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

PHASE2TerminatedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

February 13, 2020

Primary Completion Date

November 7, 2024

Study Completion Date

November 7, 2024

Conditions
Facioscapulohumeral Muscular Dystrophy (FSHD)
Interventions
DRUG

Losmapimod

Patients 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. The study drug should be taken with food and the date and time of each dose taken should be recorded in the subject diary.

Trial Locations (17)

14642

University of Rochester Medical Center, Rochester

21205

Kennedy Krieger Institute, Baltimore

23298

Virginia Commonwealth University, Richmond

32610

University of Florida, Gainesville

43221

Ohio State University, Columbus

46026

Hospital UiP La Fe, Valencia

63110

Washington University School of Medicine, St Louis

66160

University of Kansas Medical Center, Kansas City

84132

University of Utah, Salt Lake City

90095

University of California Los Angeles (UCLA), Los Angeles

92868

University of California Irvine, Irvine

98195

University of Washinton Medical Center, Seattle

01655

University of Massachusetts Memorial Medical Center, Worcester

K1Y 4E9

Ottawa Hospital Research Institute, Ottawa

H3A 2B4

Montreal Neurological Institute and Hospital, Montreal

06001

CHU de NICE- CHU pasteur2, Nice

08041

Hospital de la Sta Creu i St Pau, Barcelona

Sponsors
All Listed Sponsors
lead

Fulcrum Therapeutics

INDUSTRY

NCT04264442 - Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE) | Biotech Hunter | Biotech Hunter