A Phase 2b Multicenter, Randomized, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis
Phase: PHASE2
Conditions: Plaque Psoriasis
Sponsor: Janssen Research & Development, LLC

CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
1
Status: Approved,  Date:  12 January 2022
Janssen Research & Development *
Clinical Protocol
Protocol Title
A Phase 2b Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Evaluate the
Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis
FRONTIER 1
Short Title
A Dose-Ranging Study of the Efficacy and Safety of JNJ-77242113
in Participants with Moderate-to-Severe Plaque Psoriasis
Protocol 77242113PSO2001; Phase 2b
JNJ-77242113 Amendment 2
*Janssen Research & Development is a global organization that operates through different legal entities in
various countries. Therefore, the legal entity acting as the sponsor for Janssen Research & Development
studies may vary, such as, but not limited to Janssen Biotech, Inc.; Janssen Products, LP; Janssen
Biologics, BV; Janssen-Cilag International NV; Janssen, Inc; Janssen Pharmaceutica NV; Janssen
Sciences Ireland UC; Janssen Biopharma Inc.; 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
United States (US)sites of this study will be conducted under US Food & Drug Administration
Investigational New Drug (IND) regulations (21 CFR Part 312).
Regulatory Agency Identifier Number(s):
IND: 156446
EudraCT NUMBER:   2021-003700-41
Status: 
Approved
Date: 
12 January 2022
Prepared by: Janssen Research & Development, LLC
EDMS number: 
EDMS-RIM-428455, 3.0
GCP Compliance: This study will be conducted in compliance with Good Clinical Practice, and applicable regulatory
requirements.
Confidentiality Statement
The information provided herein contains Company trade secrets, commercial or financial information that the Company
customarily holds close and treats as confidential.  The information is being provided under the assurance that the recipient
will maintain the confidentiality of the information under applicable statutes, regulations, rules, protective orders or
otherwise.
NCT05223868

JNJ-77242113 
Clinical Protocol 77242113PSO2001 Amendment 2
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
2
Status: Approved,  Date:  12 January 2022
TABLE OF CONTENTS
TABLE OF CONTENTS............................................................................................................................... 2
LIST OF IN-TEXT TABLES AND FIGURES................................................................................................ 5
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE ............................................................... 7
1.
PROTOCOL SUMMARY:.................................................................................................................... 9
1.1. 
Synopsis........................................................................................................................................... 9
1.2. 
Schema.......................................................................................................................................... 19
1.3. 
Schedule of Activities (SoA)........................................................................................................... 20
2.
INTRODUCTION................................................................................................................................ 26
2.1. 
Study Rationale.............................................................................................................................. 26
2.2. 
Background .................................................................................................................................... 27
2.3. 
Benefit-Risk Assessment............................................................................................................... 31
2.3.1. 
Risks for Study Participation....................................................................................................... 31
2.3.2. 
Benefits for Study Participation .................................................................................................. 33
2.3.3. 
Benefit-Risk Assessment for Study Participation ....................................................................... 33
3.
OBJECTIVES AND ENDPOINTS..................................................................................................... 33
4.
STUDY DESIGN ................................................................................................................................ 36
4.1. 
Overall Design................................................................................................................................ 36
4.2. 
Scientific Rationale for Study Design............................................................................................. 37
4.2.1. 
Study-Specific Ethical Design Considerations ........................................................................... 38
4.3. 
Justification for Dose...................................................................................................................... 38
4.4. 
End of Study Definition................................................................................................................... 39
5.
STUDY POPULATION ...................................................................................................................... 39
5.1. 
Inclusion Criteria............................................................................................................................ 40
5.2. 
Exclusion Criteria........................................................................................................................... 42
5.3. 
Lifestyle Considerations................................................................................................................. 48
5.4. 
Screen Failures.............................................................................................................................. 49
6.
STUDY INTERVENTION AND CONCOMITANT THERAPY............................................................ 49
6.1. 
Study Interventions Administered .................................................................................................. 50
6.2. 
Preparation/Handling/Storage/Accountability ................................................................................ 52
6.3. 
Measures to Minimize Bias: Randomization and Blinding............................................................. 53
6.4. 
Study Intervention Compliance...................................................................................................... 54
6.5. 
Dose Modification........................................................................................................................... 54
6.6. 
Continued Access to Study Intervention After the End of the Study ............................................. 54
6.7. 
Treatment of Overdose .................................................................................................................. 54
6.8. 
Concomitant Therapy..................................................................................................................... 55
6.8.1. 
Vaccinations (including COVID-19)............................................................................................ 56
7.
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL............................................................................................... 56
7.1. 
Discontinuation of Study Intervention ............................................................................................ 56
7.2. 
Participant Discontinuation/Withdrawal From the Study................................................................ 58
7.2.1. 
Withdrawal From the Use of Research Samples ....................................................................... 59
7.3. 
Lost to Follow-up............................................................................................................................ 59
8.
STUDY ASSESSMENTS AND PROCEDURES............................................................................... 60
8.1. 
Efficacy Assessments .................................................................................................................... 61
8.1.1. 
Psoriasis Area and Severity Index (PASI).................................................................................. 62
8.1.2. 
Body Surface Area (BSA)........................................................................................................... 62
8.1.3. 
Investigator’s Global Assessment (IGA)..................................................................................... 62

JNJ-77242113 
Clinical Protocol 77242113PSO2001 Amendment 2
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
3
Status: Approved,  Date:  12 January 2022
8.1.4. 
Nail Psoriasis Area and Severity Index (NAPSI)........................................................................ 62
8.1.5. 
Fingernail Physician’s Global Assessment (f-PGA) ................................................................... 62
8.1.6. 
Static Physician’s Global Assessment of Genitalia (s-PGA-G).................................................. 62
8.1.7. 
Physician's Global Assessment of Hands and/or Feet (hf-PGA) ............................................... 63
8.1.8. 
Scalp Specific Investigator Global Assessment (ss-IGA)........................................................... 63
8.1.9. 
Psoriasis Symptom and Sign Diary (PSSD)............................................................................... 63
8.1.10. 
Dermatological Life Quality Index (DLQI)................................................................................... 63
8.1.11. 
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29).................... 63
8.1.12. 
Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ)............................................ 63
8.1.13. 
Patient Global Impression- Severity (PGI-S) and Change (PGI-C)............................................ 64
8.1.14. 
Treatment Satisfaction Questionnaire for Medications (TSQM-9 domains)............................... 64
8.1.15. 
Photographs ............................................................................................................................... 64
8.2. 
Safety Assessments....................................................................................................................... 64
8.2.1. 
Physical Examinations................................................................................................................ 65
8.2.2. 
Vital Signs................................................................................................................................... 65
8.2.3. 
Electrocardiograms..................................................................................................................... 65
8.2.4. 
Clinical Safety Laboratory Assessments .................................................................................... 65
8.2.5. 
Concomitant Medication ............................................................................................................. 65
8.2.6. 
Pregnancy Testing...................................................................................................................... 65
8.2.7. 
Columbia-Suicide Severity Rating Scale (C-SSRS)................................................................... 66
8.2.8. 
Tuberculosis Evaluation(s) ......................................................................................................... 67
8.3. 
Adverse Events, Serious Adverse Events, and Other Safety Reporting ....................................... 68
8.3.1. 
Time Period and Frequency for Collecting Adverse Event and Serious Adverse Event
Information.................................................................................................................................. 69
8.3.2. 
Method of Detecting Adverse Events and Serious Adverse Events .......................................... 69
8.3.3. 
Follow-up of Adverse Events and Serious Adverse Events ....................................................... 69
8.3.4. 
Regulatory Reporting Requirements for Serious Adverse Events ............................................. 70
8.3.5. 
Pregnancy................................................................................................................................... 70
8.3.6. 
Disease-Related Events and Disease-Related Outcomes Not Qualifying as Adverse
Events or Serious Adverse Events............................................................................................. 70
8.3.7. 
Adverse Events of Special Interest............................................................................................. 70
8.4. 
Pharmacokinetics........................................................................................................................... 70
8.4.1. 
Evaluations ................................................................................................................................. 71
8.4.2. 
Analytical Procedures................................................................................................................. 71
8.4.3. 
Pharmacokinetic Parameters and Evaluations........................................................................... 71
8.5. 
Genetics and Pharmacogenomics................................................................................................. 72
8.6. 
Biomarkers..................................................................................................................................... 72
8.6.1. 
Ex vivo whole blood cytokine release assay .............................................................................. 73
8.6.2. 
Serum Psoriasis Pharmacodynamic Changes ........................................................................... 73
8.6.3. 
Skin Psoriasis-Associated Gene Expression Changes.............................................................. 73
8.6.4. 
Flow cytometric analysis............................................................................................................. 73
8.7. 
Immunogenicity Assessments ....................................................................................................... 73
8.8. 
Medical Resource Utilization and Health Economics .................................................................... 74
9. 
STATISTICAL CONSIDERATIONS.................................................................................................. 74
9.1. 
Statistical Hypotheses.................................................................................................................... 74
9.2. 
Sample Size Determination ........................................................................................................... 74
9.3. 
Populations for Analysis Sets ........................................................................................................ 75
9.4. 
Statistical Analyses ........................................................................................................................ 75
9.4.1. 
Statistical Methods...................................................................................................................... 75
9.4.2. 
Efficacy Analyses........................................................................................................................ 76
9.4.2.1. 
Primary Endpoint(s)................................................................................................................. 76
9.4.2.1.1. 
Estimand .............................................................................................................................. 76
9.4.2.1.1.1. 
Primary Estimand.............................................................................................................. 76
9.4.3. 
Secondary Endpoint(s)............................................................................................................... 77
9.4.4. 
Tertiary/Exploratory Endpoint(s)................................................................................................. 78
9.4.5. 
Safety Analyses.......................................................................................................................... 79
9.4.6. 
Other Analyses ........................................................................................................................... 80

JNJ-77242113 
Clinical Protocol 77242113PSO2001 Amendment 2
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
4
Status: Approved,  Date:  12 January 2022
9.5. 
Interim Analysis.............................................................................................................................. 82
10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS............................ 83
10.1. 
Appendix 1: Abbreviations ............................................................................................................. 83
10.2. 
Appendix 2: Clinical Laboratory Tests ........................................................................................... 85
10.3. 
Appendix 3: Regulatory, Ethical, and Study Oversight Considerations......................................... 87
10.3.1. 
Regulatory and Ethical Considerations ...................................................................................... 87
10.3.2. 
Financial Disclosure.................................................................................................................... 90
10.3.3. 
Informed Consent Process ......................................................................................................... 91
10.3.4. 
Data Protection........................................................................................................................... 92
10.3.5. 
Long-Term Retention of Samples for Additional Future Research ............................................ 92
10.3.6. 
Committees Structure................................................................................................................. 93
10.3.7. 
Publication Policy/Dissemination of Clinical Study Data............................................................ 93
10.3.8. 
Data Quality Assurance.............................................................................................................. 94
10.3.9. 
Case Report Form Completion................................................................................................... 95
10.3.10. Source Documents ..................................................................................................................... 95
10.3.11. Monitoring ................................................................................................................................... 96
10.3.12. On-Site Audits............................................................................................................................. 97
10.3.13. Record Retention........................................................................................................................ 97
10.3.14. Study and Site Start and Closure ............................................................................................... 98
10.4. 
Appendix 4: Psoriasis Area and Severity Index (PASI) ................................................................. 99
10.5. 
Appendix 5: Photographs............................................................................................................. 100
10.6. 
Appendix 6: Adverse Events, Serious Adverse Events, Product Quality Complaints, and
Other Safety Reporting: Definitions and Procedures for Recording, Evaluating, Follow-up,
and Reporting............................................................................................................................... 102
10.6.1. 
Adverse Event Definitions and Classifications ......................................................................... 102
10.6.2. 
Attribution Definitions................................................................................................................ 103
10.6.3. 
Severity Criteria........................................................................................................................ 103
10.6.4. 
Special Reporting Situations .................................................................................................... 103
10.6.5. 
Procedures ............................................................................................................................... 104
10.6.6. 
Product Quality Complaint Handling......................................................................................... 105
10.6.7. 
Contacting Sponsor Regarding Safety, Including Product Quality........................................... 106
10.7. 
Appendix 7: Columbia Suicide Severity Rating Scale ................................................................. 107
10.8. 
Appendix 8: Contraceptive and Barrier Guidance ....................................................................... 113
10.9. 
Appendix 9: Liver Safety: Suggested Actions and Follow-up Assessments................................ 116
10.9.1. 
Stopping Algorithm ................................................................................................................... 116
10.9.2. 
FOLLOW-UP ASSESSMENTS ................................................................................................ 117
10.9.2.1. 
Phase 2 Liver Chemistry Stopping Criteria and Follow-up Assessments............................. 117
10.9.2.2. 
Phase 2 Liver Chemistry Increased Monitoring Criteria with Continued Study
Intervention............................................................................................................................ 119
10.10. Appendix 10: Hepatitis B Virus (HBV) Screening with HBV DNA................................................ 120
10.11. Appendix 11: Guidance on Study Conduct during the COVID-19 Pandemic.............................. 121
10.12. Appendix 12: Criteria for Assessing Potential Cases of Anaphylaxis.......................................... 123
10.13. Appendix 13: Protocol Amendment History................................................................................. 124
11. REFERENCES................................................................................................................................. 126
INVESTIGATOR AGREEMENT............................................................................................................... 128

JNJ-77242113 
Clinical Protocol 77242113PSO2001 Amendment 2
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
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Status: Approved,  Date:  12 January 2022
LIST OF IN-TEXT TABLES AND FIGURES
TABLES
Table 1: 
77242113PSO2001 SOA Screening through Week 16............................................................ 20
Table 2: 
Potential Risks of JNJ-77242113 for the Treatment of Psoriasis ............................................. 31

JNJ-77242113 
Clinical Protocol 77242113PSO2001 Amendment 2
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
6
Status: Approved,  Date:  12 January 2022
FIGURES
Figure 1: Schematic Overview of 77242113PSO2001 ............................................................................ 19

JNJ-77242113 
Clinical Protocol 77242113PSO2001 Amendment 2
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
7
Status: Approved,  Date:  12 January 2022
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE
DOCUMENT HISTORY
Document 
Date
Amendment 2 
12 January 2022
Amendment 1 
17 November 2021
Original Protocol 
23 September 2021
Amendment 2 (12 January 2022)
Overall Rationale for the Amendment:  The protocol is primarily being amended to update the study
intervention dosing instructions to include a fasting requirement and to update the analysis strategy
regarding discontinuations due to COVID-19 (intercurrent event number 3) to a Treatment Policy strategy.
Section Number 
and Name
Description of Change 
Brief Rationale
SOA 
Update Footnote e text to remove examples of the 
samples that need to be recorded per study manual. 
The study manual will outline which
samples the date and time should be
recorded for and where that
information should be recorded.
Section 2.2, 
Background 
Add interim results from an ongoing bioavailability 
study (77242113PSO1003). 
This information was added to
justify the change from dosing with
or without food to dosing on an
empty stomach as defined in Section
4.1 and Section 6.1.
Section 4.1, Overall 
Design; Section 6.1, 
Study Interventions 
Administered 
Update 
study 
intervention 
administration 
instructions to include taking study intervention on 
an empty stomach. 
Interim results from an ongoing,
multipart, randomized, open-label,
single-dose, crossover study in
healthy 
participants
(77242113PSO1003) indicate that
the oral bioavailability and PK
profile 
of 
JNJ-77242113
administered 
under 
fasted
conditions as an immediate-release
(IR) tablet formulation is similar to
the oral solution used in the FIH
study PN-235-01.  The PK results
also indicate that concomitant food
(high calorie, high-fat breakfast)
increased the median time to reach
tmax and significantly reduced the
rate (Cmax) and extent (AUC) of
JNJ 77242113 absorption. Based on
the interim food effect data from
protocol 77242113PSO1003, study
intervention should be administered
under fasted conditions.
Section 5.2,
Exclusion Criteria
Modified Exclusion Criterion #5 to clarify it refers 
to agents that deplete B cells.
Clarify the exclusion criterion.
Section 8.2.1,
Physical
Examinations
Update timing of full physical exams to align with 
the SoA. 
Error in text. Timing of the full
physical exam was updated to match
the SoA.
Section 9.4.2.1.1.1,
Primary Estimand
Changed the analysis strategy for addressing 
Intercurrent Event 3 (Discontinuation of study 
intervention due to COVID-19 related reasons 
(excluding COVID-19 infection) to Treatment 
Since COVID-19 can no longer be
viewed as a temporary problem, all
COVID-19 related reasons will be
treated 
similarly  
to

JNJ-77242113 
Clinical Protocol 77242113PSO2001 Amendment 2
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
8
Status: Approved,  Date:  12 January 2022
Section Number 
and Name
Description of Change 
Brief Rationale
Policy strategy  and combined it with Intercurrent 
Event 4 
“Discontinuations 
of 
study
intervention due to other reasons
(excluding reasons indicative of lack
of efficacy)” for which  treatment
policy strategy was used in the past.
Section 8.2.4 
Clinical Safety 
Laboratory 
Assessments; 
Section 10.2,
Appendix 2:
Clinical Laboratory
Tests
The text was modified since some of the listed 
laboratory tests will be performed locally, instead of
centrally. The location is defined in the study
manual. 
Error in text.
Throughout the 
protocol 
Minor grammatical, formatting, or spelling changes 
were made.
Minor errors were noted

JNJ-77242113 
Clinical Protocol 77242113PSO2001 Amendment 2
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
9
Status: Approved,  Date:  12 January 2022
1. 
PROTOCOL SUMMARY:
1.1. 
Synopsis
A Phase 2b Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy
and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis
DESCRIPTION OF COMPOUND
JNJ-77242113 is a 13-amino acid peptide that binds directly to the interleukin 23 receptor (IL-23R)subunit
and prevents IL-23p19 from engaging its receptor, thereby inhibiting proximal IL-23R signaling and
downstream effector functions (eg, cytokine secretion). JNJ-77242113 has high potency with an IC50 of
~20 to 30 pM in peripheral human cell based functional assays, so despite its very low oral bioavailability
(<1%), it has the potential to provide systemic/skin efficacy.
OBJECTIVES AND ENDPOINTS
Objectives 
Endpoints
Primary
To evaluate the dose response of JNJ-77242113 at 
Week 16 in participants with moderate-to-severe 
plaque psoriasis 
Proportion of participants achieving PASI 75
(≥75% improvement from baseline in PASI) at
Week 16
Secondary
To characterize additional efficacy of 
JNJ-77242113 versus placebo in participants with 
moderate-to-severe plaque psoriasis 
 
Change from baseline in PASI total score at
Week 16
 
Proportion of participants achieving PASI 90
(≥90% improvement from baseline in PASI)
at Week 16
 
Proportion of participants achieving PASI 100
(100% improvement from baseline in PASI)
at Week 16
 
Proportion of participants achieving an IGA
score of cleared (0) or minimal (1) at Week 16
 
Proportion of participants achieving an IGA
score of cleared (0) at Week 16
 
Change from baseline in BSA at Week 16
To evaluate the effect of JNJ-77242113 treatment 
on patient-reported psoriasis severity versus 
placebo in participants with moderate-to-severe 
plaque psoriasis 
 
Change from baseline in Psoriasis Symptoms
and Signs Diary (PSSD) symptoms score at
Week 16
 
Change from baseline in PSSD signs score at
Week 16
 
Proportion of participants achieving PSSD
symptoms score=0 at Week 16 among
participants with a baseline symptoms
scores ≥1.
 
Proportion of participants achieving PSSD
signs score=0 at Week 16 among participants
with a baseline signs score ≥1.
To evaluate the effect of JNJ-77242113 treatment 
on dermatology-specific health-related quality of 
life versus placebo in participants with 
moderate-to-severe plaque psoriasis
 
Proportion of participants achieving a DLQI
of 0 or 1 at Week 16 among participants with
baseline DLQI score >1

JNJ-77242113 
Clinical Protocol 77242113PSO2001 Amendment 2
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
10
Status: Approved,  Date:  12 January 2022
Objectives 
Endpoints
To evaluate the effect of JNJ-77242113 treatment 
on general health-related quality of life versus 
placebo in participants with moderate-to-severe 
plaque psoriasis 
 
Change from baseline in domain scores of the
Patient-Reported Outcomes Measurement
Information System (PROMIS-29) at
Week 16
 
Proportion of participants who achieve at least
a 5-point improvement from baseline in each
PROMIS-29 domain at Week 16
To assess the safety and tolerability of 
JNJ-77242113 in participants with
moderate-to-severe plaque psoriasis
 Frequency and type of AEs and SAEs
Exploratory
To evaluate the PK and immunogenicity of JNJ- 
77242113, and explore the PK/PD relationship of 
JNJ-77242113 for biomarkers, efficacy, and 
safety in participants with moderate-to-severe 
plaque psoriasis
 
JNJ-77242113 PK parameters (ie, plasma
concentration just prior to the beginning or at
the end of the dosing interval [Ctrough], Cmax,
tmax, and AUC)
 
The relationship between PK parameters and
PD (ie, skin, blood cellular and molecular
biomarker activity as well as clinical endpoints
and safety parameters)
 
The incidence of anti-drug antibodies to
JNJ-77242113
To characterize additional efficacy of 
JNJ-77242113 versus placebo for the treatment of 
regional psoriasis 
 
Proportion of participants achieving an
ss-IGA score of absence of disease (0) or very
mild disease (1) and at least a 2-grade
improvement from baseline at Week 16
among those participants randomized with
scalp psoriasis and an ss-IGA score ≥2 at
baseline
 
Percent change from baseline in NAPSI at
Week 16 among participants randomized with
a NAPSI score >0 at baseline
 
Proportion of participants achieving an f-PGA
score of clear (0) or minimal (1) at Week 16
among those participants randomized with
nail psoriasis and an f-PGA ≥2 score at
baseline
 
Proportion of participants who achieve an
hf-PGA score of clear (0) or almost clear (1)
and a reduction of at least 2 grades on the
hf-PGA scale from baseline at Week 16
among those participants with hand and/or
foot psoriasis and an hf-PGA score ≥2 at
baseline
 
Proportion of participants achieving a sPGA
of genitalia score of clear (0) or minimal (1) at
Week 16 among participants randomized with
genital psoriasis and an sPGA of genitalia
score ≥3 at baseline

JNJ-77242113 
Clinical Protocol 77242113PSO2001 Amendment 2
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
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Status: Approved,  Date:  12 January 2022
Objectives 
Endpoints
 
Proportion of participants achieving a
GenPs-SFQ item 2 score of never (0) or
rarely (1) at Week 16 among those
participants with a GenPs-SFQ item 2 score
≥2 at baseline
To further assess the safety and tolerability of
JNJ-77242113 in participants with
moderate-to-severe plaque psoriasis
 
Frequency and type of related AEs, and AEs
leading 
to 
discontinuation 
of 
study
intervention
 
Laboratory parameters and change from
baseline 
in 
laboratory 
parameters
(hematology and chemistry) over time
 
Systolic and diastolic blood pressures over
time
To explore biomarkers in participants with
moderate-to-severe plaque psoriasis
 
Change from baseline in levels of skin and
blood biomarkers
To explore treatment satisfaction after using
JNJ-77242113 in participants with moderate-to-
severe plaque psoriasis
 
Assessment of treatment satisfaction domains
at Week 16 using the Treatment Satisfaction
Questionnaire for Medications-9 items
(TSQM‑9)
Hypothesis
The hypothesis of this study is that there is a dose response relationship for JNJ-77242113 in the proportion
of participants achieving a Psoriasis Area Severity Index (PASI) 75 response at Week 16.
OVERALL DESIGN
This is a randomized, double-blind, placebo-controlled, dose-ranging, parallel group, multicenter,
interventional study in participants with moderate-to-severe plaque psoriasis.
At Week 16, eligible participants will have the option to enroll in a 36-week treatment long term extension
(LTE) study; all participants will be treated with active study intervention in the LTE. The study design of
the LTE will be detailed in a separate protocol (77242113PSO2002).
Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed according to
the Schedule of Activities (SoA; Section 1.3). In addition, there will be four optional substudy collections
for participants who consent (where local regulations permit): a pharmacogenomic blood sample, ex vivo
cytokine release blood sample, skin biopsy, and photograph collection (lesional or lesional and full body).
One planned database lock (DBL) will occur at Week 16.
Two interim analyses will occur in this study at Week 4 and Week 16.
An external Independent Data Monitoring Committee (iDMC) will be commissioned for this study.
NUMBER OF PARTICIPANTS
A target of 240 participants will be enrolled in this study with 40 participants planned per intervention
group.

JNJ-77242113 
Clinical Protocol 77242113PSO2001 Amendment 2
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
12
Status: Approved,  Date:  12 January 2022
INTERVENTION GROUPS AND DURATION
The total duration of this study is up to 24 weeks: a screening period of ≤4 weeks, a 16-week treatment
period, and a 4-week safety follow-up period after the last study intervention administration for participants
who are ineligible or have decided to not enroll in the LTE study at Week 16. At the Week 16 visit, eligible
participants who enroll in the LTE will continue treatment after the Week 16 visit under the LTE protocol.
Group 1: JNJ-77242113 (25mg QD): Participants will receive JNJ-77242113 25 mg QD from Week 0
through Week 16
Group 2: JNJ-77242113 (50 mg QD): Participants will receive JNJ-77242113 50 mg QD from Week 0
through Week 16
Group 3: JNJ-77242113 (100 mg QD): Participants will receive JNJ-77242113 100 mg QD from Week 0
through Week 16
Group 4: JNJ-77242113 (25mg BID): Participants will receive JNJ-77242113 25 mg BID from Week 0
through Week 16
Group 5: JNJ-77242113 (100 mg BID): Participants will receive JNJ-77242113 100 mg BID from Week 0
through Week 16
Group 6: Placebo: Participants will receive placebo BID from Week 0 through Week 16
EFFICACY EVALUATIONS
Investigator assessments and patient-reported outcomes (PROs) of efficacy include the following:
 
PASI
 
IGA
 
BSA
 
NAPSI
 
f-PGA
 
s-PGA of genitalia
 
hf-PGA
 
ss-IGA
 
Photographs
 
PRO measures to assess: PSSD, DLQI, PROMIS-29, GenPs-SFQ, PGI-S, PGI-C, TSQM-9
PHARMACOKINETIC EVALUATIONS
Plasma samples will be used to evaluate the PK of JNJ-77242113.
IMMUNOGENICITY EVALUATIONS
Antibodies to JNJ-77242113 will be evaluated in serum samples collected from all participants according
to the Schedule of Assessments (SoA). Additionally, serum samples should also be collected at the final
visit from participants who discontinued study intervention or were withdrawn from the study.
PHARMACODYNAMIC AND BIOMARKER EVALUATIONS
Pharmacodynamic markers will be evaluated using blood and skin (optional) samples collected at visits as
indicated in the SoA. Biomarker assessments will be made to examine the biological response to treatment

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and to identify biomarkers that are relevant to JNJ-77242113 treatment response and/or psoriasis, where
local regulations permit. Assessments will include the evaluation of relevant biomarkers in serum, plasma,
whole blood, peripheral blood mononuclear cells, and skin biopsy samples (optional) collected as specified
in the SoA where local regulations permit.
PHARMACOGENOMIC (DNA) EVALUATIONS
Participation in pharmacogenomic research is optional. A pharmacogenomic blood sample will be collected
from participants who consent separately to this component of the study to allow for pharmacogenomic
research, where local regulations permit.
SAFETY EVALUATIONS
Key safety assessments include adverse events (AE)s, serious adverse events (SAE)s, adverse events of
special interest (AESI), laboratory parameters (hematology and chemistry, including lipid panel, and
urinalysis), vital signs, systolic and diastolic blood pressures over time, and the Columbia-Suicide Severity
Rating Scale (C-SSRS).
STATISTICAL METHODS
Simple descriptive summary statistics, such as n, mean, standard deviation (SD), median, interquartile
range, minimum, and maximum for continuous variables, and counts and percentages for discrete variables
will be used to summarize most data.
To assess the primary objective of the dose response profile of JNJ-77242113 dose groups and facilitate the
selection of JNJ-77242113 doses and dosing regimen for future studies, Multiple Comparison Procedures
with modeling (MCP-Mod) techniques will be used to analyze the primary endpoint, the proportion of
participants achieving PASI 75 at Week 16.
In addition, for binary response efficacy endpoints, comparisons between each of the JNJ-77242113 groups
versus placebo will be performed using a Cochran-Mantel-Haenszel (CMH) test stratified by the baseline
weight (≤90 kg, >90 kg). For continuous efficacy endpoints, treatment comparisons will be performed using
a Mixed-Effect Model Repeated Measure (MMRM) model. The MMRM model will have treatment group,
baseline weight (≤90 kg, >90 kg), and baseline value for the corresponding efficacy endpoint as explanatory
factors. The MMRM model will also include visit, treatment group by visit interaction, baseline weight
(≤90 kg, >90 kg) by visit interaction, and baseline value by visit interaction as additional explanatory
factors. The Least Square mean (LSmean) estimates and their corresponding 95% confidence interval (CI)
will be provided at each time point. In addition, the estimates of LSmean difference and 95% CIs between
the JNJ-77242113 groups and placebo will be provided.
In general, all statistical testing will be performed at a significance level of 0.05 (2-sided) unless otherwise
specified. Nominal p-values will be displayed for all treatment comparisons.
Efficacy Analyses
Primary Endpoint(s)
The primary efficacy endpoint is the proportion of participants achieving PASI 75 response at Week 16,
defined as at least a 75% reduction from baseline in PASI total score.

