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

Study acronym: FORTITUDE-3
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Avidity Biosciences, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified
    • Secondary endpoints: 7 to 10
    • Study description expanded, about 6 words
    • Site details revised at 6 of 46 sites
    v9
  2. Trial sites expanded: 22 → 46 locationsv8
  3. Study sites: 14 to 22v7
  4. Site details revised at 3 of 14 sitesv6
  5. Site details revised at 5 of 14 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Site details revised at 1 of 14 sitesv4
  2. Study sites: 13 to 14v3
  3. Site details revised at 4 of 13 sitesv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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 Details
NCT Number NCT07038200
Lead Sponsor Avidity Biosciences, Inc.
Conditions
(from sponsor)		 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
Related terms Facioscapulohumeral muscular dystrophy 1a, Facioscapulohumeral Muscular Dystrophy 1B, Muscular Dystrophy, Facioscapulohumeral
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov