A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 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
- 79
- Locations
- 50
- Primary Endpoint
- Proportion of Subjects Achieving a 50% Reduction in PPPASI Score
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
RIST4721 400 mg
RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
Intervention: RIST4721
RIST4721 200 mg
RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks
Intervention: RIST4721
RIST4721 200 mg
RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks
Intervention: Placebo
Placebo
Placebo: 4 placebo tablets once daily for 12 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Proportion of Subjects Achieving a 50% Reduction in PPPASI Score
Time Frame: 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 Outcomes
- Absolute Change From Baseline in PPPGA(Baseline to Week 12)
- Absolute Change From Baseline in PPPASI(Baseline to Week 12)