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

Launched by ACLARIS THERAPEUTICS, INC. · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ATI-045 to see how well it works compared to a placebo (a non-active treatment) for people with moderate-to-severe atopic dermatitis, which is also known as eczema. The goal is to find out if ATI-045 can help improve skin symptoms in patients who have had chronic atopic dermatitis for at least six months and have not had significant flare-ups in the four weeks before the study starts.

To participate in the trial, candidates should have active moderate to severe eczema, as shown by certain scoring criteria. They should also have previously found that topical treatments (like creams) were not effective for them or were not safe to use. Participants will need to apply a moisturizer daily and avoid other specific treatments before joining the study. This trial is currently recruiting participants of all genders, aged between 6 and 74 years old. If you join, you will be monitored throughout the study to see how the new medication affects your condition compared to the placebo.

Gender

ALL

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.