A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: 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
In brief
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)
Key facts
- Study ID
- NCT07038200
- Run by
- Avidity Biosciences, Inc.
- People needed
- 200
- Starts
- 2025-06-10
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-07-27
Who can join
Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Royal Hallamshire Hospital — Sheffield, United Kingdom (enrolling)
- Universitaetsklinikum Ulm — Ulm, Germany (enrolling)
- Fondazione Serena ETS - Centro Clinico NeMO Milano — Milan, Italy (enrolling)
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy (enrolling)
- Azienda Ospedaliero-Universitaria Sant'Andrea — Roma, Italy (enrolling)
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore — Roma, Italy (enrolling)
- National Hospital Organization Osaka Toneyama Medical Center — Osaka, Japan (enrolling)
- The University of Osaka Hospital — Osaka, Japan (enrolling)
- National Hospital Organization Sendai Nishitaga Hospital — Sendai, Japan (enrolling)
- National Center of Neurology and Psychiatry — Tokyo, Japan (enrolling)
- Academisch Ziekenhuis Leiden — Leiden, Netherlands (enrolling)
- Stichting Radboud Universitair Medisch Centrum — Nijmegen, Netherlands (enrolling)
- Hospital Universitari de Bellvitge — Barcelona, Spain (enrolling)
- Hospital Universitario Vall d'Hebron — Barcelona, Spain (enrolling)
- Hospital Universitario Donostia — San Sebastián, Spain (enrolling)
- Hospital Universitari i Politecnic La Fe — Valencia, Spain (enrolling)
- National Hospital for Neurology & Neurosurgery — London, United Kingdom (enrolling)
- St. George's University Hospitals NHS Foundation Trust — London, United Kingdom (enrolling)
- Royal Victoria Infirmary — Newcastle upon Tyne, United Kingdom (enrolling)
- University of Calgary - Cumming School of Medicine — Calgary, Alberta, Canada (enrolling)
- University of Alberta Hospital — Edmonton, Alberta, Canada (enrolling)
- The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
- Genge Partners Inc — Montreal, Quebec, Canada (enrolling)
- Rigshospitalet — Copenhagen, Denmark (enrolling)
- AP-HP Hopital Pitie-Salpetriere — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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