A Phase 3, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Phase: PHASE3
Conditions: Generalized Pustular Psoriasis, Erythrodermic Psoriasis
Sponsor: Janssen Pharmaceutical K.K.

CONFIDENTIAL – FOIA Exemptions Apply in U.S. 
1
Status: Approved,  Date:  29 August 2023
Janssen Pharmaceutical K.K.*
Clinical Protocol
Protocol Title
A Phase 3, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of
JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or
Erythrodermic Psoriasis
Short Title
A Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of
Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Protocol 77242113PSO3005; Phase 3
Version: Original
JNJ-77242113
*This study is being conducted by Janssen Pharmaceutical K.K. in Japan. The term “sponsor” is used
throughout the protocol to represent Janssen Pharmaceutical K.K. in Japan.
Status: 
Approved
Date: 
29 August 2023
Prepared by: Janssen Pharmaceutical K.K.
EDMS number: 
EDMS-RIM-1068595, 1.0
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 confidentialit y of the information under applicable statutes, regulations, rules, protective orders or otherwise.
NCT06295692

JNJ-77242113  
Clinical Protocol 77242113PSO3005 Original
 
CONFIDENTIAL – FOIA Exemptions Apply in U.S. 
2
Status: Approved,  Date:  29 August 2023
TABLE OF CONTENTS
TABLE OF CONTENTS .......................................................................................................................... 2
LIST OF IN-TEXT FIGURES ................................................................................................................... 5 
ABBREVIATIONS ................................................................................................................................... 6
1. 
PROTOCOL SUMMARY ................................................................................................................ 8
1.1. 
Synopsis ..................................................................................................................................... 8
1.2. 
Schema .................................................................................................................................... 12
1.3. 
Schedule of Activities (SoA) ...................................................................................................... 13
1.3.1. 
Schedule of Activities – Screening Through Week 52 ............................................................. 13
1.3.2. 
Schedule of Activities – Long-term Extension Treatment Period ............................................. 17
2. 
INTRODUCTION .......................................................................................................................... 20
2.1. 
Study Rationale......................................................................................................................... 20
2.2. 
Background............................................................................................................................... 21
2.3. 
Benefit-risk Assessment ............................................................................................................ 23
2.3.1. 
Risks for Study Participation .................................................................................................. 24
2.3.2. 
Benefits for Study Participation .............................................................................................. 25
2.3.3. 
Benefit-risk Assessment for Study Participation ...................................................................... 25
3. 
OBJECTIVES, ENDPOINTS, AND ESTIMANDS .......................................................................... 25
4. 
STUDY DESIGN ........................................................................................................................... 27
4.1. 
Overall Design .......................................................................................................................... 27
4.2. 
Scientific Rationale for Study Design ......................................................................................... 28
4.2.1. 
Participant Input into Design .................................................................................................. 29
4.2.2. 
Study-specific Ethical Design Considerations ......................................................................... 29
4.3. 
Justification for Dose ................................................................................................................. 30
4.4. 
End of Study Definition .............................................................................................................. 30
5. 
STUDY POPULATION ................................................................................................................. 30
5.1. 
Inclusion Criteria ....................................................................................................................... 31
5.2. 
Exclusion Criteria ...................................................................................................................... 33
5.3. 
Lifestyle Considerations ............................................................................................................ 40
5.4. 
Screen Failures ......................................................................................................................... 40
5.5. 
Criteria for Temporarily Delaying Enrollment/Administration of Study Intervention ...................... 41
6. 
STUDY INTERVENTION AND CONCOMITANT THERAPY ......................................................... 41
6.1. 
Study Intervention Administered ................................................................................................ 41
6.2. 
Preparation/Handling/Storage/Accountability ............................................................................. 44
6.3. 
Assignment to Study Intervention .............................................................................................. 44
6.4. 
Blinding, Masking ...................................................................................................................... 45
6.5. 
Study Intervention Compliance .................................................................................................. 45
6.6. 
Dose Modification ..................................................................................................................... 45
6.7. 
Continued Access to Study Intervention After the End of the Study............................................ 45
6.8. 
Treatment of Overdose ............................................................................................................. 45
6.9. 
Prior and Concomitant Therapy ................................................................................................. 46
6.9.1. 
Prohibited Therapy ................................................................................................................ 46
6.9.1.1. 
GPP/EP Concomitant Medications ...................................................................................... 46
6.9.1.2. 
Concomitant Medications for Indications Other Than Psoriasis ............................................ 48
6.9.1.3. 
Vaccines ............................................................................................................................. 48
7. 
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL ........................................................................................... 48
7.1. 
Discontinuation of Study Intervention ........................................................................................ 48
NCT06295692

JNJ-77242113  
Clinical Protocol 77242113PSO3005 Original
 
CONFIDENTIAL – FOIA Exemptions Apply in U.S. 
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Status: Approved,  Date:  29 August 2023
7.1.1. 
Liver Chemistry Stopping Criteria ........................................................................................... 49
7.1.2. 
Temporary Interruption (Withholding) of Study Intervention .................................................... 49
7.1.3. 
Permanent Discontinuation of Study Intervention ................................................................... 49
7.2. 
Participant Discontinuation/Withdrawal From the Study ............................................................. 50
7.2.1. 
Withdrawal From the Use of Research Sample ...................................................................... 51
7.3. 
Lost to Follow-up ....................................................................................................................... 51
8. 
STUDY ASSESSMENTS AND PROCEDURES ............................................................................ 52
8.1. 
Administrative and General/Baseline Procedures ...................................................................... 53
8.1.1. 
Physical Examinations ........................................................................................................... 53
8.2. 
Efficacy Assessments ............................................................................................................... 53
8.2.1. 
Clinician-reported Outcomes .................................................................................................. 54
8.2.1.1. 
Clinical Global Impression Scale ......................................................................................... 54
8.2.1.2. 
Japanese Dermatological Association Severity Index .......................................................... 54
8.2.1.3. 
Body Surface Area .............................................................................................................. 55
8.2.1.4. 
Psoriasis Area and Severity Index ....................................................................................... 55
8.2.1.5. 
Investigator’s Global Assessment........................................................................................ 55
8.2.2. 
Participant-reported Outcomes............................................................................................... 55
8.2.2.1. 
Dermatology Life Quality Index ........................................................................................... 55
8.2.2.2. 
EuroQol 5-Dimension 5 Level Questionnaire ....................................................................... 55
8.2.2.3. 
Children’s Dermatology Life Quality Index ........................................................................... 56
8.2.3. 
Endpoints .............................................................................................................................. 56
8.2.3.1. 
Primary Endpoints............................................................................................................... 56
8.2.3.2. 
Secondary Endpoints .......................................................................................................... 56
8.2.3.3. 
Exploratory Endpoints ......................................................................................................... 57
8.3. 
Safety Assessments .................................................................................................................. 57
8.3.1. 
Vital Signs ............................................................................................................................. 57
8.3.2. 
Electrocardiograms ................................................................................................................ 57
8.3.3. 
Clinical Safety Laboratory Assessments ................................................................................. 58
8.3.4. 
Pregnancy Testing ................................................................................................................. 58
8.3.5. 
Depression Screening and Symptoms Monitoring .................................................................. 58
8.3.6. 
Suicidal Ideation and Behavior Risk Monitoring ...................................................................... 59
8.3.7. 
Tuberculosis Evaluation ......................................................................................................... 59
8.4. 
Adverse Events, Serious Adverse Events, and Other Safety Reporting...................................... 60
8.4.1. 
Time Period and Frequency for Collecting Adverse Event and Serious Adverse Event
Information ............................................................................................................................ 61
8.4.2. 
Follow-up of Adverse Events and Serious Adverse Events ..................................................... 61
8.4.3. 
Regulatory Reporting Requirements for Serious Adverse Events ........................................... 62
8.4.4. 
Pregnancy ............................................................................................................................. 62
8.4.5. 
Adverse Events of Special Interest ......................................................................................... 62
8.5. 
Pharmacokinetics ...................................................................................................................... 63
8.5.1. 
Evaluations ............................................................................................................................ 63
8.5.2. 
Analytical Procedures ............................................................................................................ 63
8.6. 
Pharmacodynamics................................................................................................................... 63
8.7. 
Genetics and Pharmacogenomics ............................................................................................. 63
8.8. 
Biomarkers ............................................................................................................................... 64
8.9. 
Immunogenicity Assessments ................................................................................................... 64
8.10. 
Health Economics/Medical Resource Utilization and Health Economics ..................................... 65
9. 
STATISTICAL CONSIDERATIONS .............................................................................................. 65
9.1. 
Statistical Hypotheses ............................................................................................................... 65
9.2. 
Analysis Sets ............................................................................................................................ 65
9.3. 
Statistical Analyses ................................................................................................................... 65
9.3.1. 
General Considerations ......................................................................................................... 65
9.3.2. 
Primary Efficacy Endpoints/Estimand Analysis ....................................................................... 66
9.3.3. 
Secondary Efficacy Endpoints/Estimand Analysis .................................................................. 67
9.3.4. 
Other Secondary and Exploratory Endpoints/Estimand Analysis............................................. 67
9.3.5. 
Safety Analyses ..................................................................................................................... 68
NCT06295692

JNJ-77242113  
Clinical Protocol 77242113PSO3005 Original
 
CONFIDENTIAL – FOIA Exemptions Apply in U.S. 
4
Status: Approved,  Date:  29 August 2023
9.3.6. 
Other Analyses ...................................................................................................................... 69
9.3.6.1. 
Pharmacokinetic Analyses .................................................................................................. 69
9.3.6.2. 
Biomarkers Analyses .......................................................................................................... 69
9.3.6.3. 
Immunogenicity Analyses.................................................................................................... 70
9.3.6.4. 
Pharmacokinetic/Pharmacodynamic Analyses .................................................................... 70
9.3.6.5. 
Pharmacogenomic Analyses ............................................................................................... 70
9.4. 
Interim Analysis/Analyses ......................................................................................................... 70
9.5. 
Sample Size Determination ....................................................................................................... 70
10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ........................... 71
10.1. 
Appendix 1: Clinical Laboratory Tests........................................................................................ 71
10.2. 
Appendix 2: Regulatory, Ethical, and Study Oversight Considerations ....................................... 73
10.2.1. 
Regulatory and Ethical Considerations ................................................................................... 73
10.2.2. 
Financial Disclosure ............................................................................................................... 76
10.2.3. 
Informed Consent Process and Assent Form ......................................................................... 76
10.2.4. 
Recruitment Strategy ............................................................................................................. 78
10.2.5. 
Data Protection ...................................................................................................................... 78
10.2.6. 
Long-term Retention of Samples for Additional Future Research ............................................ 79
10.2.7. 
Committees Structure ............................................................................................................ 79
10.2.8. 
Publication Policy/Dissemination of Clinical Study Data .......................................................... 79
10.2.9. 
Data Quality Assurance ......................................................................................................... 80
10.2.10. Case Report Form Completion ............................................................................................... 81
10.2.11. Source Documents ................................................................................................................ 81
10.2.12. Monitoring.............................................................................................................................. 83
10.2.13. On-site Audits ........................................................................................................................ 83
10.2.14. Record Retention ................................................................................................................... 84
10.2.15. Study and Site Start and Closure ........................................................................................... 84
10.3. 
Appendix 3: Adverse Events, Serious Adverse Events, Product Quality Complaints, and
Other Safety Reporting: Definitions and Procedures for Recording, Evaluating, Follow-up,
and Reporting ........................................................................................................................... 86
10.3.1. 
Adverse Event Definitions and Classifications ........................................................................ 86
10.3.2. 
Attribution Definitions ............................................................................................................. 87
10.3.3. 
Severity Criteria ..................................................................................................................... 87
10.3.4. 
Special Reporting Situations .................................................................................................. 87
10.3.5. 
Procedures ............................................................................................................................ 88
10.3.6. 
Product Quality Complaint Handling ....................................................................................... 89
10.3.7. 
Contacting Sponsor Regarding Safety, Including Product Quality ........................................... 90
10.4. 
Appendix 4: Contraceptive and Barrier Guidance ...................................................................... 91
10.5. 
Appendix 5: Liver Safety: Suggested Actions and Follow-up Assessments ................................ 93
10.5.1. 
Liver Chemistry Increased Monitoring With Continued Study Intervention ............................... 93
10.5.2. 
Liver Chemistry Stopping Criteria and Follow-up Assessments .............................................. 94
10.6. 
Appendix 6: Study Conduct During a Natural Disaster/Major Disruption/Pandemic .................... 97
10.7. 
Appendix 7: Hepatitis B and Hepatitis C Virus Screening ........................................................... 99
10.8. 
Appendix 8: Diagnostic Criteria of Generalized Pustular Psoriasis ........................................... 100
10.9. 
Appendix 9: Japanese Dermatological Association Severity Index ........................................... 102
10.10. Appendix 10: Protocol Amendment History .............................................................................. 103
11. REFERENCES ........................................................................................................................... 104
INVESTIGATOR AGREEMENT .......................................................................................................... 106
NCT06295692

JNJ-77242113  
Clinical Protocol 77242113PSO3005 Original
 
CONFIDENTIAL – FOIA Exemptions Apply in U.S. 
5
Status: Approved,  Date:  29 August 2023
LIST OF IN-TEXT FIGURES
FIGURES
Figure 1: Schematic Overview of the Study ......................................................................................... 12
NCT06295692

JNJ-77242113  
Clinical Protocol 77242113PSO3005 Original
 
CONFIDENTIAL – FOIA Exemptions Apply in U.S. 
6
Status: Approved,  Date:  29 August 2023
ABBREVIATIONS
β-hCG 
β-human chorionic gonadotropin
ADA 
anti-dru  g antibody 
AE 
adverse event
AESI 
adverse event of special interest
ALT 
alanine aminotransferase
AST 
aspartate aminotransferase
AUC 
area under the plasma concentration versus time curve
AxMP 
Auxiliar y Medicinal Product (also known as NIMP)
BCG 
Bacillus Calmette-Guérin
BID 
twice daily 
BSA 
bod y surface area
CGI 
Clinical Global Impression
ClinRO 
clinician-reported outcome
Cmax 
maximum plasma concentration
COVID-19 
Coronavirus disease 2019
CPK 
creatine phosphokinase
CRF 
case report form(s) (paper or electronic as appropriate for this study)
CRP 
C-reactive protein
C-SSRS 
Columbia-Suicide Severit y Ratin  g Scale
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events
DBL 
database lock 
DLQI 
Dermatological Life Qualit y Index
ECG 
Electrocardiogram
eDC 
electronic data capture
eGFR 
estimate d glomerular filtration rate
EP 
erythrodermic psoriasis
EQ-VAS 
EuroQol visual analo g scale
EQ-5D 
EuroQol-5 Dimension
EQ-5D-5L 
EuroQol-5 Dimension 5-level
E-R 
exposure-response
ET 
earl y termination
FAS 
full analysis set
FDA 
Food and Dru  g Administration (United States)
FIH 
first-in-human
FOIA 
Freedom of Information Act
FSH 
follicle stimulatin  g hormone
GCP 
Good Clinical Practice
GPP 
generalized pustular psoriasis
HBc 
hepatitis B core antibody 
HBs 
hepatitis B surface antibody 
HBsAg 
hepatitis B surface antigen
HBV 
hepatitis B virus
HCV 
hepatitis C virus
HIV 
human immunodeficienc y virus
HRQoL 
health-related qualit y of life
HRT 
hormonal replacement therapy 
IB 
Investigator’s Brochure
IC50 
half-maximal inhibitor y concentration
ICE 
intercurrent events
ICF 
informed consent form
ICH 
International Council on Harmonization
IEC 
Independent Ethics Committee
IFN-γ 
interferon gamma
IGA 
Investigator Global Assessment
IGRA 
interferon gamma release assay 
NCT06295692

JNJ-77242113  
Clinical Protocol 77242113PSO3005 Original
 
CONFIDENTIAL – FOIA Exemptions Apply in U.S. 
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Status: Approved,  Date:  29 August 2023
IL 
Interleukin
IL-12Rβ1 
IL-12 receptor beta 1
IL-23R 
IL-23 receptor
IMP 
Investigational Medicinal Product
INR 
international normalized ratio
IR 
immediate-release
IRB 
Institutional Review Board
IV 
Intravenous
JAK 
Janus kinase
JDA 
Japanese Dermatological Association
LC-MS/MS 
liquid chromatography/mass spectrometry/mass spectrometry
LDH 
lactate dehydrogenase
LTE 
Long-term extension
MCH 
mean corpuscular hemoglobin
MCV 
mean corpuscular volume
MedDRA 
Medical Dictionar y for Regulator y Activities
MTX 
Methotrexate
NOAEL 
no-observed-adverse-effect-level
PASI 
Psoriasis Area and Severit y Index
PCR 
polymerase chain reaction
PD 
pharmacodynamic(s)
PDE4 
phosphodiesterase 4
PHQ-9 
Patient Health Questionnaire-9
PK 
pharmacokinetic(s)
PQC 
Product Qualit y Complaint
PRO 
participant-reported outcome(s) (paper or electronic as appropriate for this study)
Qol 
qualit y of life
RBC 
red blood cells
SAE 
serious adverse event
SAP 
statistical analysis plan
SAS 
safet y analysis set
SD 
standard deviation
SoA 
Schedule of Activities
t1/2 
apparent elimination half-life calculated as loge2/λz
TB 
Tuberculosis
Tbili 
total bilirubin
tmax  
time to reach the maximum observed plasma analyte concentration
TNF 
tumor necrosis factor
ULN 
upper limit of normal
VAS 
visual analo g scale
WBC 
white blood cells
NCT06295692

JNJ-77242113  
Clinical Protocol 77242113PSO3005 Original
 
CONFIDENTIAL – FOIA Exemptions Apply in U.S. 
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Status: Approved,  Date:  29 August 2023
1. 
PROTOCOL SUMMARY
1.1. 
Synopsis
A Phase 3, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the
Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Short Title: A Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants
With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
JNJ-77242113 is a peptide that binds directly to the interleukin-23 receptor (IL-23R) subunit and prevents
IL-23 binding, 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. Despite its low oral bioavailability (<1%), JNJ 77242113 has demonstrated
systemic effects and has provided substantial efficacy in plaque psoriasis clearance in doses 25 mg once
daily and greater in the Phase 2b, 77242113PSO2001 study. Therefore, JNJ-77242113 is a promising
candidate for further development in systemic, IL-23-driven diseases such as psoriasis.
BENEFIT-RISK ASSESSMENT
JNJ-77242113 has provided substantial efficacy in plaque psoriasis clearance in Phase 2b
Study 77242113PSO2001. No risks associated with JNJ-77242113 have been identified in the previous
studies; however, potential risks associated with other IL-23 inhibitors (hypersensitivity reactions, anti-drug
antibody (ADA) production, infection) and study procedures could occur.
OBJECTIVES AND ENDPOINTS
Objectives 
Endpoints
Primary
 
To 
evaluate 
the 
efficacy 
of
JNJ-77242113 in participants with
generalized pustular psoriasis (GPP) or
erythrodermic psoriasis (EP)
 
Proportion of participants with GPP who
experience treatment success (based on Clinical
Global Impression [CGI] according to Japanese
Dermatological Association [JDA] total score) at
Week 16.
 
