Status:
COMPLETED
Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis
Lead Sponsor:
AbbVie
Conditions:
Palmoplantar Pustulosis (PPP)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Palmoplantar pustulosis is a chronic inflammatory skin disease that causes repeated on and off symptoms like erythema (reddening, irritation), vesicle (swelling, cyst), pustules, scale, and crusts in ...
Eligibility Criteria
Inclusion
- 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
- \- History of active skin disease other than PPP which could interfere with the assessment of PPP.
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2022
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT04451720
Start Date
July 20 2020
End Date
November 21 2022
Last Update
December 5 2022
Active Locations (39)
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1
Ichinomiya Municipal Hospital /ID# 222581
Ichinomiya-shi, Aichi-ken, Japan, 491-8558
2
Chukyo Hospital /ID# 218894
Nagoya, Aichi-ken, Japan, 457-8510
3
Nagoya City University Hospital /ID# 221258
Nagoya, Aichi-ken, Japan, 467-8602
4
Fujita Health University Hospital /ID# 221285
Toyoake-shi, Aichi-ken, Japan, 470-1192