RECRUITING

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

Conditions

Atopic Dermatitis Atopic Dermatitis AD Eczema

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-06

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07011706

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Aclaris Clinical Operations

CONTACT

(484) 324-7933

clintrials@aclaristx.com

Study Locations (Sites)

Aclaris Study Site

Bryant, Arkansas, 71913

United States

Aclaris Study Site

Encinitas, California, 92024

United States

Aclaris Study Site

Los Angeles, California, 90045

United States

Aclaris Study Site

Oceanside, California, 92056

United States

Aclaris Study Site

Sacramento, California, 95815

United States

Aclaris Study Site

Santa Monica, California, 90404

United States

Aclaris Study Site

Coral Gables, Florida, 33134

United States

Aclaris Study Site

North Miami Beach, Florida, 33162

United States

Aclaris Study Site

Sweetwater, Florida, 33172

United States

Aclaris Study Site

Tampa, Florida, 33607

United States

Aclaris Study Site

Clarksville, Indiana, 47129

United States

Aclaris Study Site

Indianapolis, Indiana, 46250

United States

Aclaris Study Site

Bowling Green, Kentucky, 42104

United States

Aclaris Study Site

Auburn Hills, Michigan, 48326

United States

Aclaris Study Site

St. Joseph, Missouri, 64506

United States

Aclaris Study Site

New York, New York, 10023

United States

Aclaris Study Site

New York, New York, 10075

United States

Aclaris Study Site

San Antonio, Texas, 78213

United States

Aclaris Study Site

San Antonio, Texas, 78218

United States

Aclaris Study Site

Norfolk, Virginia, 23502

United States

Collaborators and Investigators

Sponsor: 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 Registration Dates

Study Start Date2025-06

Study Completion Date2026-10

Study Record Updates

Study Start Date2025-06

Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

Atopic Dermatitis
Atopic
Dermatitis
AD
Eczema