A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
Trial ID or NCT#
The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in participants with moderate-to-severe atopic dermatitis.
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis
- - Male or female, 18 years or older. - Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year before the screening visit . - Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline visit. - Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and the baseline visit. - ≥10% body surface area (BSA) of AD involvement at the screening and the baseline visit.
- - Treatment with any of the following agents within 4 weeks prior to the baseline visit: - Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.) - Phototherapy and photochemotherapy (PUVA) for AD. - Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week prior to the baseline visit. - Treatment with: - An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to the baseline visit. - Dupilumab within 3 months prior to baseline visit. - Cell-depleting biologics, including rituximab, within 6 months prior to the baseline visit. - Other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit (whichever is longer). - Use of prescription moisturizers within 7 days of the baseline visit.