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Ph2 Open-label Study of AOC 1044 in Duchenne Muscular Dystrophy Participants With Mutations Amenable to Exon44 Skipping

Study acronym: EXPLORE44OLE
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Study completion moved earlier from Jul 31, 2027 to Apr 30, 2027v5
  2. Primary completion date: Dec 31, 2025 to Apr 30, 2027v4 Show 5 more changesShow less
    • Primary endpoint revised
    • Enrollment target: estimated 35 to confirmed 39
    • Study completion date: Dec 31, 2026 to Jul 31, 2027
    • Secondary endpoints: 3 to 1
    • Study description shortened, about 18 words
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 10 of 10 sites
    v3
  4. Trial status: Enrolling by Invitation to Recruitingv2 Show 4 more changesShow less
    • Enrollment target: 24 to 35
    • Study sites: 1 to 10
    • Eligibility criteria expanded, about 130 words
    • Study description shortened, about 32 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
AOC 1044-CS2 (EXPLORE44-OLE) is an Open-label Study to Evaluate the Long-Term Safety and Tolerability of AOC 1044 Administered Intravenously to DMD Participants with Mutations Amenable to Exon 44 Skipping.
Trial Details
NCT Number NCT06244082
Lead Sponsor Avidity Biosciences, Inc.
Conditions
(from sponsor)		 DMD, Duchenne Muscular Dystrophy, Duchenne, Exon 44
Related terms Muscular Dystrophy, Duchenne
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov