JPRN-jRCT2071230104
Not yet recruiting
Phase 3
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
akano Masayoshi0 sites16 target enrollmentDecember 25, 2023
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Generalized Pustular PsoriasisErythrodermic Psoriasis
- Sponsor
- akano Masayoshi
- Enrollment
- 16
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Not specified
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