A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
- Registration Number
- NCT05194839
- Lead Sponsor
- Aristea Therapeutics, Inc.
- Brief Summary
A 12-week Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis followed by an Open-label Extension Phase.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 79
- At least 6 months history of moderate or severe PPP, as defined by PPPASI ≥12 and PPPGA ≥3 at screening
- Males and females must be willing to use birth control as indicated
- Moderate to severe psoriasis covering ≥10% of total body surface area (BSA) at screening
- Breastfeeding or pregnant
- Known immunodeficiency or subject is immunocompromised
- Active/latent infection with HBV, HCV, HIV, SARS-CoV-2 or TB
- Any topical medications for PPP excluding emollients within two weeks of randomization and systemic therapies (including phototherapy) within 4 weeks of randomization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RIST4721 400 mg RIST4721 RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks RIST4721 200 mg RIST4721 RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks Placebo Placebo Placebo: 4 placebo tablets once daily for 12 weeks RIST4721 200 mg Placebo RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Proportion of Subjects Achieving a 50% Reduction in PPPASI Score Baseline to Week 12 In the Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI), the left palm, right palm, left foot, and right foot are assessed based on 3 target symptoms: erythema, desquamation (scaling), and pustules, as seen on the day of the examination. The severity of each sign is assessed using a 5-point scale (0 = not present, 1 = slight, 3 = moderate, 4 = severe, 5 = very severe). The affected area within a given anatomic site (left palm, right palm, left foot, and right foot) is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of PPP involvement (0 = no involvement, 2 = 10 to less than 30% involvement, 3 = 30 to less than 50% involvement, 4 = 50 to less than 70% involvement, 5 = 70 to less than 90% involvement, 6 = 90 to less than 100% involvement). PPPASI score for palms and soles is obtained using a formula and can vary from 0 (absence of disease) to 72 (most severe disease).
- Secondary Outcome Measures
Name Time Method Absolute Change From Baseline in PPPGA Baseline to Week 12 Absolute Change From Baseline in PPPASI Baseline to Week 12
Trial Locations
- Locations (50)
Total Skin & Beauty Dermatology Center, PC
🇺🇸Birmingham, Alabama, United States
Dermatology Trial Associates
🇺🇸Bryant, Arkansas, United States
Cosmetic Laser Dermatology
🇺🇸San Diego, California, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Driven Research LLC
🇺🇸Coral Gables, Florida, United States
Encore Medical Research, LLC
🇺🇸Hollywood, Florida, United States
Tory Sullivan, MD PA
🇺🇸North Miami Beach, Florida, United States
Advanced Medical Research PC
🇺🇸Sandy Springs, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
DS Research
🇺🇸Louisville, Kentucky, United States
Scroll for more (40 remaining)Total Skin & Beauty Dermatology Center, PC🇺🇸Birmingham, Alabama, United States