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MAP Kinase Inhibitor

Losmapimod for Facioscapulohumeral Muscular Dystrophy

Phase 3
Waitlist Available
Research Sponsored by Fulcrum Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be between 18 and 65 years of age, inclusive
Genetically confirmed diagnosis of FSHD 1 or FSHD 2
Must not have
Known active opportunistic or life-threatening infections including Human Immunodeficiency virus (HIV) and hepatitis B or C
Participants who are on drug(s) or supplements that may affect muscle function, as determined by the Investigator: participants 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 48
Awards & highlights
Pivotal Trial

Summary

This trial is testing the safety and effectiveness of a drug called losmapimod for people with a muscle disease called Facioscapulohumeral Muscular Dystrophy (FSHD). Participants will take the drug regularly, and those who complete the initial phase can continue taking it to see how it works over a longer duration. The goal is to see if losmapimod can help reduce muscle inflammation and slow down muscle weakening.

Who is the study for?
Adults aged 18-65 with genetically confirmed Facioscapulohumeral Muscular Dystrophy (FSHD1 or FSHD2) and a specific range of muscle strength loss can join. They must not be wheelchair-dependent, have no MRI contraindications, and cannot be on certain drugs affecting muscle function unless stable for 3 months.
What is being tested?
The trial is testing Losmapimod's effectiveness in treating FSHD by comparing it to a placebo. Participants will take the drug or placebo twice daily. After this phase, they may continue in an extension study to assess long-term effects.
What are the potential side effects?
Potential side effects are not explicitly listed but could include reactions related to liver or kidney health due to exclusion criteria regarding these organs' conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have a genetic diagnosis of FSHD type 1 or 2.
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I can walk without needing a wheelchair or walker.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have HIV, hepatitis B or C, or any severe infections.
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I have been on a stable dose of medication or supplements that affect muscle function for at least 3 months.
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I have severe kidney problems.
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I have a heart rhythm problem that needs medication.
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I am not taking any medications that affect certain liver enzymes or kidney transporters while on losmapimod.
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I have been diagnosed with tuberculosis, whether active or not.
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I have a history of liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A: Change from Baseline in total Relative surface area (RSA) Quadrants 1 to 5 (Q1-Q5) with 500 grams (g) wrist weight averaged over both arms as assessed by Reachable workspace (RWS) at Week 48
Secondary study objectives
Part A: Change from Baseline in Quality of Life in Neurologic Disorders upper extremity (Neuro-QoL UE) Scale at Week 48
Part A: Change from Baseline in Whole body (WB) longitudinal composite Muscle Fat Infiltration (MFI) of B muscles at Week 48
Part A: Change from Baseline in average shoulder abductor strength by hand-held quantitative dynamometry at Week 48
+1 more

Side effects data

From 2016 Phase 2 trial • 17 Patients • NCT02000440
29%
Headache
24%
Fatigue
18%
Vomiting
18%
Muscle spasms
18%
Rash
18%
Oropharyngeal pain
18%
Blood creatinine increased
18%
Nausea
18%
Dizziness
12%
Oedema peripheral
12%
Abdominal pain
12%
Dyspepsia
12%
Blood pressure increased
12%
Upper respiratory tract infection
6%
Bronchitis
6%
Dizziness postural
6%
Sinusitis
6%
Nasal congestion
6%
Anaemia
6%
Skin papilloma
6%
Breast pain
6%
Vitamin D decreased
6%
Back pain
6%
Decreased appetite
6%
Hyperglycaemia
6%
Animal bite
6%
Contusion
6%
Confusional state
6%
Proteinuria
6%
Joint stiffness
6%
Hyperhidrosis
6%
Musculoskeletal stiffness
6%
Gout
6%
Dysuria
6%
Multiple allergies
6%
Eosinophils urine
6%
Abdominal pain upper
6%
Diarrhoea
6%
Presyncope
6%
Localised oedema
6%
Ear infection
6%
Gastroenteritis viral
6%
Nasopharyngitis
6%
Pneumonia
6%
Respiratory tract infection viral
6%
Urinary tract infection
6%
Asthma
6%
Cough
6%
Epistaxis
6%
Blood urea increased
6%
Cystatin C increased
6%
Flatulence
6%
Chest discomfort
6%
Palpitations
6%
Ear pain
6%
Pyrexia
6%
Swelling
6%
Anxiety
6%
Blood albumin increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Losmapimod 7.5 mg BID / 15 mg BID

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: Open-label extensionExperimental Treatment1 Intervention
Participants will receive losmapimod, upon completion of all assessments for Part A.
Group II: Part A: Placebo-controlled treatment period: LosmapimodExperimental Treatment1 Intervention
Participants will be randomized to receive losmapimod.
Group III: Part A: Placebo-controlled treatment period: PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Losmapimod
2012
Completed Phase 2
~150

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Losmapimod, a selective p38 MAP kinase inhibitor, works by blocking the p38 MAP kinase pathway, which is involved in inflammatory responses and muscle degeneration. This mechanism is particularly relevant for patients with Facioscapulohumeral Muscular Dystrophy (FSHD) because the disease is characterized by progressive muscle weakness and inflammation. By inhibiting this pathway, Losmapimod aims to reduce inflammation and muscle damage, potentially slowing disease progression and improving muscle function. This approach is significant for FSHD patients as it targets the underlying molecular processes contributing to their symptoms.

Find a Location

Who is running the clinical trial?

Fulcrum TherapeuticsLead Sponsor
7 Previous Clinical Trials
419 Total Patients Enrolled
Marie-Helene Jouvin, MDStudy DirectorFulcrum Therapeutics
3 Previous Clinical Trials
108 Total Patients Enrolled
Santiago Arroyo, MD, PhDStudy DirectorFulcrum Therapeutics
2 Previous Clinical Trials
90 Total Patients Enrolled

Media Library

Losmapimod (MAP Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05397470 — Phase 3
Facioscapulohumeral Muscular Dystrophy Research Study Groups: Part A: Placebo-controlled treatment period: Losmapimod, Part A: Placebo-controlled treatment period: Placebo, Part B: Open-label extension
Facioscapulohumeral Muscular Dystrophy Clinical Trial 2023: Losmapimod Highlights & Side Effects. Trial Name: NCT05397470 — Phase 3
Losmapimod (MAP Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05397470 — Phase 3
~80 spots leftby Oct 2025