Proportion of participants with EP who experience
treatment success (based on CGI) at Week 16.
Secondary
 
To further evaluate the efficacy of
JNJ-77242113 in participants with GPP
or EP
 
Proportion of participants with GPP or EP who
experience treatment success (for GPP: based on
CGI scale according to JDA total score and for EP:
based on CGI scale) over time.
 
Change from baseline in the total score of the JDA
severity index for GPP over time.
 
Change from baseline in severity classification
(mild, moderate, severe) of the JDA severity index
for GPP over time.
 
Change from baseline in body surface area (BSA)
NCT06295692

JNJ-77242113  
Clinical Protocol 77242113PSO3005 Original
 
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Status: Approved,  Date:  29 August 2023
Objectives 
Endpoints
of involvement of lesion for EP over time.
 
Proportion of participants who achieve an
Investigator’s Global Assessment (IGA) score of
cleared (0) or minimal (1) over time.
 
Proportion of participants who achieve an IGA
score of cleared (0) over time.
 
Percent improvement from baseline in Psoriasis
Area and Severity Index (PASI) over time.
 
To evaluate the effect of JNJ-77242113
treatment on health-related quality of life
(HRQoL) in participants with GPP or EP
 
Change from baseline in Dermatology Life Quality
Index (DLQI) score over time.
 
Proportion of participants who achieve a DLQI
score of 0 or 1 over time.
 
Change from baseline in EQ-5D-5L (domain scores
and visual analog scale [VAS]) over time.
 
To assess the safety and tolerability of
JNJ-77242113 in participants with GPP
or EP
 
Frequency and type of AEs and SAEs.
Exploratory
 
To further explore the efficacy of
JNJ-77242113 in participants with GPP
 
Change from baseline in components (skin
symptoms, 
systemic 
symptoms/laboratory
findings) of the JDA severity index for GPP over
time.
 
To further evaluate the effect of
JNJ-77242113 on HRQoL in adolescent
participants with GPP or EP
 
Change from baseline in Children’s DLQI
(CDLQI) over time.
 
Change from baseline in Children’s DLQI
(CDLQI) score of 0 or 1 and over time.
 
To evaluate the PK and immunogenicity
of JNJ-77242113
 
JNJ-77242113 PK parameters.
 
Incidence of anti-drug antibodies to JNJ-77242113.
 
To explore biomarkers in participants
with GPP or EP
 
Change from baseline in levels of blood
biomarkers.
Hypothesis
The primary hypothesis of this study is that JNJ-77242113 is efficacious in treating GPP or EP as assessed
by the proportion of participants with GPP and EP who experience treatment success defined as at least
"Minimally Improved" rating in the Clinical Global Impression (CGI) scale for GPP (according to Japanese
Dermatological Association [JDA] total score) and EP, respectively, at Week 16.
NCT06295692

JNJ-77242113  
Clinical Protocol 77242113PSO3005 Original
 
CONFIDENTIAL – FOIA Exemptions Apply in U.S. 
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Status: Approved,  Date:  29 August 2023
OVERALL DESIGN
This is a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of JNJ-77242113 for the
treatment of participants with GPP or EP.
No Data Monitoring Committee will be commissioned for this study.
NUMBER OF PARTICIPANTS
A target of 16 (GPP, n=8; EP, n=8) participants will be enrolled in this study. All participants will take
JNJ-77242113 from Week 0.
STUDY ARMS AND DURATION
The total duration of this study for each participant is approximately 165 weeks, which includes: a ~5-week
screening period, a 52-week treatment period, a 104-week long-term extension treatment period (LTE), and
a 4-week safety follow-up period. All the participants will receive JNJ-77242113 200 mg once daily for
52 weeks. Participants completing Week 52 visit may be eligible to enroll in the LTE. The LTE will begin
at the end of Week 52 and will continue until Week 156. All the participants will have a 4-week safety
follow-up period at the end of the treatment period or after the last dose of study intervention.
The first database lock (DBL) will occur when all patients complete Week 24 of the study. Additional DBLs
may occur after Week 24 to support regulatory submissions and scientific disclosures.
EFFICACY EVALUATIONS
Investigator assessments (Clinician-reported Outcomes [ClinROs]) and PROs will be used to assess
efficacy in this study per the Schedule of Activities (SoA) (Section 1.3) and are listed below.
ClinROs
 
CGI scale
 
JDA severity index (only for participants with GPP)
 
Body surface area (BSA) of involvement of lesion (only for participants with EP)
 
Investigator’s Global Assessment (IGA)
 
Psoriasis Area and Severity Index (PASI)
PROs
 
Dermatology Life Quality Index (DLQI) for adult participants (≥18 years of age on the first date of
the Screening Visit)
 
Euro QoL-5 Dimension-5 Level Questionnaire (EQ-5D-5L) (domain scores and visual analog scale
[VAS])
 
Children’s Dermatology Life Quality Index (CDLQI) for adolescent participants (≥12 years and
<18 years of age on the first date of the Screening Visit)
Photographs (Optional)
Photography will be conducted to record skin lesions at each visit indicated in the SoA (Section 1.3). The
details such as how to take photos of the lesion site are shown in the photography manual.
PHARMACOKINETIC EVALUATIONS
Plasma samples will be used to evaluate the pharmacokinetics of JNJ-77242113.
NCT06295692

JNJ-77242113  
Clinical Protocol 77242113PSO3005 Original
 
CONFIDENTIAL – FOIA Exemptions Apply in U.S. 
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Status: Approved,  Date:  29 August 2023
IMMUNOGENICITY EVALUATIONS
Serum samples will be evaluated for antibodies to JNJ-77242113.
PHARMACODYNAMIC AND BIOMARKER EVALUATIONS
Biomarker assessments will be made to examine the biological response to treatment and to identify
biomarkers that are relevant to JNJ-77242113 treatment response and/or psoriasis. Assessments will include
the evaluation of relevant biomarkers in serum samples collected.
PHARMACOGENOMIC (DNA) EVALUATIONS
A pharmacogenomic blood sample will be collected to allow for pharmacogenomic research, as necessary.
Participation in the pharmacogenomic research is optional.
SAFETY EVALUATIONS
Safety assessments for all participants will include AEs, SAEs, AESIs, clinical laboratory assessments
(hematology, chemistry including lipid panel, high-sensitivity C-reactive protein, pregnancy testing, and
urinalysis), vital signs (including temperature, pulse/heart rate, respiratory rate, blood pressure),
electrocardiograms, depression screening and symptoms monitoring (Patient Health Questionnaire-9
[PHQ-9]), suicidal ideation and behavioral risk monitoring (Columbia-Suicide Severity Rating Scale
[C-SSRS]), and tuberculosis (TB) evaluations.
STATISTICAL METHODS
Descriptive summary statistics, such as n, mean, standard deviation, median, interquartile range, minimum,
and maximum for continuous variables, and counts and percentages for discrete variables will be used to
summarize the data by GPP and EP group wherever applicable.
Efficacy
For primary analysis, the full analysis set which is the population of participants who received at least
1 dose of study intervention will be used. The primary endpoint is the proportion of participants with GPP
or EP who experience treatment success at Week 16. Frequencies, percentages, and 95% Clopper-Pearson
exact confidence interval (CI) of percentages will be provided by GPP and EP group.
Secondary efficacy endpoints will be summarized descriptively by GPP and EP group. Descriptive statistics
will include counts and proportions for categorical data, and median, mean, interquartile range, and range
for continuous data. Graphical data displays may also be used to summarize the data.
Safety
All safety analyses will be based on the population of participants who received at least 1 dose of study
intervention. Safety data, including but not limited to, AEs, SAEs, AESIs (active TB, malignancy, possible
Hy’s Law cases), discontinuation of study intervention due to AEs, changes in laboratory assessments, vital
signs, weight, changes in PHQ-9 scores, and changes in C-SSRS will be summarized. Treatment-emergent
AEs will be summarized per MedDRA system organ class and preferred terms.
Other Analyses
Pharmacokinetic analyses of plasma JNJ-77242113 concentrations will be summarized by visit.
Immunogenicity analyses of the incidence and titer of antibodies to JNJ-77242113 will be summarized for
all participants who receive at least 1 dose of JNJ-77242113 and have appropriate serum samples for
detection of antibodies to JNJ-77242113 (ie, participants with at least 1 sample obtained after their first
dose of JNJ-77242113).
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1.2. 
Schema
Figure 1: 
Schematic Overview of the Study
*Additional DBLs may occur after Week 24 to support regulatory submissions and scientific disclosures.
DBL=database lock, EP=erythrodermic psoriasis, GPP=generalized pustular psoriasis, PE=primary endpoint,
SE=secondary endpoints
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r. 
Urinalysis may be performed any time during the study visit including before PRO collection.
s. 
Collect 1 trough and 1 peak sample at Week 4 and Week 16. Details to be specified during training. If peak/trough collection at the Week 4 and Week 16 visits is
not feasible, collection at an alternative visit is allowed.
t. 
All medications taken and new or worsening AEs reported after signing the ICF will be recorded. See CRF completion guidelines.
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g. 
Height will be measured only for participants <18 years on the first date of Screening.
h. 
Vital signs will include temperature, pulse/heart rate, respiratory rate, and blood pressure.
i. 
PHQ-9 and C-SSRS will be completed after PROs and before all other study procedures.
j. 
If TB is suspected at any time during the study, a chest radiograph or chest CT, and QuantiFERON-TB® or T-SPOT® test should be performed.
k. 
A negative urine test result is required at each visit prior to dispensing study intervention. A urine pregnancy test may be performed at any time during the visit,
including before PRO collection.
l. 
Urinalysis may be performed any time during the study visit including before PRO collection.
m. At all study visits where applicable, the date and time of the dose prior to the PK sample should be recorded as instructed in the CRF completion guidelines.
n. 
All medications taken and new or worsening AEs reported will be recorded. See CRF completion guidelines.
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2. 
INTRODUCTION
Interleukin-23 (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). IL-23p19 binding
to the N-terminal immunoglobulin-like domain of IL-23R is followed by IL-12/23p40 binding to
IL-12Rβ1. Ligand binding leads to phosphorylation and nuclear translocation of STAT proteins.
JNJ-77242113 is a peptide that binds directly to the IL-23R subunit and prevents IL-23 binding,
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. Despite its low oral bioavailability (<1%), JNJ-77242113 has
demonstrated systemic effects and has provided substantial efficacy in plaque psoriasis clearance
in doses 25 mg once daily and greater in the Phase 2b Study, 77242113PSO2001. Therefore,
JNJ-77242113 is a promising candidate for further development in systemic, IL-23-driven diseases,
such as psoriasis.
To date, JNJ-77242113 has been studied in several Phase 1 and Phase 2 studies. For the most
comprehensive nonclinical and additional clinical information regarding JNJ-77242113, refer to
the latest version of the Investigator’s Brochure (IB) and Addenda 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 Protocol
Supplementary Information page(s), which will be provided as a separate document.
2.1. 
Study Rationale
Generalized Pustular Psoriasis (GPP) is rare and represents active, unstable disease. The patient is
pyrexial with red, painful, inflamed skin studded with monomorphic, sterile pustules which may
coalesce to form sheets. Patients with GPP frequently need to be admitted to the hospital for
management. Total or subtotal involvement of the skin by active psoriasis is known as
Erythrodermic Psoriasis (EP). Chronic plaque psoriasis may gradually progress as plaques become
confluent and extensive. EP may impair the thermoregulatory capacity of the skin, leading to
hypothermia, high output cardiac failure, and metabolic changes including hypoalbuminaemia and
anaemia due to loss of iron, vitamin B12, and folate (Langley 2005). Multiple therapies have been
approved in Japan, however, there are still substantial unmet need for GPP and EP.
Targeting IL-23 is a highly effective approach for treating moderate to severe plaque psoriasis,
GPP, and EP. GPP alone is associated with mutations in IL36RN (Sugiura 2014). However,
increased expression of IL-36 is correlated with increased expression of cytokines that are known
to be involved in the pathogenesis of psoriasis (IL-17A, IL-22, TNF-α, IL-23, and IFN-γ, but not
IL-12 and IL-17F). The results indicate that the IL-36 cytokines are not only regulated by Th17
cytokines, but that they themselves can regulate the expression and enhance the function of Th17
cytokines (Carrier 2011). IL-23 is composed of a unique p19 subunit coupled with the common
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p40 subunit shared with IL-12, and signals through the heterodimeric IL-23 receptor
(IL-23R)/IL-12 receptor beta 1 (IL-12Rβ1) complex (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 ultimately causing
reduced signaling. In addition, guselkumab and risankizumab have already been approved for the
treatment of GPP and EP in Japan (Sano 2018; Yamanaka 2023).
JNJ-77242113 is a 13-amino acid peptide that binds directly to the IL-23R subunit and prevents
IL-23, inhibiting proximal IL-23R signaling and downstream effector functions (eg, cytokine
secretion). For those patients who prefer oral medication, oral therapies with high efficacy, long-
term clinical remission, and good safety profile are more convenient and JNJ-77242113 may meet
this unmet need. It has shown encouraging efficacy and safety results in Phase 2b study
(77212113PSO2001) in participants with plaque psoriasis.
Based on the positive results observed in the Phase 2 study, JNJ-77242113 is being further
assessed in this Phase 3 program. Study 77242113PSO3005 is a Phase 3, open-label, multicenter
study to evaluate the efficacy and safety of JNJ-77242113 for the treatment of participants with
GPP or EP.
2.2. 
Background
Two Phase 1 studies (PN-235-01 and 77242113PSO1002) in healthy participants have been
completed and 1 Phase 1 study (77242113PSO1003) is ongoing in healthy participants. One
Phase 2b study of JNJ-77242113 for the treatment of moderate to severe plaque psoriasis
(77242113PSO2001) has also been completed and demonstrated a favorable efficacy and safety
profile for JNJ-77242113.
Clinical Studies
Efficacy/Safety Studies
Phase 1
Overall, the safety data from 3 Phase 1 studies in healthy participants demonstrate that single and
multiple oral doses of JNJ-77242113 administered as an oral solution (PN-235-01, final data) and
single oral doses administered as immediate-release (IR) tablets or 
 (77242113PSO1002 in Japanese and Chinese healthy participants, final data
and 77242113PSO1003 in non-Japanese healthy participants, preliminary data) were generally
well tolerated and with no safety signals.
Phase 2
Study 77242113PSO2001, was a Phase 2b multicenter, randomized, double-blind, placebo-
controlled, dose-ranging, parallel-group, multicenter study to evaluate the efficacy and safety of
JNJ-77242113 treatment in 255 adults with moderate to severe plaque psoriasis over 16 weeks. In
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Study 77242113PSO2001, a dose response was observed for the primary endpoint (Psoriasis Area
and Severity Index [PASI] 75 response at Week 16). A statistically significant higher proportion
of participants in each JNJ-77242113 dose group achieved a PASI 75 response at Week 16 (37.2%
for 25 mg once daily, 58.1% for 50 mg once daily, 51.2% for 25 mg twice daily, 65.1% for 100 mg
once daily, 78.6% for 100 mg twice daily; nominal p=0.002 for 25 mg once daily; nominal
p<0.001 for all other dose groups) than the placebo group (9.3%). All statistical testing was
performed at the 2-sided 0.05 significance level.
Secondary endpoints (Investigator Global assessment [IGA] score of cleared [0] or minimal [1],
IGA score of cleared [0], PASI 90 score, PASI 100 score and Dermatology Life Quality Index
[DLQI] score of 0 or 1) achieved statistical significance at a nominal significance level of 0.05 (2-
sided) at Week 16 for all doses compared with placebo. At Week 16, participants in each of the
JNJ-77242113 dose groups had a statistically significant greater improvement (reduction) as
measured by PASI total score, body surface area (BSA), Psoriasis Symptom and Sign Diary
(PSSD) symptom score, and PSSD sign score from baseline than participants treated with placebo.
Safety data are summarized for participants who completed 77242113PSO2001 at the Week 16
visit:
 
Overall, there was no clear evidence of a dose-dependent increase in the occurrence of specific
adverse events (AEs) across the JNJ-772421113 groups.
 
