AD, Atopic, Atopic Dermatitis, Dermatitis, Eczema
Conditions
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.
Interventions
DRUGATI-045
ATI-045 group
DRUGPlacebo
Placebo group
Sponsors
Aclaris Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Eczema Area and Severity Index (EASI) | Baseline to Week 24 | Percent change from baseline in EASI score at Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada, United States
Outcome results
None listed