A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ATI-450 vs Placebo in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Overview
- Phase
- Phase 2
- Intervention
- ATI-450
- Conditions
- Hidradenitis Suppurativa
- Sponsor
- Aclaris Therapeutics, Inc.
- Enrollment
- 95
- Locations
- 20
- Primary Endpoint
- Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 12
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
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).
Detailed Description
This is a Phase 2a, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 vs placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).
Investigators
Eligibility Criteria
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.
Arms & Interventions
ATI-450
ATI-450 50 milligrams (mg) oral tablet twice daily (BID)
Intervention: ATI-450
Placebo
Placebo oral tablet BID
Intervention: Placebo oral tablet
Outcomes
Primary Outcomes
Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 12
Time Frame: Baseline, Week 12
AN count was the sum of number of abscess and inflammatory nodules across anatomical regions. The least square (LS) mean change from baseline in the count at Week 12 was estimated from the Mixed Model Repeated Measures (MMRM) model.
Secondary Outcomes
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 12(Week 12)
- Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) at Week 12(Baseline, Week 12)
- Percentage of Participants Achieving NRS30(Week 12)
- Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HSPGA) at Week 12(Baseline, Week 12)
- Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12(Baseline, Week 12)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Baseline through Day 115)
- ATI-450 and Metabolite (CDD-2164) Concentrations(2 hours postdose on Days 1, 8, and 85)