Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Facioscapulohumeral Muscular Dystrophy (FSHD)

In brief

This study is an open-label extension to evaluate the safety and tolerability of long-term dosing of Losmapimod in patients with FSHD1 who participated in the ReDux4 study.

Key facts

Study ID

NCT04264442

Run by

Fulcrum Therapeutics

People needed

76

Starts

2020-02-13

Expected to finish

2024-11-07

Last updated by the study team

2025-09-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient must have consented to participate and must have provided signed, dated and witnessed an IRB-approved informed consent form that conforms to federal and institutional guidelines.
• Male or female subjects
• Patients must be between 18 and 65 years of age, inclusive
• Must be willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines and other study procedures.
• Will practice an approved method of birth control

You may not qualify if…

• Has a history of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. This may include, but is not limited to, a history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; neuromuscular diseases except FSHD (eg, myopathy, neuropathy, neuromuscular junction disorders); or clinically significant history of mental disease.
• For subjects who are on drug(s) or supplements that may affect muscle function, as determined by the treating physician, or that are included in the list of drugs presented in the protocol, subjects must be on a stable dose of that drug(s) or supplement for at least 3 months prior to the first dose of study drug and remain on that stable dose for the duration of the study. Changes to the dose or treatment discontinuation during the study can only be done for strict medical reasons by the treating physician with clear documentation and notification to the sponsor.

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 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
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Ohio State University — Columbus, Ohio, United States
• University of Utah — Salt Lake City, Utah, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• University of Washinton Medical Center — Seattle, Washington, United States
• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada
• Montreal Neurological Institute and Hospital — Montreal, Quebec, Canada
• CHU de NICE- CHU pasteur2 — Nice, France
• Hospital de la Sta Creu i St Pau — Barcelona, Spain
• Hospital UiP La Fe — Valencia, Spain

Full record on ClinicalTrials.gov

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