A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

Phase 2

Completed

• Conditions: Palmoplantar Pustulosis
• Interventions: Drug: RIST4721; Drug: Placebo

• Registration Number: NCT03988335
• Lead Sponsor: Aristea Therapeutics, Inc.

Brief Summary

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-13
• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-17
• Primary Completion: 2019-11-05
• Study Completion: 2019-11-19
• Results First Submitted: 2021-11-01
• Results First Submitted QC: 2021-12-10
• Status Verified: 2022-03
• Results First Posted: 2022-03-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• At least a 6-month history of PPP as defined by the presence of pustules on palms and/or soles, but without evidence of infection on palms and soles
• Moderate or severe PPP, as defined by Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) ≥8 and Palmoplantar Pustulosis Physician Global Assessment (PPPGA) ≥3 at Day -1, and a minimum of 8 fresh pustules at screening (fresh pustule count on both right/left palms and soles) and 20 fresh pustules at Day -1 (fresh pustule count on both right/left palms and soles)
• Males and females must be willing to use birth control as indicated

Exclusion Criteria

• Moderate to severe psoriasis, as defined by plaque psoriasis covering ≥10% of total Body Surface Area (BSA) at Day -1
• Subject is known to have an immune deficiency or is immunocompromised
• Positive test for hepatitis, human immunodeficiency virus (HIV) or tuberculosis
• Use of topical therapies for PPP within 2 weeks of Day -1 and/or systemic therapies for PPP within 4 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIST4721	RIST4721	RIST4721 as once-daily 300mg oral solution for 28 days.
Placebo	Placebo	Placebo as once-daily 300mg oral solution for 28 days.

Primary Outcome Measures

Name	Time	Method
Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline	Baseline to Day 28	Relative change from baseline in fresh pustule count at Day 28
Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline	Baseline to Day 28	Relative change from baseline in total pustule count at Day 28

Trial Locations

Locations (17)

Brunswick Dermatology Center; 🇨🇦 Fredericton, New Brunswick, Canada

Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus; 🇩🇪 Bochum, Germany

Lynderm Research Inc.; 🇨🇦 Markham, Ontario, Canada

Hautarztpraxis Dr. Wilfried Steinborn; 🇩🇪 Straubing, Germany

Fachklinik Bad Bentheim; 🇩🇪 Bad Bentheim, Germany

SimcoDerm Medical and Surgical Dermatology Center; 🇨🇦 Barrie, Ontario, Canada

Dr. Lyne Giroux Medicine Professional Corporation; 🇨🇦 Sudbury, Ontario, Canada

Kirk Barber Research; 🇨🇦 Calgary, Alberta, Canada

Alberta DermaSurgery Centre; 🇨🇦 Edmonton, Alberta, Canada

CARe Clinic (Central Alberta Research Clinic); 🇨🇦 Red Deer, Alberta, Canada

Winnipeg Clinic; 🇨🇦 Winnipeg, Manitoba, Canada

Innovaderm Research Inc.; 🇨🇦 Montréal, Quebec, Canada

Dre Angelique Gagne-Henley MD Inc.; 🇨🇦 St-Jérôme, Quebec, Canada

North Bay Dermatology Centre; 🇨🇦 North Bay, Ontario, Canada

York Dermatology Center; 🇨🇦 Richmond Hill, Ontario, Canada

Rothhaar Studien GmbH; 🇩🇪 Berlin, Germany

MensingDerma research GmbH; 🇩🇪 Hamburg, Germany