Study Overview

Study Details

Study overview

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)

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)

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

Condition
Facioscapulohumeral Muscular Dystrophy
Intervention / Treatment

-

Contacts and Locations

Orange

University of California Irvine, Orange, California, United States, 92868

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

Denver

University of Colorado, Denver, Colorado, United States, 80045

Gainesville

University of Florida, Gainesville, Florida, United States, 32608

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Kansas City

Kansas University Medical Center, Kansas City, Kansas, United States, 66205

Baltimore

Kennedy Krieger Institute, Baltimore, Maryland, United States, 21205

Worcester

University of Massachusetts, Worcester, Massachusetts, United States, 01655

Rochester

University of Rochester Medical Center, Rochester, New York, United States, 14642

Durham

Duke University, Durham, North Carolina, United States, 27708

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

16 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Avidity Biosciences, Inc.,

Study Record Dates

2028-07