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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 12 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06295692
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Janssen Pharmaceutical K.K.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Janssen Pharmaceutical K.K., Japan Clinical Trial
Principal Investigator Affiliation Janssen Pharmaceutical K.K.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Generalized Pustular Psoriasis, Erythrodermic Psoriasis
Arms & Interventions

Arms

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

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

Interventions

Drug: - JNJ-77242113

JNJ-77242113 tablet will be administered orally.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

JR Sapporo Hospital, Hokkaido, Japan

Status

Recruiting

Address

JR Sapporo Hospital

Hokkaido, , 060-0033

Ichinomiya Municipal Hospital, Ichinomiya, Japan

Status

Recruiting

Address

Ichinomiya Municipal Hospital

Ichinomiya, , 491-8558

Teikyo University Hospital, Itabashi Ku, Japan

Status

Recruiting

Address

Teikyo University Hospital

Itabashi Ku, , 173 8606

Kitakyushu-shi, Japan

Status

Recruiting

Address

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, , 807-8556

Kumamoto University Hospital, Kumamoto, Japan

Status

Recruiting

Address

Kumamoto University Hospital

Kumamoto, , 860-8556

Nagoya City University Hospital, Nagoya, Japan

Status

Recruiting

Address

Nagoya City University Hospital

Nagoya, , 467 8602

Osaka, Japan

Status

Recruiting

Address

Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital

Osaka, , 550 0006

Tohoku University Hospital, Sendai, Japan

Status

Recruiting

Address

Tohoku University Hospital

Sendai, , 980-8574

Dokkyo Medical University Hospital, Shimotsuga Gun, Japan

Status

Recruiting

Address

Dokkyo Medical University Hospital

Shimotsuga Gun, , 321-0293

Tokyo Medical University Hospital, Shinjuku, Japan

Status

Recruiting

Address

Tokyo Medical University Hospital

Shinjuku, , 160-0023

Fujita Health University Hospital, Toyoake, Japan

Status

Recruiting

Address

Fujita Health University Hospital

Toyoake, , 470-1192

Mie University Hospital, Tsu, Japan

Status

Recruiting

Address

Mie University Hospital

Tsu, , 514 8507

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