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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Dermatitis; Eczema; Atopic Dermatitis; AD; Atopic
• Intervention / Treatment: Drug: Placebo; Drug: ATI-045

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Aclaris Clinical Site
    • Markham, Ontario, Canada, L3P 1X3
      • Aclaris Site
    • Mississauga, Ontario, Canada, L4Y 4C5
      • Aclaris Site
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • Aclaris Site
    • Toronto, Ontario, Canada, M2N 3A6
      • Aclaris Clinical Site
    • Toronto, Ontario, Canada, M4W 2N2
      • Aclaris Site
  • Quebec
    • Montreal, Quebec, Canada, H1Y3L1
      • Aclaris Clinical Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Aclaris Clinical Site
    • Tucson, Arizona, United States, 85704
      • Aclaris Clinical Site
  • Arkansas
    • Bryant, Arkansas, United States, 71913
      • Aclaris Study Site
  • California
    • Beverly Hills, California, United States, 90212
      • Aclaris Clinical Site
    • Encinitas, California, United States, 92024
      • Aclaris Study Site
    • Encino, California, United States, 91436
      • Aclaris Clinical Site
    • Huntington Beach, California, United States, 92647
      • Aclaris Clinical Site
    • Los Angeles, California, United States, 90045
      • Aclaris Study Site
    • Oceanside, California, United States, 92056
      • Aclaris Study Site
    • Santa Monica, California, United States, 90404
      • Aclaris Study Site
    • Sherman Oaks, California, United States, 91403
      • Aclaris Clinical Site
    • Thousand Oaks, California, United States, 91320
      • Aclaris Clinical Site
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Aclaris Study Site
    • Hollywood, Florida, United States, 33486
      • Aclaris Clinical Site
    • Jacksonville, Florida, United States, 32256
      • Aclaris Clinical Site
    • Margate, Florida, United States, 33063
      • Aclaris Clinical Site
    • North Miami Beach, Florida, United States, 33162
      • Aclaris Study Site
    • Sweetwater, Florida, United States, 33172
      • Aclaris Study Site
    • Tampa, Florida, United States, 33607
      • Aclaris Study Site
    • Wellington, Florida, United States, 33449
      • Aclaris Clinical Site
  • Georgia
    • Atlanta, Georgia, United States, 30315
      • Aclaris Clinical Site
    • Savannah, Georgia, United States, 31405
      • Aclaris Clinical Site
  • Idaho
    • Boise, Idaho, United States, 83706
      • Aclaris Study Site
  • Indiana
    • Clarksville, Indiana, United States, 47129
      • Aclaris Study Site
    • Indianapolis, Indiana, United States, 46250
      • Aclaris Study Site
    • Lafayette, Indiana, United States, 47906
      • Aclaris Clinical Site
    • West Lafayette, Indiana, United States, 47906
      • Aclaris Study Site
  • Kentucky
    • Bowling Green, Kentucky, United States, 42104
      • Aclaris Study Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • Aclaris Clinical Site
    • Auburn Hills, Michigan, United States, 48326
      • Aclaris Study Site
    • Troy, Michigan, United States, 48084
      • Aclaris Clinical Site
  • Mississippi
    • Ridgeland, Mississippi, United States, 39157
      • Aclaris Clinical Site
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Aclaris Study Site
  • Montana
    • Missoula, Montana, United States, 59804
      • Aclaris Clinical Site
  • New York
    • New York, New York, United States, 10023
      • Aclaris Study Site
    • New York, New York, United States, 10075
      • Aclaris Study Site
    • New York, New York, United States, 10128
      • Aclaris Clinical Site
    • The Bronx, New York, United States, 10455
      • Aclaris Clinical Site
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Aclaris Clinical Site
    • Wilmington, North Carolina, United States, 28405
      • Aclaris Clinical Site
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Aclaris Study Site
    • Philadelphia, Pennsylvania, United States, 19103
      • Aclaris Clinical Site
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29588
      • Aclaris Clinical Site
  • Texas
    • Dallas, Texas, United States, 75230
      • Aclaris Clinical Site
    • Houston, Texas, United States, 77004
      • Aclaris Clinical Site
    • San Antonio, Texas, United States, 78213
      • Aclaris Study Site
    • San Antonio, Texas, United States, 78218
      • Aclaris Study Site
    • The Woodlands, Texas, United States, 77380
      • Aclaris Clinical Site
    • Webster, Texas, United States, 77598
      • Aclaris Study Site
  • Utah
    • Providence, Utah, United States, 84332
      • Aclaris Clinical Site
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Aclaris Study Site
  • Washington
    • Seattle, Washington, United States, 98004
      • Aclaris Clinical Site
    • Spokane, Washington, United States, 99202
      • Aclaris Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Drug: Placebo; Placebo group
Experimental: ATI-045 group	Drug: ATI-045; ATI-045 group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Eczema Area and Severity Index (EASI)	Percent change from baseline in EASI score at Week 24	Baseline to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Global Assessment (vIGA) treatment success (IGA-TS)	Proportion of patients with validated Investigator Global Assessment (vIGA) treatment success (IGA-TS)	Baseline to Week 24
EASI reduction	Proportion of patients with EASI reduction of 75% (EASI75), 50% (EASI50), 90% (EASI90)	Baseline to Week 24
Peak Pruritus Numerical Rating Scale (PP-NRS) score	Change and percent change from baseline in weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score	Baseline to Week 24
PP-NRS improvement	Proportion of patients with a 4-point improvement or greater from baseline in weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS)	Baseline to Week 24
Body Surface Area (BSA)	Change from baseline in BSA	Baseline to Week 24
Incidence and severity of safety measurements	Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) after first study drug dose on W0D1 until patient's last visit.	From Baseline to Week 34
Anti-ATI-045 antidrug antibody (ADA)	ADA evaluation	From Baseline to Week 34

Collaborators and Investigators

• Sponsor: Aclaris Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: May 27, 2025
• First Submitted That Met QC Criteria: June 5, 2025
• First Posted (Actual): June 10, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: ATI-045-AD-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No