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

Hidradenitis Suppurativa Clinical Trial

Official title:

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 HS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05216224
• Other study ID #: ATI-450-HS-201
• Status: Completed
• Phase: Phase 2
• Start date: December 29, 2021
• Est. completion date: January 24, 2023

Study information

• Verified date: December 2023
• Source: Aclaris Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 24, 2023
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• ATI-450
Oral, small molecule MK2 inhibitor
• Placebo oral tablet
Placebo tablet manufactured to match ATI-450 in appearance

Locations

Country	Name	City	State
United States	Aclaris Investigational Site	Anderson	South Carolina
United States	Aclaris Investigational Site	Athens	Ohio
United States	Aclaris Investigational Site	Birmingham	Alabama
United States	Aclaris Investigational Site	Boca Raton	Florida
United States	Aclaris Investigational Site	Charlotte	North Carolina
United States	Aclaris Investigational Site	Encino	California
United States	Aclaris Investigational Site	Fort Gratiot	Michigan
United States	Aclaris Investigational Site	Fort Smith	Arkansas
United States	Aclaris Investigational Site	Hershey	Pennsylvania
United States	Aclaris Investigational Site	Hollywood	Florida
United States	Aclaris Investigational Site	Houston	Texas
United States	Aclaris Investigational Site	Marietta	Georgia
United States	Aclaris Investigational Site	Mason	Ohio
United States	Aclaris Investigational Site	Metairie	Louisiana
United States	Aclaris Investigational Site	Nashville	Tennessee
United States	Aclaris Investigational Site	San Francisco	California
United States	Aclaris Investigational Site	Sandy Springs	Georgia
United States	Aclaris Investigational Site	Sugar Land	Texas
United States	Aclaris Investigational Site	Tampa	Florida
United States	Aclaris Investigational Site	Thousand Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Aclaris Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy measured as the change from Baseline in inflammatory nodule/abscess count at Week 12.		Baseline through Week 12.
Secondary	Percentage of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.		Baseline through Week 12.
Secondary	Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) over time for the 12-week treatment period.		Baseline through Week 12.
Secondary	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.
Secondary	Change from Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HSPGA) over time for the 12-week treatment period		Baseline through Week 12.
Secondary	Change from Baseline in Dermatology Life Quality Index (DLQI) over time for the 12-week treatment period		Baseline through Week 12.
Secondary	Incidence of adverse events (AEs), serious AEs (SAEs), laboratory value abnormalities, electrocardiogram (ECG) abnormalities, vital signs abnormalities		Baseline through Week 12.
Secondary	To assess trough and 2 hour concentrations of ATI-450 and its metabolite		Day 1, 8, and 85