-use prefilled syringe 
assembled with a facilitated injection device referred to as the SelfDose device. The dose regimens are as 
follows:

Group I (n=60): guselkumab 100 mg at Weeks 0, 4, 12, 20, and 28; placebo at Week 16 to maintain 
the study blind.

Group II (n=15): placebo at Weeks 0, 4, and 12; cross over to guselkumab 100 mg at Weeks 16, 20, 
and 28.
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
14
Status: Approved, Date: 16 November 2016
EFFICACY EVALUATIONS
Efficacy evaluations include:

Investigator’s Global Assessment

Psoriasis Area and Severity Index
USABILITY AND ACCEPTABILITY ASSESSMENTS
The usability and acceptability of the SelfDose device will be assessed using the Observer Injection
Checklist and the subject-completed SIAQ, respectively.
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 Time and Events Schedule. 
Serum samples will also be collected at the final visit from subjects who terminate study participation 
early. 
SAFETY EVALUATIONS
Safety evaluations include assessments of the following: adverse events (AEs, including injection site and 
allergic reactions), clinical laboratory tests (hematology, chemistry, and pregnancy testing), physical 
examinations, vital sign measurements, concomitant medication review, eC-SSRS questionnaires, and 
early detection of tuberculosis. Safety data will be summarized using descriptive statistics.
STATISTICAL METHODS
A total of approximately 75 subjects randomized in a 4:1 ratio to guselkumab (n=60) and placebo (n=15) 
will have at least 99% power to detect differences for both co-primary endpoints at a significance level of 
0.05. This sample size was also chosen to provide adequate power for major secondary endpoints. 
For the primary analysis and major secondary analyses, all randomized and treated subjects will be 
included. For all the efficacy analyses, subjects will be analyzed according to the treatment group to 
which they were randomized, regardless of the treatment they actually received.
Primary Endpoint
The 2 co-primary endpoints will be compared between the guselkumab group and the placebo group. The 
analysis will be performed using a Fisher’s exact test, 2-sided (α=0.05).
Major Secondary Endpoints
The major secondary endpoints will be compared between the guselkumab group and the placebo group.
The analyses will be performed using a Fisher’s exact test, 2-sided (α=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. 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.
Other Secondary Endpoints
Efficacy endpoints will be compared between the guselkumab group and the placebo group and nominal 
p-values will be provided.
Endpoints related to usability and acceptability will be summarized by treatment group and for the overall
population. 
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
15
Status: Approved, Date: 16 November 2016
Additional Endpoints

Serum guselkumab concentrations over time will be summarized by treatment group using 
descriptive statistics. 

The incidence and titers of antibodies to guselkumab and incidence of neutralizing antibodies to 
guselkumab will be summarized. 

Safety data will be summarized using descriptive statistics.
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
16
Status: Approved, Date: 16 November 2016
TIME AND EVENTS SCHEDULE 
Table 1:
Time and Events Schedule
Phase
Screeninga
Placebo-Controlled Period
Guselkumab Treatment Period
Follow-upb
Week
0
(baseline)c
4
8
12
16
20
24
28
32
40
Study Proceduresd
Screening/Administrative
Informed consent
X
Inclusion/exclusion criteria
X
X
Medical history and demographics
X
Study Drug Administration
Randomization
X
Dispense/administer study druge
X
X
X
X
X
X
Safety Assessments
Physical examination including skin examination
X
X
Vital signs
X
X
X
X
X
X
X
X
X
X
X
Weight
X
Height
X
Chest X-Ray
X
eColumbia-Suicide Severity Rating Scale (eC-SSRS)h
X
X
X
X
X
X
X
X
X
X
X
Pregnancy test – urinef
X
X
X
X
X
X
X
X
Tuberculosis evaluation
X
X
X
X
X
X
X
X
X
X
X
Concomitant therapy
X
X
X
X
X
X
X
X
X
X
X
Adverse events
X
X
X
X
X
X
X
X
X
X
X
Efficacy Assessments
Body surface area (BSA)
X
X
Investigator’s global assessment (IGA)
X
X
X
X
X
X
X
X
X
X
X
Psoriasis Area and Severity Index (PASI)
X
X
X
X
X
X
X
X
X
X
X
Usability and Acceptability Assessments
Observer Injection Checklist (usability)
X
Self-Injection Assessment Questionnaire (SIAQ; 
acceptability)g
X
X
X
X
Device inspection to confirm delivery of complete dose
X
X
X
X
X
X
Product Quality Complaints (PQCs)
X
X
X
X
X
X
SelfDose Subject Questionnairei
X
Clinical Laboratory Assessments
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
17
Status: Approved, Date: 16 November 2016
Table 1:
Time and Events Schedule
Phase
Screeninga
Placebo-Controlled Period
Guselkumab Treatment Period
Follow-upb
Week
0
(baseline)c
4
8
12
16
20
24
28
32
40
Hematologyj
X
X
X
X
X
X
X
X
X
X
Chemistryj
X
X
X
X
X
X
X
X
X
X
Lipid panelj
X
QuantiFERON-TB test
X
Hepatitis B and C virus (HBV and HCV) serologyk
X
Human immunodeficiency virus (HIV) antibody test
X
High-sensitivity C-reactive protein (hs-CRP)j
X
Pharmacokinetics and Immunogenicity
Serum guselkumab concentration
X
X
X
X
X
X
X
X
X
X
Antibodies to guselkumab
X
X
X
X
X
X
a: The screening visit should occur within approximately 4 weeks prior to the Week 0 visit.
b: Week 40 assessments should be completed at least 12 weeks after the last study drug administration for subjects who discontinue study treatment or withdraw 
from the study as discussed in Sections 0 and Section 10.3, respectively.
c: Subjects must fast (ie, no food or beverages [except water]) for at least 8 hours before blood is drawn for lipid panel at Week 0. 
d: All study procedures and evaluations should be completed before the subject self-administers the study drug, except for completion of the Observer Injection 
Checklist (during study drug administration) and the POST-self-injection SIAQ which must be completed after study drug administration. 
e: Subjects will be trained to self-administer study injections at the study site using the SelfDose device and are required to self-administer all doses of study drug
throughout the study.
f: Women of childbearing potential must have a negative urine pregnancy test before randomization, before study drug administration at applicable visits, and at 
Week 40 or at least 12 weeks after the last study drug administration for subjects who discontinue study treatment or withdraw from the study.
g: The SIAQ has 2 modules: PRE-self-injection to be completed prior to study drug administration at Week 0, and POST-self-injection to be completed after study 
drug administration at Weeks 0, 4, 12, and 28. At Week 0, the PRE-self-injection SIAQ should be completed by the subject before any tests, procedures, or 
other consultations to prevent influencing subject perceptions. 
h: The eC-SSRS should be completed by the subject: 1) as the first assessment at screening after signing informed consent and before any tests, procedures, or 
other consultations, 2) after the pre-SIAQ at Week 0/baseline and before any tests, procedures, or other consultations, and 3) as the first assessment for all post-
baseline visits, before any tests, procedures, or other consultations to prevent influencing subject perceptions.
i:    Subjects will complete the SelfDose Subject Questionnaire after all study evaluations are completed, including after they self-inject study drug and after they 
have completed the POST-self-injection SIAQ at Week 12. 
j: Laboratory tests are listed in Section 9.5, Safety Evaluations. All clinical laboratory samples should be collected prior to study drug administration. Details will 
be provided in the Laboratory Manual.
k:  Subjects who are seropositive for antibodies to hepatitis C virus (at screening) may be allowed to participate in the study provided they have 2 negative HCV 
RNA test results 6 months apart after completing antiviral treatment and prior to screening, and have a third negative HCV RNA test result at screening.
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
18
Status: Approved, Date: 16 November 2016
ABBREVIATIONS
AE
adverse event
BCG
Bacille Calmette-Guérin
BQL
below the lowest quantifiable sample concentration of the assay
BSA
body surface area
CI
confidence interval
DBL
database lock
eDC
electronic data capture
eCRF
electronic case report form 
eC-SSRS
FDA
electronic Columbia-Suicide Severity Rating Scale
Food and Drug Administration
FSH
follicle-stimulating hormone
GCP
Good Clinical Practice
HBV
hepatitis B virus
HCV
hepatitis C virus
HDL
high density lipoprotein cholesterol
HIV
human immunodeficiency virus
ICF
informed consent form
ICH
International Conference on Harmonisation
IEC
Independent Ethics Committee
IFN- γ
interferon gamma
IGA
Investigator’s Global Assessment
IL
interleukin
IND
investigational new drug
IRB
Institutional Review Board
IWRS
interactive web response system
mAb
monoclonal antibody
MACE
major adverse cardiovascular event
NAbs
neutralizing antibodies
NCI-CTCAE
National Cancer Institute-Common Terminology Criteria for Adverse Events
PASI
Psoriasis Area and Severity Index 
PFS
prefilled syringe
PFS-U
prefilled syringe with an UltraSafe Plus™ Passive Needle Guard Delivery System
PGA
Physician’s Global Assessment
PK
pharmacokinetic(s)
PQC
product quality complaint
PsA
psoriatic arthritis
qXw
every X weeks
RA
Rheumatoid Arthritis
SAE
serious adverse event
SAP
Statistical Analysis Plan
SC
subcutaneous
SIAQ
Self-Injection Assessment Questionnaire 
SUSAR
suspected unexpected serious adverse reaction
TB
tuberculosis
Th
T helper
TNF
tumor necrosis factor alpha
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
19
Status: Approved, Date: 16 November 2016
INTRODUCTION
Guselkumab (CNTO 1959) is a fully human immunoglobulin G1 lambda (IgG1λ) monoclonal 
antibody (mAb) 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. In this manner, guselkumab 
inhibits the biological activity of IL-23 in all in vitro assays examined.
Guselkumab is currently being studied using a prefilled syringe (PFS) in an UltraSafe PlusTM
Passive Needle Guard Delivery System (PFS-U) in several Phase 2 and Phase 3 studies across 
several indications. This placebo-controlled study is designed to evaluate efficacy, safety, 
pharmacokinetic (PK), immunogenicity, usability, and acceptability using the PFS facilitated 
injection device referred to as the SelfDose™ device in subjects with moderate to severe 
plaque-type psoriasis which will be used to support the approval of the SelfDose presentation.
For the most comprehensive nonclinical and clinical information regarding guselkumab, refer to 
the latest version of the Investigator’s Brochure and Addenda 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.
1.1.
Background
1.1.1.
Clinical Development of Guselkumab
The clinical development program to support use of guselkumab in the treatment of psoriasis 
includes one Phase 1 study in healthy subjects and in subjects with psoriasis, and one Phase 2 
and three Phase 3 global studies. In addition, clinical studies have been or are being conducted in
subjects with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) as well as studies in subjects 
with palmoplantar pustulosis, generalized pustular psoriasis, or erythrodermic psoriasis 
conducted in Japan.
The following 3 global Phase 3 clinical studies of guselkumab in the treatment of moderate to 
severe plaque psoriasis are ongoing:

CNTO1959PSO3001, a Phase 3 study to evaluate the efficacy and safety of guselkumab in 
subjects with moderate to severe plaque psoriasis.

CNTO1959PSO3002, a Phase 3 study to evaluate the efficacy and safety of guselkumab in 
subjects with moderate to severe plaque psoriasis with randomized withdrawal and 
retreatment.

CNTO1959PSO3003, a Phase 3 study to evaluate the efficacy and safety of guselkumab in 
subjects with moderate to severe plaque psoriasis and an inadequate response to 
ustekinumab.
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
20
Status: Approved, Date: 16 November 2016
One Phase 0 study (CNTO1959NAP0001) assessed the usability of a similar version of the 
SelfDose device in subjects with RA or psoriasis who self-injected placebo. A Phase 1 study 
(CNTO1959NAP1001) was also conducted to assess PK comparability of 2 formulations of 
guselkumab and to evaluate the PK comparability of guselkumab delivered by 2 different 
devices (PFS-U and SelfDose) in healthy subjects. One Phase 1 study (CNTO1959PSO1001) 
and one Phase 2 study (CNTO1959PSO2001) of guselkumab for the treatment of moderate to 
severe plaque-type psoriasis have been completed and demonstrated a favorable efficacy and 
safety profile for guselkumab. Relevant results from the Phase 0 study, the Phase 1 study 
comparing the 2 devices, and the Phase 2 study are presented below; details about the individual 
studies and Phase 1 efficacy and PK are provided in the Investigator’s Brochure.
Phase 0 Study CNTO1959NAP0001
The design features and ability of subjects with RA or psoriasis to self-administer using a similar 
version of the SelfDose device were investigated in the randomized, single-center, open-label, 
Phase 0 study CNTO1959NAP0001. Subjects were randomized in a 1:1 ratio to 1 of 2 sequences 
of injection site locations (thigh-abdomen, abdomen-thigh) using randomized permuted blocks 
stratified by disease type (RA or psoriasis) and characteristics (presence or absence of hand 
impairment in RA group or body mass index [<30 kg/m2 or ≥30 kg/m2] in the psoriasis group at 
screening).
The results of the study showed that subjects required little training to use the SelfDose device 
for self-administration without any assistance, and that the operation of the device was easy for 
subjects. Based on responses to questions related to their experience with the SelfDose device, 
subjects were confident in their ability to use the SelfDose device and were willing to 
self-administer medications with the device. They also accepted using the device on both their
abdomen and thigh. Rheumatoid arthritis subjects with impaired hand function felt that SelfDose 
device seemed well-designed for arthritic patients. Subjects reported that it was easy to know 
when the injection was completed and that the full dose was delivered. No significant safety 
findings were observed. Three treatment-emergent injection site reactions of mild intensity and 
reasonably related (possibly, probably, or very likely related) to the SelfDose device were 
reported in the study in the psoriasis group: 2 events of injection site induration and 1 event of 
injection site erythema. No treatment-emergent adverse events (AEs) were reported in the RA 
group. No deaths, serious adverse events (SAEs), or AEs leading to discontinuation were 
reported during the study.
Phase 1 Study CNTO1959NAP1001
CNTO1959NAP1001 was a study conducted to assess the PK comparability of guselkumab in 
liquid formulation versus the lyophilized formulation as well as to assess the PK comparability 
of guselkumab in liquid formulation with 2 different delivery devices (PFS-U and SelfDose). In 
this Phase 1 study, a large inter-subject variability in systemic exposure to guselkumab was 
observed in each delivery device group. With respect to the comparison of PK of guselkumab 
between the 2 different delivery devices (PFS-U and SelfDose) with the same liquid formulation, 
the ratios of the geometric means of the maximum observed serum concentration (Cmax) and area 
under the serum concentration versus time curve (AUC) from the liquid formulation with 
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
21
Status: Approved, Date: 16 November 2016
SelfDose (Test) to those from the liquid formulation with PFS-U (Reference) were slightly 
greater than 1 (1.18 to 1.20), nevertheless, the 90% confidence intervals (CIs) for the geometric 
mean ratios were still within the interval of 0.70 to 1.43. It should be noted that despite the fact 
that the guselkumab exposures of the SelfDose and PFS-U devices were not technically 
equivalent based on ratios of the geometric means and 90% CIs, there was substantial overlap in 
the distribution of systemic exposure between the PFS-U and SelfDose groups.
With respect to safety of the 2 different devices, the incidence of treatment-emergent AEs was 
73.2% in the SelfDose group and 65.0% in the PFS-U group. Incidence of injection site reactions 
was higher in the SelfDose group (51.2%) compared with the PFS-U group (25.0%); the most 
commonly reported injection site reactions in the SelfDose and PFS-U groups were erythema 
(51.2% and 25.0%, respectively), induration (22.0% and 7.5 %, respectively), and pain (12.2% 
and 12.5%, respectively). No deaths or AEs leading to discontinuation occurred during the study.
Phase 2 Study CNTO1959PSO2001 (X-PLORE)
In the X-PLORE study, 293 subjects with moderate to severe plaque-type psoriasis were 
randomized to receive 1 of 5 guselkumab subcutaneous (SC) dose regimens (5 mg at Weeks 0, 4, 
and then every 12 weeks [q12w], 15 mg every 8 weeks [q8w], 50 mg at Weeks 0, 4, and then 
q12w, 100 mg q8w, or 200 mg at Weeks 0, 4, and then q12w), placebo, or adalimumab 
(HUMIRA®) 80 mg at Week 0, 40 mg at Week 1, and then 40 mg every 2 weeks (q2w).
The proportions of subjects who achieved a Physician’s Global Assessment (PGA) score of 
cleared (0) or minimal (1) were significantly higher at Week 16 in all guselkumab treatment 
groups compared with the placebo group. In addition, higher proportions of subjects in the 
guselkumab 50 mg q12w, 100 mg q8w, and 200 mg q12w groups achieved a PGA score of 
0 or 1 compared with the adalimumab group at Week 16. Improvements in psoriasis were 
demonstrated at Week 4 in the guselkumab groups and continued to improve through Week 16. 
A dose-response in efficacy was observed up to 100 mg q8w; the proportions of subjects who 
achieved a PGA score of 0 or 1 were similar in the 100 mg q8w and 200 mg q12w dose groups. 
Results for improvements in Psoriasis Area and Severity Index (PASI) scores were generally 
similar to those observed for PGA.
Treatment with guselkumab was generally well-tolerated through Week 52. The proportions of 
subjects with 1 or more AEs were comparable across the combined guselkumab, placebo, and the 
adalimumab groups through Week 16, with no evidence of a dose-response in the occurrence of 
AEs across the guselkumab groups. The most common events in the combined guselkumab 
group were nasopharyngitis, headache, and upper respiratory tract infection. Through Week 16, 
the proportion of subjects with 1 or more SAEs was low across all treatment groups. Two serious 
infections (guselkumab 50 mg group), no malignancies, and no major adverse cardiovascular 
events (MACE) were reported. Similar patterns of AEs were observed through Week 52. Events 
of interest through Week 52 included the 2 serious infections noted through Week 16, 
1 malignancy in the 200 mg q12w group, and 3 MACE (1 in the 5 mg q12w group and 2 in the 
100 mg q8w group).
NCT02905331


CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
22
Status: Approved, Date: 16 November 2016
Approximate dose-proportionality in serum guselkumab concentrations through Week 52 was 
observed after multiple SC administrations at dose levels ranging from 15 to 200 mg. 
Steady-state serum guselkumab concentrations were achieved by approximately Week 16 for 
both the q8w and q12w regimens. In each treatment group, mean or median trough serum 
guselkumab concentrations were maintained at steady state through Week 40 (q8w groups) or 
Week 52 (q12w groups). There was no evidence of accumulation in serum guselkumab 
concentrations over time with SC q8w or q12w administrations. Serum guselkumab 
concentrations appeared to be affected by subject body weight; higher-weight subjects (>90 kg) 
had lower mean steady-state trough serum guselkumab concentrations compared with 
lower-weight subjects (≤90 kg).
The overall incidence of antibodies to guselkumab across all guselkumab treatment groups 
through Week 52 was 6.3%, with generally low titers. None of the subjects who were positive 
for antibodies to guselkumab had antibodies that were able to neutralize the bioactivity of 
guselkumab in vitro. No consistent impact of antibodies to guselkumab on serum guselkumab 
concentrations was observed across the guselkumab treatment groups.
1.1.2.
SelfDose Device
The guselkumab presentation used in this Phase 3 psoriasis clinical study is a prefilled 1 mL 
glass syringe with a 27 gauge, 1/2 inch-long thin-wall needle as the primary drug container
referred to as the PFS. This PFS is assembled with a facilitated injection device and in 
combination is referred to as the SelfDose device. This same PFS is used for assembly with the 
UltraSafe Plus device for the PFS-U presentation. The sponsor intends to seek approval for
guselkumab as a single-use, SC self-administered product in the SelfDose presentation. 
The SelfDose device is a manually operated, disposable device designed to insert the PFS needle 
to a fixed depth and to deliver the contents of a PFS for SC injection. The device incorporates a 
needle safety guard that automatically locks over and shields the needle after injection to prevent 
accidental needle sticks. By design, the SelfDose device is highly intuitive and eliminates user 
difficulties that have been associated with auto-injector actuation button interlocks and with 
premature removal of the device from the skin prior to completion of an auto-injector’s delivery 
cycle. Additional details describing the SelfDose device are provided in the Site Investigational 
Product Procedures Manual.
1.2.
Overall Rationale for the Study
1.2.1.
Role of Interleukin-23 in the Treatment of Psoriasis
IL-23 is a member of the IL-12 family of heterodimeric cytokines. IL-23 shares the p40 subunit 
with IL-12. However, in contrast to IL-12, which is formed from p40/p35 heterodimers, the 
p40 subunit is paired with a p19 subunit to form IL-23.13 Although IL-12 and IL-23 are closely 
related cytokines, which are expressed by antigen-presenting cells such as dendritic cells, 
increasing evidence suggests that these 2 cytokines drive divergent immunological pathways. 
IL-12 induces the production of interferon-gamma (IFN-γ) producing T helper 1 (Th1) cells, 
which are important in host defense to intracellular pathogens by promoting cytotoxic, 
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antimicrobial, and antitumor responses. IL-23, alone or in combination with other cytokines 
(transforming growth factor β [TGF-β] and IL-6 or IL-1β), drives the expansion and/or 
maintenance of mouse and human CD4+ IL-17 producing T helper 17 (Th17) cells. Th17 cells 
produce the pro-inflammatory cytokines, IL-17A, IL-17F, IL-22, IL-6, and tumor necrosis factor 
alpha (TNFα).2,6,21
Guselkumab, a human mAb directed against the p19 subunit of IL-23 specifically targets IL-23. 
A rapidly growing body of literature suggests that the IL-23/IL-17 pathway contributes to the 
chronic inflammation underlying the pathophysiology of many immune-mediated diseases,15,20
including psoriasis,9 inflammatory bowel disease, ankylosing spondylitis, and PsA. In addition, 
susceptibility to psoriasis, PsA, and inflammatory bowel disease has been shown to be associated 
with genetic polymorphisms in IL-23/IL-23R components.1,3,8,12,14 Finally, the clinical response 
to guselkumab observed in Phase 1 and Phase 2 psoriasis studies demonstrates the specific 
importance of IL-23 in the pathogenesis of plaque psoriasis and supports further investigation in 
Phase 3 clinical studies.
1.2.2.
Dose Justification
A dose regimen of guselkumab 100 mg at Weeks 0 and 4 and q8w thereafter was selected for the 
global Phase 3 studies of guselkumab for the treatment of moderate to severe plaque-type
psoriasis and will also be utilized in this study. This dose regimen was chosen based on results of 
the guselkumab dose-ranging study (CNTO1959PSO2001) in subjects with moderate to severe
plaque-type psoriasis and PK/pharmacodynamic modeling based on the data from that study.
1.2.3.
Device Justification
The SelfDose is a manually operated, disposable device designed to manually insert the needle 
of a PFS to a fixed depth and to deliver the contents of a PFS for SC injection. The SelfDose 
presentation of guselkumab uses the same PFS as the UltraSafe PlusTM Passive Needle Guard 
(UltraSafe Plus) presentation that is currently being used in Phase 3 global clinical trials. Though 
both the SelfDose and the UltraSafe Plus are effective needle safety devices intended to shield 
the needle after injection to prevent accidental needle sticks, the SelfDose further incorporates 
usability features that make the device simple and intuitive to use. In addition, the usability of the 
SelfDose device has been established in several formative human factors studies, a summative 
human factors study, and an actual use study (CNTO1959NAP0001). Of note, the SelfDose 
device to be used in this study differs slightly from that used in previous studies 
(CNTO1959NAP0001, CNTO1959NAP1001) in order to yield a needle injection depth similar 
to the PFS. This change is expected to decrease the small PK differences observed between the 
SelfDose and PFS-U devices in the CNTO1959NAP1001 study.
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2.
OBJECTIVES, ENDPOINTS, AND HYPOTHESES
2.1.
Objectives and Endpoints
2.1.1.
Objectives
Primary Objectives
The primary objectives are:

To evaluate the efficacy of guselkumab delivered using the SelfDose device for the 
treatment of subjects with moderate to severe plaque-type psoriasis.

To assess the safety and tolerability of guselkumab delivered using the SelfDose device in 
subjects with moderate to severe plaque-type psoriasis.
Secondary Objectives
The secondary objectives are:

To assess the PK and immunogenicity of guselkumab following SC administration using the 
SelfDose device in subjects with moderate to severe plaque-type psoriasis.

To assess usability and acceptability of the SelfDose device.
2.1.2.
Endpoints
Co-Primary Endpoints

The proportion of subjects who achieve an Investigator’s Global Assessment (IGA) score of 
cleared (0) or minimal (1) at Week 16.

The proportion of subjects who achieve a PASI 90 response at Week 16.
Major Secondary Endpoints

The proportion of subjects who achieve an IGA score of cleared (0) at Week 16.

The proportion of subjects who achieve a PASI 100 response at Week 16.
Other Secondary Endpoints

The proportion of subjects achieving an IGA score of mild or better (≤2) at Week 16. 

The proportion of subjects who achieve a PASI 75 response and a PASI 50 response at 
Week 16. 

The percent improvement from baseline in PASI response at Week 16.

The proportion of subjects with successful, problem-free injections (assessment of usability) 
at Week 0. 

Self-Injection Assessment Questionnaire (SIAQ) domain scores on the 3 domains with items 
common to the SIAQ PRE- (Week 0) and POST- (Week 0 and Week 12) self-injection 
modules.  
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
Self-Injection Assessment Questionnaire POST-self-injection domain scores and change 
from baseline scores for each domain at Weeks 0, 4, 12, and 28.

The proportion of subjects who had full delivery of the dose confirmed by inspection of the
device at Weeks 4 and 12.
Additional Endpoints

Serum guselkumab concentrations and antibodies to guselkumab will be analyzed to assess 
the PK and immunogenicity of guselkumab.

Safety data will be summarized using descriptive statistics

Ratings for the SelfDose Subject Questionnaire will be summarized using descriptive 
statistics.
2.2.
Hypotheses
The hypotheses are that guselkumab treatment delivered using the SelfDose device is superior to 
placebo as demonstrated by 1) the proportion of subjects achieving an IGA score of cleared (0) 
or minimal (1); and 2) the proportion of subjects achieving a PASI 90 response, both at Week 16.
3.
STUDY DESIGN AND RATIONALE
3.1.
Overview of Study Design
This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled study evaluating the 
efficacy, safety, PK, immunogenicity, usability, and acceptability of guselkumab delivered using 
the SelfDose device in subjects with moderate to severe plaque-type psoriasis. The target 
population is adult men or women, with a diagnosis of plaque-type psoriasis (with or without
PsA) for at least 6 months before the first administration of study drug. Subjects must have 
moderate to severe plaque type psoriasis defined by PASI ≥12, IGA ≥3, and involved body 
surface area (BSA) ≥10%. Subjects must be candidates for either systemic therapy or 
phototherapy for psoriasis, and may have previously received some systemic therapies 
(Section 4.1, Inclusion Criteria, 4.2, Exclusion Criteria) or phototherapy for psoriasis. Subjects 
with nonplaque forms of psoriasis (eg, erythrodermic, guttate, or pustular) or with drug-induced 
psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium 
channel blockers, or lithium) are excluded. Subjects who have ever received guselkumab are also 
excluded.
Approximately 75 subjects who satisfy all inclusion and exclusion criteria will be randomized in 
a 4:1 ratio to 1 of 2 arms:

Group I (n=60): guselkumab 100 mg at Weeks 0, 4, 12, 20, and 28; placebo at Week 16 to 
maintain the study blind.

Group II (n=15): placebo at Weeks 0, 4, and 12; cross over to guselkumab 100 mg at 
Weeks 16, 20, and 28.
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Week 28 is the last dosing visit; subjects will be followed for an additional 12 weeks and have a 
final safety visit at Week 40. The end of the study is defined as the time the last subject 
completes the Week 40 visit.
There are 2 database locks (DBLs) in this study, 1 at Week 20, and 1 at Week 40. 
A diagram of the study design is provided below in Figure 1.
Figure 1:
Schematic Overview of the Guselkumab SelfDose Device Study
3.2.
Study Design Rationale
As described in Section 1.2.1, there is substantial scientific and clinical evidence supporting the 
critical role of IL-23 in the pathogenesis of psoriasis. Specifically, the clinical response to 
guselkumab observed in Phase 1 and Phase 2 psoriasis studies provides compelling evidence of 
the specific importance of this cytokine.
In this study, subjects will self-administer guselkumab using the SelfDose device (Section 1.1.2) 
to assess the usability and acceptability of the device in administration of study drug.
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. Primary comparisons are planned 
between guselkumab and placebo at Week 16, which is within the range that has been used in 
previous studies of biologic therapies for psoriasis (12 to 16 weeks).7,10,16,19 Randomization will 
be used to minimize bias in the assignment of subjects to treatment groups, to increase the 
likelihood that known and unknown subject attributes (eg, demographic and baseline 
characteristics) are evenly balanced across treatment groups, and to enhance the validity of 
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statistical comparisons across treatment groups. Blinded treatment will be used to reduce 
potential bias during data collection and evaluation of clinical endpoints.
4.
SUBJECT POPULATION
Screening for eligible subjects will be performed within approximately 4 weeks before
administration of the study drug.
The inclusion and exclusion criteria for enrolling subjects in this study are described in the 
following 2 subsections. If there is a question about the inclusion or exclusion criteria below, the 
investigator must consult with the appropriate sponsor representative and resolve any issues 
before enrolling a subject in the study. Waivers are not allowed. 
For a discussion of the statistical considerations of subject selection, refer to Section 11.2, 
Sample Size Determination.
4.1.
Inclusion Criteria
Each potential subject must satisfy all of the following criteria to be enrolled in the study:
1.
Be a man or a woman at least 18 years of age (or the legal age of consent in the 
jurisdiction in which the study is taking place).
2.
Have a diagnosis of plaque-type psoriasis (with or without PsA) for at least 6 months 
before the first administration of study drug.
3.
Have a PASI ≥12 at screening and at baseline.
4.
Have an IGA ≥3 at screening and at baseline.
5.
Have an involved BSA ≥10% at screening and at baseline.
6.
Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or 
history of previous treatment).
7.
Before randomization, a woman must be either:

Not of childbearing potential: premenarchal; postmenopausal (>45 years of age 
with amenorrhea for at least 12 months or any age with amenorrhea for at least 
6 months and a serum follicle-stimulating hormone level (FSH) >40 IU/L); 
permanently sterile (eg, tubal occlusion, hysterectomy, bilateral salpingectomy); or 
otherwise be incapable of pregnancy. 

Of childbearing potential and practicing a highly effective method of birth control, 
consistent with local regulations regarding the use of birth control methods for 
subjects participating in clinical studies: eg, established use of oral, injected or 
implanted hormonal methods of contraception; placement of an intrauterine 
device (IUD) or intrauterine system (IUS); barrier methods: condom or occlusive 
cap 
(diaphragm 
or 
cervical/vault 
caps) 
plus 
spermicidal 
foam/gel/
film/cream/suppository (if available in their locale); male partner sterilization (the 
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vasectomized partner should be the sole partner for that subject); true abstinence 
(when this is in line with the preferred and usual lifestyle of the subject).
Note: If a female subject’s childbearing potential changes after start of the study (eg, a 
woman who is not heterosexually active becomes active, a premenarchal woman 
experiences menarche), she must begin practicing a highly effective method of birth 
control, as described above.
8.
A woman of childbearing potential must have a negative urine pregnancy test (β-human 
chorionic gonadotropin [β-hCG]) at screening and at Week 0.
9.
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted 
reproduction during the study and for at least 12 weeks after receiving the last 
administration of guselkumab.
10.
A man 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 (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 guselkumab. All men must also 
agree to not donate sperm during the study and for at least 12 weeks after receiving the 
last administration of guselkumab.
11.
Are considered eligible according to the following tuberculosis (TB) screening criteria:

Have no history of latent or active TB prior to screening. An exception is made for 
subjects who have a history of latent TB and satisfy 1 of the following 3 criteria:

are currently receiving treatment for latent TB 

will initiate treatment for latent TB prior to first administration of study drug

have documentation of having completed appropriate treatment for latent TB 
within 5 years prior to the first administration of study drug. It is the 
responsibility of the investigator to verify the adequacy of previous anti-TB 
treatment and provide appropriate documentation.  

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 or, if there has been 
such contact, will be referred to a physician specializing in TB to undergo 
additional evaluation and, if warranted, receive appropriate treatment for latent TB 
prior to the first administration of study drug. 

Within 2 months prior to the first administration of study drug, have a negative 
QuantiFERON®-TB Gold test result (see Attachment 1), or have a newly identified 
positive QuantiFERON-TB Gold test result in which active TB has been ruled out 
and for which appropriate treatment for latent TB (see Section 9.1.2, Screening 
Phase) has been initiated prior to the first administration of study agent.  
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
Indeterminate results should be handled as outlined in Section 9.1.2, Screening 
Phase.
NOTE: The QuantiFERON-TB Gold test is not required at screening for subjects with a 
history of latent TB and ongoing treatment for latent TB or documentation of having 
completed adequate treatment as described above; subjects with documentation of 
having completed adequate treatment as described above are not required to initiate 
additional treatment for latent TB.

Have a chest radiograph (both posterior-anterior and lateral views), taken within 
3 months prior to the first administration of study drug and read by a qualified 
radiologist, with no evidence of current, active TB or old, inactive TB.
12.
Agree not to receive a live virus or live bacterial vaccination during the study, or within 
3 months after the last administration of study drug. For information on Bacille 
Calmette-Guérin (BCG) vaccination, see Inclusion Criterion 13.
13.
Agree not to receive a BCG vaccination during the study, or within 12 months after the 
last administration of study drug.
14.
Have screening laboratory test results within the following parameters, if one or more of 
the laboratory parameters is out of range, a single retest of laboratory values is 
permitted:

Hemoglobin
≥10 g/dL
(SI: ≥100 g/L)

White blood cells
≥3.5 x 103/µL
(SI: ≥3.5 GI/L)

Neutrophils
≥1.5 x 103/µL
(SI: ≥1.5 GI/L)

Platelets
≥100 x 103/µL
(SI: ≥100 GI/L)

Serum creatinine
≤1.5 mg/dL
(SI: ≤135 μmol/L)
Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase levels 
must be ≤2 × upper limit of normal for the laboratory conducting the test.
15.
Agree to avoid prolonged sun exposure and avoid use of tanning booths or other 
ultraviolet light sources during study.
16.
Be willing and able to adhere to the prohibitions and restrictions specified in this 
protocol.
17.
Be willing to self-administer study drug independently and assessed by the investigator 
as physically able to do so.
18.
Must sign an informed consent form (ICF) indicating that he or she understands the
purpose of, and procedures required for, the study and is willing to participate in the
study.
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4.2.
Exclusion Criteria
Any potential subject who meets any of the following criteria will be excluded from participating
in the study:
1.
Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, 
cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, 
rheumatologic, psychiatric, or metabolic disturbances.
2.
Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, 
unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization 
within the last 3 months.
3.
Currently has a malignancy or has a history of malignancy within 5 years before 
screening (with the exception of a non-melanoma skin cancer that has been adequately 
treated with no evidence of recurrence for at least 3 months before the first study drug 
administration or cervical carcinoma in situ that has been treated with no evidence of 
recurrence for at least 3 months before the first study drug administration).
4.
Has a 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.
5.
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.
6.
Has a transplanted organ (with exception of a corneal transplant >3 months before the 
first administration of study drug).
7.
Has a history of an infected joint prosthesis, or has received antibiotics for a suspected 
infection of a joint prosthesis, if that prosthesis has not been removed or replaced.
8.
Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis), or has 
been hospitalized or received intravenous antibiotics for an infection during the 
2 months before screening.
9.
Has or has had herpes zoster within the 2 months before screening.
10.
Is pregnant, nursing, or planning a pregnancy (both men and women) while enrolled in 
the study or within 12 weeks following the last administration of study drug.
11.
Has a nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular).
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12.
Has current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of 
psoriasis from beta blockers, calcium channel blockers, or lithium).
13.
Has previously received guselkumab.
14.
Has received any anti-TNFα biologic therapy within 3 months before the first 
administration of study drug.
15.
Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23 within 
6 months before the first administration of study drug (including but not limited to 
ustekinumab, tildrakizumab [MK3222], risankizumab
[BI-655066], secukinumab 
[AIN457], ixekizumab [LY2439821], or brodalumab [AMG827]).
16.
Has received natalizumab, belimumab, or agents that modulate B cells or T cells (eg, 
rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months before the first 
administration of study drug.
17.
Has received any systemic immunosuppressants (eg, methotrexate, azathioprine, 
cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus) or 
anakinra within 4 weeks before the first administration of study drug.
18.
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 before
the first 
administration of study drug.
19.
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 before the first administration of study drug.
20.
Is currently receiving lithium, antimalarials, or intramuscular gold, or has received 
lithium, antimalarials, or intramuscular gold within 4 weeks before the first 
administration of study drug.
21.
Has received an experimental antibody or biologic therapy within the previous 
6 months, or received any other experimental therapy or new investigational agent 
within 30 days or 5 half-lives (whichever is longer) of any study drug administration or 
is currently enrolled in another study using an investigational agent, device, or 
procedure.
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22.
Has received, or is expected to receive, any live virus or bacterial vaccination within 
3 months before the first administration of study drug. For BCG vaccine, see Exclusion 
Criterion 23.
23.
Has had a BCG vaccination within 12 months before screening.
24.
Has known intolerance or hypersensitivity to any biologic medication, or known 
allergies or clinically significant reactions to murine, chimeric, or human proteins, 
mAbs, or antibody fragments.
25.
Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients 
(refer to Investigator’s Brochure).
26.
Has a history of active granulomatous infection, including histoplasmosis or 
coccidioidomycosis, before screening. Refer to Inclusion Criterion 11 for information 
regarding eligibility with a history of latent TB.
27.
Has a chest radiograph within 3 months before the first administration of study drug that 
shows an abnormality suggestive of a malignancy or current active infection, including 
TB.
28.
Has ever had a nontuberculous mycobacterial infection or opportunistic infection (eg, 
cytomegalovirus, pneumocystosis, aspergillosis).
29.
Has persistently indeterminate (indeterminate on repeat sampling) QuantiFERON-TB 
Gold test results. Indeterminate results should be handled as described in Section 9.1.2, 
Screening Phase.
30.
Is infected with human immunodeficiency virus (HIV, positive serology for HIV 
antibody).
31.
Tests positive for hepatitis B virus (HBV) infection (Attachment 2) or is seropositive for 
antibodies to hepatitis C virus (HCV) at screening; unless they have 2 negative HCV 
RNA test results 6 months apart after completing antiviral treatment and prior to 
screening, and have a third negative HCV RNA test result at screening.
32.
Has had major surgery (eg, requiring general anesthesia and hospitalization) within 
8 weeks before screening, or has not fully recovered from such surgery, or has such 
surgery planned during the time the subject is expected to participate in the study 
(40 weeks).
Note: Subjects with planned surgical procedures to be conducted under local anesthesia 
may participate.
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33.
Is known to have had a substance abuse (drug or alcohol) problem within the previous 
12 months.
34.
Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or 
lack of easy access to veins.
35.
Lives in an institution on court or authority order.
36.
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 subject or that could 
prevent, limit, or confound the protocol-specified assessments.
37.
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.
38.
Has unstable suicidal ideation or suicidal behavior, that may be defined as an eC-SSRS 
rating at screening of: Suicidal ideation with intention to act (“4”), Suicidal ideation 
with specific plan and intent (“5”), or a suicide attempt (interrupted suicide attempt, 
aborted suicide attempt, or preparatory behaviors for making a suicide attempt) in the 
last 6 months and is confirmed to be at risk by the investigator based on an evaluation 
by a mental health professional. The final decision on excluding a subject will be made 
at the judgment of the investigator.
NOTE: Investigators should ensure that all study enrollment criteria have been met at screening.
If a subject’s clinical status changes (including any available laboratory results or receipt of
additional medical records) after screening but before the first dose of study drug is given such
that he or she no longer meets all eligibility criteria, then the subject should be excluded from
participation in the study. Section 9.1.3 Screen Failure/Rescreening, describes options for
retesting. Section 17.4, Source Documentation, describes the required documentation to support
meeting the enrollment criteria.
4.3.
Prohibitions and Restrictions 
Potential subjects must be willing and able to adhere to the following prohibitions and
restrictions during the course of the study to be eligible for participation:
1.
A woman of childbearing potential who is heterosexually active must remain on a 
highly effective method of birth control (Inclusion Criterion 7) during the study and for 
at least 12 weeks after receiving the last administration of guselkumab.
2.
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted 
reproduction during the study and for at least 12 weeks after receiving the last 
administration of guselkumab.
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3.
A man 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 (eg, male condom, 
female diaphragm or cervical cap or condom; see Inclusion Criterion 10) during the 
study and for at least 12 weeks after receiving the last administration of guselkumab.
4.
All men must agree to not donate sperm during the study and for at least 12 weeks after 
receiving the last administration of guselkumab.
5.
Subjects must not receive a live virus or bacterial vaccination during the study and for 
3 months after the last administration of any study drug. See Prohibition 6 for 
information regarding BCG vaccination.
6.
Subjects must not receive a BCG vaccination during the study and for 12 months after 
the last administration of study drug.
7.
Subjects must comply with restrictions on concomitant medications and therapies 
during the study (Section 8).
8.
Subjects must avoid prolonged sun exposure and avoid use of tanning booths or other 
ultraviolet light sources during the study.
5.
TREATMENT ALLOCATION AND BLINDING
5.1.
Procedures for Randomization and Stratification
Central randomization will be implemented in this study. At Week 0, subjects will be randomly 
assigned to 1 of 2 treatment groups based on a computer-generated randomization schedule 
prepared under the supervision of the sponsor. Permuted block randomization with stratification 
by country will be used. The interactive web response system (IWRS) will assign a unique 
treatment code, which will dictate the treatment assignment and matching study drug kit for the 
subject. The requestor must use his or her own user identification and personal identification 
number when contacting the IWRS, and will then give the relevant subject details to uniquely 
identify the subject.
5.2.
Blinding
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 subject.
Data that may potentially unblind the treatment assignment (eg, study drug serum concentrations, 
antibodies to study drug, 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 DBL and unblinding.
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Under normal circumstances, the blind should not be broken to subjects, investigators, or site 
monitors until the Week 40 database is locked and finalized. Otherwise, the blind should be 
broken only if specific emergency treatment/course of action would be dictated by knowing the
treatment status of the subject. In such cases, the investigator may in an emergency determine the 
identity of the treatment by contacting 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 of unblinding must be documented by the IWRS, in the appropriate section of 
the electronic case report form (eCRF), and in the source document; the reason for unblinding 
must be documented in the appropriate section of the eCRF and in the source document. The 
documentation received from the IWRS indicating the code break must be retained with the 
subject’s source documents in a secure manner.
Subjects who have had their treatment assignment unblinded should continue to return for 
scheduled evaluations. The decision to continue or discontinue study treatment for these subjects 
will be based upon consultation of the investigator with the medical monitor.
There are 2 DBLs in this study, 1 at Week 20, and 1 at Week 40. The sponsor, with exception 
below, will be unblinded after the last subject has completed the Week 20 visit and the Week 20 
DBL has occurred. The investigators, subjects, and sponsor site monitors will be unblinded after 
the last subject has completed the Week 40 visit, and the Week 40 DBL has occurred.
6.
DOSAGE AND ADMINISTRATION
Subjects randomized to guselkumab will receive 100 mg of guselkumab as a 100 mg/mL 
solution in a single-use PFS assembled in a SelfDose device. These subjects will also receive 
liquid placebo for guselkumab supplied in a PFS assembled in a SelfDose device at Week 16. 
Subjects randomized to placebo will receive liquid placebo for guselkumab, also supplied as a 
PFS assembled in a SelfDose device. Subjects in the placebo group will cross over at Week 16 
and receive 100 mg guselkumab as a 100 mg/mL solution in a PFS assembled in a SelfDose 
device. The dose regimens are as follows:

Group I (n=60): guselkumab 100 mg at Weeks 0, 4, 12, 20, and 28; placebo at Week 16 to 
maintain the study blind.

