Title
A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Palmoplantar Pustulosis
Phase
Phase 2Lead Sponsor
Aristea Therapeutics, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Palmoplantar PustulosisIntervention/Treatment
RIST4721 ...Study Participants
35A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
RIST4721 oral solution
Placebo oral solution
Inclusion Criteria: At least a 6-month history of PPP as defined by the presence of pustules on palms and/or soles, but without evidence of infection on palms and soles Moderate or severe PPP, as defined by Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) ≥8 and Palmoplantar Pustulosis Physician Global Assessment (PPPGA) ≥3 at Day -1, and a minimum of 8 fresh pustules at screening (fresh pustule count on both right/left palms and soles) and 20 fresh pustules at Day -1 (fresh pustule count on both right/left palms and soles) Males and females must be willing to use birth control as indicated Exclusion Criteria: Moderate to severe psoriasis, as defined by plaque psoriasis covering ≥10% of total Body Surface Area (BSA) at Day -1 Subject is known to have an immune deficiency or is immunocompromised Positive test for hepatitis, human immunodeficiency virus (HIV) or tuberculosis Use of topical therapies for PPP within 2 weeks of Day -1 and/or systemic therapies for PPP within 4 weeks
| Event Type | Organ System | Event Term | RIST4721 300 mg | Placebo |
|---|
Relative change from baseline in fresh pustule count at Day 28
Relative change from baseline in total pustule count at Day 28
