Clinical Trial

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

Study acronym: FORTITUDE-3
Recruiting Phase 3
View on ClinicalTrials.gov →
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)
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-07-28
notable Trial sites expanded: 22 -> 46 locations 2026-05-30
Trial Details
NCT Number NCT07038200
Lead Sponsor Avidity Biosciences, Inc.
Conditions Facioscapulohumeral Muscular Dystrophy, FSHD, FSHD - Facioscapulohumeral Muscular Dystrophy, FSHD1, FSHD2, Fascioscapulohumeral Muscular Dystrophy, Fascioscapulohumeral Muscular Dystrophy Type 1, Fascioscapulohumeral Muscular Dystrophy Type 2 +9 more
Enrollment 200 participants
Start Date 2025-06-10
Primary Completion 2028-05 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-27