A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)

Hidradenitis Suppurativa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05348681
• Other study ID #: RIST4721-221
• Status: Terminated
• Phase: Phase 2
• Start date: July 18, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2023
• Source: Aristea Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• RIST4721
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
• Placebo
Matching placebo

Locations

Country	Name	City	State
Canada	SKiN Health	Cobourg	Ontario
Canada	Enverus Medical Research	Surrey	British Columbia
United States	Cahaba Dermatology & Skin Center	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Florida Academic Centers Research and Education, LLC	Coral Gables	Florida
United States	Wright State Physicians	Fairborn	Ohio
United States	USC IDS Pharmacy	Los Angeles	California
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	The Indiana Clinical Trials Center, P.C.	Plainfield	Indiana
United States	Progressive Clinical Research	San Antonio	Texas
United States	Investigate MD, LLC	Scottsdale	Arizona
United States	ForCare Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Aristea Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of TEAEs		Baseline to Week 12 (or end of study participation)
Primary	Incidence of SAEs		Baseline to Week 12 (or end of study participation)
Secondary	Proportion of Subjects Achieving HiSCR50 at Week 12		Baseline to Week 12