Actively Recruiting
Phase 2 Study of Apitegromab to Evaluate Safety and Effectiveness in Adults Aged 18-60 With Facioscapulohumeral Muscular Dystrophy
Led by Scholar Rock, Inc. · Updated on 2026-08-11
60
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating apitegromab, a monoclonal antibody, for treating adults aged 18 to 60 with facioscapulohumeral muscular dystrophy FSHD in a Phase 2 randomized, double-blind, placebo-controlled study. The trial aims to assess the drugs efficacy, safety, and tolerability compared to placebo over a 52-week period. Participants will receive either apitegromab or a placebo through intravenous infusions every 4 weeks. The study compares a 10 mgkg dose of apitegromab to placebo, with treatments administered across multiple centers. The trials design includes a parallel allocation and triple masking to ensure unbiased results. During the study, participants will be monitored regularly with assessments including walkrun tests and clinical severity scoring. Researchers will evaluate the drugs effects on muscle function and safety throughout the 52 weeks. The study includes detailed follow-up visits to observe pharmacokinetics, pharmacodynamics, and any adverse effects, ensuring comprehensive data collection during and after treatment.
CONDITIONS
Brief Title
Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD
Research Team
S
Scholar Rock, Inc. Clinical Trials Administration
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
