Cerprobe to commence Phase 3 study of lenabasum
Corbus Pharmaceuticals announced that the company will proceed with a Phase 3 trial evaluating the efficacy and safety of lenabasum for the treatment of dermatomyositis, or DM. Dermatomyositis is a rare and serious multisystem inflammatory autoimmune disease affecting muscle and skin. The FDA provided guidance on the overall study design of this trial at a recent end-of-Phase 2 meeting. The Phase 3 study is planned to begin at the end of 2018. The international Phase 3 trial will be a 1-year, double-blind, randomized, placebo-controlled study testing efficacy and safety of lenabasum in approximately 150 adults with DM. Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome will be American College of Rheumatology/European League Against Rheumatism 2016 Total Improvement Score in myositis, a composite measure of improvement from baseline in six endpoints: Physician Global Activity, Patient Global Activity, Health Assessment Questionnaire, Manual Muscle Testing, and measurement of muscle enzymes and extra muscular activity. Change in the Cutaneous Dermatomyositis Activity and Severity index activity score will be a secondary efficacy outcome.