RIST4721 in Subjects with Palmoplantar Pustulosis
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
IRAS ID
1006173
Contact name
Sara McCutchan
Contact email
Sponsor organisation
Aristea Therapeutics Inc.
Eudract number
2021-003029-31
Clinicaltrials.gov Identifier
Research summary
Aristea Therapeutics, Inc. is a company who is developing a drug called RIST4721 for the treatment of moderate to severer palmoplantar pustulosis (PPP). PPP is a chronic inflammatory skin condition characterised by the appearance of fluid-filled pustules or blisters on the hands and feet. It is a rare disease.
RIST4721 has been shown to block a certain protein that is involved in serious inflammatory diseases, including PPP. The purpose of this study is to test whether RIST4721 is effective and safe in the treatment of moderate to severe PPP at multiple oral doses.
The study consists of two parts. In part A, participants will receive either 200 mg of RIST4721, 400 mg of RIST4721, or placebo, in tablet form. The tablets will be taken once a day for 12 weeks. In part B, all participants will receive 400 mg of RIST4721 for up to an additional 72 weeks. Participants can take part in just Part A, or Parts A and B.
About 156 participants from approximately 55 study sites from the UK, the EU, Canada and the USA will participate in this study.
REC name
London - Central Research Ethics Committee
REC reference
22/LO/0570
Date of REC Opinion
12 Oct 2022
REC opinion
Further Information Favourable Opinion