Phase 2
N=35
A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
Palmoplantar Pustulosis
Bottom Line
View on ClinicalTrials.gov: NCT03988335 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline — 0.86; 0.53 Log transformed ratio — p=0.24
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RIST4721 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aristea Therapeutics, Inc.
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline |
0.86; 0.53 | 0.24 |
| PRIMARY Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline |
0.99; 0.96 | 0.804 |
Summary
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
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
Data sourced from ClinicalTrials.gov (NCT03988335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.