TerminatedPhase 2

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

Stopped: Due to safety findings in ongoing Phase 2 trials.

United States79 participantsStarted 2022-01-05

Plain-language 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.

Who can participate

Age range18 Years – 74 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Proportion of Subjects Achieving a 50% Reduction in PPPASI Score

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT05194839

SponsorAristea Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-13

Results submitted2023-06-07

View on ClinicalTrials.gov More Palmoplantar Pustulosis trials