Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)

PHASE3TerminatedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

June 16, 2022

Primary Completion Date

November 19, 2024

Study Completion Date

November 19, 2024

Conditions
Facioscapulohumeral Muscular Dystrophy (FSHD)
Interventions
DRUG

Losmapimod

Losmapimod 15 mg will be administered BID by mouth along with food.

DRUG

Placebo oral tablet

Placebo will be administered BID by mouth along with food.

Trial Locations (33)

2100

Rigshospitalet, Copenhagen

8200

Aarhus Universitetshospital, Aarhus

9101

Radboudumc, Nijmegen

14642

University of Rochester Medical Center, Rochester

20014

Hospital Universitario Donostia, San Sebastián

20133

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan

20162

Fondazione Serena Onlus- Centro Clinico NEMO, Milan

21205

Kennedy Krieger Institute, Baltimore

23298

Virginia Commonwealth University, Richmond

32610

University of Florida, Gainesville

43210

Ohio State University Medical Center, Columbus

46026

Hospital Universitari i Politecnic La Fe, Valencia

53127

University Hospital Bonn, Bonn

55905

Mayo Clinic, Rochester

63110

Washington University School of Medicine, St Louis

66160

University of Kansas Medical Center, Kansas City

75013

Institute de Myologie, Groupe Hospitalier Pitié-Salpêtrière, Paris

80045

University of Colorado Anschutz Medical Campus, Aurora

80336

LMU Klinikum Ludwig-Maximilians-Universität München, München

84132

University of Utah, Salt Lake City

89081

Universitätsklinikum Ulm, Ulm

90095

University of California Los Angeles (UCLA), Los Angeles

92868

University of California Irvine, Irvine

98195

University of Washington Medical Center, Seattle

01655

University of Massachusetts Memorial Medical Center, Worcester

T2N 4Z6

University of Calgary, Calgary

K1Y 4E9

The Ottawa Hospital Research Institute, Ottawa

H3A 2B4

Montreal Neurological Institute and Hospital, Montreal

06001

Nice University Hospital - CHU Nice, Nice

2333 ZA

Leiden University Medical Centre, Leiden

08035

Hospital Universitario Vall d'Hebron, Barcelona

WC1N 3BG

University College of London Hospitals, London

NE1 3BZ

Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Fulcrum Therapeutics

INDUSTRY