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A Randomized, Controlled, Open-label, Single-ascending Dose, Phase I/II Study to Investigate the Safety and Tolerability, and Efficacy of Intravenous SGT-001 in Male Adolescents and Children With Duchenne Muscular Dystrophy

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Trial Profile

A Randomized, Controlled, Open-label, Single-ascending Dose, Phase I/II Study to Investigate the Safety and Tolerability, and Efficacy of Intravenous SGT-001 in Male Adolescents and Children With Duchenne Muscular Dystrophy

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 16 Jul 2024

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At a glance

  • Drugs SGT 001 (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms IGNITE DMD
  • Sponsors Solid Biosciences

    • Most Recent Events

    • 12 Apr 2023 Planned End Date changed from 1 Dec 2028 to 1 Dec 2027.
    • 12 Apr 2023 Planned primary completion date changed from 1 Dec 2023 to 1 Dec 2026.
    • 19 Mar 2023 According to a Solid Biosciences media release, one-year post-treatment data relating to safety, efficacy and microdystrophin expression in muscle biopsies presented at the Muscular Dystrophy Association Clinical and Scientific Conference 2023.

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