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Global Study of Del-desiran for the Treatment of DM1
Sponsor: Avidity Biosciences, Inc.
Summary
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Global Study to Evaluate the Efficacy and Safety of Intravenous Delpacibart Etedesiran (abbreviated del-desiran, formerly AOC 1001) for the Treatment of Myotonic Dystrophy Type 1
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Global Study to Evaluate the Efficacy and Safety of Intravenous AOC 1001 for the Treatment of Myotonic Dystrophy Type 1
Key Details
Gender
All
Age Range
16 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
159
Start Date
2024-05-30
Completion Date
2026-09
Last Updated
2026-01-22
Healthy Volunteers
No
Conditions
Interventions
AOC 1001 (del-desiran)
Del-desiran will be administered by intravenous (IV) infusion.
Placebo
Placebo will be administered by intravenous (IV) infusion.
Locations (34)
Stanford University
Stanford, California, United States
University of Colorado
Denver, Colorado, United States
University of Florida
Gainesville, Florida, United States
University Research Center of South Florida
Tampa, Florida, United States
Indiana University (IU)
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest
Winston-Salem, North Carolina, United States
University of Cincinnati Gardner Neuroscience Institute
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
The Ottawa Hospital
Ottawa, Ontario, Canada
Montreal Neurological Institute
Montreal, Quebec, Canada
Aarhus University Hospital
Aarhus N, Denmark
Rigshospitalet
Copenhagen, Denmark
AP-HP Hopital Pitie-Salpetriere
Paris, France
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
Munich, Germany
Fondazione Serena Onlus - Centro Clinico NeMO Milano
Milan, Italy
Aomori Hospital
Aomori, Aomori, Japan
National Hospital Organization Osaka Toneyama Medical Center
Osaka, Japan
Osaka University Hospital
Osaka, Japan
National Center of Neurology and Psychiatry
Tokyo, Japan
Maastricht University Medical Center
Maastricht, Netherlands
Stichting Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
Hospital Universitario Donostia
Donostia / San Sebastian, Spain
University College London Hospital
London, United Kingdom
St. Georges University Hospitals NHS Foundation Trust
London, United Kingdom