The proportions of participants who experienced 1 or more AEs were similar in the combined
JNJ-77242113 (52.4%) and placebo (51.2%) groups.
 
The most frequently reported AEs were in the Infections and infestations system organ class
(SOC) and were similar between the combined JNJ-77242113 (30.2%) and placebo (27.9%)
groups. The most common AEs by preferred term (PT) in this SOC were COVID-19 (10.8%
and 11.6%), nasopharyngitis (7.1% and 4.7%), and upper respiratory tract infection (2.4% and
2.3%) in the combined JNJ-77242113 and placebo groups, respectively. In the
Gastrointestinal disorders SOC, AEs were reported in 11.3% of participants in the combined
JNJ-77242113 group and 11.6% in the placebo group. Other AEs by PT reported by at least
5% of participants included headache and cough.
 
The percentage of participants with 1 or more serious adverse events (SAEs) through the end
of study was small, with 3 participants (1.4%) experiencing 1 SAE each. All events were
singular in nature and deemed not related to study intervention per the investigator.
 
The proportion of participants who discontinued study intervention due to 1 or more AEs was
small (n=6). Three out of the 6 events were in the Gastrointestinal SOC (n=1 each: abdominal
pain, abdominal discomfort, and nausea). The other 3 events included suicide attempt, weight
increase, and transaminases increase (n=1 each).
 
Rates of abnormal laboratory test result were generally low and comparable between the
treatment groups.
 
There were no deaths or malignancies reported.
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Human Pharmacokinetics and Immunogenicity
The clinical data available to date supporting the safety, pharmacokinetics (PK) and
pharmacodynamics (PD) of JNJ-77242113 are from completed Phase 1 studies in healthy
volunteers and Phase 2 studies in adults with moderate to severe plaque psoriasis.
PK data from first-in-human (FIH) study PN-235-01 indicate that systemic exposure (Cmax and
AUC) to JNJ-77242113 is dose proportional across the dose range evaluated to date. After multiple
once daily doses, 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.
The PK results 77242113PSO1002 indicate that the exposure (Cmax and AUC) of JNJ-77242113
increased with dose (100 to 300 mg) in Japanese participants, with no apparent difference in
exposure between Japanese and Chinese participants (300 mg). The PK results from this study are
also consistent with and comparable to the PK in predominantly white participants in both FIH
Study PN-235-01 and the ongoing Study 77242113PSO1003.
The PK results from 77242113PSO1003 indicate that concomitant food (high calorie, high-fat or
low calorie, low-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 food effect data from
Protocol 77242113PSO1003, study intervention should be administered under fasted conditions.
Using the population PK model, a number of baseline participant characteristics were evaluated as
potential covariates affecting JNJ-77242113 PK parameters. Of the covariates evaluated, only
 were found to be significant. Of note, laboratory markers of renal and hepatic
function were not found to be significant covariates affecting the PK of JNJ-77242113, consistent
with the nonclinical and clinical metabolic clearance and excretion of the drug.
No 
 have been detected in the completed Phase 1 clinical studies. The overall incidence of
 in the Phase 2b study (77242113PSO2001) was low. Given that the peptide is administered
by the oral route and does not have an endogenous counterpart, the risk of adverse effects caused
by 
 is expected to be minimal.
Refer to the JNJ-77242113 IB for more information on clinical studies, pharmacokinetic,
nonclinical pharmacology, and toxicology.
2.3. 
Benefit-risk Assessment
Detailed information about the known and expected benefits and risks of JNJ-77242113 may be
found in the IB. The list provided in Section 2.3.1 describes the potential risks associated with the
blockage of IL-23.
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2.3.1. 
Risks for Study Participation
Potential Risks 
of Clinical 
Significance
Summary of Data/ 
Rationale for Risk
Mitigation Strategy
Potential Risks Due to Study Intervention JNJ-77242113
Hypersensitivity 
reactions 
 
Exogenous peptides 
administered orally or 
systemically have the potential 
to cause hypersensitivity 
reactions. 
 This potential risk will be explained in the
informed consent form (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.
 Any participant who develops a serious
hypersensitivity reaction such as
anaphylaxis must discontinue study
intervention (Section 7).
ADA production 
 
Exogenous peptides
administered orally or
systemically have the potential
to induce anti-drug antibodies
(ADA) production, which may
mediate untoward reactions
such as reduced efficacy or
hypersensitivity.
 This potential risk will be explained in the
ICF and evaluated by measuring ADA and
pharmacokinetics (PK) for analysis.
 Participants are encouraged to consistently
take their study intervention 24 hours apart,
as directed.
Infection 
Clinical experience with
marketed IL-23 pathway
blockers includes precautions
for infections and tuberculosis
(TB).
 This potential risk will be explained in the
ICF.
 Participants with evidence of active TB will
be excluded from the study (Section 5.2).
 Participants must agree not to receive a live
viral or live bacterial vaccination 4 weeks
prior to enrollment in the study or during
the study and for 4 weeks after receiving the
last dose of study intervention (Section 5.2).
Additional guidance is provided for the
BCG vaccine in 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 are instructed to
monitor for signs or symptoms of
infections, including TB (Section 8.3.7).
 Discontinuation of a participant’s study
intervention must be strongly considered if
the participant develops a serious infection,
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Potential Risks
of Clinical
Significance
Summary of Data/
Rationale for Risk
Mitigation Strategy
including but not limited to sepsis or
pneumonia. In 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).
2.3.2. 
Benefits for Study Participation
JNJ-77242113 has demonstrated significant efficacy compared with placebo for ClinROs and
PROs including disease severity and extent, quality of life measures, and participant-reported signs
and symptoms of psoriasis based on Phase 2b Study 77242113PSO2001 (Section 2.2). Participants
with GPP and EP may benefit from receiving JNJ-77242113 and receiving routine clinical care
during this study.
2.3.3. 
Benefit-risk Assessment for Study Participation
Taking into account the measures taken to minimize risk to participants of this study, the potential
risks identified in association with JNJ-77242113 are justified by the anticipated benefits that may
be afforded to participants with GPP and EP.
3. 
OBJECTIVES, ENDPOINTS, AND ESTIMANDS
Objectives 
Endpoints
Primary
 
To evaluate the efficacy of JNJ-77242113 
in participants with GPP or EP  
 
Proportion of participants with GPP who
experience treatment success (based on Clinical
Global Impression CGI scale according to
Japanese Dermatological Association [JDA]
total score) at Week 16.
 
Proportion of participants with EP who
experience treatment success (based on CGI
scale) at Week 16.
Secondary
 
To further evaluate the efficacy of
JNJ-77242113 in participants with GPP or
EP
 
Proportion of participants with GPP or EP who
experience treatment success (for GPP: based on
CGI scale according to JDA total score and for
EP: based on CGI scale) over time.
 
Change from baseline in the total score of the
JDA severity index for GPP over time.
 
Change in baseline in severity classification
(mild, moderate, severe) of the JDA severity
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Objectives 
Endpoints
index for GPP over time.
 
Change from baseline in body surface area
(BSA) of involvement of lesion for EP over
time.
 
Proportion of participants who achieve an
Investigator’s Global Assessment (IGA) score
of cleared (0) or minimal (1) over time.
 
Proportion of participants who achieve an IGA
score of cleared (0) over time.
 
Percent improvement from baseline in Psoriasis
Area and Severity Index (PASI) over time.
 
To evaluate the effect of JNJ-77242113
treatment on health-related quality of life
(HRQoL) in participants with GPP or EP
 
Change from baseline in Dermatology Life
Quality Index (DLQI) score over time.
 
Proportion of participants who achieve a DLQI
score of 0 or 1 over time.
 
Change from baseline in EQ-5D-5L (domain
scores and visual analog scale [VAS]) over time.
 
To assess the safety and tolerability of
JNJ-77242113 in participants with GPP or
EP
 
Frequency and type of AEs and SAEs.
Exploratory
 
To further explore the efficacy of
JNJ-77242113 in participants with GPP
 
Change from baseline in components (skin
symptoms, 
systemic 
symptoms/laboratory
findings) of the JDA severity index for GPP
over time.
 
To further evaluate the effect of
JNJ-77242113 on HRQoL in adolescent
participants with GPP or EP
 
Change from baseline in Children’s DLQI
(CDLQI) over time.
 
Change from baseline in Children’s DLQI
(CDLQI) score 0 or 1 over time.
 
To evaluate the PK and immunogenicity of
JNJ-77242113
 
JNJ-77242113 PK parameters.
 
Incidence 
of 
anti-drug 
antibodies 
to
JNJ-77242113.
 
To explore biomarkers in participants with
GPP or EP
 
Change from baseline in levels of blood
biomarkers.
ESTIMANDS
The primary estimand (ie, a precise definition of the primary targeted treatment effect) is defined
for GPP and EP, respectively by the following 5 attributes:
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Study Intervention:
Experimental: JNJ-77242113
Population:
 
Participants ≥12 years of age with GPP
 
Participants ≥12 years of age with EP
Variable:
Binary response variables for the primary endpoints:
 
Treatment success for GPP: a responder (participant with treatment success defined as at least
"Minimally Improved" rating in CGI scale for GPP according to JDA total score) at Week 16.
 
Treatment success for EP: a responder (participant with treatment success defined as at least
"Minimally Improved" rating in CGI scale for EP) at Week 16.
Intercurrent Event (ICE):
Intercurrent event 
Corresponding Strategy
Discontinuation of study intervention for any 
reason prior to Week 16. 
Treatment Policy: observed data will be used
regardless of whether or not this ICE had
occurred.
Population Level Summary:
 
Proportion of participants with GPP who experience treatment success at Week 16.
 
Proportion of participants with EP who experience treatment success at Week 16.
Refer to Section 8 for evaluations related to endpoints.
HYPOTHESIS
The primary hypothesis of this study is that JNJ-77242113 is efficacious in treating GPP or EP as
assessed by proportion of participants with GPP or EP who experience treatment success defined
as at least "Minimally Improved" rating in CGI scale for GPP (according to JDA total score) and
EP, respectively at Week 16.
4. 
STUDY DESIGN
4.1. 
Overall Design
This is a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of
JNJ-77242113 for the treatment of participants with GPP or EP.
A target of 16 (GPP, n=8; EP, n=8) participants will be enrolled in this study. All participants will
take JNJ-77242113 from Week 0.
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The total duration of this study for each participant is approximately 165 weeks, which includes:
a ~5-week screening period, a 52-week treatment period, a 104-week long-term extension
treatment period (LTE), and a 4-week safety follow-up period.
All the participants will receive JNJ-77242113 200 mg once daily for 52 weeks. Participants
completing Week 52 visit may be eligible to enroll in the LTE. The LTE will begin at the end of
Week 52 and will continue until Week 156. All the participants will have a 4-week safety
follow-up period at the end of the treatment period or after the last dose of study intervention.
Efficacy, safety, PK, immunogenicity, and biomarkers will be assessed according to the Schedule
of Activities (SoA) (Section 1.3). In addition, there will be 2 optional substudies for participants
who provide consent. Sample collections for these substudies include a pharmacogenomic blood
sample and photograph collection.
The first database lock (DBL) will occur when all participants complete Week 24 of the study.
Additional DBLs may occur after Week 24 to support regulatory submissions and scientific
disclosures. Details of the DBLs will be described in the statistical analysis plan (SAP), as
necessary.
No Data Monitoring Committee will be commissioned for this study.
A diagram of the study design is provided in Section 1.2.
4.2. 
Scientific Rationale for Study Design
Study Design
The open-label study design seems appropriate for this study considering GPP and EP are rare and
severe forms of psoriasis that require continuous access of an effective treatment and frequent
hospitalization for the management of complications. The endpoints and the treatment duration
selected for the study are generally considered standard for GPP or EP studies (Imafuku 2016,
Sano 2018, Yamanaka 2023).
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 GPP or EP.
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
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evaluate the PD of JNJ-77242113 and aid in evaluating the intervention-clinical response
relationship.
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. Sample collection
and testing will comply with local regulations.
Health Economics Data Collection
The EQ-5D-5L will be used in this study to evaluate health economics for participants with GPP
or EP.
4.2.1. 
Participant Input into Design
In setting the strategy for the treatment of GPP and EP, patients were engaged early, systematically,
and directly across important aspects of the drug development process.
Patient input was used to design the following elements of this study:
 
The once daily dose regimen was chosen to increase convenience compared with twice daily
regimen.
 
Lifestyle considerations were modified based on patient feedback related to sun exposure.
 
The SoA was modeled to ensure the number of visits, frequency of visits, and tests within
each visit were manageable for a patient with GPP or EP.
The results of the study may be made available to all the participants through a plain language
summary. A technical summary of results will be made available on clinicaltrials.gov and/or
clinicaltrialsregister.eu and/or other national registries at the conclusion of the study according to
local standards/restrictions.
4.2.2. 
Study-specific Ethical Design Considerations
Potential participants and legal guardian(s) of adolescent participants, if appropriate 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 (and assent, if applicable) 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 and adolescent participants’ legal guardian(s) who are fully
able to understand the risks, benefits, and potential AEs of the study, and provide their consent
voluntarily will be enrolled. Written consent/assent may be obtained through various sources (eg,
paper or electronic such as eConsent, eSignature, or digital signature) as determined by regulations
as well as study and/or participant preferences.
The primary ethical concern for the participants is that the study intervention may not provide benefit
in relieving the signs and symptoms of GPP or EP as anticipated, in the absence of suitable alternative
therapy. Participants will be discontinued from study intervention if the investigator considers it is
in the best interest of the participant (Section 7.1).
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The total blood volume to be collected (up to approximately 320 mL) 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 blood donation rule by Japanese Red Cross Society (400 mL of
blood for donation). For more details regarding blood collection, see Blood Sample Collection in
Section 8.
4.3. 
Justification for Dose
The JNJ-77242113 dose selection for the Phase 3 studies in psoriasis is 
 Therefore, considering the 
 a dose of JNJ-77242113 200 mg once daily
has been selected for the Phase 3 efficacy and safety studies. The 
 in the rat and
monkey studies.
The dose and regimen of JNJ-77242113 selected for this Phase 3 study, 
 will maximize the likelihood of a positive study outcome,
and are supported by human safety and tolerability data from the Phase 1 and Phase 2 studies and
the toxicology margins. Furthermore, the same dose of JNJ-77242113 is being evaluated in
ongoing Phase 3 studies in participants with plaque psoriasis.
4.4. 
End of Study Definition
End of Study Definition
The end of study is considered as the last scheduled study assessment shown in the SoA
(Section 1.3) for the last participant in the study. The final data from the study site will be sent to
the sponsor (or designee) after completion of the final participant assessment at that study site, in
the time frame specified in the Clinical Trial Agreement.
Participant Study Completion Definition
A participant will be considered to have completed the study if the participant has completed
assessments at Week 160. Disposition of study participation will be collected at the DBL.
5. 
STUDY POPULATION
Screening for eligible participants will be performed within 5 weeks before first dose
administration of the study intervention. Refer to Section 5.4 for conditions under which the repeat
of any screening procedures is allowed.
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The inclusion and exclusion criteria for enrolling participants in this study are described below. If
there is a question about these criteria, the investigator must consult with the appropriate sponsor
representative and resolve any issues before enrolling a participant in the study. Waivers are not
allowed. For a discussion of the statistical considerations of participant selection, refer to
Section 9.5.
5.1. 
Inclusion Criteria
Each potential participant must satisfy all of the following criteria to be enrolled in the study:
Age
1. 
The study participant has ≥12 years of age at the Screening Visit.
Type of Participant and Disease Characteristic(s)
2. 
The study participant has a diagnosis of GPP or EP at screening.
a. for GPP, a diagnosis must be classified based on the criteria for diagnosis of
GPP by the Japanese Dermatological Association (Appendix 8: Diagnostic
Criteria of Generalized Pustular Psoriasis)
b. for EP, has a history of plaque-type psoriasis. In addition, has an involved BSA
of lesion ≥80% at baseline.
3. 
Candidate for phototherapy or systemic treatment for psoriasis (either naïve or history
of previous treatment).
Concomitant Therapy
4.  
a. In case of receiving methotrexate (MTX) or cyclosporine, the participant must
be on stable dose from 2 weeks before the first administration of study
intervention with doses of MTX <20 mg/week OR cyclosporine
≤5 mg/kg/day.
Note: Participants must not be on both MTX and cyclosporine at the same time
from 2 weeks before the first administration of study intervention.
b. In case of receiving retinoid, the participant must be on stable dose from
2 weeks before the first administration of study intervention.
Weight
5. 
For participants ≥12 to <18 years of age body weight must be ≥40 kg at baseline.
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Sex and Contraceptive/Barrier Requirements
6. 
A female participant of childbearing potential must have a negative highly sensitive serum
pregnancy test (-human chorionic gonadotropin [-hCG]) at screening and have a
negative urine pregnancy test at Week 0 prior to administration of study intervention.
7. 
A female participant must agree not to be pregnant, breastfeeding, or planning to become
pregnant while enrolled in this study or within 4 weeks after the last dose of study
intervention.
8. 
A female participant must be
a. not of childbearing potential
OR
b. of childbearing potential and
o 
Practicing a highly effective method of contraception (failure rate of <1%
per year when used consistently and correctly) and agrees to remain on a
highly effective method while receiving study intervention and until
4 weeks after last dose – the end of relevant systemic exposure. The
investigator should evaluate the potential for contraceptive method failure
(eg, noncompliance, recently initiated) in relationship to the first dose of
study intervention. Examples of highly effective methods of contraception
are located in Appendix 4: Contraceptive and Barrier Guidance.
Note: If a participant’s childbearing potential changes after start of the study
(eg, a premenarchal female participant experiences menarche) or the risk of
pregnancy changes (eg, a female participant who is not heterosexually active
becomes active), a female participant must begin using a highly effective
method of contraception.
9. 
A female participant must agree not to donate eggs (ova, oocytes) or freeze for future
use for the purposes of assisted reproduction during the study and for a period of at least
4 weeks after the last dose administration of study intervention administration.
10. A male participant must agree not to plan to father a child while enrolled in this study
or within 90 days after the last dose of study intervention.
11. 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, a
condom [with spermicidal foam/gel/film/cream/suppository if available in their
locale]), during the study and for at least 90 days after receiving the last administration
of study intervention. Male participants must also be advised of the benefit for a female
partner to use a highly effective method of contraception as condom may break or leak.
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12. A male participant must agree not to donate sperm for the purpose of reproduction
during the study and for a minimum of 90 days after receiving the last dose of study
intervention.
Informed Consent
13. The study participant must sign an ICF (or their legally acceptable representative must
sign) indicating that the participant understands the purpose of, and procedures required
for, the study and is willing to participate in the study.
For participants under the legal age of consent, parent(s) (preferably both if available or
per local requirements) (or their legally acceptable representative) must sign an ICF
indicating that they understand the purpose of, and procedures required for, the study
and is/are willing to allow the child to participate in the study. Per local requirements,
assent is also required of children capable of understanding the nature of the study and
once children or minors have reached the legal age of consent, they may be required to
sign the ICF as described in Informed Consent Process in Appendix 2: Regulatory,
Ethical, and Study Oversight Considerations.
14. The study participant must sign the ICF (or their legally acceptable representative must
sign) if the participant agrees to provide an optional DNA sample or photographs for
research. Refusal to give consent for the optional DNA research sample does not
exclude a participant from participation in the study.
For participants under the legal age of consent, parent(s) (preferably both if available or
per local requirements) (or their legally acceptable representative) must sign the ICF for
the substudies if they agree to the child providing an optional DNA sample or
photographs for research. Per local requirements, assent is also required of children
capable of understanding the nature of the study and once children or minors have
reached the legal age of consent, they may be required to sign the ICF as described in
the Informed Consent Process and Assent in Appendix 2: Regulatory, Ethical, and
Study Oversight Considerations.
15. The study participant 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:
Medical Conditions
1. 
The study participant has a total score of JDA severity index for GPP ≥14 at baseline if
participants have a diagnosis of GPP.
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2. 
The study participant has a differential diagnosis of the erythroderma (eg, erythroderma
caused by lymphoma or drug eruption) other than EP.
3. 
The study participant has a history of or current diagnosis or signs or symptoms of severe,
progressive, or uncontrolled liver, renal; cardiac, vascular, pulmonary, gastrointestinal,
endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic
disturbances.
4. 
The study participant has a history of amyloidosis.
5. 
Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients (refer
to the IB).
6. 
The study participant had major surgery, (eg, requiring general anesthesia) 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.
7. 
The study participant had transplanted organ (with exception of a corneal transplant
>12 weeks before the first dose administration of study intervention).
8. 
All participants with:
 
suicidal ideation in the 26 weeks prior to screening that may be defined as a C-SSRS
rating of: Wish to be Dead, Non-Specific Active Suicidal Thoughts, or Active
Suicidal Ideation with Any Methods (Not Plan) without Intent to Act and is
considered to be at risk by the investigator.
Participants ≥18 years if age with:
 
suicidal ideation or suicidal behavior in the 26 weeks prior to screening that may be
defined as a C-SSRS rating of: Suicidal Ideation with Intention to Act, Suicidal
Ideation with Specific Plan and Intent, 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.
Participants ≥12 to <18 years of age with:
 
suicidal ideation or non-suicidal self-injurious behavior in the 26 weeks prior to
screening that may be defined as a C-SSRS rating of: Suicidal Ideation with Intention
to Act, Suicidal Ideation with Specific Plan and Intent, or non-suicidal self-injurious
behavior.
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 
any suicidal behavior in their lifetime that maybe defined as a C-SSRS rating at
screening of: Actual suicide attempt, interrupted suicide attempt, aborted suicide
attempt, or preparatory behaviors for making a suicide attempt.
9. 
PHQ-9 score ≥15 at screening or baseline.
10. History of drug or alcohol abuse within 1 year before screening.
Prior/Concomitant Therapy
11. The study participant has previously received JNJ-77242113.
12. The study participant has experienced primary efficacy failure (no response within
16 weeks) to 1 or more agents directly targeting IL-23 or has had a clinically significant
AE to 1 or more agents directly targeted to IL-23.
Note: This criterion does not apply to previous IL-12/23 inhibitor use.
 
 
Prohibited Medication or Class of Medications or 
Therapy 
Restriction Duration
(See Section 6.9 for
more information)
13. 
Agents that deplete B-cells (eg, rituximab, 
alemtuzumab) 
26 weeks prior to the
first administration of
study intervention
14. 
Agents targeting TNFα (eg, infliximab etanercept, 
adalimumab, golimumab, certolizumab pegol) 
8 weeks prior to the first
administration of study
intervention
15. 
Any biologic therapy including (For agents targeting 
TNFα, please see Exclusion Criterion 14):  
a. IL-23-inhibitors: eg, guselkumab, 
tildrakizumab, risankizumab (Additional
exclusions apply, see Exclusion Criteria 11
and 12).
b. IL-17 inhibitors: eg, secukinumab,
brodalumab, ixekizumab
c. IL-12/23 inhibitors: eg, ustekinumab,
briakinumab
d. IL-36: eg, spesolimab
e. natalizumab
f. belimumab
g. abatacept
h. visilizumab
12 weeks prior to the
first administration of
study intervention
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16. 
Any experimental or investigational antibody or 
biological therapy 
12 weeks or 5 half-lives,
whichever is longer
17. 
Granulocyte and monocyte apheresis (GMA) 
12 weeks prior to the
first administration of
study intervention
18. 
Systemic immunomodulating treatments including but 
not limited to: 
 azathioprine, corticosteroids,
cyclophosphamide, tofacitinib, apremilast,
deucravacitinib
Other therapeutic procedures:
 phototherapy
Systemic medications that could affect psoriasis
evaluations including, but not limited to:
 herbal treatments, or traditional Taiwanese,
Korean, or Chinese medicines
Nonbiologic experimental therapies or investigational
agents
4 weeks prior to the first
administration of study
intervention
19. 
Topical medications/treatments that could affect
psoriasis or efficacy evaluations including, but not
limited to e.g.,
 Corticosteroids*, calcineurin inhibitors, tar,
anthralin, calcipotriene, tazarotene,
methoxsalen, trimethylpsoralen, fumarate,
PDE4 inhibitors, topical JAK inhibitors, aryl
hydrocarbon receptor-modulating agents
 Shampoos that contain corticosteroids, coal,
tar, or vitamin D3 analog
 Herbal treatments or traditional Taiwanese,
Korean, or Chinese medicines
*Exception: Weak or medium ranked topical
corticosteroid on face, palms, soles, and
intertriginous areas is allowed with restriction use
2 weeks prior to the first
administration of study
intervention
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within 24 hours prior to study visits.
20. 
Live virus or bacterial vaccine 
4 weeks (or longer if
required per vaccine
package insert) prior to
first administration of
study intervention
21. 
BCG vaccination 
1 year prior to the first
administration of study
intervention
 
Diagnostic Assessments
22. Screening laboratory test results within the following parameters:
a. 
Hemoglobin: <10 g/dL (SI: <100 g/L)
b. White blood cells: <3.5×103/μL (SI: <3.5 GI/L)
c. 
Neutrophils: <1.5×103/μL (SI: <1.5 GI/L)
d. Platelets:<100×103/μL (SI: <100 GI)
e. 
eGFR: <45 mL/min/1.73 m2
f. 
Aspartate aminotransferase (AST): >2×ULN
g. Alanine aminotransferase (ALT): >2×ULN
If 1 or more of the laboratory parameters is out of range, a single retest of laboratory values
is permitted during the screening period.
23. The study participant tests positive for the following infections at screening:
a. hepatitis B virus (HBV) tests (Appendix 7: Hepatitis B and Hepatitis C Virus
Screening for instructions)
b. hepatitis C antibody test (seropositive for antibodies and positive confirmatory test
for hepatitis C virus (HCV), ie, HCV polymerase chain reaction (PCR)
[Appendix 7: Hepatitis B and Hepatitis C Virus Screening])
c. human immunodeficiency virus (HIV) antibody
Infections or Predisposition to Infections
24. 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 non-remitting cystitis), severe fungal infection
(mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers.
25. 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.
26. Known or suspected immunodeficiency, including history of invasive opportunistic
infections (eg, active tuberculosis [TB], nontuberculous mycobacterial infection,
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histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis, HIV) or
otherwise recurrent infections of abnormal frequency or prolonged duration, despite
infection resolution, suggesting an immune-compromised status, as judged by the
investigator.
27. Serious infection (eg, disseminated herpes zoster, sepsis, pneumonia, or pyelonephritis),
or has been hospitalized or received intravenous (IV) antibiotics for an infection during
the 8 weeks before screening.
28. The study participant has tested positive for or been exposed to COVID-19 within 4 weeks
prior to the first dose of study intervention.
Exceptions: Participants who have tested positive for or been exposed to COVID-19 may
participate if they have both an absence of symptoms and a negative validated COVID-19
test obtained at least 2 weeks after symptom onset (or the first positive test for
asymptomatic infection) or exposure.
Follow local regulations for validated COVID-19 testing procedures and standard
definition of COVID-19 exposure.
29. The study participant meets ANY of the following tuberculosis (TB) screening criteria.
Note: Interferon gamma release assay (IGRA) testing with T-SPOT®TB (or
QuantiFERON-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 at least 3 weeks 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.
If the presence of latent TB is established, appropriate treatment has to be initiated at least
3 weeks before the first administration of study intervention.
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 8 weeks prior to the first administration of
study intervention. An exception is made for participants who:
- 
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
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been initiated at least 3 weeks prior to the first administration of study
intervention.
- 
have a false-positive IGRA test as determined by the following:
 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 8.3.7.
e. The study participant has a chest radiograph or chest computed tomography (CT)
within 12 weeks prior to the first administration of study intervention that shows
abnormalities suggestive of active or inactive TB.
Malignancy or Increased Potential of Malignancy
30. The study participant currently has a malignancy or history of malignancy within 5 years
before screening (exceptions are a non-melanoma skin cancer or cervical carcinoma in situ
that has been adequately treated with no evidence of recurrence for at least 12 weeks before
the first study intervention administration).
31. The study participant 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.
Other Exclusions
32. 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.
33. 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 (eg, psychiatric disorders who
cannot evaluate PRO properly).
NOTE: Investigators must 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 must be
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excluded from participation in the study. Section 5.4, describes options for retesting. The required
source documentation to support meeting the enrollment criteria are noted in Appendix 2:
Regulatory, Ethical, and Study Oversight Considerations.
5.3. 
Lifestyle Considerations
Participants must be willing and able to adhere to the following lifestyle restrictions to be eligible
for participation:
1. Recommended to be up to date on all age-appropriate vaccinations prior to screening per
routine 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 labeling, guidelines, and standards-of-care for participants receiving
immune-targeted therapy when determining an appropriate interval between vaccination and
study enrollment (Section 6.9.1.3).
2. Refer to Section 6.9 for details regarding prohibited and restricted therapy during the study.
3. Agree to take study interventions and comply with fasting requirements (Section 6.1).
4. Agree to fast for at least 6 hours prior to lipid panel blood sample collection unless medically
contraindicated (Section 1.3).
5. Strenuous exercise (eg, body building, long distance training [running/cycling]) may affect
study specified assessments and safety laboratory results; for this reason, strenuous exercise
should be avoided within 2 to 3 days before all planned study visits where laboratory tests are
collected.
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 study participation.
7. For adolescent participants, who are not of legal age of consent, a legal guardian or primary
caregiver is recommended to:
a. Accompany the participant to the study site on each assessment day according to the
Section 1.3.
b. Accurately and reliably dispense study intervention as directed.
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. This study will not use Interactive Web Response
System (IWRS).
The participant identification and enrollment log will be treated as confidential and will be filed
by the investigator in the study file. To ensure participant confidentiality, no copy will be made.
All reports and communications relating to the study will identify participants by participant
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identification and 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.
Rescreening
Individuals who do not meet the criteria for participation in this study (screen failure) may be
rescreened. Medical Monitor’s approval is required prior to rescreening. Rescreened participants
must be assigned new participant numbers, undergo the informed consent process, and meet all
criteria as defined in Section 5.
Retesting
Retesting of abnormal screening values that lead to exclusion will be allowed once. Retesting can
occur at an unscheduled visit during the screening period (to reassess eligibility) within the
specified screening window of up to 5 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. 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.
5.5. 
Criteria for Temporarily Delaying Enrollment/Administration of Study
Intervention
Not applicable for this study.
6. 
STUDY INTERVENTION AND CONCOMITANT THERAPY
6.1. 
Study Intervention Administered
For adult participants:
For adult participants, the study intervention must be swallowed whole. Participants will be
instructed to take the study intervention at approximately the same time every day upon waking
with 240 mL (8 oz) water on an empty stomach (no food intake for at least 2 hours before and for
at least 30 minutes after taking the study intervention).
For adolescent participants:
For adolescent participants, the participant’s legal guardian or caregiver may assist with
administration of the study intervention.
For adolescent participants, the study intervention should be swallowed whole. Adolescent
participants will be instructed to take the study intervention at approximately the same time every
day upon waking with 240 mL (8 oz) water on an empty stomach (no food intake for at least
2 hours before and for at least 30 minutes after taking the study intervention).
If adolescent participants have difficulty swallowing tablets, the study intervention may be
 It may take
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Study personnel should review dose administration requirements with the participant, as
appropriate, and with the delegated caregiver(s) before administration and throughout the study as
necessary.
Designation 
Product
Investigational Medicinal Product 
JNJ-77242113
Non-investigational Medicinal Product(s) 
(NIMP)/Auxiliary Medicinal Product(s) (AxMP)
Not applicable
Study intervention administration must be captured in the source documents and the case report
form (CRF). Study site personnel will instruct participants on how to store study intervention for
at-home use as indicated for this protocol.
JNJ-77242113 will be manufactured and provided under the responsibility of the sponsor. Refer to
the IB for a list of excipients.
For a definition of study intervention overdose, refer to Section 6.8.
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Description of Interventions
Intervention Name 
JNJ-77242113
Intervention Description 
film-coated tablet containin  g 200 m  g JNJ-77242113
Type 
Drug
Dose Formulation 
Tablet
Unit Dose Strength 
200 m  g per tablet
Dosage Level 
1×200 m  g tablet once daily 
Route of Administration 
Oral
Use 
Experimental
Investigational Medicinal Product (IMP) 
Yes
Non-Investigational Medicinal Product/Auxiliary 
Medicinal Product (NIMP/AxMP)
No
Sourcing 
Provided centrall y b y the sponsor
Packaging and Labeling 
(Labels will contain information to meet the applicable 
regulatory requirements) 
Study intervention will be provided in blister packs. Each
pack will be labeled as required per local requirements.
The blisters are packaged in child resistant Dosepaks.
Delivery Instructions 
Swallow tablet whole. Given with 240 mL water. The
tablet should not be broken or crushed.
Fasting Requirement 
At least 2 hours before taking the study intervention and
for at least 30 minutes after takin  g the stud y intervention.
Current/Former Names or Aliases 
JNJ-77242113 and previously referred to as aPi2915,
PN21235, PN-21235, and PN-235.
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6.2. 
Preparation/Handling/Storage/Accountability
Preparation/Handling/Storage
All study intervention must be stored at controlled temperatures ranging from 1°C to 30°C.
Refer to the study site investigational product and 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 (if applicable), must be
documented on the intervention accountability form. Participants, or their legally acceptable
representatives where applicable, must be instructed to return all original containers, whether empty
or containing study intervention. All study intervention will be stored and disposed of according
to the sponsor's instructions. Study site personnel must not combine contents of the study
intervention containers.
Study intervention must be handled in strict accordance with the protocol and as indicated on 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.
Study intervention must 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 or their legally acceptable representatives where applicable
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 Site Investigational
Product Procedures Manual.
6.3. 
Assignment to Study Intervention
Intervention Allocation
Randomization will not be used in this study as this is a single-arm study. All the participants will
be assigned to only JNJ-77242113.
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6.4. 
Blinding, Masking
As this is an open-label study, blinding procedures are not applicable.
6.5. 
Study Intervention Compliance
Participant compliance with study intervention will be assessed at each visit during the treatment
period by counting returned tablets.
Each participant’s overall compliance with study intervention since the first dose of study
intervention will be assessed by the site at each visit. A participant will be considered noncompliant
with the study intervention if they take less than 80% or greater than 120% of the expected tablets
during participation in this study, unless study intervention is withheld for safety reasons. Protocol
deviations for compliance will be assessed at Week 16, 24, and 52 or the Early Termination (ET)
Visit, if performed before Week 52.
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
may be discontinued from study intervention by the investigator or medical monitor (Section 7).
Study intervention compliance will be further detailed in the SAP.
6.6. 
Dose Modification
Not applicable for this study.
6.7. 
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 completed/discontinued study intervention and that they should return to their primary
physician to determine standard of care.
6.8. 
Treatment of Overdose
For this study, any dose of JNJ-77242113 greater than 200 mg in 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.
 
