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An Open-Label, Systemic Gene Delivery Study to Evaluate the Safety, Tolerability and Expression of SRP-9001 in association with imlifidase in Subjects with Duchenne Muscular Dystrophy with pre-existing Antibodies to rAAVrh74

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Trial Profile

An Open-Label, Systemic Gene Delivery Study to Evaluate the Safety, Tolerability and Expression of SRP-9001 in association with imlifidase in Subjects with Duchenne Muscular Dystrophy with pre-existing Antibodies to rAAVrh74

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

Latest Information Update: 09 Apr 2025

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At a glance

  • Drugs Delandistrogene moxeparvovec (Primary) ; Imlifidase (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Pharmacodynamics; Therapeutic Use
  • Sponsors Sarepta Therapeutics

    • 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 Mar 2025 According to a Roche media release, company will present new data at the Muscular Dystrophy Association (MDA) conference, 16-19 March, 2025, in Dallas, Texas.
    • 03 Mar 2025 Planned End Date changed from 28 May 2025 to 31 Oct 2027.

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