Active — Not RecruitingPhase 2

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

United States110 participantsStarted 2025-05-30

Plain-language summary

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

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Intravenous immunoglobulin within 12 weeks prior to the baseline visit (W0D1)
✕. Systemic antibiotics within 2 weeks prior to the baseline visit (W0D1)
✕. Topical antibiotics within 1 week prior the baseline visit (W0D1)
✕. 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.
✕. Topical products containing urea within 1 week prior to baseline visit (W0D1)
✕. Doxepin, hydroxyzine, or diphenhydramine within 1 week prior to the baseline visit (W0D1)
✕. 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.
✕. 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)

Percent Change in Eczema Area and Severity Index (EASI)

Timeframe: Baseline to Week 24

NCT IDNCT07011706

SponsorAclaris Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Intravenous immunoglobulin within 12 weeks prior to the baseline visit (W0D1)
✕. Systemic antibiotics within 2 weeks prior to the baseline visit (W0D1)
✕. Topical antibiotics within 1 week prior the baseline visit (W0D1)
✕. 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.
✕. Topical products containing urea within 1 week prior to baseline visit (W0D1)
✕. Doxepin, hydroxyzine, or diphenhydramine within 1 week prior to the baseline visit (W0D1)
✕. 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.
✕. 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)