A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD (NCT07038200) | Clinical Trial Compass
RecruitingPhase 3
A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD
United States200 participantsStarted 2025-06-10
Plain-language summary
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)
Who can participate
Age range16 Years – 70 Years
SexALL
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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