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A Phase 3 Study to Evaluate the Safety and Efficacy of AOC 1044 (Also Referred to as Delpacibart Zotadirsen) in Participants With DMD With Gene Mutations Amenable to Exon 44 Skipping

Study acronym: SAFARI44
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 17 to 18
  2. Study sites: 15 to 17
  3. Study sites: 14 to 15
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 11 entries
  4. Study sites: 13 to 14v8
  5. Study sites: 12 to 13
    • Start date changed from estimate of Aug 2026 to Sep 1, 2026
    v7
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  1. Study sites: 11 to 12v6
  2. Study sites: 10 to 11v5
  1. Trial sites expanded: 7 → 10 locationsv4
  2. Recruitment opened
    • Start date: Jun 2026 to Aug 2026
    • Trial sites expanded: 0 → 7 locations
    v3
  3. Re-verified, no change to tracked fieldsv2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 1044 for the treatment of Duchenne Muscular Dystrophy (DMD) with Gene Mutations Amenable to Exon 44 Skipping
Trial Details
NCT Number NCT07587242
Lead Sponsor Avidity Biosciences, Inc.
Conditions
(from sponsor)		 Muscular Dystrophies, Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy), Muscular Disorders, Atrophic, Muscular Disease, Musculoskeletal Diseases, Neuromuscular Diseases (NMD), Nervous System Diseases, Genetic Diseases +6 more
Related terms Genetic Diseases, Inborn, Infant, Newborn, Diseases, Muscular Diseases, Muscular Disorders, Atrophic, Muscular Dystrophies, Muscular Dystrophy, Duchenne, Musculoskeletal Diseases, Myotonic Dystrophy, Nervous System Diseases, Neuromuscular Diseases
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov