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Trial record 1 of 1 for:    NCT05194839
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A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

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ClinicalTrials.gov Identifier: NCT05194839
Recruitment Status : Recruiting
First Posted : January 18, 2022
Last Update Posted : May 9, 2022
Sponsor:
Information provided by (Responsible Party):
Aristea Therapeutics, Inc.

Study Description
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Brief Summary:
A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 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, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Palmoplantar Pustulosis
Actual Study Start Date : January 5, 2022
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RIST4721 400 mg
RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
 Drug: RIST4721
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
Experimental: RIST4721 200 mg
RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks
 Drug: RIST4721
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets

Drug: Placebo
Matching placebo
Placebo Comparator: Placebo
Placebo: 4 placebo tablets once daily for 12 weeks
 Drug: Placebo
Matching placebo


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects achieving a 50% reduction in PPPASI score [ Time Frame: Baseline to Week 12 ]

Secondary Outcome Measures :
  1. Absolute change from baseline in PPPGA [ Time Frame: Baseline to Week 12 ]
  2. Absolute change from baseline in PPPASI [ Time Frame: Baseline to Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 6 months history of moderate or severe PPP, as defined by PPPASI ≥12 and PPPGA ≥3 at screening
  • Males and females must be willing to use birth control as indicated

Exclusion Criteria:

  • Moderate to severe psoriasis covering ≥10% of total body surface area (BSA) at screening
  • Breastfeeding or pregnant
  • Known immunodeficiency or subject is immunocompromised
  • Active/latent infection with HBV, HCV, HIV, SARS-CoV-2 or TB
  • Any topical medications for PPP excluding emollients within two weeks of randomization and systemic therapies (including phototherapy) within 4 weeks of randomization
Contacts and Locations
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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): NCT05194839


Contacts
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Contact: Aristea Therapeutics 858-465-6142 info@aristeatx.com

Locations
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Sponsors and Collaborators
Aristea Therapeutics, Inc.
More Information
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Responsible Party: Aristea Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05194839    
Other Study ID Numbers: RIST4721-202
First Posted: January 18, 2022    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases