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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: 19 Aug 2026

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At a glance

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

Most Recent Events

  • 06 Aug 2026 According to Solid Biosciences media release, company plans to meet with the FDA late in the fourth quarter of 2026 to discuss the INSPIRE DUCHENNE SGT-003 data package and to seek guidance on a potential accelerated approval pathway for SGT-003, the Company expects to provide an update as discussions progress.
  • 13 May 2026 Results presented in the Solid Biosciences media release.
  • 07 May 2026 According to Solid Biosciences media release, As of 46 participants have been dosed with SGT-003 in the Phase 1/2 INSPIRE DUCHENNE clinical trial using a steroid-only prophylactic immunomodulation regimen; SGT-003 has been generally well tolerated as of a May 4, 2026, cutoff date -

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