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A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03988335
Recruitment Status : Completed
First Posted : June 17, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Aristea Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Palmoplantar Pustulosis Drug: RIST4721 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Palmoplantar Pustulosis
Actual Study Start Date : February 13, 2019
Actual Primary Completion Date : November 5, 2019
Actual Study Completion Date : November 19, 2019


Arm Intervention/treatment
Experimental: RIST4721
RIST4721 as once-daily 300mg oral solution for 28 days.
Drug: RIST4721
RIST4721 oral solution

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




Primary Outcome Measures :
  1. Relative change in fresh pustule count [ Time Frame: Baseline to Day 28 ]
  2. Relative change in total pustule count [ Time Frame: Baseline to Day 28 ]

Secondary Outcome Measures :
  1. Absolute change in fresh pustule count [ Time Frame: Baseline to Day 28 ]
  2. Absolute change in total pustule count [ Time Frame: Baseline to Day 28 ]
  3. Proportion of subjects achieving at least a 50% reduction in fresh pustule count [ Time Frame: Baseline to Day 28 ]
  4. Proportion of subjects achieving at least a 50% reduction in total pustule count [ Time Frame: Baseline to Day 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988335


Locations
Show Show 17 study locations
Sponsors and Collaborators
Aristea Therapeutics, Inc.
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Responsible Party: Aristea Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03988335    
Other Study ID Numbers: RIST4721-201
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aristea Therapeutics, Inc.:
PPP
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases