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

Phase 2

Recruiting

• Conditions: Atopic Dermatitis; Atopic; Dermatitis; AD; Eczema
• Interventions: Drug: ATI-045; Drug: Placebo

• Registration Number: NCT07011706
• Lead Sponsor: Aclaris Therapeutics, Inc.

Brief Summary

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

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 Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-27
• Study Start: 2025-06
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Primary Completion: 2026-08
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATI-045 group	ATI-045	ATI-045 group
Placebo group	Placebo	Placebo group

Primary Outcome Measures

Name	Time	Method
Percent Change in Eczema Area and Severity Index (EASI)	Baseline to Week 24	Percent change from baseline in EASI score at Week 24

Secondary Outcome Measures

Name	Time	Method
Investigator Global Assessment (vIGA) treatment success (IGA-TS)	Baseline to Week 24	Proportion of patients with validated Investigator Global Assessment (vIGA) treatment success (IGA-TS)
EASI reduction	Baseline to Week 24	Proportion of patients with EASI reduction of 75% (EASI75), 50% (EASI50), 90% (EASI90)
Peak Pruritus Numerical Rating Scale (PP-NRS) score	Baseline to Week 24	Change and percent change from baseline in weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score
PP-NRS improvement	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)
Body Surface Area (BSA)	Baseline to Week 24	Change from baseline in BSA
Incidence and severity of safety measurements	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.
Anti-ATI-045 antidrug antibody (ADA)	From Baseline to Week 34	ADA evaluation

Trial Locations

Locations (1)

Aclaris Study Site; 🇺🇸 Norfolk, Virginia, United States