A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

NCT ID: NCT03988335

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-13
• Study Completion Date: 2019-11-19

Brief Summary

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

Conditions

Palmoplantar Pustulosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RIST4721

RIST4721 as once-daily 300mg oral solution for 28 days.

Group Type: EXPERIMENTAL

RIST4721

Intervention Type: DRUG

RIST4721 oral solution

Placebo

Placebo as once-daily 300mg oral solution for 28 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo oral solution

Interventions

RIST4721

RIST4721 oral solution

Intervention Type: DRUG

Placebo

Placebo oral solution

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristea Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Brunswick Dermatology Center

Fredericton, New Brunswick, Canada

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, Canada

Dr. Lyne Giroux Medicine Professional Corporation

Greater Sudbury, Ontario, Canada

Lynderm Research Inc.

Markham, Ontario, Canada

North Bay Dermatology Centre

North Bay, Ontario, Canada

York Dermatology Center

Richmond Hill, Ontario, Canada

Innovaderm Research Inc.

Montreal, Quebec, Canada

Dre Angelique Gagne-Henley MD Inc.

Saint-Jérôme, Quebec, Canada

Fachklinik Bad Bentheim

Bad Bentheim, , Germany

Rothhaar Studien GmbH

Berlin, , Germany

Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus

Bochum, , Germany

MensingDerma research GmbH

Hamburg, , Germany

Hautarztpraxis Dr. Wilfried Steinborn

Straubing, , Germany

Countries

Canada; Germany

References

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.

Reference Type: DERIVED

PMID: 34716902 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://link.springer.com/content/pdf/10.1007/s13555-021-00632-7.pdf

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

Other Identifiers

RIST4721-201

Identifier Type: -

Identifier Source: org_study_id