A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)

May 18, 2023 updated by: Aristea Therapeutics, Inc.

A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Hidradenitis Suppurativa

A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Hidradenitis Suppurativa

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 0C6
        • Enverus Medical Research
    • Ontario
      • Cobourg, Ontario, Canada, K9A 0Z4
        • Skin Health
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Cahaba Dermatology & Skin Center
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Investigate MD, LLC
    • California
      • Los Angeles, California, United States, 90033
        • USC IDS Pharmacy
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Florida Academic Centers Research and Education, LLC
      • Tampa, Florida, United States, 33613
        • Forcare Clinical Research
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center, P.C.
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Ohio
      • Fairborn, Ohio, United States, 45324
        • Wright State Physicians
    • Texas
      • San Antonio, Texas, United States, 78213
        • Progressive Clinical Research
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of HS for at least 1 year prior to screening
  • HS lesions must be present in at least 2 distinct anatomic areas
  • A total AN count (sum of abscesses and inflammatory nodules) > 6 across all anatomical sites at both the screening and baseline visits
  • Willing to use contraception for the duration of the study

Exclusion Criteria:

  • Presence of other skin conditions which may interfere with study assessments
  • Presence of active, chronic or latent bacterial, viral, fungal mycobacterial infection (including latent TB) or history of infection within 4 weeks of screening
  • Body Mass Index (BMI) >48kg/m2
  • Breastfeeding or pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of TEAEs
Time Frame: Baseline to Week 12 (or end of study participation)
Baseline to Week 12 (or end of study participation)
Incidence of SAEs
Time Frame: Baseline to Week 12 (or end of study participation)
Baseline to Week 12 (or end of study participation)

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Subjects Achieving HiSCR50 at Week 12
Time Frame: Baseline to Week 12
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristea Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIST4721-221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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