New Atopic Dermatitis Therapy To Be Evaluated in Phase 2b Trial
A new phase 2b dose-ranging study will evaluate the safety and efficacy of lebrikizumab (Dermira Inc.) for the treatment of moderate to severe atopic dermatitis in adult patients following the initial success of their proof-of-concept trial.
Lebrikizumab is a novel, humanized monoclonal antibody that is designed to bind to IL-13 to prevent heterodimerization of the IL-13/IL-4 receptor and subsequent signaling, which plays a central role in atopic dermatitis-associated inflammation, according to the company.
The double-blind, placebo-controlled randomized trial is expected to enroll about 275 patients aged 18 years and older with moderate to severe atopic dermatitis to examine the safety and efficacy of the therapy, as well as establish the dosing regimen for a phase 3 study. Patients will be divided into 3 active treatment groups and 1 placebo group and receive lebrikizumab or placebo for 16 weeks at various dosages and intervals. An additional follow-up period will be conducted for 16 weeks.
Primary endpoints include the percent change in Eczema Area Severity Index (EASI) from baseline to week 16, the proportion of patients with a 75% improvement from baseline EASI, the proportion of patients achieving an Investigator’s Global Assessment score of 0 or 1, the proportion of patients achieving EASI-50 and EASI-90, and changes in sleep loss and pruritus scores from baseline.