Hidradenitis Suppurativa
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Hidradenitis Suppurativa
RIST4721-221 Enrolling

Hidradenitis Suppurativa Clinical Research Trial (20 Weeks)


Treatment: Oral Age: 18 Years

Adults aged 18 or over with a diagnosis of hidradenitis suppurativa (HS) for at least 1 year, may qualify to participate. Individuals must have HS lesions present in at least 2 distinct anatomic areas of the body. Moderate-to-severe disease must also be present, defined as a total abscess and inflammatory nodule (AN) count of 6 or more. In addition, participants must have an inadequate response to a course of at least 3-months of a systemic antibiotic treatment or demonstrate intolerance to oral antibiotic treatment.

Participants will receive investigational oral medication (active study drug) or placebo. Study medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.

Total study duration lasts about 20 weeks and involves about 7 visits to the study centre.


The following information is from ClinicalTrials.gov

Last Update Posted: October 02, 2022

Official Title

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

ClinicalTrials.gov ID

NCT05348681

Sponsor

Aristea Therapeutics, Inc.

Study Description

  • Brief Summary:

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

  • Condition or Disease:

    Hidradenitis Suppurativa

  • Intervention/Treatment:

    Drug: RIST4721
    Drug: Placebo
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

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


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
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Australia

Participating Experts

Dr. Peter Foley

Dermatologist

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