ATI-450 vs Placebo in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
NCT ID: NCT05216224
Last Updated: 2026-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
95 participants
INTERVENTIONAL
2021-12-29
2023-01-24
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
QUADRUPLE
Study Groups
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ATI-450
ATI-450 50 milligrams (mg) oral tablet twice daily (BID)
ATI-450
Oral, small molecule MK2 inhibitor
Placebo
Placebo oral tablet BID
Placebo oral tablet
Placebo tablet manufactured to match ATI-450 in appearance
Interventions
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ATI-450
Oral, small molecule MK2 inhibitor
Placebo oral tablet
Placebo tablet manufactured to match ATI-450 in appearance
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant must have stable HS.
* Total abscesses and/or nodule (AN) count of ≥5 at Baseline visit.
* HS lesions present in at least 2 distinct anatomical areas at Screening and Baseline.
Exclusion Criteria
* Participant has an uncontrolled non-immunoinflammatory disease that may place the participant at increased risk during the study or impact the interpretation of results, e.g., previous malignancy, previous venous thromboembolism.
* Participant has experience with \>2 biologics, \>1 Janus kinase (JAK) inhibitor, or a combination of 1 biologic experience and 1 JAK inhibitor.
* Are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of the Screening visit.
18 Years
70 Years
ALL
No
Sponsors
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Aclaris Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ajay Aggarwal
Role: STUDY_DIRECTOR
Aclaris Therapeutics, Inc.
Locations
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Aclaris Investigational Site
Birmingham, Alabama, United States
Aclaris Investigational Site
Fort Smith, Arkansas, United States
Aclaris Investigational Site
Encino, California, United States
Aclaris Investigational Site
San Francisco, California, United States
Aclaris Investigational Site
Thousand Oaks, California, United States
Aclaris Investigational Site
Boca Raton, Florida, United States
Aclaris Investigational Site
Hollywood, Florida, United States
Aclaris Investigational Site
Tampa, Florida, United States
Aclaris Investigational Site
Marietta, Georgia, United States
Aclaris Investigational Site
Sandy Springs, Georgia, United States
Aclaris Investigational Site
Metairie, Louisiana, United States
Aclaris Investigational Site
Fort Gratiot, Michigan, United States
Aclaris Investigational Site
Charlotte, North Carolina, United States
Aclaris Investigational Site
Athens, Ohio, United States
Aclaris Investigational Site
Mason, Ohio, United States
Aclaris Investigational Site
Hershey, Pennsylvania, United States
Aclaris Investigational Site
Anderson, South Carolina, United States
Aclaris Investigational Site
Nashville, Tennessee, United States
Aclaris Investigational Site
Houston, Texas, United States
Aclaris Investigational Site
Sugar Land, Texas, United States
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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ATI-450-HS-201
Identifier Type: -
Identifier Source: org_study_id
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