Generalized Pustular Psoriasis Erythrodermic Psoriasis
Conditions
Interventions
JNJ-77242113:Drug:JNJ-77242113- Participants With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP):Participants with GPP or EP will receive JNJ-77242113 tablet orally.
Sponsors
Kano Yuya
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Week 16 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. Percentage of Participants With Erythrodermic Psoriasis (EP) who Experience Treatment Success Based on CGI Scale at Week 16 Week 16 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
| Measure | Time frame |
|---|---|
| Percentage of Participants With GPP who Experience Treatment Success Based on CGI Scale According to JDA Total Score Over Time Up to Week 156 GPP treatment success is defined as at least ""minimally improved"" rating according to total JDA score for GPP. The CGI score is defined as 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = Worsened. Percentage of Participants With EP who Experience Treatment Success Based on CGI Scale Over Time Up to Week 156 EP treatment success is defined as at least 'Minimally Improved' rating in CGI scale for EP. The CGI score is defined as 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = Worsened. Change From Baseline in Total Score of JDA Severity Index for GPP Baseline up to Week 156 The JDA Severity Index (JDA-SI) includes assessment of skin symptoms (area of erythema, area of erythema with pustules, and area of edema) and systemic symptoms/laboratory findings (fever, white blood cell count, C-reactive protein [CRP], serum albumin). The total score ranges from 0 to 17 with higher score indicating more severe disease . Change From Baseline in Severity Classification of JDA Severity Index for GPP Baseline up to Week 156 Change from baseline in severity classification (mild, moderate and severe) of JDA severity index for GPP will be reported. The JDA-SI includes assessment of skin symptoms (area of erythema, area of erythema with pustules, and area of edema) and systemic symptoms/laboratory findings (fever, white blood cell count, CRP, serum albumin). The total score ranges from 0 to 17 and classifies disease severity as mild (0-6), moderate (7-10), or severe (11-17). Higher score indicate more severe disease. Change From Baseline in Body Surface Area (BSA) for EP Baseline up to Week 156 BSA is a commonly used measure of extent of skin disease. It is defined as the percentage of surface area of the body involved with the condition being assessed. Percentage of | — |
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed