Fibrogen Inc. recently announced the initiation of a Phase 3 placebo-controlled trial of pamrevlumab in combination with systematic corticosteroids. Pamrevlumab is an antibody developed by FibroGen to inhibit the activity of CTGF, a common factor in disorders characterized by organ dysfunction and failure.
The main objective of this study is to evaluate the effect of pamrevlumab on muscle function in non-ambulatory patients with DMD. Approximately 90 patients will be randomized to receive pamrevlumab plus systematic corticosteroids, or placebo plus systematic corticosteroids for up to 52 weeks.
The performance of the upper limb in each patient will be assessed from Week 1 until Week 52 in addition to the placement of pulmonary and cardiac function tests. Subjects who complete the 52-Week study will be eligible for rollover into a study extension with pamrevlumab and systematic corticosteroids.
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