A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD
Recruiting
Phase 3
Interventional Study
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
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 – 70
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- Avidity Biosciences, Inc. · Industry
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About This Trial
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)
Trial Locations
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Eligibility Criteria
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…
Contacts