Phase 3 Study
Planned Phase 3 Study of Anabasum for the Treatment of Diffuse Cutaneous Systemic Sclerosis (Scleroderma)
Corbus will be proceeding with a Phase 3 study to support a New Drug Application (NDA) for anabasum for the treatment of diffuse cutaneous systemic sclerosis. The U.S. Food and Drug Administration has provided guidance on the development program and the design of the study. The planned international Phase 3 trial will be a double-blind, randomized, placebo-controlled study conducted in adults with systemic sclerosis. Subjects will be randomized to receive anabasum 20 mg twice per day, anabasum 5 mg twice per day, or placebo twice per day. Corbus expects to commence this study in the fourth quarter of 2017.
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