A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)
NCT ID: NCT05348681
Last Updated: 2023-06-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
25 participants
INTERVENTIONAL
2022-07-18
2023-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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RIST4721 400 mg
RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
RIST4721
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
Placebo
Placebo: 4 placebo tablets once daily for 12 weeks
Placebo
Matching placebo
Interventions
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RIST4721
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
Placebo
Matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Aristea Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Enverus Medical Research
Surrey, British Columbia, Canada
SKiN Health
Cobourg, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RIST4721-221
Identifier Type: -
Identifier Source: org_study_id
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