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Estimand
Primary Estimand
The primary estimand (ie, a precise definition of the primary targeted treatment effect) is defined by the
following 5 attributes:
Study intervention:
 JNJ-77242113 25 mg QD, 50 mg QD, 25 mg BID, 100 mg QD, and 100 mg BID
 Placebo
Population: adult participants with moderate to severe plaque psoriasis
Variable/endpoint:  Response binary variable, where a responder is defined as a participant achieving a
PASI 75 response at Week 16 who does not have intercurrent events in categories 1-2 (defined below).
Intercurrent Events (ICEs) and their corresponding strategies.
ICEs 
Analysis Strategy for Addressing Intercurrent Events
1. Discontinuation of study 
intervention due to lack of 
efficacy or due to an AE of 
worsening of psoriasis 
2. Initiation of a protocol-prohibited 
medication or therapy during the
study that could improve psoriasis
Composite Strategy: Participants with these intercurrent
events are considered as PASI 75 non-responders after
these events, and prior to Week 16. The occurrence of
these intercurrent events is captured in the variable
definition.
3. Discontinuation of study 
intervention for reasons other 
than ICE 1
Treatment Policy: observed data will be used regardless
of whether or not this intercurrent event had occurred.
Note: For participants experiencing multiple ICEs, ICE 2 will override ICE 3.
Population level summary: Difference in the proportions of participants achieving a PASI 75 response at
Week 16 between the JNJ-77242113 and placebo intervention groups.
Primary Endpoint Analysis
In the primary efficacy analysis, data from all randomized participants who received at
least 1 administration of study intervention will be analyzed according to their assigned treatment group.
A unified strategy that combines MCP-Mod techniques, will be used to analyze the dose-response
relationship for the JNJ-77242113 doses in PASI 75 at Week 16. This approach consists of 2 major steps.
The first step consists of testing the dose-response signal via multiple contrast tests while controlling the
overall Type 1 error. If a dose-response signal is detected, the second step is to select a model that best
describes the observed data, which may be used to support dose selection in future studies. In addition, a
simple semi-parametric Bayesian normal dynamic linear model (NDLM) will also be explored to
complement the frequentist MCP-Mod analysis. The details of the dose-response analysis will be provided
in the statistical analysis plan (SAP).
The study will be considered positive if a dose-response signal for the primary endpoint is detected. In
addition to the dose-response analysis, pairwise comparisons of the JNJ-77242113 groups versus the
placebo group will be performed for PASI 75 at Week 16; these comparisons will not be adjusted for
multiplicity. For these comparisons, a CMH stratified by baseline weight category (≤ 90kg, >90kg) will be

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used. The proportion difference between each JNJ-77242113 group and placebo group and its 2-sided 95%
CI will be provided based on normal approximation with Mantel-Haenszel weights adjusting for baseline
weight category.
To examine the robustness of the primary endpoint analysis, additional analyses will be conducted using
different missing data approaches; these analyses will be described in the SAP. In addition, sensitivity
analyses will be performed for the primary endpoint using the per-protocol population, which includes
participants who are generally compliant with the protocol. To evaluate the consistency of the efficacy,
subgroup analyses of the primary endpoint will be performed.
Secondary Endpoint(s)
In addition to the primary endpoint analysis, the analyses for secondary efficacy endpoints will be
performed. No adjustments for multiple comparisons will be made for the secondary endpoints and nominal
p-values will be provided. Additional efficacy analyses may be performed and will be documented in the
SAP.
 
The proportion of participants who achieve a PASI 100 response at Week 16, will be compared
between each of the JNJ-77242113 groups and the placebo group.
 
The proportion of participants who achieve a PASI 90 response at Week 16, will be compared between
each of the JNJ-77242113 groups and the placebo group.
 
The change from baseline in PASI total score at Week 16 will be compared between each of the
JNJ-77242113 groups and the placebo.
 
The proportion of participants who achieve an IGA score of cleared (0) at Week 16 will be compared
between each of the JNJ-77242113 groups and the placebo group.
 
The proportion of participants who achieve an IGA score of cleared (0) or minimal (1) at Week 16 will
be compared between each of the JNJ-77242113 groups and the placebo group.
 
The change from baseline in PSSD symptoms score at Week 16 will be compared between each of the
JNJ-77242113 groups and the placebo group.
 
The change from baseline in PSSD signs score at Week 16 will be compared between each of the
JNJ-77242113 groups and the placebo group.
 
The proportion of participants who achieve PSSD symptoms score=0 at Week 16 will be compared
between each of the JNJ-77242113 groups and the placebo group among participants with a baseline
PSSD symptoms score ≥1.
 
The proportion of participants who achieve PSSD signs score=0 at Week 16 will be compared between
each of the JNJ-77242113 groups and the placebo group among participants with a baseline PSSD
signs score ≥1.
 
The proportion of participants with DLQI=0 or 1 at Week 16 will be compared between each of the
JNJ-77242113 groups and the placebo group respectively among participants with a baseline DLQI
score >1.
 
The proportion of participants who achieve 5-point improvement or higher in each PROMIS-29
domain from baseline to Week 16 will be compared between each of the JNJ-77242113 groups and
the placebo group.
 
The change from baseline in BSA at Week 16 will be compared between each of the JNJ-77242113
groups and the placebo group.

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 
The change from baseline in PROMIS-29 domain scores at Week 16 will be compared between each
of the JNJ-77242113 groups and the placebo group.
Safety Analyses
Safety data, including but not limited to, AEs, SAEs, AESIs (active TB, malignancy, potential Hy’s Law
cases), discontinuation of study intervention due to AEs, changes in laboratory assessments, changes in
vital signs, and changes in weight will be summarized. Intervention-emergent AEs will be summarized by
treatment group and Medical Dictionary for Regulatory Activities (MedDRA) system organ class and
preferred terms. Details will be specified in the SAP.
Adverse Events
The verbatim terms used in the electronic case report form (eCRF)by investigators to identify AEs will be
coded using the MedDRA. Intervention-emergent AEs are AEs with onset during the intervention period
or that are a consequence of a preexisting condition that has worsened since baseline. All intervention-
emergent AEs will be included in the analysis. For each AE, the percentage of participants who experience
at least 1 occurrence of the given event will be summarized by intervention group. In addition, comparisons
between intervention groups will be provided if appropriate.
The following analyses will also be used to assess the safety of participants in the study:
 
The incidence and type of AEs.
 
The incidence and type of SAEs.
 
The incidence and type of severe AEs.
 
The incidence and type of related AEs as assessed by the investigator.
 
The incidence and type of AEs leading to discontinuation of study.
Listings of participants with SAEs, severe AEs, AEs for psoriasis, AEs leading to discontinuation of study
and anaphylactic reaction/serum sickness reactions will also be provided. All safety analyses will be based
on the population of participants who received at least 1 administration of study intervention; participants
will be summarized by the intervention they received.
Clinical Laboratory Tests
Laboratory data will be summarized by type of laboratory test (eg, hematology, clinical chemistry,
urinalysis). Selected laboratory parameters will be summarized by treatment groups. Common Terminology
Criteria for Adverse Events (CTCAE) and Upper Limit of Normal (ULN) will be used to identify abnormal
laboratory test results, and the incidence and severity of abnormal laboratory parameters (hematology and
chemistry) will be summarized by treatment group.
In addition, a listing of participants with Grade 2 or higher laboratory test results (based on the CTCAE
criteria) will also be provided.
C-SSRS
Suicide-related thoughts and behaviors based on the C-SSRS will be summarized descriptively by treatment
group.

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Vital Signs
Descriptive statistics of heart rate and blood pressure (systolic and diastolic) values and changes from
baseline will be summarized at each scheduled time point.
Weight
Descriptive statistics of changes from baseline will be summarized at selected scheduled time points.
Other Analyses
Pharmacokinetic Analyses
The PK evaluable population is defined as all the participants who received at least 1 complete dose of
JNJ-77242113 and had at least 1 valid blood sample drawn for PK analysis after their first dose of
JNJ-77242113.
Plasma JNJ-77242113 concentrations will be summarized by visit and treatment group. Descriptive
statistics will be calculated at each sampling timepoint. Concentrations below the lowest quantifiable
concentration will be treated as zero in the summary statistics. All plasma concentrations below the lowest
quantifiable concentration or missing data will be labeled as such in the concentration database. PK data
may also be displayed graphically.
If feasible, population PK analysis of plasma concentration-time data of JNJ-77242113 may be performed
using nonlinear mixed-effects modeling. Data may be combined with those of other selected studies to
support a relevant structural model. Available baseline participant characteristics (eg, demographics,
laboratory variables, genotypes, race) will be tested as potential covariates affecting PK parameters. Details
will be given in a population PK analysis plan and the results of the population PK analysis will be presented
in a separate report.
Pharmacokinetic/Pharmacodynamic Analyses
If data permit, the relationships between plasma JNJ-77242113 concentration and efficacy may be
examined when appropriate. If a relationship is observed, a suitable PK/PD model may be developed to
describe the exposure-response relationship and will be presented in a separate technical report.
Immunogenicity Analyses
The incidence and titers of antibodies to JNJ-77242113 will be summarized for all participants who receive
at least 1 dose of JNJ-77242113 and have appropriate samples for detection of antibodies to JNJ-77242113
(ie, participants with at least 1 sample obtained after their first dose of JNJ-77242113).
A listing of participants who are positive for antibodies to JNJ-77242113 will be provided. The maximum
titers of antibodies to JNJ-77242113 will be summarized for participants who are positive for antibodies to
JNJ-77242113.
The incidence of neutralizing antibodies (NAbs) to JNJ-77242113 will be summarized for participants who
are positive for antibodies to JNJ-77242113 and have samples evaluable for NAbs to JNJ-77242113.
Other immunogenicity analyses may be performed to further characterize the immune responses that are
generated.

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Biomarkers Analyses
Planned biomarker analyses may be deferred if emerging study data show no likelihood of providing useful
scientific information. Any biomarker samples received by the contract vendor or sponsor after the cutoff
date will not be analyzed, and therefore, excluded from the biomarker analysis.
Changes in biomarkers over time will be summarized by treatment group. Associations between baseline
levels and changes from baseline in select markers and response to treatment will be explored. The analyses
will aim to identify biomarker relevant to treatment. Results of biomarker analyses will be reported in
separate technical reports.
Pharmacogenomic Analyses
DNA samples will be used for research related to JNJ-77242113 or psoriasis. They may also be used to
develop tests/assays related to JNJ-77242113 and/or psoriasis. Pharmacogenomic research may consist of
the analysis of one or more candidate genes or of the analysis of genetic markers throughout the genome or
analysis of the entire genome (as appropriate) in relation to JNJ-77242113 or psoriasis clinical endpoints.
Results will be presented in a separate report.

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1.2. 
Schema
Figure 1: 
Schematic Overview of 77242113PSO2001

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Abbreviations:  ADA=anti-drug antibody; ClinRO=clinician-reported outcome; BSA=Body Surface Area; C-SSRS=Columbia-Suicide Severity Rating Scale;
DLQI=Dermatological Life Quality Index; DNA=deoxyribonucleic acid; ECG=electrocardiogram; f-PGA=Fingernail Physician’s Global Assessment; GenPs-
SFQ=Genital Psoriasis Sexual Frequency Questionnaire; hs-CRP=High sensitivity C-reactive protein; HIV=human immunodeficiency virus; ICF=informed consent form;
IGA=Investigator Global Assessment; IGRA=Interferon gamma release assay; LTE=long-term extension; NAPSI=Nail Psoriasis Area and Severity Index; PASI=Psoriasis
Area and Severity Index; PBMC=  peripheral blood mononuclear cells; PGI-C=Patient Global Assessment-Change; PGI-S=Patient Global Assessment – Severity;
PK=pharmacokinetic(s); PRO=patient-reported outcome; PROMIS-29=Patient Reported Outcomes Measurement Information System-29; PSSD=Psoriasis Symptom and
Sign Diary; SoA=Schedule of Activities; s-PGA=Static Physician’s Global Assessment; ss-IGA=Scalp Specific Investigator Global Assessment; TB=tuberculosis;
TSQM-9=Treatment Satisfaction Questionnaire for Medications
Footnotes:
a. 
For participants who DO NOT enter the LTE protocol, a Final Safety Follow-up Visit (ie, Week 20) will be conducted approximately 4 weeks after the last
administration of study intervention. Participants who enter the LTE will enter at or after the Week 16 visit.
b. 
Participants who terminate study intervention early should have an Early Termination Visit approximately 4 weeks after their last administration of study
intervention.
c. 
Length of time between Week 1 and Week 2 visits must not exceed 10 days.
d. 
At all visits where study intervention will be dispensed, all study procedures and evaluations are to be completed before study intervention is dispensed.
e. 
At Week 0, all blood samples should be collected prior to study intervention administration and the date and time of collection should be recorded in the source
document. At all other study visits where applicable, the date and time of the two previously administered doses and the date and time ofthe samples should be
recorded as instructed in the study manual.

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2. 
INTRODUCTION
Interleukin (IL)-23 is a disulfide-linked heterodimer of the IL-23p19 and IL-12/23p40 subunits.
The receptor for IL-23 comprises the IL-23R and IL-12R subunits (Bloch 2018). Interleukin-23p19
binding to the N-terminal immunoglobulin (Ig)-like domain of IL-23R is followed by IL-12/23p40
binding to IL-12Rβ1. Ligand binding results in the phosphorylation of Janus kinase (JAK2) and
tyrosine kinase 2 (TYK2), leading to phosphorylation and nuclear translocation of signal
transducer and activator of transcription (STAT) proteins.
JNJ-77242113 is a 13-amino acid peptide that binds directly to the IL-23R subunit and prevents
IL-23p19 from engaging its receptor, thereby inhibiting proximal IL-23R signaling and
downstream effector functions (eg, cytokine secretion). JNJ-77242113 has high potency with a
half maximal inhibitory concentration IC50 of ~20-30 pM in peripheral human cell based functional
assays, so despite its very low oral bioavailability (<1%), it has the potential to provide
systemic/skin efficacy. This makes JNJ-77242113 a promising candidate for development in
systemic, IL-23-driven diseases, such as psoriasis and psoriatic arthritis (PsA). Once present in the
systemic circulation, JNJ-77242113 is expected to have good distribution to target organs such as
the skin.
To date, JNJ-77242113 has been studied in one Phase 1a clinical study (PN-235-01) of healthy
participants to assess the safety and tolerability of JNJ-77242113 over the dose range tested.
For the most comprehensive nonclinical and clinical information regarding JNJ-77242113, refer
to the latest version of the Investigator's Brochure (IB) for JNJ-77242113.
The term “study intervention” throughout the protocol, refers to study drug as defined in
Section 6.1.
The term "sponsor" used throughout this document refers to the entities listed in the Contact
Information page(s), which will be provided as a separate document.
2.1. 
Study Rationale
In the United States (US), European Union (EU), and Japan, there are approximately 3.5 million
patients living with moderate to severe psoriasis (body surface area [BSA] >10%). These patients
are traditionally managed with topical and conventional therapies prior to advancing to
subcutaneously administered biologics targeting tumor necrosis factor (TNF), IL-23, IL-12/23, or
IL-17. Oral therapies, such as apremilast (phosphodiesterase 4 [PDE4] inhibitor), are also available
as advanced therapeutic options, but only provide modest efficacy relative to subcutaneously
administered biologics (Armstrong 2019) and have demonstrated gastrointestinal intolerability in
some patients (Otezla USPI 2017). For those patients who prefer oral medication, healthcare
providers agree that oral therapies with high efficacy and long-term clinical remission, remain a
substantial unmet need (Nasa 2019).
Targeting IL-23 is a highly validated approach for treating moderate to severe psoriasis.
Interleukin‑23 is composed of a unique p19 subunit coupled with the common p40 subunit shared

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with IL-12, and signals through the heterodimeric IL-23 receptor (IL-23R)/IL-12 receptor beta 1
(IL-12Rβ1) complex (Teng 2015). The IL-23R is expressed by cells of both the innate and adaptive
immune systems, including innate lymphoid cells, natural killer (NK) cells, NK T cells, gamma
delta T cells, and subsets of memory CD4+ and CD8+ alpha beta T cells (Teng 2015). Binding of
IL-23 to the IL-23R complex leads to phosphorylation of STAT3 and IL-23 induced expression of
proinflammatory cytokines, such as IL-17A/F and IL‑22.
Existing highly successful biologic therapies targeting the p19 subunit of IL-23, such as
guselkumab (Blauvelt 2017; Reich 2017) and risankizumab (Gordon 2018), act by preventing
engagement of this ligand with the IL-23R and ultimately cause reduced signaling through IL-23R.
Moreover, since polymorphisms in IL-23R are associated with susceptibility to psoriasis and the
precise anatomical expression of IL‑23R dictates where disease develops (Sherlock 2012),
targeting this receptor directly is expected to treat psoriasis at a fundamental level and in a way
comparable to inhibiting the ligand.
JNJ-77242113 is a 13-amino acid peptide that binds directly to the IL-23R subunit and prevents
IL-23 p19 from engaging its receptor, inhibiting proximal IL-23R signaling and downstream
effector functions (eg, cytokine secretion). Because of this validated mechanism of action in the
treatment of moderate to severe psoriasis patients, JNJ-77242113 has the potential to have similar
efficacy and safety profiles to subcutaneously administered anti-IL23 biologics, but with the
convenience of oral administration. Validation of this treatment pathway in an orally administered
form would significantly increase the therapeutic options for those patients in need of advanced
therapies who prefer oral to subcutaneously administered medications. 
This 
study, 
77242113PSO2001, 
is 
a 
randomized, 
double-blinded, 
dose-ranging,
placebo-controlled study of JNJ-77242113 and is designed to evaluate the efficacy and safety of
JNJ-77242113 in adults with moderate-to-severe plaque psoriasis.
2.2. 
Background
Nonclinical Pharmacology and Toxicology
The toxicology profile of JNJ-77242113 has been evaluated in a comprehensive program of Good
Laboratory Practice (GLP)-compliant studies that have also included toxicokinetic profiles. The
Sprague-Dawley rat and cynomolgus monkey were selected for toxicology testing based on the
ability of JNJ-77242113 to bind to IL-23R from rat and cynomolgus monkey and inhibit its
activity. 
JNJ-77242113 was not genotoxic in the bacterial reverse mutation (Ames) assay, in the in vitro
chromosome aberration assay, and in the in vivo rat comet and micronucleus assay. JNJ-77242113,
given orally via gavage, did not elicit any treatment-related adverse effects in any in vivo GLP
safety pharmacology studies assessing effects on cardiovascular function in telemeterized
cynomolgus monkeys, (up to 300 mg/kg), and respiratory function and neurobehavioral endpoints
in rats (up to 600 mg/kg).

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In repeat-dose studies in rats, JNJ-77242113 was well tolerated with no adverse toxicological
findings at oral doses up to 1000 mg/kg/day for 7 days (non-GLP), 600 mg/kg/day for 14 days
(GLP), 70 mg/kg/day for 6 weeks (GLP), or 20 mg/kg for 4 months (GLP).  The
no-observed-adverse-effect-level (NOAEL) was the highest dose tested in each study. In the
2-week study, area under the plasma concentration versus time curve (AUC) exposures on Day 14
were higher (5 to 47 times) than Day 1 exposures and the accumulation ratio further increased up
to 300 times following 6 weeks of dosing, and up to 206 times following 4 months of dosing. 
In cynomolgus monkeys, JNJ-77242113 was well tolerated with no adverse toxicological findings
following a single oral dose up to 1000 mg/kg/day (non-GLP) and repeat-doses up to 300 mg/kg
for 14 days (GLP) or up to 600 mg/kg/day for 17 weeks (GLP).  The NOAEL was the highest dose
tested in each study. In the 2-week study, plasma AUC exposures on Day 14 were within 2-fold
of the Day 1 exposures, indicating no meaningful accumulation. 
JNJ-77242113 was evaluated for effects on embryo fetal development in rats dosed up to
1000 mg/kg (for 12 days) and rabbits dosed up to 500 mg/kg (for 13 days). In rats, no maternal or
fetal developmental toxicity was reported at any dose and the NOAEL was the highest dose tested
(1000 mg/kg). 
. In rabbits, JNJ-77242113 dosing was associated with
maternal toxicity leading to abortions in 2 dams on GD26. There was a slight increase, above
historical control values, in the incidence of fused ribs in fetuses from dams dosed at 500 mg/kg.
 The NOAEL was the 
 dose of
, and AUC
exposure was
 over the expected exposure level in humans following a dose of
 Although the relevance to humans of these adverse findings at the high dose
(150 times exposure margins) is unknown, based on the high margins at the NOAEL, the risk to
pregnant women is considered low (International Council for Harmonisation [ICH] S5[R3]
Guidance 2020).
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI

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of JNJ-77242113 in humans. It is not uncommon with biologics to have only one species to assess
toxicity (generally on-target).
 
In summary, the available in vitro and in vivo pharmacology and nonclinical safety evaluation
studies support the proposed Phase 2b clinical study in participants with moderate-to-severe plaque
psoriasis.
Pharmacokinetic Profile
The pharmacokinetics (PK), distribution, and metabolism of JNJ-77242113 have been evaluated
in multiple in vitro and in vivo studies in nonclinical species. JNJ-77242113 has low passive
permeability and poor absorption. Oral bioavailability ranged from 0.1% to 0.3% in rat and
monkey studies.  JNJ-77242113 is not a P-glycoprotein substrate or inhibitor.
Plasma exposure levels were evaluated in multiple nonclinical safety studies. The longest GLP
nonclinical safety studies to date were conducted in rat (4 months of daily dosing) and cynomolgus
monkey (17 weeks of daily dosing). In the 6-week rat study, male and female Sprague-Dawley
rats were orally administered JNJ-77242113 at dose levels of 0, 5, 20, or 70 mg/kg/day. Increases
in JNJ-77242113 Cmax and AUC0-24 values were generally dose proportional or less than dose
proportional. 
 The NOAEL was the
highest dose tested in the study (70 mg/kg/day); Cmax and AUC0-24 values on Day 42 at this dose
were 614 ng/mL and 11,300 ng*hr/mL in males; the corresponding values were 720 ng/mL and
12,100 ng*hr/mL in females. In the most recent GLP rat study, male and female Sprague-Dawley
rats were orally administered JNJ-77242113 at 0, 1, 5, and 20 mg/kg/day for 4 months. Following
repeated daily oral administration of JNJ-77242113, exposure generally increased with dose and
notable accumulation of JNJ-77242113 was observed on Days 23, 58, and 114 when compared to
Day 1, with Day 114/Day 1 AUC accumulation ratios ranging from 22.2 to 206. The NOAEL was
the highest dose tested in the study (20 mg/kg/day); Cmax and AUC0-24 values on Day 114 at this
dose were 324 ng/mL and 4,170 ng*hr/mL in males; the corresponding values were 116 ng/mL
and 760 ng*hr/mL in females. In general, there was no significant difference in exposure between
sexes across the study arms; the difference in this group was mostly due to one animal with higher
exposure. In the 17-week monkey study, cynomolgus monkeys were orally administered
JNJ-77242113 at dose levels of 0, 30, 200, or 600 mg/kg/day. JNJ-77242113 mean Cmax and
AUC0-24 values were similar or slightly higher on Day 28 and 116 compared to Day 1, indicating
CCI
CCI
CCI

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minor accumulation of JNJ-77242113 after multiple doses.
 The NOAEL was the highest
dose tested in the study (600 mg/kg/day); Cmax and AUC0-24 values on Day 116 at this dose were
989 ng/mL and 9,440 ng*hr/mL in males; the corresponding values were 438 ng/mL and
4,610 ng*hr/mL in females.
Clinical Studies
The PN-235-01 study was a first-in-human (FIH), randomized, placebo-controlled study of single
and multiple ascending (SAD and MAD) doses of JNJ-77242113. The objectives were to assess
the safety and tolerability of JNJ-77242113 after single (10, 25, 100, 300, or 1000 mg, Part 1,
double-blinded) and multiple (10, 25, 100, 300, or 1000 mg, once daily [QD] dosing for 10 days,
Part 2, double-blinded) ascending oral dose administration in healthy participants, to evaluate the
PK and PD of JNJ-77242113, to assess the bioavailability of a tablet formulation of JNJ-77242113
relative to a solution, and to evaluate the effect of a high-fat meal on the tablet formulation PK
(25 mg, Part 3).
Safety results from PN-235-01 show that JNJ-77242113 was well tolerated with no significant
safety signals or concerns identified. There were no deaths or SAEs reported. The final cohort of
the MAD (1000 mg QD) was interrupted after a preliminary echocardiogram for a single
participant was misread and on final report was deemed to be normal.  At the time the study was
interrupted, in the 1000 mg QD cohort, 8 participants had completed 8 out of the planned 10 days
of treatment, and 2 participants had completed 7 days of treatment.
Refer to the JNJ-77242113 IB for the most up to date safety information from this clinical study.
Pharmacokinetic Summary
Preliminary PK data from FIH study PN-235-01 indicate that systemic exposure (Cmax  and AUC)
to JNJ-77242113 is approximately dose proportional across the dose range evaluated to date. After
multiple QD  dosing, steady state was achieved by Day 7 (earliest timepoint evaluated), with
minimal drug accumulation consistent with the observed mean terminal phase half-life of
approximately 9 to 12 hours.
Interim results from an ongoing, multipart, randomized, open-label, single-dose, crossover study
in healthy participants (77242113PSO1003) indicate that the oral bioavailability and PK profile of
JNJ-77242113 administered under fasted conditions as an immediate-release (IR) tablet
formulation is similar to the oral solution used in the FIH study PN-235-01.  The PK results also
indicate that concomitant food (high calorie, high-fat breakfast) increased the median time to reach
tmax and significantly reduced the rate (Cmax) and extent (AUC) of JNJ-77242113 absorption. Based
on the interim food effect data from protocol 77242113PSO1003, study intervention should be
administered under fasted conditions.
Refer to the JNJ-77242113 IB for more information on human PK.
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2.3. 
Benefit-Risk Assessment
Study 77242113PSO2001 is the first JNJ-77242113 study conducted in participants with psoriasis.
Therefore, the benefit-risk profile of JNJ-77242113 in patients with psoriasis has not been
established. No risks have been observed for JNJ-77242113. The risks described in Table 2 are
based on the drug platform (ie, a peptide therapeutic), risks that could occur from blocking the
IL-23 pathway based on information from monoclonal antibodies (mAbs), or study procedures.
2.3.1. 
Risks for Study Participation
More detailed information about the known and expected benefits and risks of JNJ-77242113 may
be found in the IB.
Table 2: 
Potential Risks of JNJ-77242113 for the Treatment ofPsoriasis
Potential Risks of Clinical
Significance
Summary of Data/
Rationale for Risk  
Mitigation Strategy
Risks Due to Study Intervention
Hypersensitivity Reactions 
Exogenous peptides administered
orally or systemically have the
potential to cause hypersensitivity
reactions.
 This potential risk will be
explained 
in 
the 
ICF 
and
participants will be trained to
recognize early signs of impending
anaphylaxis (Sampson 2006) and
seek medical attention.
 Participants with known allergy,
hypersensitivity, or intolerance to
JNJ-77242113 or its excipients
will be excluded from the study.
 Sites are instructed that before the
first administration 
of study
intervention 
(Week 
0),
appropriately trained personnel
and medications (eg, injectable
epinephrine) must be available to
treat hypersensitivity reactions,
including anaphylaxis. In addition,
all participants must be observed
carefully for signs and symptoms
of a hypersensitivity reaction
during the first administration (eg,
urticaria, pruritus, angioedema,
wheezing, 
dyspnea, 
or
hypotension; Section 6.1).
 Any participant who develops a
serious hypersensitivity reaction
such 
as 
anaphylaxis 
must
discontinue study intervention
(Section 7.1).
ADA production 
Exogenous peptides administered
orally or systemically can have the
potential to induce ADA
 This potential risk will be
explained in the ICF and evaluated

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Table 2: 
Potential Risks of JNJ-77242113 for the Treatment ofPsoriasis
Potential Risks of Clinical
Significance
Summary of Data/
Rationale for Risk  
Mitigation Strategy
production, which may mediate
untoward reactions such as reduced
efficacy or hypersensitivity.
by measuring ADAs and PK for
analysis.
 Participants are encouraged to
consistently take their study
intervention 12 hours apart, as
directed.
Drug 
accountability 
will 
be
performed at each study visit to
assess 
study 
intervention
compliance.
Infection 
Clinical experience with marketed
IL-23 pathway blockers include
precautions for infections and TB.
 This risk is included in the ICF.
 Participants with a history of, or
ongoing, chronic or recurrent
infectious 
disease, 
including
human immunodeficiency virus
(HIV), Hepatitis B or C virus
(HBV, HCV), will be excluded
from 
the 
study. 
Similarly,
participants with evidence of
active 
or 
untreated 
latent
tuberculosis (TB) will be excluded
from the study (Section 5.2).
 Participants who have received a
live viral or bacterial vaccination
within 12 weeks of baseline or
who have received the BCG
vaccine within 12 months of
baseline, will be excluded from the
study. In addition, participants
must agree not to receive a live
viral or live bacterial vaccination
during the study and for 4 weeks
after receiving the last dose of
study intervention (Section 5.2).
 Participants will be educated and
instructed 
to 
seek 
medical
attention if they develop signs or
symptoms 
suggestive 
of an
infection, and investigators will be
instructed to monitor for signs or
symptoms of infections, including
TB (Section 8.2.8).
 Discontinuation of a participant’s
study 
intervention 
must 
be
strongly 
considered 
if 
the
participant develops a serious
infection, including but not limited
to sepsis or pneumonia. In

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Table 2: 
Potential Risks of JNJ-77242113 for the Treatment ofPsoriasis
Potential Risks of Clinical
Significance
Summary of Data/
Rationale for Risk  
Mitigation Strategy
addition, any serious infection
should be discussed with the
medical monitor or designee, and
study intervention should be
withheld 
until 
the 
clinical
assessment 
is 
complete
(Section 7.1).
Risks Due to Study Procedures
Skin biopsy (optional substudy) 
Mild bleeding, pain, discomfort,
scarring, discoloration, and
infection may occur as part of
biopsy procedure.
This risk will be included in the
sub-study ICF. Trained and
experienced physicians will be
performing the procedure during
this study.
2.3.2. 
Benefits for Study Participation
Inhibiting IL-23 has been shown to be efficacious in patients with psoriasis as shown in studies
with monoclonal antibodies such as ustekinumab (IL-12/23), guselkumab, tildrakizumab, and
risankizumab (IL-23). The clinical benefit of JNJ-77242113 in patients with psoriasis remains to
be established.
2.3.3. 
Benefit-Risk Assessment for Study Participation
Study 77242113PSO2001 is the first study conducted in patients with psoriasis, and therefore, the
benefit-risk profile of JNJ-77242113 in patients with psoriasis has not been established. However,
JNJ-77242113 blocks the IL-23 receptor and thereby targets the IL-23 pathway, similar to
approved mAbs, ustekinumab (targeting IL-12/IL-23), guselkumab, tildrakizumab, and
risankizumab (targeting IL-23). JNJ-77242113 has the potential for efficacy in psoriasis given the
observed systemic exposures and high potency against the IL-23 receptor. The potential benefits
should justify the risks, which will be mitigated by measures taken during the conduct of the study.
3. 
OBJECTIVES AND ENDPOINTS
Objectives 
Endpoints
Primary
To evaluate the dose response of JNJ-77242113 at 
Week 16 in participants with moderate-to-severe 
plaque psoriasis 
Proportion of participants achieving PASI 75
(≥75% improvement from baseline in PASI) at
Week 16
Secondary
To characterize additional efficacy of 
JNJ-77242113 versus placebo in participants with 
moderate-to-severe plaque psoriasis 
 
Change from baseline in PASI total score at
Week 16
 
Proportion of participants achieving PASI 90
(≥90% improvement from baseline in PASI)
at Week 16

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Objectives 
Endpoints
 
Proportion of participants achieving PASI 100
(100% improvement from baseline in PASI)
at Week 16
 
Proportion of participants achieving an IGA
score of cleared (0) or minimal (1) at Week 16
 
Proportion of participants achieving an IGA
score of cleared (0) at Week 16
 
Change from baseline in BSA at Week 16
To evaluate the effect of JNJ-77242113 treatment
on patient-reported psoriasis severity versus
placebo in participants with moderate-to-severe
plaque psoriasis
 
Change from baseline in Psoriasis Symptoms
and Signs Diary (PSSD) symptoms scores at
Week 16
 
Change from baseline in PSSD signs score at
Week 16
 
Proportion of participants achieving PSSD
symptoms score=0 at Week 16 among
participants with a baseline symptoms score
≥1
 
Proportion of participants achieving PSSD
signs score=0 at Week 16 among participants
with a baseline signs score ≥1
To evaluate the effect of JNJ-77242113 treatment
on dermatology-specific health-related quality of
life versus placebo in participants with
moderate-to-severe plaque psoriasis
 
Proportion of participants achieving a DLQI
of 0 or 1 at Week 16 among participants with
baseline DLQI score >1
To evaluate the effect of JNJ-77242113 treatment
on general health-related quality of life versus
placebo in participants with moderate-to-severe
plaque psoriasis
 
Change from baseline in domain scores of the
Patient-Reported Outcomes Measurement
Information System (PROMIS-29) at
Week 16
 
Proportion of participants who achieve at least
a 5-point improvement from baseline in each
PROMIS-29 domain at Week 16
To assess the safety and tolerability of
JNJ-77242113 in participants with
moderate-to-severe plaque psoriasis
 Frequency and type of AEs and SAEs
Exploratory
To evaluate the PK and immunogenicity of JNJ-
77242113, and explore the PK/PD relationship of
JNJ-77242113 for biomarkers, efficacy, and
safety in participants with moderate-to-severe
plaque psoriasis
 
JNJ-77242113 PK parameters (ie, plasma
concentration just prior to the beginning or at
the end of the dosing interval [Ctrough], Cmax,
tmax, and AUC)
 
The relationship between PK parameters and
PD (ie, skin, blood cellular and molecular
biomarker activity as well as clinical endpoints
and safety parameters)
 
The incidence of anti-drug antibodies to
JNJ-77242113
To characterize additional efficacy of
JNJ-77242113 versus placebo for the treatment of
regional psoriasis
 
Proportion of participants achieving an
ss-IGA score of absence of disease (0) or very
mild disease (1) and at least a 2-grade
improvement from baseline at Week 16

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Objectives 
Endpoints
among those participants randomized with
scalp psoriasis and an ss-IGA score ≥2 at
baseline
 
Percent change from baseline in NAPSI at
Week 16 among participants randomized with
a NAPSI score >0 at baseline
 
Proportion of participants achieving an f-PGA
score of clear (0) or minimal (1) at Week 16
among those participants randomized with
nail psoriasis and an f-PGA score ≥2 at
baseline
 
Proportion of participants who achieve an
hf-PGA score of clear (0) or almost clear (1)
and a reduction of at least 2 grades on the
hf-PGA scale from baseline at Week 16
among those participants with hand and/or
foot psoriasis and an hf-PGA score ≥2 at
baseline
 
Proportion of participants achieving a sPGA
of genitalia score of clear (0) or minimal (1) at
Week 16 among participants randomized with
genital psoriasis and an sPGA of genitalia
score ≥3 at baseline
 
Proportion of participants achieving a
GenPs-SFQ item 2 score ofnever (0) or
rarely (1) at Week 16 among those
participants with a GenPs-SFQ item 2 score
≥2 at baseline
To further assess the safety and tolerability of
JNJ-77242113 in participants with
moderate-to-severe plaque psoriasis
 
Frequency and type of related AEs, and AEs
leading 
to 
discontinuation 
of 
study
intervention
 
Laboratory parameters and change from
baseline 
in 
laboratory 
parameters
(hematology and chemistry) over time
 
Systolic and diastolic blood pressures over
time
To explore biomarkers in participants with
moderate-to-severe plaque psoriasis
 
Change from baseline in levels of skin and
blood biomarkers
To explore treatment satisfaction after using
JNJ-77242113 in participants with moderate-to-
severe plaque psoriasis
 
Assessment of treatment satisfaction domains
at Week 16 using the Treatment Satisfaction
Questionnaire for Medications-9 items
(TSQM‑9)
Refer to Section 8, Study Assessments and Procedures for evaluations related to endpoints.
HYPOTHESIS:
The hypothesis of this study is that there is a dose response relationship for JNJ-77242113 in the
proportion of participants achieving a PASI 75 response at Week 16.

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4. 
STUDY DESIGN
4.1. 
Overall Design
This is a randomized, double-blind, placebo-controlled, dose-ranging, parallel group, multicenter,
interventional study in participants with moderate-to-severe plaque psoriasis.
A target of 240 participants will be enrolled in this study with 40 participants planned per
intervention group.
Participants will be instructed to take the study intervention  in the morning (AM) and in the
evening (PM) on an empty stomach with  approximately 240 mL of noncarbonated water at
approximately the same time every day. An empty stomach is defined as abstaining from food
intake for at least 2 hours before taking the study intervention and abstaining from food and liquid
intake for at least 30 min after taking the study intervention. Dietary intake should be recorded per
study manual.
The study intervention may be delivered directly to the participants from a courier as permitted by
local requirements and/or regulations if approved by the Independent Ethics Committee (IEC)/
Institutional Review Board (IRB); Section 6.2. Details regarding delivery are provided in the study
manual. The participant has the ability to opt-in or opt-out of using this service throughout the
duration of the study.
Group 1: JNJ-77242113 (25mg QD): Participants will receive JNJ-77242113 25 mg QD from
Week 0 through Week 16
Group 2: JNJ-77242113 (50 mg QD): Participants will receive JNJ-77242113 50 mg QD from
Week 0 through Week 16
Group 3: JNJ-77242113 (100 mg QD): Participants will receive JNJ-77242113 100 mg QD from
Week 0 through Week 16
Group 4: JNJ-77242113 (25mg BID): Participants will receive JNJ-77242113 25 mg BID from
Week 0 through Week 16
Group 5: JNJ-77242113 (100 mg BID): Participants will receive JNJ-77242113 100 mg BID
from Week 0 through Week 16
Group 6: Placebo: Participants will receive placebo BID from Week 0 through Week 16
At Week 16, eligible participants will have the option to enroll in a 36-week treatment long term
extension (LTE) study; all participants will be treated with active study intervention in the LTE.
The study design of the LTE will be detailed in a separate protocol (77242113PSO2002).
The total duration of this study is up to 24 weeks: a screening period of ≤4 weeks, a 16-week
treatment period, and a 4-week safety follow-up period after the last study intervention
administration for participants who are ineligible or have decided to not enroll in the LTE study at

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Week 16. All eligible participants who enroll in the LTE will continue treatment after the Week 16
visit under the LTE protocol.
Efficacy, safety, PK, immunogenicity, and biomarkers will be assessed according to the Schedule
ofActivities (SoA; Section 1.3, Table 1). In addition, there will be 4 optional substudy collections
for participants who consent (where local regulations permit): a pharmacogenomic blood sample,
ex vivo cytokine release blood sample, skin biopsy, and photograph collection (lesional or lesional
and full body).
One planned database lock (DBL) will occur at Week 16.
Two interim analyses will occur in this study at Week 4 and Week 16, as specified in Section 9.5.
An external Independent Data Monitoring Committee (iDMC) will be commissioned for this study
(Section 10.3.6).
A diagram of the study design is provided in Figure 1.
4.2. 
Scientific Rationale for Study Design
Blinding, Control, Study Phase/Periods, Intervention Groups
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 intervention. Randomization will be used to
minimize bias in the assignment of participants to intervention groups, to increase the likelihood
that known and unknown participant attributes (eg, demographic and baseline characteristics) are
evenly balanced across intervention groups, and to enhance the validity of statistical comparisons
across intervention groups. Blinded intervention will be used to reduce potential bias during data
collection and evaluation of clinical endpoints.
DNA and Biomarker Collection
It is recognized that genetic variation can be an important contributory factor to interindividual
differences in intervention distribution and response and can also serve as a marker for disease
susceptibility and prognosis. Pharmacogenomic research may help to explain interindividual
variability in clinical outcomes and may help to identify population subgroups that respond
differently to an intervention. The goal of the pharmacogenomic component is to collect DNA to
allow the identification of genetic factors that may influence the PK, PD, efficacy, safety, or
tolerability of JNJ-77242113 and to identify genetic factors associated with psoriasis.
Biomarker samples will be collected to evaluate the mechanism of action of JNJ-77242113 or help
to explain interindividual variability in clinical outcomes or may help to identify population
subgroups that respond differently to an intervention. The goal of the biomarker analyses is to
evaluate the PD of JNJ-77242113 and aid in evaluating the intervention-clinical response
relationship.

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DNA and biomarker samples may be used to help address emerging issues and to enable the
development of safer, more effective, and ultimately individualized therapies.
4.2.1. 
Study-Specific Ethical Design Considerations
Potential participants will be fully informed of the risks and requirements of the study and, during
the study, participants will be given any new information that may affect their decision to continue
participation. They will be told that their consent to participate in the study is voluntary and may be
withdrawn at any time with no reason given and without penalty or loss of benefits to which they
would otherwise be entitled. Only participants who are fully able to understand the risks, benefits,
and potential AEs of the study, and provide their consent voluntarily will be enrolled.
The study design includes a placebo treatment arm through Week 16. All eligible participants will
have the option to enroll into a 36-week treatment LTE study where all participants will receive
active treatment (LTE design detailed in a separate protocol).
Participants will be discontinued from study intervention if the investigator considers it is in the best
interest of the participant.
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 in this study based upon the standard of the
American Red Cross standard limit for whole blood donation (approximately 450 mL every
8 weeks) and is, therefore, considered an acceptable amount of blood to be collected over this time.
(Section 8).
4.3. 
Justification for Dose
A FIH study, (PN-235-01) was conducted to evaluate single ascending and multiple (QD  for
10 days) ascending doses of JNJ-77242113 (10, 25, 100, 300, and 1000 mg) in healthy participants.
The study demonstrated that single and multiple oral doses up to 1000 mg/day are safe and generally
well tolerated with no safety signal of concern. Systemic exposure (Cmax and AUC) to JNJ-77242113
was approximately dose-proportional across the dose range evaluated. After multiple QD dosing,
steady state was achieved by Day 7 (earliest timepoint evaluated), consistent with the observed mean
terminal phase half-life of approximately 9 to 12 hours. Refer to the IB for additional details
regarding the FIH study results. 
The dose selection for the Phase 2b study is based on observed PK and ex vivo PD data (ie, inhibition
of IL-23-stimulated interferon gamma production in whole blood) from the FIH study and a
comparative analysis of in vitro IL-23/IL-23R pathway inhibition for JNJ-77242113 relative to
 The
observed human 
 were used to develop preliminary population
 along with the in vitro pathway inhibition data. The observed data from the
FIH study are consistent with these predictions and indicate that 
CCI
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are associated with systemic activity as evidenced by 
 (whole blood IL-23-stimulated
interferon gamma production and peripheral blood mononuclear cells [PBMC] pSTAT3 assays).
The daily doses selected for the Phase 2b study range from 25 mg to 200 mg per day and include
both once-daily (25 mg QD, 50 mg QD, and 100 mg QD) and BID dosing regimens (25 mg BID and
100 mg BID). 
In summary, the doses and dosing regimens of JNJ-77242113 selected for this Phase 2b study are
based on preclinical and clinical exposure-response modeling to maximize the likelihood of a
positive study outcome and supported by human safety/tolerability data from the FIH study and the
toxicology margins.
4.4. 
End of Study Definition
End of Study Definition
The end of study is considered as the last visit for the last participant in the study. The final data
from the study site will be sent to the sponsor (or designee) after completion of the final participant
visit at that study site, in the time frame specified in the Clinical Trial Agreement.
Study Completion Definition
Participants who enroll in the LTE will be considered to have completed the study if theycomplete
all scheduled study interventions through Week 16. Participants who do not enroll in the LTE will
be considered to have completed the study if they complete all assessments at the safety follow-up
visit (ie, Week 20).
5. 
STUDY POPULATION
Screening for eligible participants will be performed up to 28 days before randomization. Refer to
Section 5.4, Screen Failures for conditions under which the repeat of any screening procedures is
allowed.
The inclusion and exclusion criteria for enrolling participants in this study are described below. If
there is a question about these criteria, the investigator must consult with the appropriate sponsor
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representative and resolve any issues before enrolling a participant in the study. Waivers are not
allowed.
For a discussion of the statistical considerations of participant selection, refer to Section 9.
5.1. 
Inclusion Criteria
Each potential participant must satisfy all of the following criteria to be enrolled in the study:
Age
1. 
Be ≥18 (or the legal age of consent if it is higher in the jurisdiction in which the study is
taking place) years of age, inclusive.
Type of Participant and Disease Characteristic
2. 
Criterion modified per Amendment 1
2.1 Has a diagnosis of plaque psoriasis, with or without PsA, for at least 6 months prior
to the first administration of study intervention.
3. 
Has a total BSA ≥10% at screening and baseline.
4. 
Has a total PASI ≥12 at screening and baseline.
5. 
Has a total IGA ≥3 at screening and baseline.
6. 
Be a candidate for phototherapy or systemic treatment for plaque psoriasis.
7. 
Must agree to avoid prolonged sun exposure and avoid use of tanning booths or other
ultraviolet (UV) light sources during the study.
8. 
Otherwise healthy on the basis of physical examination, medical history, and vital signs,
and 12-lead triplicate electrocardiogram (ECG) performed at screening. Any
abnormalities, must be consistent with the underlying illness in the study population and
this determination must be recorded in the participant’s source documents and initialed
by the investigator.
Sex and Contraceptive/Barrier Requirements
9. 
A woman of childbearing potential must have a negative highly sensitive serum (-human
chorionic gonadotropin [-hCG]) at screening and a negative urine pregnancy test at
Week 0 prior to administration of study intervention.
10. 
Before randomization, a woman must be either:
a. Not of childbearing potential (Section 10.8).

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b. Of childbearing potential and
o 
Practicing a highly effective method of contraception (failure rate of <1%
per year when used consistently and correctly) prior to receiving study
intervention, during the study, and for at least 12 weeks after receiving the
last administration of study intervention, consistent with local regulations
regarding the use of birth control methods for participants participating in
clinical studies. Examples of highly effective methods of contraception are
located in Section 10.8.
o 
The investigator should evaluate the potential for contraceptive method
failure (eg, noncompliance, recently initiated) in relationship to the first
dose of study intervention.
Note: If a female participant’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.
11. 
A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the
purposes of assisted reproduction during the studyand for at least 12 weeks after receiving
the last administration of study intervention.
12. 
A male participant 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 study  intervention. Male
participants should also be advised of the benefit for female partner to use a highly
effective method of contraceptive as condoms may break or leak.
13. 
A male participant must agree not to donate sperm for the purpose of reproduction during
the study and for at least 12 weeks after receiving the last administration of study
intervention.
Screening Laboratory Test Parameters
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:
a. Hemoglobin ≥10 g/dL (SI: ≥100 g/L)
b. White blood cells ≥3.5 x 103/μL (SI: ≥3.5 GI/L)
c. Neutrophils ≥1.5 x 103/μL (SI: ≥1.5 GI/L)
d. Platelets ≥100 x 103/μL (SI: ≥100 GI/L)
e. Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2
f. Aspartate aminotransferase ≤2 × upper limit of normal (ULN)

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g. Alanine aminotransferase ≤2 × ULN
h. Alkaline phosphatase ≤2 × ULN
Vaccination
15. 
Agree not to receive a live virus or live bacterial vaccination during the study, or within
4 weeks after the last administration of study intervention.
General
16. 
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.
17. 
Must sign a separate ICF(s) if he or she agrees to provide optional deoxyribonucleic acid
(DNA) and/or biomarkers samples and/or photographs for research (where local
regulations permit). Refusal to give consent for the optional DNA and/or biomarker
samples and/or photographs does not exclude a participant from participation in the study.
18. 
Willing and able to adhere to the lifestyle restrictions specified in this protocol.
5.2. 
Exclusion Criteria
Any potential participant who meets any of the following criteria will be excluded from
participating in the study:
Disease Characteristics
1. 
Has a nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular).
2. 
Has current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of
psoriasis from beta blockers, calcium channel blockers, or lithium).
Prior/Concomitant Therapy
3. 
Has previously received any other therapeutic agent directly targeted to IL-23
(including but not limited to guselkumab, tildrakizumab, or risankizumab).
4. 
Has received any therapeutic agent directly targeted to IL-17 or IL-12/23 (including but
not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received
anti-TNFα biologic therapy (including, but not limited to adalimumab) within 12 weeks
or 5 half-lives, whichever is longer, of the first administration of study intervention.
5. 
Criterion modified per Amendment 2
Has received agents that deplete B cells (including, but not limited to, rituximab, or
alemtuzumab) within 26 weeks of the first administration of study intervention.

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6. 
Has received natalizumab, belimumab, or agents that modulate T cells (including, but
not limited to abatacept or visilizumab) 12 weeks or 5 half-lives, whichever is longer,
of the first administration of study intervention.
7. 
Has received JAK inhibitor therapy within 4 weeks of the first administration of study
intervention.
8. 
Has received phosphodiesterase 4 (PDE4) inhibitor therapy (including but not limited
to apremilast) within 4 weeks of the first administration of study intervention.
9. 
Has received any systemic immunosuppressants (including, but not limited to,
methotrexate [MTX], azathioprine, cyclosporine, 6-thioguanine, mercaptopurine,
mycophenolate mofetil, and tacrolimus) within 4 weeks of the first administration of
study intervention.
10. 
Has received, or is expected to receive, any live virus or bacterial vaccination within
12 weeks before the first administration of study intervention. For exclusions related to
the bacille Calmette Guerin (BCG)vaccine, see Exclusion 11.
11. 
Has received the BCG vaccine within 12 months of the first administration of study
intervention.
12. 
Has received phototherapy or any systemic medications that could affect psoriasis or
the PASI or IGA evaluations (including, but not limited to, oral or injectable
corticosteroids, acitretin, retinoids, 1,25-dihydroxy vitamin D3 and analogues, herbal
treatments or traditional Taiwanese, Korean, or Chinese medicines) within 4 weeks of
the first administration of study intervention.
13. 
Has received topical therapies that could affect psoriasis or the PASI or IGA evaluation
(including, but not limited to corticosteroids, tar, anthralin, calcipotriene, tazarotene,
methoxsalen, pimecrolimus, tacrolimus, and traditional Taiwanese, Korean, or Chinese
medicines) within 2 weeks of the first administration of study intervention.
Prior/Concurrent Clinical Study Experience
14. 
Has received an experimental antibody or biologic therapy within 12 weeks or
5 half-lives of the first administration of study intervention or received any other
experimental therapy or new investigational agent within 4 weeks or 5 half-lives
(whichever is longer) of the first study intervention administration or is currently
enrolled in another study using an investigational agent, device, or procedure.

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Medical Conditions
15. 
Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled
renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,
hematologic, rheumatologic, psychiatric, or metabolic disturbances.
16. 
Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
(refer to the JNJ-77242113 IB).
17. 
Has had major surgery within 8 weeks before screening, or will not have fully recovered
from surgery, or has surgery planned during the time the participant is expected to
participate in the study.
Note: Participants with planned surgical procedures to be conducted under local
anesthesia may participate.
18. 
Has a transplanted organ (with exception of a corneal transplant >3 months before the
first administration of study intervention).
19. 
Has suicidal ideation or suicidal behavior in the last 6 months that may be defined as a
Columbia-Suicide Severity Rating Scale (C-SSRS) rating at screening of: Suicidal
Ideation with Intention to Act (“Ideation level 4”), Suicidal Ideation with Specific Plan
and Intent (“Ideation level 5”), or suicidal behavior (actual suicide attempt, interrupted
suicide attempt, aborted suicide attempt, or preparatory behaviors for making a suicide
attempt), and is considered to be at risk by the investigator based on an evaluation by a
mental health professional. In addition, participants with C-SSRS ratings of Wish to be
Dead (“Ideation level 1”), Non-Specific Active Suicidal Thoughts (“Ideation level 2”),
Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act (“Ideation
level 3”) or non-suicidal self-injurious behavior who are determined to be at risk by the
investigator may not be randomized.
Infections or Predisposition to Infections
20. 
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.
21. 
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.
22. 
Has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis), or has been
hospitalized or received IV antibiotics for an infection during the 2 months before
screening.

