RecruitingPhase 3NCT07038200
A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With 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)
Sponsor
Avidity Biosciences, Inc.
Enrollment
200 participants
Start Date
Jun 10, 2025
Study Type
INTERVENTIONAL
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 Syndrome
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)
Eligibility
Min Age: 16 YearsMax Age: 70 Years
Inclusion Criteria3
- 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 Criteria6
- 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
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Interventions
DRUGAOC-1020
Placebo
DRUGPlacebo
Placebo will be administered by intravenous (IV) infusion.
Locations(46)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07038200
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