The trial is taking place at:
E

EP-SOGO Co., Ltd. | Nagoya City University Hospital

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

J

Janssen (J&J Innovative Medicine)

Status and phase

Enrolling
Phase 3

Conditions

Generalized Pustular Psoriasis
Erythrodermic Psoriasis

Treatments

Drug: JNJ-77242113

Study type

Interventional

Funder types

Industry

Identifiers

NCT06295692
77242113PSO3005 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

16 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

JNJ-77242113- Participants With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP)
Experimental group
Description:
Participants with GPP or EP will receive JNJ-77242113 tablet orally.
Treatment:
Drug: JNJ-77242113

Trial contacts and locations

12

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Central trial contact

Study Contact

Data sourced from clinicaltrials.gov

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