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A Two-Part, Open-Label Systemic Gene Delivery Study to Evaluate the Safety and Expression of RO7494222 (SRP-9001) in Subjects Under the Age of Four With Duchenne Muscular Dystrophy

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Trial Profile

A Two-Part, Open-Label Systemic Gene Delivery Study to Evaluate the Safety and Expression of RO7494222 (SRP-9001) in Subjects Under the Age of Four With Duchenne Muscular Dystrophy

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 09 Apr 2025

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At a glance

  • Drugs Delandistrogene moxeparvovec (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions
  • Acronyms ENVOL

    • Most Recent Events

    • 04 Apr 2025 According to a Sarepta Therapeutics media release, Following the safety update on acute liver failure European Union (EU) reference member country authorities requested that the independent data monitoring committee (DMC) meet to review the adverse event. While the analysis is being finalized, recruitment and dosing in certain clinical studies of ELEVIDYS are temporarily halted. This study has been affected by the temporary halt.
    • 17 Feb 2025 Planned primary completion date changed from 30 Nov 2032 to 30 May 2033.
    • 18 Dec 2024 Planned End Date changed from 26 Oct 2032 to 30 May 2033.

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