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23. 
Has or has had herpes zoster within the 2 months before screening.
24. 
Has a history of active granulomatous infection, including histoplasmosis or
coccidioidomycosis, before screening. Refer to Exclusion Criterion 32 for information
regarding eligibility with a history of latent TB.
25. 
Has a chest radiograph within 3 months before the first administration of study
intervention that shows an abnormality suggestive of a malignancy or current active
infection, including TB.
26. 
Has ever had a nontuberculous mycobacterial infection or opportunistic infection (eg,
cytomegalovirus, pneumocystis, or aspergillosis).
27. 
Tests positive for hepatitis B virus (HBV) infection (Section 10.10) or who are
seropositive for antibodies to hepatitis C virus (HCV) at screening.
28. 
Has a history of human immunodeficiency virus (HIV) antibody positive or tests
positive for HIV at screening.
29. 
Criteria modified per Amendment 2.
29.1 COVID-19 Infection:
During the 6 weeks prior to baseline, have had ANY of the following (regardless of
vaccination status): (a) confirmed severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) infection (test positive) OR (b) suspected SARS-CoV-2 infection
(clinical features of COVID-19 without documented test results), OR (c) close contact
with a person with known or suspected SARS-CoV-2 infection:
 
Exception: may be included with a documented negative result for a validated
SARS-CoV-2 test:
(i) 
obtained at least 2 weeks after conditions (a), (b), (c) above (timed from
resolution of key clinical features if present, [eg, fever, cough, or dyspnea])
AND
(ii) with absence of ALL conditions (a), (b), (c) above during the period between the
negative test result and the baseline study visit.
NOTE on COVID-related exclusion:
 
The field of COVID-related testing (for presence of, and immunity to, the
SARS-CoV-2 virus) is rapidly evolving. Additional testing may be performed as
part of screening and/or during the study if deemed necessary by the investigator
and in accordance with current regulations/guidance from authorities/standards of
care.

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Precaution: for those who may carry a higher risk for severe COVID-19 illness, follow
guidance from local health authorities when weighing the potential benefits and risks
of enrolling in the study, and during participation in the study.
Malignancy or Increased Potential for Malignancy
30. 
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
intervention administration or cervical carcinoma in situ that has been treated with no
evidence of recurrence for at least 3 months before the first study intervention
administration).
31. 
Has a history of lymphoproliferative disease, including lymphoma; a history of
monoclonal gammopathy of undetermined significance; or signs and symptoms
suggestive of possible lymphoproliferative disease, such as splenomegaly or significant
lymphadenopathy.
Tuberculosis
32. 
Meet ANYof the following tuberculosis (TB) screening criteria.
Note: Interferon gamma release assay (IGRA) testing includes either
QuantiFERON-TB® or T-SPOT®TB.
a. Have a history of active TB or show signs or symptoms suggestive of active
TB upon medical history and/or physical examination at screening.
b. Have a history of untreated latent TB prior to screening. An exception is made
for participants who are currently receiving treatment or will initiate treatment
for latent TB prior to first administration of study intervention.
Note: For participants with a history of treated latent TB there must be
documentation of appropriate treatment prior to the first administration of
study intervention. It is the responsibility of the investigator to verify the
adequacy of previous TB treatment and provide appropriate documentation.
IGRA testing is not required at screening for participants with a history of
treated latent TB or ongoing treatment for latent TB.
c. Have had recent close contact with a person with active TB. An exception is
made if such participants are referred to a physician specializing in TB to
determine if treatment is warranted or not. This evaluation must be adequately
documented and, if treatment is recommended, the participant must be
receiving appropriate treatment prior to the first administration of study
intervention.
d. Have a positive IGRA test result within 2 months prior to the first
administration of study intervention. An exception is made for participants
who:

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- have a history of adequately treated latent TB described above.
- have a newly identified positive IGRA test result in which active TB has
been ruled out and for which appropriate treatment for latent TB has been
initiated prior to the first administration of study intervention.
- have a false-positive IGRA test as determined by the following:
o A suspected false-positive initial IGRA test must be repeated. If
repeat testing is NOT positive, the participant must be referred to a
physician specializing in TB to determine if the initial test can be
considered a false-positive. This evaluation must be adequately
documented prior to the first administration of study intervention.
If repeat testing is positive, however, it will be considered a true-
positive and the participant is only eligible if active TB has been
ruled out and appropriate treatment for latent TB has been initiated
as described above.
Note: Indeterminate/borderline results should be handled as outlined in
Section 8.2.8.
e. Have a chest radiograph or chest computed tomography within 3 months prior
to the first administration of study intervention that shows abnormalities
suggestive of active or inactive TB.
Other Exclusions
33. 
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.
34. 
Is pregnant, nursing, or planning a pregnancy (both men and women) while enrolled in
the study or within 12 weeks following the last dose of study intervention.
35. 
Has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual
of Mental Disorders (5th edition) criteria within 12 months before screening.
36. 
Has any condition for which, in the opinion of the investigator, participation would not
be in the best interest of the participant (eg, compromise the well-being) or that could
prevent, limit, or confound the protocol-specified assessments.
NOTE: Investigators should ensure that all study enrollment criteria have been met at screening.
If a participant's clinical status changes (including any available laboratory results or receipt of
additional medical records) after screening but before the first dose of study intervention is given
such that the participant no longer meets all eligibility criteria, then the participant should be
excluded from participation in the study. The required source documentation to support meeting
the enrollment criteria are noted in Section 10.3.10.

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5.3. 
Lifestyle Considerations
Potential participants must be willing and able to adhere to the following lifestyle restrictions
during the study to be eligible for participation:
1. 
Refer to Section  6.8, Concomitant Therapy  for details regarding prohibited and
restricted therapy during the study.
It is recommended to be up to date on all age-appropriate vaccinations prior to screening
as per routine local medical guidelines. It is strongly recommended that participants
will have completed a locally-approved (or emergency use-authorized) COVID-19
vaccination regimen at least 2 weeks prior to study-related visits or procedures. Study
participants should follow applicable local vaccine labelling, guidelines, and standards-
of-care for patients receiving immune-targeted therapy when determining an
appropriate interval between vaccination and study enrollment (Section 6.8).
2. 
A woman of childbearing potential who is heterosexually active must remain on a
highly effective method of birth control (Inclusion Criterion 10) during the study and
for at least 12 weeks after receiving the last administration of study intervention.
3. 
A woman must agree not to donate eggs (ova, oocytes; Inclusion Criterion 11) during
the study and for a period of at least 12 weeks following the last administration of study
intervention.
4. 
A man who is sexually active with a female of childbearing potential and has not had a
vasectomy must agree to use a barrier method of birth control (Inclusion Criterion 12)
during the study and for at least 12 weeks after receiving the last administration of study
intervention.
5. 
A man must agree to not donate sperm during the study and for at least 12 weeks after
receiving the last administration of study intervention (Inclusion Criterion 13).
6. 
Agree to use sun protective measures (such as a hat, sunglasses, protective clothing,
sunscreen), limit prolonged exposure to natural sunlight, and avoid artificial sunlight
(tanning beds or phototherapy)during the study.
7. 
Agree to remove nail polish and/or artificial nails prior to or at all visits where nail
psoriasis is assessed.
8. 
Agree to follow all requirements that must be met during the study as noted in the
Inclusion and Exclusion Criteria (eg, contraceptive requirements).

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5.4. 
Screen Failures
Participant Identification, Enrollment, and Screening Logs
The investigator agrees to complete a participant identification and enrollment log to permit easy
identification of each participant during and after the study. This document will be reviewed by
the sponsor study site contact for completeness.
The participant identification and enrollment log will be treated as confidential and will be filed
by the investigator in the study file. To ensure participant confidentiality, no copy will be made.
All reports and communications relating to the study will identify participants by age at initial
informed consent. In cases where the participant is not enrolled into the study, the date seen and
age at initial informed consent will be used.
Retesting
Retesting of abnormal laboratory values that may lead to exclusion will be allowed once. Retesting
can occur at an unscheduled visit during the screening phase, as long as this is done within the
specified screening window of up to 4 weeks. In such cases, the first abnormal test result will not
constitute a screen failure. If a laboratory abnormality occurs, the site is encouraged to wait for all
laboratory tests to be completed to ensure other laboratory tests do not need to be repeated, as only
1 retest of laboratory tests is allowed. A screening laboratory test(s) analyzed by the central
laboratory may be repeated more than once in the event of suspected error in sample collection or
analysis as long as the result is obtained within the screening period.
Rescreening
Individuals who do not meet the criteria for participation in this study (screen failure) may be
rescreened 1 time. Rescreened participants will be assigned a new participant number, undergo the
informed consent process, and then start a new screening phase. Waivers to eligibility criteria are
not permitted. Previous TB evaluation results (including IGRA testing and chest radiograph) from
the first screening event may be used if they meet the specified protocol criteria as described in
Sections 5.1 and 5.2. Medical Monitor approval is required prior to the study site obtaining a new
informed consent for rescreening. The investigator must also complete a participant screening log,
which reports on all participants who were seen to determine eligibility for inclusion in the study.
6. 
STUDY INTERVENTION AND CONCOMITANT THERAPY
Study site personnel will instruct participants on how to store study intervention for at-home use
as indicated for this protocol.
JNJ-77242113 will be manufactured and provided under the responsibility of the sponsor. Refer to
the JNJ-77242113 IB for a list of excipients.
For a definition of study intervention overdose, refer to Section 6.7, Treatment of Overdose.

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6.1. 
Study Interventions Administered
Group/Arm Name 
Group 1 
Group 2 
Group 3 
Group 4 
Group 5 
Group 6
Intervention Name 
JNJ-77242113 
JNJ-77242113 
JNJ-77242113 
JNJ-77242113 
JNJ-77242113 
Placebo
Dose Formulation 
Yellow colored, 
film-coated tablets 
Yellow colored, 
film-coated tablets 
Yellow colored, 
film-coated tablets 
Yellow colored, 
film-coated tablets 
Yellow colored, 
film-coated tablets 
Yellow colored,
film-coated tablets
Unit Dose Strength(s) 
25 mg 
25mg 
100mg 
25mg 
100mg 
N/A
Dosage Level(s) and 
Frequency  
25 mg QD (AM) 
and placebo (PM) 
50mg QD (AM) and 
placebo (PM) 
100mg QD (AM) 
and placebo (PM) 
25mg BID (AM and 
PM) 
100mg BID (AM 
and PM) 
Placebo (AM) and
(PM)
Route of 
Administration
☒Oral 
☒Oral 
☒Oral 
☒Oral 
☒Oral 
☒Oral
Dosing instructions 
Participants should
take study
intervention in the
morning (AM) and
in the evening (PM)
on an empty
stomach with
approximately
240 mL of
noncarbonated
water. An empty
stomach is defined
as abstaining from
food intake for at
least 2 hours before
taking the study
intervention and
abstaining from
food and liquid
intake for at least 30
minutes after taking
the study
intervention.
Placebo will be
administered to
maintain the blind.
Participants should
take study
intervention in the
morning (AM) and
in the evening (PM)
on an empty
stomach with
approximately
240 mL of
noncarbonated
water. An empty
stomach is defined
as abstaining from
food intake for at
least 2 hours before
taking the study
intervention and
abstaining from
food and liquid
intake for at least 30
minutes after taking
the study
intervention.
Placebo will be
administered to
maintain the blind.
Participants should
take study
intervention in the
morning (AM) and
in the evening (PM)
on an empty
stomach with
approximately
240 mL of
noncarbonated
water. An empty
stomach is defined
as abstaining from
food intake for at
least 2 hours before
taking the study
intervention and
abstaining from
food and liquid
intake for at least 30
minutes after taking
the study
intervention.
Placebo will be
administered to
maintain the blind.
Participants should
take study
intervention in the
morning (AM) and
in the evening (PM)
on an empty
stomach with
approximately
240 mL of
noncarbonated
water. An empty
stomach is defined
as abstaining from
food intake for at
least 2 hours before
taking the study
intervention and
abstaining from
food and liquid
intake for at least 30
minutes after taking
the study
intervention.
Placebo will be
administered to
maintain the blind.
Participants should
take study
intervention in the
morning (AM) and
in the evening (PM)
on an empty
stomach with
approximately
240 mL of
noncarbonated
water. An empty
stomach is defined
as abstaining from
food intake for at
least 2 hours before
taking the study
intervention and
abstaining from
food and liquid
intake for at least 30
minutes after taking
the study
intervention.
Placebo will be
administered to
maintain the blind.
Participants should
take study
intervention in the
morning (AM) and
in the evening (PM)
on an empty
stomach with
approximately
240 mL of
noncarbonated
water. An empty
stomach is defined
as abstaining from
food intake for at
least 2 hours before
taking the study
intervention and
abstaining from food
and liquid intake for
at least 30 minutes
after taking the study
intervention.

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Group/Arm Name 
Group 1 
Group 2 
Group 3 
Group 4 
Group 5 
Group 6
Use 
☒Experimental 
☒Experimental 
☒Experimental 
☒Experimental 
☒Experimental 
☒Placebo
Investigational 
Medicinal Product
(IMP)
☒Yes 
☐No 
☒Yes 
☐No 
☒Yes 
☐No 
☒Yes 
☐No 
☒Yes 
☐No 
☒Yes 
☐No
Non-Investigational 
Medicinal Product
(NIMP)
☐Yes 
☒No 
☐Yes 
☒No 
☐Yes 
☒No 
☐Yes 
☒No 
☐Yes 
☒No 
☐Yes 
☒No

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6.2. 
Preparation/Handling/Storage/Accountability
Preparation/Handling/Storage
The study intervention may be delivered directly to the participants from the site by a courier. Each
courier will adhere to privacy requirements approved by the IEC/IRB. The capability to utilize
these direct-to-patient shipments will be assessed by the sponsor to ensure that it is allowable per
local regulations.
All study intervention must be stored at controlled temperatures ranging from 2°C to 8°C. Study
site personnel will instruct participants on how to store and administer study intervention for
at‑home use as indicated in this protocol.
Refer to the Site Investigational Product Procedures Manual for additional guidance on study
intervention preparation, handling, and storage.
Accountability
The investigator is responsible for ensuring that all study intervention received at the site is
inventoried and accounted for throughout the study. The dispensing of study intervention to the
participant and the return of study intervention from the participant must be documented on the
intervention accountability form. Participants must be instructed to return all original containers,
whether empty or containing study intervention.
Study intervention must be handled in strict accordance with the protocol and the container label
and must be stored at the study site in a limited-access area or in a locked cabinet under appropriate
environmental conditions. Unused study intervention  and study intervention returned by the
participant, must be available for verification by the sponsor’s study site monitor during on-site
monitoring visits. The return to the sponsor of unused study intervention, or used returned study
intervention for destruction, will be documented on the intervention return form. When the study
site is an authorized destruction unit and study intervention supplies are destroyed on-site, this
must also be documented on the intervention return form.
Potentially hazardous materials should be disposed of immediately in a safe manner and therefore
will not be retained for intervention accountability purposes.
Study intervention should be dispensed under the supervision of the investigator or a qualified
member of the study site personnel, or by a hospital/clinic pharmacist. Study intervention will be
supplied only to participants participating in the study. Returned study intervention must not be
dispensed again, even  to the same participant. Study intervention may not be relabeled or
reassigned for use by other participants. The investigator agrees neither to dispense the study
intervention from, nor store it at, any site other than the study sites agreed upon with the sponsor.
Further guidance and information for the final disposition of unused study interventions are
provided in the Study Reference Manual.

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6.3. 
Measures to Minimize Bias: Randomization and Blinding
Intervention Allocation
Procedures for Randomization and Stratification
Dynamic central randomization will be implemented in conducting this study. Participants will be
assigned to 1 of 6 intervention groups based on an algorithm implemented in the interactive web
response system (IWRS) before the study. Dynamic central randomization minimizes the
imbalance in the distribution of the number of participants across intervention groups within the
levels of each individual stratification factor: study site and baseline weight (≤90 kg, >90 kg). In
addition, the Japanese sites will be pooled in the randomization process to better ensure treatment
balance across Japanese participants. Based on the algorithm, the IWRS will assign a unique
intervention code, which will dictate the intervention assignment and matching study intervention
kit for the participant.
Blinding
The investigator will not be provided with randomization codes. The codes will be maintained
within the interactive web response system (IWRS), which has the functionality to allow the
investigator to break the blind for an individual participant.
Data that may potentially unblind the intervention assignment (ie, study  intervention plasma
concentrations, anti-JNJ-77242113 antibodies, study intervention preparation/accountability data,
intervention allocation, and biomarker data) 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 database lock and unblinding.
Under normal circumstances, the blind should not be broken until all participants have completed
the study and the database is finalized. The investigator may, in an emergency, determine the
identity of the intervention by contacting the IWRS. While the responsibility to break the
intervention code in emergency situations resides solely with the investigator, 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, time, and reason for the unblinding must be documented
by the IWRS and in the source document. The documentation received from the IWRS indicating
the code break must be retained with the participant's source documents in a secure manner.
Participants who have had their intervention assignment unblinded should continue to return for
scheduled evaluations.
In general, randomization codes will be disclosed fully only if the study is completed, and the
clinical database is closed. However, for the interim analyses (Section 9.5), the randomization
codes and, if required, the translation of randomization codes into intervention and control groups

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will be disclosed to those authorized (ie, internal independent IAC)and only for those participants
included in the interim analysis.
6.4. 
Study Intervention Compliance
Participant compliance with study intervention will be assessed at each visit during the treatment
period by counting returned tablets.
A participant will be considered noncompliant if he or she misses more than 20% of the prescribed
doses of study intervention during the study, unless study intervention is withheld for safety
reasons. Similarly, a participant will be considered significantly noncompliant if he or she is
judged by the investigator to have intentionally or repeatedly taken 20% or more than prescribed
amount of study intervention during the study.
If a participant’s study intervention intake is not according to the protocol, the investigator will
take the necessary measures to ensure future adherence to the protocol. If necessary, the participant
maybe discontinued from study intervention by the investigator or medical monitor (Section 7).
Study intervention compliance will be further detailed in the statistical analysis plan (SAP).
6.5. 
Dose Modification
Dose modifications will not be applicable to this study.
6.6. 
Continued Access to Study Intervention After the End of the Study
Participants will be instructed that study intervention will not be made available to them after they
have discontinued study intervention for any reason outlined in Section 7.1 and that they should
return to their primary physician to determine standard of care.
At the end of study treatment (Week 16), participants who meet all eligibility requirements
outlined in the LTE protocol, (77242113PSO2002), will be offered the opportunity to enter the
36-week treatment LTE study. Further details about the LTE study design will be outlined in a
separate protocol (772424113PSO2002).
6.7. 
Treatment of Overdose
For this study, any dose of JNJ-77242113 greater than the highest dose at a single day will be
considered an overdose. The sponsor does not recommend specific treatment for an overdose.
Decisions regarding dose interruptions will be made by the investigator in consultation with the
medical monitor based on the clinical evaluation of the participant.
In the event of an overdose, the investigator or treating physician should:
 
Contact the Medical Monitor immediately.
 
Closely monitor the participant for AE/SAE and laboratory abnormalities.

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 
Document the quantity of the excess dose as well as the duration of the overdosing in the
eCRF.
 
Evaluate the participant to determine, in consultation with the Medical Monitor, whether study
intervention should be interrupted.
 
Obtain a plasma sample for PK analysis if requested by the Medical Monitor (determined on
a case-by-case basis).
6.8. 
Concomitant Therapy
Modification of an effective preexisting therapy should not be made for the explicit purpose of
entering a participant into the study. Concomitant therapies must be recorded throughout the study
beginning with start of the first dose of study intervention to 4 weeks after the last dose of study
intervention.
All therapies (prescription or over-the-counter medications) different from the study intervention
must be recorded in the eCRF. Every effort should be made to keep participants on stable
concomitant medications. If a 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 participant’s medical records.
Any questions regarding treatment with concomitant medication during the study should be
directed to the medical monitor.
Prohibited Therapy
All experimental therapies or new investigational interventions (except for JNJ-77242113),
including therapies for psoriasis or other conditions, must be discontinued prior to the first
administration of study intervention per Exclusion Criteria (Section 5.2) and remain prohibited
during the study. For guidance regarding the COVID-19 vaccine see Section 6.8.1.
If a prohibited therapy is administered during the active treatment phase (ie, Week 0 to Week 16),
the medical monitor should be notified, and the participant may be required to discontinue from
the study treatment per medical monitor’s discretion. If a prohibited therapy is initiated during the
safety follow-up period, the participant should still complete his or her final study visit, and the
medication should be recorded as a concomitant medication.
The sponsor must be notified in advance (or as soon as possible thereafter) of any instances in
which prohibited therapies are administered.
Psoriasis Concomitant Medications
Topical Therapy
Topical therapies that could affect psoriasis or the PASI/IGA evaluation (eg, corticosteroids, tar,
anthralin, calcipotriene, tazarotene, methoxsalen, pimecrolimus, tacrolimus, and traditional
Taiwanese, Korean, or Chinese medicines) are not permitted during the study. The only allowable
concomitant treatments throughout the study are shampoos (containing salicylic acid only) and

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topical moisturizers. Participants should not use these topical agents (shampoos and moisturizers)
the day of a study visit. Nonmedicated shampoos may be used on the day of the study visit.
Phototherapy or Systemic Therapy
The use of phototherapy or systemic medications that could affect psoriasis or the PASI/IGA
evaluation is not permitted at any time during the study. These medications include, but are not
limited to, those targeted for reducing TNF (including but not limited to infliximab or etanercept),
drugs targeted for reducing IL-12/23, IL-17, or IL-23 (including but not limited to ustekinumab,
guselkumab, tildrakizumab [MK3222], secukinumab, risankizumab [BI-655066], ixekizumab
[LY2439821], or brodalumab [AMG827]), alpha-4 integrin antagonists (including but not limited
to natalizumab), JAK inhibitors (including but not limited to tyrosine kinase 2 inhibitors),
phosphodiesterase 4 (PDE4) inhibitors (including but not limited to apremilast), oral and injectable
(IV, intramuscular, or intralesional) corticosteroids, any other conventional systemic therapies that
could affect psoriasis or the PASI/IGA evaluation (including but not limited to methotrexate,
cyclosporine, acitretin, or other retinoids), 1,25-dihydroxy vitamin D3 and analogues, antimalarial
agents, herbal treatments, or traditional Taiwanese, Korean, or Chinese medicines, and any other
biological agent or other systemic medication that could affect psoriasis or the PASI/IGA
evaluation.
The use of systemic corticosteroids for indications other than psoriasis should be limited to
situations for which, in the opinion of the treating physician, there are no adequate alternatives.
They should be used on a short-term basis, preferably for ≤2 weeks. Longer term use of
corticosteroids should be discussed with the medical monitor or designee and may require
discontinuation of study intervention. Inhaled, otic, ocular, nasal, or other routes of mucosal
delivery of corticosteroids are allowed throughout the study.
6.8.1. 
Vaccinations (including COVID-19)
Live attenuated vaccines are prohibited for the duration of study participation.
When considering use of locally-approved non-live vaccines (including emergency use-authorized
COVID-19 vaccines) in study participants, follow applicable local vaccine labelling, guidelines,
and standards-of-care for participants receiving immune-targeted therapy.
7. 
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL
7.1. 
Discontinuation of Study Intervention
A participant's study intervention must be discontinued if:
 
The participant withdraws consent to receive study intervention.
 
The investigator believes that for safety reasons or tolerability reasons (eg, AE) it is in the
best interest of the participant to discontinue study intervention.

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 
The participant meets the Sampson criteria for anaphylaxis (Sampson 2006) following study
intervention administration (Section 10.12).
 
The participant has a reaction resulting in myalgia and/or arthralgia with fever and/or rash
(suggestive of serum sickness and not representative of signs and symptoms of other
recognized clinical syndromes) occurring 1 to 14 days after an administration of study
intervention. These may be accompanied by other events including pruritus, facial, hand, or
lip edema, dysphagia, urticaria, sore throat, and/or headache.
 
The participant becomes pregnant or plans a pregnancy during the study period. Refer to
Section 10.8.
 
The initiation of protocol-prohibited medications, treatments, or interventions (outlined in
Section 6.8) that have an impact on psoriasis efficacy evaluations at the discretion of the
medical monitor.
 
The participant has a malignancy including squamous cell skin cancer. Consideration may be
given to allow participants, who develop ≤2 basal cell skin cancers and who are adequately
treated with no evidence of residual disease, to continue to receive study intervention.
 
The participant develops a systemic opportunistic infection during the study period.
 
The participant develops a recurrent or chronic serious infection during the study period.
 
The participant meets ANY of the following TB related conditions:
 
A diagnosis of active TB is made.
 
A participant has symptoms suggestive of active TB based on follow-up assessment
questions and/or physical examination or has had recent close contact with a person with
active TB and cannot or will not continue to undergo additional evaluation.
 
A participant undergoing evaluation has chest imaging with evidence of current active
TB and/or a positive IGRA test result, unless active TB can be ruled out and appropriate
treatment for latent TB can be initiated prior to the next administration of study
intervention and continued to completion. Indeterminate/borderline results should be
handled as outlined in Section 8.2.8.
 
A participant receiving treatment for latent TB discontinues this treatment prematurely
or is noncompliant with the therapy
 
The participant is unable to adhere to the study visit schedule or comply with protocol
requirements.
 
The participant has a possible Hy’s Law case, as defined by the occurrence of alanine
aminotransferase (ALT) or aspartate aminotransferase (AST)≥3xULN, together with total
bilirubin ≥2xULN or International Normalized Ratio (INR) >1.5 (if measured) without an
identifiable cause (Section 10.9).
 
The participant has his/her treatment assignment unblinded by the investigator.
 
Sponsor decision.

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Discontinuation of a participant’s study intervention should be considered for participants with
any type of suicidal ideation or behavior, or any self-injurious behavior, who are deemed to be at
risk by the investigator. Discussion of such participants with the medical monitor or designee is
required.
For participants who report Suicidal Ideation with Intention to Act (“Ideation level 4”), suicidal
ideationwith specific plan and intent(“Ideation level 5”), suicidal behavior (actual suicide attempt,
interrupted suicide attempt, aborted suicide attempt, or preparatory behaviors for making a suicide
attempt) or any self-injurious behavior on a post-baseline C-SSRS assessment, the investigator
risk assessment must be based upon evaluation by a mental health professional (Section 10.7).
Participants who decide to discontinue study intervention administration for reasons other than
those outlined above must be interviewed by the investigator to determine if a specific reason for
discontinuing study intervention can be identified. Participants should be explicitly asked about
the possible contribution of AEs to their decision to discontinue study intervention; investigators
should confirm that any AE information elicited has been documented. If a participant elects to
discontinue study intervention due to an AE, the event should be recorded as the reason for study
intervention discontinuation, even if the investigator’s assessment is that the AE would not require
study intervention discontinuation. The reason for study intervention discontinuation must be
documented in the eCRF and in source documents. Study intervention assigned to a participant
who discontinues may not be assigned to another participant.
A participant will not be automatically withdrawn from the study if he or she must discontinue
treatment before the end of the treatment regimen. Participants who discontinue study intervention
but do not terminate study participation will continue to return for protocol-specified procedures
and evaluations for approximately 4 weeks following the last administration of study intervention.
The procedures and evaluations listed for the Early Termination Visit should also be performed
approximately 4 weeks after the last administration of study intervention.
All procedures and evaluations must be conducted prior to a participant’s withdrawal of consent.
7.2. 
Participant Discontinuation/Withdrawal From the Study
A participant will be withdrawn from the study for any of the following reasons:
 
Lost to follow-up
 
Withdrawal of consent
 
The participant is not in compliance with requirements of the study, including prohibitions
and restrictions
 
Death
When a participant withdraws before study completion, the reason for withdrawal is to be
documented in the CRF and in the source document. If the reason for withdrawal from the study
is withdrawal of consent, then no additional assessments are allowed.

