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A Study of SGT-003 Gene Therapy in Duchenne Muscular Dystrophy (INSPIRE DUCHENNE)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contacts updated at 2 of 15 sitesv26
  2. 4 versions Re-verified since Jan 30, 2026, no change to tracked fieldsv22-v25
  3. Site contacts updated at 1 of 15 sitesv21
  4. Re-verified, no change to tracked fieldsv20
  5. Enrollment target: 40 to 60 Study sites: 12 to 15 · Eligibility criteria expanded, about 12 words · Secondary endpoints revised (12) · 1 morev19 Show 4 more changesShow less
    • Study sites: 12 to 15
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints revised (12)
    • Primary endpoints revised (2)

    See this version in full on ClinicalTrials.gov ↗

Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 11 to 12v18
  2. Study sites: 10 to 11v17
  3. Study sites: 9 to 10v16
  4. Primary endpoints: 1 to 2 Enrollment target: 43 to 40 · Study sites: 6 to 9 · Eligibility criteria expanded, about 133 words · 2 morev15 Show 5 more changesShow less
    • Enrollment target: 43 to 40
    • Study sites: 6 to 9
    • Eligibility criteria expanded, about 133 words
    • Secondary endpoints: 3 to 12
    • Study arms: 2 to 5

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv14
  6. Site contacts updated at 2 of 6 sitesv13
  7. Re-verified, no change to tracked fieldsv12
  8. Site contacts updated at 2 of 6 sitesv11
  9. Study sites: 4 to 6v10
  10. Study sites: 2 to 4v9
  11. Site contacts updated at 2 of 2 sitesv8
  12. Eligibility criteria revisedv7 See this version in full on ClinicalTrials.gov ↗
  13. Enrollment target: 6 to 43 Primary completion date: May 6, 2026 to May 6, 2027 · Completion date: May 6, 2030 to May 6, 2031 · Eligibility criteria shortened, about 9 words · 2 morev6 Show 5 more changesShow less
    • Primary completion date: May 6, 2026 to May 6, 2027
    • Completion date: May 6, 2030 to May 6, 2031
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site contacts updated at 2 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  14. Re-verified, no change to tracked fieldsv5
  15. Secondary endpoints: details revised at 1 of 3 entries Primary endpoint revisedv4 Show 1 more changeShow less
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  16. Primary completion date: Jan 15, 2026 to May 6, 2026 Completion date: Jan 15, 2030 to May 6, 2030 · Start date changed from estimate of Apr 5, 2024 to May 6, 2024 · Eligibility criteria expanded, about 31 words · 1 morev3 Show 4 more changesShow less
    • Completion date: Jan 15, 2030 to May 6, 2030
    • Start date changed from estimate of Apr 5, 2024 to May 6, 2024
    • Eligibility criteria expanded, about 31 words
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  17. Trial status: Not Yet Recruiting to Recruiting Start date: Jan 15, 2024 to Apr 5, 2024 · Site details revised at 2 of 2 sitesv2 Show 2 more changesShow less
    • Start date: Jan 15, 2024 to Apr 5, 2024
    • Site details revised at 2 of 2 sites
  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 multicenter, open-label, non-randomized study to investigate the safety, tolerability, and efficacy of a single intravenous (IV) infusion of SGT-003 in participants with Duchenne muscular dystrophy. There will be 5 cohorts in this study. Cohort 1 will include participants 4 to \< 7 years of age. Cohort 2 will include participants 7 to \< 12 years of age. Cohort 3 will include participants 0 to \< 4 years of age. Cohort 4 will include participants 12 to \< 18 years of age. Cohort 5 will include participants 10 to \< 18 years of age. Initiation of participant enrollment in Cohorts 4 and 5 will be subject to the accrual of safety and efficacy data from Cohorts 1-3. All participants will receive SGT-003 and will be enrolled in the study for 5 total years for long-term follow up.
Trial Details
NCT Number NCT06138639
Lead Sponsor Solid Biosciences Inc.
Conditions Duchenne Muscular Dystrophy
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov