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NS-050/NCNP-03 in Boys With DMD (Meteor50)

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion pushed from May 2027 to Mar 2028v6
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 18 to 19 · Completion date: May 2027 to Mar 2028 · Eligibility criteria revisedv5 Show 3 more changesShow less
    • Study sites: 18 to 19
    • Completion date: May 2027 to Mar 2028
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 11 to 18v4
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 11 · Start date changed from estimate of Jul 2024 to Sep 18, 2024 · Eligibility criteria expanded, about 1 wordv3 Show 3 more changesShow less
    • Study sites: 1 to 11
    • Start date changed from estimate of Jul 2024 to Sep 18, 2024
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Jun 2026 to May 2027 Start date: Oct 2023 to Jul 2024 · Study sites: 0 to 1 · Completion date: Jul 2026 to May 2027 · 2 morev2 Show 5 more changesShow less
    • Start date: Oct 2023 to Jul 2024
    • Study sites: 0 to 1
    • Completion date: Jul 2026 to May 2027
    • Secondary endpoints revised (11)
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase 1/2 study of Multiple-Ascending Dose (MAD) levels for 12 weeks of treatment followed by 24 weeks of open-label treatment with a selected dose of NS-050/NCNP-03 administered once weekly to ambulant boys with DMD, who have a DMD exon deletion amenable to exon 50 skipping.
Trial Details
NCT Number NCT06053814
Lead Sponsor NS Pharma, Inc.
Collaborators: Nippon Shinyaku Co., Ltd.
Conditions Duchenne Muscular Dystrophy
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov