A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

May 7, 2026 updated by: Janssen Pharmaceutical K.K.

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

The purpose of this study is to evaluate how effective JNJ-77242113 is in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hokkaido, Japan, 060-0033
        • JR Sapporo Hospital
      • Ichinomiya, Japan, 491-8558
        • Ichinomiya Municipal Hospital
      • Itabashi Ku, Japan, 173 8606
        • Teikyo University Hospital
      • Kitakyushu-shi, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Nagoya, Japan, 467 8602
        • Nagoya City University Hospital
      • Osaka, Japan, 550 0006
        • Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
      • Sendai, Japan, 980 8574
        • Tohoku University Hospital
      • Shimotsuga Gun, Japan, 321 0293
        • Dokkyo Medical University Hospital
      • Shinjuku, Japan, 160 0023
        • Tokyo Medical University Hospital
      • Toyoake, Japan, 470-1192
        • Fujita Health University Hospital
      • Tsu, Japan, 514 8507
        • Mie University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The study participant has a diagnosis of generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP) at screening. For GPP, a diagnosis must be classified based on the criteria for diagnosis of GPP by the Japanese Dermatological Association (JDA); for EP, has a history of plaque-type psoriasis. In addition, has an involved body surface area (BSA) of lesion greater than or equal to (>=) 80 percent (%) at baseline
  • Candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment)
  • A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and have a negative urine pregnancy test at Week 0 prior to administration of study intervention
  • 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
  • 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

Exclusion Criteria:

  • The study participant has a total score of JDA severity index for GPP >=14 at baseline if participants have a diagnosis of GPP
  • The study participant has a differential diagnosis of the erythroderma (for example, erythroderma caused by lymphoma or drug eruption) other than EP
  • 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
  • The study participant has a history of amyloidosis
  • Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
  • The study participant who doesn't meet the criteria of prior/current concomitant therapy and/or history/conditions of infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JNJ-77242113- Participants With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP)
Participants with GPP or EP will receive JNJ-77242113 tablet orally.
Drug: JNJ-77242113
JNJ-77242113 tablet will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Generalized Pustular Psoriasis (GPP) Who Experienced Treatment Success at Week 16
Time Frame: Week 16
Percentage of participants with GPP who experienced treatment success at Week 16 was reported. Treatment success for GPP was defined as at least "minimally improved" rating in Clinical Global Impression (CGI) scale for GPP based on Japanese Dermatological Association (JDA) total score. JDA severity index includes skin symptoms (area of erythema with pustules, total area of erythema, and area of edema; each scored 0-3) and systemic/laboratory findings (fever, white blood cell count, C-reactive protein, and serum albumin; each scored 0-2). JDA total score was sum of 2 assessments ranging from 0 (best) to 17 (worst). CGI ratings were defined as: 1=Very much improved (greater than or equal to [>=]3-point reduction in JDA total score), 2=Much improved (1-2-point reduction), 3=Minimally improved (no change in JDA total score, but >=20 percent (%) reduction in area of erythema with pustules or meaningful improvement in >=1 other parameter), 4=No change, 5=Worsened. Higher score = worsening.
Week 16
Percentage of Participants With Erythrodermic Psoriasis (EP) Who Experience Treatment Success at Week 16
Time Frame: Week 16
Percentage of participants with EP who experienced treatment success at Week 16 was reported. Treatment success for EP was defined as at least "minimally improved" rating in CGI scale for EP. The CGI scale is a clinician-rated 5-point scale with the following categories: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Worsened. Higher score indicated worsening.
Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With GPP Who Experienced Treatment Success Over Time Based on CGI Scale According to JDA Total Score
Time Frame: From baseline (Week 0) to Week 156
From baseline (Week 0) to Week 156
Percentage of Participants With EP Who Experienced Treatment Success Over Time Based on CGI Scale
Time Frame: From Baseline (Week 0) to Week 156
From Baseline (Week 0) to Week 156
Change From Baseline in the Total Score of the Japanese Dermatological Association (JDA) Severity Index for GPP Over Time
Time Frame: From baseline (Week 0) up to Week 156
From baseline (Week 0) up to Week 156
Change From Baseline in Severity Classification of JDA Severity Index for GPP Over Time
Time Frame: From baseline (Week 0) up to Week 156
From baseline (Week 0) up to Week 156
Change From Baseline in the Body Surface Area (BSA) of Involvement of Lesion for EP Over Time
Time Frame: From baseline (Week 0) up to Week 156
From baseline (Week 0) up to Week 156
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) Over Time
Time Frame: Baseline (Week 0) up to Week 156
Baseline (Week 0) up to Week 156
Percentage of Participants Who Achieved an IGA Score of Cleared (0) Over Time
Time Frame: Baseline (Week 0) up to Week 156
Baseline (Week 0) up to Week 156
Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Over Time
Time Frame: From baseline (Week 0) up to Week 156
From baseline (Week 0) up to Week 156
Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time
Time Frame: From baseline (Week 0) up to Week 156
From baseline (Week 0) up to Week 156
Percentage of Participants Who Achieved DLQI Score of 0 or 1 Over Time
Time Frame: Baseline (Week 0) up to Week 156
Baseline (Week 0) up to Week 156
Change From Baseline in EuroQol-5 Dimension 5-Level (EQ-5D-5L) Over Time: Domain Scores
Time Frame: From baseline (week 0) up to Week 156
From baseline (week 0) up to Week 156
Change From Baseline in EQ-5D-5L Over Time: Visual Analog Scale (VAS) Scores
Time Frame: From baseline (Week 0) up to Week 156
From baseline (Week 0) up to Week 156
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time Frame: Baseline (Week 0) up to 160 weeks
Baseline (Week 0) up to 160 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Pharmaceutical K.K.

Investigators

  • Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial, Janssen Pharmaceutical K.K.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2024

Primary Completion (Actual)

January 14, 2025

Study Completion (Estimated)

October 14, 2027

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 77242113PSO3005 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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