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

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.