A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)
Study Details
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 | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: RIST4721 400 mg RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks |
Drug: RIST4721
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
|
Placebo Comparator: Placebo Placebo: 4 placebo tablets once daily for 12 weeks |
Drug: Placebo
Matching placebo
|
Outcome Measures
Primary Outcome Measures
- Incidence of TEAEs and SAEs [Baseline to Week 12]
Secondary Outcome Measures
- Proportion of subjects achieving HiSCR50 at Week 12 [Baseline to Week 12]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cahaba Dermatology & Skin Center | Birmingham | Alabama | United States | 35244 |
2 | Investigate MD, LLC | Scottsdale | Arizona | United States | 85255 |
3 | Florida Academic Centers Research and Education, LLC | Coral Gables | Florida | United States | 33134 |
4 | Virginia Clinical Research, Inc. | Norfolk | Virginia | United States | 23502 |
5 | SKiN Health | Cobourg | Ontario | Canada | K9A 0Z4 |
Sponsors and Collaborators
- Aristea Therapeutics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RIST4721-221