FSHD drug trial halted midway: what happened?

NCT ID NCT05397470

Terminated Disease control Sponsor: Fulcrum Therapeutics Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called losmapimod for people with a rare muscle-weakening disease called FSHD. The goal was to see if the drug could slow muscle loss and improve arm function over 48 weeks. About 260 adults with FSHD were randomly assigned to receive either losmapimod or a placebo. The study was terminated early, so results are limited.

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Conditions

The condition(s) this trial relates to.

facioscapulohumeral muscular dystrophy facioscapulohumeral muscular dystrophy 1 facioscapulohumeral muscular dystrophy 2 muscular dystrophy musculoskeletal system disorder neuromuscular disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY (FSHD)

Contacts and locations

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Locations

Aarhus Universitetshospital

Aarhus, 8200, Denmark
Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy
Fondazione Serena Onlus- Centro Clinico NEMO

Milan, Lombardy, 20162, Italy
Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain
Hospital Universitario Donostia

San Sebastián, Guipuzkoa, 20014, Spain
Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain
Institute de Myologie, Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France
Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States
LMU Klinikum Ludwig-Maximilians-Universität München

München, 80336, Germany
Leiden University Medical Centre

Leiden, Southern Holland, 2333 ZA, Netherlands
Mayo Clinic

Rochester, Minnesota, 55905, United States
Montreal Neurological Institute and Hospital

Montreal, Quebec, H3A 2B4, Canada
Newcastle upon Tyne NHS Foundation Trust

Newcastle upon Tyne, NE1 3BZ, United Kingdom
Nice University Hospital - CHU Nice

Nice, PACA, 06001, France
Ohio State University Medical Center

Columbus, Ohio, 43210, United States
Radboudumc

Nijmegen, Gelderland, 9101, Netherlands
Rigshospitalet

Copenhagen, 2100, Denmark
The Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada
University College of London Hospitals

London, WC1N 3BG, United Kingdom
University Hospital Bonn

Bonn, 53127, Germany
University of Calgary

Calgary, Alberta, T2N 4Z6, Canada
University of California Irvine

Irvine, California, 92868, United States
University of California Los Angeles (UCLA)

Los Angeles, California, 90095, United States
University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States
University of Florida

Gainesville, Florida, 32610, United States
University of Kansas Medical Center

Kansas City, Kansas, 66160, United States
University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States
University of Rochester Medical Center

Rochester, New York, 14642, United States
University of Utah

Salt Lake City, Utah, 84132, United States
University of Washington Medical Center

Seattle, Washington, 98195, United States
Universitätsklinikum Ulm

Ulm, 89081, Germany
Virginia Commonwealth University

Richmond, Virginia, 23298, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States