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RecruitingPhase 3NCT07038200

A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1020 for the Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD)

Sponsor

Avidity Biosciences, Inc.

Enrollment

200 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

facioscapulohumeral muscular dystrophyFascioscapulohumeral Muscular DystrophyFacio-Scapulo-Humeral DystrophyFSHD1FSHD2Facioscapulohumeral DystrophyFSHD - Facioscapulohumeral Muscular DystrophyFacioscapulohumeral Muscular Dystrophy Type 1 (FSHD1)FSH Muscular DystrophyFSHDFascioscapulohumeral Muscular Dystrophy Type 1Fascioscapulohumeral Muscular Dystrophy Type 2Facioscapulohumeral Muscular Dystrophy 1Facioscapulohumeral Muscular Dystrophy 2Landouzy Dejerine DystrophyLandouzy-Dejerine Muscular DystrophyLandouzy-Dejerine Syndrome

Summary

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1020 for the Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD)

Eligibility

Min Age: 16 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AOC-1020 and a drug called Placebo for people with fsh muscular dystrophy, fshd, and other related conditions. The study is currently recruiting participants at 46 locations. People eligible for this study include aged 16 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAOC-1020

Del-brax will be administered by intravenous (IV) infusion.

DRUGPlacebo

Placebo will be administered by intravenous (IV) infusion.

Locations(46)

University of California Irvine

Orange, California, United States

Stanford University

Palo Alto, California, United States

University of Colorado

Denver, Colorado, United States

University of Florida

Gainesville, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Kansas University Medical Center

Kansas City, Kansas, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

University of Massachusetts

Worcester, Massachusetts, United States

University of Rochester Medical Center

Rochester, New York, United States

Duke University

Durham, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

University of Calgary - Cumming School of Medicine

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Genge Partners Inc

Montreal, Quebec, Canada

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Centre de Reference des Maladies Neuromusculaires et de la SLA - AP-HM Hopital de La Timone

Marseille, France

CHU de Montpellier - Hopital Gui de Chauliac

Montpellier, France

CHU de Nice - Hopital Pasteur 2 - Centre de reference des Maladies Neuromusculaires

Nice, France

AP-HP Hopital Pitie-Salpetriere

Paris, France

Universitaetsklinikum Bonn

Bonn, Germany

Georg-August-Universitaet Goettingen Stiftung oeffentlichen Rechts Universitaetsmedizin Goettingen

Göttingen, Germany

Klinikum der Ludwig-Maximilians-Universitaet Muenchen

München, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Fondazione Serena ETS - Centro Clinico NeMO Milano

Milan, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

Roma, Italy

National Hospital Organization Osaka Toneyama Medical Center

Osaka, Japan

The University of Osaka Hospital

Osaka, Japan

National Hospital Organization Sendai Nishitaga Hospital

Sendai, Japan

National Center of Neurology and Psychiatry

Tokyo, Japan

Academisch Ziekenhuis Leiden

Leiden, Netherlands

Stichting Radboud Universitair Medisch Centrum

Nijmegen, Netherlands

Hospital Universitari de Bellvitge

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Universitario Donostia

San Sebastián, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

National Hospital for Neurology & Neurosurgery

London, United Kingdom

St. George's University Hospitals NHS Foundation Trust

London, United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

Royal Hallamshire Hospital

Sheffield, United Kingdom

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NCT07038200

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