Clinical trial NCT03988335: A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Palmoplantar Pustulosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Palmoplantar Pustulosis
Keywords: PPP
Lead sponsor: Aristea Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline
timeFrame: Baseline to Day 28
measure: Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline
timeFrame: Baseline to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre
state: Alberta
city: Red Deer
country: Canada
facility: CARe Clinic (Central Alberta Research Clinic)
state: Alberta
city: Winnipeg
country: Canada
facility: Winnipeg Clinic
state: Manitoba
city: Fredericton
country: Canada
facility: Brunswick Dermatology Center
state: New Brunswick
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Center
state: Ontario
city: Sudbury
country: Canada
facility: Dr. Lyne Giroux Medicine Professional Corporation
state: Ontario
city: Montréal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: St-Jérôme
country: Canada
facility: Dre Angelique Gagne-Henley MD Inc.
state: Quebec
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: Rothhaar Studien GmbH
city: Bochum
country: Germany
facility: Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus
city: Hamburg
country: Germany
facility: MensingDerma research GmbH
city: Straubing
country: Germany
facility: Hautarztpraxis Dr. Wilfried Steinborn
Study officials:
References:
citation: 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.