A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

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

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

Study Overview

• Status: Completed
• Conditions: Palmoplantar Pustulosis
• Intervention / Treatment: Drug: Placebo; Drug: RIST4721

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2G 1B1
      • Kirk Barber Research
    • Edmonton, Alberta, Canada, T6G 1C3
      • Alberta Dermasurgery Centre
    • Red Deer, Alberta, Canada, T4N 6V7
      • CARe Clinic (Central Alberta Research Clinic)
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Winnipeg Clinic
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Brunswick Dermatology Center
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoDerm Medical and Surgical Dermatology Center
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc.
    • North Bay, Ontario, Canada, P1B 3Z7
      • North Bay Dermatology Centre
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • York Dermatology Center
    • Sudbury, Ontario, Canada, P3A 1W8
      • Dr. Lyne Giroux Medicine Professional Corporation
  • Quebec
    • Montréal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc.
    • St-Jérôme, Quebec, Canada, J7Z 3B8
      • Dre Angelique Gagne-Henley MD Inc.
• Germany
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim
  • Berlin, Germany, 10783
    • Rothhaar Studien GmbH
  • Bochum, Germany, 44793
    • Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus
  • Hamburg, Germany, 22391
    • MensingDerma research GmbH
  • Straubing, Germany, 94315
    • Hautarztpraxis Dr. Wilfried Steinborn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIST4721; RIST4721 as once-daily 300mg oral solution for 28 days.	Drug: RIST4721; RIST4721 oral solution
Placebo Comparator: Placebo; Placebo as once-daily 300mg oral solution for 28 days.	Drug: Placebo; Placebo oral solution

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aristea Therapeutics, Inc.

Publications and helpful links

General Publications

• Bissonnette R, Maari C, Tsianakas A, Reid D, McCutchan S, Baumgartner S, Mackay J, Bhakta N. A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis. Dermatol Ther (Heidelb). 2021 Dec;11(6):2179-2193. doi: 10.1007/s13555-021-00632-7. Epub 2021 Oct 30.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Actual): November 5, 2019
• Study Completion (Actual): November 19, 2019

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: PPP
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: RIST4721-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No