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MAP Kinase Inhibitor

Losmapimod for Facioscapulohumeral Muscular Dystrophy

Phase 2
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
Patients must be between 18 and 65 years of age, inclusive
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 24 weeks from the date of enrollment through study completion, up to 60 months
Awards & highlights

Summary

This trial is testing if the medication Losmapimod is safe for long-term use in patients with FSHD1. Patients will take the medication twice daily and visit the clinic regularly to check for any side effects. Losmapimod has been previously tested in other conditions but did not show significant efficacy.

Who is the study for?
This trial is for adults aged 18-65 with Facioscapulohumeral Muscular Dystrophy (FSHD) who were in the ReDux4 study. Participants must be able to follow the study plan and use approved birth control methods. Those with illnesses that could affect results or pose risks, allergies, heart or brain diseases, other muscle disorders, or significant mental illness cannot join.
What is being tested?
The trial tests Losmapimod's long-term safety and effectiveness in treating FSHD. It's an open-label extension meaning all participants know they are receiving Losmapimod and there is no placebo group involved.
What are the potential side effects?
While specific side effects of Losmapimod aren't listed here, common ones may include nausea, diarrhea, headaches, fatigue or allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I've been on a stable dose of medication or supplements that could affect muscle function for at least 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 24 weeks from the date of enrollment through study completion, up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 24 weeks from the date of enrollment through study completion, up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Tolerability of Losmapimod
Secondary study objectives
Lean Muscle Volume
Muscle Fat Fraction
Muscle Fat Infiltration
+1 more
Other study objectives
FSHD Health Index (FSHD-HI) - Clinical Outcome Assessment
Motor Function Measure (MFM) Domain 1 - Clinical Outcome Assessment
Muscle Strength - Clinical Outcome Assessment
+3 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

Trial Design

1Treatment groups
Experimental Treatment
Group I: LosmapimodExperimental Treatment1 Intervention
FSHD1 patients with genetic confirmation will receive Losmapimod 15 mg by mouth twice daily for a total of 30 mg daily until 90 days after commercial drug is available post regulatory approval or until the study is discontinued by the Sponsor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Losmapimod
Not yet FDA approved

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 MAPK inhibitor, works by targeting the p38 MAPK pathway, which is crucial in inflammatory responses and cellular stress signaling. By inhibiting this pathway, Losmapimod aims to reduce inflammation and muscle damage, key contributors to the progression of Facioscapulohumeral Muscular Dystrophy (FSHD). This mechanism is significant for FSHD patients as it may slow disease progression and improve muscle function, ultimately enhancing their quality of life.

Find a Location

Who is running the clinical trial?

Fulcrum TherapeuticsLead Sponsor
7 Previous Clinical Trials
603 Total Patients Enrolled
Michelle Mellion, MDStudy DirectorFulcrum Therapeutics
3 Previous Clinical Trials
112 Total Patients Enrolled
Santiago Arroyo, MD, PhDStudy DirectorFulcrum Therapeutics
2 Previous Clinical Trials
274 Total Patients Enrolled

Media Library

Losmapimod (MAP Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04264442 — Phase 2
Facioscapulohumeral Muscular Dystrophy Research Study Groups: Losmapimod
Facioscapulohumeral Muscular Dystrophy Clinical Trial 2023: Losmapimod Highlights & Side Effects. Trial Name: NCT04264442 — Phase 2
Losmapimod (MAP Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04264442 — Phase 2
~14 spots leftby Oct 2025
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