ATI-450 vs Placebo in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)

Completed · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

This is a Phase 2a study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 vs placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).

Key facts

Study ID

NCT05216224

Run by

Aclaris Therapeutics, Inc.

People needed

95

Starts

2021-12-29

Expected to finish

2023-01-24

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to comprehend and be willing to sign the Institutional Review Board (IRB)-approved participant informed consent form prior to administration of any study-related procedures.
• 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.

You may not qualify if…

• Participant has a history of active skin disease other than HS that could interfere with the assessment of HS.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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