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

Phase 2

Completed

• Conditions: Hidradenitis Suppurativa
• Interventions: Drug: ATI-450; Drug: Placebo oral tablet

• Registration Number: NCT05216224
• Lead Sponsor: Aclaris Therapeutics, Inc.

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).

Study Timeline

• Study Start: 2021-12-29
• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-01-31
• Primary Completion: 2022-12-23
• Study Completion: 2023-01-24
• Status Verified: 2023-12
• Disposition First Submitted: 2023-12-20
• Last Update Submitted: 2023-12-20
• Disposition First Posted: 2023-12-22
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

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

• Patient has a history of active skin disease other than HS that could interfere with the assessment of HS.
• Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results, e.g., previous malignancy, previous venous thromboembolism.
• Patient 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATI-450	ATI-450	ATI-450 50mg oral tablet BID
Placebo	Placebo oral tablet	Placebo oral tablet BID

Primary Outcome Measures

Name	Time	Method
Efficacy measured as the change from Baseline in inflammatory nodule/abscess count at Week 12.	Baseline through Week 12.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.	Baseline through Week 12.
Change from Baseline in Dermatology Life Quality Index (DLQI) over time for the 12-week treatment period	Baseline through Week 12.
Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) over time for the 12-week treatment period.	Baseline through Week 12.
Percentage of patients achieving at least a 30% reduction and at least 1 unit reduction from Baseline in the numerical rating scale (NRS30) in Patient's Global Assessment of Skin Pain at Week 12 among patients with Baseline NRS ≥3.	Baseline through Week 12.
Change from Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HSPGA) over time for the 12-week treatment period	Baseline through Week 12.
Incidence of adverse events (AEs), serious AEs (SAEs), laboratory value abnormalities, electrocardiogram (ECG) abnormalities, vital signs abnormalities	Baseline through Week 12.
To assess trough and 2 hour concentrations of ATI-450 and its metabolite	Day 1, 8, and 85

Trial Locations

Locations (1)

Aclaris Investigational Site; 🇺🇸 Sugar Land, Texas, United States