Group II (n=15): placebo at Weeks 0, 4, and 12; cross over to guselkumab 100 mg at 
Week 16, 20, and 28.
All study drug injections will be independently, self-administered by the subject at the study site 
after receiving training on the proper use of the SelfDose device. The first self-injection 
(Week 0) will also be observed by site staff (Section 9.3.1, Observer Assessment of Device 
Usability).
7.
TREATMENT COMPLIANCE
Because study drug will be administered at the investigational site for all randomized subjects, 
treatment compliance will be controlled by site personnel.
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All visits through Week 32 should occur within ±7 days of the scheduled visit. If a study visit 
occurs outside this window, the sponsor should be consulted about how the subject should 
resume his/her normal dosing schedule relative to the baseline visit (Week 0). The Week 40 
study visit should occur within +14 days of the scheduled visit.
Information regarding study drug administrations that are administered outside of the scheduled 
windows or missed will be recorded. Source data will be reviewed and compared with the data 
entries on the eCRFs to ensure accuracy. Although it is understood that treatment may be 
interrupted for many reasons, compliance with the treatment schedule is strongly encouraged.
SelfDose device complaints occurring during the study should be handled as instructed in 
Section 13, Product Quality Complaint Handling.
8.
CONCOMITANT THERAPY
Concomitant therapies must be recorded throughout the study from screening and continuing 
until 12 weeks after the last dose of study drug for randomized subjects. Concomitant therapies 
should also be recorded beyond Week 40 only in conjunction with SAEs that meet the criteria 
outlined in Section 12.3.2, Serious Adverse Events.
All therapies (prescription or over-the-counter medications, including vaccines, vitamins, herbal 
supplements) different from the study drug, as well as all shampoos, moisturizers or emollients
used to treat psoriasis, must be recorded in the eCRF. Modification of an effective preexisting 
therapy should not be made for the explicit purpose of entering a subject into the study.
The sponsor must be notified in advance (or as soon as possible thereafter) of any instances in 
which prohibited therapies are administered.
8.1.
Concomitant Medications for Treatment of Psoriasis
8.1.1.
Topical Therapy
Topical therapies that could affect psoriasis or the IGA evaluation (eg, corticosteroids, tar, 
anthralin, calcipotriene, tazarotene, methoxsalen, pimecrolimus, tacrolimus, or traditional 
Taiwanese, Korean, or Chinese medicines) are not permitted at any time during the study. The 
only allowable concomitant treatments for psoriasis throughout the study are shampoos 
(containing tar or salicylic acid only) and topical moisturizers. Subjects 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.
8.1.2.
Systemic or Phototherapy for Psoriasis
The use of systemic or phototherapy antipsoriatic medications is not permitted at any time during 
the study. These medications include steroids, any conventional systemic therapy that could 
affect psoriasis or the IGA evaluation (including but not limited to methotrexate, cyclosporine, 
acitretin), those targeted for reducing TNFα (including but not limited to adalimumab, 
infliximab, etanercept), drugs targeted for reducing IL-12, IL-17, or IL-23 (including but not 
limited to ustekinumab, tildrakizumab [MK3222], risankizumab [BI-655066], secukinumab 
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[AIN457], ixekizumab [LY2439821], or brodalumab [AMG827]), alpha-4 integrin antagonists 
(including but not limited to natalizumab), 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.
8.2.
Concomitant Medications for Conditions Other Than Psoriasis
Every effort should be made to keep subjects 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 for it should be 
clearly documented in the subject’s medical record.
The use of stable doses of nonsteroidal anti-inflammatory drugs is allowed. However, 
disease-modifying agents such as methotrexate, sulfasalazine, or intramuscular gold are 
prohibited during the study. Antimalarial agents may not be used. Lithium 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 drug. 
Inhaled, otic, ocular, nasal, or other routes of mucosal delivery of corticosteroids are allowed 
throughout the study.
9.
STUDY EVALUATIONS
9.1.
Study Procedures
9.1.1.
Overview
The Time and Events Schedule summarizes the frequency and timing of efficacy, PK, 
immunogenicity, safety measurements, and usability and acceptability assessments for the 
SelfDose device applicable to this study.
Efficacy evaluations (ie, IGA and PASI; Section 9.2) should be completed before study drug 
administration at applicable visits. 
Usability of the SelfDose device will be assessed by study-site personnel during a subject’s first 
self-administered dose using the Observer Injection Checklist (Section 9.3.1). Potential 
device-related problems will be reported at all visits as product quality complaints (PQCs;
Section 13). After each injection, study-site personnel will inspect the device to confirm that the 
complete dose was delivered by checking that the orange dose indicator is no longer visible and 
record completion of this inspection in source documents. 
Acceptability of the SelfDose device by subjects will be assessed using the SIAQ (Section 9.3.2).
Additional questions regarding the SelfDose device will be assessed using the SelfDose Subject 
Questionnaire (Section 9.3.3).
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Details about who will perform and/or complete the assessments/data and the order of 
completion are provided in Section 9.1.4, Placebo-Controlled and Guselkumab Treatment 
Periods.
For females of childbearing potential, a urine pregnancy test will be performed to establish the 
absence of pregnancy prior to every study drug administration and at other visits as indicated on
the Time and Events schedule.
The total blood volume to be collected from each subject will be approximately 142 mL. In 
addition, repeat or unscheduled samples may be collected for safety reasons or for technical
issues with the samples.
9.1.2.
Screening Phase
All subjects will have a screening visit that will occur within approximately 4 weeks prior to
their Week 0 visit. The screening phase is designed to assess inclusion/exclusion criteria and 
establish baseline characteristics for a subject’s psoriasis.
Each subject will be asked to sign the consent form at the screening visit before any study-related 
procedures are conducted. 
The recording of AEs and concomitant medications will start after the signing of the informed 
consent and will continue until the last study-related procedure has been completed. The eC-
SSRS (‘Baseline/Screening’ version) should be completed after the subject signs consent but as 
the first assessment by the subject before any tests, procedures, or other consultations to prevent 
influencing subject perceptions.
With the exception of subjects with a history of appropriately treated latent TB within 5 years of 
the first administration of study drug (Inclusion Criterion 11), subjects must undergo testing for 
TB (see Attachment 1) and their medical history assessment must include specific questions 
about a history of TB or known occupational or other personal exposure to individuals with 
active TB. The subject should be asked about past testing for TB, including chest radiograph 
results and responses to tuberculin skin or other TB testing.
Subjects with a negative QuantiFERON-TB Gold test result are eligible to continue with 
screening procedures. Subjects with a newly identified positive QuantiFERON-TB Gold test 
result must undergo an evaluation to rule out active TB and initiate appropriate treatment for 
latent TB. Appropriate treatment for latent TB (ie, antituberculous drugs and duration of 
treatment) is defined according to local country guidelines for immunocompromised patients. If 
no local country guidelines for immunocompromised patients exist, United States (US)
guidelines must be followed, or the subject will be excluded from the study.
A subject whose first QuantiFERON-TB Gold test result is indeterminate should have the test 
repeated. In the event that the second QuantiFERON-TB Gold test result is also indeterminate, 
the subject must be excluded from the study.
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Subjects will undergo screening for HBV (see Attachment 2) and antibodies to HCV and HIV.
9.1.3.
Screen Failure/Rescreening
If, during the screening phase, the subject has 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 
subject is considered to be a screen failure and is not eligible to be randomized at that time.
In general, if a subject is a screen failure, but at some point in the future meets all of the subject 
eligibility criteria, the subject may be rescreened after a new informed consent has been 
obtained. Subjects who are rescreened will be assigned a new subject number, sign a new ICF,
and will restart a new screening phase. Rescreening will be permitted once.
9.1.4.
Placebo-Controlled and Guselkumab Treatment Periods
Week 0/Randomization
At Week 0, subjects who meet all inclusion criteria and do not demonstrate any exclusion criteria 
will be randomized.
Randomization visit procedures will be performed as specified in the Time and Events Schedule. 
The PRE self injection SIAQ (pre-SIAQ) should be completed by the subject first followed by 
the ‘Since Last Visit’ version of the eC-SSRS questionnaire in order to prevent influencing 
subject perceptions. All tests, procedures and other consultations will be performed after these 
questionnaires and before study agent administration (Section 9.5.1).
At Week 0, if a mental health evaluation is required based on the Week 0 eC-SSRS score, either 
this evaluation must be conducted prior to randomization or, if not feasible, the subject should be 
screen-failed and then re-screened after a completed mental health evaluation, if appropriate (see 
Section 9.5.1).
Week 4 through Week 12 (placebo-controlled period) and Week 16 through Week 32 
(guselkumab treatment period)
All visit procedures will be performed as specified in the Time and Events Schedule. The ‘Since 
Last Visit’ version of the eC-SSRS should be completed by the subject first before any tests, 
procedures, or other consultations at post-baseline study visits to prevent influencing subject 
perceptions (Section 9.5.1). All other study procedures and evaluations should be completed 
before the subject self-administers the study drug at each visit, except for the POST self injection 
SIAQ (post-SIAQ) at Weeks 4, 12, and 28 which must be completed by the subject after 
completion of study drug administration (Section 9.3.2) and the SelfDose Subject Questionnaire 
which must be completed after the post-SIAQ (Section 9.3.3) at Week 12.
9.1.5.
Follow-Up Phase
Subjects will be followed for safety, efficacy, PK, and immunogenicity information through 
week 40 as indicated in the Time and Events Schedule. The ‘Since Last Visit’ version of the eC-
SSRS should be completed by the subject first before any tests, procedures, or other 
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consultations at the follow-up visit to prevent influencing subject perceptions (Section 9.5.1). If a 
subject discontinues study treatment before his or her last scheduled injection, procedures 
described in Section 10.2, Discontinuation of Study Treatment, should be followed.
9.2.
Efficacy Evaluations
Efficacy evaluations chosen for this study are consistent with those utilized to evaluate other 
therapies for psoriasis. 
Efficacy evaluations will include the following:

Investigator’s Global Assessment: The IGA documents the investigator’s assessment of 
the subject’s psoriasis at a given time point (Attachment 3). Overall lesions are graded 
for induration, erythema, and scaling. The patient’s psoriasis is assessed as cleared (0), 
minimal (1), mild (2), moderate (3), or severe (4).

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 (Attachment 4).4 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 erythema, induration, and scaling, 
which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range 
from 0 to 72. A higher score indicates more severe disease.
Efficacy assessments will be performed at the site by an efficacy assessor trained by the sponsor 
and will be captured electronically in a tablet device at the appropriate visits as outlined in the 
Time and Events Schedule.
9.3.
Usability and Acceptability Assessments
9.3.1.
Observer Assessment of Device Usability 
Successful, problem-free self-injection (usability) using the SelfDose device will be assessed by 
the completion of the Observer Injection Checklist at Week 0 (Attachment 5). Study-site 
personnel will observe the subject to confirm successful completion of the 3 steps, as described 
in the instructions for use, required to effectively and safely use the device to deliver the correct 
dose: (1) remove the cap, (2) position device on the injection site, and (3) inject complete dose.17
The Observer Injection Checklist will be captured electronically on a tablet device. 
Study-site personnel will also report potential SelfDose device-related problems (eg, accidental 
needle sticks, device breakage) at all visits; any occurrences should be reported as a PQC 
(Section 13). 
After each injection, study-site personnel will inspect the device to confirm that the complete 
dose was delivered by checking that the orange dose indicator is no longer visible and record 
completion of this inspection in source documents.
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9.3.2.
Self-Injection Assessment Questionnaire
Subjects will be asked to rate the acceptability of their experience using the SelfDose device with 
the SIAQ which was developed and validated in patients with RA.5,17 A paper version of the 
SIAQ will be used in this study.
The SIAQ (representative sample is provided in Attachment 6) includes 6 domains: feelings 
about injections, self-image, self-confidence, pain and skin reactions during or after the injection, 
ease of use of the self-injection device, and satisfaction with self-injection. Each domain is 
derived from one or multiple items. The subject rates each item of the SIAQ on a 5 or 6-point
semantic Likert-type scale. Item scores will be transformed to obtain a score ranging from 
0 (worst experience) to 10 (best experience) for each item. The domain score is the mean of the 
item scores included in the domain. Domain scores will be calculated only if at least half of the 
domain items are completed. 
The PRE-self-injection module of the SIAQ includes items assessing domains of feelings about 
injections, self-confidence, and satisfaction with self-injection, while the POST-self-injection 
module of the SIAQ includes items assessing all 6 domains. In this study, the subject 
will complete the PRE-self-injection module before the first self-injection at Week 0, 
and will complete the POST-self-injection module after self-injection at Weeks 0, 4, 12, and 28. 
In addition, injection site reactions may be identified in completed POST-self-injection SIAQs 
when a subject positively responds (all responses except “not at all”) to the questions in section
“Pain and skin reactions during or after the injection.” These injection site reactions should 
be recorded on the AE page of the eCRF.
9.3.3.
SelfDose Subject Questionnaire
The SelfDose Subject Questionnaire consists of 3 questions to gauge aspects of a subjects’
impression of the SelfDose device (Attachment 7). These questions are intended to supplement 
the SIAQ. Subjects will complete the questionnaire after all study evaluations are completed, 
including after they self-inject study drug and after they have completed the POST-self-injection 
module of the SIAQ at Week 12. Subjects will rate each question using a 5-point scale (strongly 
disagree, disagree, neither agree or disagree, agree, or strongly agree).
9.4.
Pharmacokinetics and Immunogenicity
9.4.1.
Sample Collection and Handling
Venous blood samples of approximately 7.5 mL each will be collected at the time points shown 
in the Time and Events Schedule for the determination of serum guselkumab concentrations and 
antibodies to guselkumab. A sample will also be collected at the final visit from subjects who 
complete or terminate study participation early. Each sample will be split into 3 aliquots (1 
aliquot for serum guselkumab concentration, 1 aliquot for antibodies to guselkumab, and 1 
aliquot as a back-up). Samples must be collected before study drug administration at visits when 
a study drug administration is scheduled. The exact dates and times of blood sample collection 
must be recorded in the laboratory requisition form.
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Additional information about the collection, handling, and shipment of biological samples can be 
found in the Laboratory Manual.
9.4.2.
Pharmacokinetic Assessments
Serum samples will be analyzed to determine serum guselkumab concentrations using a 
validated, specific, and sensitive immunoassay method by the sponsor or sponsor’s designee. 
Sponsor, or its designee, under conditions in which the subjects’ identity remains blinded, will 
assay these samples.
9.4.3.
Immunogenicity Assessments
Serum samples will be evaluated for the presence of antibodies to guselkumab using a validated 
assay method by the sponsor or sponsor’s designee.
Serum 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). 
9.5.
Safety Evaluations
The safety and tolerability of study drugs (guselkumab and placebo) will be monitored by 
collecting information on AEs, including injection site and allergic reactions, clinical laboratory 
tests, physical examinations, vital sign measurements, eC-SSRS questionnaires, concomitant
medication review, and early detection of TB at specified time points in the Time and Events 
Schedule and as described below. Serum and/or plasma samples collected for PK analyses may 
also be used to evaluate safety concerns that may arise during or after the study period.
Safety will be monitored through Week 40 or for 12 weeks after the last study drug 
administration for subjects who discontinue early. Any clinically relevant changes occurring
during the study must be recorded on the Adverse Event section of the eCRF.
Any clinically important abnormalities persisting at the end of the study or at early withdrawal
may be followed by the investigator until resolution or until a clinically stable endpoint is
reached.
Adverse Events
Adverse events will be reported by the subject for the duration of the study. Adverse events will 
be followed by the investigator as specified in Section 12, Adverse Event Reporting.
Early Detection of Active Tuberculosis
To aid in the early detection of TB reactivation or new TB infection during study participation, 
subjects must be evaluated for signs and symptoms of active TB at all scheduled visits or by 
telephone contact approximately every 8 to 12 weeks. The following series of questions is 
suggested for use during the evaluation:

“Have you had a new cough of >14 days’ duration or a change in a chronic cough?”
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
“Have you had any of the following symptoms:

Persistent fever?

Unintentional weight loss?

Night sweats?”

“Have you 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.)
If the evaluation raises suspicion that a subject may have TB reactivation or new TB infection, 
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 subjects may present 
as disseminated disease or with extrapulmonary features. Subjects with evidence of active TB 
should be referred for appropriate treatment.
Subjects who experience close contact with an individual with active TB during the conduct of 
the study must have a repeat chest radiograph, a repeat QuantiFERON-TB Gold test and, if 
possible, referral to a physician specializing in TB to determine the subject’s risk of developing 
active TB and whether treatment for latent TB is warranted.
Study drug administration should be interrupted during the investigation. A positive 
QuantiFERON-TB Gold test result should be considered detection of latent TB. If the 
QuantiFERON-TB Gold test result is indeterminate, the test should be repeated as outlined in 
Section 9.1.2, Screening Phase. Subjects who discontinue treatment for latent TB prematurely or 
who are noncompliant with therapy must immediately discontinue further administration of 
study drug and be encouraged to return for all subsequent scheduled study visits according to the 
Time and Events Schedule.
Refer to Attachment 1 for details of TB testing.
Allergic Reactions
The sponsor will proactively monitor reported AEs and query the site, if necessary, to capture 
anaphylactic reaction/serum sickness events in the eCRF.
Injection Site Reactions
An injection site reaction is any unfavorable or unintended sign that occurs at the study drug 
injection site. Any adverse reaction (eg, pain, erythema, and/or induration) should be recorded on 
the AE page of the eCRF. See Section 9.3.2 for information regarding injection site reactions that 
may be identified in completed POST-self-injection SIAQs.
Clinical Laboratory Tests
Blood samples for serum chemistry and hematology will be collected. The investigator must 
review the laboratory report, document this review, and record any clinically relevant changes 
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occurring during the study in the AE section of the eCRF. The laboratory reports must be filed 
with the source documents.
All abnormal laboratory values will be evaluated for clinical significance by the investigator. If 
clinically significant abnormal laboratory values (in the opinion of the investigator) are detected, 
then the test(s) should be repeated until they return to normal or are otherwise explained by the 
Investigator.
Instructions for the collection, handling, and shipping of blood samples are provided in the 
Laboratory Manual.
The following tests will be performed by the central laboratory:

Hematology Panel
-hemoglobin
-neutrophils
-hematocrit
-bands
-red blood cell (RBC) count
-eosinophils
-white blood cell (WBC) count
-basophils
-lymphocytes
-platelets
-monocytes

Serum Chemistry Panel
-sodium
-calcium
-potassium
-albumin
-chloride
-total protein
-alkaline phosphatase
-alanine aminotransferase
-urea
-total CO2
-creatinine
-total bilirubin
-glucose
-high-sensitivity C-reactive protein (hs-CRP)
-aspartate aminotransferase
-FSHa
a
Testing required for selected subjects as defined in Inclusion Criterion 7.

Lipids
(Week 0 only; subjects must fast (ie, no food or beverages [except water]) for at least 
8 hours before blood is drawn for lipid panel)
-total cholesterol
-total cholesterol to HDL ratio
-low density lipoprotein cholesterol (LDL)
-triglycerides
-high density lipoprotein cholesterol (HDL)

Serology:  HBV, including HBV serology and HBV DNA, as appropriate (see 
Attachment 2) and antibodies to HCV and HIV.
Pregnancy Testing
Urine pregnancy testing is required for all women of childbearing potential at screening, before 
study drug administration at applicable visits, and at Week 40 or at least 12 weeks after the last 
study drug administration for subjects who discontinue study treatment or withdraw from the 
study. Pregnancy tests must be completed and negative at the study visit prior to 
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self-administration of study drug. All pregnancy test results must be recorded in source 
documents.
Physical Examination
Physical examinations will be performed by the investigator or designated physician, nurse 
practitioner, or physician’s assistant as specified in the Time and Events Schedule. Any new, 
clinically significant finding (in the opinion of the investigator) must be captured as an AE 
(Section 12, Adverse Event Reporting). In addition, resolution of these findings during the study
will be noted in the source document and in the eCRF.
Height and Weight 
Height and weight will be measured at baseline (Week 0). Subjects will be instructed to remove 
shoes and outdoor apparel and gear prior to these measurements.
Vital Signs
Blood pressure and heart rate measurements will be assessed at the time points specified in the 
Time and Events Schedule.
If any clinically significant changes in vital signs are noted, they must be reported as AEs 
(Section 12, Adverse Event Reporting) and followed to resolution, or until reaching a clinically 
stable endpoint.
9.5.1.
Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)
In light of the recent reports concerning suicidal ideation and behavior in patients with plaque 
psoriasis treated with an IL-17R antagonist (brodalumab), the electronic Columbia-Suicide 
Severity Rating Scale (eC-SSRS) will be used as a screening tool to prospectively evaluate the 
potential of guselkumab to induce suicidal ideation and behavior. The eC-SSRS defines five 
subtypes of suicidal ideation and behavior in addition to self-injurious behavior with no suicidal 
intent, and is a fully-structured, subject self-report C-SSRS questionnaire, including standardized 
questions, follow-up prompts, error handling routines, and scoring conventions.11,18 Two 
versions of the eC-SSRS will be used in this study, the ‘Baseline/Screening’ version and the 
‘Since Last Visit’ version. The ‘Baseline/Screening’ version of the eC-SSRS will be conducted 
during the screening visit followed by the ‘Since Last Visit’ version of the eC-SSRS at all other 
visits through Week 40.
Subjects will complete the eC-SSRS questionnaire using the sponsor-provided electronic tablets. 
Study site personnel will train the subjects on how to use the electronic device. The eC-SSRS 
will be provided in the local languages in accordance with local guidelines.
The eC-SSRS will be performed during each evaluation visit according to the assessment 
schedule. During a visit, subjects will be directed to a private, quiet place with the electronic 
device to complete the assessment. Subjects who do not have suicidal behavior or ideation will 
answer a limited number of questions and will usually complete the assessment in about 3 
minutes. Subjects with significant suicidal ideation and behavior may require up to 10 minutes to 
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answer all relevant questions. The eC-SSRS will be performed first at the screening visit (after 
signing informed consent), after the pre-SIAQ at Week 0/baseline, and before study agent 
administration. At all post-baseline visits, the eC-SSRS will be the first assessment/questionnaire 
that the subject must complete.
At the conclusion of each assessment, the site will receive an eC-SSRS Findings Report. At 
screening and Week 0, subjects with an eC-SSRS score greater than 0 or a response to the 
question of “Self-injurious behavior without suicidal intent” other than ‘NO’ must be determined 
to be not at risk by the investigator based on an evaluation by a mental health professional in 
order to be randomized. Subjects with a score on the eC-SSRS that is greater than 0 or a response 
to the question of “Self-injurious behavior without suicidal intent” other than ‘NO’ at any post-
baseline visit will also be referred to an appropriate mental health professional for evaluation. If 
a subject’s psychiatric disorder can be adequately treated with psychotherapy and/or 
pharmacotherapy then the subject, at the discretion of the investigator, should be continued with 
treatment. Ultimately, the determination of suicidality and risk is up to the investigator’s clinical 
judgment following evaluation by a mental health professional (eg, psychiatrist, psychologist, or 
appropriately trained social worker or nurse).
Positive reports are generated from the eC-SSRS vendor for ANY of the following findings:

Suicidal ideation with intention to act (“4”)

Suicidal ideation with specific plan and intent (“5”)

Made suicide attempt

Interrupted suicide attempt

Aborted suicide attempt

Preparatory behaviors for making a suicide attempt.
Negative suicidality indication reports are generated from the eC-SSRS vendor when there are 
NO indications of the above.
The subject should not be released from the site until the eC-SSRS Findings Report (both for 
negative and positive reports) is reviewed by the investigator and the subject’s risk has been 
assessed and follow-up determined, as appropriate.
For each score, the following actions and associated alerts will be generated, if applicable:

Score of 0: No further action is needed. 