Document the quantity of the excess dose as well as the duration of the overdosing in the
source documents.
 
Evaluate the participant to determine, in consultation with the medical monitor, whether study
intervention must be interrupted.
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 
Obtain a plasma sample for PK analysis if requested by the medical monitor (determined on
a case-by-case basis).
6.9. 
Prior and Concomitant Therapy
All prestudy therapies and COVID-19 vaccination administered before signing the ICF must be
recorded at screening per CRF completion guidelines.
Concomitant therapies must be recorded throughout the study beginning with signing of the ICF
through the last study visit. Concomitant therapies must also be recorded beyond the last study
visit in conjunction with SAEs that meet the criteria outlined in Section 8.4.1.
All therapies (prescription or over-the-counter medications) different from the study intervention
must be recorded in the CRF. Modification of an effective pre-existing therapy should not be made
for the explicit purpose of entering a participant into the study.
Any questions regarding treatment with concomitant medication during the study should be
directed to the sponsor. The sponsor must be notified in advance (or as soon as possible thereafter)
of any instances in which prohibited therapies are administered.
6.9.1. 
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 dose
administration of study intervention per Exclusion Criteria (Section 5.2) and remain prohibited
during the study (until ET Visit for participants who terminate early or until last study intervention
administration visit). For guidance regarding the COVID-19 vaccine see Section 6.9.1.3.
The sponsor’s medical monitor must be notified in advance (or as soon as possible thereafter) of
any instances in which prohibited therapies are administered. The participant may be required to
discontinue study intervention (Section 7.1.3).
6.9.1.1. 
GPP/EP Concomitant Medications
Topical Therapy
Shampoos (containing salicylic acid only) and bland emollients are allowed on all body regions
but should not be used within 24 hours before any study visit. Non-medicated shampoos may be
used on the day of the study visit.
Other topical therapies that could affect psoriasis evaluations including but not limited to (eg,
topical corticosteroids*, topical calcineurin inhibitors, tar, anthralin, calcipotriene, tazarotene,
methoxsalen, trimethylpsoralens, fumarate, PDE4 inhibitors, topical JAK inhibitors, aryl
hydrocarbon receptor-modulating agents; shampoos that contain corticosteroids, coal, tar or
vitamin D3 analogs; and herbal treatments and traditional Taiwanese, Korean, or Chinese
medicines) are not permitted from Week 0 through Week 52.
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*Exception: weak or medium ranked topical corticosteroid on face, palms, soles, and intertriginous
areas with stable use is allowed with restriction use within 24 hours prior to study visits.
After Week 52, topical therapies are permitted for treatment of GPP or EP.
Phototherapy or Systemic Therapy
The use of phototherapy or systemic medications (other than MTX, retinoid, and cyclosporine)
that could affect psoriasis or the efficacy evaluation, is not permitted at any time during the study
(until ET Visit for participants who terminate early or until last study intervention administration
visit).
These medications include, but are not limited to,
 
those targeted for reducing TNFα (including but not limited to infliximab, etanercept, or
adalimumab).
 
drugs targeted for reducing IL-12/23, IL-17, IL-23, IL-36 (including but not limited to
ustekinumab, guselkumab, tildrakizumab, secukinumab, risankizumab, ixekizumab,
brodalumab, or spesolimab).
 
alpha-4 integrin antagonists (including but not limited to natalizumab).
 
JAK inhibitors (including but not limited to tyrosine kinase 2 inhibitors).
 
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 efficacy evaluation.
 
antimalarial agents.
 
herbal treatments.
 
traditional Taiwanese, Korean, or Chinese medicines.
MTX, Retinoids, or Cyclosporine for Treatment of Psoriasis
In case of receiving retinoids, 2 weeks with stable dose before the first administration of study
intervention is necessary, and any change in the dose should be avoided through Week 52. Dose
can be reduced; however, it cannot be re-escalated once it is reduced. After Week 52, there is no
limitation on retinoid.
In case of receiving MTX (<20 mg/week) or cyclosporine (≤5 mg/kg/day) at screening, at least
2 weeks with stable dose before the first administration of study intervention is necessary and this
stable dose should continue through Week 16. In case of participants with confirmed clinical
improvement, dose reduction is allowed before Week 16, but dose cannot be re-escalated. After
Week 16, cyclosporine should be tapered off and discontinued by Week 32. If the condition of a
participant worsens after tapering cyclosporine, the investigators should consider discontinuation
of study drug and pursue alternative treatment options. After Week 16, MTX should be tapered
off and an attempt should be made to discontinue MTX by Week 32. Minimal dose of MTX should
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be maintained throughout the study if the participant is not able to discontinue MTX completely.
Participants are not permitted to receive both MTX and cyclosporine at the same time during the
study.
6.9.1.2. 
Concomitant Medications for Indications Other Than Psoriasis
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 must be recorded
in the CRF.
The use of stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs) is allowed during the
treatment phase. However, disease modifying agents such as sulfasalazine, or intramuscular gold
(MTX is excluded) are prohibited during the study (until ET Visit for participants who terminate
early or until last study intervention administration visit).
The use of systemic corticosteroids for indications other than psoriasis should be limited to
situations for which, there are no adequate alternatives in the opinion of the treating physician.
Systemic corticosteroids should be used on a short-term basis, preferably for ≤2 weeks. Longer
term and multiple use of corticosteroids should be discussed with the sponsor 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. After Week 52, intra-
articular corticosteroids are allowed for indications other than psoriasis. Vitamin D3 and analogs
for dietary supplementation are permitted.
6.9.1.3. 
Vaccines
When considering use of locally approved non-live vaccines (including emergency use-authorized
COVID-19 vaccines) in study participants, follow applicable local vaccine labeling, guidelines,
and standards-of-care for participants receiving immune-targeted therapy. It is recommended to
avoid use of vaccines 2 weeks prior to Week 16 and 2 weeks prior to Week 52.
7. 
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL
7.1. 
Discontinuation of Study Intervention
If a participant discontinues study intervention for any reason before the end of the study, then the
ET Visit assessments must be obtained (Section 1.3) as soon as possible. Study intervention
assigned to the participant who discontinued study intervention may not be assigned to another
participant (Section 6.2). Additional participants will not be entered in this study. Participants who
discontinue study intervention but do not terminate study participation will continue to return for
protocol specified procedures and evaluations. Discontinuation from study intervention does not
mean that the participant is required to withdraw informed consent and leave the study.
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7.1.1. 
Liver Chemistry Stopping Criteria
Stopping of study intervention for abnormal liver tests is required by the investigator when a
participant meets one of the conditions outlined in Appendix 5: Liver Safety: Suggested Actions
and Follow-up Assessments.
7.1.2. 
Temporary Interruption (Withholding) of Study Intervention
Some possible reasons for temporarily withholding study intervention include, but are not limited
to, the following:
 
The participant develops a serious infection.
 
The participant is suspected of having tuberculosis infection (Section 8.3.7).
 
The participant has a hepatic event or liver test abnormality per Appendix 5: Liver Safety:
Suggested Actions and Follow-up Assessments.
 
The participant has a PHQ-9 score of ≥20 (Section 8.3.5).
Cases that may merit temporary withholding of the study intervention should be discussed with
the medical monitor. The medical monitor, in consultation with the investigator, will determine
when it is appropriate to recommence study intervention.
7.1.3. 
Permanent Discontinuation of Study Intervention
A participant's study intervention must be permanently discontinued if:
 
The participant withdraws consent or assent 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.
 
Participant meets the Sampson criteria for anaphylaxis (Sampson 2006) following study
intervention administration.
 
The participant becomes pregnant or plans a pregnancy during the study period. Refer to
Appendix 4: Contraceptive and Barrier Guidance.
 
Participant initiates protocol-prohibited medications, treatments, or interventions (outlined in
Section 6.9) that have an impact on psoriasis efficacy evaluations at the discretion of the
medical monitor.
 
Participant develops 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.
 
Participant develops a recurrent or chronic serious infection during the study period.
 
The participant is deemed ineligible according to the following TB screening criteria:
 
A diagnosis of active TB is made.
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 
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 a chest radiograph with evidence of current
active TB and/or a positive IGRA 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 IGRA results should be handled
as in Section 8.3.7. Participants with persistently indeterminate IGRA results may
continue without treatment for latent TB if active TB is ruled out, their chest radiograph
(both posterior-anterior and lateral views, substitutable with chest CT) shows no
abnormality suggestive of TB (active or old, inactive TB) and the participant has no
additional risk factors for TB as determined by the investigator and medical monitor.
 
A participant receiving treatment for latent TB discontinues this treatment prematurely 
or is noncompliant with the therapy.
 
Substantial noncompliance with study visits schedule (Section 1.3) or study intervention
administration (Section 6.5). Consideration for discontinuation must be discussed with the
medical monitor.
 
Hepatic or liver test abnormality outlined in Appendix 5: Liver Safety: Suggested Actions and
Follow-up Assessments
 
Participant reports suicidal ideation by answering “Yes” to Question 4 or 5 on the C-SSRS,
or documents suicidal behavior on the C-SSRS at any time during the study and is considered
at risk by the investigator after evaluation by a mental health professional. The investigator
should contact the medical monitor for discussion.
 
Sponsor decision.
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 or assent
 
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 or assent, then no additional assessments are allowed.
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.
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Withdrawal of consent must be an infrequent occurrence in clinical studies (Rodriguez 2015),
therefore, prior to the start of the study the sponsor and the investigator must discuss and reach a
clear understanding of what constitutes withdrawal of consent in the context of the available
reduced follow-up mechanisms listed.
7.2.1. 
Withdrawal From the Use of Research Sample
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
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 genetic (DNA) analyses 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 Sample While Remaining in the Main 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 Appendix 2: Regulatory, Ethical, and
Study Oversight Considerations). In such a case, samples will be destroyed after they are no longer
needed for the clinical study. Details of the sample retention for research are presented in the 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 enrollment 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 the participant repeatedly fails to return for
scheduled visits and is unable to be contacted by the study site. A participant cannot be deemed
lost to follow-up until all reasonable efforts made by the study site personnel to contact the
participant are deemed futile. The following actions must be taken if a participant fails to return to
the study site for a required study visit:
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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.
 
Site personnel, or an independent third party, will attempt to collect the vital status of the
participant within legal and ethical boundaries for all participants enrolled, including those
who did not get study intervention. Public sources may be searched for vital status information.
Should a study site close, eg, for operational, financial, or other reasons, and the investigator cannot
reach the participant to inform them, their contact information will be transferred to another study
site.
8. 
STUDY ASSESSMENTS AND PROCEDURES
Overview
The SoA (Section 1.3) summarizes the frequency and timing of efficacy, PK, immunogenicity, PD,
biomarkers, pharmacogenomic, health economics, and safety measurements applicable to this
study.
All visit-specific PRO assessments followed by C-SSRS must be conducted/completed before any
tests, procedures, or other consultations to prevent influencing participant responses, unless
otherwise specified in the SoA. The PROs are to be conducted/completed in the sequence as
mentioned in the SoA. Refer to the PRO completion guidelines for instructions on the
administration of PROs.
If multiple assessments are scheduled for the same timepoint, it is recommended that procedures
be performed in the following sequence: ECGs should precede vital signs and both procedures
should be completed prior to any invasive procedure. Vital signs should be recorded from the
opposite arm from which blood samples are being taken.
Blood collections for PK and biomarker assessments should be kept as close to the specified time
as possible. Other measurements may be done earlier than specified timepoints if needed. Actual
dates and times of assessments will be recorded in the source documentation and according to the
CRF guidelines and laboratory manual.
Blood Sample Collection
The total blood volume to be collected from each participant through the duration of the study will
be approximately 320 mL (this total includes the optional blood sampling).
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Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the
samples.
Sample Collection and Handling
The actual dates and times of sample collection must be recorded in the CRF or laboratory
requisition form.
Refer to the SoA (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.
Study-Specific Materials
The investigator will be provided with the following supplies:
 
Investigator site file (includes protocol and IB)
 
Photography manual
 
Laboratory kits
 
ClinRO scales
 
PRO scales
 
eCRF completion instructions
8.1. 
Administrative and General/Baseline Procedures
8.1.1. 
Physical Examinations
Full or Targeted 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). Targeted physical exams
will include a skin examination, general examination, and any other organ system examination
based on clinical judgment of the participant’s presenting complaints or symptoms. 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.
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. BMI will
be calculated for all the participants.
8.2. 
Efficacy Assessments
Efficacy evaluations chosen for this study are consistent with those utilized to evaluate other
therapies for psoriasis. Investigator assessments (ClinROs) and PROs will be used to assess
efficacy in this study per the SoA (Section 1.3) and listed below.
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ClinROs
 
CGI scale
 
JDA severity index (only for participants with GPP)
 
BSA of involvement of lesion (only for participants with EP)
 
IGA
 
PASI
PROs
 
DLQI for adult participants (≥18 years of age on the first date of the Screening Visit)
 
EQ-5D-5L (domain scores and VAS)
 
CDLQI for adolescent participants (≥12 years and <18 years of age on the first date of the
Screening Visit)
The PRO instrument will be provided in the local language in accordance with local guidelines.
The PRO instrument will be available for regulators and for IRB/IEC submissions and will be
provided separately in a companion manual with the instruments that will be submitted with the
protocol.
The PRO and AE data will not be reconciled with each other.
Photographs (Optional)
Photography will be conducted to record skin lesions at each visit indicated in the SoA
(Section 1.3). The details such as how to take photos of the lesion site are shown in the photography
manual.
8.2.1. 
Clinician-reported Outcomes
8.2.1.1. 
Clinical Global Impression Scale
The CGI scale is a brief clinician-rated instrument. The CGI scale has proved to be a robust
measure of efficacy in many clinical drug trials, and is easy and quick to administer, provided that
the clinician knows the patient well. The CGI has 5 categories (Very much improved [1], Much
improved [2], Minimally improved [3], No change [4], Worsened [5]) in this study. For GPP, the
rating of the CGI scale is based on JDA severity index and for EP, the rating will be as provided
in the study manual. Evaluation for CGI will include comparison to the previous assessment at
screening, comparison to screening assessment at Week 0, and comparison to Week 0 assessment
for all other visits from Week 2.
8.2.1.2. 
Japanese Dermatological Association Severity Index
The JDA severity index for GPP consists of area of erythema with pustules, area of erythema
(total), area of edema, fever, WBC, CRP, and serum albumin (provided in the study manual). The
total score of JDA severity index for GPP ranges between 0 and 17 (0=best, 17=worst). Area of
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erythema with pustules, area of erythema (total), and area of edema are rated as 0 to 3. Fever,
WBC, CRP, and serum albumin are rated as 0 to 2 (Iwatsuki 2010).
8.2.1.3. 
Body Surface Area
The BSA is a commonly used measure of involvement of skin disease. It is defined as the
percentage of surface area of the body involved with the condition being assessed, (ie, GPP or EP).
The handprint method for assessing BSA will be used in this study, where the surface area of the
participant's hand including the palm and all 5 digits is used as a guide to estimate 1% BSA
(Long 1992; Rossiter 1996; Thomas 2007).
8.2.1.4. 
Psoriasis Area and Severity Index
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their
response to therapy (Fredriksson 1978) (provided in the study manual). 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.
8.2.1.5. 
Investigator’s Global Assessment
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) (provided in the study
manual).
8.2.2. 
Participant-reported Outcomes
8.2.2.1. 
Dermatology Life Quality Index
The DLQI will be utilized in the adult population and 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 (provided in the study manual). The total score ranges from
0 to 30 with a higher score indicating greater impact on HRQoL.
8.2.2.2. 
EuroQol 5-Dimension 5 Level Questionnaire
The EQ-5D-5L will be used in the adult and adolescent population and is a self-administered,
standardized measure of health status in a wide range of health conditions and treatments (provided
in the study manual). The recall period for all items is ‘Today’. The EQ-5D-5L consists of the
EQ-5D descriptive system and the EQ-VAS. The EQ-5D descriptive system is comprised 5 items
across the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and
anxiety/depression. The EQ-5D-5L uses a 5-point Likert response scale ranging from “No
problems” to “Extreme problems”. The EQ-5D also includes a visual analog scale (EQ-VAS) that
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has endpoints labeled "best imaginable health state" and "worst imaginable health state" anchored
at 100 and 0, respectively. Participants are asked to indicate how they rate their own health by
indicating the point on the EQ-VAS which best represents their own health on that day
(EuroQol 1990; Herdman 2011; Janssen 2013).
8.2.2.3. 
Children’s Dermatology Life Quality Index
The CDLQI is an adapted version of the DLQI for the pediatric population and will be utilized in
the adolescent population in this study. The adaption and validation of the CDLQI was undertaken
by the original developer of the DLQI to ensure it addressed the specific needs of the pediatric
population (Lewis-Jones 1995). The CDLQI is a 10-item instrument that has 4 item response
options and a recall period of 1 week. Higher scores indicate greater impact on HRQoL. The
instrument is designed for use in children, is self-explanatory and can be simply handed to the
participant who is asked to fill it in with the help of the child's parent or caregiver (provided in the
study manual).
8.2.3. 
Endpoints
8.2.3.1. 
Primary Endpoints
 
Proportion of participants with GPP who experience treatment success at Week 16. Treatment
success for GPP is defined as at least "Minimally Improved" rating in CGI scale (according
to JDA total score) at Week 16.
 
