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FibroGen initiates second phase III study of pamrevlumab to treat Duchenne muscular dystrophy .

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Published:18th Mar 2021
FibroGen, Inc. announced the initiation of LELANTOS-2, a Phase III, randomized, double-blind, placebo-controlled trial of pamrevlumab or placebo in combination with systemic corticosteroids in patients with 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 70 patients ages 6 to 12 years will be randomized 1:1 to receive pamrevlumab plus systemic corticosteroids, or placebo plus systemic corticosteroids every two weeks, for up to 52 weeks. The primary efficacy endpoint is ambulatory function assessment, measured by the change in North Star Ambulatory Assessment (NSAA) from baseline to Week 52. Additional secondary endpoints will be assessed in the study. Subjects who complete the 52-week study will be eligible for rollover into an open-label extension study with pamrevlumab and systemic corticosteroids. For more information about LELANTOS-2 please visit www.clinicaltrials.gov (NCT04632940). Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Importantly, skeletal muscle from DMD patients shows elevated levels of CTGF, and a major manifestation of DMD is cardiac fibrosis..
Condition: Duchenne Muscular Dystrophy
Type: drug

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