Clinical Trial

Phase 2 Open-label Extension Study of AOC 1020 in Participants With Facioscapulohumeral Muscular Dystrophy (FSHD)

Study acronym: FORTITUDE-OLE
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
A Phase 2 Open-label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of AOC 1020 Administered Intravenously to Participants with Facioscapulohumeral Muscular Dystrophy (FSHD)
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-08-07; most recent amendment 2026-07-13.
Status change: Enrolling by Invitation → Active, Not Recruiting 2026-05-12
Trial Details
NCT Number NCT06547216
Lead Sponsor Avidity Biosciences, Inc.
Conditions FSHD, FSHD1, FSHD2, FMD, FMD2, Fascioscapulohumeral Muscular Dystrophy, Fascioscapulohumeral Muscular Dystrophy Type 1, Fascioscapulohumeral Muscular Dystrophy Type 2 +19 more
Enrollment 84 participants
Start Date 2024-07-25
Primary Completion 2030-04 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-14