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

RecruitingPhase 3Ages 16 Years - 70 YearsAllAvidity Biosciences, Inc.
NCT07038200 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
Inclusion Criteria: * Clinical and genetic diagnosis of FSHD1 or FSHD2 * Ability to walk independently at pre-specified walking speed (orthoses and ankle braces allowed) for at least 10 meters at screening * Adequate muscle strength based on QMT composite score Exclusion Criteria: * Breastfeeding, pregnancy, or intent to become pregnant during the study * Unwilling or unable to comply with contraceptive requirements * Abnormal lab values, conditions or diseases that would make the participant unsuitable for the study * Blood Pressure \> 140/90 mmHg at Screening * Treatment with another investigational drug or biological agent within 1 month of Screening or 5 half-lives of the drug, whichever is longer * Treatment with an oligonucleotide within 9 months of Screening
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What it tests

  • AOC-1020
  • Placebo
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Where

46 sites
University of California Irvine
Orange, United States
Stanford University
Palo Alto, United States
University of Colorado
Denver, United States
University of Florida
Gainesville, United States
University of Iowa
Iowa City, United States
Kansas University Medical Center
Kansas City, United States
Kennedy Krieger Institute
Baltimore, United States
University of Massachusetts
Worcester, United States

…and 38 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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