Clinical trial NCT07011706: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Atopic
Dermatitis
AD
Eczema
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-10
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change in Eczema Area and Severity Index (EASI)
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Investigator Global Assessment (vIGA) treatment success (IGA-TS)
timeFrame: Baseline to Week 24
measure: EASI reduction
timeFrame: Baseline to Week 24
measure: Peak Pruritus Numerical Rating Scale (PP-NRS) score
timeFrame: Baseline to Week 24
measure: PP-NRS improvement
timeFrame: Baseline to Week 24
measure: Body Surface Area (BSA)
timeFrame: Baseline to Week 24
measure: Incidence and severity of safety measurements
timeFrame: From Baseline to Week 34
measure: Anti-ATI-045 antidrug antibody (ADA)
timeFrame: From Baseline to Week 34
Other outcomes:
Locations:
city: Bryant
country: United States
facility: Aclaris Study Site
state: Arkansas
city: Encinitas
country: United States
facility: Aclaris Study Site
state: California
city: Los Angeles
country: United States
facility: Aclaris Study Site
state: California
city: Oceanside
country: United States
facility: Aclaris Study Site
state: California
city: Sacramento
country: United States
facility: Aclaris Study Site
state: California
city: Santa Monica
country: United States
facility: Aclaris Study Site
state: California
city: Coral Gables
country: United States
facility: Aclaris Study Site
state: Florida
city: North Miami Beach
country: United States
facility: Aclaris Study Site
state: Florida
city: Sweetwater
country: United States
facility: Aclaris Study Site
state: Florida
city: Tampa
country: United States
facility: Aclaris Study Site
state: Florida
city: Clarksville
country: United States
facility: Aclaris Study Site
state: Indiana
city: Indianapolis
country: United States
facility: Aclaris Study Site
state: Indiana
city: Bowling Green
country: United States
facility: Aclaris Study Site
state: Kentucky
city: Auburn Hills
country: United States
facility: Aclaris Study Site
state: Michigan
city: St. Joseph
country: United States
facility: Aclaris Study Site
state: Missouri
city: New York
country: United States
facility: Aclaris Study Site
state: New York
city: New York
country: United States
facility: Aclaris Study Site
state: New York
city: San Antonio
country: United States
facility: Aclaris Study Site
state: Texas
city: San Antonio
country: United States
facility: Aclaris Study Site
state: Texas
city: Norfolk
country: United States
facility: Aclaris Study Site
state: Virginia
Study officials:
References: