A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
- Conditions
- Generalized Pustular PsoriasisErythrodermic Psoriasis
- Registration Number
- JPRN-jRCT2071230104
- Lead Sponsor
- akano Masayoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 16
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Generalized Pustular Psoriasis (GPP) who Experience Treatment Success Based on Clinical Global Impression (CGI) Scale According to Japanese Dermatological Association (JDA) Total Score at Week 16<br>Week 16<br>GPP treatment success is defined as at least minimally improved rating according to total JDA score for GPP at Week 16. The CGI score is defined as 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = Worsened.<br><br>Percentage of Participants With Erythrodermic Psoriasis (EP) who Experience Treatment Success Based on CGI Scale at Week 16<br>Week 16<br>EP treatment success is defined as at least 'Minimally Improved' rating in CGI scale for EP at Week 16. The CGI score is defined as 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = Worsened.
- Secondary Outcome Measures
Name Time Method