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Withdrawal of Consent
A participant declining to return for scheduled visits does not necessarily constitute withdrawal of
consent. Alternate follow-up mechanisms that the participant agreed to when signing the consent
form apply (eg, consult with family members, contacting the participant’s other physicians,
medical records, database searches, use of locator agencies at study completion) as local
regulations permit.
7.2.1. 
Withdrawal From the Use of Research Samples
A participant who withdraws from the study will have the following options regarding the optional
research sample:
 
The collected sample will be retained and used in accordance with the participant’s original
separate informed consent for optional research samples.
 
The participant may withdraw consent for optional research sample, in which case the sample
will be destroyed, and no further testing will take place. To initiate the sample destruction
process, the investigator must notify the sponsor study site contact of withdrawal of consent
for the optional research samples and to request sample destruction. The sponsor study site
contact will, in turn, contact the biomarker representative to execute sample destruction. If
requested, the investigator will receive written confirmation from the sponsor that the sample
has been destroyed.
Withdrawal From the Optional Research Samples While Remaining in the Study
The participant may withdraw consent for optional research samples while remaining in the study.
In such a case, the optional research sample will be destroyed. The sample destruction process will
proceed as described above.
Withdrawal From the Use of Samples in Future Research
The participant may withdraw consent for use of samples for research (refer to Long-Term
Retention of Samples for Additional Future Research in Section 10.3.5, Appendix 3: Regulatory,
Ethical, and Study Oversight Considerations). In such a case, samples will be destroyed after they
are no longer needed for the clinical study. Details of the sample retention for research are
presented in the main ICF and in the separate ICF for optional research samples.
7.3. 
Lost to Follow-up
To reduce the chances of a participant being deemed lost to follow-up, prior to randomization
attempts should be made to obtain contact information from each participant, eg, home, work, and
mobile telephone numbers and email addresses for both the participant as well as appropriate
family members.
A participant will be considered lost to follow-up if he or she repeatedly fails to return for
scheduled visits and is unable to be contacted by the study site. A participant cannot be deemed
lost to follow-up until all reasonable efforts made by the study site personnel to contact the
participant are deemed futile. The following actions must be taken if a participant fails to return to
the study site for a required study visit:

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 
The study site personnel must attempt to contact the participant to reschedule the missed visit
as soon as possible, to counsel the participant on the importance of maintaining the assigned
visit schedule, to ascertain whether the participant wishes to or should continue in the study.
 
Before a participant is deemed lost to follow-up, the investigator or designee must make every
reasonable effort to regain contact with the participant (where possible, 3 telephone calls,
emails, fax, and, if necessary, a certified letter to the participant’s last known mailing address,
or local equivalent methods). Locator agencies may also be used as local regulations permit.
These contact attempts should be documented in the participant’s medical records.
Should the participant continue to be unreachable, they will be considered to have withdrawn from
the study.
8. 
STUDY ASSESSMENTS AND PROCEDURES
Overview
The Schedule of Activities (Section 1.3) summarizes the frequency and timing of efficacy, PK,
immunogenicity, biomarker, pharmacogenomic, and safety measurements applicable to this study.
It is strongly recommended that the same investigator perform the efficacy assessments at every
visit.
Participants will be provided with an electronic device to enter patient-reported outcome (PRO)
data at each study visit. Study-site personnel will train participants on how to use the electronic
device (ePRO).
All visit-specific PRO assessments should be conducted/completed before any tests, procedures or
other clinical assessments, with the exception of the urine pregnancy test and urinalysis, to prevent
influencing participant perceptions. Refer to the site manual for instructions on the administration
of PROs.
Electrocardiograms (ECGs) should precede vital signs and both procedures should be completed
prior to any invasive procedures. Vital signs should be recorded from the opposite arm from which
blood samples are being taken.
All samples (including safety, efficacy, PK, and biomarkers) must be obtained after the PRO and
ECG assessments. Blood collections for PK and biomarker assessments should be kept as close to
the specified time as possible. Actual dates of all assessments and blood collections will be
recorded in the source documentation; in addition, times of all blood collections will be recorded
in the source documentation (laboratory requisition form).
Additional serum or urine pregnancy tests may be performed, as determined necessary by the
investigator or required by local regulation, to establish the absence of pregnancy at any time
during the participation in the study. Results of all pregnancy testing should be documented in the
participants’ source documents.
Guidelines for handling of assessments affected by the COVID-19 pandemic are found in
Section 10.11.

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Blood Sample Collection
The total blood volume to be collected from each participant through Week 16 of the study will be
approximately 215 mL. An additional ~6 mL blood volume will be collected at the safety
follow-up visit for those participants who do not enter the LTE (total ~221 mL). In addition, repeat
or unscheduled samples may be collected for safety reasons or for technical issues with the
samples. Total blood volume may vary slightly per region.
Sample Collection and Handling
The actual dates and times of sample collection must be recorded in the eCRF or laboratory
requisition form. Refer to the Schedule of Activities (Section 1.3) 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.
Study-Specific Materials
The investigator will be provided with the following supplies:
 
Protocol
 
Investigator’s Brochure for JNJ-77242113
 
Site Investigational Product Procedures Manual
 
Laboratory manual
 
Laboratory Kits
 
IWRS Manual
 
Sample eCRF
 
eCRF Completion Guidelines
 
ePRO equipment (tablet device questionnaires, completion instructions)
 
Participant Study Participation Card
 
Investigative Site File
 
Recruitment materials, as needed
 
Digital photographic equipment and instruction manual, as needed
8.1. 
Efficacy Assessments
Investigator assessments and PROs of efficacy are included in this section.
 
The PRO instrument will be provided in  the local language in accordance with local
guidelines.

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 
The PRO instrument must be available for regulators and for IRB/ERC submissions.
 
The PRO and AE data will not be reconciled with one another.
8.1.1. 
Psoriasis Area and Severity Index (PASI)
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their
response to therapy (Section 10.4; Fredriksson, 1978). 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 and scored separately for erythema, induration, and scaling, which are each rated on a
scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score
that can range from 0 to 72. A higher score indicates more severe disease.
8.1.2. 
Body Surface Area (BSA)
Body Surface Area is a commonly used measure of severity of skin disease. It is defined as the
percentage of surface area of the body involved with the condition being assessed, (ie, plaque
psoriasis). The handprint method for assessing BSA will be used in this study, where the surface
area of the patient's hand including the palm and all five digits is used as a guide to estimate 1%
BSA (Long 1992; Rossiter 1996; Thomas 2007).
8.1.3. 
Investigator’s Global Assessment (IGA)
The IGA documents the investigator’s assessment of the participant’s psoriasis at a given time
point. Overall lesions are graded for induration, erythema, and scaling. The participant’s psoriasis
is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
8.1.4. 
Nail Psoriasis Area and Severity Index (NAPSI)
The NAPSI is an index used for assessing and grading the severity of nail psoriasis (Rich, 2003).
Each of the participant’s 20 nails (fingernails and toenails) is divided into quadrants and is assessed
for any presence of nail psoriasis in the nail matrix (pitting, leukonychia, red spots in the lunula,
and nail plate crumbling) and any presence of nail psoriasis in the nail bed (onycholysis, splinter
hemorrhages, oil drop discoloration, and nail bed hyperkeratosis). Both the nail matrix (score 0-4)
and nail bed (score 0-4) scores equal the number of quadrants affected by nail/nailbed psoriasis.
The total individual nail score is the sum of the nail matrix and nail bed score and ranges from 0
to 8. The sum of all 20 individual nail scores is the total NAPSI score (0 to 160).
8.1.5. 
Fingernail Physician’s Global Assessment (f-PGA)
The f-PGA is used to evaluate the current status of a participant’s fingernail psoriasis on a scale of
0 to 4 similar to the IGA (clear [0], minimal [1], mild [2], moderate [3], or severe [4]).
8.1.6. 
Static Physician’s Global Assessment of Genitalia(s-PGA-G)
The s-PGA-G is a 6-point numerical rating scale to assess the severity of genital psoriasis at a
given time point (Merola 2017). The s-PGA-G evaluates erythema, plaque elevation and scale of
genital psoriatic lesions. The severity of genital psoriasis is assessed as clear [0], minimal [1], mild
[2], moderate [3], severe [4], and very severe [5].

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8.1.7. 
Physician's Global Assessment of Hands and/or Feet (hf-PGA)
The severity of hand and foot psoriasis has been assessed in various clinical studies using an
hf-PGA instrument (Leonardi 2011; Goldblum 2013). The plaques on the hands and feet are scored
on a 5-point scale as: clear [0], almost clear [1], mild [2], moderate [3], and severe [4].
8.1.8. 
Scalp Specific Investigator Global Assessment (ss-IGA)
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are
assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as:
absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe
disease (4).
8.1.9. 
Psoriasis Symptom and Sign Diary (PSSD)
The PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms
and signs for the assessment of treatment benefit (Feldman 2016). This study will use a 7-day
recall version of the PSSD that asks the participant to answer the questions thinking about the last
7 days. The PSSD is a self-administered PRO instrument and includes 11 items covering
symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin
dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical
rating scales for severity. Two subscores will be derived each ranging from 0 to 100: the psoriasis
symptom score and the psoriasis sign score. A higher score indicates more severe disease.
8.1.10. 
Dermatological Life Quality Index (DLQI)
The DLQI is a dermatology-specific health-related quality of life (HRQoL) instrument designed
to assess the impact of the disease on a participant’s HRQoL (Finlay 1994). It is a 10-item
questionnaire that assesses HRQoL over the past week and in addition to evaluating overall
HRQoL, can be used to assess 6 different aspects that may affect quality of life: symptoms and
feelings, daily activities, leisure, work or school performance, personal relationships, and
treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on
HRQoL.
8.1.11. 
Patient-Reported Outcomes Measurement Information System-29
(PROMIS-29)
The PROMIS-29 is a 29-item generic HRQoL survey, assessing each of the 7 PROMIS domains
(depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to
participate in social roles and activities) with 4 questions. The questions are ranked on a 5-point
Likert Scale. There is also one 11-point rating scale for pain intensity (Cella 2010).
8.1.12. 
Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ)
The GenPs-SFQ is a 2-item patient reported survey used to assess the impact of genital psoriasis
on the frequency of sexual activity in the last 7-days; Gottlieb 2018). Item 1 assesses overall
frequency of sexual activity in the last 7-days (none/zero, once, or two or more times) and item 2
assesses how frequently genital psoriasis symptoms have limited the frequency of sexual activity
in the last 7-days (never [0], rarely [1], sometimes [2], often [3], or always [4]).

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8.1.13. 
Patient Global Impression- Severity (PGI-S) and Change (PGI-C)
Interpreting meaningful change in scores on PRO instruments is an important step in evaluating
results and is included in FDA guidelines (FDA Guidance 3). The methods for interpreting
meaningful change have evolved over time and various approaches exist.  Anchor-based methods
are often preferred.  Anchor-based methods link scores on the PRO to an external criterion that
identifies participants who have experienced an important change in their condition. The PGI-S
and PGI-C will be used as anchors, external criteria, to determine meaningful change in scores for
other PROs in this population. The PGI-S contains 1 question on how the participant would
currently rate severity of disease in the past 7 days, with responses ranging from 1=”None” to
5=”Very severe.” The PGI-C contains 1 question on how the participant would rate the change
from their first treatment in this study. The response options are presented on a 7-point scale from
1="A lot better now” to 7="A lot worse now.”
8.1.14. 
Treatment Satisfaction Questionnaire for Medications (TSQM-9
domains)
The abbreviated 9-item TQSM-9 includes 3 treatment satisfaction domains: effectiveness,
convenience, and global satisfaction. Positive changes in domain scores (0 to 100) indicate
improvement. The questions are ranked on a 5-point or 7-point Likert Scale (Bharmal 2009).
8.1.15. 
Photographs
Efforts to standardize efficacy assessments in inflammatory dermatologic conditions have been
challenging, but the visual nature of many manifestations of dermatologic disease provides
opportunity for photographic assessment of efficacy endpoints. In this substudy, photographs of
either two lesional psoriasis areas or two lesional psoriasis areas and full body (front and back)
will be taken. These photographs will be used to virtually assess psoriasis disease severity by
comparing investigator reported PASI scores to PASI scores assessed by a central reader. See
Section 10.5 for details regarding the assessment. Details of these analyses will be provided in a
separate sub-study SAP. See site manual for photography instructions.
8.2. 
Safety Assessments
Details regarding the Independent Data Monitoring Committee are provided in Section 10.3.6.
Adverse events will be reported and followed by the investigator as specified in Section 8.3 and
Section 10.6.
Any clinically relevant changes occurring during the study must be recorded on the Adverse Event
section of the eCRF.
Any clinically significant abnormalities persisting at the end of the study/early withdrawal will be
followed by the investigator until resolution or until a clinically stable condition is reached if
possible.
The study will include the following evaluations of safety and tolerability according to the time
points provided in the SoA (Section 1.3).

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8.2.1. 
Physical Examinations
Physical Examination
Physical examinations will be performed by the investigator or designated physician, nurse
practitioner or physician assistant as specified in the SoA (Section  1.3). A full physical
examination will be completed at Screening, Week 16, and either the final safety visit or early
termination visit. A targeted physical examination will be completed at all other visits as specified
in the SoA. Any new, clinically significant finding (in the opinion of the investigator) must be
captured as an AE. In addition, resolution of any abnormal findings during the study will be noted
in the source document and in the eCRF.
Height and Weight
Height and weight will be measured as specified in the SoA (Section 1.3). Participants will be
instructed to remove shoes and outdoor apparel and gear prior to these measurements.
8.2.2. 
Vital Signs
Vital signs (including temperature, pulse/heart rate, respiratory rate, and blood pressure) will be
obtained at visits specified in the SoA (Section 1.3).
8.2.3. 
Electrocardiograms
A triplicate 12-lead ECG will be performed during screening to serve as a baseline reference for
comparison, should a subsequent cardiovascular related safety event occur. The 3 individual ECG
tracings should be obtained as closely as possible in succession about 2 minutes apart. The full set
of triplicates should be completed in about 5 minutes. Additional 12-lead triplicate ECGs will be
performed at visits specified in the SoA (Section 1.3). Details regarding collection of ECGs are
available in the site manual.
8.2.4. 
Clinical Safety Laboratory Assessments
Blood samples for serum chemistry and hematology and urine samples for urinalysis will be
collected as noted in Section 10.2. The investigator must review the laboratory results, document
this review, and record any clinically relevant changes occurring during the study in the AE section
of the eCRF. The laboratory reports must be filed with the source documents.
The tests that will be performed by the central laboratory unless otherwise specified in the study
manual or approved by the medical monitor are specified in Section 10.2.
8.2.5. 
Concomitant Medication
Concomitant medications will be reviewed at each visit and recorded in the source documents and
eCRF.
8.2.6. 
Pregnancy Testing
Pregnancy testing (serum and urine) is planned at times indicated in the SoA (Section 1.3).

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Additional serum or urine pregnancy tests may be performed, as determined necessary by the
investigator or required by local regulation, to establish the absence of pregnancy at any time
during the participation in the study.
8.2.7. 
Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS defines 5 subtypes of suicidal ideation and 4 possible suicidal behaviors, as well as
non-suicidal self-injurious behavior and completed suicide. It will be used as a screening tool to
prospectively evaluate suicidal ideation and behavior in this study, as part of a comprehensive
evaluation of safety. The C-SSRS is an investigator-administered questionnaire and will be
conducted on the electronic clinical outcomes assessment (eCOA)device provided to the site.
Two versions of it will be used in this study: the ‘Baseline/Screening’ version of the C-SSRS
(Section 10.7) will be conducted during the screening visit and the ‘Since Last Visit’ version of
the C-SSRS ([Section 10.7) will be completed at Week 0 and all other visits through the end of the
study.
The investigator or trained study-site personnel will interview the participant in a private place and
complete the C-SSRS on the eCOA device. At the conclusion of each assessment, the trained
personnel administering the C-SSRS will determine the level of suicidal ideation or behavior, if
any. They will then determine the next course of action if any level of suicidal ideation or behavior
is reported. The participant should not be released from the site until the C-SSRS has been
reviewed by the investigator and the participant’s risk has been assessed and follow-up determined,
as appropriate.
At screening (within the last 6 months) and Week 0, participants with a C-SSRS rating of Suicidal
Ideation with Intention to Act (“Ideation level 4”), Suicidal Ideation with Specific Plan and Intent
(“Ideation level 5”), or suicidal behavior (actual suicide attempt, interrupted suicide attempt,
aborted suicide attempt, or preparatory behaviors for making a suicide attempt), must be
determined to not be at risk by the investigator based on an evaluation by a mental health
professional (eg, psychiatrist, psychologist, or appropriately trained social worker or nurse) in
order to be randomized. Participants with C-SSRS ratings of Wish to be Dead (“Ideation level 1”),
Non-Specific Active Suicidal Thoughts (“Ideation level 2”), Active Suicidal Ideation with Any
Methods (Not Plan) without Intent to Act (“Ideation level 3”) or non-suicidal self-injurious
behavior must be determined not to be at risk by the investigator in order to be randomized. Any
questions regarding eligibility of such participants should be discussed with the medical monitor
or designee.
For each assessment after Week 0, the following actions should be taken, if applicable:
- No suicidal ideation or behaviors (including self-injurious behavior without suicidal
intent): No further action is needed.
- Suicidal ideation levels 1-3 or non-suicidal self-injurious behavior: Participant risk is
assessed by the investigator.

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- Suicidal ideation levels 4 or 5 or any suicidal behavior: Participant risk assessed and
referral to a mental health professional.
Interruption or the discontinuation of study intervention should be considered for any participant
who reports Suicidal Ideation with Intention to Act (“Ideation level 4”), Suicidal Ideation with
Specific Plan and Intent (“Ideation level 5”), or suicidal behavior (actual suicide attempt,
interrupted suicide attempt, aborted suicide attempt, or preparatory behaviors for making a suicide
attempt) on a post-baseline C-SSRS assessment and who is deemed to be at risk by the investigator
based upon evaluation by a mental health professional. If a participant can be adequately treated
with psychotherapy and/or pharmacotherapy then the participant, at the discretion of the
investigator, may be continued with treatment if agreed to by the medical monitor or designee.
Discussion of such participants with the medical monitor or designee is required (Section 7.1).
Any C-SSRS finding, which in the opinion of the investigator is new or considered to be a
worsening and clinically significant, should be reported on the AE eCRF (Section 10.7).
8.2.8. 
Tuberculosis Evaluation(s)
Initial Tuberculosis Evaluation
Participant 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 participant
should be asked about past testing for TB, including chest imaging results and responses to
tuberculin skin or other TB testing. Investigators have the option to use the tuberculin skin test in
addition to IGRA testing to screen for latent TB if preferred by local health authorities, or if they
believe based on their judgment that both tests are clinically indicated to evaluate a participant at
high risk for latent TB. 
Participants with a negative IGRA test result are eligible to continue with prerandomization
procedures. Participants with a newly identified positive IGRA test result must undergo an
evaluation for active or latent TB, or suspected false-positive initial testing, and initiate appropriate
treatment if needed (Section 5.2). Appropriate treatment for latent TB is defined according to local
country guidelines for immunocompromised patients. If no local country guidelines for
immunocompromised patients exist, US guidelines must be followed. 
Participants with indeterminate/borderline IGRA test results should have the test repeated.
Participants with persistently indeterminate/borderline IGRA test results may be randomized or
continued in the trial without treatment for latent TB, if active TB is ruled out, chest imaging shows
no abnormality suggestive of TB (active or inactive), and the participant has no additional risk
factors for TB as determined by the investigator. This determination must be promptly reported to
the sponsor’s medical monitor and recorded in the participant’s source documents and initialed by
the investigator.

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Ongoing Tuberculosis Evaluation
To aid in the early detection of TB infection or exposure during study participation, participants
must be evaluated for TB signs, symptoms, and close contacts at scheduled visits (refer to
Section 1.3) or by telephone 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?”
 
“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 for TB infection or the participant has had a close contact
exposure to TB, study intervention must be withheld and an immediate and thorough investigation
must be undertaken, including consultation with a physician specializing in TB to determine if
treatment is warranted prior to any further study intervention. Participants should be encouraged
to return for all subsequent scheduled study visits according to the protocol.
Note:Investigators should be aware that TB reactivation in immunocompromised participants may
also present as extrapulmonary or disseminated disease.
8.3. 
Adverse Events, Serious Adverse Events, and Other Safety Reporting
Timely, accurate, and complete reporting and analysis of safety information, including AEs, SAEs,
and product quality complaint (PQC), from clinical studies are crucial for the protection of
participants, investigators, and the sponsor, and are mandated by regulatory agencies worldwide.
The sponsor has established Standard Operating Procedures in conformity with regulatory
requirements worldwide to ensure appropriate reporting of safety information; all clinical studies
conducted by the sponsor or its affiliates will be conducted in accordance with those procedures.
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate,
or the participant’s legally acceptable representative) for the duration of the study. Collection of
additional medical records may be requested by the medical monitor or the sponsor to support
safety monitoring and reporting.
Further details on AEs, SAEs, and PQC can be found in Section 10.6.

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8.3.1. 
Time Period and Frequency for Collecting Adverse Event and Serious
Adverse Event Information
All Adverse Events
All AEs and special reporting situations, whether serious or non-serious, will be reported from the
time a signed and dated ICF is obtained until completion of the participant’s last study-related
procedure, which may include contact for follow-up of safety. Any clinically relevant changes
during the study must be recorded in the AE section of the eCRF.
Serious Adverse Events
All SAEs, as well as PQC, 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.
Serious adverse events, including those spontaneously reported to the investigator within 4 weeks
after the last dose of study intervention, must be reported. The sponsor will evaluate any safety
information that is spontaneously reported by an investigator beyond the time frame specified in
the protocol.
Information regarding SAEs will be transmitted to the sponsor using the SAE Form, which must
be completed and signed by a physician from the study site and transmitted to the sponsor within
24 hours. The initial and follow-up reports of a SAE should be transmitted electronically or by
facsimile (fax). Telephone reporting should be the exception and the reporter should be asked to
complete the appropriate form(s) first.
8.3.2. 
Method of Detecting Adverse Events and Serious Adverse Events
Care will be taken not to introduce bias when detecting AEs or SAEs. Open-ended and nonleading
verbal questioning of the participant is the preferred method to inquire about AE occurrence.
Solicited Adverse Events
Solicited AEs are predefined local and systemic events for which the participant is specifically
questioned.
Unsolicited Adverse Events
Unsolicited AEs are all AEs for which the participant is not specifically questioned.
8.3.3. 
Follow-up of Adverse Events and Serious Adverse Events
The investigator is obligated to perform or arrange for the conduct of supplemental measurements
and evaluations as medically indicated to elucidate the nature and causality of the AE, SAE, or
PQC as fully as possible. This may include additional laboratory tests or investigations,
histopathological examinations, or consultation with other health care professionals.
AEs, including pregnancy, will be followed by the investigator as specified in Section 10.6.

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8.3.4. 
Regulatory Reporting Requirements for Serious Adverse Events
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.
8.3.5. 
Pregnancy
All initial reports of pregnancy in female participants or partners of male participants must be
reported to the sponsor by the study site personnel within 24 hours of their knowledge of the event
using the appropriate pregnancy notification form. Abnormal pregnancy outcomes (eg,
spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy) are
considered SAEs and must be reported using a SAE reporting form. Any participant who becomes
pregnant during the study must promptly discontinue further study intervention. Participants who
are found to be pregnant in between study visits should immediately stop taking the study
intervention and contact the investigator.
Follow-up information regarding the outcome of the pregnancy and any postnatal sequelae in the
infant will be required.
8.3.6. 
Disease-Related Events and Disease-Related Outcomes Not
Qualifying as Adverse Events or Serious Adverse Events
All events that meet the definition of a SAE will be reported as SAEs, regardless of whether they
are protocol-specific assessments.
8.3.7. 
Adverse Events of Special Interest
An adverse event of special interest (AESI; serious or non-serious) is one of scientific and medical
concern specific to the sponsor’s product or program, for which ongoing monitoring and expedited
communication (within 24 hours) by the investigator to the sponsor is warranted. The AESIs for
JNJ-77242113 are, active TB, malignancy, and potential Hy's Law cases.
Any newly identified malignancy, case of active TB, or potential Hy's law case occurring after the
first study intervention administration(s) must be reported by the investigator according to the
procedures in Section 10.6). Investigators are also advised that active TB is considered a reportable
disease in most countries. These events are to be considered serious only if they meet the definition
of an SAE.
8.4. 
Pharmacokinetics
Plasma samples will be used to evaluate the PK of JNJ-77242113. Plasma collected for PK may
additionally be used to evaluate safety or efficacy aspects that address concerns arising during or

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after the study period. Genetic analyses will not be performed on these plasma samples. Participant
confidentiality will be maintained.
8.4.1. 
Evaluations
Venous blood samples for determination of JNJ-77242113 plasma concentrations will be collected
at the time points indicated in the SoA (Section 1.3). During the study, the nominal sample
collection times may be changed by the sponsor with clear communication to the investigator, but
the total blood volume will not exceed 450 mL every 8 weeks. The exact dates and times of blood
sample collection must be recorded in the CRF or on the laboratory requisition form.
The laboratory manual contains further information regarding the collection, handling, labeling,
and shipment of plasma samples.
8.4.2. 
Analytical Procedures
Pharmacokinetics
Plasma samples will be analyzed to determine concentrations of JNJ-77242113 using a validated,
specific, and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS)method by
or under the supervision of the sponsor. The sponsor, or its designee, under conditions in which
the participants’ identity remains blinded, will assay these samples.
8.4.3. 
Pharmacokinetic Parameters and Evaluations
Parameters
Pharmacokinetic analysis will be performed by or under the responsibility of the sponsor.
Using the actual sampling times (see the SoA [Section 1.3]), if feasible, the following
pharmacokinetic parameters will be estimated for JNJ-77242113 using a population PK approach:
Cmax  
Maximum observed plasma analyte concentration.
tmax  
Actual sampling time to reach the maximum observed plasma analyte concentration.
AUC24h  
Area under the plasma analyte concentration-time curve from time 0 to 24 hours
postdose, calculated by linear-linear trapezoidal summation.
AUClast 
Area under the plasma analyte concentration vs time curve from time 0 to time of the
last measurable (non-below quantification limit [BQL]) concentration calculated by
linear-linear trapezoidal summation.
AUC 
Area under the analyte concentration vs. time curve from time 0 to infinite time,
calculated as AUClast + Clast/λz, where Clast is the last observed measurable (non-BQL)
plasma analyte concentration; extrapolations of more than 20.00% of the total AUC
are reported as approximations.
t1/2
Apparent elimination half-life calculated as 0.693/λz
λz
Apparent terminal elimination rate constant, estimated by linear regression using the
terminal log-linear phase of the log transformed concentration-time curve.

