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Experimental drug losmapimod tested for rare muscle disease

NCT ID NCT04264442

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This phase 2 trial tested the drug losmapimod in 76 adults with FSHD, a genetic condition that causes progressive muscle weakness. Participants took either losmapimod or a placebo for 48 weeks to see if the drug was safe and could help control the disease. The study was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Losmapimod (a drug taken as a pill twice daily)
What this could lead to
If it works, this could point toward a treatment that slows or controls muscle weakness in people with FSHD.
What could go wrong
This trial was terminated early, so results are limited. It is a small, phase 2 study, and the drug may not prove effective or safe in larger groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

76 people

The number who actually took part.

Started

Feb 2020

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

facioscapulohumeral muscular dystrophy facioscapulohumeral muscular dystrophy 1 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

Locations

  • CHU de NICE- CHU pasteur2

    Nice, 06001, France

  • Hospital UiP La Fe

    Valencia, 46026, Spain

  • Hospital de la Sta Creu i St Pau

    Barcelona, 08041, Spain

  • Kennedy Krieger Institute

    Baltimore, Maryland, 21205, United States

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4, Canada

  • Ohio State University

    Columbus, Ohio, 43221, United States

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1Y 4E9, Canada

  • University of California Irvine

    Irvine, California, 92868, United States

  • University of California Los Angeles (UCLA)

    Los Angeles, California, 90095, 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 Washinton Medical Center

    Seattle, Washington, 98195, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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