A Study of Subcutaneous Risankizumab Injection for Pediatric Participants with Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
- Conditions
- Psoriasis
- Registration Number
- JPRN-jRCT2051210069
- Lead Sponsor
- Fujimura Kimino
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 132
Diagnosis of chronic plaque psoriasis for at least 6 months before the Baseline Visit.
- Stable severe or moderate to severe plaque psoriasis as defined in each study part by body surface area (BSA) psoriasis involvement and scores on the PASI and sPGA.
- Candidate for systemic therapy as assessed by the investigator and meet the disease activity criteria at both the Screening and Baseline Visits per the protocol.
- Concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk by participating in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)<br>- Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear
- Secondary Outcome Measures
Name Time Method