A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ATI-045 in Patients With Moderate-to-Severe Atopic Dermatitis

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study evaluates ATI-045 versus placebo in patients with Moderate-to-Severe Atopic Dermatitis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Diagnosis of chronic atopic dermatitis that has been present for ≥ 6 months before the screening visit and with no significant AD flares during the past 4 weeks before screening

• Have active moderate to severe AD at screening and baseline visits

• EASI score ≥ 16 and ≥10% BSA at the screening and baseline visits

• History of inadequate response to treatment for AD with topical medications; or determination that topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks)

• Patient applied a stable dose of non-medicated topical moisturizer (ideally once or twice daily) for ≥ 7 days prior to the baseline visit and agrees to continue use during study

Locations
United States
Arkansas
Aclaris Study Site
RECRUITING
Bryant
California
Aclaris Study Site
RECRUITING
Encinitas
Aclaris Study Site
RECRUITING
Los Angeles
Aclaris Study Site
RECRUITING
Oceanside
Aclaris Study Site
RECRUITING
Santa Monica
Florida
Aclaris Study Site
RECRUITING
Coral Gables
Aclaris Study Site
RECRUITING
North Miami Beach
Aclaris Study Site
RECRUITING
Sweetwater
Aclaris Study Site
RECRUITING
Tampa
Indiana
Aclaris Study Site
RECRUITING
Clarksville
Aclaris Study Site
RECRUITING
Indianapolis
Kentucky
Aclaris Study Site
RECRUITING
Bowling Green
Michigan
Aclaris Study Site
RECRUITING
Auburn Hills
Missouri
Aclaris Study Site
RECRUITING
Saint Joseph
North Carolina
Aclaris Clinical Site
RECRUITING
Cary
New York
Aclaris Study Site
RECRUITING
New York
Aclaris Study Site
RECRUITING
New York
Texas
Aclaris Study Site
RECRUITING
San Antonio
Aclaris Study Site
RECRUITING
San Antonio
Virginia
Aclaris Study Site
ACTIVE_NOT_RECRUITING
Norfolk
Other Locations
Canada
Aclaris Site
RECRUITING
Markham
Aclaris Site
RECRUITING
Mississauga
Aclaris Site
RECRUITING
Richmond Hill
Aclaris Site
RECRUITING
Toronto
Contact Information
Primary
Aclaris Clinical Operations
clintrials@aclaristx.com
(484) 324-7933
Time Frame
Start Date: 2025-05-30
Estimated Completion Date: 2026-10
Participants
Target number of participants: 96
Treatments
Experimental: ATI-045 group
ATI-045 group
Placebo_comparator: Placebo group
Placebo group
Related Therapeutic Areas
Sponsors
Leads: Aclaris Therapeutics, Inc.

This content was sourced from clinicaltrials.gov