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Microdystrophin Gene Transfer Study in Adolescents and Children With DMD

Study acronym: IGNITE DMD
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. 10 versions Re-verified since Aug 1, 2025, no change to tracked fieldsv27-v36
  2. Primary endpoint revised Secondary endpoints: 13 to 14v26 Show 1 more changeShow less
    • Secondary endpoints: 13 to 14

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Oct 17, 2022 to Oct 15, 2026 Primary endpoints: 6 to 1 · Eligibility criteria shortened, about 31 words · Secondary endpoints expanded, about 39 wordsv25 Show 3 more changesShow less
    • Primary endpoints: 6 to 1
    • Eligibility criteria shortened, about 31 words
    • Secondary endpoints expanded, about 39 words

    See this version in full on ClinicalTrials.gov ↗

  4. 7 versions Re-verified since Aug 9, 2024, no change to tracked fieldsv18-v24
  5. Enrollment target: estimated 16 to confirmed 12 Primary completion date changed from estimate of Dec 2026 to Oct 17, 2022 · Completion date: Dec 2027 to Oct 15, 2026v17 Show 2 more changesShow less
    • Primary completion date changed from estimate of Dec 2026 to Oct 17, 2022
    • Completion date: Dec 2027 to Oct 15, 2026
Show 15 earlier versionsHide 15 earlier versions
  1. Re-verified, no change to tracked fieldsv16
  2. Primary completion date: Dec 2023 to Dec 2026 Completion date: Dec 2028 to Dec 2027v15 Show 1 more changeShow less
    • Completion date: Dec 2028 to Dec 2027
  3. Trial status: Recruiting to Active, Not Recruiting Study sites: 4 to 2v14 Show 1 more changeShow less
    • Study sites: 4 to 2
  4. Primary completion date: Apr 2022 to Dec 2023 Completion date: Apr 2027 to Dec 2028 · Site contacts updated at 1 of 4 sitesv13 Show 2 more changesShow less
    • Completion date: Apr 2027 to Dec 2028
    • Site contacts updated at 1 of 4 sites
  5. Site details revised at 1 of 4 sitesv12
  6. Study sites: 3 to 4v11
  7. Re-verified, no change to tracked fieldsv10
  8. Trial status: Active, Not Recruiting to Recruiting Site details revised at 3 of 3 sitesv9 Show 1 more changeShow less
    • Site details revised at 3 of 3 sites
  9. Re-verified, no change to tracked fieldsv8
  10. Eligibility criteria expanded, about 20 wordsv7 See this version in full on ClinicalTrials.gov ↗
  11. Trial status: Suspended to Active, Not Recruiting Study sites: 2 to 3 · Primary completion date: Mar 2023 to Apr 2022 · Completion date: Mar 2024 to Apr 2027 · 1 morev6 Show 4 more changesShow less
    • Study sites: 2 to 3
    • Primary completion date: Mar 2023 to Apr 2022
    • Completion date: Mar 2024 to Apr 2027
    • Eligibility criteria expanded, about 13 words

    See this version in full on ClinicalTrials.gov ↗

  12. Primary completion date: Mar 2020 to Mar 2023 Completion date: Mar 2021 to Mar 2024 · Study arms: 4 to 3v5 Show 2 more changesShow less
    • Completion date: Mar 2021 to Mar 2024
    • Study arms: 4 to 3
  13. Re-verified, no change to tracked fieldsv4
  14. Trial status: Recruiting to Suspended Sponsor's reason: Clinical Hold Site details revised at 2 of 2 sitesv3 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  15. Study sites: 1 to 2v2
  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 controlled, open-label, single-ascending dose study to evaluate the safety and tolerability of SGT-001 in adolescents and children with Duchenne muscular dystrophy (DMD). Participants will receive a single intravenous (IV) infusion of SGT-001 and will be followed for approximately 5 years. The protocol was amended to drop the control arm after 4 participants were dosed.
Trial Details
NCT Number NCT03368742
Lead Sponsor Solid Biosciences Inc.
Conditions Duchenne Muscular Dystrophy
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov