Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Facioscapulohumeral Muscular Dystrophy (FSHD)
In brief
This is a study to evaluate the safety and efficacy of losmapimod in treating participants with Facioscapulohumeral Muscular Dystrophy (FSHD). Participants diagnosed with Facioscapulohumeral muscular dystrophy type 1 (FSHD1) or Facioscapulohumeral muscular dystrophy type 2 (FSHD2) will participate in Part A (Placebo-controlled treatment period) and will be randomized in a 1:1 ratio to receive losmapimod 15 milligrams (mg) or placebo orally twice daily (BID). Upon completion of Part A, participants will have the option to rollover into Part B (open-label extension) to evaluate the long-term safety, tolerability, and efficacy of losmapimod and will receive losmapimod 15 mg orally BID.
Key facts
- Study ID
- NCT05397470
- Run by
- Fulcrum Therapeutics
- People needed
- 260
- Starts
- 2022-06-16
- Expected to finish
- 2024-11-19
- Last updated by the study team
- 2025-11-10
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California Irvine — Irvine, California, United States
- University of California Los Angeles (UCLA) — Los Angeles, California, United States
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- University of Florida — Gainesville, Florida, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Kennedy Krieger Institute — Baltimore, Maryland, United States
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- University of Rochester Medical Center — Rochester, New York, United States
- Ohio State University Medical Center — Columbus, Ohio, United States
- University of Utah — Salt Lake City, Utah, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
- University of Washington Medical Center — Seattle, Washington, United States
- University of Calgary — Calgary, Alberta, Canada
- The Ottawa Hospital Research Institute — Ottawa, Ontario, Canada
- Montreal Neurological Institute and Hospital — Montreal, Quebec, Canada
- Aarhus Universitetshospital — Aarhus, Denmark
- Rigshospitalet — Copenhagen, Denmark
- Nice University Hospital - CHU Nice — Nice, PACA, France
- Institute de Myologie, Groupe Hospitalier Pitié-Salpêtrière — Paris, France
- University Hospital Bonn — Bonn, Germany
- LMU Klinikum Ludwig-Maximilians-Universität München — München, Germany
- Universitätsklinikum Ulm — Ulm, Germany
- Fondazione Serena Onlus- Centro Clinico NEMO — Milan, Lombardy, Italy
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.