A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)
- Registration Number
- NCT05348681
- Lead Sponsor
- Aristea Therapeutics, Inc.
- Brief Summary
A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Hidradenitis Suppurativa
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo: 4 placebo tablets once daily for 12 weeks RIST4721 400 mg RIST4721 RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Incidence of TEAEs Baseline to Week 12 (or end of study participation) Incidence of SAEs Baseline to Week 12 (or end of study participation)
- Secondary Outcome Measures
Name Time Method Proportion of Subjects Achieving HiSCR50 at Week 12 Baseline to Week 12
Related Research Topics
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Trial Locations
- Locations (12)
Cahaba Dermatology & Skin Center
🇺🇸Birmingham, Alabama, United States
Investigate MD, LLC
🇺🇸Scottsdale, Arizona, United States
USC IDS Pharmacy
🇺🇸Los Angeles, California, United States
Florida Academic Centers Research and Education, LLC
🇺🇸Coral Gables, Florida, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
The Indiana Clinical Trials Center, P.C.
🇺🇸Plainfield, Indiana, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Wright State Physicians
🇺🇸Fairborn, Ohio, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
Scroll for more (2 remaining)Cahaba Dermatology & Skin Center🇺🇸Birmingham, Alabama, United States