Score > 0: Subject risk assessed and referral to a mental health professional.

Score of 1, 2, or 3: Negative findings report will be generated.
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
Score of 4 or higher: Positive findings report will be generated. When the system 
reports that the subject has a positive suicidal indication (including for an incomplete 
assessment), the site will be immediately notified by fax/email and a telephone call 
from the eC-SSRS vendor.

Self-injurious behavior without suicidal intent = YES or ‘Question Mark (ambiguous 
response)’: Subject risk assessed and referral to a mental health professional. Negative 
findings report will be generated.
Interruption or the discontinuation of study treatment should be considered for any subject who 
reports suicidal ideation with intention to act (“4”), suicidal ideation with specific plan and intent 
(“5”), or a suicide attempt (interrupted suicide attempt, aborted suicide attempt, or preparatory 
behaviors for making a suicide attempt) on a post-baseline eC-SSRS assessment and who is 
deemed to be at risk by the investigator based upon evaluation by a mental health professional. 
Discussion of such subjects with the medical monitor or designee is required (See Section 10.2).
The final decision on suitability for continuing in the study will be made by the investigator.
Any eC-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 eCRF (see Section 12).
9.6.
Sample Collection and Handling
The actual dates and times of sample collection must be recorded in the laboratory requisition 
form.
Refer to the Time and Events Schedule 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.
10.
SUBJECT COMPLETION/DISCONTINUATION OF STUDY TREATMENT/ 
WITHDRAWAL FROM THE STUDY
10.1.
Completion
A subject will be considered to have completed the study if he or she has completed assessments 
at Week 40 of the study. Subjects who prematurely discontinued study treatment for any reason 
before completion of the study will not be considered to have completed the study.
10.2.
Discontinuation of Study Treatment
If a subject’s study treatment must be discontinued before the end of the treatment regimen, it 
will not result in automatic withdrawal of the subject from the study. 
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A subject’s study treatment should be discontinued if:

The investigator believes that for safety reasons (eg, AE) it is in the best interest of the 
subject to discontinue study treatment.

The subject becomes pregnant.

The subject is diagnosed with a malignancy, with the exception of no more than 2 localized 
basal cell skin cancers that are treated with no evidence of recurrence or residual disease. 

The subject is deemed ineligible according to the following TB screening criteria: 

A diagnosis of active TB is made.

A subject 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 subject undergoing evaluation has a chest radiograph with evidence of current active 
TB and/or a positive QuantiFERON-TB Gold test result, unless active TB can be ruled 
out and appropriate treatment for latent TB can be initiated before the next 
administration of study drug and continued to completion. Indeterminate 
QuantiFERON-TB Gold test results should be handled as described in Section 9.1.2, 
Screening Phase.  

A subject receiving treatment for latent TB discontinues this treatment prematurely or is 
noncompliant with the therapy.

The subject initiates a protocol-prohibited medication, eg, for a worsening of his or her 
psoriasis (unless agreed to by the medical monitor).

The subject withdraws consent for administration of study drug.

The subject is unable to adhere to the study visit schedule or comply with protocol 
requirements.

The subject develops an allergic reaction such as bronchospasm with wheezing and/or 
dyspnea requiring ventilatory support, or symptomatic hypotension that occurs following a 
study drug administration.

The subject 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 drug. These 
may be accompanied by other events including pruritus, facial, hand, or lip edema, 
dysphagia, urticaria, sore throat, and/or headache.

Discontinuation of study treatment should be considered for subjects who report suicidal 
ideation with intention to act (“4”), suicidal ideation with specific plan and intent (“5”), or a 
suicide attempt (interrupted suicide attempt, aborted suicide attempt, or preparatory 
behaviors for making a suicide attempt) on a post-baseline eC-SSRS assessment. Discussion 
of such subjects with the medical monitor or designee is required.

Discontinuation of study treatment should be considered for subjects who develop a serious 
or opportunistic infection. Discussion of such subjects with the medical monitor or designee 
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should also be considered. The final decision on suitability for continuing with study agent 
will be made by the investigator, based upon evaluation by a mental health professional.
If a subject discontinues study treatment before his or her last scheduled injection, he or she 
should return for the remaining regularly scheduled study visits for at least 12 weeks after 
receiving the last administration of study drug. For subjects who complete their final study visit 
prior to Week 40, every effort should be made to conduct the Week 40 assessments as indicated 
in the Time and Events Schedule; serum samples for PK and immunogenicity assessments 
should also be collected at that final visit. 
Subjects who decide to discontinue study drug administration must be interviewed by the 
investigator to determine if a specific reason for discontinuing study drug can be identified. 
Subjects should be explicitly asked about the possible contribution of AEs to their decision to 
discontinue study drug; investigators should confirm that any AE information elicited has been 
documented. If a subject elects to discontinue study drug due to an AE, the event should be 
recorded as the reason for study drug discontinuation, even if the investigator’s assessment is 
that the AE would not require study drug discontinuation. The reason for study drug 
discontinuation must be documented in the eCRF and in source documents. Study drug assigned 
to a subject who discontinues may not be assigned to another subject.
10.3.
Withdrawal From the Study
A subject will be withdrawn from the study for any of the following reasons:

Lost to follow-up

Withdrawal of consent

Death
To ensure access for subject follow-up, study sites should try to obtain both primary and 
secondary telephone contact numbers from subjects (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 subject, before randomization. 
For subjects who withdraw from study participation, every effort should be made to conduct the 
Week 40 assessments, as indicated in the Time and Events Schedule.  
If a subject fails to return for study visits, study site personnel must make all reasonable efforts to 
contact the subject to determine the subject’s reason for discontinuation/withdrawal before 
considering the subject to be lost to follow-up. Such efforts should include repeated telephone 
calls, certified letters, email requests, etc. Measures taken to obtain follow-up information must 
be documented.
Withdrawal of consent should be a very unusual occurrence in a clinical trial; the investigator
should make every effort to maintain good subject relationships to avoid withdrawals of consent. 
For subjects who truly request withdrawal of consent, it is recommended that the subject 
withdraw consent in writing; if the subject or the subject’s representative refuses to do so or is 
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physically unavailable, the study site should document the reason for the subject’s failure to 
withdraw consent in writing, sign the documentation, and maintain it with the subject’s source 
records.
When a subject withdraws before completing the study, the reason for withdrawal is to be 
documented in the eCRF and in the source document. Study drug assigned to the withdrawn 
subject may not be assigned to another subject. Subjects who withdraw from the study will not 
be replaced.
Withdrawal From the Use of Samples in Future Research
The subject may withdraw consent for use of samples for research (refer to Section 16.2.5, 
Long-Term Retention of Samples for Additional Future Research). 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.
11.
STATISTICAL METHODS
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. Graphical data displays may also be used to 
summarize the data.
The Fisher’s exact test will be used to compare the proportion of subjects responding to 
treatment. Continuous response parameters will be compared using an analysis of variance 
model, with country as a covariate. All statistical testing will be performed 2-sided.
11.1.
Subject Information
Subjects will be included in the efficacy analyses according to their assigned treatment group 
regardless of whether or not they received the assignment treatment. For the primary efficacy 
analysis, data from all randomized and treated subjects will be analyzed. The treated population, 
which includes all randomized subjects who receive at least 1 dose (complete or partial) of study 
drug, will be used for the PK, immunogenicity, and safety analyses; subjects will be included 
according to the actual treatment received.
Descriptive statistics by the randomized treatment group based on all randomized and treated 
subjects will be provided for subject dispositions, demographics, baseline disease characteristics, 
and prior and concomitant medications. The baseline measurement is defined as the closest 
measurement taken before or at Week 0.
11.2.
Sample Size Determination
This study is designed to evaluate the efficacy of guselkumab vs placebo using the SelfDose
device.
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The assumptions for the sample size and power calculations are based on the data from the 
guselkumab CNTO1959PSO2001 study:

The proportion of placebo subjects who achieved an IGA score of cleared (0) or minimal (1) 
and a PASI 90 response was 10% and 5%, respectively. Note PGA was used in 
CNTO1959PSO2001. PGA is a similar measure to IGA which will be used in this study.

The proportion of subjects who achieved an IGA score of cleared (0) or minimal (1) 
response at Week 16 was 86% in the guselkumab 100 mg group.

The proportion of subjects who achieved a PASI 90 response at Week 16 was 62% in the 
guselkumab 100 mg group.
As shown in the Table 1 below, based on the above assumptions, with a total of approximately 
75 subjects randomized in a 4:1 ratio to guselkumab 100 mg (n=60) and placebo (n=15), there 
will be at least 99% power to detect differences for both co-primary endpoints in the proportion 
of subjects achieving an IGA score of cleared (0) or minimal (1) and the proportion of subjects 
who achieve a PASI 90 response between the placebo and guselkumab groups at Week 16, at a 
significance level of 0.05. This sample size was also chosen to provide adequate power for major 
secondary endpoints.
Table 2:
Power to Detect a Treatment Effect Based on Different Proportions of Subjects Achieving the 
Co primary Endpoints
Co-primary Endpoints
Power
IGA cleared (0) or minimal (1) response at Week 16 
Placebo 
(n=15)
Guselkumab 100 mg q8w 
(n=60) 
10%
70%
>99%
75%
>99%
80%
>99%
PASI 90 response at Week 16
Placebo 
(n=15)
Guselkumab 100 mg q8w 
(n=60)
5%
55%
99%
60%
>99%
65%
>99%
IGA=Investigator’s Global Assessment; PASI=Psoriasis Area and Severity Index; q8w=every 8 weeks.
11.3.
Interim Analysis
No formal interim analyses will be performed.  
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11.4.
Efficacy Analysis
11.4.1.
Analysis Data Set
For the primary analysis and major secondary analyses, all randomized and treated subjects will 
be included. For all efficacy analyses, subjects will be analyzed according to the treatment group 
to which they were randomized, regardless of the treatment they actually received.
11.4.2.
Primary Analysis
The 2 co-primary endpoints (Section 2.1.2) will be compared between the guselkumab group and 
the placebo group. Subjects who meet treatment failure criteria (Section 11.6), Criteria for 
Endpoints, before Week 16 will be considered nonresponders for the co-primary endpoints at 
Week 16. In addition, subjects who do not return for evaluation at Week 16 will be considered 
nonresponders at Week 16.
The analysis will be performed using a Fisher’s exact test, 2-sided (α=0.05).
11.4.3.
Major Secondary Analyses
The major secondary endpoints (Section 2.1.2) will be compared between the guselkumab group 
and the placebo group. The analyses will be performed using a Fisher’s exact test, 2-sided 
(α=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. That is, the first major secondary endpoint will be 
tested only if the co-primary endpoints are positive. Similarly, the second major secondary 
endpoint will be tested only if the first major secondary endpoint is positive.
11.4.4.
Other Efficacy Analyses
Efficacy endpoints (Section 2.1.2) will be compared between the guselkumab group and the 
placebo group and nominal p-values will be provided. The efficacy endpoints will also be 
summarized over time through Week 16, and from Week 16 through Week 40.
Furthermore, subgroup analyses will be performed to evaluate consistency of the co-primary 
endpoints over demographics, baseline disease characteristics, and prior medications. Additional 
efficacy analyses may be performed and will be documented in the SAP.
11.5.
Usability and Acceptability Assessments
Endpoints related to usability and acceptability (Section 2.1.2) will be summarized by treatment 
group and for the overall population. 
Ratings for the SelfDose Subject Questionnaire will be summarized at Week 12 by question, by 
treatment group, and for the overall population. 
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11.6.
Criteria for Endpoints
Treatment Failure: Subjects 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: Subjects with ≥50% improvement in PASI from baseline.
PASI 75 Responders: Subjects with ≥75% improvement in PASI from baseline.
PASI 90 Responders: Subjects with ≥90% improvement in PASI from baseline.
PASI 100 Responders: Subjects with 100% improvement in PASI from baseline.
11.7.
Pharmacokinetic Analyses 
Serum guselkumab concentrations over time will be summarized by treatment group. Descriptive 
statistics, including arithmetic mean, standard deviation, median, interquartile range, minimum, 
and maximum will be calculated at each sampling time point. 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.
11.8.
Immunogenicity Analyses
The incidence and titers of antibodies to guselkumab will be summarized for all subjects who 
receive at least 1 dose of guselkumab and have appropriate samples for detection of antibodies to 
guselkumab (ie, subjects with at least 1 sample obtained after their first dose of guselkumab). A 
listing of subjects who are positive for antibodies to guselkumab will be provided.
The incidence of NAbs to guselkumab will be summarized for subjects who are positive for 
antibodies to guselkumab and have samples evaluable for NAbs.
11.9.
Safety Analyses
Adverse Events
The verbatim terms used in the eCRF by investigators to identify AEs will be coded using the 
Medical Dictionary for Regulatory Activities (MedDRA). All reported AEs with onset during the 
treatment phase (ie, treatment-emergent AEs and AEs that have worsened since baseline) will be 
included in the analysis. For each AE, the percentage of subjects who experience at least 
1 occurrence of the given event will be summarized by treatment group.
Summaries, listings, and/or subject narratives may be provided, as appropriate, for those subjects 
who die, who discontinue treatment due to an AE, or who experience a severe or a serious AE.
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The following analyses will also be used to assess the safety of subjects in the study:

The incidence and type of AEs.

The incidence and type of SAEs.

The incidence and type of infections.

The incidence and type of reasonably related AEs.

The incidence and type of injection site reactions.

The laboratory parameters and change from baseline in laboratory parameters (hematology 
and chemistry).

National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 
grades will be used in the summary of select hematology and chemistry parameters. A 
listing of subjects with post-baseline abnormal laboratory results based on NCI-CTCAE 
grades will also be provided.
Vital Signs
Descriptive statistics of heart rate and blood pressure (systolic and diastolic) values and changes 
from baseline will be summarized by treatment group.
Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)
Suicide-related thoughts and behaviors based on the eC-SSRS will be summarized descriptively 
by treatment group.
12.
ADVERSE EVENT REPORTING
Timely, accurate, and complete reporting and analysis of safety information from clinical studies 
are crucial for the protection of subjects, 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.
12.1.
Definitions
12.1.1.
Adverse Event Definitions and Classifications
Adverse Event
An AE is any untoward medical occurrence in a clinical study subject administered a medicinal 
(investigational or non-investigational) product. An AE does not necessarily have a causal 
relationship with the treatment. An AE 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])
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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 AEs starting with the signing of the ICF (refer to Section 12.3.1, All 
Adverse Events, for time of last AE recording).
Serious Adverse Event
An SAE based on ICH and European Union (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 subject 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 subject 
or may require intervention to prevent one of the other outcomes listed in the definition above. 
These should usually be considered serious.
If a serious and unexpected AE occurs for which there is evidence suggesting a causal 
relationship between the study drug 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 AE is considered unlisted if the nature or severity is not consistent with the applicable
product reference safety information. For guselkumab, the expectedness of an AE will be
determined by whether or not it is listed in the Investigator’s Brochure.
Adverse Event Associated With the Use of the Drug
An AE is considered associated with the use of the drug if the attribution is possible, probable, or 
very likely by the definitions listed in Section 12.1.2, Attribute Definitions.
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12.1.2.
Attribution Definitions
Not Related
An AE that is not related to the use of the drug.
Doubtful
An AE for which an alternative explanation is more likely, eg, concomitant drug(s), concomitant 
disease(s), or the relationship in time suggests that a causal relationship is unlikely.
Possible
An AE that might be due to the use of the drug. An alternative explanation, eg, concomitant
drug(s), concomitant disease(s), is inconclusive. The relationship in time is reasonable; therefore,
the causal relationship cannot be excluded.
Probable
An AE that might be due to the use of the drug. The relationship in time is suggestive 
(eg, confirmed by dechallenge). An alternative explanation is less likely, eg, concomitant
drug(s), concomitant disease(s).
Very Likely
An AE that is listed as a possible adverse reaction and cannot be reasonably explained by an 
alternative explanation, eg, concomitant drug(s), concomitant disease(s). The relationship in time 
is very suggestive (eg, it is confirmed by dechallenge and rechallenge).
12.1.3.
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
interfering with everyday activities.
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 subject (eg, laboratory abnormalities).
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12.2.
Special Reporting Situations
Safety events of interest on a sponsor study drug that may require expedited reporting and/or 
safety evaluation include, but are not limited to:

Overdose of a sponsor study drug

Suspected abuse/misuse of a sponsor study drug

Accidental or occupational exposure to a sponsor study drug

Medication error involving a sponsor product (with or without subject/patient exposure to 
the sponsor study drug, eg, name confusion)
Any special reporting situation that also meets the criteria of an SAE should be recorded on the
SAE page of the eCRF. Refer to Section 12.3.2, Serious Adverse Events, for information on 
reporting SAEs.
12.3.
Procedures
12.3.1.
All Adverse Events
All AEs and special reporting situations (Section 12.2), whether serious or non-serious, will be 
reported from the time a signed and dated ICF is obtained until completion of the subject’s last 
study-related procedure (which may include contact for follow-up of safety). Serious AEs, 
including those spontaneously reported to the investigator within 12 weeks after the last dose of 
study drug, 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. Anticipated events will be recorded and reported as described in
Attachment 8.
All events that meet the definition of an SAE will be reported as SAEs, regardless of whether 
they are protocol-specific assessments.
All AEs, regardless of seriousness, severity, or presumed relationship to study drug, must be 
recorded using medical terminology in the source document and the eCRF. 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 eCRF their opinion concerning the relationship of 
the AE to study therapy. All measures required for AE management must be recorded in the 
source document and reported according to sponsor instructions.
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The sponsor assumes responsibility for appropriate reporting of AEs to the regulatory authorities. 
The sponsor will also report to the investigator (and the head of the investigational institute 
where required) all suspected unexpected serious adverse reactions (SUSARs). 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.
Serious AEs 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 described in Attachment 8.
All SAEs and nonserious AEs that represent any of the following diagnoses or any symptoms 
associated with the following diagnoses (eg, chest pain, dizziness) must be reported to the 
sponsor and will require efforts to obtain additional medical records:

myocardial infarction

stroke

cardiovascular death

unstable angina

coronary revascularization (percutaneous coronary intervention or coronary artery bypass 
graft surgery)

transient ischemic attack

venous and peripheral arterial vascular thrombotic events (ie, deep vein thrombosis and 
pulmonary embolism)

congestive heart failure

cardiac arrhythmia

syncope of a cardiovascular origin

severe/accelerated hypertension leading to hospitalization
If the event is an SAE, the procedures outlined in Section 12.3.2, Serious Adverse Events, should 
be followed. If the event is a nonserious AE, procedures outlined in the Trial Center File for 
nonserious AEs (as described above) should be followed.
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For all studies with an outpatient phase, including open-label studies, the subject 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 subject 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

Subject number

Any other information that is required to do an emergency breaking of the blind
12.3.2.
Serious Adverse Events
All SAEs occurring during the study must be reported to the appropriate sponsor contact person
by study-site personnel within 24 hours of their knowledge of the event.
Information regarding SAEs 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 an SAE should be made by
facsimile (fax) or electronic mail.
All SAEs that have not resolved by the end of the study, or that have not resolved upon 
discontinuation of the subject’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 drug or to factors unrelated to 
study conduct