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8.5. 
Genetics and Pharmacogenomics
Participation in pharmacogenomic research is optional. A pharmacogenomic (DNA)blood sample
will be collected, preferably at baseline, from participants who consent separately to this
component of the study to allow for pharmacogenomic research, where local regulations permit.
Genetic (DNA) variation may be an important contributory factor to interindividual variability in
drug response and associated clinical outcomes. Genetic and epigenetic factors may also serve as
markers for disease susceptibility and prognosis and may identify population subgroups that
respond differently to an intervention.
The optional pharmacogenomic samples may  be analyzed for identification of genetic and
epigenetic factors that may be associated with the disease and/or the response to JNJ-77242113. 
This research may consist of the analysis of one or more candidate genes, or the analysis of genetic
and epigenetic markers throughout the genome, or analysis of the entire genome (as appropriate)
in relation to the disease and the treatments. Whole blood samples of approximately 6 mL will be
collected for the genetic and pharmacogenomics analyses.
These analyses will be performed at the sponsor’s discretion and may be reported separately.
8.6. 
Biomarkers
Biomarker assessments will be used to define and identify PD markers of therapeutic response to
better understand the mechanism of action of JNJ-77242113 in participants with psoriasis, and aid
in evaluating the drug exposure clinical response relationship, and the pathophysiology of
psoriasis. This will include evaluation of relevant disease and pathway engagement biomarkers in
skin, serum, whole blood and PBMCs. These assessments could also help explain inter-individual
variability including differences between responders and non-responders to support patient
stratification. Biomarker samples may also be used to help address emerging issues and to enable
the development of safer, more effective, and ultimately individualized therapies as well as
development of tests/ assays related to JNJ-77242113 and psoriasis.
Biomarker samples will be collected per the Schedule of Activities (Section 1.3). Instructions for
collection and shipment of samples will be outlined in the Laboratory and Biopsy reference
manuals and will include the following assessments.
Stopping Analysis
Biomarker analyses are dependent upon the availability of appropriate biomarker assays and
clinical response rates. Biomarker analysis may be deferred or not performed, if during or at the
end of the study, it becomes clear that the analysis will not have sufficient scientific value for
biomarker evaluation, or if there are not enough samples or responders to allow for adequate
biomarker evaluation. In the event the study is terminated early or shows poor clinical efficacy,
completion of biomarker assessments is based on justification and intended utility of the data.

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8.6.1. 
Ex vivo whole blood cytokine release assay
An optional ex vivo whole blood IL-23 induced cytokine release assay will be used to measure
systemic PD activity from inhibition of IL-23 induced signaling as it relates to exposure to confirm
systemic IL-23 pathway engagement with JNJ-77242113 in participants with psoriasis. 
8.6.2. 
Serum Psoriasis Pharmacodynamic Changes
Inflammatory mediators relevant to the pathophysiology of psoriasis including but not limited to
IL-22, IL-17A, IL-17F and beta-defensin-2 will be evaluated to assess the impact of JNJ-77242113
on inflammatory proteins in the serum.
8.6.3. 
Skin Psoriasis-Associated Gene Expression Changes
Total RNA will be extracted from lesional and non-lesional skin biopsies to assess impact of
JNJ-77242113 on psoriasis-associated gene signatures and individual genes to better define the
therapeutic response. Non-invasive tape strip sampling will be performed as an additional
approach to characterize JNJ-77242113 driven skin transcriptional changes in participants with
psoriasis.
8.6.4. 
Flow cytometric analysis
Peripheral blood mononuclear cells isolated from whole blood will be used to determine the impact
of JNJ-77242113 on psoriasis-relevant immune cell subset distribution changes in the periphery.
8.7. 
Immunogenicity Assessments
Antibodies to JNJ-77242113 will be evaluated in serum samples collected from all participants
according to the SoA. Additionally, serum samples should also be collected at the final visit from
participants who discontinued study intervention or were withdrawn from the study. These samples
will be tested by the sponsor or sponsor's designee.
Serum samples will be screened for antibodies binding to JNJ-77242113 and the titer of confirmed
positive samples will be reported. Other analyses may be performed to verify the stability of
antibodies to JNJ-77242113 and/or further characterize the immunogenicity of JNJ-77242113.
Serum samples will be used to evaluate the immunogenicity of anti-JNJ-77242113 antibodies.
Samples collected for immunogenicity analyses may additionally be used to evaluate safety or
efficacy aspects that address concerns arising during or after the study period. Genetic analyses
will not be performed on these serum samples. Participant confidentiality will be maintained.
Analytical Procedures
The detection and characterization of antibodies to JNJ-77242113 will be performed using a
validated assay method by or under the supervision of the sponsor. All samples collected for
detection of antibodies to JNJ-77242113 will also be evaluated for corresponding JNJ-77242113
plasma concentration to enable interpretation of the antibody data. Antibodies may be further
characterized and/or evaluated for their ability to neutralize the activity of the study
intervention(s). Samples may be stored up to 15 years (or according to local regulations) following

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the last participant’s last visit for the study at a facility selected by the sponsor to enable further
analysis of immune responses to JNJ-77242113.
8.8. 
Medical Resource Utilization and Health Economics
Health Economics/Medical Resource Utilization and Health Economics parameters are not
evaluated in this study.
9. 
STATISTICAL CONSIDERATIONS
Statistical analysis will be done by the sponsor or under the authority of the sponsor. A general
description of the statistical methods to be used to analyze the efficacy and safety data is outlined
below. Specific details will be provided in the Statistical Analysis Plan.
9.1. 
Statistical Hypotheses
The hypothesis of this study is that there is a dose response relationship for JNJ-77242113 in the
proportion of participants achieving a PASI 75 response at Week 16.
9.2. 
Sample Size Determination
This study is designed to enroll approximately 240 participants, in order to provide sufficient data
to have adequate power to detect a JNJ-77242113 dose-response signal for the proportion of
participants achieving PASI 75 at Week 16 using the Multiple Comparison Procedures with
modeling techniques (MCP-Mod) method.
The sample size of 240 participants was also chosen in order to have sufficient power to detect a
difference between the JNJ-77242113 groups and the placebo group for the primary endpoint of
the proportion of participants achieving PASI 75 at Week 16.
The assumptions for the sample size and power calculations specified below were mainly based
on the clinical data from the guselkumab Phase 2 and Phase 3 clinical studies that evaluated the
safety and efficacy of guselkumab in the treatment of adult participants with moderate-to-severe
plaque psoriasis.
The null hypothesis of no dose-response relationship is to be tested at an overall Type 1 error rate
of 0.05 (2-sided). Assuming a PASI 75 response rate of 6% and 70% in the placebo and
JNJ-77242113 highest dose groups, respectively, a sample size of approximately 40 participants
in the placebo group and each of the JNJ-77242113 treatment groups will provide an average
power of at least 90% to detect a dose-response signal across different candidate dose-response
models (to be detailed in the SAP).
Furthermore, assuming PASI 75 response rates at Week 16 are 5% to 10% for placebo, 30% to
80% for the JNJ-77242113 dose groups, respectively, with 40 participants in each of the treatment
groups, approximately 240 participants are planned to be randomized in equal ratio to the placebo
and each of JNJ-77242113 dose groups (n=40/arm), this study provides:

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 
At least 90% power to detect a 35% treatment difference between the JNJ-77242113 treatment
groups (n=40) and the placebo group (n=40) in the proportion of participants who achieve a
PASI 75 response at Week 16 at a significant level of 0.05 (2-sided) based on a 2-sample
Z-test.
9.3. 
Populations for Analysis Sets
For purposes of analysis, the following populations are defined:
For the efficacy analyses in this study, the full analysis set (FAS) will be used according to the
participants’ assigned treatment to which they were randomized, regardless of the treatment they
actually received. The FAS includes all randomized participants who receive at least 1
administration of study intervention. The FAS will be used for all primary and secondary efficacy
analyses.
Safety analyses will include all randomized participants who received at least 1 administration of
study intervention and participants will be analyzed based on the treatment they actually received,
regardless of the treatment groups to which they were assigned. Pharmacokinetics analyses for
JNJ-77242113 will include all randomized participants who receive at least 1 complete dose of
JNJ-77242113 and have at least 1 valid blood sample drawn for PK analysis after their first dose
of JNJ-77242113. Antibodies to JNJ-77242113 will be analyzed for all randomized participants
who receive at least 1 dose of JNJ-77242113 and have at least 1 sample obtained after the first
dose of JNJ-77242113 for the detection of antibodies to JNJ-77242113.
Population 
Description
Enrolled 
All participants who sign the ICF
Randomized 
All participants who were randomized in the study
FAS  
All randomized participants who take at least 1 dose of study intervention
Safety Analysis 
Set
All randomized participants who take at least 1 dose of study intervention.
PK Analysis Set 
All randomized participants who received at least 1 complete dose of JNJ-77242113 and
had at least 1 valid blood sample drawn for PK analysis after their first dose of
JNJ-77242113
Immunogenicity 
Analysis Set 
All randomized participants who received at least 1 dose of JNJ-77242113 and who had at
least 1 sample obtained after the first dose of JNJ-77242113 for the detection of antibodies
to JNJ-77242113
9.4. 
Statistical Analyses
9.4.1. 
Statistical Methods
Simple descriptive summary statistics, such as n, mean, standard deviation (SD), median,
interquartile range, minimum, and maximum for continuous variables, and counts and percentages
for discrete variables will be used to summarize most data.
To assess the primary objective of the dose response profile of JNJ-77242113 dose groups and
facilitate the selection of JNJ-77242113 doses and dosing regimen for future studies, Multiple

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Comparison Procedures with modeling (MCP-Mod) techniques will be used to analyze the primary
endpoint, the proportion of participants achieving PASI 75 at Week 16.
In addition, for binary response efficacy endpoints, comparisons between each of the
JNJ-77242113 groups versus placebo will be performed using a Cochran-Mantel-Haenszel (CMH)
test stratified by the baseline weight (≤90 kg, >90 kg). For continuous efficacy endpoints, treatment
comparisons will be performed using a Mixed-Effect Model Repeated Measure (MMRM) model.
The MMRM model will have treatment group, baseline weight (≤90 kg, >90 kg), and baseline
value for the corresponding efficacy endpoint as explanatory factors. The MMRM model will also
include visit, treatment group by visit interaction, baseline weight (≤90 kg, >90 kg) by visit
interaction, and baseline value by visit interaction as additional explanatory factors. The Least
Square mean (LSmean) estimates and their corresponding 95% confidence interval (CI) will be
provided at each time point. In addition, the estimates of LSmean difference and 95% CIs between
the JNJ-77242113 groups and placebo will be provided.
In general, all statistical testing will be performed at a significance level of 0.05 (2-sided) unless
otherwise specified. Nominal p-values will be displayed for all treatment comparisons.
9.4.2. 
Efficacy Analyses
9.4.2.1. 
Primary Endpoint(s)
The primary efficacy endpoint is the proportion of participants achieving PASI 75 response at
Week 16, defined as at least a 75% reduction from baseline in PASI total score.
9.4.2.1.1. 
Estimand
9.4.2.1.1.1. 
Primary Estimand
The primary estimand (ie, a precise definition of the primary targeted treatment effect) is defined
by the following 5 attributes:
Study intervention:
 JNJ-77242113 25 mg QD, 50 mg QD, 25 mg BID, 100 mg QD, and 100 mg BID
 Placebo
Population: adult participants with moderate to severe plaque psoriasis
Variable/endpoint:  Response binary variable, where a responder is defined as a participant
achieving a PASI 75 response at Week 16 who does not have intercurrent events in categories 1-2
(defined below).
Intercurrent Events (ICEs) and their corresponding strategies
ICEs 
Analysis Strategy for Addressing Intercurrent Events
1. Discontinuation of study
intervention due to lack of
efficacy or due to an AE of
worsening of psoriasis
Composite Strategy: Participants with these intercurrent
events are considered as PASI 75 non-responders after
these events, and prior to Week 16. The occurrence of
these intercurrent events is captured in the variable
definition.

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2. Initiation of a protocol-prohibited
medication or therapy during the
study that could improve psoriasis
3. Discontinuation of study 
intervention for reasons other 
than ICE 1
Treatment Policy: observed data will be used regardless
of whether or not this intercurrent event had occurred.
Note: For participants experiencing multiple ICEs, ICE 2 will override ICE 3.
Population level summary: Difference in the proportions of participants achieving a PASI 75
response at Week 16 between the JNJ-77242113 and placebo intervention groups.
Primary Endpoint Analysis
In the primary efficacy analysis, data from all randomized participants who received at
least 1 administration of study intervention will be analyzed according to their assigned treatment
group.
A unified strategy that combines MCP-Mod techniques, will be used to analyze the dose-response
relationship for the JNJ-77242113 doses in PASI 75 at Week 16. This approach consists of 2 major
steps. The first step consists of testing the dose-response signal via multiple contrast tests while
controlling the overall Type 1 error. If a dose-response signal is detected, the second step is to
select a model that best describes the observed data, which may be used to support dose selection
in future studies. In addition, a simple semi-parametric Bayesian normal dynamic linear model
(NDLM) will also be explored to complement the frequentist MCP-Mod analysis. The details of
the dose-response analysis will be provided in the SAP.
The study will be considered positive if a dose-response signal for the primary endpoint is detected.
In addition to the dose-response analysis, pairwise comparisons of the JNJ-77242113 groups
versus the placebo group will be performed for PASI 75 at Week 16; these comparisons will not
be adjusted for multiplicity. For these comparisons, a CMH stratified by baseline weight category
(≤ 90kg, >90kg) will be used. The proportion difference between each JNJ-77242113 group and
placebo group and its 2-sided 95% CI will be provided based on normal approximation with
Mantel-Haenszel weights adjusting for baseline weight category.
To examine the robustness of the primary endpoint analysis, additional analyses will be conducted
using different missing data approaches; these analyses will be described in the SAP. In addition,
sensitivity analyses will be performed for the primary endpoint using the per-protocol population,
which includes participants who are generally compliant with the protocol. To evaluate the
consistency of the efficacy, subgroup analyses of the primary endpoint will be performed.
9.4.3. 
Secondary Endpoint(s)
In addition to the primary endpoint analysis, the analyses for secondary efficacy endpoints will be
performed. No adjustments for multiple comparisons will be made for the secondary endpoints

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and nominal p-values will be provided. Additional efficacy analyses may be performed and will
be documented in the SAP.
 
The proportion of participants who achieve a PASI 100 response at Week 16, will be
compared between each of the JNJ-77242113 groups and the placebo group.
 
The proportion of participants who achieve a PASI 90 response at Week 16, will be compared
between each of the JNJ-77242113 groups and the placebo group.
 
The change from baseline in PASI total score at Week 16 will be compared between each of
the JNJ-77242113 groups and the placebo.
 
The proportion of participants who achieve an IGA score of cleared (0) at Week 16 will be
compared between each of the JNJ-77242113 groups and the placebo group.
 
The proportion of participants who achieve an IGA score of cleared (0) or minimal (1) at
Week 16 will be compared between each of the JNJ-77242113 groups and the placebo group.
 
The change from baseline in PSSD symptoms score at Week 16 will be compared between
each of the JNJ-77242113 groups and the placebo group.
 
The change from baseline in PSSD signs score at Week 16 will be compared between each of
the JNJ-77242113 groups and the placebo group.
 
The proportion of participants who achieve PSSD symptoms score=0 at Week 16 will be
compared between each of the JNJ-77242113 groups and the placebo group among
participants with a baseline PSSD symptoms score ≥1.
 
The proportion of participants who achieve a PSSD signs score=0 at Week 16 will be
compared between each of the JNJ-77242113 groups and the placebo group among
participants with a baseline PSSD signs score ≥1.
 
The proportion of participants with DLQI=0 or 1 at Week 16 will be compared between each
of the JNJ-77242113 groups and the placebo group respectively among participants with a
baseline DLQI score >1.
 
The proportion of participants who achieve 5-point improvement or higher in each
PROMIS-29 domain from baseline to Week 16 will be compared between each of the
JNJ-77242113 groups and the placebo group.
 
The change from baseline in BSA at Week 16 will be compared between each of the
JNJ-77242113 groups and the placebo group.
 
The change from baseline in PROMIS-29 domain scores at Week 16 will be compared
between each of the JNJ-77242113 groups and the placebo group.
9.4.4. 
Tertiary/Exploratory Endpoint(s)
The following endpoints will be explored as exploratory endpoints. The secondary efficacy
endpoints specified in Section 9.4.2 and selected efficacy endpoints in this section will also be
summarized over time as tertiary/exploratory analyses. Detailed analyses will be specified in the
SAP.

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 
The proportion of participants who achieve an ss-IGA score of absence of disease (0) or very
mild disease (1) and at least a 2-grade improvement from baseline at Week 16 will be
compared between each of the JNJ-77242113 groups and the placebo group among
participants with scalp psoriasis and an ss-IGA score ≥2 at baseline.
 
The proportion of participants who achieve an f-PGA score of clear (0) or minimal (1) and
have at least a 1-grade improvement from baseline at Week 16 will be compared between each
of the JNJ-77242113 groups and the placebo group among participants with nail psoriasis and
an f‑PGA score ≥2 at baseline.
 
The percent improvement from baseline in NAPSI at Week 16 will be compared between each
of the JNJ-77242113 groups and the placebo group among participants with a NAPSI >0 at
baseline.
 
The proportion of participants who achieve an hf-PGA score of clear (0) or almost clear (1)
and a reduction of at least 2 grades on the hf-PGA scale from baseline at Week 16 will be
compared between each of JNJ-77242113 groups and the placebo group among participants
with hand and/or foot psoriasis and an hf-PGA score ≥2 at baseline.
 
The proportion of participants who achieve an sPGA of genitalia score of clear (0) or minimal
(1) at Week 16 will be compared between each of the JNJ-77242113 groups and the placebo
group among participants with genital psoriasis and an sPGA of genitalia score ≥3 at baseline.
 
The proportion of participants who achieve a score of never (0) or rarely (1) in GenPs-SFQ
item 2 at Week 16 will be compared between each of the JNJ-77242113 groups and the
placebo group among participants with an item 2 score ≥2 at baseline.
 
Assessment of Treatment Satisfaction Questionnaire for Medications (TSQM-9) domains at
Week 16 will be summarized.
9.4.5. 
Safety Analyses
Safety data, including but not limited to, AEs, SAEs, AESIs (active TB, malignancy, potential
Hy’s Law cases), discontinuation of study intervention due to AEs, changes in laboratory
assessments, changes in vital signs, and changes in weight will be summarized.
Intervention-emergent AEs will be summarized by treatment group and Medical Dictionary for
Regulatory Activities (MedDRA) system organ class and preferred terms. Details will be specified
in the SAP.
Adverse Events
The verbatim terms used in the eCRF by investigators to identify AEs will be coded using the
MedDRA. Intervention-emergent AEs are AEs with onset during the intervention period or that
are a consequence of a preexisting condition that has worsened since baseline. All intervention-
emergent AEs will be included in the analysis. For each AE, the percentage of participants who
experience at least 1 occurrence of the given event will be summarized by intervention group. In
addition, comparisons between intervention groups will be provided if appropriate.
The following analyses will also be used to assess the safety of participants in the study:

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 
The incidence and type of AEs.
 
The incidence and type of SAEs.
 
The incidence and type of severe AEs.
 
The incidence and type of related AEs as assessed by the investigator.
 
The incidence and type of AEs leading to discontinuation of study.
Listings of participants with SAEs, severe AEs, AEs for psoriasis, AEs leading to discontinuation
of study and anaphylactic reaction/serum sickness reactions will also be provided. All safety
analyses will be based on the population of participants who received at least 1 administration of
study intervention; participants will be summarized by the intervention they received.
Clinical Laboratory Tests
Laboratory data will be summarized by type of laboratory test (eg, hematology, clinical chemistry).
Selected laboratory parameters will be summarized by treatment groups. Common Terminology
Criteria for Adverse Events (CTCAE) and ULN will be used to identify abnormal laboratory test
results, and the incidence and severity of abnormal laboratory parameters (hematology and
chemistry) will be summarized by treatment group.
In addition, a listing of participants with Grade 2 or higher laboratory test results (based on the
CTCAE criteria) will also be provided.
C-SSRS
Suicide-related thoughts and behaviors based on the C-SSRS will be summarized descriptively by
treatment group.
Vital Signs
Descriptive statistics of heart rate and blood pressure (systolic and diastolic) values and changes
from baseline will be summarized at each scheduled time point.
Weight
Descriptive statistics of changes from baseline will be summarized at selected scheduled time
points.
9.4.6. 
Other Analyses
Pharmacokinetic Analyses
The PK evaluable population is defined as all the participants who received at least 1 complete
dose of JNJ-77242113 and had at least 1 valid blood sample drawn for PK analysis after their first
dose of JNJ-77242113.
Plasma JNJ-77242113 concentrations will be summarized by visit and treatment group.
Descriptive statistics will be calculated at each sampling timepoint. Concentrations below the
lowest quantifiable concentration will be treated as zero in the summary statistics. All plasma

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concentrations below the lowest quantifiable concentration or missing data will be labeled as such
in the concentration database. PK data may also be displayed graphically.
If feasible, population PK analysis of plasma concentration-time data of JNJ-77242113 may be
performed using nonlinear mixed-effects modeling. Data may be combined with those of other
selected studies to support a relevant structural model. Available baseline participant
characteristics (eg, demographics, laboratory variables, genotypes, race)will be tested as potential
covariates affecting PK parameters. Details will be given in a population PK analysis plan and the
results of the population PK analysis will be presented in a separate report.
Pharmacokinetic/Pharmacodynamic Analyses
If data permit, the relationships between plasma JNJ-77242113 concentration and efficacy may be
examined when appropriate. If a relationship is observed, a suitable PK/PD model may be
developed to describe the exposure-response relationship and will be presented in a separate
technical report.
Immunogenicity Analyses
The incidence and titers of antibodies to JNJ-77242113 will be summarized for all participants
who receive at least 1 dose of JNJ-77242113 and have appropriate samples for detection of
antibodies to JNJ-77242113 (ie, participants with at least 1 sample obtained after their first dose
of JNJ-77242113).
A listing of participants who are positive for antibodies to JNJ-77242113 will be provided. The
maximum titers of antibodies to JNJ-77242113 will be summarized for participants who are
positive for antibodies to JNJ-77242113.
The incidence of neutralizing antibodies (NAbs) to JNJ-77242113 will be summarized for
participants who are positive for antibodies to JNJ-77242113 and have samples evaluable for NAbs
to JNJ-77242113.
Other immunogenicity analyses may be performed to further characterize the immune responses
that are generated.
Biomarkers Analyses
Planned biomarker analyses may be deferred if emerging study data show no likelihood of
providing useful scientific information. Any biomarker samples received by the contract vendor
or sponsor after the cutoff date will not be analyzed, and therefore, excluded from the biomarker
analysis.
Changes in biomarkers over time will be summarized by treatment group. Associations between
baseline levels and changes from baseline in select markers and response to treatment will be
explored. The analyses will aim to identify biomarker relevant to treatment. Results of biomarker
analyses will be reported in separate technical reports.

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Pharmacogenomic Analyses
DNA samples will be used for research related to JNJ-77242113 or psoriasis. They may also be
used to develop tests/assays related to JNJ-77242113 and/or psoriasis. Pharmacogenomic research
may consist of the analysis of one or more candidate genes or of the analysis of genetic markers
throughout the genome or analysis of the entire genome (as appropriate) in relation to
JNJ-77242113 or psoriasis clinical endpoints. Results will be presented in a separate report.
9.5. 
Interim Analysis
An internal independent interim analysis committee (IAC)will be established to review the interim
data including data from the LTE available at the time of the IA to formulate recommended
decisions and/or actions in accordance with the objectives of the interim analyses. The IAC will
consist of at least a clinician and a statistician (neither of whom are involved in study conduct),
one of whom will chair the committee, and other members as required. The details will be provided
in a separate IAC charter.
The IAC will review the unblinded efficacy data and provide recommendations about the next step
of study conduct and the future development of the compound based upon the results of the first
(when approximately 50% (n=120) of the participants reach Week 4) and/or second (when
approximately 2/3 (n=160) of the participants reach Week 16) interim efficacy analyses. The first
IA will be for nonbinding futility based on the proportion of participants achieving PASI 50
response at Week 4. The second IA will be used for planning of future studies and will be based
on the primary endpoint which is the proportion of participants achieving PASI 75 response at
Week 16. Other selected supportive efficacy endpoints could also be reviewed. The unblinded
results will be limited to specific sponsor personnel not involved in the study conduct. Interim
analysis results will not be disseminated to investigators or individuals associated with the conduct
of the study.
Details of the plan for the interim analyses will be specified in the Interim Analysis SAP.

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10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Abbreviations
ADAs 
anti-drug antibodies
AE 
adverse event
AESI 
adverse event of special interest
ALT  
alanine aminotransferase
anti-HCV  
hepatitis C antibody
AST  
aspartate aminotransferase
AUC  
area under the plasma concentration versus time curve
AUC0-24 
area under the plasma analyte concentration-time curve from time 0 to 24 hours postdose
BCG  
bacille Calmette-Guerin
BID  
twice daily
BSA 
body surface area
ClinRO  
clinician-reported outcome
Cmax  
maximum observed plasma concentration
COVID-19 
Coronavirus Disease 2019
C-SSRS  
Columbia-Suicide Severity Rating Scale
CTCAE 
Common Terminology Criteria for Adverse Events
Ctrough
plasma concentration just prior to the beginning or at the end of the dosing interval
DBL  
database lock
DILI 
drug-induced liver injury
DLQI 
Dermatological Life Quality Index
ECG  
Electrocardiogram
eCOA  
electronic clinical outcomes assessment
eDC  
electronic data capture
eCRF  
electronic case report form(s)
EU  
European Union
FAS  
full analysis set
FDA  
Food and Drug Administration
FIH  
first-in-human
f-PGA  
Fingernail Physician’s Global Assessment
FSH  
follicle stimulating hormone
GCP  
Good Clinical Practice
GenPs-SFQ  
Genital Psoriasis Sexual Frequency Questionnaire
GLP  
Good Laboratory Practice
HBsAg 
hepatitis B surface antigen
HDL 
high-density lipoprotein
hf-PGA  
Physician’s Global Assessment of Hands and/or Feet
HIV  
human immunodeficiency virus
HRQOL 
Health-Related Quality of life
HRT  
hormone replacement therapy
IAC  
Interim Analysis Committee
IB  
Investigator’s Brochure
IC50 
half maximal inhibitory concentration
ICEs 
intercurrent events
ICF  
informed consent form
ICH  
International Council for Harmonisation
ICMJE 
International Committee of Medical Journal Editors
iDMC  
Independent Data Monitoring Committee
IEC  
Independent Ethics Committee
Ig 
Immunoglobulin
IGA  
Investigator Global Assessment
IGRA  
Interferon gamma release assay
IL 
Interleukin
IL-12Rβ1 
interleukin 12 receptor beta 1
IL-23R 
interleukin 23 receptor

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IMP  
Investigational Medicinal Product
IND  
Investigational New Drug
INR  
International Normalized Ratio
IRB  
Institutional Review Board
IWRS  
interactive web response system
JAK  
Janus kinase
LC-MS/MS  
liquid chromatography/mass spectrometry/mass spectrometry
LDL 
low-density lipoprotein
LSmeans 
Least Square means
LTE 
long-term extension
MAD  
multiple ascending doses
MedDRA  
Medical Dictionary for Regulatory Activities
NAbs 
neutralizing antibodies
NAPSI 
Nail Psoriasis Area and Severity Index
NIMP  
Non-Investigational Medicinal Product
NK  
natural killer
NOAEL 
no-observed-adverse-effect-level
PASI 
Psoriasis Area and Severity Index
PCC  
protocol clarification communication
PD 
pharmacodynamic(s)
PDE 
Phosphodiesterase
PGI-C 
Patient Global Impression-Change
PGI-S 
Patient Global Impression-Severity
PK 
pharmacokinetic(s)
PQC  
Product Quality Complaint
PRO  
patient-reported outcome(s) (paper or electronic as appropriate for this study)
PROMIS-29 
Patient-Reported Outcomes Measurement Information System-29
PSSD  
Psoriasis Symptom and Sign Diary
QD 
once daily
RBC  
red blood cell
SAD  
single ascending doses
SAE 
serious adverse event
SAP  
statistical analysis plan
SD 
standard deviation
SoA  
Schedule of Activities
s-PGA  
Static Physician’s Global Assessment
ss-IGA  
Scalp Specific Investigator Global Assessment
STAT  
signal transducers and activators of transcription
SUSAR  
suspected unexpected serious adverse reaction
TB  
Tuberculosis
tmax  
time to maximum plasma concentration
TNF  
tumor necrosis factor
TSQM-9 
Treatment Satisfaction Questionnaire for Medications-9 items
TYK  
tyrosine kinase
ULN  
upper limit of normal
US  
United States
WBC  
white blood cell

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Routine 
Urinalysis 
Dipstick  
Specific gravity  
pH  
Glucose 
Protein  
Blood 
Ketones 
Bilirubin
Urobilinogen
Nitrite
Leukocyte esterase
Sediment
Red blood cells
White blood cells
Epithelial cells
Crystals
Casts
Bacteria
If dipstick result is abnormal, microscopy will be used to measure sediment.
In the microscopic examination, observations other than the presence of WBC, RBC
and casts may also be reported by the laboratory.
Specific gravity, pH, glucose, protein, blood, ketones, bilirubin, and urobilinogen will
be determined using a dipstick. Red blood cells, WBCs, epithelial cells, crystals, casts,
and bacteria will be measured using microscopy. If there is discordance between the
dipstick results, the sediment will be examined microscopically.
Other Tests 
 
Serum Pregnancy Testing for women of childbearing potential only (at Screening
only)
 
Urine Pregnancy Testing for women of childbearing potential only (all other
visits)
 
Serology (HIV antibody, hepatitis B surface antigen [HBsAg], and hepatitis C
virus antibody)
 
hs-CRP

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10.3. Appendix 3: Regulatory, Ethical, and Study Oversight Considerations
10.3.1. 
Regulatory and Ethical Considerations
Investigator Responsibilities
The investigator is responsible for ensuring that the study is performed in accordance with the
protocol, current ICH guidelines on Good Clinical Practice (GCP), and applicable regulatory and
country-specific requirements.
Good Clinical Practice is an international ethical and scientific quality standard for designing,
conducting, recording, and reporting studies that involve the participation of human participants.
Compliance with this standard provides public assurance that the rights, safety, and well-being of
study participants are protected, consistent with the principles that originated in the Declaration of
Helsinki, and that the study data are credible.
Protocol Clarification Communications
If text within a final approved protocol requires clarification (eg, current wording is unclear or
ambiguous) that does not change any aspect of the current study conduct, a protocol clarification
communication (PCC) may be prepared. The PCC Document will be communicated to the
Investigational Site, Site Monitors, Local Trial Managers (LTMs), Clinical Trial Managers
(CTMs), and/or Contract Research Organizations (CROs) who will ensure that the PCC
explanations are followed by the investigators.
The PCC Document may be shared by the sites with Independent Ethics Committees/Institutional
Review Boards (IECs/IRBs) per local regulations.
The PCC Documents must NOT be used in place of protocol amendments, but the content of the
PCC Document must be included in any future protocol amendments.
Protocol Amendments
Neither the investigator nor the sponsor will modify this protocol without a formal amendment by
the sponsor. All protocol amendments must be issued by the sponsor and signed and dated by the
investigator. Protocol amendments must not be implemented without prior IEC/IRB approval, or
when the relevant competent authority has raised any grounds for non-acceptance, except when
necessary to eliminate immediate hazards to the participants, in which case the amendment must
be promptly submitted to the IEC/IRB and relevant competent authority. Documentation of
amendment approval by the investigator and IEC/IRB must be provided to the sponsor. When the
change(s) involve only logistic or administrative aspects of the study, the IEC/IRB (where
required) only needs to be notified.
In situations where a departure from the protocol is unavoidable during the study, 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

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agree on an appropriate course of action. The data recorded in the CRF and source documents will
reflect any departure from the protocol, and the source documents will describe this departure and
the circumstances requiring it.
Regulatory Approval/Notification
This protocol and any amendment(s) must be submitted to the appropriate regulatory authorities
in each respective country, if applicable. A study may not be initiated until all local regulatory
requirements are met.
Required Prestudy Documentation
The following documents must be provided to the sponsor before shipment of study intervention
to the study site:
 
Protocol and amendment(s), if any, signed and dated by the principal investigator
 
A copy of the dated and signed (or sealed, where appropriate per local regulations), written
IEC/IRB approval of the protocol, amendments, ICF, any recruiting materials, and if
applicable, participant compensation programs. This approval must clearly identify the
specific protocol by title and number and must be signed (or sealed, where appropriate per
local regulations) by the chairman or authorized designee.
 
Name and address of the IEC/IRB, including a current list of the IEC/IRB members and their
function, with a statement that it is organized and operates according to GCP and the
applicable laws and regulations. If accompanied by a letter of explanation, or equivalent, from
the IEC/IRB, a general statement may be substituted for this list. If an investigator or a
member of the study site personnel is a member of the IEC/IRB, documentation must be
obtained to state that this person did not participate in the deliberations or in the vote/opinion
of the study.
 
Regulatory authority approval or notification, if applicable
 
Signed and dated statement of investigator (eg, Form FDA 1572), if applicable
 
Documentation of investigator qualifications (eg, curriculum vitae)
 
Completed investigator financial disclosure form from the principal investigator, where
required
 
Signed and dated clinical trial agreement, which includes the financial agreement
 
Any other documentation required by local regulations
The following documents must be provided to the sponsor before enrollment of the first
participant:
 
Completed investigator financial disclosure forms from all subinvestigators
 
Documentation of subinvestigator qualifications (eg, curriculum vitae)
 
Name and address of any local laboratory conducting tests for the study, and a dated copy of
current laboratory normal ranges for these tests, if applicable

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 
Local laboratory documentation demonstrating competence and test reliability
(eg, accreditation/license), if applicable
Independent Ethics Committee or Institutional Review Board
Before the start of the study, the investigator (or sponsor where required) will provide the IEC/IRB
with current and complete copies of the following documents (as required by local regulations):
 
Final protocol and, if applicable, amendments
 
Sponsor-approved ICF (and any other written materials to be provided to the participants)
 
IB (or equivalent information) and amendments/addenda
 
Sponsor-approved participant recruiting materials
 
Information on compensation for study-related injuries or payment to participants for
participation in the study, if applicable
 
Investigator's curriculum vitae or equivalent information (unless not required, as documented
by the IEC/IRB)
 
Information regarding funding, name of the sponsor, institutional affiliations, other potential
conflicts of interest, and incentives for participants
 
Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after the IEC/IRB has given full approval of the final protocol,
amendments (if any, excluding the ones that are purely administrative, with no consequences for
participants, data or study conduct, unless required locally), the ICF, applicable recruiting
materials, and participant compensation programs, and the sponsor has received a copy of this
approval. This approval letter must be dated and must clearly identify the IEC/IRB and the
documents being approved.
Approval for the collection of optional samples for research and for the corresponding ICF must
be obtained from the IEC/IRB. Approval for the protocol can be obtained independent of this
optional research component.
During the study the investigator (or sponsor where required) will send the following documents
and updates to the IEC/IRB for their review and approval, where appropriate:
 
Protocol amendments (excluding the ones that are purely administrative, with no
consequences for participants, data or study conduct)
 
Revision(s) to ICF and any other written materials to be provided to participants
 
If applicable, new or revised participant recruiting materials approved by the sponsor
 
Revisions to compensation for study-related injuries or payment to participants for
participation in the study, if applicable
 
New edition(s) of the IB and amendments/addenda

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 
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
intervention
 
New information that may adversely affect the safety of the participants or the conduct of the
study
 
Deviations from or changes to the protocol to eliminate immediate hazards to the participants
 
Report of deaths of participants under the investigator's care
 
Notification if a new investigator is responsible for the study at the site
 
Development Safety Update Report and Line Listings, where applicable
 
Any other requirements of the IEC/IRB
For all protocol amendments (excluding the ones that are purely administrative, with no
consequences for participants, data or study conduct), the amendment and applicable ICF revisions
must be submitted promptly to the IEC/IRB for review and approval before implementation of the
change(s).
At least once a year, the IEC/IRB will be asked to review and reapprove this study, where required.
At the end of the study, the investigator (or sponsor where required) will notify the IEC/IRB about
the study completion (if applicable, the notification will be submitted through the head of
investigational institution).
Country Selection
This study will only be conducted in those countries where the intent is to launch or otherwise help
ensure access to the developed product if the need for the product persists, unless explicitly
addressed as a specific ethical consideration in Section  4.2.1, Study-Specific Ethical Design
Considerations.
Other Ethical Considerations
For study-specific ethical design considerations, refer to Section 4.2.1.
10.3.2. 
Financial Disclosure
Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial
information in accordance with local regulations to allow the sponsor to submit complete and
accurate financial certification or disclosure statements to the appropriate regulatory authorities.
Investigators are responsible for providing information on financial interests during the study and
for 1 year after completion of the study.
Refer to Required Prestudy Documentation (above) for details on financial disclosure.

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10.3.3. 
Informed Consent Process
Each participant (or a legally acceptable representative) must give written consent according to
local requirements after the nature of the study has been fully explained. The ICF(s) must be signed
before performance of any study-related activity. The ICF(s) that is/are used must be approved by
both the sponsor and by the reviewing IEC/IRB and be in a language that the participant can read
and understand. The informed consent should be in accordance with principles that originated in
the Declaration of Helsinki, current ICH and GCP guidelines, applicable regulatory requirements,
and sponsor policy.
Informed consent may be obtained remotely. Refer to the Monitoring Guideline.
Before enrollment in the study, the investigator or an authorized member of the study site personnel
must explain to potential participants or their legally acceptable representatives the aims, methods,
reasonably anticipated benefits, and potential hazards of the study, and any discomfort
participation in the study may entail. Participants will be informed that their participation is
voluntary and that they may withdraw consent to participate at any time. They will be informed
that choosing not to participate will not affect the care the participant will receive for the treatment
of his or her disease. Participants will be told that alternative treatments are available if they refuse
to take part and that such refusal will not prejudice future treatment. Finally, they will be told that
the investigator will maintain a participant identification register for the purposes of long-term
follow-up if needed and that their records may be accessed by health authorities and authorized
sponsor personnel without violating the confidentiality of the participant, to the extent permitted
by the applicable law(s) or regulations. By signing the ICF the participant or legally acceptable
representative is authorizing such access. It also denotes that the participant agrees to allow his or
her study physician to recontact the participant for the purpose of obtaining consent for additional
safety evaluations, and subsequent disease-related treatments, if needed. The physician may also
recontact the participant for the purpose of obtaining consent to collect information about his or
her survival status.
The participant or legally acceptable representative will be given sufficient time to read the ICF
and the opportunity to ask questions. After this explanation and before entry into the study, consent
should be appropriately recorded by means of either the participant's or his or her legally
acceptable representative's personally dated signature. After having obtained the consent, a copy
of the ICF must be given to the participant.
Participants who are rescreened are required to sign a new ICF.
Participants will be asked for consent to provide optional samples for research  (where local
regulations permit). After informed consent for the study is appropriately obtained, the participant
or his or her legally acceptable representative will be asked to sign and personally date a separate
ICF indicating agreement to participate in the optional research component. Refusal to participate
in the optional research will not result in ineligibility for the study. A copy of this signed ICF will
be given to the participant.

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Where local regulations require, a separate ICF may be used for the required DNA component of
the study.
If the participant or legally acceptable representative is unable to read or write, an impartial witness
should be present for the entire informed consent process (which includes reading and explaining
all written information) and should personally date and sign the ICF after the oral consent of the
participant or legally acceptable representative is obtained.
10.3.4. 
Data Protection
Privacy of Personal Data
The collection and processing of personal data from participants enrolled in this study will be
limited to those data that are necessary to fulfill the objectives of the study.
These data must be collected and processed with adequate precautions to ensure confidentiality
and compliance with applicable data privacy protection laws and regulations. Appropriate
technical and organizational measures to protect the personal data against unauthorized disclosures
or access, accidental or unlawful destruction, or accidental loss or alteration must be put in place.
Sponsor personnel whose responsibilities require access to personal data agree to keep the identity
of participants confidential.
The informed consent obtained from the participant (or his or her legally acceptable representative)
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 participant has the right to request through the investigator access to his or her personal data
and the right to request rectification of any data that are not correct or complete. 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.
Exploratory DNA, PD biomarker, PK, immunogenicity, and photographic research is not
conducted under standards appropriate for the return of data to participants. In addition, the
sponsor cannot make decisions as to the significance of any findings resulting from exploratory
research. Therefore, exploratory research data will not be returned to participants or investigators,
unless required by law or local regulations. Privacy and confidentiality of data generated in the
future on stored samples will be protected by the same standards applicable to all other clinical
data.
10.3.5. 
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 JNJ-77242113, to understand
psoriasis, to understand differential intervention responders, and to develop tests/assays related to

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JNJ-77242113 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. Participants may withdraw their consent for their samples to be
stored for research (Section 7.2.1).
10.3.6. 
Committees Structure
Data Monitoring Committee
An external independent data monitoring committee (iDMC) whose members are not directly
involved in the conduct of the 77242113PSO2001 study, will review unblinded safety data to
ensure the safety of the participants enrolled in this study. The committee will meet regularly to
review unblinded safety data. After the review, the iDMC will make recommendations to the
sponsor regarding the conduct of the study. The iDMC will consist of at least one clinical physician
and one statistician, not involved in the conduct of the study. The iDMC responsibilities,
authorities, and procedures will be documented in the iDMC charter.
10.3.7. 
Publication Policy/Dissemination of Clinical Study Data
All information, including but not limited to information regarding JNJ-77242113 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, including pharmacogenomic, exploratory  biomarker, or
photographic research 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 JNJ-77242113, and thus may be
disclosed as required to other clinical investigators or regulatory agencies. To permit the
information derived from the clinical studies to be used, the investigator is obligated to provide
the sponsor with all data obtained in the study.
The results of the study will be reported in a Clinical Study Report generated by the sponsor and
will contain data from all study sites that participated in the study as per protocol. Recruitment
performance or specific expertise related to the nature and the key assessment parameters of the
study will be used to determine a coordinating investigator for the study. Results of
pharmacogenomic, exploratory biomarker, or photographic analyses performed after the Clinical
Study Report has been issued will be reported in a separate report and will not require a revision
of the Clinical Study Report.
Study participant identifiers will not be used in publication of results. Any work created in
connection with performance of the study and contained in the data that can benefit from copyright

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protection (except any publication by the investigator as provided for below) shall be the property
of the sponsor as author and owner of copyright in such work.
Consistent with Good Publication Practices and International Committee of Medical Journal
Editors (ICMJE) guidelines, the sponsor shall have the right to publish such primary (multicenter)
data and information without approval from the investigator. The investigator has the right to
publish study site-specific data after the primary data are published. If an investigator wishes to
publish information from the study, a copy of the manuscript must be provided to the sponsor for
review at least 60 days before submission for publication or presentation. Expedited reviews will
be arranged for abstracts, poster presentations, or other materials. If requested by the sponsor in
writing, the investigator will withhold such publication for up to an additional 60 days to allow for
filing of a patent application. In the event that issues arise regarding scientific integrity or
regulatory compliance, the sponsor will review these issues with the investigator. The sponsor will
not mandate modifications to scientific content and does not have the right to suppress information.
For multicenter study designs and sub-study approaches, secondary results generally should not
be published before the primary endpoints of a study have been published. Similarly, investigators
will recognize the integrity of a multicenter study by not submitting for publication data derived
from the individual study site until the combined results from the completed study have been
submitted for publication, within 18 months after the study end date, or the sponsor confirms there
will be no multicenter study publication. Authorship of publications resulting from this study will
be based on the guidelines on authorship, such as those described in the ICMJE Recommendations
for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals, which
state that the named authors must have made a significant contribution to the conception or design
of the work; or the acquisition, analysis, or interpretation of the data for the work; and drafted the
work or revised it critically for important intellectual content; and given final approval of the
version to be published; and agreed to be accountable for all aspects of the work in ensuring that
questions related to the accuracy or integrity of any part of the work are appropriately investigated
and resolved.
Registration of Clinical Studies and Disclosure of Results
The sponsor will register and disclose the existence of and the results of clinical studies as required
by law. The disclosure of the final study results will be performed after the end of study in order
to ensure the statistical analyses are relevant.
10.3.8. 
Data Quality Assurance
Data Quality Assurance/Quality Control
Steps to be taken to ensure the accuracy and reliability of data include the selection of qualified
investigators and appropriate study sites, review of protocol procedures with the investigator and
study site personnel before the study, and periodic monitoring visits by the sponsor, and direct
transmission of clinical laboratory data from a central laboratory into the sponsor's data base.
Written instructions will be provided for collection, handling, storage, and shipment of samples.

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Guidelines for eCRF completion will be provided and reviewed with study site personnel before
the start of the study. The sponsor may review the eCRF 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.
10.3.9. 
Case Report Form Completion
Electronic case report forms are prepared and provided by the sponsor for each participant in
electronic format. All data relating to the study must be recorded in the eCRF. All eCRF entries,
corrections, and alterations must be made by the investigator or authorized study site personnel.
The investigator must verify that all data entries in the eCRF are accurate and correct.
The study data will be transcribed by study site personnel from the source documents onto an
eCRF, if applicable. Study-specific data will be transmitted in a secure manner to the sponsor.
Worksheets may be used for the capture of some data to facilitate completion of the eCRF. Any
such worksheets will become part of the participant's source documents. Data must be entered into
the eCRF in English. The eCRF must be completed as soon as possible after a participant visit and
the forms should be available for review at the next scheduled monitoring visit.
All participative measurements (eg, pain scale information or other questionnaires) will be
completed by the same individual who made the initial baseline determinations whenever possible.
If necessary, queries will be generated in the eDC tool. If corrections to an eCRF are needed after
the initial entry into the eCRF, this can be done in either of the following ways:
 Investigator and study site personnel can make corrections in the eDC tool at their own
initiative or as a response to an auto query (generated by the eDC tool).
 Sponsor or sponsor delegate can generate a query for resolution by the investigator and study
site personnel.
10.3.10. 
Source Documents
At a minimum, source documents consistent in the type and level of detail with that commonly
recorded at the study site as a basis for standard medical care must be available for the following:
participant identification, eligibility, and study identification; study discussion and date of signed
informed consent; dates of visits; results of safety and efficacy parameters as required by the
protocol; record of all AEs and follow-up of AEs; concomitant medication; intervention
receipt/dispensing/return records; study intervention administration information; and date of study
completion and reason for early discontinuation of study intervention  or withdrawal from the
study, if applicable.
The author of an entry in the source documents should be identifiable. Given that patient-reported
outcomes (PROs) are reports of a patient's health condition that come directly from the patient,
without interpretation by a clinician or anyone else, the responses to PRO measures entered by
study participants into source records cannot be overridden by site staff or investigators.

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Specific details required as source data for the study and source data collection methods will be
reviewed with the investigator before the study and will be described in the monitoring guidelines
(or other equivalent document).
The following data will be recorded directly into the eCRF and will be considered source data:
 Race
 History of smoking, all nicotine use, eg, cigarettes (including e-cigarettes or the equivalent of
e-cigarettes), cigars, chewing tobacco, patch, gum
 Blood pressure and pulse/heart rate
 Height and weight
 Details of physical examination
 Investigator-completed scales and assessments and PROs
The minimum source documentation requirements for Section 5.1, Inclusion Criteria and
Section 5.2, Exclusion Criteria that specify a need for documented medical history are as follows:
 Referral letter from treating physician or
 Complete history of medical notes at the site
 Discharge summaries
Inclusion and exclusion criteria not requiring documented medical history must be verified at a
minimum by participant interview or other protocol required assessment (eg, physical
examination, laboratory assessment) and documented in the source documents.
An eSource system may be utilized, which contains data traditionally maintained in a hospital or
clinic record to document medical care (eg, electronic source documents) as well as the clinical
study-specific data fields as determined by the protocol. This data is electronically extracted for
use by the sponsor. If eSource is utilized, references made to the CRF in the protocol include the
eSource system but information collected through eSource may not be limited to that found in the
CRF.
10.3.11. 
Monitoring
The sponsor will use a combination of monitoring techniques: central, remote, or on-site
monitoring to monitor this study.
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 may  compare the data entered into the eCRF with the source documents
(eg, hospital/clinic/physician’s office medical records). The nature and location of all source
documents will be identified to ensure that all sources of original data required to complete the

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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.
10.3.12. 
On-Site Audits
Representatives of the sponsor's clinical quality assurance department may visit the study site at
any time during or after completion of the study to conduct an audit of the study in compliance
with regulatory guidelines and company policy. These audits will require access to all study
records, including source documents, for inspection. Participant privacy must, however, be
respected. The investigator and study site personnel are responsible for being present and available
for consultation during routinely scheduled study site audit visits conducted by the sponsor or its
designees.
Similar auditing procedures may also be conducted by agents of any regulatory body, either as part
of a national GCP compliance program or to review the results of this study in support of a
regulatory submission. The investigator should immediately notify the sponsor if he or she has
been contacted by a regulatory agency concerning an upcoming inspection.
10.3.13. 
Record Retention
In compliance with the ICH/GCP guidelines, the investigator/institution will maintain all CRF and
all source documents that support the data collected from each participant, as well as all study
documents as specified in ICH/GCP Section 8, Essential Documents for the Conduct of a Clinical
Trial, and all study documents as specified by the applicable regulatory requirement(s). The
investigator/institution will take measures to prevent accidental or premature destruction of these
documents.
Essential documents must be retained until at least 2 years after the last approval of a marketing
application in an ICH region and until there are no pending or contemplated marketing applications
in an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical
development of the investigational product. These documents will be retained for a longer period

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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.
10.3.14. 
Study and Site Start and Closure
First Act of Recruitment
The first site open is considered the first act of recruitment and it becomes the study start date.
Study/Site 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 andstudy supplies have been collected
and a study site closure visit has been performed.
The investigator may initiate study site closure at any time, provided there is reasonable cause and
sufficient notice is given in advance of the intended termination.
Reasons for the early closure of a study site by the sponsor or investigator may include but are not
limited to:
 Failure of the investigator to comply with the protocol, the requirements of the IEC/IRB or
local health authorities, the sponsor's procedures, or GCP guidelines
 Inadequate recruitment of participants by the investigator
 Discontinuation of further study intervention development

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10.4. Appendix 4: Psoriasis Area and Severity Index (PASI)
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 BSA,
respectively.  Each of these areas is assessed separately for erythema, induration and scaling, which
are each rated on a scale of 0 to 4.
The scoring system for the signs of the disease (erythema, induration, and scaling) are:  0 = none,
1 = slight, 2 = moderate, 3 = severe, and 4 = very severe.
The scale for estimating the area of involvement for psoriatic lesions is outlined below.
0 = no involvement
1 = 1% to 9% involvement
2 = 10% to 29% involvement
3 = 30% to 49% involvement
4 = 50% to 69% involvement
5 = 70% to 89% involvement
6 = 90% to 100% involvement
To help with the area assessments, the following conventions should be noted:
a. 
The neck is considered part of the head
b. 
The axillae and groin are part of the trunk
c. 
The buttocks are part of the lower extremities
The PASI formula is:
PASI = 0.1 (Eh + Ih + Sh) Ah + 0.3 (Et + It + St) At + 0.2 (Eu + Iu + Su) Au + 0.4 (El + Il + Sl) A  
l
Where E = erythema, I = induration, S = scaling, and A = area

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10.5. Appendix 5: Photographs
Background and rationale
Objective measurement and quantification of skin lesion characteristics derived from longitudinal
photographic images of the enrolled patients may provide robust metrics of disease activity.
Historically, total body photography has been employed in dermatology for the process of “mole
mapping,” ie, documenting, monitoring and assessing the development or change of nevi on the
skin over time.
While PASI score provides a non-invasive approach to measure severity of psoriasis, it is poorly
correlated with Quality-of-Life measures [1] and is not widely used by clinicians in real-world
practice. The PASI score is also susceptible to inter and intra-clinician variability.
In the current study, imaging is planned for visual evaluation of disease severity and to contribute
to our objective of developing a computer vision approach for quantifying of disease activity.
Photographic imaging in the current study will allow for assessing the efficacy of JNJ-77242113
with objectivity and sensitivity.
Approach
In the proposed study, visible photography will be employed in a subset of patients, acquired at
the clinical site. Participating patients will have two options for image collection:
1. 
Lesional photographs: two areas of lesional skin will be photographed per patient. The
same two areas will be photographed over time.
2. 
Full body photographs + lesional photographs: In addition to the two lesional
photographs, full body photographs (front and back) will be collected.
Photographic imaging will be conducted with quasi-standardized photographic equipment (iPhone
or iPad based, handheld imaging) following instructions that establish specific imaging conditions,
such as approximate distance between the camera and the surface of interest, and uniformity of
light distribution. Images will be collected at baseline, Week 8, and Week 16 (primary endpoint
timing).
Lesion assessment of relevant PSO lesional features (such as erythema, desquamation, and
induration) will be conducted by central readers in a blinded fashion. As an exploratory analysis
and depending on the volume and quality of image data collected, the images may be used to create
an automated image-based disease severity assessment via deep learning modeling or low-level
vision, such as traditional image analysis algorithms.
[1] Schmitt J, Wozel G. The psoriasis area and severity index is the adequate criterion to define severity in chronic
plaque-type psoriasis. Dermatology. 2005;210(3):194-9. doi: 10.1159/000083509. PMID: 15785046.

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Images acquired in this study will also contribute to broader effort to develop a curated image
database of dermatological conditions for use in development of computer vision algorithms to
automate assessment of disease states of interest.
[1] Schmitt J, Wozel G. The psoriasis area and severity index is the adequate criterion to define severity in chronic
plaque-type psoriasis. Dermatology. 2005;210(3):194-9. doi: 10.1159/000083509. PMID: 15785046.

