Clinical activity established in two earlier 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 plans to initiate a Phase 2b dose-ranging study assessing lebrikizumab in adult patients with moderate-to-severe atopic dermatitis in the first quarter of 2018. The objective of the study will be to optimize the dose of lebrikizumab for the design of a Phase 3 program.
Roche will retain certain rights to lebrikizumab, including exclusive rights to develop and promote lebrikizumab for interstitial lung diseases, such as idiopathic pulmonary fibrosis. Dermira is not involved in this clinical development program.