NCT03988335
Completed
Phase 2
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Palmoplantar Pustulosis
Overview
- Phase
- Phase 2
- Intervention
- RIST4721
- Conditions
- Palmoplantar Pustulosis
- Sponsor
- Aristea Therapeutics, Inc.
- Enrollment
- 35
- Locations
- 17
- Primary Endpoint
- Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
Investigators
Eligibility Criteria
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
Arms & Interventions
RIST4721
RIST4721 as once-daily 300mg oral solution for 28 days.
Intervention: RIST4721
Placebo
Placebo as once-daily 300mg oral solution for 28 days.
Intervention: Placebo
Outcomes
Primary Outcomes
Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline
Time Frame: Baseline to Day 28
Relative change from baseline in fresh pustule count at Day 28
Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline
Time Frame: Baseline to Day 28
Relative change from baseline in total pustule count at Day 28
Study Sites (17)
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