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Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients With Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy

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Trial Profile

Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients With Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy

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

Latest Information Update: 26 Aug 2024

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At a glance

  • Drugs Apitegromab (Primary)
  • Indications Spinal muscular atrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms SAPPHIRE
  • Sponsors Scholar Rock

    • Most Recent Events

    • 07 Nov 2023 According to a Scholar Rock media release, data read out expected in Q4 2024.
    • 11 Oct 2023 Planned primary completion date changed from 1 Jun 2024 to 1 Oct 2024.
    • 19 Sep 2023 According to Scholar Rock media release, top-line data from this trial expected in Q4 2024; An exploratory population that targeted enrolling up to 48 patients aged 13-21 years old will also separately be evaluated

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