Status:
TERMINATED
A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
Lead Sponsor:
Aristea Therapeutics, Inc.
Conditions:
Palmoplantar Pustulosis
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
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 Ex...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2023
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT05194839
Start Date
January 5 2022
End Date
March 6 2023
Last Update
June 29 2023
Active Locations (51)
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1
Total Skin & Beauty Dermatology Center, PC
Birmingham, Alabama, United States, 35205
2
Dermatology Trial Associates
Bryant, Arkansas, United States, 72022
3
Cosmetic Laser Dermatology
San Diego, California, United States, 92121
4
Clinical Science Institute
Santa Monica, California, United States, 90404