A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Palmoplantar Pustulosis

In brief

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.

Key facts

Study ID

NCT05194839

Run by

Aristea Therapeutics, Inc.

People needed

79

Starts

2022-01-05

Expected to finish

2023-03-06

Last updated by the study team

2023-06-29

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Great Lakes Research Group, Inc. — Bay City, Michigan, United States
• Washington University School of Medicine-Dermatology — St Louis, Missouri, United States
• Skin Specialists, PC (Schlessinger MD) — Omaha, Nebraska, United States
• ALLCUTIS Research, LLC. — Portsmouth, New Hampshire, United States
• Aventiv Research Inc. — Dublin, Ohio, United States
• Apex Clinical Research Center — Mayfield Heights, Ohio, United States
• Central Sooner Research — Norman, Oklahoma, United States
• UPMC Department of Dermatology — Pittsburgh, Pennsylvania, United States
• Dermatology Clinical Research Center of San Antonio — San Antonio, Texas, United States
• Alberta DermaSurgery Centre — Edmonton, Alberta, Canada
• Vida Dermatology — Edmonton, Alberta, Canada
• Central Alberta Research Clinic (CARe Clinic) — Red Deer, Alberta, Canada
• SimcoDerm Medical and Surgical — Barrie, Ontario, Canada
• Lynderm Research Inc. — Markham, Ontario, Canada
• Centre De Recherche Dermatologique Du Quebec Metropolitan Inc. — Québec, Canada
• Total Skin & Beauty Dermatology Center, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.