Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis
Phase 3
Completed
- Conditions
- palmoplantar pusutulosis
- Registration Number
- JPRN-jRCT2080225259
- Lead Sponsor
- AbbVie GK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 116
Inclusion Criteria
Stable moderate to severe Palmoplantar Pustulosis (PPP) with a Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score of >= 12 at the Screening and Baseline Visits.
- Moderate or severe pustules/vesicles on at least one palm or sole (>= 2 PPPASI severity score) at the Screening and Baseline Visits.
- Experienced inadequate response (or intolerant) to treatment with topical corticosteroids and/or vitamin D3 derivative preparations and/or phototherapy and/or systemic etretinate.
Exclusion Criteria
- History of active skin disease other than PPP which could interfere with the assessment of PPP.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score
- Secondary Outcome Measures
Name Time Method efficacy<br>Percentage of Participants Achieving at least 50% Improvement in PPPASI (PPPASI-50)<br>efficacy<br>Percentage of Participants Achieving at least 75% Improvement in PPPASI (PPPASI-75)