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

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-30

Study Completion Date

2026-10-31

Brief Summary

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

Detailed Description

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

Conditions

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Atopic Dermatitis Atopic Dermatitis AD Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ATI-045 group

Group Type EXPERIMENTAL

ATI-045

Intervention Type DRUG

ATI-045 group

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo group

Interventions

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ATI-045

ATI-045 group

Intervention Type DRUG

Placebo

Placebo group

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

ATI-045 group

ATI-045

Placebo group

Placebo

Interventions

ATI-045

Placebo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Aclaris Therapeutics, Inc.

Responsible Party

Locations

Aclaris Clinical Site

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Countries

Central Contacts

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Facility Contacts

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