A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis

Phase 3 Completed 286 enrolled Eli Lilly and Company

RandomizedParallel-groupDouble-blindTreatment

Summary

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in combination with a topical corticosteroids in Japanese participants with atopic dermatitis.

Timeline

Start: 2021-03-10
Primary completion: 2022-07-31
Completion: 2023-02-01

Outcome

Met primary endpoint

registry analysis (superiority test); Induction - Placebo vs Induction - Lebrikizumab 250 mg Q4W; p <0.001; Risk Difference (RD) 22.6 (95% CI 11.6 to 33.6) NCT04760314 ↗

registry analysis (superiority test); Induction - Placebo vs Induction - Lebrikizumab 250 mg Q4W; p <0.001; Risk Difference (RD) 33.2 (95% CI 20.6 to 45.8) NCT04760314 ↗

Publications

Katoh N, Tanaka A, Takahashi H, Shimizu R, Kataoka Y, Torisu-Itakura H, Morisaki Y, Yamamoto C, Igawa K. Long-term management of moderate-to-severe atopic dermatitis with lebrikizumab and concomitant topical corticosteroids: a 68-week randomized double-blind placebo-controlled phase III trial in Japan (ADhere-J). Br J Dermatol. 2025 Mar 18;192(4):597-610. doi: 10.1093/bjd/ljae394.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lebrikizumab	Monoclonal antibody	250 mg	Subcutaneous