Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.

Phase 3 Completed 228 enrolled Eli Lilly and Company Dermira, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.

Timeline

Start: 2020-02-03
Primary completion: 2021-08-11
Completion: 2021-09-16

Outcome

Met primary endpoint

paper At week 16, IGA (0,1) was achieved by 145 (41.2%) patients in the LEB+TCS group vs 66 (22.1%) receiving PBO+TCS (P = .01); PMID 36630140 ↗

paper corresponding proportions of patients achieving EASI-75 were 69.5% vs 42.2% (P < .001). PMID 36630140 ↗

release “third pivotal Phase 3 trial (ADhere). By Week 16, the study met all primary and key secondary endpoints” lilly.com ↗

Publications

Simpson EL, Gooderham M, Wollenberg A, Weidinger S, Armstrong A, Soung J, Ferrucci S, Lima RG, Witte MM, Xu W, ElMaraghy H, Natalie CR, Pierce E, Blauvelt A; ADhere Investigators. Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial (ADhere). JAMA Dermatol. 2023 Feb 1;159(2):182-191. doi: 10.1001/jamadermatol.2022.5534.

Drugs

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