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A Study of SGT-003 Gene Therapy in Ambulant Males With Duchenne Muscular Dystrophy (IMPACT DUCHENNE)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 1 entry Eligibility criteria expanded, about 10 words · Secondary endpoints: details revised at 3 of 15 entries · Site details revised at 5 of 7 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 3 of 15 entries
    • Site details revised at 5 of 7 sites
  2. Study sites: 6 to 7 Secondary endpoints: 12 to 15 · Eligibility criteria expanded, about 3 wordsv9 Show 2 more changesShow less
    • Secondary endpoints: 12 to 15
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 5 to 6v8
  4. Trial sites expanded: 2 → 5 locationsv7
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 1 to 2v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Oct 2025 to Oct 22, 2025 · Eligibility criteria expanded, about 9 words · 1 morev3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2025 to Oct 22, 2025
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints revised (12)

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 3, double-blind, placebo-controlled study with the primary objective of evaluating the efficacy of a single IV infusion of SGT-003 in pediatric ambulant male participants with DMD. The secondary objectives include the evaluation of additional efficacy and safety outcomes. The study will be divided into 2 parts. Participants will be randomized 1:1 to either SGT-003 in Part 1 followed by placebo in Part 2 or to placebo in Part 1 followed by SGT-003 in Part 2. Participants will continue to be monitored in long term follow up (LTFU) for at least 5 years from their SGT-003 dosing date.
Trial Details
NCT Number NCT07160634
Lead Sponsor Solid Biosciences Inc.
Conditions Duchenne Muscular Dystrophy
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov