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A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

Primary Purpose

Palmoplantar Pustulosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RIST4721
Placebo
Sponsored by
Aristea Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Palmoplantar Pustulosis focused on measuring PPP

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kirk Barber Research
  • Alberta DermaSurgery Centre
  • CARe Clinic (Central Alberta Research Clinic)
  • Winnipeg Clinic
  • Brunswick Dermatology Center
  • SimcoDerm Medical and Surgical Dermatology Center
  • Lynderm Research Inc.
  • North Bay Dermatology Centre
  • York Dermatology Center
  • Dr. Lyne Giroux Medicine Professional Corporation
  • Innovaderm Research Inc.
  • Dre Angelique Gagne-Henley MD Inc.
  • Fachklinik Bad Bentheim
  • Rothhaar Studien GmbH
  • Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus
  • MensingDerma research GmbH
  • Hautarztpraxis Dr. Wilfried Steinborn

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RIST4721

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline
Relative change from baseline in fresh pustule count at 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

Secondary Outcome Measures

Full Information

First Posted
June 13, 2019
Last Updated
March 8, 2022
Sponsor
Aristea Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03988335
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 13, 2019 (Actual)
Primary Completion Date
November 5, 2019 (Actual)
Study Completion Date
November 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aristea Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmoplantar Pustulosis
Keywords
PPP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIST4721
Arm Type
Experimental
Arm Description
RIST4721 as once-daily 300mg oral solution for 28 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo as once-daily 300mg oral solution for 28 days.
Intervention Type
Drug
Intervention Name(s)
RIST4721
Intervention Description
RIST4721 oral solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral solution
Primary Outcome Measure Information:
Title
Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline
Description
Relative change from baseline in fresh pustule count at Day 28
Time Frame
Baseline to Day 28
Title
Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline
Description
Relative change from baseline in total pustule count at Day 28
Time Frame
Baseline to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Kirk Barber Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
Country
Canada
Facility Name
Alberta DermaSurgery Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Facility Name
CARe Clinic (Central Alberta Research Clinic)
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Winnipeg Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
Brunswick Dermatology Center
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
SimcoDerm Medical and Surgical Dermatology Center
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
North Bay Dermatology Centre
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
York Dermatology Center
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 9M7
Country
Canada
Facility Name
Dr. Lyne Giroux Medicine Professional Corporation
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3A 1W8
Country
Canada
Facility Name
Innovaderm Research Inc.
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Facility Name
Dre Angelique Gagne-Henley MD Inc.
City
St-Jérôme
State/Province
Quebec
ZIP/Postal Code
J7Z 3B8
Country
Canada
Facility Name
Fachklinik Bad Bentheim
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Rothhaar Studien GmbH
City
Berlin
ZIP/Postal Code
10783
Country
Germany
Facility Name
Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus
City
Bochum
ZIP/Postal Code
44793
Country
Germany
Facility Name
MensingDerma research GmbH
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Hautarztpraxis Dr. Wilfried Steinborn
City
Straubing
ZIP/Postal Code
94315
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34716902
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.
Results Reference
derived
Links:
URL
http://link.springer.com/content/pdf/10.1007/s13555-021-00632-7.pdf
Description
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis

Learn more about this trial

A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

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