A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP) (NCT03988335) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
Canada, Germany35 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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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