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

NCT ID: NCT06295692

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-09

Study Completion Date

2027-10-14

Brief Summary

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

Detailed Description

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Conditions

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Generalized Pustular Psoriasis Erythrodermic Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 tablet will be administered orally.

Interventions

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JNJ-77242113

JNJ-77242113 tablet will be administered orally.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

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JR Sapporo Hospital

Hokkaido, , Japan

Site Status

Ichinomiya Municipal Hospital

Ichinomiya, , Japan

Site Status

Teikyo University Hospital

Itabashi Ku, , Japan

Site Status

Hospital of the University of Occupational and Enviromental Health

Kitakyushu-shi, , Japan

Site Status

Kumamoto University Hospital

Kumamoto, , Japan

Site Status

Nagoya City University Hospital

Nagoya, , Japan

Site Status

Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital

Osaka, , Japan

Site Status

Tohoku University Hospital

Sendai, , Japan

Site Status

Dokkyo Medical University Hospital

Shimotsuga Gun, , Japan

Site Status

Tokyo Medical University Hospital

Shinjuku, , Japan

Site Status

Fujita Health University Hospital

Toyoake, , Japan

Site Status

Mie University Hospital

Tsu, , Japan

Site Status

Countries

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Japan

Other Identifiers

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77242113PSO3005

Identifier Type: OTHER

Identifier Source: secondary_id

77242113PSO3005

Identifier Type: -

Identifier Source: org_study_id