Dermira announced treatment commencement in the first patient for a phase 3 study evaluating lebrikizumab in adult and adolescents with moderate to severe atopic dermatitis.
Lebrikizumab is an investigational, monoclonal antibody designed to bind to interleukin-13 (IL-13) to prevent the formation of the IL-13 receptor alpha/IL-4 receptor alpha heterodimer complex and signaling, according to the company press release.
The phase 3 study encompasses two identical, randomized, double-blind, placebo-controlled studies across 200 sites in the U.S., Europe and Asia.
Eight hundred adolescents and adults aged at least 12 years presenting with chronic atopic dermatitis for at least 1 year are expected to enroll.
After a loading dose of lebrikizumab 500 mg at baseline and week 2, the studies will evaluate lebrikizumab 250 mg injection every 2 weeks vs. placebo for 16 weeks.
After week 16, those who respond via a reduction of at least 2 points in the Investigator’s Global Assessment score from baseline to final score (the primary endpoint of the study) or with an Eczema Area Severity Index (EASI)-75 response, will be re-randomized into one of three treatment groups for an additional 36 weeks:
- lebrikizumab 250 mg every 2 weeks;
- lebrikizumab 250 mg every 4 weeks; or
- placebo given every 2 weeks.
Those who do not achieve the week-16 benchmarks and patients who do not maintain an EASI-50 during the maintenance period will be assigned an open-label treatment of lebrikizumab 250 mg, every 2 weeks through week 52.
The company expects to announce the 16-week induction period data in the first half of 2021. Additionally, plans are underway to include a study in this program to evaluate lebrikizumab when used in combination with topical corticosteroids, according to the release.