Status:
TERMINATED
Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)
Lead Sponsor:
Fulcrum Therapeutics
Conditions:
Facioscapulohumeral Muscular Dystrophy (FSHD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is a study to evaluate the safety and efficacy of losmapimod in treating participants with Facioscapulohumeral Muscular Dystrophy (FSHD). Participants diagnosed with Facioscapulohumeral muscular ...
Eligibility Criteria
Inclusion
- Key
- Participants must be between 18 and 65 years of age, inclusive.
- Genetically confirmed diagnosis of FSHD 1 or FSHD 2.
- Clinical severity score of 2 to 4 (Ricci Score; Range 0-5), at screening. Participants who are wheelchair-dependent or dependent on walker or wheelchair for activities are not permitted to enroll in the study.
- Screening total RSA (Q1-Q4) without weight in the dominant UE assessed by RWS ≥ 0.2 and ≤ 0.7.
- No contraindications to MRI.
- Key
Exclusion
- Previously diagnosed cancer that has not been in complete remission for at least 5 years. Localized carcinomas of the skin and carcinoma in situ of the cervix that have been resected or ablated for cure are not exclusionary.
- 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.
- Known active opportunistic or life-threatening infections including Human Immunodeficiency virus (HIV) and hepatitis B or C.
- Known active or inactive tuberculosis infection.
- Acute or chronic history of liver disease.
- Known severe renal impairment.
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s); or history or evidence of abnormal ECGs.
- Use of another investigational product within 30 days or 5 half-lives (whichever is longer) or currently participating in a study of an investigational device.
- Current or anticipated participation in a natural history study. Previous participation is allowed but participants cannot continue after enrollment in Study 1821-FSH-301.
- Known hypersensitivity to losmapimod or any of its excipients.
- Previous participation in a Fulcrum-sponsored FSHD losmapimod study (FIS-001-2019 or FIS-002-2019).
- Note that all other inclusion and exclusion criteria are listed in the protocol and only key are presented.
Key Trial Info
Start Date :
June 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2024
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT05397470
Start Date
June 16 2022
End Date
November 19 2024
Last Update
November 7 2025
Active Locations (33)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California Irvine
Irvine, California, United States, 92868
2
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
3
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
4
University of Florida
Gainesville, Florida, United States, 32610