A Study of Lebrikizumab in Combination With Topical Corticosteroids in Patients With Atopic Dermatitis (AD) That Are Not Adequately Controlled With or Are Non-eligible for Cyclosporine

Summary

The main purpose of this study is to evaluate the efficacy of lebrikizumab compared with placebo in participants not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to Week 16.

Timeline

Start

2021-12-23

Primary completion

2023-01-30

Completion

2024-05-07

Outcome

Met primary endpoint

registry analysis (superiority test); Double-blind Induction Period: Lebrikizumab +TCS vs Double-blind Induction Period: Placebo +TCS; p <0.0001; Difference in percentages 27.88 (95% CI 15.63 to 40.14); Cochran-Mantel-Haenszel NCT05149313 ↗

release “The ADvantage phase IIIb study met the primary endpoint at the Week 16 analysis.” almirall.com ↗

release “in the Phase III ADvantage study. xiii The study met the primary endpoint at Week 16.” almirall.com ↗

Drugs

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

Indications