RECRUITING

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

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Conditions

Facioscapulohumeral Muscular DystrophyFSHDFSHD - Facioscapulohumeral Muscular DystrophyFSHD1FSHD2Fascioscapulohumeral Muscular DystrophyFascioscapulohumeral Muscular Dystrophy Type 1Fascioscapulohumeral Muscular Dystrophy Type 2Facioscapulohumeral Muscular Dystrophy 1Facioscapulohumeral DystrophyFacio-Scapulo-Humeral DystrophyFacioscapulohumeral Muscular Dystrophy 2Facioscapulohumeral Muscular Dystrophy Type 1 (FSHD1)FSH Muscular DystrophyLandouzy Dejerine DystrophyLandouzy-Dejerine Muscular DystrophyLandouzy-Dejerine SyndromeFORWARDAvidityAvidity Biosciencesdel-braxdel braxdelbraxAOC1020AOC 1020delpacibart braxlosiran

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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)

Quick Facts

Study Start:2025-06-10
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07038200

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.

Ages Eligible for Study:16 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinical and genetic diagnosis of FSHD1 or FSHD2
  2. * Ability to walk independently at pre-specified walking speed (orthoses and ankle braces allowed) for at least 10 meters at screening
  3. * Adequate muscle strength based on QMT composite score
  1. * Breastfeeding, pregnancy, or intent to become pregnant during the study
  2. * Unwilling or unable to comply with contraceptive requirements
  3. * Abnormal lab values, conditions or diseases that would make the participant unsuitable for the study
  4. * Blood Pressure \> 140/90 mmHg at Screening
  5. * Treatment with another investigational drug or biological agent within 1 month of Screening or 5 half-lives of the drug, whichever is longer
  6. * Treatment with an oligonucleotide within 9 months of Screening

Contacts and Locations

Study Contact

Avidity Biosciences, Inc.
CONTACT
858-771-7038
medinfo@aviditybio.com

Study Locations (Sites)

University of California Irvine
Orange, California, 92868
United States
Stanford University
Palo Alto, California, 94304
United States
University of Colorado
Denver, Colorado, 80045
United States
University of Florida
Gainesville, Florida, 32608
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Kansas University Medical Center
Kansas City, Kansas, 66205
United States
Kennedy Krieger Institute
Baltimore, Maryland, 21205
United States
University of Massachusetts
Worcester, Massachusetts, 01655
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Duke University
Durham, North Carolina, 27708
United States
Ohio State University
Columbus, Ohio, 43221
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Avidity Biosciences, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-10
Study Completion Date2028-07

Study Record Updates

Study Start Date2025-06-10
Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

  • FORWARD
  • Avidity
  • Avidity Biosciences
  • del-brax
  • del brax
  • delbrax
  • AOC1020
  • AOC 1020
  • delpacibart braxlosiran

Additional Relevant MeSH Terms

  • Facioscapulohumeral Muscular Dystrophy
  • FSHD
  • FSHD - Facioscapulohumeral Muscular Dystrophy
  • FSHD1
  • FSHD2
  • Fascioscapulohumeral Muscular Dystrophy
  • Fascioscapulohumeral Muscular Dystrophy Type 1
  • Fascioscapulohumeral Muscular Dystrophy Type 2
  • Facioscapulohumeral Muscular Dystrophy 1
  • Facioscapulohumeral Dystrophy
  • Facio-Scapulo-Humeral Dystrophy
  • Facioscapulohumeral Muscular Dystrophy 2
  • Facioscapulohumeral Muscular Dystrophy Type 1 (FSHD1)
  • FSH Muscular Dystrophy
  • Landouzy Dejerine Dystrophy
  • Landouzy-Dejerine Muscular Dystrophy
  • Landouzy-Dejerine Syndrome