A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP) (NCT03988335) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
Canada35 participantsStarted 2019-02-13
Plain-language summary
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
Who can participate
Age range18 Years – 70 Years
SexALL
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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
What they're measuring
1
Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline
Timeframe: Baseline to Day 28
2
Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline