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

Study acronym: FORTITUDE-OLE
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Primary completion date: Apr 2028 to Apr 2030
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Study completion date: Apr 2028 to Jun 2030
    • Study description revised
    v4
  3. Enrollment target: 72 to 84
    • Eligibility criteria expanded, about 34 words
    • Study description shortened, about 12 words
    • Study title revised
    v3
  4. Study arms: 3 to 1v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT06547216
Lead Sponsor Avidity Biosciences, Inc.
Conditions
(from sponsor)		 FSHD, FSHD1, FSHD2, FMD, FMD2, Fascioscapulohumeral Muscular Dystrophy, Fascioscapulohumeral Muscular Dystrophy Type 1, Fascioscapulohumeral Muscular Dystrophy Type 2 +19 more
Related terms Facioscapulohumeral muscular dystrophy 1a, Facioscapulohumeral Muscular Dystrophy 1B, Muscular Dystrophies, Muscular Dystrophy, Facioscapulohumeral
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov