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ACTIVE NOT RECRUITING

NCT07011706

PHASE2

ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic Dermatitis

Sponsor: Aclaris Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2025-05-30

Completion Date

2026-10

Last Updated

2026-03-25

Healthy Volunteers

Conditions

Atopic Dermatitis Atopic Dermatitis AD Eczema

Interventions

DRUG

ATI-045

ATI-045 group

DRUG

Placebo

Placebo group

Inclusion Criteria: * 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 Exclusion Criteria: * Treatment with any of the following: 1. Intravenous immunoglobulin within 12 weeks prior to the baseline visit (W0D1) 2. Systemic antibiotics within 2 weeks prior to the baseline visit (W0D1) 3. Topical antibiotics within 1 week prior the baseline visit (W0D1) 4. Topical medicated treatment that could affect atopic dermatitis should be prohibited for at least 2 weeks prior to baseline visit. Example: topical corticosteroids, crisaborole, calcineurin inhibitors, ruxolitinib, roflumilast, tars, antimicrobials, medical devices, and bleach baths. 5. Topical products containing urea within 1 week prior to baseline visit (W0D1) 6. Doxepin, hydroxyzine, or diphenhydramine within 1 week prior to the baseline visit (W0D1) 7. Patient has used systemic treatments (other than biologics) that could affect AD less than 4 weeks or 5 half-lives (whichever is longer) prior to the baseline visit (W0D1), including, but not limited to, retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine, oral/injectable corticosteroids, baricitinib, upadacitinib, and abrocitinib. 8. Biologics for AD treatments (such as dupilumab, tralokinumab, lebrikizumab, investigational biologics) within 5 half- lives or 12 weeks, whichever is longer prior to the baseline visit (W0D1) 9. An investigational drug (non-biologic) within 4 weeks or within 5 half-lives (if known), whichever is longer prior to the baseline visit (W0D1) 10. Phototherapy and photochemotherapy for AD within 4 weeks prior to the baseline visit (W0D1) 11. A live (attenuated) vaccine within 12 weeks prior to the baseline visit (W0D1) * History of anaphylaxis following biologic therapy. * History of allergy to corticosteroids, diphenhydramine, hydroxyzine, cetirizine, or fexofenadine.

Locations (60)

Aclaris Clinical Site

Phoenix, Arizona, United States

Aclaris Clinical Site

Tucson, Arizona, United States

Aclaris Study Site

Bryant, Arkansas, United States

Aclaris Clinical Site

Beverly Hills, California, United States

Aclaris Study Site

Encinitas, California, United States

Aclaris Clinical Site

Encino, California, United States

Aclaris Clinical Site

Huntington Beach, California, United States

Aclaris Study Site

Los Angeles, California, United States

Aclaris Study Site

Oceanside, California, United States

Aclaris Study Site

Santa Monica, California, United States

Aclaris Clinical Site

Sherman Oaks, California, United States

Aclaris Clinical Site

Thousand Oaks, California, United States

Aclaris Study Site

Coral Gables, Florida, United States

Aclaris Clinical Site

Hollywood, Florida, United States

Aclaris Clinical Site

Jacksonville, Florida, United States

Aclaris Clinical Site

Margate, Florida, United States

Aclaris Study Site

North Miami Beach, Florida, United States

Aclaris Study Site

Sweetwater, Florida, United States

Aclaris Study Site

Tampa, Florida, United States

Aclaris Clinical Site

Wellington, Florida, United States

Aclaris Clinical Site

Atlanta, Georgia, United States

Aclaris Clinical Site

Savannah, Georgia, United States

Aclaris Study Site

Boise, Idaho, United States

Aclaris Study Site

Clarksville, Indiana, United States

Aclaris Study Site

Indianapolis, Indiana, United States

Aclaris Clinical Site

Lafayette, Indiana, United States

Aclaris Study Site

West Lafayette, Indiana, United States

Aclaris Study Site

Bowling Green, Kentucky, United States

Aclaris Clinical Site

Ann Arbor, Michigan, United States

Aclaris Study Site

Auburn Hills, Michigan, United States

Aclaris Clinical Site

Troy, Michigan, United States

Aclaris Clinical Site

Ridgeland, Mississippi, United States

Aclaris Study Site

Saint Joseph, Missouri, United States

Aclaris Clinical Site

Missoula, Montana, United States

Aclaris Study Site

New York, New York, United States

Aclaris Study Site

New York, New York, United States

Aclaris Clinical Site

New York, New York, United States

Aclaris Clinical Site

The Bronx, New York, United States

Aclaris Clinical Site

Cary, North Carolina, United States

Aclaris Clinical Site

Wilmington, North Carolina, United States

Aclaris Study Site

Camp Hill, Pennsylvania, United States

Aclaris Clinical Site

Philadelphia, Pennsylvania, United States

Aclaris Clinical Site

Myrtle Beach, South Carolina, United States

Aclaris Clinical Site

Dallas, Texas, United States

Aclaris Clinical Site

Houston, Texas, United States

Aclaris Study Site

San Antonio, Texas, United States

Aclaris Study Site

San Antonio, Texas, United States

Aclaris Clinical Site

The Woodlands, Texas, United States

Aclaris Study Site

Webster, Texas, United States

Aclaris Clinical Site

Providence, Utah, United States

Aclaris Study Site

Norfolk, Virginia, United States

Aclaris Clinical Site

Seattle, Washington, United States

Aclaris Clinical Site

Spokane, Washington, United States

Aclaris Clinical Site

Barrie, Ontario, Canada

Aclaris Site

Markham, Ontario, Canada

Aclaris Site

Mississauga, Ontario, Canada

Aclaris Site

Richmond Hill, Ontario, Canada

Aclaris Clinical Site

Toronto, Ontario, Canada

Aclaris Site

Toronto, Ontario, Canada

Aclaris Clinical Site

Montreal, Quebec, Canada

Clinical Research Directory

ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic Dermatitis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (60)