A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)

Phase 2

Terminated

• Conditions: Hidradenitis Suppurativa
• Interventions: Drug: Placebo; Drug: RIST4721

• 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

Study Timeline

• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-27
• Study Start: 2022-07-18
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-05
• Results First Submitted: 2023-05-18
• Results First Submitted QC: 2023-05-18
• Last Update Submitted: 2023-05-18
• Results First Posted: 2023-06-13
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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 & 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

Trial Locations

Locations (12)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Florida Academic Centers Research and Education, LLC; 🇺🇸 Coral Gables, Florida, United States

USC IDS Pharmacy; 🇺🇸 Los Angeles, California, United States

The Indiana Clinical Trials Center, P.C.; 🇺🇸 Plainfield, Indiana, United States

Wright State Physicians; 🇺🇸 Fairborn, Ohio, United States

Virginia Clinical Research, Inc.; 🇺🇸 Norfolk, Virginia, United States

SKiN Health; 🇨🇦 Cobourg, Ontario, Canada

Enverus Medical Research; 🇨🇦 Surrey, British Columbia, Canada

Investigate MD, LLC; 🇺🇸 Scottsdale, Arizona, United States

Cahaba Dermatology & Skin Center; 🇺🇸 Birmingham, Alabama, United States

ForCare Clinical Research; 🇺🇸 Tampa, Florida, United States

Progressive Clinical Research; 🇺🇸 San Antonio, Texas, United States