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10.6. Appendix 6: Adverse Events, Serious Adverse Events, Product Quality
Complaints, and Other Safety Reporting: Definitions and Procedures for
Recording, Evaluating, Follow-up, and Reporting
10.6.1. 
Adverse Event Definitions and Classifications
Adverse Event
An AE is any untoward medical occurrence in a clinical study participant administered a
pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have
a causal relationship with the intervention. 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 Council for
Harmonisation [ICH]).
This includes any occurrence that is new in onset or aggravated in severity or frequency from the
baseline condition, or abnormal results of diagnostic procedures, including laboratory test
abnormalities.
Note: The sponsor collects AEs starting with the signing of the ICF (refer to Section 8.3.1, for time
of last AE recording).
Serious Adverse Event
An  SAE based on ICH and EU Guidelines on Pharmacovigilance for Medicinal Products for
Human Use is any untoward medical occurrence that at any dose:
 
Results in death
 
Is life-threatening
(The participant was at risk of death at the time of the event. It does not refer to an event that
hypothetically might have caused death if it were more severe.)
 
Requires inpatient hospitalization or prolongation of existing hospitalization
 
Results in persistent or significant disability/incapacity
 
Is a congenital anomaly/birth defect
 
Is a suspected transmission of any infectious agent via a medicinal product
 
Is Medically Important*
*Medical and scientific judgment should be exercised in deciding whether expedited reporting
is also appropriate in other situations, such as important medical events that may not be
immediately life-threatening or result in death or hospitalization but may jeopardize the
participant or may require intervention to prevent one of the other outcomes listed in the
definition above. These should usually be considered serious.
If a serious and unexpected AE occurs for which there is evidence suggesting a causal relationship
between the study intervention and the event (eg, death from anaphylaxis), the event must be

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reported as a serious and unexpected suspected adverse reaction even if it is a component of the
study endpoint.
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 JNJ-77242113, the expectedness of an AE will be determined by
whether or not it is listed in the IB. For standard-of-care background therapies with a marketing
authorization, the expectedness of an AE will be determined by whether or not it is listed in the
package insert/summary of product characteristics.
10.6.2. 
Attribution Definitions
Assessment of Causality
The causal relationship to study intervention is determined by the Investigator. The following
selection should be used to assess all AEs.
Related
There is a reasonable causal relationship between study intervention administration and the AE.
Not Related
There is not a reasonable causal relationship between study intervention administration and the
AE.
The term "reasonable causal relationship" means there is evidence to support a causal relationship.
10.6.3. 
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 participant (eg, laboratory abnormalities).
10.6.4. 
Special Reporting Situations
Safety events of interest on a sponsor study intervention in an interventional studythat may require
expedited reporting or safety evaluation include, but are not limited to:
 
Overdose of a sponsor study intervention

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 
Suspected abuse/misuse of a sponsor study intervention
 
Accidental or occupational exposure to a sponsor study intervention
 
Medication error, intercepted medication error, or potential medication error involving a
Johnson & Johnson medicinal product (with or without patient exposure to the Johnson &
Johnson medicinal product, eg, product name confusion, product label confusion, intercepted
prescribing or dispensing errors)
 
Exposure to a sponsor study intervention from breastfeeding
Special reporting situations should be recorded in the CRF. Any special reporting situation that
meets the criteria of an SAE should be recorded on the SAE page of the CRF.
10.6.5. 
Procedures
All Adverse Events
All AEs, regardless of seriousness, severity, or presumed relationship to study intervention, must
be recorded using medical terminology in the source document and the CRF. Whenever possible,
diagnoses should be given when signs and symptoms are due to a common etiology (eg, cough,
runny nose, sneezing, sore throat, and head congestion should be reported as "upper respiratory
infection"). Investigators must record in the CRF their opinion concerning the relationship of the
AE to study therapy. All measures required for AE management must be recorded in the source
document and reported according to sponsor instructions.
For all studies with an outpatient phase, including open-label studies, the participant must be
provided with a "wallet (study) card" and instructed to carry this card with them for the duration
of the study indicating the following:
 
Study number
 
Statement, in the local language(s), that the participant is participating in a clinical study
 
Investigator's name and 24-hour contact telephone number
 
Local sponsor's name and 24-hour contact telephone number (for medical personnel only)
 
Site number
 
Participant number
 
Any other information that is required to do an emergency breaking of the blind
Serious Adverse Events
All SAEs that have not resolved by the end of the study, or that have not resolved upon  the
participant's discontinuation from 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

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 
The event can be attributed to agents other than the study intervention or to factors unrelated
to study conduct
 
It becomes unlikely that any additional information can be obtained (participant or health care
practitioner refusal to provide additional information, lost to follow-up after demonstration of
due diligence with follow-up efforts)
Any event requiring hospitalization (or prolongation of hospitalization) that occurs during
participation in the study must be reported as an SAE, except hospitalizations for the following:
 
Hospitalizations not intended to treat an acute illness or AE (eg, social reasons such as pending
placement in long-term care facility)
 
Surgery or procedure planned before entry into the study (must be documented in the eCRF).
Note: Hospitalizations that were planned before the signing of the ICF, and where the
underlying condition for which the hospitalization was planned has not worsened, will not be
considered SAEs. Any AE that results in a prolongation of the originally planned
hospitalization is to be reported as a new SAE.
 
For convenience the investigator may choose to hospitalize the participant for the duration of
the intervention period.
The cause of death of a participant in a study within 4 weeks of the last dose of study intervention,
whether or not the event is expected or associated with the study intervention, is considered an
SAE.
Information regarding SAEs will be transmitted to the sponsor using an SAE reporting form and
safety report form of the eCRF, which must be completed and reviewed by a physician from the
study site and transmitted in a secure manner to the sponsor within 24 hours. The initial and
follow-up reports of an SAE should be transmitted in a secure manner electronically or by
facsimile (fax). Telephone reporting should be the exception and the reporter should be asked to
complete the appropriate form(s) first.
10.6.6. 
Product Quality Complaint Handling
Definition
A product quality complaint (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, reliability, or performance of a distributed product, including its labeling, drug delivery
system, or package integrity. A PQC may have an impact on the safety and efficacy of the product.
In addition, it includes any technical complaints, defined as any complaint that indicates a potential
quality issue during manufacturing, packaging, release testing, stability monitoring, dose
preparation, storage or distribution of the product or the drug delivery system.
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.

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A sample of the suspected product should be maintained under the correct storage conditions until
a shipment request is received from the sponsor.
10.6.7. 
Contacting Sponsor Regarding Safety, Including Product Quality
The names (and corresponding telephone numbers) of the individuals who should be contacted
regarding safety issues, PQC, or questions regarding the study are listed in the Contact Information
page(s), which will be provided as a separate document.

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10.8. Appendix 8: Contraceptive and Barrier Guidance
Participants must follow contraceptive measures as outlined in Section 5.1. Pregnancy information
will be collected and reported as noted in Section 8.3.5 and Section 10.3.
Definitions
Woman of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming postmenopausal unless
permanently sterile (see below).
Woman Not of Childbearing Potential
 
premenarchal
A premenarchal state is one in which menarche has not yet occurred.
 
postmenopausal
A postmenopausal state is defined as no menses for 12 months without an alternative medical
cause. A high follicle stimulating hormone (FSH) level (>40 IU/L or mIU/mL) in the
postmenopausal range may be used to confirm a postmenopausal state in women not using
hormonal contraception or hormonal replacement therapy (HRT), however in the absence of
12 months 
of 
amenorrhea, 
a 
single 
FSH 
measurement 
is 
insufficient.
If there is a question about menopausal status in women on HRT, the woman will be required
to use one of the non-estrogen-containing hormonal highly effective contraceptive methods if
she wishes to continue HRT during the study.
 
permanently sterile (for the purpose of this study)
Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral
oophorectomy.
Note: If the childbearing potential changes after start of the study (eg, a premenarchal woman
experiences menarche) or the risk of pregnancy changes (eg, a woman who is not heterosexually
active becomes active), a woman must begin a highly effective method of contraception, as
described throughout the inclusion criteria.
If reproductive status is questionable, additional evaluation should be considered.
Contraceptive (birth control) use by men or women should be consistent with local regulations
regarding the acceptable methods of contraception for those participating in clinical studies.
Typical use failure rates may differ from those when used consistently and correctly. Use should
be consistent with local regulations regarding the use of contraceptive methods for participants in
clinical studies.

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Examples of Contraceptives
EXAMPLES OF CONTRACEPTIVESa ALLOWED DURING THE STUDY FOR FEMALE
PARTICIPANTS INCLUDE:
USER INDEPENDENT
Highly Effective Methods That Are User Independent Failure rate of <1% per year when used
consistently and correctly.
 Implantable progestogen-only hormone contraception associated with inhibition of ovulationb
 Intrauterine device (IUD)
 Intrauterine hormone-releasing system (IUS)
 Tubal closure (eg, bilateral tubal occlusion, bilateral tubal ligation)
 Azoospermic partner (vasectomized or due to medical cause)
(Vasectomized partner is a highly effective contraceptive method provided that the partner is the
sole sexual partner of the woman of childbearing potential and the absence of sperm has been
confirmed. If not, additional highly effective method of contraception should be used.
Spermatogenesis cycle is approximately 74 days.)
USER DEPENDENT
Highly Effective Methods That Are User Dependent Failure rate of <1% per year when used
consistently and correctly.
 Combined (estrogen- and progestogen-containing) hormonal contraception associated with
inhibition of ovulationb
 oral
 intravaginal
 transdermal
 injectable
 Progestogen-only hormone contraception associated with inhibition of ovulationb
 oral
 injectable
 Sexual abstinence
(Sexual abstinence is considered a highly effective method only if defined as refraining from
heterosexual intercourse during the entire period of risk associated with the study intervention.
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study
and the preferred and usual lifestyle of the participant.)
NOT ALLOWED AS SOLE METHOD OF CONTRACEPTION DURING THE STUDY FOR
FEMALE PARTICIPANTS (not considered to be highly effective - failure rate of 1% per year)
 Progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary
mode of action.
 Male or female condom with or without spermicidec
 Cap, diaphragm, or sponge with spermicide
 A combination of male condom with either cap, diaphragm, or sponge with spermicide
(double-barrier methods)c
 Periodic abstinence (calendar, symptothermal, post-ovulation methods)
 Withdrawal (coitus-interruptus)
 Spermicides alone
 Lactational amenorrhea method (LAM)

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a) Typical use failure rates may differ from those when used consistently and correctly. Use should be
consistent with local regulations regarding the use of contraceptive methods for participants in
clinical studies.
b) Hormonal contraception may be susceptible to interaction with the study intervention, which may
reduce the efficacy of the contraceptive method. In addition, consider if the hormonal contraception
may interact with the study intervention.
c) Male condom and female condom should not be used together (due to risk of failure with friction).

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10.9. Appendix 9: Liver Safety: Suggested Actions and Follow-up Assessments
10.9.1. 
Stopping Algorithm
Study intervention will be discontinued for a participant if liver chemistry stopping criteria are
met.

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10.9.2. 
FOLLOW-UP ASSESSMENTS
10.9.2.1. 
Phase 2 Liver Chemistry Stopping Criteria and Follow-up
Assessments
Phase 2 liver chemistry stopping criteria are designed to assure participant safety and to evaluate
liver event etiology.
Liver Chemistry Stopping Criteria
ALT/AST- 
absolute
ALT or AST- 5xULN
ALT/AST- 
Increase 
If cannot monitor:
ALT or AST- 3 x ULN and cannot be monitored weekly for 4 weeks
Or if able to monitor:
ALT or AST- 3xULN persists for 4 weeks
Total 
bilirubin1, 2 
ALT or AST- 3xULN and total bilirubin 2xULN (or at least a doubling
of direct bilirubin in known Gilbert’s syndrome)
INR2 
ALT or AST- 3xULN and international normalized ratio (INR) >1.5, if
INR measured
Symptomatic3 
ALT or AST- 3xULN associated with symptoms (new or worsening)
believed to be related to liver injury or hypersensitivity
Suggested Actions, Monitoring and Follow-up Assessments
Actions 
Follow-up Assessments
 Immediately stop study intervention  
 Report the event to the sponsor within 
24 hours 
 Complete the CRF according to CRF 
completion guidelines, and complete an SAE 
data collection tool if the event also met the 
criteria for an SAE2 
 Perform follow-up assessments as described in 
the Follow Up Assessment column  
 Monitor the participant until liver chemistry 
test abnormalities resolve, stabilize, or return 
to baseline (see MONITORING) 
MONITORING:
If ALP <2 x ULN, ALT or AST- 3xULN AND 
total bilirubin 2xULN (or at least a doubling 
of direct bilirubin in known Gilbert’s 
syndrome) or INR >1.5 (if measured): 
 Repeat liver chemistry tests (include ALT, 
aspartate transaminase [AST], alkaline 
phosphatase, total and direct bilirubin and 
 Viral hepatitis serology4
 Obtain INR and recheck with each
liver chemistry assessment until the
transaminase values show downward
trend
 Obtain blood sample for
pharmacokinetic (PK) analysis within
48 hours after the most recent dose5
 Obtain serum creatine phosphokinase
(CPK), lactate dehydrogenase (LDH),
gamma-glutamyltransferase [GGT],
glutamate dehydrogenase [GLDH],
and serum albumin
 Fractionate bilirubin
 Obtain complete blood count with
differential to assess eosinophilia
 Record the appearance or worsening of
clinical symptoms of liver injury, or
hypersensitivity, on the CRF as per
CRF completion guidelines

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INR) and perform liver event follow-up
assessments within 24 hours
 Monitor participant twice weekly until liver
chemistry test abnormalities resolve, stabilize,
or return to baseline
 A specialist or hepatology consultation is
recommended
If ALT or AST- 3xULN AND total bilirubin
<2xULN and INR 1.5:
 Repeat liver chemistry tests (include ALT,
AST, alkaline phosphatase, total and direct
bilirubin and INR) and perform liver chemistry
follow-up assessments within 24 to 72 hours
 Monitor participants weekly until liver
chemistry abnormalities resolve, stabilize, or
return to baseline
RESTART/RECHALLENGE
 Do not restart/rechallenge participant with
study intervention. PERMANENTLY
DISCONTINUE STUDY INTERVENTION
AND CONTINUE PARTICIPANT IN THE
STUDY FOR ANY PROTOCOL SPECIFIED
FOLLOW-UP ASSESSMENTS
 Record use of concomitant
medications (including
acetaminophen, herbal remedies,
recreational drugs and other over-the-
counter medications)
 Record alcohol use on the CRF as per
CRF completion guidelines
If ALT or AST 3xULN AND total
bilirubin 2xULN or INR >1.5(if
measured) obtain the following in
addition to the assessments listed above:
 Anti-nuclear antibody, anti-smooth
muscle antibody, Type 1 anti-liver
kidney microsomal antibodies, and
quantitative total immunoglobulin G
(IgG) or gamma globulins
 Serum acetaminophen adduct assay,
when available, to assess potential
acetaminophen contribution to liver
injury in participants with definite or
likely acetaminophen use in the
preceding week
 Liver imaging (ultrasound, magnetic
resonance, or computerized
tomography) and/or liver biopsy to
evaluate liver disease; complete CRF
as per CRF completion guidelines
 Liver biopsy may be considered and
discussed with local specialist if
available:
 In participants when serology raises
the possibility of autoimmune
hepatitis (AIH)
 In participants when suspected
DILI progresses or fails to resolve
on withdrawal of study intervention
 In participants with acute or chronic
atypical presentation
 If liver biopsy conducted complete
CRF as per CRF completion
guidelines
1. Serum bilirubin fractionation should be performed if testing is available. If serum bilirubin fractionation is not
immediately available, discontinue study intervention if ALT 3xULN and total bilirubin 2xULN.
Additionally, if serum bilirubin fractionation testing is unavailable, record the absence/presence of detectable
urinary bilirubin on dipstick which is indicative of direct bilirubin elevations suggesting liver injury.

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2. All events ofALP <2 x ULN, ALT or AST- 3 x ULN and total bilirubin 2xULN (or at least a doubling of
direct bilirubin in known Gilbert’s sydnrome) or ALP <2 x ULN , ALT or AST- 3 x ULN and INR >1.5 (if
measured) may indicate severe liver injury (possible ‘Hy’s Law’) and must be reported to sponsor in an
expedited manner and as an SAE if SAE criteria are met (excluding studies of hepatic impairment or
cirrhosis). The INR stated threshold value will not apply to participants receiving anticoagulants.
3. New or worsening symptoms believed to be related to liver injury (such as fatigue, nausea, vomiting, right upper
quadrant pain or tenderness, or jaundice) or hypersensitivity (such as fever, rash or eosinophilia).
4. Includes: hepatitis A immunoglobulin M (IgM) antibody; HBsAgG and HBcAB; hepatitis C RNA;
cytomegalovirus IgM antibody; Epstein-Barr viral capsid antigen IgM antibody (or if unavailable, heterophile
antibody or monospot testing); and hepatitis E IgM antibody.
5. PK sample may not be required for participants known to be receiving placebo or non-comparator interventions.
Record the date/time of the PK blood sample draw and the date/time of the last dose of study intervention prior
to the blood sample draw on the CRF. If the date or time of the last dose is unclear, provide the participant’s best
approximation. If the date/time of the last dose cannot be approximated OR a PK sample cannot be collected in
the time period indicated above, do not obtain a PK sample. Instructions for sample handling and shipping are in
the Study Reference Manual.
10.9.2.2. 
Phase 2 Liver Chemistry Increased Monitoring Criteria with
Continued Study Intervention
Liver Chemistry Increased Monitoring Criterion and Actions with Continued Study
Intervention
Criterion 
Actions
ALT or AST- 3xULN and <5xULN 
and total bilirubin <2xULN or 
INR<1.5 (if measured), without 
symptoms believed to be related to 
liver injury or hypersensitivity, and  
who can be monitored weekly for 4 
weeks
 Notify the sponsor within 24 hours of learning of
the abnormality to discuss participant safety
 Participant must return weekly for repeat liver
chemistry tests (ALT, AST, alkaline phosphatase,
total bilirubin) until the abnormalities resolve,
stabilize or return to baseline
 If at any time, the participant meets liver chemistry
stopping criteria, proceed as described in
Section 10.9
 If, after 4 weeks of monitoring, ALT or AST-
<3xULN and total bilirubin <2xULN, monitor
participants twice monthly until liver chemistry
tests resolve, stabilize, or return to baseline

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10.11. Appendix 11: Guidance on Study Conduct during the COVID-19 Pandemic
It is recognized that the Coronavirus Disease 2019 (COVID-19) pandemic may have an impact on
the conduct of this clinical study due to, for example, self-isolation/quarantine by participants and
study-site personnel; travel restrictions/limited access to public places, including hospitals; study
site personnel being unavailable, isolated, or reassigned to critical tasks.
The sponsor is providing options for study-related participant management in the event of
disruption to the conduct of the study. This guidance does not supersede any local or government
guidelines or requirements or the clinical judgement of the investigator to protect the health and
well-being of participants and site staff. If at any time a participant’s safety is considered to be at
unacceptable risk, study intervention will be discontinued, and study follow-up will be conducted.
If, as a result of the COVID-19 pandemic, visits cannot be conducted in person at the study site,
they will be performed to the extent possible remotely/virtually or delayed until such time that
on-site visits can be resumed. At each contact, participants will be interviewed to collect safety
data. Key efficacy endpoint assessments should be performed if required and as feasible.
Participants will also be questioned regarding general health status to fulfill any physical
examination requirement.
Every effort should be made to adhere to protocol-specified assessments for participants on study
intervention, including follow-up. Modifications to protocol-required assessments may be
permitted after consultation between the participant and investigator, and the sponsor.
The sponsor will continue to monitor the conduct and progress of the clinical study, and any
changes will be communicated to the sites and to the health authorities according to local guidance.
If a participant has tested positive for COVID-19, the investigator should contact the sponsor’s
medical officer or designee to discuss plans for administration of study intervention, performing
study assessments, and follow-up. Modifications made to the study conduct as a result of the
COVID-19 pandemic should be summarized in the clinical study report.
ADDITIONAL ELEMENTS, WHERE APPLICABLE:
 Certain protocol-mandated visits to the study site may not be possible during the COVID-19
outbreak. Therefore, temporary measures may be implemented if considered appropriate by
the sponsor and Investigator to maintain continuity of patient care and study integrity. Certain
measures, such as those listed below, may be necessary and should be instituted in accordance
with applicable (including local) laws, regulations, guidelines, and procedures:
o remote (eg, by phone / telemedicine) or in-person, off-site (eg, in-home) interactions
between site staff (or designees) and patients for study procedures (eg, those related to
safety monitoring / efficacy evaluation / study intervention storage and administration
[including training where pertinent])

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o procurement of study intervention by patients (or designee) or shipment of study drug
from the study site directly to patients for at home administration
o laboratory assessments using a suitably accredited local laboratory; for selected
measures (eg, urine pregnancy), home testing may be employed
o other procedures may be conducted at an appropriate facility
 Missed assessments/visits will be captured in the clinical trial management system for protocol
deviations.  Discontinuations of study interventions and withdrawal from the study should be
documented with the prefix “COVID-19-related” in the eCRF. 
o other relevant study data elements impacted by the pandemic should also be
documented / labeled as “COVID-19-related” in eCRFs and / or other study systems,
as directed by detailed sponsor guidance. These may include missed / delayed /
modified study visits / assessments / dosing, and instances where temporary measures
such as those above are implemented. 
 The sponsor will evaluate the totality of impact of COVID-19 on collection of key study data
and additional data analyses will be outlined in study SAP(s).

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10.12. Appendix 12: Criteria for Assessing Potential Cases of Anaphylaxis
Anaphylaxis is highly likely when any one of the following 3 criteria are fulfilled (Sampson 2006):
1. Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue,
or both (eg, generalized hives, pruritus or flushing, swollen lips-tongue-uvula)
AND AT LEAST ONE OF THE FOLLOWING:
a. Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF,
hypoxemia)
b. Reduced BP or associated symptoms of end-organ dysfunction (eg, hypotonia [collapse],
syncope, incontinence)
2. Two or more of the following that occur rapidly after exposure to a likely allergen for that
participant (minutes to several hours):
a. Involvement of the skin-mucosal tissue (eg, generalized hives, itch-flush, swollen lips-tongue-
uvula)
b. Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF,
hypoxemia)
c. Reduced BP or associated symptoms (eg, hypotonia [collapse], syncope, incontinence)
d. Persistent gastrointestinal symptoms (eg, crampy abdominal pain, vomiting)
3. Reduced BP after exposure to known allergen for that participant (minutes to several hours):
a. Infants and children: low systolic BP (age specific) or greater than 30% decrease in systolic
BP*
b. Adults: systolic BP of less than 90 mm Hg or greater than 30% decrease from that person's
baseline
Key: PEF=Peak expiratory flow; BP=blood pressure.
*Low systolic blood pressure for children is defined as less than 70 mm Hg from 1 month to 1 year, less than
(70 mm Hg + [2 x age]) from 1 to 10 years, and less than 90 mm Hg from 11 to 17 years.

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10.13. Appendix 13: Protocol Amendment History
Amendment 1 (17 November 2021)
Overall Rationale for the Amendment:  The protocol is being amended to clarify stratification and to
clarify the contraceptive appendix.
Section Number 
and Name
Description of Change 
Brief Rationale
Section 1.3 
Schedule of 
Activities 
Table 1
PGI-C evaluation at Week 0 was deleted. 
This evaluation at Week 0 was
added in error in the original
protocol and therefore deleted.
Section 5.1 
Inclusion Criteria 
Criterion #2 
Criterion #12 
The criterion has been modified as follows: 
Has a diagnosis of plaque psoriasis, with or without 
PsA, for at least 6 months prior to the first 
administration of study intervention, confirmed by 
medical record. 
The criterion has been modified as follows: 
A male participant 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 study intervention. Male
participants should also be advised of the
benefit for female partner to use a highly
effective method of contraceptive as condoms
may break or leak.
Aligning this criterion with that
noted in other programs conducted
by the Sponsor and acknowledging
the challenges in a global study to
have medical record confirmation
of the term "plaque psoriasis" given
regional variability.
To provide clarification on
contraception information for male
participants
Section 6.1 Study 
Intervention
Administered 
Investigational
Medicinal Product
(IMP)
Group 6: 
The ‘YES’ box has been checked and the ‘NO’ box
unchecked
Placebo is considered IMP.
Section 6.3 
Measures to 
Minimize Bias:
Randomization and
Blinding
Intervention
Allocation
Dynamic 
central 
randomization 
will 
be
implemented in conducting this study. Participants
will be assigned to 1 of 6 intervention groups based
on an algorithm implemented in the interactive web
response system (IWRS) before the study. Dynamic
central randomization minimizes the imbalance in
the distribution of the number of participants across
intervention groups within the levels of each
individual stratification factor: study site and
baseline weight (≤90 kg, >90 kg). In addition, the
Japanese 
sites 
will 
be 
pooled 
in 
the
The stratification of Japanese sites
has been clarified.

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Section Number 
and Name
Description of Change 
Brief Rationale
Procedures for 
Randomization and 
Stratification 
randomization 
process 
to 
better 
ensure
treatment balance across Japanese participants. 
Based on the algorithm, the IWRS will assign a
unique intervention code, which will dictate the
intervention assignment and matching study
intervention kit for the participant.
Section 10.8 
Appendix 8 
Contraceptive and 
Barrier Guidance 
The headers and sub-headers in the table for 
Examples of Contraceptives have been modified as 
follows: 
EXAMPLES OF CONTRACEPTIVESa
ALLOWED DURING THE STUDY FOR
FEMALE PARTICIPANTS INCLUDE:
NOT ALLOWED AS SOLE METHOD OF
CONTRACEPTION DURING THE STUDY FOR
FEMALE PARTICIPANTS (not considered to be
highly effective - failure rate of ≥1% per year)
Clarification that this table, which
lists examples of contraceptives, is
applicable to female participants
only
Throughout the 
protocol 
Minor grammatical, formatting, or spelling changes 
were made.
Minor errors were noted

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11. 
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Status: Approved,  Date:  12 January 2022
INVESTIGATOR AGREEMENT
I have read this protocol and agree that it contains all necessary details for carrying out this study. I will
conduct the study as outlined herein and will complete the study within the time designated.
I will provide copies of the protocol and all pertinent information to all individuals responsible to me who
assist in the conduct of this study. I will discuss this material with them to ensure that they are fully informed
regarding the study intervention, the conduct of the study, and the obligations of confidentiality.
Coordinating Investigator (where required):
Name (typed or printed):
Institution and Address:
Signature: 
Date:
(Day Month Year)
Principal (Site) Investigator:
Name (typed or printed):
Institution and Address:
Telephone Number:
Signature: 
Date:
(Day Month Year)
Sponsor's Responsible Medical Officer:
Name (typed or printed): 
 MD
Institution: 
Janssen Research & Development
Signature: 
electronic signature appended at the end of the protocol 
Date:
(Day Month Year)
Note: If the address or telephone number of the investigator changes during the study, written notification will be
provided by the investigator to the sponsor, and a protocol amendment will not be required
PPD

Signature
User 
Date 
Reason
 
13-Jan-2022 
14:56:44
(GMT)
Document Approval
PPD