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NS-089/NCNP-02-201 in Boys With Duchenne Muscular Dystrophy (DMD)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Sep 11, 2026 → Feb 26, 2027
See other at-risk trials from NS Pharma, Inc.

Record History

  1. Enrollment closed, study ongoing Primary and study completion pushed from Sep 11, 2026 to Feb 26, 2027 · Trial sites expanded: 25 → 29 locations · Interventions: NS-089/NCNP-02 (Drug) to NS-089/NCNP-02 (Drug) · 2 more Show 5 more changesShow less
    • Primary and study completion pushed from Sep 11, 2026 to Feb 26, 2027
    • Trial sites expanded: 25 → 29 locations
    • Interventions: NS-089/NCNP-02 (Drug) to NS-089/NCNP-02 (Drug)
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 3 of 11 entries
  2. Study sites: 22 to 25 Eligibility criteria shortened, about 18 wordsv9 Show 1 more changeShow less
    • Eligibility criteria shortened, about 18 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 17 to 22v8
  4. Study sites: 8 to 17v7
  5. Primary and study completion dates: Nov 28, 2025 to Sep 11, 2026 Study sites: 9 to 8 · Eligibility criteria expanded, about 24 wordsv6 Show 2 more changesShow less
    • Study sites: 9 to 8
    • Eligibility criteria expanded, about 24 words

    See this version in full on ClinicalTrials.gov ↗

Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 10 to 9 Eligibility criteria revisedv5 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 9 to 10 Primary and study completion dates: Sep 28, 2025 to Nov 28, 2025 · Start date changed from estimate of Jan 31, 2024 to Feb 22, 2024v4 Show 2 more changesShow less
    • Primary and study completion dates: Sep 28, 2025 to Nov 28, 2025
    • Start date changed from estimate of Jan 31, 2024 to Feb 22, 2024
  3. Trial status: Not Yet Recruiting to Recruiting Start date: Aug 10, 2023 to Jan 31, 2024 · Study sites: 1 to 9 · Primary and study completion dates: May 28, 2025 to Sep 28, 2025 · 2 morev3 Show 5 more changesShow less
    • Start date: Aug 10, 2023 to Jan 31, 2024
    • Study sites: 1 to 9
    • Primary and study completion dates: May 28, 2025 to Sep 28, 2025
    • Eligibility criteria expanded, about 21 words
    • Collaborators expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 2 to 1v2
  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.
This is a Phase 2, open-label, multi-center, 2-part study of NS-089/NCNP-02 administered by weekly IV infusion to ambulant boys aged ≥4 to \<15 years with DMD due to mutations amenable to exon 44 skipping. Participants will receive a selected dose of NS-089/NCNP-02 administered once weekly. The study consists of 2 parts: Part 1 and Part 2. Six participants (Cohort 1) will participate in both Part 1 and Part 2, and 14 participants (Cohort 2) will be added for Part 2.
Trial Details
NCT Number NCT05996003
Lead Sponsor NS Pharma, Inc.
Collaborators: Nippon Shinyaku Co., Ltd.
Conditions Duchenne Muscular Dystrophy, Exon 44, DMD
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov