A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

Palmoplantar Pustulosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03988335
• Other study ID #: RIST4721-201
• Status: Completed
• Phase: Phase 2
• Start date: February 13, 2019
• Est. completion date: November 19, 2019

Study information

• Verified date: March 2022
• Source: Aristea Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 19, 2019
• Est. primary completion date: November 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Palmoplantar Pustulosis
• Psoriasis

Intervention

Drug:
• RIST4721
RIST4721 oral solution
• Placebo
Placebo oral solution

Locations

Country	Name	City	State
Canada	SimcoDerm Medical and Surgical Dermatology Center	Barrie	Ontario
Canada	Kirk Barber Research	Calgary	Alberta
Canada	Alberta DermaSurgery Centre	Edmonton	Alberta
Canada	Brunswick Dermatology Center	Fredericton	New Brunswick
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	Innovaderm Research Inc.	Montréal	Quebec
Canada	North Bay Dermatology Centre	North Bay	Ontario
Canada	CARe Clinic (Central Alberta Research Clinic)	Red Deer	Alberta
Canada	York Dermatology Center	Richmond Hill	Ontario
Canada	Dre Angelique Gagne-Henley MD Inc.	St-Jérôme	Quebec
Canada	Dr. Lyne Giroux Medicine Professional Corporation	Sudbury	Ontario
Canada	Winnipeg Clinic	Winnipeg	Manitoba
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Aristea Therapeutics, Inc.

Countries where clinical trial is conducted

Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

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