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

NCT07011706 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: ATI-045-AD-201
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 60

Brief Summary

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

Conditions

Atopic Dermatitis; Atopic; Dermatitis; AD; Eczema

Outcome Measures

Primary Outcomes (1)

• Percent Change in Eczema Area and Severity Index (EASI)

  Percent change from baseline in EASI score at Week 24

  Baseline to Week 24

Secondary Outcomes (7)

• Investigator Global Assessment (vIGA) treatment success (IGA-TS)

  Baseline to Week 24

• EASI reduction

  Baseline to Week 24

• Peak Pruritus Numerical Rating Scale (PP-NRS) score

  Baseline to Week 24

• PP-NRS improvement

  Baseline to Week 24

• Body Surface Area (BSA)

  Baseline to Week 24

Study Arms (2)

ATI-045 group

EXPERIMENTAL

ATI-045 group

Drug: ATI-045

Placebo group

PLACEBO COMPARATOR

Placebo group

Drug: Placebo

Interventions

ATI-045 DRUG

ATI-045 group

ATI-045 group

Placebo DRUG

Placebo group

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (60)

Aclaris Clinical Site

Phoenix, Arizona, 85008, United States

Location

Aclaris Clinical Site

Tucson, Arizona, 85704, United States

Location

Aclaris Study Site

Bryant, Arkansas, 71913, United States

Location

Aclaris Clinical Site

Beverly Hills, California, 90212, United States

Location

Aclaris Study Site

Encinitas, California, 92024, United States

Location

Aclaris Clinical Site

Encino, California, 91436, United States

Location

Aclaris Clinical Site

Huntington Beach, California, 92647, United States

Location

Aclaris Study Site

Los Angeles, California, 90045, United States

Location

Aclaris Study Site

Oceanside, California, 92056, United States

Location

Aclaris Study Site

Santa Monica, California, 90404, United States

Location

Aclaris Clinical Site

Sherman Oaks, California, 91403, United States

Location

Aclaris Clinical Site

Thousand Oaks, California, 91320, United States

Location

Aclaris Study Site

Coral Gables, Florida, 33134, United States

Location

Aclaris Clinical Site

Hollywood, Florida, 33486, United States

Location

Aclaris Clinical Site

Jacksonville, Florida, 32256, United States

Location

Aclaris Clinical Site

Margate, Florida, 33063, United States

Location

Aclaris Study Site

North Miami Beach, Florida, 33162, United States

Location

Aclaris Study Site

Sweetwater, Florida, 33172, United States

Location

Aclaris Study Site

Tampa, Florida, 33607, United States

Location

Aclaris Clinical Site

Wellington, Florida, 33449, United States

Location

Aclaris Clinical Site

Atlanta, Georgia, 30315, United States

Location

Aclaris Clinical Site

Savannah, Georgia, 31405, United States

Location

Aclaris Study Site

Boise, Idaho, 83706, United States

Location

Aclaris Study Site

Clarksville, Indiana, 47129, United States

Location

Aclaris Study Site

Indianapolis, Indiana, 46250, United States

Location

Aclaris Clinical Site

Lafayette, Indiana, 47906, United States

Location

Aclaris Study Site

West Lafayette, Indiana, 47906, United States

Location

Aclaris Study Site

Bowling Green, Kentucky, 42104, United States

Location

Aclaris Clinical Site

Ann Arbor, Michigan, 48103, United States

Location

Aclaris Study Site

Auburn Hills, Michigan, 48326, United States

Location

Aclaris Clinical Site

Troy, Michigan, 48084, United States

Location

Aclaris Clinical Site

Ridgeland, Mississippi, 39157, United States

Location

Aclaris Study Site

Saint Joseph, Missouri, 64506, United States

Location

Aclaris Clinical Site

Missoula, Montana, 59804, United States

Location

Aclaris Study Site

New York, New York, 10023, United States

Location

Aclaris Study Site

New York, New York, 10075, United States

Location

Aclaris Clinical Site

New York, New York, 10128, United States

Location

Aclaris Clinical Site

The Bronx, New York, 10455, United States

Location

Aclaris Clinical Site

Cary, North Carolina, 27518, United States

Location

Aclaris Clinical Site

Wilmington, North Carolina, 28405, United States

Location

Aclaris Study Site

Camp Hill, Pennsylvania, 17011, United States

Location

Aclaris Clinical Site

Philadelphia, Pennsylvania, 19103, United States

Location

Aclaris Clinical Site

Myrtle Beach, South Carolina, 29588, United States

Location

Aclaris Clinical Site

Dallas, Texas, 75230, United States

Location

Aclaris Clinical Site

Houston, Texas, 77004, United States

Location

Aclaris Study Site

San Antonio, Texas, 78213, United States

Location

Aclaris Study Site

San Antonio, Texas, 78218, United States

Location

Aclaris Clinical Site

The Woodlands, Texas, 77380, United States

Location

Aclaris Study Site

Webster, Texas, 77598, United States

Location

Aclaris Clinical Site

Providence, Utah, 84332, United States

Location

Aclaris Study Site

Norfolk, Virginia, 23502, United States

Location

Aclaris Clinical Site

Seattle, Washington, 98004, United States

Location

Aclaris Clinical Site

Spokane, Washington, 99202, United States

Location

Aclaris Clinical Site

Barrie, Ontario, L4M 7G1, Canada

Location

Aclaris Site

Markham, Ontario, L3P 1X3, Canada

Location

Aclaris Site

Mississauga, Ontario, L4Y 4C5, Canada

Location

Aclaris Site

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Aclaris Clinical Site

Toronto, Ontario, M2N 3A6, Canada

Location

Aclaris Site

Toronto, Ontario, M4W 2N2, Canada

Location

Aclaris Clinical Site

Montreal, Quebec, H1Y3L1, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 10, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7); US (53)