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A Phase 1/2, Multicenter, Open-Label Study to Investigate the Safety, Tolerability, and Efficacy of a Single Intravenous Dose of SGT-003 in Males With Duchenne Muscular Dystrophy (INSPIRE DUCHENNE)

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Trial Profile

A Phase 1/2, Multicenter, Open-Label Study to Investigate the Safety, Tolerability, and Efficacy of a Single Intravenous Dose of SGT-003 in Males With Duchenne Muscular Dystrophy (INSPIRE DUCHENNE)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 24 Jun 2025

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At a glance

  • Drugs SGT 003 (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions; First in man
  • Acronyms INSPIRE DUCHENNE
  • Sponsors Solid Biosciences

Most Recent Events

  • 15 May 2025 According to a Solid Biosciences media release, The Company plans to meet with the FDA later this year to share safety and efficacy results from additional treated participants in the INSPIRE DUCHENNE study and to discuss accelerated regulatory pathways. The Company expects the meeting to occur in the fourth quarter of 2025.
  • 15 May 2025 According to a Solid Biosciences media release, trial now has eight active sites in the U.S., Canada and Italy, with additional sites expected to be activated by year-end.
  • 29 Apr 2025 According to a Solid Biosciences media release, company will present data from this study at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), from May 13-17, 2025, in New Orleans, LA.

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