Proportion of participants with EP who experience treatment success at Week 16. Treatment
success for EP is defined as at least "Minimally Improved" rating in CGI scale at Week 16.
8.2.3.2. 
Secondary Endpoints
 
Proportion of participants with GPP or EP who experience treatment success (for GPP: based
on CGI scale according to JDA total score and for EP based on CGI scale) over time.
 
Change from baseline in the total score of the JDA severity index for GPP over time.
 
Change from baseline in in severity classification (mild, moderate, severe) of the JDA severity
index for GPP over time.
 
Change from baseline in BSA of involvement of lesion for EP over time.
 
Proportion of participants who achieve an IGA score of cleared (0) or minimal (1) over time.
 
Proportion of participants who achieve an IGA score of cleared (0) over time.
 
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) over time.
 
Change from baseline in DLQI score over time.
 
Proportion of participants who achieve a DLQI score of 0 or 1 over time.
 
Change from baseline in EQ-5D-5L (domain scores and VAS) over time.
 
Frequency and type of AEs and SAEs.
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8.2.3.3. 
Exploratory Endpoints
 
Change from baseline in components (skin symptoms, systemic symptoms/laboratory
findings) of the JDA severity index for GPP over time.
 
Change from baseline in CDLQI over time.
 
Change from baseline in CDLQI score 0 or 1 over time.
 
JNJ-77242113 PK parameters.
 
Incidence of anti-drug antibodies to JNJ-77242113.
 
Change from baseline in levels of blood biomarkers.
8.3. 
Safety Assessments
Adverse events will be reported and followed by the investigator as specified in Section 8.4 and
Appendix 3: Adverse Events, Serious Adverse Events, Product Quality Complaints, and Other
Safety Reporting: Definitions and Procedures for Recording, Evaluating, Follow-up, and
Reporting.
Any clinically relevant changes occurring during the study must be recorded on the Adverse Event
section of the CRF.
Any clinically significant abnormalities persisting at the end of the study/early withdrawal will be
followed by the investigator until resolution or until a clinically stable condition is reached.
The study will include the following evaluations of safety and tolerability according to the time
points provided in the SoA (Section 1.3).
8.3.1. 
Vital Signs
Temperature (axillary), pulse/heart rate, respiratory rate, and blood pressure will be assessed.
Blood pressure and pulse/heart rate measurements will be assessed in a seated position preceded
by at least 5 minutes of rest in a quiet setting without distractions (eg, television, cell phones) with
a completely automated device. Manual techniques will be used only if an automated device is not
available.
8.3.2. 
Electrocardiograms
During the collection of ECGs, participants should be in a quiet setting without distractions (eg,
television, cell phones). Participants should rest in a supine position for at least 5 minutes before
ECG collection and should refrain from talking or moving arms or legs. If blood sampling or vital
sign measurement is scheduled for the same time point as ECG recording, the procedures should
be performed in the following order: ECG(s), vital signs, blood draw.
Details regarding collection of ECGs are available in the site manual.
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8.3.3. 
Clinical Safety Laboratory Assessments
Blood samples for serum chemistry and hematology and a random urine sample for urinalysis will
be collected as noted in Appendix 1: Clinical Laboratory Tests. The investigator must review the
laboratory results, document this review, and record any clinically relevant changes occurring
during the study in the AE section of the CRF. 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
Laboratory Manual or approved by the medical monitor are specified in Appendix 1: Clinical
Laboratory Tests.
8.3.4. 
Pregnancy Testing
Both serum and urine pregnancy testing will be performed for all females of childbearing potential
according to the SoA (Section 1.3). 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.
8.3.5. 
Depression Screening and Symptoms Monitoring
The PHQ-9 is a self-administered, 9-item questionnaire measuring symptoms and severity of
depression. The recall period for all items is the past 2 weeks. The items include diminished
interest or pleasure, depressed mood, insomnia/hypersomnia, fatigue or loss of energy, weight loss
or weight gain/appetite loss or appetite gain, feelings of worthlessness, diminished
concentration/indecisiveness, psychomotor agitation/retardation, and thoughts of death/suicide.
Each item is rated on a 4-point Likert scale ranging from 0 “not at all” to 3 “nearly every day.”
The PHQ-9 can generally be completed in 2 to 3 minutes (Kroenke 2001).
The PHQ-9 scores for depression range from 0 to 27 with higher scores indicating worse state
(more severe depressive symptoms). A score of 5 to 9 is considered to be minimal symptoms of
depression. A score of 10 to 14 is considered minor depression, dysthymia, or mild major
depression. A score of 15 to 19 is considered to indicate moderately severe major depression, and
a score ≥20 is considered to be severe major depression.
The PHQ-9 will be completed per the Section 1.3. The PHQ-9 result should be reviewed by the
site staff prior to the participant leaving the visit to assess the level of depression.
A participant who scores ≥15 on the PHQ-9 during the study suggestive of moderately severe
major depression should immediately be referred to a mental health professional for further
evaluation. The investigator should contact the medical monitor for discussion.
In addition, a participant who scores ≥20 on the PHQ-9 should be temporarily discontinued from
study intervention (refer to Section 7.1.2.).
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8.3.6. 
Suicidal Ideation and Behavior Risk Monitoring
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.
Two versions of C-SSRS will be used in this study: the ‘Baseline/Screening’ version of the
C-SSRS will be conducted during the screening visit and the ‘Since Last Visit’ version of the
C-SSRS will be completed at Week 0 and all other visits through the end of the study. The C-
SSRS must be completed after performing PROs and before performing any other tests or study
procedures.
The investigator or trained study-site personnel will interview the participant in a private place and
complete the C-SSRS. 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.
For each assessment after Week 0, the following actions should be taken, if applicable:
a. No suicidal ideation or behaviors (including self-injurious behavior without suicidal
intent): No further action is needed.
b. Suicidal ideation levels 1-3 or non-suicidal self-injurious behavior: Participant risk is
assessed by the investigator.
c. Suicidal ideation levels 4 or 5 or any suicidal behavior: Participant risk assessed and
referral to a mental health professional.
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.
In addition, caregivers of the participants will be instructed to immediately report any suicidal
ideation, suicidal behavior, or suicide attempt to the investigator.
8.3.7. 
Tuberculosis Evaluation
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 other
TB testing. T-SPOT® may be processed at either the central or local laboratory.
Participants with a negative IGRA test result are eligible to continue with screening 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
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(see Section 5.2, Exclusion Criterion 29). Appropriate treatment for latent TB is defined according
to Japan guidelines for immunocompromised patients.
Participants with indeterminate/borderline IGRA test results should have the test repeated.
Participants with persistently indeterminate/borderline IGRA test results must undergo an
evaluation for active or latent TB, or suspected false-positive initial testing, and initiate appropriate
treatment if needed (see Section 5.2, Exclusion Criterion 29).
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 during the initial
52 weeks of the study (refer to Section 1.3) or by telephone approximately every 2 to 12 weeks
during the LTE. The following series of questions is suggested for use during the evaluation:
For participants and/or caregivers, the following series of questions is suggested for use during the
evaluation:
a. “Have you had a new cough of >14 days’ duration or a change in a chronic cough?”
b. “Have you had any of the following symptoms:
o 
Persistent fever?
o 
Unintentional weight loss?
o 
Night sweats?”
c. “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 (Section 7.1), 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.
During the study, a participant with confirmed latent TB must initiate appropriate treatment for
latent TB as defined by Japan guidelines.
Note: Investigators should be aware that TB reactivation in immunocompromised participants may
also present as extrapulmonary or disseminated disease.
8.4. 
Adverse Events, Serious Adverse Events, and Other Safety Reporting
Timely, accurate, and complete reporting and analysis of safety information, including AEs, SAEs,
and PQCs, 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
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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.
Further details on AEs, SAEs, and PQCs can be found in Appendix 3: Adverse Events, Serious
Adverse Events, Product Quality Complaints, and Other Safety Reporting: Definitions and
Procedures for Recording, Evaluating, Follow-up, and Reporting.
8.4.1. 
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. All AEs with an onset date after the
signing of the ICF and up to 4 weeks after study intervention discontinuation must be recorded on
specific AE pages of the eCRF.
Serious Adverse Events
All SAEs occurring during the study must be reported to the appropriate sponsor contact person
by study site personnel immediately, but no later than 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.
All SAEs occurring after signature of the ICF up to 4 weeks after study intervention
discontinuation must be recorded on AE pages in the eCRF and on an SAE form, regardless of the
investigator-attributed causal relationship with study intervention or study mandated procedures.
Information regarding SAEs will be transmitted to the sponsor using the Serious Adverse Event
Form, which must be completed and signed by a physician from the study site and transmitted to
the sponsor immediately but no later than within 24 hours of their knowledge of the event. 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.
8.4.2. 
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 or SAE as
fully as possible. This may include additional laboratory tests or investigations, histopathological
examinations, or consultation with other health care professionals.
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Adverse events and the special reporting situation of pregnancy will be followed by the
investigator as specified in Appendix 3: Adverse Events, Serious Adverse Events, Product Quality
Complaints, and Other Safety Reporting: Definitions and Procedures for Recording, Evaluating,
Follow-up, and Reporting.
8.4.3. 
Regulatory Reporting Requirements for Serious Adverse Events
The sponsor assumes responsibility for appropriate reporting of the safety information to the
regulatory authorities/Independent Ethics Committee (IEC)/Institutional Review Board (IRB), as
applicable.
8.4.4. 
Pregnancy
All initial reports of pregnancy in female participants or partners of male participants must be
reported to the sponsor by the study site personnel within 24 hours of their knowledge of the event
using the appropriate pregnancy notification form. Abnormal pregnancy outcomes (eg,
spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy) are
considered SAEs and must be reported using an SAE reporting form. Any participant who becomes
pregnant during the study must discontinue further study intervention.
Follow-up information regarding the outcome of the pregnancy for female participants who
become pregnant, or where the pregnancy was the result of male participant and his partner, and
any postnatal sequelae in the infant will be required. The pregnant female participants may be
asked to return to the study site for the collection of safety assessments.
8.4.5. 
Adverse Events of Special Interest
An AESI, which may be serious or non-serious, is an AE 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 possible Hy's Law cases.
A possible Hy’s Law case is defined by the occurrence of ALT/AST ≥3 x ULN together with
Tbili ≥2 x ULN or INR >1.5 (if measured). Any possible Hy’s Law case is considered an important
medical event and must be reported to the sponsor in an expedited manner using the AESI form,
even before all other possible causes of liver injury have been excluded (FDA 2009). AESI must
be reported using the SAE form.
Any newly identified malignancy or case of active TB occurring after the first administration of
study intervention must be reported by the investigator according to the procedures in Appendix 3:
Adverse Events, Serious Adverse Events, Product Quality Complaints, and Other Safety
Reporting: Definitions and Procedures for Recording, Evaluating, Follow-up, and Reporting.
Investigators are also advised that active TB is considered a reportable disease in most
countries/territories.
An AESI is considered serious only if it meets the definition of an SAE.
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8.5. 
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
after the study period. Participant confidentiality will be maintained.
8.5.1. 
Evaluations
Venous blood samples of approximately 4 mL will be collected for measurement of plasma
concentrations of JNJ-77242113 as indicated in the SoA (Section 1.3).
Samples collected for analyses of JNJ-77242113 plasma concentration 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 plasma samples. Participant confidentiality will
be maintained. Additional information about the collection, handling, and shipment of biological
samples can be found in the laboratory manual.
8.5.2. 
Analytical Procedures
Plasma samples will be analyzed to determine concentrations of JNJ-77242113 using a validated,
specific, and sensitive LC-MS/MS method by or under the supervision of the sponsor.
8.6. 
Pharmacodynamics
Pharmacodynamic assessments are described in Section 8.8.
8.7. 
Genetics and Pharmacogenomics
Sample collection and testing will comply with local regulations.
A pharmacogenomic blood sample will be collected from participants who consent to this
component of the study to allow for pharmacogenomic research, as necessary. Participant
participation in pharmacogenomic research is optional. The sponsor will store the DNA samples
in a secure storage space with adequate measures to protect confidentiality.
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 psoriasis or the
response to JNJ-77242113. They may also be used to develop tests or assays related to psoriasis
or JNJ-77242113. This research may consist of the analysis of 1 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 treatments. These analyses will be performed at the
sponsor’s discretion and may be reported separately.
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8.8. 
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 versus clinical response relationship, and the pathophysiology of
psoriasis. This will include evaluation of relevant disease and pathway engagement biomarkers in
serum. Serum will be collected from all participants. These assessments could also help explain
interindividual variability including differences between responders and non-responders to support
participant 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
collection will be conducted at the timepoints indicated in the Section 1.3 and instruction for the
collection and shipment of these samples can be found in the laboratory manual.
Sample collection and testing will comply with local regulations.
Serum Biomarkers
Level of mediators relevant to the pathophysiology of psoriasis or inflammation including but not
limited to IL-23, IL-17A, IL-17F, IL-22 and beta-defensin-2 will be evaluated to assess the impact
of JNJ-77242113 on inflammatory proteins in the serum.
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.
8.9. 
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 further characterize the
immunogenicity of JNJ-77242113.
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.
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Analytical Procedures
Antibodies to JNJ-77242113 will be further characterized and evaluated for their ability to
neutralize the activity of the study intervention using validated assays.
8.10. 
Health Economics/Medical Resource Utilization and Health Economics
Health Economics will be evaluated in this study utilizing the EQ-5D-5L (Refer to Section 8.2.2.
for details). Medical Resource Utilization parameters will not be 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 are outlined
below. Specific details will be provided in the SAP.
9.1. 
Statistical Hypotheses
The primary hypothesis of this study is that JNJ-77242113 is efficacious in treating GPP or EP as
assessed by proportion of participants with GPP and EP who experience treatment success defined
as at least "Minimally Improved" rating in CGI scale for GPP (according to JDA total score) and
EP, respectively at Week 16.
9.2. 
Analysis Sets
For purposes of analysis, the following analysis sets are defined:
Analysis Sets 
Description
Enrolled 
All participants who sign the ICF.
Full Analysis Set 
(FAS)
All enrolled participants who received at least 1 dose of JNJ-77242113.
Safety Analysis 
Set (SAS)
All enrolled participants who received at least 1 dose of JNJ-77242113.
PK Analysis Set 
All enrolled participants who received at least 1 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 enrolled 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.
9.3. 
Statistical Analyses
The SAP will be finalized prior to first DBL and it will include a more technical and detailed
description of the statistical analyses described in this section. This section is a summary of the
planned statistical analyses of the most important endpoints including primary and secondary
endpoints.
9.3.1. 
General Considerations
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 data, as applicable.
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9.3.2. 
Primary Efficacy Endpoints/Estimand Analysis
There are 2 primary endpoints for GPP and EP in this study as given below.
For GPP:
 
Proportion of participants with GPP who experience GPP treatment success at Week 16. GPP
treatment success is defined as at least "Minimally Improved" rating in CGI scale according
to JDA total score for GPP at Week 16.
For EP:
 
Proportion of participants with EP who experience EP treatment success at Week 16. EP
treatment success is defined as at least "Minimally Improved" rating in CGI scale for EP at
Week 16.
The primary estimand (ie, a precise definition of the primary targeted treatment effect) is defined
for GPP and EP, respectively by the following 5 attributes:
Study Intervention:
Experimental: JNJ-77242113
Population:
 
Participants ≥12 years of age with GPP
 
Participants ≥12 years of age with EP
Variable:
Binary response variables for the primary endpoints:
 
Treatment success for GPP: a responder (participant with treatment success defined as at least
"Minimally Improved" rating in CGI scale for GPP according to the JDA total score) at
Week 16.
 
Treatment success for EP: a responder (participant with treatment success defined as at least
"Minimally Improved" rating in CGI scale for EP) at Week 16.
Intercurrent Event:
Intercurrent Event 
Corresponding Strategy
Discontinuation of study intervention for any 
reason prior to Week 16. 
Treatment Policy: observed data will be used
regardless of whether or not this ICE had
occurred.
Population Level Summary:
 
Proportion of participants with GPP who experience treatment success at Week 16.
 
Proportion of participants with EP who experience treatment success at Week 16.
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Primary Endpoint Analyses
For the primary endpoint analyses, data from full analysis set (FAS) which is the population of
participants who received at least 1 dose of study intervention will be analyzed. The number,
proportion of participants with treatment success, and 95% Clopper-Pearson exact confidence
interval (CI) will be provided for GPP and EP groups.
The primary endpoints will be analyzed using the primary estimand.
After accounting for the ICE for the primary estimand, participants with missing data for the
primary endpoints at Week 16 will be considered as non-responders.
The detailed methods of analysis and the data-handling rules for primary endpoints will be
described in the SAP.
9.3.3. 
Secondary Efficacy Endpoints/Estimand Analysis
The secondary efficacy endpoints are:
 
Proportion of participants with GPP or EP (for GPP: based on CGI scale according to JDA
total score and for EP based on CGI scale) who experience treatment success over time.
 
Change from baseline in the total score of the JDA severity index for GPP over time.
 
Change from baseline in severity classification (mild, moderate, severe) of the JDA severity
index for GPP over time.
 
Change from baseline in BSA of involvement of lesion for EP over time.
 
Proportion of participants who achieve an IGA score of cleared (0) or minimal (1) over time.
 
Proportion of participants who achieve an IGA score of cleared (0) over time.
 
Percent improvement from baseline in PASI over time.
 
Change from baseline in DLQI score over time.
 
Proportion of participants who achieve a DLQI score of 0 or 1 over time.
 
Change from baseline in EQ-5D-5L (domain scores and VAS) over time.
All the secondary efficacy endpoints will be summarized descriptively. Graphical data displays
may also be used to summarize the data.
The detailed methods of analysis and the data-handling rules for the key secondary endpoints will
be specified in the SAP.
9.3.4. 
Other Secondary and Exploratory Endpoints/Estimand Analysis
Other secondary and exploratory endpoints are listed in Section 3. The analyses for other
secondary and exploratory efficacy endpoints at Week 16 and over time will be performed. A
complete list of the planned analyses of other secondary and exploratory endpoints will be
described in the SAP.
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9.3.5. 
Safety Analyses
All safety analyses will be made on the Safety Analysis Set.
Safety data, including but not limited to, AEs, SAEs, AESIs (active TB, malignancy, possible Hy’s
Law cases), discontinuation of study intervention due to AEs, changes in laboratory assessments,
changes in vital signs, changes in weight, changes in PHQ-9 scores, and changes in C-SSRS will
be summarized. Treatment-emergent AEs will be summarized by MedDRA SOC and PT. Details
will be specified in the SAP.
Adverse Events
The verbatim terms used in the CRF by investigators to identify AEs will be coded using the
Medical Dictionary for Regulatory Activities (MedDRA). Any AE occurring at or after the initial
administration of study intervention or that is a consequence of a pre-existing condition that has
worsened since baseline is considered to be treatment-emergent. All reported treatment-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.
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 AESIs.
 
The incidence and type of severe AEs.
 
The incidence and type of treatment-related AEs and SAEs as assessed by the investigator.
 
The incidence and type of AEs leading to discontinuation of study intervention.
Listings of participants with SAEs, severe AEs, AEs of psoriasis, AESIs, and AEs leading to
discontinuation of study intervention will also be provided. Summaries, listings, datasets, or
participant narratives may be provided, as appropriate, for those participants who die, who
discontinue intervention due to an AE, or who experience a severe or an SAE.
Clinical Laboratory Tests
Laboratory data will be summarized by type of laboratory test. 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. In addition, a listing of participants with Grade 2 or higher laboratory test results
(based on the CTCAE criteria) will also be provided.
Reference ranges and markedly abnormal results (specified in the SAP) will be used in the
summary of laboratory data. Descriptive statistics will be calculated for all selected laboratory
analytes at baseline and for observed values and changes from baseline at each scheduled time
point. A listing of participants with any laboratory results outside the reference ranges will be
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provided. A listing of participants with any markedly abnormal laboratory results will also be
provided.
Vital Signs
Vital signs including temperature, pulse/heart rate, respiratory rate, and blood pressure (systolic
and diastolic) will be summarized over time, using descriptive statistics and/or graphically. The
percentage of participants with values beyond clinically important limits will be summarized.
Physical Examinations
Physical examination findings will be summarized at each scheduled time point. Descriptive
statistics will be calculated at baseline and for observed values and changes from baseline at each
scheduled time point. Frequency tabulations of the abnormalities will be made.
Weight
Descriptive statistics of weight will be summarized over time for adult participants. Descriptive
statistics of weight and height will be summarized over time for adolescent participants.
PHQ-9
Depression severity based on the PHQ-9 will be summarized descriptively.
C-SSRS
Suicide-related thoughts and behaviors based on the C-SSRS will be summarized descriptively.
9.3.6. 
Other Analyses
9.3.6.1. 
Pharmacokinetic Analyses
The PK evaluable population is defined as all the participants who received at least 1 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. Descriptive statistics will be
calculated at each sampling timepoint.
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 (demographics, laboratory variables, race) will be evaluated 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.
9.3.6.2. 
Biomarkers Analyses
Planned biomarker analyses may be deferred if emerging study data show no likelihood of
providing useful scientific information.
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Changes in serum biomarkers over time will be summarized by GPP and EP groups. Associations
between baseline levels and changes from baseline in selected markers and clinical response to
treatment will be explored. Biomarker analyses will be summarized in separate technical reports.
9.3.6.3. 
Immunogenicity Analyses
The incidence and titer of anti-JNJ-77242113 antibodies 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.
9.3.6.4. 
Pharmacokinetic/Pharmacodynamic Analyses
If data permit, the relationships between JNJ-77242113 concentrations and efficacy and safety
may be analyzed graphically. If any visual trend is observed, a suitable exposure-response (E-R)
model may be developed to describe the E-R relationship. Details will be given in an E-R analysis
plan and results will be presented in a separate technical report.
9.3.6.5. 
Pharmacogenomic Analyses
Genetic (DNA) analyses will be conducted only in participants who sign the consent form to
participate in the optional pharmacogenetics substudy. These results are considered exploratory
and will be presented in a separate report.
9.4. 
Interim Analysis/Analyses
No interim analyses are planned.
9.5. 
Sample Size Determination
The number of patients with GPP or those with EP is limited with 1.5% to 2.3% of the entire
patients with psoriasis in Japan Therefore, based on the feasibility, approximately 16 participants
(8 each for GPP and EP) will be targeted to enroll in the study.
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10.2. 
Appendix 2: Regulatory, Ethical, and Study Oversight Considerations
10.2.1. 
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- or territory-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 Study
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
Protocol Supplementary Information page(s), which will be provided as a separate document.
Except in emergency situations, this contact must 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
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the situation and agree on an appropriate course of action. The data recorded in the case report
form (CRF) and source documents will reflect any departure from the protocol, and the source
documents will describe this departure and the circumstances requiring it.
Regulatory Approval/Notification
This protocol and any amendment(s) must be submitted to the appropriate regulatory authorities
in each respective country/territory, 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, informed consent form (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 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).
Other Ethical Considerations
For study-specific ethical design considerations, refer to Section 4.2.2.
10.2.2. 
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.
10.2.3. 
Informed Consent Process and Assent Form
Each participant or a legally acceptable representative must give consent according to local
requirements after the nature of the study has been fully explained. The ICF(s) must be signed
before performance of any study-related activity. The ICF(s) and assent form that is/are used must
be approved by both the sponsor and by the reviewing IEC/IRB and be in a language that the
participant can read and understand. The informed consent must be in accordance with principles
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that originated in the Declaration of Helsinki, current ICH and GCP guidelines, applicable
regulatory requirements, and sponsor policy.
Before enrollment in the study, the investigator or an authorized member of the study site personnel
must explain to potential participants or their legally acceptable representatives the aims, methods,
reasonably anticipated benefits, and potential hazards of the study, and any discomfort
participation in the study may entail. Participants will be informed that their participation is
voluntary and that they may withdraw consent to participate at any time. They will be informed
that choosing not to participate will not affect the care the participant will receive for the treatment
of his or her disease. Participants will be told that alternative treatments are available if they refuse
to take part and that such refusal will not prejudice future treatment. Finally, they will be told that
the investigator will maintain a participant identification register for the purposes of long-term
follow-up if needed and that their records may be accessed by health authorities and authorized
sponsor personnel without violating the confidentiality of the participant, to the extent permitted
by the applicable law(s) or regulations. By signing the ICF the participant or legally acceptable
representative is authorizing such access, which includes permission to obtain information about
his or her survival status. It also denotes that the participant agrees to allow his or her study
physician to recontact the participant for the purpose of obtaining consent for additional safety
evaluations, and subsequent disease-related treatments, if needed. The 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
must 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. 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 the 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 the signed ICF will be given to the participant.
If required, the ICF may be used for the required DNA component of the study.
Children (minors) or participants who are unable to comprehend the information provided can be
enrolled only after obtaining consent of a legally acceptable representative. Assent must be
obtained from children (minors) capable of understanding the nature of the study, typically
participants 7 years of age and older, depending on the institutional policies. Assent must be
obtained from participants who are able to write. A separate assent form in the language the
participant can understand must be developed for adolescents. After having obtained the assent, a
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copy of the assent form must be given to the participant, and to the participant's parent(s) or if
applicable legally acceptable representative.
10.2.4. 
Recruitment Strategy
Various resources will be developed to support study awareness and provide information and
education to potential participants about the study and clinical studies in general. Materials may
include posters, informational brochures, advertisements, study guides, and thank you cards.
10.2.5. 
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 information about, and where required per applicable regulations, explicit consent for the
processing of personal data and for the investigator/institution to allow direct access to his or her
original medical records (source data/documents) for study-related monitoring, audit, IEC/IRB
review, and regulatory inspection. The informed consent also provides information to address the
lawful transfer of the data to other entities and to other countries/territories.
The participant has the right to request through the investigator access to his or her personal data
and the right to request rectification of any data that are not correct or complete or make requests
concerning his or her personal data in accordance with applicable data protection law. Reasonable
steps will be taken to respond to such a request, taking into consideration the nature of the request,
the conditions of the study, and the applicable laws and regulations.
In the event of a data security breach, the sponsor will apply measures to adequately manage and
mitigate possible adverse effects taking into consideration the nature of the data security breach as
necessary to address other obligations such as notifying appropriate authorities in accordance with
applicable data protection law.
Exploratory research is not conducted under standards appropriate for the return of data to
participants. In addition, the sponsor cannot make decisions as to the significance of any findings
resulting from exploratory research. Therefore, exploratory research data will not be returned to
participants or investigators, unless required by law or local regulations. Privacy and
confidentiality of data generated in the future on stored samples will be protected by the same
standards applicable to all other clinical data.
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10.2.6. 
Long-term Retention of Samples for Additional Future Research
No additional research on study participants, study samples, or data derived from the study other
than that stipulated in this section will be conducted by the institution(s) or by a third party, without
the prior written consent of the sponsor.
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
GPP or EP to understand differential intervention responders, and to develop tests/assays related
to JNJ-77242113 and GPP or EP. The research may begin at any time during the study or during
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 (refer to Section 7.2.1).
10.2.7. 
Committees Structure
Adjudication Committee
The sponsor may perform adjudication on certain AEs during this study. If adjudication is required,
the site will be required to provide medical records and other anonymized source documentation
to the sponsor for this purpose. A separate adjudication charter will be available if the sponsor
chooses to perform adjudication.
10.2.8. 
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 exploratory 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 the
goals of 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 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 and exploratory biomarker analyses performed after the Clinical Study Report
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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 the publication of results. Any work created in
connection with performance of the study and contained in the data that can benefit from copyright
protection (except any publication by the investigator as provided for below) shall be the property
of the sponsor as author and owner of copyright in such work.
Consistent with Good Publication Practices and International Committee of Medical Journal
Editors (ICMJE) guidelines, the sponsor shall have the right to publish such primary (multicenter)
data and information without approval from the investigator. The investigator has the right to
publish study site-specific data after the primary data are published. If an investigator wishes to
publish information from the study, a copy of the manuscript must be provided to the sponsor for
review at least 60 days before submission for publication or presentation. Expedited reviews will
be arranged for abstracts, poster presentations, or other materials. If requested by the sponsor in
writing, the investigator will withhold such publication for up to an additional 60 days to allow for
filing of a patent application. In the event that issues arise regarding scientific integrity or
regulatory compliance, the sponsor will review these issues with the investigator. The sponsor will
not mandate modifications to scientific content and does not have the right to suppress information.
For multicenter study designs and substudy approaches, secondary results generally should not be
published before the primary endpoints of a study have been published. Similarly, investigators
will recognize the integrity of a multicenter study by not submitting for publication data derived
from the individual study site until the combined results from the completed study have been
submitted for publication, within 18 months after the study end date, or the sponsor confirms there
will be no multicenter study publication. Authorship of publications resulting from this study will
be based on the guidelines on authorship, such as those described in the ICMJE Recommendations
for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals, which
state that the named authors must have made a significant contribution to the conception or design
of the work; or the acquisition, analysis, or interpretation of the data for the work; and drafted the
work or revised it critically for important intellectual content; and given final approval of the
version to be published; and agreed to be accountable for all aspects of the work in ensuring that
questions related to the accuracy or integrity of any part of the work are appropriately investigated
and resolved.
Registration of Clinical Studies and Disclosure of Results
The sponsor will register and disclose the interim results of clinical studies as required by law. The
disclosure of the study results will be performed after the closure of clinical database in order to
ensure the statistical analyses are relevant.
10.2.9. 
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
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study site personnel before the study, periodic monitoring visits by the sponsor, and direct
transmission of clinical laboratory data from a central laboratory into the sponsor's database.
Written instructions will be provided for collection, handling, storage, and shipment of samples.
Guidelines for CRF completion will be provided and reviewed with study site personnel before
the start of the study.
The sponsor may review the CRF for accuracy and completeness during on-site monitoring visits
and after transmission to the sponsor; any discrepancies will be resolved with the investigator or
designee, as appropriate. After upload of the data into the study database they will be verified for
accuracy and consistency with the data sources.
10.2.10. 
Case Report Form Completion
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 CRF as described in the CRF
guidelines. All CRF entries, corrections, and alterations must be made by the investigator or
authorized study site personnel. The investigator must verify that all data entries in the CRF are
accurate and correct.
The study data will be transcribed by study site personnel from the source documents onto an
electronic CRF, if applicable. Study-specific data will be transmitted in a secure manner to the
sponsor.
Worksheets may be used for the capture of some data to facilitate completion of the CRF. Any
such worksheets will become part of the participant's source documents. Data must be entered into
the CRF in English. The CRF must be completed as soon as possible after a participant visit and
the forms must be available for review at the next scheduled monitoring visit.
All participative measurements (eg, pain scale information or other questionnaires) will be
completed by the same individual who made the initial baseline determinations whenever possible.
If necessary, queries will be generated in the eDC tool. If corrections to a CRF are needed after
the initial entry into the CRF, this can be done in either of the following ways:
 Investigator and study site personnel can make corrections in the eDC tool at their own
initiative or as a response to an auto query (generated by the eDC tool).
 Sponsor or sponsor delegate can generate a query for resolution by the investigator and study
site personnel.
10.2.11. 
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
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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 must be identifiable. Given that participant-
reported outcomes (PROs) are reports of a participant's health condition that come directly from
the participant, 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.
In order to minimize inclusion bias, investigators participating in this study must agree not to
change such PRO data items once entered and saved permanently into the source records for the
following instruments (and visits) as set forth in the Data Management Plan for this study:
PROs
 
Dermatology Life Quality Index (DLQI) for adult participants (≥18 years of age on the first
date of the Screening Visit)
 
Euro QoL-5 Dimension 5 Level Questionnaire (EQ-5D-5L)
 
Children’s Dermatology Life Quality Index (CDLQI) for adolescent participants (≥12 years
and <18 years of age on the first date of the Screening Visit)
 
