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

Aclaris Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Placebo oral tablet; Drug: ATI-450

Study type: Interventional

Funder types: Industry

Identifiers

NCT05216224

ATI-450-HS-201

Details and patient eligibility

About

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).

Enrollment: 95 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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95 participants in 2 patient groups

ATI-450

Experimental group

Description:

ATI-450 50 milligrams (mg) oral tablet twice daily (BID)

Treatment:

Drug: ATI-450

Placebo

Experimental group

Description:

Placebo oral tablet BID

Treatment:

Drug: Placebo oral tablet