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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)

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: 08 Dec 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

  • 06 Nov 2025 According to Solid Biosciences media release, the trial is enrolling participants at 15 active clinical trial sites across the US, UK, Italy and Canada.
  • 04 Nov 2025 Interim results presented in the Solid Biosciences media release.
  • 04 Nov 2025 According to Solid Biosciences media release, as of 31 October 2025, 23 patients has been dosed in the study and expects to have dosed 30 participants in total by early 2026. And, company plans to meet with the FDA to discuss potential registrational pathways in first half of 2026.

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