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

NCT07038200

RecruitingPhase 3

Sponsor: Avidity Biosciences, Inc.

Conditions: Facioscapulohumeral Muscular Dystrophy, FSHD, FSHD - Facioscapulohumeral Muscular Dystrophy, FSHD1, FSHD2

Interventions: AOC-1020, Placebo

Countries: United States, Canada, Denmark, France, Germany, Italy, Japan, Netherlands

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 overview

Sex: ALL

Age: 16 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (46)
  • Orange, California, United States
  • Palo Alto, California, United States
  • Denver, Colorado, United States
  • Gainesville, Florida, United States
  • Iowa City, Iowa, United States
  • Kansas City, Kansas, United States
  • Baltimore, Maryland, United States
  • Worcester, Massachusetts, United States
  • Rochester, New York, United States
  • Durham, North Carolina, United States
  • Columbus, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • San Antonio, Texas, United States
  • Richmond, Virginia, United States
  • Calgary, Alberta, Canada
  • Edmonton, Alberta, Canada
  • Ottawa, Ontario, Canada
  • Montreal, Quebec, Canada
  • Aarhus, Denmark
  • Copenhagen, Denmark
  • Marseille, France
  • Montpellier, France
  • Nice, France
  • Paris, France
  • Bonn, Germany
  • Göttingen, Germany
  • München, Germany
  • Ulm, Germany
  • Milan, Italy
  • Pisa, Italy
  • + 16 more on CT.gov