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
1 other identifier
interventional
35
2 countries
17
Brief Summary
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2019
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 13, 2019
CompletedFirst Submitted
Initial submission to the registry
June 13, 2019
CompletedFirst Posted
Study publicly available on registry
June 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2019
CompletedResults Posted
Study results publicly available
March 3, 2022
CompletedApril 5, 2022
March 1, 2022
9 months
June 13, 2019
November 1, 2021
March 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
RIST4721
EXPERIMENTALRIST4721 as once-daily 300mg oral solution for 28 days.
Placebo
PLACEBO COMPARATORPlacebo as once-daily 300mg oral solution for 28 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Kirk Barber Research
Calgary, Alberta, T2G 1B1, Canada
Alberta DermaSurgery Centre
Edmonton, Alberta, T6G 1C3, Canada
CARe Clinic (Central Alberta Research Clinic)
Red Deer, Alberta, T4N 6V7, Canada
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2, Canada
Brunswick Dermatology Center
Fredericton, New Brunswick, E3B 1G9, Canada
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1, Canada
Dr. Lyne Giroux Medicine Professional Corporation
Greater Sudbury, Ontario, P3A 1W8, Canada
Lynderm Research Inc.
Markham, Ontario, L3P 1X2, Canada
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7, Canada
York Dermatology Center
Richmond Hill, Ontario, L4C 9M7, Canada
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1, Canada
Dre Angelique Gagne-Henley MD Inc.
Saint-Jérôme, Quebec, J7Z 3B8, Canada
Fachklinik Bad Bentheim
Bad Bentheim, 48455, Germany
Rothhaar Studien GmbH
Berlin, 10783, Germany
Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus
Bochum, 44793, Germany
MensingDerma research GmbH
Hamburg, 22391, Germany
Hautarztpraxis Dr. Wilfried Steinborn
Straubing, 94315, Germany
Related Publications (1)
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.
PMID: 34716902DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Aristea Therapeutics
- Organization
- Aristea Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2019
First Posted
June 17, 2019
Study Start
February 13, 2019
Primary Completion
November 5, 2019
Study Completion
November 19, 2019
Last Updated
April 5, 2022
Results First Posted
March 3, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share