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Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON)
Sponsor: Edgewise Therapeutics, Inc.
Summary
A study of sevasemten (EDG-5506) in Becker muscular dystrophy (known as CANYON) and pivotal cohort (known as GRAND CANYON). The EDG-5506-201 CANYON study was expanded to include an additional 120 adult participants in a cohort called GRAND CANYON, that is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of sevasemten in adults with Becker. CANYON and GRAND CANYON are fully enrolled.
Official title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of EDG-5506 on Safety, Biomarkers, Pharmacokinetics, and Functional Measures in Adults and Adolescents With Becker Muscular Dystrophy
Key Details
Gender
MALE
Age Range
12 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
244
Start Date
2022-11-10
Completion Date
2026-09
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
Sevasemten 10 mg
Sevasemten is administered orally once per day
Sevasemten 5 mg
Sevasemten is administered orally once per day
Sevasemten 12.5 mg
Sevasemten is administered orally once per day
Placebo
Placebo is administered orally once per day
Locations (51)
Arkansas Children's Hospital
Little Rock, Arkansas, United States
UC San Diego
La Jolla, California, United States
UCLA Medical Center
Los Angeles, California, United States
UC Irvine Medical Center
Orange, California, United States
Stanford Neuroscience Health Center
Palo Alto, California, United States
UC Davis Medical Center
Sacramento, California, United States
UC Denver
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
Rare Disease Research
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Rochester Medical Center
Rochester, New York, United States
Rare Disease Research, LLC NC
Hillsborough, North Carolina, United States
University of Cincinnati Gardner Neuroscience Institute
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
National Neuromuscular Research Institute
Austin, Texas, United States
Neurology Rare Disease Center
Denton, Texas, United States
Virginia Commonwealth University Health
Richmond, Virginia, United States
St Vincent's Hospital Melbourne
Fitzroy, Australia
University Hospital Gent
Ghent, Belgium, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Centre Hospitalier Régional de la Citadelle
Liège, Belgium
Rigshospitalet
Copenhagen, Denmark
Centre de Reference des Maladies Neuromusculaires et de la SLA - AP-HM Hopital de La Timone
Marseille, France
CHU de Nantes
Nantes, France
CHU de Nice - Hopital Pasteur 2 - Centre de reference des Maladies Neuromusculaires
Nice, France
AP-HP Hopital Pitie-Salpetriere
Paris, France
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
Munich, Germany
Hadassah University Hospital
Jerusalem, Israel
Schneider Children's Hospital of Israel
Petah Tikva, Israel
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico di Milano
Milan, Italy
Azienda Ospedale - Università Padova
Padova, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, Italy
Leids Universitair Medisch Centrum
Leiden, Netherlands
Optimal Clinical Trials
Auckland, New Zealand
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
University College London Hospital
London, United Kingdom
St. George's University Hospitals NHS Foundation Trust
London, United Kingdom
Newcastle Freeman Hospital
Newcastle, United Kingdom
Salford Royal Hospital
Salford, United Kingdom