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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis, Atopic, Dermatitis, AD, Eczema

In brief

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

Key facts

Study ID

NCT07011706

Run by

Aclaris Therapeutics, Inc.

People needed

110

Starts

2025-05-30

Expected to finish

2026-10-01

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Treatment with any of the following:
• Intravenous immunoglobulin within 12 weeks prior to the baseline visit (W0D1)
• Systemic antibiotics within 2 weeks prior to the baseline visit (W0D1)
• Topical antibiotics within 1 week prior the baseline visit (W0D1)
• 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.
• Topical products containing urea within 1 week prior to baseline visit (W0D1)
• Doxepin, hydroxyzine, or diphenhydramine within 1 week prior to the baseline visit (W0D1)
• 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.
• 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)
• An investigational drug (non-biologic) within 4 weeks or within 5 half-lives (if known), whichever is longer prior to the baseline visit (W0D1)
• Phototherapy and photochemotherapy for AD within 4 weeks prior to the baseline visit (W0D1)
• 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.

Where it is running

• 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 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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