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

NCT06295692 | Active Not Recruiting Phase 3 Results FDA Drug

• 1 other identifier: 77242113PSO3005
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Erythrodermic Psoriasis; Generalized Pustular Psoriasis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Generalized Pustular Psoriasis (GPP) Who Experienced Treatment Success at 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

  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 Outcomes (13)

• Percentage of Participants With GPP Who Experienced Treatment Success Over Time Based on CGI Scale According to JDA Total Score

  From baseline (Week 0) to Week 156

• Percentage of Participants With EP Who Experienced Treatment Success Over Time Based on CGI Scale

  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

  From baseline (Week 0) up to Week 156

• Change From Baseline in Severity Classification of JDA Severity Index for GPP Over Time

  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

  From baseline (Week 0) up to Week 156

Study Arms (1)

JNJ-77242113- Participants With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP)

EXPERIMENTAL

Participants with GPP or EP will receive JNJ-77242113 tablet orally.

Drug: JNJ-77242113

Interventions

JNJ-77242113 DRUG

JNJ-77242113 tablet will be administered orally.

JNJ-77242113- Participants With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (12)

JR Sapporo Hospital

Hokkaido, 060-0033, Japan

Location

Ichinomiya Municipal Hospital

Ichinomiya, 491-8558, Japan

Location

Teikyo University Hospital

Itabashi Ku, 173 8606, Japan

Location

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, 807-8556, Japan

Location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Nagoya City University Hospital

Nagoya, 467 8602, Japan

Location

Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital

Osaka, 550 0006, Japan

Location

Tohoku University Hospital

Sendai, 980 8574, Japan

Location

Dokkyo Medical University Hospital

Shimotsuga Gun, 321 0293, Japan

Location

Tokyo Medical University Hospital

Shinjuku, 160 0023, Japan

Location

Fujita Health University Hospital

Toyoake, 470-1192, Japan

Location

Mie University Hospital

Tsu, 514 8507, Japan

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Global Medical Head Dermatology
• Organization: Janssen Research and Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: February 9, 2024
• Primary Completion: January 14, 2025
• Study Completion (Estimated): October 14, 2027
• Last Updated: April 13, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (12)