Completion of enrollment in the phase III REACH clinical trial of losmapimod in facioscapulohumeralmuscular dystrophy
Fulcrum Therapeutics, Inc., announced that it has completed enrollment in REACH, a Phase III clinical trial evaluating losmapimod in patients with FSHD (facioscapulohumeral muscular dystrophy) at sites in the United States, Canada, and Europe
REACH is a Phase III multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of losmapimod for the treatment of FSHD. The trial enrolled 260 patients who were randomized 1:1 to receive either losmapimod, administered orally as a 15 mg tablet twice a day, or placebo, and will be evaluated over a 48-week treatment period. The primary endpoint of the study is the absolute change from baseline in Reachable Workspace (RWS). Secondary endpoints include muscle fat infiltration (MFI), Patient Global Impression of Change (PGIC), and Quality of Life in Neurological Disorders of the Upper Extremity (Neuro QoL UE). REACH also includes patient-centered assessments of healthcare utilization. More information about the study is available at ClinicalTrials.gov (NCT Number: NCT05397470).
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