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Study on the Effectiveness and Safety of Losmapimod for Patients with Facioscapulohumeral Muscular Dystrophy (FSHD)

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Losmapimod on a condition known as Facioscapulohumeral Muscular Dystrophy (FSHD). FSHD is a genetic disorder that causes progressive muscle weakness, particularly affecting the face, shoulders, and upper arms. The study aims to evaluate how effective and safe Losmapimod is in treating patients with this condition. Losmapimod is taken in the form of tablets, and some participants will receive a placebo, which looks like the medication but does not contain the active ingredient.

The study is designed to last for 48 weeks, during which participants will be randomly assigned to receive either Losmapimod or a placebo. This is a double-blind study, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. The main goal is to see if Losmapimod can slow down the progression of muscle weakness in FSHD patients. Participants will have regular check-ups to monitor their health and any changes in their condition.

In addition to assessing the effectiveness of Losmapimod, the study will also focus on its long-term safety and how well patients tolerate the medication. This will involve regular assessments of participants' overall health, including laboratory tests, heart monitoring through ECGs, and physical examinations. The study will help determine if Losmapimod can be a beneficial treatment option for those living with FSHD.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to receive either the active medication, losmapimod, or a placebo. The placebo is designed to look like the losmapimod tablets but does not contain the active ingredient.

    The study is double-blind, meaning neither the patient nor the researchers will know which treatment the patient is receiving.

  2. Step 2

    Medication administration

    The patient will take the assigned tablets orally. If receiving losmapimod, the dosage is 15 mg per tablet.

    The medication will be taken as directed by the study protocol, which typically involves a regular schedule over the course of the study.

  3. Step 3

    Study duration

    The study is divided into two parts: Part A and Part B.

    Part A lasts for 48 weeks, during which the patient will be monitored for changes in their condition and any side effects.

    If the patient completes Part A, they may continue to Part B, which focuses on the long-term safety and tolerability of losmapimod.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the patient will undergo regular assessments to monitor the progression of their condition and the effects of the treatment.

    These assessments may include physical examinations, laboratory tests, and other evaluations to ensure the patient's safety and to measure the effectiveness of the treatment.

  5. Step 5

    Completion of the study

    At the end of the study, the patient will have a final assessment to evaluate the overall impact of the treatment.

    The study is expected to conclude by May 31, 2027, at which point all data will be analyzed to determine the efficacy and safety of losmapimod for treating facioscapulohumeral muscular dystrophy.

Who can join the trial?

11 criteria

  • The patient must sign and date an informed consent form, which is a document that explains the study and confirms their willingness to participate.
  • The patient must have a diagnosis of **Facioscapulohumeral Muscular Dystrophy (FSHD)**, confirmed by genetic testing. FSHD is a genetic muscle disorder.
  • The patient must have a **Clinical Severity Score** between 2 and 4. This score measures the severity of the disease, with 0 being no symptoms and 5 being the most severe. Patients who need a wheelchair or walker cannot join the study.
  • The patient must have a specific range of muscle strength in their dominant arm, measured by a test called **RWS**. This test checks how well the muscles work without any weight.
  • The patient must be willing and able to attend scheduled visits and follow the treatment plan and other study procedures.
  • The patient must not have any reasons that prevent them from having an **MRI**, which is a type of scan that takes pictures of the inside of the body.
  • The patient must be between 18 and 65 years old.
  • Female patients who can have children must use a highly effective method to prevent pregnancy during the study and for 90 days after the last dose of the study drug. This includes methods like surgery to prevent pregnancy or being postmenopausal, which means not having periods for 12 months for reasons other than medical conditions.
  • Male patients must agree to use a method of contraception during the study and for 90 days after the last dose of the study drug.
  • For Part B of the study, the patient must have completed 48 weeks of treatment in Part A.
  • The patient must agree to follow the study's rules, including visits, treatment plans, and laboratory tests.

Who cannot join the trial?

10 criteria

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or attend study visits.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who have a history of heart problems or uncontrolled high blood pressure.
  • Patients who have a history of liver or kidney disease.
  • Patients who have a history of mental health disorders that are not well controlled.
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Investigated drugs

Losmapimod is a medication being studied for its potential to treat patients with Facioscapulohumeral Muscular Dystrophy (FSHD). The trial aims to evaluate how effective losmapimod is in slowing down the progression of the disease. It also looks at the long-term safety and how well patients can tolerate the medication.

What is already known about the treatment

Losmapimod – Losmapimod is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating Facioscapulohumeral Muscular Dystrophy (FSHD). It is in the late stages of clinical research, specifically a Phase 3 trial, which evaluates its efficacy and safety. The main therapeutic indication for losmapimod is to slow the progression of FSHD, a genetic muscle disorder. At the molecular level, losmapimod works by inhibiting certain enzymes known as p38 MAP kinases, which are involved in inflammatory responses and muscle degeneration. It is classified pharmacologically as a kinase inhibitor.

Investigated diseases

Facioscapulohumeral Muscular Dystrophy – This is a genetic muscle disorder characterized by progressive muscle weakness and wasting. It primarily affects the muscles of the face, shoulders, and upper arms, leading to difficulties in facial expressions, lifting objects, and raising the arms. The progression of muscle weakness can vary significantly among individuals, with some experiencing mild symptoms and others facing more severe muscle loss. Over time, the weakness may extend to other muscle groups, including those in the lower body. The onset of symptoms typically occurs in adolescence or early adulthood, but it can also appear later in life. The rate of progression is generally slow, allowing individuals to adapt to changes over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512737-33-00Protocol code1821-FSH-301Estimated enrolment260 patientsSponsorFulcrum Therapeutics Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).