FibroGen initiates Phase III LELANTOS trial for pamrevlumab in combination with corticosteroids in patients with non-ambulatory Duchenne muscular dystrophy.

FibroGen, Inc. announced the initiation of LELANTOS, a Phase III, randomized, double-blind, placebo-controlled trial of pamrevlumab or placebo in combination with systemic corticosteroids in patients with non-ambulatory Duchenne muscular dystrophy (DMD). The primary objective of this global study is to evaluate the effect of pamrevlumab on muscle function in patients with DMD. Approximately 90 patients will be randomized 1:1 to receive pamrevlumab plus systemic corticosteroids, or placebo plus systemic corticosteroids, for up to 52 weeks. The primary efficacy endpoint is the change in the total score of performance of upper limb (PUL) assessment, from baseline to Week 52, and additional endpoints include pulmonary and cardiac function tests. Subjects who complete the 52-week study will be eligible for rollover into an open-label extension study with pamrevlumab and systemic corticosteroids.