It becomes unlikely that any additional information can be obtained (subject 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 an SAE.
Any event requiring hospitalization (or prolongation of hospitalization) that occurs during the 
course of a subject’s participation in a study must be reported as an SAE, except hospitalizations 
not intended to treat an acute illness or AE (eg, social reasons such as pending placement in
long-term care facility).
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The cause of death of a subject in a study within 12 weeks of the last dose of study drug, whether 
or not the event is expected or associated with the study drug, is considered an SAE.
12.3.3.
Pregnancy 
All initial reports of pregnancy 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. Abnormal pregnancy outcomes (eg, spontaneous abortion, stillbirth, and congenital 
anomaly) are considered SAEs and must be reported using the Serious Adverse Event Form. Any 
subject who becomes pregnant during the study must discontinue further study treatment.
Because the effect of the study drug on sperm is unknown, pregnancies in partners of male 
subjects included in the study will be reported by the study-site personnel within 24 hours of 
their knowledge of the event using the appropriate pregnancy notification form.
Follow-up information regarding the outcome of the pregnancy and any postnatal sequelae in the 
infant will be required.
12.3.4.
Events of Special Interest
Any newly identified malignancy or case of active TB occurring after the first administration of 
study drug in subjects participating in this clinical study must be reported by the investigator 
according to the procedures in Section 12.3.2, Serious Adverse Events. 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.
12.4.
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.
13.
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 from studies are crucial for the protection of subjects, 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.
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13.1.
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. All PQCs will be documented in source documents and the 
eCRF.
If the defect is combined with an SAE, the study-site personnel must report the PQC to the 
sponsor according to the SAE reporting timelines (refer to Section 12.3.2, Serious Adverse 
Events) and complete both the PQC and SAE reporting forms. A sample of the suspected product
should be maintained for further investigation if requested by the sponsor.
13.2.
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.
14.
STUDY DRUG INFORMATION
14.1.
Physical Description of Study Drugs
The guselkumab PFS supplied for this study is a single-use sterile solution in a 1-mL glass 
syringe with a 27 gauge, 1/2 inch fixed needle assembled with a facilitated injection device
(referred to as the SelfDose device). Each single-use SelfDose device contains 100 mg/mL of 
guselkumab in 1 mL syringe volume. No preservatives are present. The guselkumab solution 
should be essentially free of visible particulate matter. SelfDose device is manually operated, 
disposable, and intended to deliver the contents of the PFS for SC injection. The SelfDose device 
incorporates a needle guard that automatically shields the needle after complete injection of the 
PFS contents. Guselkumab will be manufactured and provided under the responsibility of the 
sponsor. Refer to the Investigator’s Brochure for a list of excipients.
Placebo for guselkumab is supplied as a single-use sterile solution in a SelfDose device, as 
described above. Each single-use placebo SelfDose device contains a 1 mL syringe volume of 
placebo.
14.2.
Packaging
The study drug will be packaged in individual subject kits. The investigational supplies will be 
uniquely packaged to assure that they are appropriately managed throughout the supply chain 
process.
14.3.
Labeling
Study drug labels will contain information to meet the applicable regulatory requirements.
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14.4.
Handling, and Storage 
All study drug must be stored at controlled temperatures ranging from 36°F to 46°F (2°C to 8°C) 
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. Protection from light is not 
required during administration. 
Further details regarding the handling and storage of guselkumab and placebo will be provided in
the Site Investigational Product Procedures Manual.
14.5.
Drug Accountability
The investigator is responsible for ensuring that all study drug received at the site is inventoried 
and accounted for throughout the study. The dispensing of study drug to the subject must be 
documented on the drug accountability form. All study drugs will be stored and disposed of 
according to the sponsor’s instructions. Study-site personnel must not combine contents of the
study drug containers.
Study drug 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 
environmental conditions. Unused study drug 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 
drug, or used returned study drug for destruction, will be documented on the drug return form. 
When the study site is an authorized destruction unit and study drug 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. The immediate destruction of these drug supplies
should be documented in the drug accountability records on site.
Study drug 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 drug will be supplied only 
to subjects participating in the study. Returned study drug must not be dispensed again, even to 
the same subject. Study drug may not be relabeled or reassigned for use by other subjects. The 
investigator agrees neither to dispense the study drug from, nor store it at, any site other than the 
study sites agreed upon with the sponsor.
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15.
STUDY-SPECIFIC MATERIALS
The investigator will be provided with the following supplies:

Investigator Brochure for guselkumab

Site Investigational Product Procedures Manual

Laboratory Manual

Laboratory kits

Self-Dose practice device, associated instructions for use, and training materials

Interactive web response system manual

Electronic data capture (eDC) manual

Electronic tablet device and user manual 

Self-Injection Assessment Questionnaire

Electronic Columbia-Suicide Severity Rating Scale

Observer Injection Checklist

SelfDose Subject Questionnaire

Sample ICF

Recruitment materials as needed
16.
ETHICAL ASPECTS
16.1.
Study-Specific Design Considerations
Potential subjects will be fully informed of the risks and requirements of the study and, during the 
study, subjects 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 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 subjects who are fully able to understand the risks, benefits, and 
potential AEs of the study, and provide their consent voluntarily will be enrolled.
The total blood volume to be collected is considered to be an acceptable amount of blood to be 
collected over this time period from the population of this study based on the standard of the 
American Red Cross (1 pint/473 mL of blood for donation).
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16.2.
Regulatory Ethics Compliance
16.2.1.
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 subjects.
Compliance with this standard provides public assurance that the rights, safety, and well-being of 
study subjects are protected, consistent with the principles that originated in the Declaration of 
Helsinki, and that the study data are credible.
16.2.2.
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 subjects)

Investigator’s Brochure (or equivalent information) and amendments/addenda

Sponsor-approved subject recruiting materials

Information on compensation for study-related injuries or payment to subjects for
participation in the study, if applicable

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 subjects

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 subjects, data or study conduct, unless required locally), the ICF, applicable 
recruiting materials, and subject 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.
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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 subjects, data or study conduct)

Revision(s) to ICF and any other written materials to be provided to subjects

If applicable, new or revised subject recruiting materials approved by the sponsor

Revisions to compensation for study-related injuries or payment to subjects 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 AEs that are serious, unlisted/unexpected, and associated with the study drug

New information that may adversely affect the safety of the subjects or the conduct of the 
study

Deviations from or changes to the protocol to eliminate immediate hazards to the subjects

Report of deaths of subjects 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 subjects, 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.
At the end of the study, the investigator (or sponsor where required) will notify the IEC/IRB 
about the study completion.
16.2.3.
Informed Consent
Each subject 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) that are used must be approved by both the sponsor and by the 
reviewing IEC/IRB and be in a language that the subject 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 subjects the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort participation in the study may entail. 
Subjects 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 subject will receive for the treatment of his or her disease. Subjects 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 subject 
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 subject, to the extent permitted by the applicable law(s) or regulations. By 
signing the ICF the subject is authorizing such access, and agrees to allow his or her study 
physician to recontact the subject for the purpose of obtaining consent for additional safety 
evaluations, if needed and subsequent disease-related treatments or to obtain information about 
his or her survival status.
The subject 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 the subject’s personally dated signature. After having obtained the consent, a copy 
of the ICF must be given to the subject.
16.2.4.
Privacy of Personal Data
The collection and processing of personal data from subjects 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 subjects confidential.
The informed consent obtained from the subject includes 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. This consent also addresses the transfer of the data to other entities 
and to other countries.
The subject 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. 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.
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Exploratory PK and immunogenicity research is not conducted under standards appropriate for 
the return of data to subjects. 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 subjects 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.
16.2.5.
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 
psoriasis, to understand differential drug 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. 
Stored samples will be coded throughout the sample storage and analysis process and will not be 
labeled with personal identifiers. Subjects may withdraw their consent for their samples to be 
stored for research (refer to Section 10.3, Withdrawal From the Study, Withdrawal From the Use 
of Samples in Future Research).
16.2.6.
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 16.1, Study-Specific Design 
Considerations.
17.
ADMINISTRATIVE REQUIREMENTS
17.1.
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 subjects, 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) involves only logistic or administrative aspects of the study, the 
IEC/IRB (where required) only needs to be notified.
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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 eCRF and source documents will reflect any departure from the protocol, and the source 
documents will describe this departure and the circumstances requiring it.
17.2.
Regulatory Documentation
17.2.1.
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.
17.2.2.
Required Prestudy Documentation
The following documents must be provided to the sponsor before shipment of study drug to the 
study site:

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, subject 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
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The following documents must be provided to the sponsor before enrollment of the first subject:

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
17.3.
Subject Identification, Enrollment, and Screening Logs
The investigator agrees to complete a subject identification and enrollment log to permit easy 
identification of each subject during and after the study. This document will be reviewed by the 
sponsor study-site contact for completeness.
The subject identification and enrollment log will be treated as confidential and will be filed by 
the investigator in the study file. To ensure subject confidentiality, no copy will be made. All 
reports and communications relating to the study will identify subjects by subject identification
and date of birth. In cases where the subject is not randomized into the study, the date seen and 
date of birth will be used.
The investigator must also complete a subject screening log, which reports on all subjects who 
were seen to determine eligibility for inclusion in the study.
17.4.
Source Documentation
At a minimum, source documentation must be available for the following: subject 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 AEs 
and follow-up of AEs; concomitant medication; drug receipt/dispensing/return records; study 
drug administration information; and date of study completion and reason for early 
discontinuation of study drug 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 subject 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).
Investigator-completed efficacy evaluations (IGA, PASI), the Observer Injection Checklist, and 
the subject-completed eC-SSRS will be recorded directly into an electronic tablet device during
the visit at the study site. These data will be considered electronic source documentation.
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The minimum source documentation requirements for Section 4.1, Inclusion Criteria and 
Section 4.2, 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 subject interview or other protocol required assessment (eg, physical examination, 
laboratory assessment) and documented in the source documents.
17.5.
Case Report Form Completion
Case report forms are provided for each subject in electronic format.
Electronic data capture will be used for this study. The study data will be transcribed by 
study-site personnel from the source documents onto an electronic eCRF, and transmitted in a 
secure manner to the sponsor within the timeframe agreed upon between the sponsor and the 
study site. The electronic file will be considered to be the eCRF.
Worksheets may be used for the capture of some data to facilitate completion of the eCRF. Any 
such worksheets will become part of the subject’s source documentation. All data relating to the 
study, with the exception of the investigator-reported efficacy evaluations (IGA, PASI) and the 
Observer Injection Checklist that will be entered directly into an electronic tablet device as 
electronic source documentation, must be recorded in eCRFs prepared by the sponsor. Data must
be entered into eCRFs in English. Study site personnel must complete the eCRF as soon as 
possible after a subject visit, and the forms should be available for review at the next scheduled 
monitoring visit.
All subjective measurements (eg, pain scale information or other questionnaires) will be 
completed by the same individual who made the initial baseline determinations whenever 
possible. The investigator must verify that all data entries in the eCRFs are accurate and correct.
All eCRF entries, corrections, and alterations must be made by the investigator or other 
authorized study-site personnel. If necessary, queries will be generated in the eDC tool. The 
investigator or study-site personnel must adjust the eCRF (if applicable) and complete the query.
If corrections to an eCRF are needed after the initial entry into the eCRF, this can be done in 
3 different ways:

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).

Study site manager can generate a query for resolution by the study-site personnel.

Clinical data manager can generate a query for resolution by the study-site personnel.
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17.6.
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, direct 
transmission of clinical laboratory data from a central laboratory, and direct transmission of 
efficacy data, eC-SSR questionnaires, and the Observer Injection Checklist to the vendor
database and then to the sponsor’s database. Written instructions will be provided for collection, 
handling, storage, and shipment of samples. 
Guidelines for eCRF completion will be provided and reviewed with study-site personnel before 
the start of the study. 
The sponsor will review eCRFs 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. 
17.7.
Record Retention
In compliance with the ICH/GCP guidelines, the investigator/institution will maintain all eCRF 
and all source documents that support the data collected from each subject, 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.
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.
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.
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17.8.
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 data entered into the eCRF 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 eCRF 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.
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.
17.9.
Study Completion/Termination
17.9.1.
Study Completion/End of Study
The study is considered completed with the last visit for the last subject participating in the 
study. The final data from the study site will be sent to the sponsor (or designee) after completion 
of the final subject visit at that study site, in the time frame specified in the Clinical Trial 
Agreement.
17.9.2.
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.
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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 subjects by the investigator

Discontinuation of further study drug development
17.10. 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. Subject 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.
17.11. Use of Information and Publication
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 investigator and not 
previously published, and any data generated as a result of this study, are considered confidential 
and remain the sole property of the sponsor. The investigator agrees to maintain this information 
in confidence and use this information only to accomplish this study, and will not use it for other 
purposes without the sponsor’s prior written consent.
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.
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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. 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 subject 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 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 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 12 months of the availability of the final data (tables, 
listings, graphs), 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 Uniform Requirements for Manuscripts Submitted to 
Biomedical Journals, which state that the named authors must have made a significant 
contribution to the design of the study or analysis and interpretation of the data, provided critical 
review of the paper, and given final approval of the final version.
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.
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REFERENCES
1.
Bowes J, Orozco G, Flynn E, et al. Confirmation of TNIP1 and IL23A as susceptibility loci for psoriatic 
arthritis. Ann Rheum Dis. 2011;70(9):1641-1644.
2.
Chen Z, Tato CM, Muul L, Laurence A, O’Shea JJ. Distinct regulation of interleukin-17 in human T helper 
lymphocytes. Arthritis Rheum. 2007;56(9):2936-2946.
3.
Duerr RH, Taylor KD, Brant SR, et al. A genome-wide association study identifies IL23R as an inflammatory 
bowel disease gene. Science. 2006;314(5804):1461-1463.
4.
Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 
1978;157(4):238-244.
5.
Keininger D, Coteur G. Assessment of self-injection experience in patients with rheumatoid arthritis: 
psychometric validation of the Self-Injection Assessment Questionnaire (SIAQ). Health Qual Life Outcomes.
2011;9:2.
6.
Langrish CL, Chen Y, Blumenschein WM, et al. IL-23 drives a pathogenic T cell population that induces 
autoimmune inflammation. J Exp Med. 2005;201(2):233-240.
7.
Leonardi C, Langley RG, Papp K, et al. Adalimumab for treatment of moderate to severe chronic plaque 
psoriasis of the hands and feet: efficacy and safety results from REACH, a randomized, placebo-controlled, 
double-blind trial. Arch. Dermatol. 2011:147( 4) 429-436.
8.
Liu Y, Helms C, Liao W, et al. A genome-wide association study of psoriasis and psoriatic arthritis identifies
new disease loci. PLoS Genet. 2008;4(3):e1000041.
9.
Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 
2007;445(7130):866-873.
10.
Menter A, Tyring SK, Gordon K, et al. Adalimumab therapy for moderate to severe psoriasis: A randomized 
controlled phase III trial. J Am Acad Dermatol. 2008;58(1):106-115.
11.
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.
12.
Nair RP, Duffin KC, Helms C, et al. Genome-wide scan reveals association of psoriasis with IL-23 and NF κB 
pathways. Nat Genet. 2009;41(2):199-204.
13.
Oppmann B, Lesley R, Blom B, et al. Novel p19 protein engages IL-12p40 to form a cytokine, IL-23, with 
biological activities similar as well as distinct from IL-12. Immunity. 2000;13(5):715-725.
14.
O’Rielly DD, Rahman P. Genetics of susceptibility and treatment response in psoriatic arthritis. Nat Rev 
Rheumatol. 2011;7(12):718-732.
15.
Ouyang W, Kolls JK, Zheng Y. The biological functions of T helper 17 cell effector cytokines in 
inflammation. Immunity. 2008; 28(4):454-467.
16.
Papp KA, Langley RG, Lebwohl M, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 
monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, 
placebo-controlled trial (PHOENIX 2). Lancet. 2008;371:1675-1684.
17.
Paul C, Lacour J-P, Tedremets L, et al. Efficacy, safety and usability of secukinumab administration by 
autoinjector/pen in: a randomized, controlled trial (JUNCTURE). J European Acad Dermatol Venereol 
(JEADV) psoriasis. 2014; DOI: 10.1111/jdv.12751.
18.
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. 
19.
Saurat JH, Stingl G, Dubertret L, et al. CHAMPION Study Investigators. Efficacy and safety results from the 
randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with 
psoriasis (CHAMPION). Br J Dermatol. 2008;158(3):558-566.
20.
Tato CM, O’Shea JJ. Immunology: what does it mean to be just 17? Nature. 2006;441(7090):166-168.
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21.
Wilson NJ, Boniface K, Chan JR, et al. Development, cytokine profile and function of human interleukin 17 
producing helper T cells. Nat Immunol. 2007;8(9):950-957.
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ATTACHMENT 1:
QUANTIFERON®-TB GOLD TESTING
The QuantiFERON®-TB Gold test is one of the interferon-(IFN-) based blood assays for TB screening 
(Cellestis, 2009). It utilizes the recently identified M. tuberculosis-specific antigens ESAT-6 and CFP-10 
in the standard format, as well as TB7.7 (p4) in the In-Tube format, to detect in vitro cell-mediated 
immune responses in infected individuals. The QuantiFERON®-TB Gold assay measures the amount of 
IFN-produced by sensitized T-cells when stimulated with the synthetic M. tuberculosis-specific 
antigens. In M. tuberculosis-infected persons, sensitized T lymphocytes will secrete IFN-in response to 
stimulation with the M. tuberculosis-specific antigens and, thus, the QuantiFERON®-TB Gold test should 
be positive. Because the antigens used in the test are specific to M. tuberculosis and not found in BCG, 
the test is not confounded by BCG vaccination, unlike the tuberculin skin test. However, there is some 
cross-reactivity with the 3 Mycobacterium species, M. kansasii, M. marinum, and M. szulgai. Thus, a 
positive test could be the result of infection with one of these 3 species of Mycobacterium, in the absence 
of M. tuberculosis infection.
In a study of the QuantiFERON®-TB Gold test (standard format) in subjects with active TB, sensitivity 
has been shown to be approximately 89% (Mori et al, 2004). Specificity of the test in healthy 
BCG-vaccinated individuals has been demonstrated to be more than 98%. In contrast, the sensitivity and 
specificity of the tuberculin skin test was noted to be only about 66% and 35% in a study of Japanese 
patients with active TB and healthy BCG-vaccinated young adults, respectively. However, sensitivity and 
specificity of the tuberculin skin test depend on the population being studied, and the tuberculin skin test 
performs best in healthy young adults who have not been BCG-vaccinated.
Data from a limited number of published studies examining the performance of the QuantiFERON®-TB 
Gold assay in immunosuppressed populations suggest that the sensitivity of the QuantiFERON®-TB Gold 
test is better than the tuberculin skin test even in immunosuppressed patients (Ferrara et al, 2005; Kobashi 
et al, 2007; Matulis et al, 2008). The ability of IFN--based tests to detect latent infection has been more 
difficult to study due to the lack of a gold standard diagnostic test; however, several TB outbreak studies 
have demonstrated that the tests correlated better than the tuberculin skin test with the degree of exposure 
that contacts had to the index TB case (Brock et al, 2004; Ewer et al, 2003). In addition, TB contact 
tracing studies have shown that patients who had a positive QuantiFERON®-TB Gold test result and were 
not treated for latent TB infection were much more likely to develop active TB during longitudinal 
follow-up than those who had a positive tuberculin skin test and a negative QuantiFERON®-TB Gold test 
result (Higuchi et al, 2007; Diel et al, 2008).
Although the performance of the new IFN--based blood tests for active or latent M. tuberculosis
infection have not been well validated in the immunosuppressed population, experts believe these new 
tests will be at least as, if not more, sensitive, and definitely more specific, than the tuberculin skin test 
(Barnes, 2004; personal communication, April, 2008 TB Advisory Board).
Performing the QuantiFERON®-TB Gold Test
The QuantiFERON®-TB Gold test In-Tube format will be provided for this study. The In-Tube format 
contains 1 additional M. tuberculosis-specific antigen, TB7.7 (p4), which is thought to increase the 
specificity of the test.
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To perform the test using the In-Tube format, blood is drawn through standard venipuncture into supplied 
tubes that already contain the M. tuberculosis-specific antigens. Approximately 3 tubes will be needed per 
subject, each requiring 1 mL of blood. One tube contains the M. tuberculosis-specific antigens, while the 
remaining tubes contain positive and negative control reagents. Thorough mixing of the blood with the 
antigens is necessary prior to incubation. The blood is then incubated for 16 to 24 hours at 37C, after 
which tubes are centrifuged for approximately 15 minutes at 2000 to 3000 g. Following centrifugation, 
plasma is harvested from each tube, frozen, and shipped on dry ice to the central laboratory. The central 
laboratory will perform an ELISA to quantify the amount of IFN-present in the plasma using 
spectrophotometry and computer software analysis.
The central laboratory will analyze and report results for each subject, and sites will be informed of the 
results. Subjects who have an indeterminate result should have the test repeated.
Adherence to Local Guidelines
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, United States (US) guidelines must be followed.
References
Barnes PF. Diagnosing latent tuberculosis infection: Turning glitter to gold [editorial]. Amer J Respir Crit 
Care Med. 2004;170:5-6.
Brock I, Weldingh K, Lillebaek T, et al. Comparison of tuberculin skin test and new specific blood test in 
tuberculosis contacts. Am J Respir Crit Care Med. 2004;170:65-69.
Cellestis. QuantiFERON-TB Gold clinicians guide and QuantiFERON-TB Gold In-Tube Method package 
insert. Downloaded from www.cellestis.com, February 2009.
Diel R, Loddenkemper R, Meywald-Walter K, Niemann S, Nienhaus A. Predictive value of a whole 
blood IFN-assay for the development of active tuberculosis disease after recent infection with 
mycobacterium tuberculosis. Am J Respir Crit Care Med. 2008;177:1164-1170.
Ewer K, Deeks J, Alvarez L, et al. Comparison of T-cell-based assay with tuberculin skin test for 
diagnosis of Mycobacterium tuberculosis infection in a school tuberculosis outbreak. Lancet.
2003;361:1168-1173.
Ferrara G, Losi M, Meacci M, et al. Routine hospital use of a new commercial whole blood interferon-
assay for the diagnosis of tuberculosis infection. Am J Respir Crit Care Med. 2005; 172:631-635.
Higuchi K, Nobuyuki H, Mori T, Sekiya Y. Use of QuantiFERON-TB Gold to investigate tuberculosis 
contacts in a high school. Respirology. 2007;12:88-92.
Kobashi Y, Mouri K, Obase Y, et al. Clinical evaluation of QuantiFERON TB-2G test for 
immunocompromised patients. Eur Respir J. 2007; 30:945-950.
Matulis G, Jüni P, Villiger PM, Gadola SD. Detection of latent tuberculosis in immunosuppressed 
patients with autoimmune diseases: performance of a Mycobacterium tuberculosis antigen-specific 
interferon assay. Rheum Dis. 2008;67:84-90.
Mori T, Sakatani M, Yamagishi F, et al. Specific detection of tuberculosis infection: An interferon--
based assay using new antigens. Am J Respir Crit Care Med. 2004;170:59-64.
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ATTACHMENT 2:
HEPATITIS B VIRUS (HBV) SCREENING WITH HBV DNA 
TESTING
Subjects must undergo screening for hepatitis B virus (HBV). At a minimum, this includes testing for 
HBsAg (HBV surface antigen), anti-HBs (HBV surface antibody), and anti-HBc total (HBV core 
antibody total): 

Subjects who test negative for all HBV screening tests (ie, HBsAg-, anti-HBc-, and anti-HBs-) are 
eligible for this study.

Subjects who test negative for surface antigen (HBsAg-) and test positive for core antibody (anti-
HBc+) and surface antibody (anti-HBs+) are eligible for this study.

Subjects who test positive only for surface antibody (anti-HBs+) are eligible for this study.

Subjects who test positive for surface antigen (HBsAg+) are NOT eligible for this study, regardless 
of the results of other hepatitis B tests.

Subjects who test positive only for core antibody (anti-HBc+) must undergo further testing for the 
presence of hepatitis B virus deoxyribonucleic acid (HBV DNA test). If the HBV DNA test is 
positive, the subject is NOT eligible for this study. If the HBV DNA test is negative, the subject is 
eligible for this study. In the event the HBV DNA test cannot be performed, the subject is NOT 
eligible for this study. 
For subjects who are not eligible for this study due to HBV test results, consultation with a physician 
with expertise in the treatment of hepatitis B virus infection is recommended.
Eligibility based on hepatitis B virus test results
Hepatitis B test result
Action
Hepatitis B 
surface antigen
(HBsAg)
Hepatitis B 
surface antibody
(anti-HBs)
Hepatitis B core 
antibody
(anti-HBc total)
Include
—
—
—
—
+
—
—
+
+
Exclude
+
— or +
— or +
Require testing for presence 
HBV DNAa
—
—
+
a
If HBV DNA is detectable, exclude from the clinical study. If HBV DNA testing cannot be performed, 
or there is evidence of chronic liver disease, exclude from the clinical study. 
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ATTACHMENT 3:
INVESTIGATOR’S GLOBAL ASSESSMENT
Induration (I) (averaged over all lesions; use the National Psoriasis Foundation Reference card for 
measurement)
0 = no evidence of plaque elevation
1 = minimal plaque elevation, = 0.25 mm
2 = mild plaque elevation, = 0.5 mm
3 = moderate plaque elevation, = 0.75 mm
4 = severe plaque elevation, > 1 mm
Erythema (E) (averaged over all lesions)
0 = no evidence of erythema, hyperpigmentation may be present
1 = faint erythema
2 = light red coloration
3 = moderate red coloration
4 = bright red coloration
Scaling (S) (averaged over all lesions)
0 = no evidence of scaling
1 = minimal; occasional fine scale over less than 5% of the lesion
2 = mild; fine scale dominates
3 = moderate; coarse scale predominates
4 = severe; thick, scale predominates
Total Average = (I + E + S) / 3
Investigator’s Global Assessment based upon above Total Average
0 = Cleared, except for residual discoloration
1 = Minimal - majority of lesions have individual scores for I + E + S / 3 that averages 1
2 = Mild - majority of lesions have individual scores for I + E + S / 3 that averages 2
3 = Moderate - majority of lesions have individual scores for I + E + S / 3 that averages 3
4 = Severe - majority of lesions have individual scores for I + E + S / 3 that averages 4
Note: Scores should be rounded to the nearest whole number. If total ≤ 1.49, score = 1; if total ≥
1.50, score = 2.
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ATTACHMENT 4:
PSORIASIS AREA AND SEVERITY INDEX
The Psoriasis Area and Severity Index (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 body surface area, 
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) is: 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) Al
Where E = erythema, I = induration, S = scaling, and A = area
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ATTACHMENT 5:
OBSERVER INJECTION CHECKLIST
This form is intended to be completed to determine if the WEEK 0 dose was delivered successfully BY 
THE SUBJECT and should be completed by the study staff observing the injections. 
Subject Number _______________
Step 1: Remove Cap
Did subject successfully remove cap*? 
Yes
    No
If No, 
a.
did they understand that they needed to remove the cap?
Yes 
    No 
b.
were they physically able to remove the cap
Yes
    No
*Note: if the subject attempts to inject without removing the cap, and self-corrects their own action, this is 
not considered a failure and the response to this question should be YES. 
Step 2: Position Device on Injection Site
Did the subject select the correct injection site?
Yes
    No
Did the subject position the device at approximately a 90 degree angle on the injection site?
Yes
    No
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Step 3: Inject Complete Dose
Did the subject push the handle all the way down so the orange dose indicator disappeared completely?
Yes
    No
Note: check device to ensure orange dose indicator is not visible.
Were there any device-related problems associated with this injection? 
Yes
    No
If Yes, please follow procedures for reporting a product quality complaint (PQC).
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ATTACHMENT 6:
SELF-INJECTION ASSESSMENT QUESTIONNAIRE
SELF-INJECTION ASSESSMENT QUESTIONNAIRE (SIAQ)
- PRE-Self-Injection -
INTRODUCTION
The following questions ask about injections in general and your feelings about giving yourself an 
injection.
Thank you for completing this questionnaire by yourself, preferably in a quiet environment. Take as much 
time as you need to complete it. There are no right or wrong answers. Your answers will remain strictly 
confidential and anonymous.
Please answer each question below by checking the box that best represents your opinion 
(Check only one box per question).
1.
In general, how afraid are you of needles?
Not at all
A little
Moderately
Very
Extremely
2.
In general, how afraid are you of having an injection?
Not at all
A little
Moderately
Very
Extremely
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3.
How anxious do you feel about giving yourself an injection? 
Not at all
A little
Moderately
Very
Extremely
4.
How confident are you about giving yourself an injection in the right way?
Not at all
A little
Moderately
Very
Extremely
5.
How confident are you about giving yourself an injection in a clean and sterile way?
Not at all
A little
Moderately
Very
Extremely
6.
How confident are you about giving yourself an injection safely? 
Not at all
A little
Moderately
Very
Extremely
7.
Overall, how satisfied are you with your current way of taking your medication?
Very dissatisfied
Dissatisfied
Neither dissatisfied 
nor satisfied
Satisfied
Very satisfied
Thank you for completing this questionnaire
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SELF-INJECTION ASSESSMENT QUESTIONNAIRE (SIAQ)
- POST-Self-Injection -
INTRODUCTION
The following questions concern the self-injection of your medication and must be answered after giving 
yourself an injection.
Thank you for completing this questionnaire by yourself, preferably in a quiet environment. Take as much 
time as you need to complete it. There are no right or wrong answers. Your answers will remain strictly 
confidential and anonymous.
FEELINGS ABOUT INJECTIONS
The following questions concern your feelings about injections. 
Please answer each question below by checking the box that best represents your opinion 
(Check only one box per question).
In general, how afraid are you of needles?
Not at all
A little
Moderately
Very
Extremely
In general, how afraid are you of having an injection?
Not at all
A little
Moderately
Very
Extremely
How anxious do you feel about giving yourself an injection? 
Not at all
A little
Moderately
Very
Extremely
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SELF-IMAGE
The following question concerns your self-image. 
Please answer the question below by checking the box that best represents your opinion 
(Check only one box).
How embarrassed would you feel if someone saw you with the self-injection device?
Not at all
A little
Moderately
Very
Extremely
SELF-CONFIDENCE
The following questions concern your confidence about giving yourself an injection. 
Please answer each question below by checking the box that best represents your opinion 
(Check only one box per question).
How confident are you about giving yourself an injection in the right way?
Not at all
A little
Moderately
Very
Extremely
How confident are you about giving yourself an injection in a clean and sterile way?
Not at all
A little
Moderately
Very
Extremely
How confident are you about giving yourself an injection safely? 
Not at all
A little
Moderately
Very
Extremely
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PAIN AND SKIN REACTIONS DURING OR AFTER THE INJECTION
The following questions ask about pain and skin reactions you may have experienced during or after the 
injection. 
Please answer each question below by checking the box that best represents your opinion 
(Check only one box per question).
During and/or after the 
injection, how bothered 
were you by:
Not at all
A little
Moderately
Very
Extremely
a. pain?
b. burning sensation?
c. cold sensation?
During and/or after the 
injection, how bothered 
were you by:
Not at all
A little
Moderately
Very
Extremely
a. itching at the 
injection site?
b. redness at the injection 
site?
c. swelling at the injection 
site?
d. bruising at the injection 
site?
e. hardening at the 
injection site?
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Status: Approved, Date: 16 November 2016
EASE OF USE OF THE SELF-INJECTION DEVICE
The following questions ask about the ease of use of the self-injection device.
Please answer each question below by checking the box that best represents your opinion 
(Check only one box per question).
How difficult or easy 
was it to:
Very 
difficult
Difficult
Somewhat 
difficult
Somewhat 
easy
Easy
Very 
easy
remove the cap?
depress the plunger or 
button on the device?
administer the injection 
without any help?
use the self-injection 
device?
How does the device fit in your hand?
Very 
uncomfortably
Uncomfortably
Somewhat  
uncomfortably
Somewhat  
comfortably
Comfortably
Very 
comfortably
SATISFACTION WITH SELF-INJECTION
The following questions ask about your satisfaction with self-injection. 
Please answer each question below by checking the box that best represents your opinion 
(Check only one box per question).
How easy was it to give yourself an injection?
Not at all
A little
Moderately
Very
Extremely
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CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSO3006 Amendment 1
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Status: Approved, Date: 16 November 2016
How satisfied are you with how often you give yourself an injection?
Very dissatisfied
Dissatisfied
Neither dissatisfied 
nor satisfied
Satisfied
Very satisfied
How satisfied are you with the time it takes to inject the medication?
Very dissatisfied
Dissatisfied
Neither dissatisfied 
nor satisfied
Satisfied
Very satisfied
Overall, how satisfied are you with your current way of taking your medication (self-injection)?
Very dissatisfied
Dissatisfied
Neither dissatisfied 
nor satisfied
Satisfied
Very satisfied
Overall, how convenient is the self-injection device?
Very
inconvenient
Inconvenient
Neither inconvenient 
nor convenient
Convenient
Very convenient
After this study, would you choose to continue self-injecting your medication?
Definitely not
Probably not
I don’t know
Yes, probably
Yes, definitely
After this study, how confident would you be to give yourself injections at home? 
Not at all
A little
Moderately
Very
Extremely
Thank you for completing this questionnaire
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ATTACHMENT 7:
SELFDOSE SUBJECT QUESTIONNAIRE
SelfDose Subject Questionnaire 
The following questions ask about your feelings when using the SelfDose device in this study.
Please answer each question below by checking the box that best represents your opinion (Check only one 
box per question).
1.
I liked being able to inject the medication at a speed that was comfortable for me. 
Strongly disagree
Disagree
Neither agree or 
disagree
Agree
Strongly agree
2.
The design of the SelfDose handle made the device easy to use.
Strongly disagree
Disagree
Neither agree or 
disagree
Agree
Strongly agree
3.
I was able to easily tell when the SelfDose injection was finished.
Strongly disagree
Disagree
Neither agree or 
disagree
Agree
Strongly agree
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Status: Approved, Date: 16 November 2016
ATTACHMENT 8:
ANTICIPATED EVENTS
Anticipated Event
An anticipated event is an adverse event (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.
Reporting of Anticipated Events
These events will be captured on the electronic case report form (eCRF) and in the database, and will be 
reported to the sponsor as described in Section 12.3.1, All Adverse Events. Any event that meets serious 
adverse event (SAE) criteria will be reported to the sponsor within the appropriate timeline as described 
in Section 12.3.2, Serious Adverse Events. 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 drug, 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 drug.
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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INVESTIGATOR AGREEMENT
NCT02905331

SAP_001.pdf: 
1
Approved, Date: 17 May 2017
Janssen Research & Development *
Statistical Analysis Plan
A Phase 3, Multicenter, Randomized, Double-blind Placebo-controlled Study Evaluating 
the Efficacy and Safety of CNTO 1959 (Guselkumab) Delivered via a SelfDose™ Device in 
the Treatment of Subjects with Moderate to Severe Plaque-Type Psoriasis
Protocol CNTO1959PSO3006; Phase 3
CNTO 1959  (Guselkumab)
Status:
Approved
Date:
17 May 2017
Prepared by:
Janssen Research & Development, LLC
Document No.: EDMS-ERI-137921864
Compliance: The study described in this report was performed according to the principles of Good Clinical Practice (GCP). 
Confidentiality Statement
The information in this document contains trade secrets and commercial information that are privileged or confidential and 
may not be disclosed unless such disclosure is required by applicable law or regulations. In any event, persons to whom the 
information is disclosed must be informed that the information is privileged or confidential and may not be further disclosed 
by them. These restrictions on disclosure will apply equally to all future information supplied to you that is indicated as 
privileged or confidential.
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CNTO 1959  (Guselkumab)
Statistical Analysis Plan CNTO1959PSO3006
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Approved, Date: 17 May 2017
TABLE OF CONTENTS
TABLE OF CONTENTS ............................................................................................................................... 2
LIST OF TABLES ......................................................................................................................................... 4
ABBREVIATIONS ........................................................................................................................................ 5
1.
INTRODUCTION.................................................................................................................................. 6
1.1.
Trial Objectives ................................................................................................................................ 6
1.2.
Trial Design ...................................................................................................................................... 6
1.3.
Statistical Hypotheses for Trial Objectives....................................................................................... 7
1.4.
Sample Size Justification ................................................................................................................. 8
1.5.
Randomization and Blinding ............................................................................................................ 9
1.5.1.
Procedures for Randomization and Stratification ......................................................................... 9
1.5.2.
Blinding ......................................................................................................................................... 9
2.
GENERAL ANALYSIS DEFINITIONS .............................................................................................. 10
2.1.
Imputation Rules for Partial or Missing AE Dates.......................................................................... 10
2.2.
Visit Windows................................................................................................................................. 10
2.3.
Analysis Sets.................................................................................................................................. 11
2.3.1.
Efficacy Analysis Set .................................................................................................................. 11
2.3.2.
Safety Analysis Set..................................................................................................................... 11
2.3.3.
Pharmacokinetics Analysis Set .................................................................................................. 11
2.3.4.
Immunogenicity Analysis Set...................................................................................................... 11
2.4.
Definition of Subgroups.................................................................................................................. 11
2.5.
Statistical Methods......................................................................................................................... 12
2.5.1.
Study Day ................................................................................................................................... 12
2.5.2.
Baseline ...................................................................................................................................... 13
3.
INTERIM ANALYSIS AND DATA MONITORING COMMITTEE REVIEW....................................... 13
4.
SUBJECT INFORMATION................................................................................................................ 13
4.1.
Demographics and Baseline Characteristics ................................................................................. 13
4.1.1.
Demographics............................................................................................................................. 13
4.1.2.
Baseline Characteristics ............................................................................................................. 14
4.2.
Disposition Information................................................................................................................... 14
4.3.
Treatment Compliance................................................................................................................... 14
4.4.
Extent of Exposure......................................................................................................................... 14
4.5.
Protocol Deviations ........................................................................................................................ 15
4.6.
Prior and Concomitant Medications ............................................................................................... 15
5.
EFFICACY ......................................................................................................................................... 15
5.1.
Analysis Specifications................................................................................................................... 16
5.1.1.
Level of Significance................................................................................................................... 16
5.1.1.1.
Multiplicity Adjustment for Testing Procedures ....................................................................... 16
5.1.2.
Definition of the Efficacy Endpoints and Calculation of the Efficacy Instruments ...................... 16
5.1.2.1.
Investigator’s Global Assessment ........................................................................................... 16
5.1.2.2.
Psoriasis Area and Severity Index .......................................................................................... 17
5.1.3.
Data Handling Rules................................................................................................................... 17
5.1.3.1.
Treatment Failure Criteria........................................................................................................ 17
5.1.3.2.
Treatment Failure Rules .......................................................................................................... 18
5.1.3.3.
Missing Data Imputation.......................................................................................................... 18
5.2.
Primary Efficacy Endpoint(s).......................................................................................................... 18
5.2.1.
Definition..................................................................................................................................... 18
5.2.2.
Estimand..................................................................................................................................... 19
5.2.3.
Analysis Methods........................................................................................................................ 19
5.2.4.
Data Handling ............................................................................................................................. 19
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5.2.5.
Sensitivity Analysis ..................................................................................................................... 19
5.2.6.
Subgroup Analysis...................................................................................................................... 20
5.3.
Major Secondary Endpoints........................................................................................................... 20
5.3.1.
Definition..................................................................................................................................... 20
5.3.2.
Analysis Methods........................................................................................................................ 20
5.3.3.
Data Handling ............................................................................................................................. 20
5.4.
Other Efficacy Variable(s) .............................................................................................................. 21
5.4.1.
Definition..................................................................................................................................... 21
5.4.2.
Analysis Methods........................................................................................................................ 21
5.4.2.1.
Analyses Related to IGA ......................................................................................................... 21
5.4.2.2.
Analyses Related to PASI ....................................................................................................... 22
5.4.3.
Data Handling ............................................................................................................................. 22
6.
USABILITY AND ACCEPTABILITY ASSESSMENTS..................................................................... 22
6.1.
Definition ........................................................................................................................................ 22
6.1.1.
Successful, Problem-Free Injections .......................................................................................... 22
6.1.2.
Self-Injection Assessment Questionnaire................................................................................... 23
6.2.
Analysis Methods ........................................................................................................................... 24
6.2.1.
Analyses Related to the Device Usability................................................................................... 24
6.2.2.
Analyses Related to Acceptability Assessments........................................................................ 24
6.2.2.1.
Analyses for Self-Injection Assessment Questionnaire........................................................... 24
6.2.2.2.
Analyses for SelfDose Subject Questionnaire......................................................................... 25
7.
SAFETY............................................................................................................................................. 25
7.1.
Adverse Events .............................................................................................................................. 26
7.2.
Clinical Laboratory Tests................................................................................................................ 27
7.3.
Vital Signs ...................................................................................................................................... 27
7.4.
Other Safety Parameters ............................................................................................................... 27
7.4.1.
Suicidal Ideation and Behavior ................................................................................................... 27
8.
PHARMACOKINETICS/PHARMACODYNAMICS ........................................................................... 29
8.1.
Pharmacokinetics........................................................................................................................... 29
8.2.
Immune Response......................................................................................................................... 30
REFERENCES............................................................................................................................................ 31
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LIST OF TABLES
Table 1:
Power to Detect a Treatment Effect Based on Different Proportions of Subjects 
Achieving the Co-primary Endpoints .......................................................................................... 8
Table 2:
Demographic Variables............................................................................................................. 13
Table 3:
The calculation of SIAQ scores are as follows: ........................................................................ 24
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ABBREVIATIONS
AE
adverse event
ANCOVA
analysis of covariance
CI
confidence interval
CRF
case report form
CSR
Clinical Study Report
DBL
database lock
DC
Discontinuation
ECG
Electrocardiogram
eCRF
electronic case report form
eC-SSRS
Electronic Columbia-Suicide Severity Rating Scale
FDA
Food and Drug Administration
IGA
Investigator’s Global Assessment
IgG1λ
immunoglobulin G1 lambda
IWRS
interactive web response system
mAb
monoclonal antibody
MedDRA
Medical Dictionary for Regulatory Activities
NAbs
neutralizing antibodies
PASI
Psoriasis Area and Severity Index
PD
Pharmacodynamic
PK
pharmacokinetic(s)
PQCs
product quality complaints
SAE
serious adverse event
SAP
Statistical Analysis Plan
SD
standard deviation
SIAQ
Self-Injection Assessment Questionnaire
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Statistical Analysis Plan CNTO1959PSO3006
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1.
INTRODUCTION
This statistical analysis plan (SAP) contains definitions of analysis sets, derived variables, and 
statistical methods for the analyses of efficacy, safety and pharmacokinetics for the guselkumab 
(CNTO
1959) clinical study CNTO1959PSO3006. Guselkumab is a fully human 
immunoglobulin G1 lambda (IgG1λ) monoclonal antibody (mAb) that inhibits the biological 
activity of IL-23 and therefore has the potential for the treatment of psoriasis.
1.1.
Trial Objectives
Primary Objectives
The primary objectives are:

To evaluate the efficacy of guselkumab delivered using the SelfDose device for the 
treatment of subjects with moderate to severe plaque-type psoriasis.

To assess the safety and tolerability of guselkumab delivered using the SelfDose device in 
subjects with moderate to severe plaque-type psoriasis.
Secondary Objectives
The secondary objectives are:

To assess the PK and immunogenicity of guselkumab following SC administration using the 
SelfDose device in subjects with moderate to severe plaque-type psoriasis.

To assess usability and acceptability of the SelfDose device.
1.2.
Trial Design
This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled study evaluating the 
efficacy, safety, PK, immunogenicity, usability, and acceptability of guselkumab delivered using 
the SelfDose device in subjects with moderate to severe plaque-type psoriasis. The target 
population is adult men or women, with a diagnosis of plaque-type psoriasis (with or without
PsA) for at least 6 months before the first administration of study drug. Subjects must have 
moderate to severe plaque-type psoriasis defined by PASI ≥12, IGA ≥3, and involved body 
surface area (BSA) ≥10%. Subjects must be candidates for either systemic therapy or 
phototherapy for psoriasis, and may have previously received some systemic therapies (Protocol 
Inclusion Criteria, Exclusion Criteria) or phototherapy for psoriasis. Subjects with nonplaque 
forms of psoriasis (eg, erythrodermic, guttate, or pustular) or with drug-induced psoriasis (eg, a 
new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel 
blockers, or lithium) are excluded. Subjects who have ever received guselkumab are also 
excluded.
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Statistical Analysis Plan CNTO1959PSO3006
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Approximately 75 subjects who satisfy all inclusion and exclusion criteria will be randomized in 
a 4:1 ratio to 1 of 2 arms:

Group I (n=60): guselkumab 100 mg at Weeks 0, 4, 12, 20, and 28; placebo at Week 16 to 
maintain the study blind.

Group II (n=15): placebo at Weeks 0, 4, and 12; cross over to guselkumab 100 mg at 
Weeks 16, 20, and 28.
Week 28 is the last dosing visit; subjects will be followed for an additional 12 weeks and have a 
final safety visit at Week 40. The end of the study is defined as the time when last subject 
completes the Week 40 visit.
There are 2 database locks (DBLs) in this study, 1 at Week 20, and 1 at Week 40. 
A diagram of the study design is provided below.
Schematic Overview of the Guselkumab SelfDose Device Study
1.3.
Statistical Hypotheses for Trial Objectives
Primary Hypotheses:
The primary hypotheses are that guselkumab treatment delivered using the SelfDose device is 
superior to placebo as demonstrated by 1) the proportion of subjects achieving an IGA score of 
cleared (0) or minimal (1) at Week 16; and 2) the proportion of subjects achieving a PASI 90 
response at Week 16.
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Major secondary hypotheses:

Guselkumab treatment delivered using the SelfDose is superior to placebo as assessed by the 
proportion of subjects achieving an IGA score of cleared (0) at Week 16. 

Guselkumab treatment delivered using the SelfDose is superior to placebo as assessed by the 
proportion of subjects achieving a PASI 100 response at Week 16.
1.4.
Sample Size Justification
This study is designed to evaluate the efficacy of guselkumab vs placebo using the SelfDose 
device.
The assumptions for the sample size and power calculations are based on the data from the 
guselkumab CNTO1959PSO2001 study:

The proportion of placebo subjects who achieved a PGA score of cleared (0) or minimal (1) 
and a PASI 90 response was 10% and 5%, respectively. Note PGA was used in 
CNTO1959PSO2001. PGA is a similar measure to IGA which will be used in this study.

The proportion of subjects who achieved a PGA score of cleared (0) or minimal (1) response 
at Week 16 was 86% in the guselkumab 100 mg group.

The proportion of subjects who achieved a PASI 90 response at Week 16 was 62% in the 
guselkumab 100 mg group.
As shown in the table below, based on the above assumptions, with a total of approximately 
75 subjects randomized in a 4:1 ratio to guselkumab 100 mg (n=60) and placebo (n=15), there 
will be at least 99% power to detect differences for both co-primary endpoints in the proportion 
of subjects achieving an IGA score of cleared (0) or minimal (1) and the proportion of subjects 
who achieve a PASI 90 response between the placebo and guselkumab groups at Week 16, at a 
significance level of 0.05. This sample size was also chosen to provide adequate power for major 
secondary endpoints.
Table 1:
Power to Detect a Treatment Effect Based on Different Proportions of Subjects Achieving the 
Co-primary Endpoints
Co-primary Endpoints
Power
IGA cleared (0) or minimal (1) response at Week 16 
Placebo 
(n=15)
Guselkumab 100 mg q8w 
(n=60) 
10%
70%
>99%
75%
>99%
80%
>99%
PASI 90 response at Week 16
Placebo 
(n=15)
Guselkumab 100 mg q8w 
(n=60)
5%
55%
99%
60%
>99%
65%
>99%
IGA=Investigator’s Global Assessment; PASI=Psoriasis Area and Severity Index; q8w=every 8 weeks.
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1.5.
Randomization and Blinding
1.5.1.
Procedures for Randomization and Stratification
Central randomization will be implemented in this study. At Week 0, subjects will be randomly 
assigned to 1 of 2 treatment groups based on a computer-generated randomization schedule 
prepared under the supervision of the sponsor. Permuted block randomization with stratification 
by country will be used. The interactive web response system (IWRS) will assign a unique 
treatment code, which will dictate the treatment assignment and matching study drug kit for the 
subject. The requestor must use his or her own user identification and personal identification 
number when contacting the IWRS, and will then give the relevant subject details to uniquely 
identify the subject.
1.5.2.
Blinding
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 subject.
Data that may potentially unblind the treatment assignment (eg, study drug serum concentrations, 
antibodies to study drug, 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 DBL and unblinding.
Under normal circumstances, the blind should not be broken to subjects, investigators, or site 
monitors until the Week 40 database is locked and finalized. Otherwise, the blind should be 
broken only if specific emergency treatment/course of action would be dictated by knowing the
treatment status of the subject. In such cases, the investigator may in an emergency determine the 
identity of the treatment by contacting 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 of unblinding must be documented by the IWRS, in the appropriate section of 
the electronic case report form (eCRF), and in the source document; the reason for unblinding 
must be documented in the appropriate section of the eCRF and in the source document. The 
documentation received from the IWRS indicating the code break must be retained with the 
subject’s source documents in a secure manner.
Subjects who have had their treatment assignment unblinded should continue to return for 
scheduled evaluations. The decision to continue or discontinue study treatment for these subjects 
will be based upon consultation of the investigator with the medical monitor.
There are 2 DBLs in this study, 1 at Week 20, and 1 at Week 40. The sponsor, with exception of 
sponsor site monitors noted below, will be unblinded after the last subject has completed the 
Week 20 visit and the Week 20 DBL has occurred. The investigators, subjects, and sponsor site 
monitors will be unblinded after the last subject has completed the Week 40 visit, and the 
Week 40 DBL has occurred.
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Statistical Analysis Plan CNTO1959PSO3006
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2.
GENERAL ANALYSIS DEFINITIONS
This analysis plan provides the general analysis definitions and describes the planned subject
information, efficacy, safety, pharmacokinetics, and antibody analyses for the two planned
DBLs.
2.1.
Imputation Rules for Partial or Missing AE Dates
Partial AE onset dates will be imputed as follows:

If the onset date of an adverse event is missing day only, it will be set to:

First day of the month that the AE occurred, if month/year of the onset of AE is 
different than the month/year of the study agent start

The day of study agent start, if the month/year of the onset of AE is the same as 
month/year of the study agent start date and month/year of the AE resolution date is 
different

The day of study agent start or day of AE resolution date, whichever is the earliest, 
if month/year of the onset of AE and month/year of the study agent start date and 
month/year of the AE resolution date are same

If the onset date of an adverse event is missing both day and month, it will be set to the 
earliest of:

January 1 of the year of onset, as long as this date is on or after the study agent start 
date

Month and day of the study agent start date, if this date is in the same year that the 
AE occurred

Last day of the year if the year of the AE onset is prior to the year of the study 
agent start date, 

The AE resolution date.
Completely missing onset dates will not be imputed.
Partial AE resolution dates not marked as ongoing will be imputed as follows:

If the resolution date of an adverse event is missing day only, it will be set to the earliest 
of the last day of the month of occurrence of resolution or the day of the date of death, if 
the death occurred in that month.

If the resolution date of an adverse event is missing both day and month, it will be set to 
the earliest of December 31 of the year or the day and month of the date of death, if the 
death occurred in that year.
Completely missing resolution dates will not be imputed.
2.2.
Visit Windows
Nominal visits will be used for all by-visit analyses in the study unless otherwise specified, 
regardless of the scheduled visit window. The study visits scheduled should occur at the times 
delineated in the Time and Events Schedule of the protocol. All visits through Week 32 should 
occur within ±7 days of the scheduled visit. If a study visit occurs outside this window, the 
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CNTO 1959  (Guselkumab)
Statistical Analysis Plan CNTO1959PSO3006
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sponsor should be consulted about how the subject should resume his/her normal dosing 
schedule relative to the baseline visit (Week 0). The Week 40 study visit should occur within 
+14 days of the scheduled visit.
2.3.
Analysis Sets
2.3.1.
Efficacy Analysis Set
For the efficacy analyses in this study, the full analysis set (FAS) will be used according to 
subjects’ assigned treatment to which they were randomized, regardless of the treatment they 
actually received. The FAS includes all randomized subjects who received at least 1 injection of 
study agent. The full analysis set will be used for all primary and secondary efficacy analyses.
For subjects randomized to placebo, only subjects who crossed over to receive guselkumab at 
Week 16 will be included in the efficacy summaries for the visits after Week 16.
2.3.2.
Safety Analysis Set
In contrast to the efficacy analysis set, safety analyses will be performed on the safety analysis 
set, which is defined as all randomized and treated subjects who received at least 1 injection of 
study agent (partial or complete) according to the actual treatment received during the study 
irrespective of the treatment assigned at randomization.  
2.3.3.
Pharmacokinetics Analysis Set
The PK analysis set is defined as subjects who received at least one injection of guselkumab and 
have at least one valid blood sample drawn for PK analysis.
2.3.4.
Immunogenicity Analysis Set
The immunogenicity analysis set is defined as all subjects who received at least one injection of 
guselkumab and have appropriate samples for anti-guselkumab antibody detection.
In both PK and immunogenicity analyses, subjects will be analyzed according to the treatment 
they actually received, regardless of the treatments they are randomized to.
2.4.
Definition of Subgroups
To evaluate the consistency of efficacy based on demographic characteristics, baseline disease 
characteristics, and psoriasis medication history, subgroup analyses will be performed for the co-
primary endpoints. The subgroups for subgroup analyses include the following:
Baseline demographics:

Sex (male, female)

Race 
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
Baseline Age (<45 years, 45 to <65 years, 65 years)

Baseline weight (≤90 kg, >90 kg) 

BMI (Normal [<25], Overweight [25 -<30], Obese [≥30])
Baseline disease characteristics:

Age at diagnosis (years) (<25, ≥25)

Psoriasis disease duration (years) (<15, ≥15)

Baseline PASI (<20, ≥20)

Baseline IGA (<4, =4)

Baseline BSA (<20%, ≥20%)

Psoriatic arthritis (Yes, No)
Psoriasis medication history:

Phototherapy (ultraviolet B light [UVB] or psoralen and ultraviolet A light therapy [PUVA]) 

Never used

Ever used

Non-biologic systemics (PUVA, MTX, cyclosporine, acitretin, apremilast, or tofacitinib)

Never used

Ever Used

Biologics
(etanercept, infliximab, alefecept, efalizumab, ustekinumab, briakinumab,
secukinumab, ixekizumab, brodalumab, or adalimumab)

Never used

Ever Used

Non-biologic systemics or biologics (as defined above)

Never used

Ever used
2.5.
Statistical Methods
2.5.1.
Study Day
Study Day 1 refers to the first study agent administration date. The study day for an event is 
defined as:

Event date - (date of Study Day 1) +1, if event date is ≥ date of Day 1

Event date - date of Day 1, if event date < date of Day 1 
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2.5.2.
Baseline
In general, the baseline measurement is defined as the closest measurement taken prior to or at 
the time of the first study agent administration date unless otherwise specified.
3.
INTERIM ANALYSIS AND DATA MONITORING COMMITTEE REVIEW
No formal interim analysis is planned for this study. No data monitoring committee is 
commissioned for this study.
4.
SUBJECT INFORMATION
The full analysis set and the safety analysis set will be used for the subject information analyses
unless otherwise noted. The number of subjects in each analysis set will be summarized by 
treatment group and overall. In addition, the distribution of subjects by country, and site will be 
presented. 
Simple descriptive statistics, such as mean, median, standard deviation, interquartile range, 
maximum, and minimum for continuous variables, and counts and percentages for discrete 
variables will be used to summarize most data and no formal statistical analyses for comparisons
of subject information between treatment groups will be performed. In addition, subject listings 
will also be used to present the data.
4.1.
Demographics and Baseline Characteristics
4.1.1.
Demographics
Table 2 presents a list of the demographic variables that will be summarized by treatment group, 
and overall for the full analysis set.  
Table 2:
Demographic Variables
Continuous Variables:
Summary Type
Age (years)
Descriptive statistics (N, mean, 
standard deviation [SD], median 
and range [minimum and 
maximum], and IQ range).
Weight (kg)
Height (cm)
Categorical Variables:
Age (<45 years, 45 to <65 years, and ≥65 years)  
Frequency distribution with the 
number and percentage of 
subjects in each category.
Sex (male, female)
Racea (American Indian or Alaska Native, Asian, Black or African 
American, Native Hawaiian or other Pacific Islander, White, Other, 
Multiple)
Ethnicity (Hispanic or Latino, not Hispanic or Latino)
BMI (Normal [<25], Overweight [25 -<30], Obese [≥30])
aIf multiple race categories are indicated, then Race is recorded as “Multiple.”
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4.1.2.
Baseline Characteristics
Psoriasis baseline disease characteristics (i.e., psoriasis disease duration [years], age at diagnosis 
[years], BSA [%], psoriatic arthritis, baseline IGA score, and baseline PASI score [0-72]) will be 
summarized by treatment group for the full analysis set.
4.2.
Disposition Information
Screened subjects will be summarized overall.
The number of subjects in the following disposition categories will be summarized by treatment 
group and overall:

Subjects randomized 

Subjects who received study agent

Subjects who completed the study

Subjects who discontinued study agent 

Reasons for discontinuation of study agent 

Subjects who terminated study prematurely

Reasons for termination of study
The above categories will include summaries over the period of Week 16, Week 20 and 
Week 40.
Listings of subjects will be provided for the following categories:

Subjects who discontinued study agent

Subjects who terminated study prematurely

Subjects who were unblinded during the study period 

Subjects who were randomized yet did not receive study agent
4.3.
Treatment Compliance
Study agent compliance will be summarized descriptively through Week 20 and Week 28 for the 
full analysis set. Number of subjects by randomized treatment versus actual treatment will be 
presented in a summary table.
4.4.
Extent of Exposure
The exposure data will be summarized through Week 20 and through Week 28. The number and 
percentage of subjects who receive study agent will be summarized by treatment group for the 
safety analysis set.  Descriptive statistics will be presented for the following parameters:

Number of injections

Cumulative total dose 
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In addition, the study agent lots received by treatment, including matching placebo for active 
treatment will be summarized.
4.5.
Protocol Deviations
In general, the following list of major protocol deviations may have the potential to impact 
subjects’ rights, safety or well-being, or the integrity and/or results of the clinical trial. Subjects
with major protocol deviations will be identified prior to database lock and will be summarized 
by category by treatment group through Week 20 and through Week 40 for the full analysis set.

Entered but did not satisfy criteria

Developed withdrawal criteria but not withdrawn

Received a disallowed concomitant treatment

Received a wrong treatment or an incorrect dose

Other
Subjects with major protocol deviations will also be listed by randomized treatment group.
4.6.
Prior and Concomitant Medications
Subjects’ prior psoriasis medication history with topical agents, phototherapy, non-biologic 
systemic therapies, and biologic medications will be summarized by treatment group. See 
Section 2.4 for lists of medications in each category. In addition, reasons for which subjects 
discontinued previous systemic therapies (contraindication, inadequate response, intolerance [ie, 
AEs], or other) will be summarized by randomized treatment group.
The number of subjects who received concomitant treatment with a moisturizer for psoriasis will 
be summarized by randomized treatment group.
Subjects who received concomitant corticosteroids for indications other than psoriasis and/or 
psoriatic arthritis will be listed. Subjects with concomitant prophylactic treatments for latent TB 
infection will also be listed.
5.
EFFICACY
In general, efficacy data summaries will be provided by treatment group for the full analysis set. 
The Fisher’s exact test will be used to compare the proportion of subjects responding to 
treatment if appropriate. Continuous response parameters (i.e. % improvement in PASI) will be 
compared using Wilcoxon rank-sum test. All statistical testing will be performed 2-sided.
Descriptive statistics, such as mean, median, standard deviation, minimum and maximum,
interquartile range for continuous variables, and counts and percentages for categorical variables 
will be used to summarize the data. Graphical data displays and subject listings may also be used 
to summarize the data.
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5.1.
Analysis Specifications
5.1.1.
Level of Significance
All statistical procedures to test superiority hypotheses will be performed at a 2-sided 
significance level of 0.05. This study is designed to maintain an overall Type I error of 0.05 or 
less for the primary analysis and major secondary analyses. Nominal p-values will be reported 
for other secondary analyses.
5.1.1.1.
Multiplicity Adjustment for Testing Procedures
There are 2 co-primary endpoints in this study: 

The proportion of subjects who achieve an IGA score of cleared (0) or minimal (1) at 
Week 16 

The proportion of subjects who achieve a PASI 90 response at Week 16
Both of the co-primary endpoint analyses will be compared between the guselkumab treatment 
group and the placebo group and tested at a 2-sided α-level of 0.05. 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, there are 2 major secondary endpoints in this study to be compared between the 
guselkumab 100 mg group and the placebo group:

The proportion of subjects who achieve an IGA score of cleared (0) at Week 16.

The proportion of subjects who achieve a PASI 100 response at Week 16.
The analyses of the major secondary endpoints will be performed only if both primary analyses 
are significant, and will be performed in the fixed sequence testing approach1, as specified
above.  If a given comparison is not significant at the 2-sided α-level of 0.05 for superiority 
hypotheses, the remaining treatment group comparisons in this sequence will be considered not 
significant and will be considered as supportive analyses.
5.1.2.
Definition of the Efficacy Endpoints and Calculation of the Efficacy 
Instruments
5.1.2.1.
Investigator’s Global Assessment 
The Investigator’s Global Assessment (IGA) documents the investigator’s assessment of the 
subject’s psoriasis at a given time point. Overall lesions are graded for induration, erythema, and 
scaling. The patient’s psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or 
severe (4).
Efficacy endpoints related to the IGA score are defined below:
IGA cleared responder 
Subjects who achieve an IGA score of cleared (0) will be considered IGA cleared responders.
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IGA cleared or minimal responder
Subjects who achieve an IGA score of cleared (0) or minimal (1) will be considered IGA cleared 
or minimal responders.
IGA mild or better responder
Subjects who achieve an IGA score of cleared (0), minimal (1), or mild (2) will be considered 
IGA mild or better responders.
5.1.2.2.
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. 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%-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 can range from 0 (no 
psoriasis) to 72. A higher score indicates more severe disease.
Efficacy endpoints related to the PASI score are defined below:
PASI 50 Responder
Subjects with ≥50% improvement in PASI from baseline will be considered PASI 50 responders.
PASI 75 Responder
Subjects with ≥75% improvement in PASI from baseline will be considered PASI 75 responders.
PASI 90 Responder
Subjects with ≥90% improvement in PASI from baseline will be considered PASI 90 responders.
PASI 100 Responder
Subjects with 100% improvement in PASI from baseline (PASI score=0) will be considered 
PASI 100 responders.
5.1.3.
Data Handling Rules
The following treatment failure rules and data handling rules will be applied to the PASI and 
IGA-related efficacy analyses in this study. 
5.1.3.1.
Treatment Failure Criteria
Subjects who discontinue study agent due to lack of efficacy, an adverse event (AE) of
worsening of psoriasis, or who started a protocol-prohibited medication/therapy during the study
that could affect their psoriasis are considered as treatment failures.
The particular protocol-prohibited medications/therapies include:
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Topical Therapies:

Any topical therapies used for psoriasis (with the exception of topical moisturizers and 
shampoos containing tar or salicylic acid only)
Phototherapy or Systemic Therapies:

Any systemic corticosteroid used for psoriatic arthritis or psoriasis with the exception of 
intra-articular corticosteroids.

Any other anti-psoriatic systemic therapy or biologic therapy.

Phototherapy of UVB or PUVA.

Any other phototherapy for psoriasis.
5.1.3.2.
Treatment Failure Rules
A subject who meets one or more treatment failure criterion specified in Section 5.1.3.1 will be 
considered a treatment failure from that point onward. The baseline values will be used for all 
directly measured endpoints regardless of the actual measurements. Zero will be assigned to 
improvement and percent improvement, and non-responder status will be assigned to binary 
response variables. 
Treatment failure is assumed to have occurred at the earlier of the following dates:  

Date of discontinuation (DC) of study treatment due to lack of efficacy or 

Date of discontinuation of study agent due to an AE of worsening of psoriasis or 

Start date of a protocol-prohibited medication/therapy during the study that could improve 
psoriasis
5.1.3.3.
Missing Data Imputation
After the treatment failure rules are applied, the remaining missing data will be handled as 
follows for all of the efficacy analyses including the analyses at the key visit (Week 16) and over
time:

Non-responder imputation will be applied for binary endpoints.

No imputation will be performed for continuous endpoints and the values will remain as 
missing. 
5.2.
Primary Efficacy Endpoint(s)
5.2.1.
Definition
There are 2 co-primary endpoints in this study: the proportion of subjects who achieve an IGA 
score of cleared (0) or minimal (1) at Week 16 and the proportion of subjects who achieve a 
PASI 90 response at Week 16. Refer to Section 5.1.2.1 and 5.1.2.2 for the definition of IGA 
score and PASI 90 responder.
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5.2.2.
Estimand
Population: subjects with moderate-to-severe plaque psoriasis who are randomized and treated 
with guselkumab or placebo using the SelfDose device.
Endpoint: the proportion of subjects who achieve an IGA score of cleared (0) or minimal (1) at 
Week 16 and the proportion of subjects who achieve a PASI 90 response at Week 16
Measure of Intervention: the effect of the initially randomized treatment regardless of what 
treatments are actually received. Non-responder status will be assigned if treatment failure 
criteria are met or data are missing.
5.2.3.
Analysis Methods
These 2 co-primary endpoints will be compared between the guselkumab 100 mg group and the 
placebo group. In these primary efficacy analyses, data from all randomized and treated subjects 
will be analyzed according to their assigned treatment group. The number and proportion of 
subjects who achieve an IGA score of cleared (0) or minimal (1) and PASI 90 response at 
Week 16 will be summarized for each treatment group respectively. The differences in 
proportions with exact 95% confidence intervals will also be presented.
To address the primary objective, a 2-sided (α=0.05) Fisher’s exact test will be used for the co-
primary endpoints.
The study will be considered positive if the guselkumab 100 mg group is significantly different 
from the placebo group for both co-primary endpoints. Both co-primary endpoints will be tested 
at a 2-sided α-level of 0.05. If one of the comparisons is not significant, the co-primary endpoints 
will be considered not significant.
5.2.4.
Data Handling
Subjects who meet treatment failure criteria specified in Section 5.1.3.1 prior to Week 16 will be 
considered not to have achieved an IGA score of cleared (0) or minimal (1) or PASI 90 at 
Week 16. In addition, subjects with a missing IGA or PASI score at Week 16 or who do not 
return for evaluation at Week 16 will be considered not to have achieved the respective endpoint 
at Week 16.
5.2.5.
Sensitivity Analysis
To assess the robustness of the co-primary endpoint analysis results, two sensitivity analyses will 
be conducted in the same manner as the co-primary endpoints. The missing data will be handled
as specified below.
Sensitivity Analysis 1
For subjects who do not return for evaluation at Week 16, the missing IGA or PASI score at 
Week 16 will not be imputed.  That is, the analysis will be performed using observed data after 
applying treatment failure rules (as defined in Section 5.1.3.2).
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Sensitivity Analysis 2
The second sensitivity analysis will be performed by using multiple imputations (MI). In this 
analysis, for subjects who meet one or more treatment failure criterion specified in 
Section 5.1.3.1, the IGA and PASI score will be treated as missing from that point onward. The 
missing IGA or PASI score will be imputed using the Markov Chain Monte Carlo (MCMC) 
algorithm which assumes that all the variables in the imputation model have a joint multivariate 
normal distribution. The IGA or PASI responses will then be derived based on the imputed score 
at Week 16.
5.2.6.
Subgroup Analysis
For each of the subgroups defined in Section 2.4, the proportion of subjects achieving IGA score 
of cleared (0) or minimal (1) and the proportion of PASI 90 responders at Week 16 by treatment 
group will be summarized. Differences in the proportion and the associated exact 95% 
confidence interval (CI) for the differences will be provided.
In addition, the proportion of subjects achieving IGA score of cleared (0) or minimal (1) and the 
proportion of PASI 90 responders at Week 16 by country and investigator site will be 
summarized.
5.3.
Major Secondary Endpoints
The analyses for the major secondary endpoints will be performed in the order listed in 
Section 5.1.1.1.
The sections below outline the major secondary analyses to be performed, as well as the analysis 
methods and the data imputation rules.
5.3.1.
Definition
There are 2 major secondary endpoints in this study to be compared between the guselkumab 
100 mg group and the placebo group:

The proportion of subjects who achieve an IGA score of cleared (0) at Week 16.

The proportion of subjects who achieve a PASI 100 response at Week 16.
5.3.2.
Analysis Methods
For the major secondary analyses, the Fisher’s exact test will be used to compare the proportion 
of subjects responding to treatment. The differences in proportions with exact 95% confidence 
intervals will be presented. All statistical testing will be performed 2-sided (α=0.05).
5.3.3.
Data Handling
Data handling rules specified in Section 5.2.4 will be applied to the major secondary analyses.
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5.4.
Other Efficacy Variable(s)
Other secondary efficacy endpoints include the endpoints related to 

PASI 

IGA 
The analyses of other secondary efficacy analyses outlined in the following sections in general 
will be carried out for 2 periods 

Analyses through Week 20:

Analyses at key endpoints: Week 16

Over time summaries: Through Week 20

Analyses through Week 40
5.4.1.
Definition
Refer to Section 5.1.2 for the definitions of the other efficacy endpoints described in the 
following section.
5.4.2.
Analysis Methods
Most of the other secondary efficacy analyses described in this section below will be based on
the full analysis set. For subjects randomized to placebo, only subjects who crossed over to 
receive guselkumab 100 mg at Week 16 will be included in the efficacy summaries for the visits 
after Week 16. All statistical testing will be performed at the 2-sided 0.05 significance level. 
Nominal p-values will be presented. 
5.4.2.1.
Analyses Related to IGA

The proportion of subjects who achieve an IGA score of mild or better (≤2) at Week 16 will 
be compared between the guselkumab 100 mg groups and the placebo group using Fisher’s 
exact test. The difference in proportions with exact 95% confidence interval will be 
presented.

The proportions of subjects achieve an IGA score of cleared (0); an IGA score of cleared (0) 
or minimal (1); and an IGA score of mild or better (≤2) will be summarized over time 
through Week 20 and through Week 40 by treatment group. Line plots will be provided 
displaying the proportions and exact 95% CIs of subjects achieve an IGA score of cleared 
(0); and an IGA score of cleared (0) or minimal (1) through Week 20 and Week 40.

The proportions of subjects achieving an IGA score of cleared (0); an IGA score of cleared 
(0) or minimal (1); and an IGA score of mild or better (≤2) will also be summarized over
time through Week 20 and through Week 40 by treatment group using observed data after 
applying treatment failure rules.
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5.4.2.2.
Analyses Related to PASI

The proportion of subjects who achieve a PASI 75 response and a PASI 50 response at 
Week 16 will be compared between the guselkumab 100 mg groups and the placebo group
using Fisher’s exact test. The differences in proportions with exact 95% confidence intervals 
will be presented.

The percent improvement from baseline in PASI score at Week 16 will be compared 
between the guselkumab 100 mg groups and the placebo group using Wilcoxon rank-sum 
test.

The proportions of PASI 100 responders, PASI 90 responders, PASI 75 responders, and 
PASI 50 responders, and the percent improvement from baseline in PASI will be 
summarized over time through Week 20 and through Week 40 by treatment group. Line 
plots will be provided displaying proportions and exact 95% CIs of PASI 100 responders 
and PASI 90 responders through Week 20 and Week 40.

The proportions of PASI 100 responders, PASI 90 responders, PASI 75 responders, and 
PASI 50 responders, and the percent improvement from baseline in PASI will be 
summarized over time through Week 20 and through Week 40 by treatment group using 
observed data after applying treatment failure rules.

The proportion of subjects who achieve 100% improvement, ≥90%, ≥75%, or ≥50% 
improvement from baseline in PASI component (induration, erythema, and scaling) and 
region component (head, trunk, upper extremities, and lower extremities) will be 
summarized at Week 16 by treatment group. 
5.4.3.
Data Handling
Data handling rules specified in Section 5.2.4 will be applied to all IGA related and PASI related 
analyses. 
6.
USABILITY AND ACCEPTABILITY ASSESSMENTS
6.1.
Definition 
6.1.1.
Successful, Problem-Free Injections
Successful, problem-free self-injection (usability) using the SelfDose device will be assessed by 
the completion of the Observer Injection Checklist at Week 0. Study-site personnel will observe 
the subject to confirm successful completion of the 3 steps, as described in the instructions for 
use, required to effectively and safely use the device to deliver the correct dose: (1) remove the 
cap, (2) position device on the injection site, and (3) inject complete dose. A successful, 
problem-free self-injection is defined as below:
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Observer Injection Checklist
Required 
completion for 
successful, 
problem-free
injection
(1) Remove cap: Did subject successfully remove cap 
Yes
(2) Position device on injection site: Did the subject select the correct injection 
site?
Yes
(2) Position device on injection site: Did the subject position the device at 
approximately a 90 degree angle on the injection site
Yes
(3) Inject complete dose: Did the subject push the handle all the way down so the 
orange dose indicator disappeared completely?
Yes
(3) Inject complete dose: Were there any device-related problems associated with 
this injection?
No
6.1.2.
Self-Injection Assessment Questionnaire
Subjects will be asked to rate the acceptability of their experience using the SelfDose device with 
the SIAQ which was developed and validated in patients with rheumatoid arthritis (RA). A paper 
version of the SIAQ will be used in this study.
The SIAQ includes 6 domains: feelings about injections, self-image, self-confidence, pain and 
skin reactions during or after the injection, ease of use of the self-injection device, and 
satisfaction with self-injection. Each domain is derived from one or multiple items. The subject 
rates each item of the SIAQ on a 5-6 point semantic Likert-type scale. 
The PRE-self-injection module of the SIAQ includes items assessing domains of feelings about 
injections, self-confidence, and satisfaction with self-injection, while the POST-self-injection 
module of the SIAQ includes items assessing all 6 domains. In this study, the subject 
will complete the PRE-self-injection module before the first self-injection at Week 0, 
and will complete the POST-self-injection module after self-injection at Weeks 0, 4, 12, and 28.
Scoring
Respondent rates items 1-9 of the PRE SIAQ and 15-21 of the POST SIAQ on a 5-point 
semantic Likert-type scale, and items 10-14 of the POST SIAQ on a 6-point semantic Likert-type 
scale. For all items, a score of 1 corresponds to the subject’s worst experience and a score of 5 or 
6 corresponds to the subject’s best experience.
The scoring of domains is performed in 2 steps (Table 3):

The raw item scores ranging from 1 to 5 (or 1 to 6) are transformed into scores ranging 
from 0 (worse experience) to 10 (best experience).

The transformed scores for items contributing to a domain are then averaged into a 
domain score. Domain scores are calculated only if at least half of the domain items are 
completed. Domain scores from the PRE module are summarized only with the 
corresponding domain scores from the POST modules.
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Table 3:
The calculation of SIAQ scores are as follows:
Items
Transformed item 
score
Domain score 
calculation
Domain score range
PRE module domain
Feeling about self-
injection
1–3
(raw score-1) x 2.5
Average of 
transformed item 
scores
0–10
Self-confidence
4–6
(raw score-1) x 2.5
Satisfaction with 
self-injection
7
(raw score-1) x 2.5
POST module domain
Feeling about self-
injection
1–3
(raw score-1) x 2.5
Average of 
transformed item 
scores
0–10
Self-image
4
(raw score-1) x 2.5
Self-confidence
5–7
(raw score-1) x 2.5
Pain and reaction 
during or after the 
injection
8–9
(raw score-1) x 2.5
Ease of use of the 
self-injection 
device
10–14
(raw score-1) x 2
Satisfaction with 
self-injection
15–21
(raw score-1) x 2.5
6.2.
Analysis Methods
The analyses of device usability and acceptability assessments will be performed through 
Week 20 and through Week 28 by treatment group for the safety analysis set. 
Other than the data handling rules specified in Section 6.1, the analyses for usability and 
acceptability will be based on observed data without missing data imputation or other data 
handling rules.
6.2.1.
Analyses Related to the Device Usability

The proportion of subjects with successful, problem-free injections (assessment of usability) 
at Week 0 will be summarized by treatment group and overall.

The proportion of subjects who had full delivery of the dose confirmed by inspection of the 
device at Weeks 4 and 12 will be summarized by treatment group and overall. 

A listing of product quality complaints (PQCs) for Selfdose device will be provided.
6.2.2.
Analyses Related to Acceptability Assessments
6.2.2.1.
Analyses for Self-Injection Assessment Questionnaire

Self-Injection Assessment Questionnaire (SIAQ) domain scores on the 3 domains with items 
common to the SIAQ PRE- (Week 0) and POST- (Week 0 and Week 12) self-injection 
modules will be summarized by treatment group and overall at Week 0 and Week 12.
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
Self-Injection Assessment Questionnaire POST-self-injection domain scores and change 
from baseline scores for each domain will be summarized by treatment group and overall at 
Weeks 0, 4, 12, and 28.
6.2.2.2.
Analyses for SelfDose Subject Questionnaire

Ratings for the SelfDose Subject Questionnaire will be summarized at Week 12 by question, 
by treatment group and overall.
7.
SAFETY
Safety will be assessed by summarizing the incidence and type of AEs and examining changes in 
laboratory parameters (hematology and chemistry), vital signs, and suicidal ideation and 
behavior.
In all the safety analysis, subjects who were randomized and received at least 1 (partial or 
complete) dose of study agent administration will be included and analyzed according to the 
treatment they actually received, regardless of the treatment assigned at randomization. No 
formal statistical comparison is planned.
Depending on the safety data categories, the cumulative safety data will be analyzed through 
different study periods which include but are not limited to through Week 16 and through the 
whole study period as appropriate.  Unless otherwise specified, tabular summaries of safety 
events for key study periods are in general presented as follows:
Summaries through Week 16 (placebo-controlled period): 
Safety data through Week 16 will be summarized by treatment groups:

Placebo   

Guselkumab
This allows between-group comparisons of safety between the guselkumab group and the 
placebo group based on similar follow-up period in each group.
Summaries through Week 20 or through Week 40
Safety data through Week 20 and through Week 40 will be summarized by treatment group 
defined as follows:
1.
Placebo → Guselkumab 100 mg: all subjects who were randomized to placebo at Week 0,
started treatment with placebo only, and later crossed over to receive treatment with 
guselkumab.  Only the safety events/measurements from these subjects that occurred on or
after their first administration of guselkumab 100 mg will be included in this group.
2.
Guselkumab 100 mg: all subjects who were randomized to guselkumab 100 mg at Week 0 
and received study agent with guselkumab 100 mg. All the safety events/measurements from 
these subjects that occurred beginning at Week 0 will be included in this group.
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3.
Combined Guselkumab 100 mg: all subjects as described above in the Placebo → 
Guselkumab 100 mg and the Guselkumab 100 mg groups.
7.1.
Adverse Events
The verbatim terms used in the CRF by investigators to identify adverse events will be coded 
using the Medical Dictionary for Regulatory Activities (MedDRA). Any AE occurring at or after 
the initial administration of study agent through the end of the trial is considered to be treatment 
emergent. If the event occurs on the day of the initial administration of study agent, and either 
event time or time of administration are missing, then the event will be assumed to be treatment 
emergent. If the event date is recorded as partial or completely missing, then the event will be 
considered to be treatment emergent unless it is known to be prior to the first administration of 
study agent based on partial onset date or resolution date. All reported treatment-emergent 
adverse events will be included in the analysis.  For each adverse event, the number and 
percentage of subjects who experience at least 1 occurrence of the given event will be 
summarized by treatment group. 
Summary tables will be provided for:

AEs

Serious AEs (SAEs)

AEs leading to discontinuation of study agent 

AEs by severity

AEs by relationship to study agent

Infections

Serious infections

Infections treated with oral or parenteral antimicrobial treatment 

Injection-site reactions

AEs of psoriasis
In addition to the summary tables, listings will be provided for subjects who:

Had SAEs

Had AEs leading to discontinuation of study agent 

AEs of severe intensity

Serum sickness-like reactions and anaphylactic reactions
In addition, a listing will be provided of all AEs that occurred after Week 16 for subjects who 
were randomized to placebo at Week 0 and were not crossed over to receive guselkumab.
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Any unfavorable or unintended sign that occurs at the injection site is an injection site reaction
and will be recorded as an injection site reaction by the investigator on the eCRF. An infection is 
defined as any AE that was recorded as an infection by the investigator on the eCRF. 
The treatment-emergent adverse events of psoriasis include any event of erythrodermic psoriasis, 
pustular psoriasis, guttate psoriasis, inverse psoriasis, palmo-plantar psoriasis and worsening or 
exacerbation of psoriasis. Frequency of these events will be summarized.
Since safety should be assessed relative to exposure and follow-up, most AE summary tables 
will include average weeks of follow-up and average number of study agent administrations for 
each treatment group.
7.2.
Clinical Laboratory Tests
All clinical laboratory reports will be displayed for the subjects included in the safety analysis 
set. The clinical laboratory parameters to be evaluated by the central laboratory include but are 
not limited to:

Hematology: hemoglobin, hematocrit, lymphocytes, neutrophils, platelets, red blood cell 
(RBC) count and white blood cell (WBC) count.

Chemistry: 
albumin, 
alkaline 
phosphatase, 
alanine 
aminotransferase, 
aspartate 
aminotransferase, total carbon dioxide (CO2), total bilirubin, blood urea nitrogen/urea, 
calcium, chloride, creatinine, glucose, potassium, total protein, sodium.
Box plots of laboratory measurements and change from baseline will be provided for selected
laboratory analytes. 
Applicable laboratory results will be graded according to National Cancer Institute’s Common 
Terminology Criteria for Adverse Events (NCI-CTCAE version 4.03). The worst NCI-CTCAE
will be summarized by treatment group. 
For nonfasting glucose, the screening measurement will be used as the baseline measurement. A 
listing of subjects with 1 or more NCI-CTCAE toxicity grade ≥2 abnormalities in hematology 
and clinical chemistry laboratory measurements will be provided.
7.3.
Vital Signs 
Vital signs variables including respiratory rate, blood pressure (systolic and diastolic) will be 
measured at visits as per the time and events schedule in the protocol. Descriptive statistics of the 
observed value and change from baseline of the vital signs will be summarized by treatment 
group.
7.4.
Other Safety Parameters
7.4.1.
Suicidal Ideation and Behavior
The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) will be used as a screening 
tool to prospectively evaluate the potential of guselkumab to induce suicidal ideation and 
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behavior. The eC-SSRS defines five subtypes of suicidal ideation and behavior in addition to 
self-injurious behavior with no suicidal intent, and is a fully-structured subject self-report 
questionnaire, including standardized questions, follow-up prompts, error handling routines, and 
scoring conventions. The Screening version of the eC-SSRS will be conducted at Screening
followed by the Since Last Visit version of the eC-SSRS at all other visits through Week 40.
The eC-SSRS will be performed during each evaluation visit according to the assessment 
schedule. The eC-SSRS will be performed at screening after signing informed consent, after the 
pre-SIAQ at Week 0, and before study agent administration, and as the first assessment for all 
post-baseline visits. The baseline is defined as the most severe/maximum eC-SSRS score at 
screening and Week 0.
In addition, potential suicide related adverse events including suicidal ideation, suicidal behavior
excluding completed suicide, and completed suicide will be identified by the investigators and 
collected in the eCRF. 
The following are eC-SSRS categories and have binary responses (yes/no). A “yes” response to 
any eC-SSRS category will be assigned a score as below:
Suicidal Ideation (1-5)
1 = Wish to be Dead
2 = Non-specific Active Suicidal Thoughts
3 = Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
4 = Active Suicidal Ideation with Some Intent to Act, without Specific Plan
5 = Active Suicidal Ideation with Specific Plan and Intent
Suicidal Behavior (6-10)
6 = Preparatory Acts or Behavior
7 = Aborted Attempt
8 = Interrupted Attempt
9 = Actual Attempt (non-fatal)
10 = Completed Suicide
If no events qualify for a score of 1 to 10, a score of 0 will be assigned (0=“Negative result [no 
suicidal ideation or behavior]”). Higher scores indicate greater severity.
The summary for suicidal ideation and behavior will be based on the safety analysis set. Suicidal 
ideation and behavior will be summarized based on the most severe/maximum post baseline eC-
SSRS outcome or AE of suicidal ideation, suicidal behavior excluding completed suicide or 
completed suicide through Week 16, Week 20, and Week 40 will be provided. In addition, 
frequency distribution of the most severe/maximum post baseline eC-SSRS outcome will be 
tabulated by treatment group through the same 3 time periods. 
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The maximum score assigned for each subject will also be summarized into one of three broad 
categories: No suicidal ideation or behavior, suicidal ideation, suicidal behavior. A shift table for 
change in categories of no suicidal ideation or behavior, suicidal ideation, and suicidal behavior
from baseline through Week 16 will be presented, where the baseline category is based on eC-
SSRS score and the post baseline is based on eC-SSRS or AE data.
8.
PHARMACOKINETICS/PHARMACODYNAMICS
8.1.
Pharmacokinetics
Blood samples for measuring serum guselkumab concentrations (pre-injection if it is an injection 
visit) will be collected from all subjects at scheduled visits as indicated in the time and events 
schedule in the protocol.  
The PK analysis will be based on subjects who received at least 1 administration of guselkumab 
and had at least one evaluable PK blood sample. No imputation of missing concentration data 
will be performed, that is, data summaries will be based on the observed data.
All concentrations below the lowest quantifiable concentration in a sample or missing data will 
be labeled as such in the concentration data listings or Statistical Analysis Softwaredataset. 
Concentrations below the lowest quantifiable concentration in a sample will be treated as zero in 
the summary statistics. All subjects and samples excluded from the analysis will be clearly 
documented.
For analysis of serum guselkumab concentrations, descriptive statistics, including arithmetic 
mean, SD, median, interquartile range, minimum, and maximum will be calculated, where 
appropriate, by treatment group at each sampling time point. Serum guselkumab concentrations 
by baseline weight (90kg, >90 kg) will also be summarized by treatment group overtime. The 
PK concentration data may be displayed graphically.  
All summaries for serum guselkumab concentration will exclude data collected after subjects (1) 
did not receive a scheduled guselkumab administration within ± 14 days of the protocol 
scheduled dosing date, or those subjects who discontinued study agent, (2) received a partial, 
incorrect, or an additional guselkumab administration, (3) or have invalid sample data if the 
sample is taken after study agent administration or a concentration value falls outside the 
predefined range (±10*SD). Of note, serum guselkumab concentrations prior to the first of such 
events will be included in the summaries. 
If needed, a population PK analysis using a nonlinear mixed-effects modeling approach will be 
used to characterize the disposition characteristics of guselkumab in the current study. Data may 
be combined with those from pivotal Phase 3 studies (CNTO1959PSO3001 and 
CNTO1959PSO3002) to support a relevant structural model. Details will be given in a 
population PK analysis plan and results of the population PK analysis will be presented in a 
separate technical report.
The effect of serum guselkumab concentrations on efficacy may be explored.
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8.2.
Immune Response
Blood samples will be collected for the detection of antibodies to guselkumab at the specified 
visits as shown in the time and event schedule in the protocol. 
The antibodies to guselkumab analysis will be based on subjects who receive at least 1 dose of 
guselkumab and have appropriate serum samples for antibody detection. No imputation of 
missing data will be performed, that is, data summaries will be based on the observed data.
The following analyses will be performed by treatment group as appropriate:

Summary of antibodies to guselkumab status (incidence of positive antibodies to 
guselkumab and antibody titers)

List of subjects who are positive for antibodies to guselkumab
In addition, the incidence of neutralizing antibodies (NAbs) to guselkumab will be summarized
for subjects who are positive for antibodies to guselkumab and have samples evaluable for 
NAbs.
The effect of antibodies to guselkumab on PK, efficacy, and safety may be explored.
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REFERENCES
1.
Maurer, W., Hothorn, L. A., Lehnacher, W. Multiple comparisons in drug clinical trials and preclinical assays: 
a prior ordered hypotheses. Biometrie in der Chemisch-in-Pharmazeutischen Industrie. 1995, 3-18
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