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
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
Condition or Disease:
Ages Eligible for Study:
18 Years and older (Adult)
Sexes Eligible for Study:
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
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.