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

March 24, 2026 updated by: Aclaris Therapeutics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change in Eczema Area and Severity Index (EASI)
Time Frame: Baseline to Week 24
Percent change from baseline in EASI score at Week 24
Baseline to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Investigator Global Assessment (vIGA) treatment success (IGA-TS)
Time Frame: Baseline to Week 24
Proportion of patients with validated Investigator Global Assessment (vIGA) treatment success (IGA-TS)
Baseline to Week 24
EASI reduction
Time Frame: Baseline to Week 24
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
Time Frame: Baseline to Week 24
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
Time Frame: Baseline to Week 24
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)
Time Frame: Baseline to Week 24
Change from baseline in BSA
Baseline to Week 24
Incidence and severity of safety measurements
Time Frame: From Baseline to Week 34
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)
Time Frame: From Baseline to Week 34
ADA evaluation
From Baseline to Week 34

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aclaris Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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