Patient Health Questionnaire-9 (PHQ-9)
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 CRF and will be considered source data:
 Race
 History of 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
The minimum source documentation requirements for Sections 5.1 and 5.2 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 or
 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.
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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.
10.2.12. 
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 as outlined in the
monitoring guidelines. The monitor will record dates of the visits in a study site visit log that will
be kept at the study site. The first post-initiation visit will be made as soon as possible after
enrollment has begun. At these visits, the monitor will compare the data entered into the CRF with
the source documents (eg, hospital/clinic/physician’s office medical record; a sample may be
reviewed. The nature and location of all source documents will be identified to ensure that all
sources of original data required to complete the CRF are known to the sponsor and study site
personnel and are accessible for verification by the sponsor study site contact. If electronic records
are maintained at the study site, the method of verification must be discussed with the study site
personnel.
Direct access to source documents (medical records) must be allowed for the purpose of verifying
that the recorded data are consistent with the original source data. Findings from this review will
be discussed with the study site personnel. The sponsor expects that, during monitoring visits, the
relevant study site personnel will be available, the source documents will be accessible, and a
suitable environment will be provided for review of study-related documents. The monitor will
meet with the investigator on a regular basis during the study to provide feedback on the study
conduct.
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.
10.2.13. 
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.
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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 must immediately notify the sponsor if he or she has been
contacted by a regulatory agency concerning an upcoming inspection.
10.2.14. 
Record Retention
In compliance with the ICH/GCP guidelines, the investigator/institution will maintain all CRF and
all source documents that support the data collected from each participant, as well as all study
documents as specified in ICH/GCP Section 8, Essential Documents for the Conduct of a Clinical
Trial, and all study documents as specified by the applicable regulatory requirement(s). The
investigator/institution will take measures to prevent accidental or premature destruction of these
documents.
Essential documents must be retained until at least 2 years after the last approval of a marketing
application in an ICH region and until there are no pending or contemplated marketing applications
in an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical
development of the investigational product. These documents will be retained for a longer period
if required by the applicable regulatory requirements or by an agreement with the sponsor. It is the
responsibility of the sponsor to inform the investigator/institution as to when these documents no
longer need to be retained.
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.
10.2.15. 
Study and Site Start and Closure
First Act of Recruitment
The first participant screened 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 and study supplies have been collected
and a study site closure visit has been performed.
The investigator may initiate study site closure at any time, provided there is reasonable cause and
sufficient notice is given in advance of the intended termination.
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Reasons for the early closure of a study site by the sponsor or investigator may include but are not
limited to:
 Failure of the investigator to comply with the protocol, the requirements of the IEC/IRB or
local health authorities, the sponsor's procedures, or GCP guidelines
 Inadequate recruitment of participants by the investigator
 Discontinuation of further study intervention development
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10.3. 
Appendix 3: Adverse Events, Serious Adverse Events, Product Quality
Complaints, and Other Safety Reporting: Definitions and Procedures for
Recording, Evaluating, Follow-up, and Reporting
10.3.1. 
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 on
Harmonization [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 All Adverse Events
under Section 8.4.1, Time Period and Frequency for Collecting Adverse Event and Serious
Adverse Event Information, 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 must be exercised in deciding whether expedited reporting
is also appropriate in other situations, such as important medical events that may not be
immediately life-threatening or result in death or hospitalization but may jeopardize the
participant or may require intervention to prevent one of the other outcomes listed in the
definition above. These should usually be considered serious.
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If a serious and unexpected 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
reported as a serious and unexpected suspected adverse reaction even if it is a component of the
study endpoint (eg, all-cause mortality).
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.
10.3.2. 
Attribution Definitions
Assessment of Causality
The causal relationship to study intervention is assessed by the investigator. The following
selection must 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.
10.3.3. 
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 must use clinical judgment in assessing the severity of events not directly
experienced by the participant (eg, laboratory abnormalities).
10.3.4. 
Special Reporting Situations
Safety events of interest on a sponsor study intervention in an interventional study that may require
expedited reporting or safety evaluation include, but are not limited to:
 
Overdose of a sponsor study intervention
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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 participant 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
 
Reporting of participant pregnancy or participant partner(s) pregnancy
Participant-specific special reporting situations must be recorded in the CRF. Any special reporting
situation that meets the criteria of an SAE must be recorded on the SAE page of the CRF.
10.3.5. 
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
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 
The event returns to baseline, if a baseline value/status is available
 
The event can be attributed to agents other than the study intervention or to factors unrelated
to study conduct
 
It becomes unlikely that any additional information can be obtained (participant or health care
practitioner refusal to provide additional information, lost to follow-up after demonstration of
due diligence with follow-up efforts)
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:
 
Surgery or procedure planned before entry into the study (must be documented in the CRF).
Note: Hospitalizations that were planned before the signing of the ICF, and where the
underlying condition for which the hospitalization was planned has not worsened, will not be
considered SAEs. Any AE that results in a prolongation of the originally planned
hospitalization is to be reported as a new SAE.
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, which
must be completed and signed by a physician from the study site and transmitted in a secure
manner to the sponsor immediately, but no later than within 24 hours of their knowledge of the
event. 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.
10.3.6. 
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.
A sample of the suspected product should be maintained under the correct storage conditions until
a shipment request is received from the sponsor.
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10.3.7. 
Contacting Sponsor Regarding Safety, Including Product Quality
The names (and corresponding telephone numbers) of the individuals who must be contacted
regarding safety issues, PQC, or questions regarding the study are listed in the Protocol
Supplementary Information page(s), which will be provided as a separate document.
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10.4. 
Appendix 4: 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 8.4.4 and Appendix 3: Adverse Events, Serious
Adverse Events, Product Quality Complaints, and Other Safety Reporting: Definitions and
Procedures for Recording, Evaluating, Follow-up, and Reporting.
Definitions
Female Participants of Childbearing Potential
A female participant is considered fertile following menarche and until becoming postmenopausal
unless permanently sterile (see below).
Female Participants 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 52 weeks 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 female participants
not using hormonal contraception or hormonal replacement therapy (HRT), however in the
absence of 52 weeks of amenorrhea, a single FSH measurement is insufficient. If there is a
question about menopausal status in female participants on HRT, the female participant will
be required to use one of the non-estrogen-containing hormonal highly effective contraceptive
methods if they wish to continue HRT during the study.
 
permanently sterile (for the purpose of this study)
 
Permanent sterilization methods include hysterectomy, or bilateral salpingectomy, or
bilateral oophorectomy.
 
Has congenital abnormalities resulting in sterility.
Note: If the childbearing potential changes after start of the study (eg, a premenarchal female
participant experiences menarche) or the risk of pregnancy changes (eg, a female participant who
is not heterosexually active becomes active), a female participant 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 male participants or female participants must 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.
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Examples of Contraceptives
EXAMPLES OF CONTRACEPTIVESa ALLOWED FOR FEMALE PARTICIPANTS DURING
THE STUDY INCLUDE:
USER INDEPENDENT
Highly Effective Methods That Are User Independent Failure rate of <1% per year when used
consistently and correctly.
 
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 female participant of childbearing potential and the absence of sperm
has been confirmed. If not, additional highly effective method of contraception must 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 ovulation
 
oral
 
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 (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 condom with or without spermicide
 
Periodic abstinence (calendar, symptothermal, post-ovulation methods)
 
Withdrawal (coitus-interruptus)
 
Lactational amenorrhea method (LAM)
a) Typical use failure rates may differ from those when used consistently and correctly.
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b. 
All events of ALT or AST ≥3×ULN and total bilirubin ≥2×ULN (or at least a doubling of direct bilirubin for known Gilbert's syndrome) or ALT or AST ≥3×ULN
and INR >1.5 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 met
(excluding studies of hepatic impairment or cirrhosis). The INR stated threshold value will not apply to participants receiving anticoagulants.
c. 
Includes: hepatitis A immunoglobulin M antibody; hepatitis B surface antigen and hepatitis B core antibody; 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. In participants with
underlying chronic hepatitis B at study entry (identified by positive hepatitis B surface antigen) check quantitative hepatitis B DNA and hepatitis delta antibody. If
hepatitis delta antibody assay cannot be performed, it can be replaced with a PCR of hepatitis D RNA virus (where needed) (Le Gal 2005).
d. 
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 PK 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.
e. 
Serum bilirubin fractionation should be performed if testing is available. If serum bilirubin fractionation is not immediately available, stop study intervention if
ALT or AST ≥3×ULN and total bilirubin ≥2×ULN. 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.
References:
Le Gal F, Gordien E, Affolabi D, Hanslik T, Alloui C, Dény P, et al Quantification of Hepatitis Delta Virus RNA in Serum by Consensus
Real-Time PCR Indicates Different Patterns of Virological Response to Interferon Therapy in Chronically Infected Patients. J Clin Microbiol.
2005;43(5):2363-2369.
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10.6. 
Appendix 6: 
Study 
Conduct 
During 
a 
Natural 
Disaster/Major
Disruption/Pandemic
GUIDANCE ON STUDY CONDUCT DURING COVID-19 PANDEMIC
It is recognized that the COVID-19 may have an impact on the conduct of this clinical study due
to, for example, isolation or quarantine of participants and study site personnel; travel
restrictions/limited-access to public places, including hospitals; study site personnel being
unavailable, isolated, or reassigned to critical tasks.
The sponsor is providing options for study-related participant management in the event of
disruption to the conduct of the study. This guidance does not supersede any local or government
requirements or the clinical judgment of the investigator to protect the health and well-being of
participants and site staff. If, at any time, a participant’s travel to the study site is considered to be
dangerous, study participation may be interrupted, and study follow-up conducted. If it becomes
necessary to discontinue participation in the study, the procedures outlined in the protocol for
discontinuing study intervention will be followed.
If, as a result of the COVID-19 scheduled visits cannot be conducted in-person at the study site,
they will be performed to the extent possible remotely/virtually or delayed until such time that on-
site visits can be resumed. At each contact, participants will be interviewed to collect safety data.
Key efficacy endpoint assessments should be performed if required and as feasible. Participants
will also be questioned regarding general health status to fulfill any physical examination
requirement.
Every effort should be made to adhere to protocol-specified assessments for participants on study
intervention, including follow-up. Modifications to protocol-required assessments may be
permitted after consultation with the participant, investigator, and the sponsor.
Related to the COVID-19 pandemic, if a participant has tested positive for the COVID-19, the
investigator should contact the sponsor’s responsible medical officer to discuss plans for
administration of study intervention, performing study assessments, and follow-up.
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.
Modifications made to the study conduct as a result of the COVID-19 should be summarized in
the Clinical Study Report.
 
Certain protocol-mandated visits to the study site may not be possible during the major
disruption events. Therefore, temporary measures may be implemented if considered
appropriate by the sponsor and investigator to maintain continuity of participant 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:
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 
remote (eg, by phone/telehealth) or in-person, off-site (eg, in-home) interactions between
site staff (or designees) and participants for study procedures, eg, those related to safety
monitoring/efficacy evaluation/study intervention storage and administration (including
training where pertinent)
 
procurement of study intervention by participants (or designee) or shipment of study
intervention from the study site directly to participants for at-home administration
(including the potential for self-administration of study intervention)
 
laboratory assessments using a suitably accredited local laboratory; for selected measures
(eg, urine pregnancy), home testing may be employed
 
other procedures, eg, imaging, 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 in the CRF.
 
other relevant study data elements impacted by the major disruption, should also be
documented in CRFs and/or other study systems, as directed by detailed sponsor guidance.
These may include missed/delayed/modified study visits/assessments/dose, and instances
where temporary measures such as those above are implemented.
 
The sponsor will evaluate the totality of impact of major disruption events on collection of
key study data and additional data analyses will be outlined in study SAP(s).
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10.8. 
Appendix 8: Diagnostic Criteria of Generalized Pustular Psoriasis
1. Definition of generalized pustular psoriasis and the primary signs parameters
required for diagnosis (2006)
Generalized pustular psoriasis (GPP) is a rare disease in which acute fever, generalized
skin rashes, and many sterile pustules develop. Histopathologically, GPP forms
subcorneal pustules characterized by Kogoj’s spongiform pustules. GPP may or may not
be preceded by psoriasis vulgaris and is characterized by repeated disease recurrence.
During the course of the disease, patients have abnormal clinical findings associated with
systemic inflammation and often present with mucosal symptoms and arthritis as
complications. Although rare, GPP may be accompanied by certain eye symptoms and
secondary amyloidosis.
1) Primary parameters:
a. Systemic symptoms such as fever and fatigue;
b. Systemic or extensive flush accompanied by multiple sterile pustules that sometimes
merge to form lakes of pus;
c. Neutrophilic subcorneal pustules histopathologically characterized by Kogoj’s
spongiform pustules;
d. The above clinical and histological features recur repeatedly. However, the diseases
mentioned below can be excluded from initial-onset cases.
A definitive diagnosis of GPP can be made in patients with all four features above, and
GPP would be suspected in those with features 2 and 3.
2. Parameters for reference in the diagnosis of GPP
1) Laboratory test findings necessary to assess the severity of the disease and
complications*:
a. Leukocytosis, left shift;
b. Elevated erythrocyte sedimentation rate (ESR), positive for C-reactive protein
(CRP);
c. Elevated immunoglobulin (Ig)G or IgA;
d. Hypoproteinemia, hypocalcemia;
e. Tonsillitis, elevated anti-streptolysin O antigens (ASLO), other infections;
f. Rheumatoid factor-negative polyarthritis, including ankylosing spondylitis;
g. Eye diseases (such as keratoconjunctivitis, uveitis, and iritis);
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h. Hepatic, renal, and urinary findings: treatment choice and evaluation of secondary
amyloidosis.
*The 3rd National Survey shows that specificity is 65% for leukocytosis, 67% for elevated
erythrocyte sedimentation rate, 81% for a high level of CRP, and 12% for hypocalcemia.
Due to insufficient data, anti-streptolysin O and Ig were not analyzed.
2) Diseases included in GPP
a. Acute GPP (von Zumbusch type): classical examples of GPP;
b. Impetigo herpetiformis: GPP associated with pregnancy and hormonal
abnormalities;
c. Acrodermatitis continua of Hallopeau: strictly speaking, this disease is rare and
therefore, requires careful diagnosis;
d. Pediatric GPP: circinate annular form is excluded.
3) In principle, cases involving transiently pustule formation are not included in this
category; which however, does not apply to the cases where recurrence is suppressed by
ongoing treatment.
3. Exclusion criteria for GPP
Three diagnoses of exclusion:
1) In principle, clear cases of psoriasis vulgaris with transient pustule formation after the
application of corticosteroids are not included in this category. However, this does not
apply to cases when pustules reoccur easily, and the dermatologists should decide
whether to include the case in this category after careful observation for a certain
period.
2) In general, the circinate annular form is excluded because of mild systemic symptoms;
but the cases exhibiting in a clear transition into GPP are included.
3) Cases where the diagnosis of subcorneal pustular dermatosis or pustular drug eruptions
(including acute generalized exanthematous pustulosis) is made after careful
observation for a certain period are excluded.
Reference:
Fujita H, Terui T, Hyama K et al. Japanese guidelines for the management and treatment of
generalized pustular psoriasis: The new pathogenesis and treatment of GPP. 2018; 45(11):1235-
1270.
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10.9. 
Appendix 9: Japanese Dermatological Association Severity Index
A. Evaluation of skin symptoms:  
Erythema, pustule, edema (0-9)
B. Evaluation 
of 
systemic
symptoms/laborator y findings:
Fever, WBC count, serum CRP, serum albumin (0-8)
o Severity classification: 
(total score) 
Mild 
(0-6) 
Moderate 
(7-10) 
Severe
(11-17)
A. Evaluation of skin symptoms (0-9)
 
Severe 
Moderate 
Mild 
None
Area of erythema (whole)*  
3 
2 
1 
0
Area of erythema with 
pustules**
3 
2 
1 
0
Area of edema**  
3 
2 
1 
0
* % relative to the body surface area (severe, 75%; moderate, <75%, 25%; mild, <25%)
** % relative to the body surface area (severe, 50%; moderate, <50%, 10%; mild, <10%)
B. Evaluation of systemic symptoms/laboratory findings (0-8)
Score 
2 
1 
0
Fever (°C)  
38.5 
<38.5, 37  
<37
WBC count (/μL) 
15,000  
<15,000, 10,000 
<10,000
CRP (mg/dL) 
7.0  
  <7.0, 0.3  
<0.3
Serum albumin (g/dL) 
<3.0 
  3.0, <3.8 
3.8
Reference:
Fujita H, Terui T, Hyama K et al. Japanese guidelines for the management and treatment of
generalized pustular psoriasis: The new pathogenesis and treatment of GPP. 2018; 45(11):1235-
1270.
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10.10. Appendix 10: Protocol Amendment History
This is an original protocol.
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11. 
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INVESTIGATOR AGREEMENT
I have read this protocol and agree that it contains all necessary details for carrying out this study. I will
conduct the study as outlined herein and will complete the study within the time designated.
I will provide copies of the protocol and all pertinent information to all individuals responsible to me who
assist in the conduct of this study. I will discuss this material with them to ensure that they are fully informed
regarding the study intervention, the conduct of the study, and the obligations of confidentiality.
Coordinating Investigator (where required):
Name (typed or printed):
Institution and Address:
Signature: 
 
Date:
  
 
(Day Month Year)
Principal (Site) Investigator:
Name (typed or printed):
Institution and Address:
Telephone Number:
Signature: 
 
Date:
  
 
(Day Month Year)
 
Sponsor's Responsible Medical Officer:
Name (typed or printed): 
 MD PhD
Institution: 
Janssen Pharmaceuticals K.K.
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.
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Signature
User 
Date 
Reason
29-Aug-2023
02:58:19
(GMT)
Document Approval
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