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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 December 2024
• Main ID: NCT04264442
• Date of registration: 30/01/2020
• Prospective Registration: Yes
• Primary sponsor: Fulcrum Therapeutics
• Public title: Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)
• Scientific title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)
• Date of first enrolment: February 13, 2020
• Target sample size: 76
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT04264442
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada, France, Germany, Spain, United States

Contacts

• Name: Marie-Helene Jouvin, MD
• Affiliation: Fulcrum Therapeutics

Key inclusion & exclusion criteria

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 will 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.


Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Facioscapulohumeral Muscular Dystrophy (FSHD)

Intervention(s)

Drug: Losmapimod

Primary Outcome(s)

Safety and Tolerability of Losmapimod [Time Frame: Every 12 Weeks from the date of enrollment through study completion, up to 60 months]

Secondary ID(s)

FIS-002-2019 OLE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors