Clinical profile established in multiple Phase 2 studies.
Lebrikizumab has been evaluated in two exploratory Phase 2 clinical studies in adult patients with moderate-to-severe atopic dermatitis. TREBLE was a double-blind, placebo-controlled study that evaluated the safety and efficacy of lebrikizumab in combination with topical corticosteroids, while ARBAN was an open-label study designed to assess the safety of lebrikizumab as a monotherapy, with an exploratory assessment of efficacy.
In both studies, data suggested clinical improvements in patients treated with lebrikizumab. The adverse events most commonly reported across all study arms were infections and conjunctivitis. Additional studies are needed to fully assess the potential benefits and risks of lebrikizumab in atopic dermatitis.
Dermira initiated a Phase 2b dose-ranging study assessing lebrikizumab in adult patients with moderate-to-severe atopic dermatitis in January 2018. The Phase 2b study was designed to evaluate the safety and efficacy of lebrikizumab as a monotherapy compared with placebo and to establish the clinical profile for a potential Phase 3 program. In March 2019, Dermira announced positive topline results from the Phase 2b study. Following feedback from an end-of-Phase 2 meeting with the FDA, a Phase 3 program is expected to be initiated by the end of 2019 to further explore lebrikizumab’s potential for patients with atopic dermatitis.