ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT07011706
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
96 participants
INTERVENTIONAL
2025-05-30
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ATI-045 group
ATI-045 group
ATI-045
ATI-045 group
Placebo group
Placebo group
Placebo
Placebo group
Interventions
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ATI-045
ATI-045 group
Placebo
Placebo group
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
70 Years
ALL
No
Sponsors
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Aclaris Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
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
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 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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ATI-045-AD-201
Identifier Type: -
Identifier Source: org_study_id
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